WO2018169805A1 - Ingestible and expandable devices and assemblies for weight-loss and methods of use thereof - Google Patents
Ingestible and expandable devices and assemblies for weight-loss and methods of use thereof Download PDFInfo
- Publication number
- WO2018169805A1 WO2018169805A1 PCT/US2018/021868 US2018021868W WO2018169805A1 WO 2018169805 A1 WO2018169805 A1 WO 2018169805A1 US 2018021868 W US2018021868 W US 2018021868W WO 2018169805 A1 WO2018169805 A1 WO 2018169805A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- intragastric
- filling
- ingestible
- magnetic component
- space
- Prior art date
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0026—Anti-eating devices using electrical stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0036—Intragastrical devices
Definitions
- the present disclosure relates generally to the field of bariatrics; more specifically, to ingestible and expandable devices and assemblies for weight-loss and methods of use thereof.
- Obesity is a condition of epidemic proportions in the United States. Recent government studies have indicated that up to 40% of Americans are obese and that, among those, almost 20% are morbidly obese. Patients who are obese tend to suffer from cardiovascular disease, heart disease, stroke, diabetes, and obstructive sleep apnea. Recent studies have indicated that obesity can reduce a person's lifespan by an average of three years in adults and twenty years in children.
- Devices have been developed in the prior art aimed at providing a sense of fullness to a patient. Such devices may be configured as stents that support the stomach or the pyloric valve or that may be configured as permanent occluders. Unfortunately, these devices are implanted in the patient on an essentially permanent basis and typically include complex mechanical or electrical features that may stop working properly over time or that may require maintenance from time to time.
- An ingestible intragastric device comprising an expandable frame having a first configuration and a second configuration, a device covering encompassing the expandable frame and coupled to the expandable frame such that expansion of the expandable frame expands the device covering, and a first magnetic component and a second magnetic component coupled to the expandable frame.
- the first magnetic component can be configured to be magnetized remotely by a portable electronic device.
- the second magnetic component can be configured to be repelled by the first magnetic component when the first magnetic component is magnetized.
- the expandable frame can be configured to expand from the first configuration to the second configuration when the second magnetic component is repelled by the first magnetic component.
- At least one of the first magnetic component and the second magnetic component can be coupled to a control unit.
- the control unit can comprise a wireless communication unit configured to receive a wireless signal from the portable electronic device over a wireless communication protocol.
- the wireless communication protocol can be at least one of a BluetoothTM communication protocol and a near field communication (NFC) communication protocol.
- the control unit can be coupled to a battery and a current generator.
- the current generator can be configured to supply an electrical pulse to the first magnetic component to magnetize the first magnetic component.
- At least one of the first magnetic component and the second magnetic component can be an electropermanent magnet.
- the electropermanent magnet can comprise a hard magnetic material, a semi-hard magnetic material, and a soft magnetic material.
- a conductive wire can be wound around the semihard magnetic material.
- the hard magnetic material can be a neodymium iron boron (NdFeB) magnet
- the semi-hard magnetic material can be an aluminum nickel cobalt (AINiCo) magnet
- the soft magnetic material can be an iron magnet.
- the hard magnetic material can have a higher intrinsic coercivity than the semi-hard magnetic material.
- the ingestible intragastric device can be configured to expand within a stomach of a patient in response to receiving a wireless signal from the portable electronic device outside of the body of the patient.
- the expandable frame can be configured or designed as an expandable Hoberman structure.
- the expandable frame can be configured or designed as an expandable origami ball structure.
- a method of treating obesity can comprise providing an ingestible intragastric device to be ingested by a patient.
- the ingestible intragastric device can comprise an expandable frame having a first configuration and a second configuration.
- a device covering can encompass the expandable frame and be coupled to the expandable frame such that expansion of the expandable frame expands the device covering.
- a first magnetic component and a second magnetic component can also be coupled to the expandable frame.
- the method of treating obesity can also comprise remotely magnetizing the first magnetic component with a portable electronic device when the ingestible intragastric device is within the stomach of the patient.
- the second magnetic component can be configured to be repelled by the first magnetic component when the first magnetic component is magnetized.
- the expandable frame can be configured to expand from the first configuration to the second configuration when the second magnetic component is repelled by the first magnetic component.
- Remotely magnetizing the first magnetic component with the portable electronic device can comprise transmitting a wireless signal to a wireless communication unit of a control unit within the ingestible intragastric device.
- the method treating obesity can further comprise supplying, using a battery and a current generator coupled to the control unit, an electrical pulse to the first magnetic component to magnetize the first magnetic component in response to the wireless signal received by the wireless communication unit.
- Supplying the electrical pulse to the first magnetic component can comprise delivering a current through a conductive wire wound around a portion of the first magnetic component.
- An intragastric assembly for weight-loss can comprise a plurality of intragastric space-filling devices.
- Each of the plurality of intragastric space-filling devices can comprise an electropermanent magnet.
- the electropermanent magnets can be configured to be magnetized remotely by a portable electronic device.
- the plurality of intragastric space-filling devices can be configured to magnetically join together into an intragastric space-filling agglomeration when the electropermanent magnets are magnetized by the portable electronic device.
- the plurality of intragastric space-filling devices can be between two and four intragastric space-filling devices.
- the plurality of intragastric spacefilling devices can be four intragastric space-filling devices.
- the plurality of intragastric space-filling devices can be between four and twenty intragastric space-filling devices.
- the electropermanent magnets can be configured to be de-magnetized by the portable electronic device.
- the intragastric space-filling agglomeration can be configured to separate back into the plurality of intragastric space-filling devices when the electropermanent magnets are demagnetized.
- the plurality of intragastric space-filling devices can be substantially shaped as spheres. Alternatively, the plurality of intragastric space-filling devices can be substantially shaped as polyhedrons.
- the intragastric space-filling agglomeration can be sized to be larger than the pyloric sphincter of a patient.
- Each of the plurality of intragastric space-filling devices can be sized to allow the intragastric space-filling device to pass through the digestive system of the patient to be excreted.
- Each of the electropermanent magnets can be coupled to a control unit.
- the control unit can comprise a wireless communication unit configured to receive a wireless signal from the portable electronic device over a wireless communication protocol.
- the wireless communication protocol can be at least one of a BluetoothTM communication protocol and a near field communication (NFC) communication protocol.
- the control unit is coupled to a battery and a current generator.
- the current generator can be configured to supply an electrical pulse to the electropermanent magnet to magnetize the electropermanent magnet.
- a method of treating obesity can comprise providing a plurality of intragastric space-filling devices to be ingested by a patient.
- Each of the plurality of intragastric space-filling devices can comprise an electropermanent magnet.
- the method can further comprise remotely magnetizing the electropermanent magnets with a portable electronic device when the plurality of intragastric space-filling devices are within the stomach of the patient.
- the plurality of intragastric space-filling devices can be configured to magnetically join together into an intragastric space-filling agglomeration when the electropermanent magnets are remotely magnetized by the portable electronic device.
- Remotely magnetizing the electropermanent magnets with the portable electronic device can comprise transmitting a wireless signal to a wireless communication unit of a control unit coupled to each of the electropermanent magnets.
- the method can further comprise supplying, using a battery and a current generator coupled to the control unit of each of the electropermanent magnets, an electrical pulse to the electropermanent magnet to magnetize the electropermanent magnet in response to the wireless signal received by the wireless communication unit.
- Supplying the electrical pulse to the electropermanent magnet can comprise delivering a current through a conductive wire wound around a portion of the electropermanent magnet.
- An intragastric assembly for weight-loss can comprise a plurality of intragastric space-filling vessels.
- Each of the plurality of intragastric space-filling vessels can comprise a vessel housing comprising a bulbous portion, an elongate narrow portion, a channel extending through the elongate narrow portion and the bulbous portion, and a conduit connecting the channel to an external environment outside of the vessel housing.
- the channel can comprise a magnetic component translatable within the channel and an expandable filling material.
- the magnetic component can be initially configured to be positioned within a segment of the channel disposed within the elongate narrow portion upon ingestion of the intragastric space-filling vessel by the patient.
- the plurality of intragastric space-filling vessels can be configured to magnetically join together into an intragastric vessel agglomeration when the magnetic component of each of the plurality of intragastric space-filling vessels is positioned within the segment of the channel disposed within the elongate narrow portion.
- the filling material within each of the plurality of intragastric space-filling vessels can be configured to expand as fluids from the external environment flows through the conduit into the channel and interacts with the filling material.
- the magnetic component can be configured to translate into the segment of the channel disposed within the bulbous portion in response to an expansion of the filling material over time. The expansion of the filling material can push or otherwise physically translate the magnetic component into the segment of the channel disposed within the bulbous portion.
- the intragastric vessel agglomeration can be configured to separate back into the plurality of intragastric space-filling vessels when the magnetic component of each of the plurality of intragastric space-filling vessels is translated into the segment of the channel disposed within the bulbous portion.
- the magnetic component can be a permanent magnet.
- the bulbous portion of the vessel housing can be substantially shaped as an ellipsoid.
- the bulbous portion of the vessel housing can be substantially shaped as a biconic structure.
- the elongate narrow portion of the vessel housing can be substantially shaped as a cylinder.
- a method of treating obesity can comprise providing a plurality of intragastric space-filling vessels to be ingested by a patient.
- Each of the plurality of intragastric space-filling vessels can comprise a vessel housing comprising a bulbous portion, an elongate narrow portion, a channel extending through the elongate narrow portion and the bulbous portion, and a conduit connecting the channel to an external environment outside of the vessel housing.
- the channel can further comprise a magnetic component translatable within the channel and an expandable filling material.
- the magnetic component can be initially configured to be positioned within a segment of the channel disposed within the elongate narrow portion upon ingestion of the plurality of intragastric space-filling vessels by the patient.
- the method can further comprise allowing the plurality of intragastric space-filling vessels to magnetically join together into an intragastric vessel agglomeration within the stomach of the patient when the magnetic component of each of the plurality of intragastric space-filling vessels is positioned within the segment of the channel disposed within the elongate narrow portion.
- the method can further comprise allowing the intragastric vessel agglomeration to separate back into the plurality of intragastric spacefilling vessels when a magnetic attraction between the plurality of intragastric space-filling vessels is weakened by the translation of the magnetic component of each of the plurality of intragastric space-filling vessels into the segment of the channel disposed within the bulbous portion.
- the magnetic component can be configured to translate into the segment of the channel disposed within the bulbous portion in response to an expansion of the filling material.
- the filling material within each of the plurality of intragastric space-filling vessels can be configured to expand as fluids from the external environment flow through the conduit into the channel and interacts with the filling material.
- Another ingestible intragastric device comprising a device covering a control unit housed within the device covering and comprising a wireless communication unit configured to receive a wireless signal from a portable electronic device, a first interior chamber housed within the device covering, a second interior chamber housed within the device covering, a first electronic valve connecting an interior of the device covering to the first interior chamber and the second interior chamber, and a second electronic valve connecting the interior of the device covering with an external environment outside of the device covering
- the first interior chamber can comprise a first chemical composition.
- the first chemical composition can be a weak acid.
- the weak acid can be acetic acid.
- the second interior chamber can comprise a second chemical composition.
- the second chemical composition can be a weak base.
- the weak base can be sodium bicarbonate.
- the first electronic valve can be electrically coupled to and controllable by the control unit.
- the first electronic valve can be configured to open in response to a signal received from the control unit.
- the first chemical composition can be configured to mix with the second chemical composition to produce a gas within the device covering when the first electronic valve is opened.
- the gas can be configured to inflate the device covering.
- the gas produced can be carbon dioxide.
- the second electronic valve can be electrically coupled to and controllable by the control unit.
- the second electronic valve can be configured to open in response to a signal received from the control unit.
- the gas can be configured to be evacuated from the interior of the device covering and deflate the device covering when the second electronic valve is opened.
- An additional ingestible intragastric device comprising a device covering, a control unit housed within the device covering, a pressure sensor electrically coupled to the control unit and configured to determine an internal pressure within the device covering, a gas cartridge housed within the device covering and comprising a pressurized gas, a first electronic valve coupled to the gas cartridge, and a second electronic valve connecting the interior of the device covering with an external environment outside of the device covering.
- the control unit can further comprise a wireless communication unit configured to receive a wireless signal from a portable electronic device.
- the first electronic valve can be electrically coupled to and controllable by the control unit.
- the first electronic valve can be configured to open or close in response to a signal received from the control unit.
- the pressurized gas can be configured to inflate the device covering when the first electronic valve is opened.
- the pressurized gas can be at least one of carbon dioxide, nitrogen, and oxygen.
- the second electronic valve can be electrically coupled to and controllable by the control unit.
- the second electronic valve can be configured to open or close in response to a signal received from the control unit when the internal pressure within the device covering is determined by the pressure sensor to exceed a predetermined threshold pressure.
- the pressurized gas can be configured to be evacuated from the interior of the device covering and deflate the device covering when the second electronic valve is opened.
- Another ingestible intragastric device comprising a device covering configured to contain a compressed gas, a control unit housed within the device covering and comprising a wireless communication unit configured to receive a wireless signal from a portable electronic device, a pressure sensor electrically coupled to the control unit and configured to determine an internal pressure within the device covering, and an electronic valve coupled to a surface of the device covering and connecting the interior of the device covering with an external environment outside of the device covering.
- the electronic valve can be electrically coupled to and controllable by the control unit.
- the electronic valve can be configured to open or close in response to a signal received from the control unit when the internal pressure within the device covering is determined by the pressure sensor to exceed a predetermined threshold pressure.
- the compressed gas can be configured to be evacuated from the interior of the device covering and deflate the device covering when the electronic valve is opened. In some instances, the compressed gas used can be liquefied nitrogen.
- Fig. 1A illustrates an example method for treating obesity using an expandable and contractible intragastric space-filling device.
- Fig. IB illustrates an example method for treating obesity using a plurality of intragastric space-filling devices configured to join together into a space-filling agglomeration and, subsequently, separate back into the plurality of intragastric spacefilling devices.
- Fig. 2A illustrates an example of an electropermanent magnet switched on by a pulse of electric current sent through a conductive coil wrapped around a portion of the electropermanent magnet in a first direction.
- Fig. 2B illustrates the electropermanent magnet of Fig. 2A switch off by a pulse of electric current sent through the conductive coil wrapped around the portion of the electropermanent magnet in a second direction.
- Fig. 3 illustrates an example of a control unit configured to control the intragastric space-filling devices described herein.
- Fig. 4 illustrates an example of a control unit coupled to an electropermanent magnet configured to receive a wireless signal from a portable electronic device over a wireless communication protocol.
- FIGs. 5 A to 5D illustrate various mechanisms for actuating the expansion of an ingestible intragastric space-filling device using a first magnetic component and a second magnetic component.
- Fig. 6A illustrates an example of a Hoberman- style ingestible intragastric device.
- Fig. 6B illustrates an example of an origami ball-style ingestible intragastric device.
- Fig. 7A illustrates an example of an intragastric assembly comprising a plurality of intragastric space-filling devices joined together into an intragastric spacefilling agglomeration.
- Fig. 7B illustrates an example of the intragastric space-filling agglomeration of Fig. 7A broken up into its constituent intragastric space-filling devices.
- Fig. 8 illustrates a side cross-sectional view of an example of an intragastric space-filling vessel.
- Fig. 9A illustrates a side cross-sectional view of a plurality of intragastric space-filling vessels joined together into an intragastric vessel agglomeration.
- Fig. 9B illustrates a side cross-sectional view of the intragastric vessel agglomeration broken up or separated into its constituent intragastric space-filling vessels.
- Fig. 10 illustrates another example of an ingestible intragastric device.
- FIG. 11 illustrates yet another example of an ingestible intragastric device.
- Fig. 12 illustrates an additional example of an ingestible intragastric device.
- Fig. 13 illustrates an example of a biodegradable intragastric device
- the devices, assemblies, systems, and methods disclosed herein are suited not only for the treatment of obesity but also for treating other ailments, such as improper glucose tolerance in a diabetic or pre-diabetic subject and the progression of diabetes itself by inhibiting fasting insulin secretion or glucose-stimulated insulin secretion.
- the devices of the present disclosure are also suited for treating other ailments deriving from obesity, including hyperphagia, dyslipidemia, Prader Willi syndrome, Froelich's syndrome, Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesen syndrome, Bardet-Biedl syndrome, or hyperlipoproteinemia, types I, II, III, and IV, etc.
- the devices, assemblies, and systems disclosed herein are well tolerated by the stomach and in general, by the gastrointestinal tract.
- FIG. 1A illustrates an example method for treating obesity using an expandable and contractible intragastric space-filling device 100.
- Fig. 1A shows the expandable and contractible intragastric space-filling device 100 within the stomach of a patient after the intragastric space-filling device 100 has been orally ingested by the patient.
- the intragastric space-filling device 100 can have the form factor of a pill or capsule.
- the esophagus (shown as ES), pylorus (shown as PY) and duodenum (shown as DU) of the patient are also depicted in Fig. 1A for reference.
- the intragastric space-filling device 100 can expand automatically within the stomach of the patient or expand in response to an action taken by a clinician, healthcare provider, or patient.
- the intragastric space-filling device 100 can be expanded through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof).
- the intragastric space-filling device 100 can remain in the expanded configuration for a period of time between approximately 1 month and 12 months. In other variations, the intragastric spacefilling device 100 can remain in the expanded configuration for a period of time between approximately 12 months and 36 months.
- the intragastric space-filling device 100 can be configured such that the intragastric space-filling device 100 in the expanded configuration is unable to pass through the pylorus and remains within the stomach. As the patient ingests food or liquids, the stomach can contract and relax, repeatedly (through peristalsis) and the intragastric space-filling device 100 in the expanded configuration can be propelled or otherwise moved by peristaltic waves through the stomach towards the pylorus. The intragastric space-filling device 100 in the expanded configuration can take up space within the stomach of the patient. The intragastric space-filling device 100 in the expanded configuration can also intermittently obstruct the pylorus. In all such cases, the intragastric space-filling device 100 in the expanded configuration can enhance or trigger the patient's feeling of satiety and result in the patient reducing their overall level of food intake.
- the intragastric space-filling device 100 can also contract or shrink in size from the expanded configuration into a contracted configuration.
- the intragastric space-filling device 100 can be contracted or shrunk in size once the treatment period has ended or once the patient has met his or her weight-loss goals.
- the intragastric space-filling device 100 can be contracted or shrunk through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof).
- the intragastric space-filling device 100 can pass through the pylorus and duodenum into the intestines of the patient.
- the intragastric space-filling device 100 in the contracted configuration can then pass out of the body of the patient.
- Fig. IB illustrates an example method for treating obesity using a plurality of intragastric space-filling devices 102 configured to join together into a space-filling agglomeration 104 and, subsequently, separate back into the plurality of intragastric spacefilling devices 102.
- Fig. IB shows the plurality of intragastric space-filling devices 102 within the stomach of a patient after the plurality of intragastric space-filling devices 102 have been orally ingested by the patient.
- the intragastric space-filling devices 102 can each have the form factor of a pill or capsule.
- the esophagus (shown as ES), pylorus (shown as PY) and duodenum (shown as DU) of the patient are also depicted in Fig. IB for reference.
- the plurality of intragastric space-filling devices 102 can join together automatically within the stomach of the patient or join together in response to an action taken by a clinician, health-care provider, or patient.
- the plurality of intragastric space- filling devices 102 can be joined together through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof).
- the plurality of intragastric space-filling devices 102 can join together into the space-filling agglomeration 104 for a period of time between approximately 1 month and 12 months. In other variations, the plurality of intragastric space-filling devices 102 can join together into the space-filling agglomeration 104 for a period of time between approximately 12 months and 36 months.
- the plurality of intragastric space-filling devices 102 can be configured such that the space-filling agglomeration 104 formed by the accumulated intragastric space-filling devices 102 is unable to pass through the pylorus and remains within the stomach.
- the stomach can contract and relax, repeatedly (through peristalsis) and the space-filling agglomeration 104 can be propelled or otherwise moved by peristaltic waves through the stomach towards the pylorus.
- the spacefilling agglomeration 104 can take up space within the stomach of the patient.
- the spacefilling agglomeration 104 can also intermittently obstruct the pylorus. In all such cases, the space-filling agglomeration 104 can enhance or trigger the patient's feeling of satiety and result in the patient reducing their overall level of food intake.
- the space-filling agglomeration 104 can also break apart or separate back into the plurality of intragastric space-filling devices 102.
- the spacefilling agglomeration 104 can break apart or separate back into the plurality of intragastric space-filling devices 102 once the treatment period has ended or once the patient has met his or her weight-loss goals.
- the space-filling agglomeration 104 can separate or break apart through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof).
- each of the intragastric space-filling devices 102 can individually pass through the pylorus and duodenum into the intestines of the patient. Each of the intragastric space-filling devices 102 can then pass out of the body of the patient.
- Fig. 2A illustrates a variation of an electropermanent magnet 200 switched to an ON configuration 202 by a pulse of electric current sent through a conductive wire 204 in a first direction 206.
- Fig. 2B illustrates that the electropermanent magnet 200 of Fig. 2A can be switched to an OFF configuration 210 by a pulse of electric current sent through the conductive wire 204 in a second direction 208.
- the conductive wire 204 can be wrapped or wound around a portion of the electropermanent magnet 200.
- the electropermanent magnet 200 can comprise a hard magnetic material
- the hard magnetic material 212 can have a greater intrinsic coercivity than the semi-hard magnetic material 213 and the soft magnetic material 214.
- the soft magnetic material 214 can have the lowest intrinsic coercivity of the three materials.
- the soft magnetic material 214 can connect or otherwise couple the hard magnetic material 212 to the semi-hard magnetic material 213.
- the electropermanent magnet 200 can comprise two instances of the soft magnetic material 214 with each instance of the soft magnetic material 214 connecting or otherwise coupling the hard magnetic material 212 to the semi-hard magnetic material 213.
- the soft magnetic material 214 can connect or otherwise couple the poles or ends of the hard magnetic material 212 to the semi-hard magnetic material 213.
- the soft magnetic material 214 can act as caps to the hard magnetic material 212 and the semihard magnetic material 213 or act as bridges between the hard magnetic material 212 and the semi-hard magnetic material 213.
- the electropermanent magnet 200 can be substantially shaped as a stadium or oval, it is contemplated by this disclosure and it should be understood by one of ordinary skill in the art that the electropermanent magnet 200 can be substantially shaped as a cuboid or other polyhedron, a disk, an annular ring, or a combination thereof.
- the hard magnetic material 212 can be or comprise one or more neodymium iron boron (NdFeB) magnets (intrinsic coercivity of approximately 1120kA/m).
- the hard magnetic material 212 can be substantially shaped as a cuboid, a cylinder, a conic or frustoconic, or a combination thereof.
- the semi-hard magnetic material 213 can be or comprise one or more aluminum nickel cobalt (AINiCo) magnets (intrinsic coercivity of approximately 50kA/m).
- AINiCo aluminum nickel cobalt
- the semi-hard magnetic material 213 can be substantially shaped as a cuboid, a cylinder, a conic or frustoconic, or a combination thereof.
- the soft magnetic material 214 can be or comprise one or more iron (Fe) magnets.
- the conductive wire 204 can be coiled, wrapped, or otherwise wound (as a solenoid) around the semi-hard magnetic material 213.
- the conductive wire 204 can be or comprise copper wire.
- the conductive wire 204 can be coiled, wrapped, or otherwise wound around the AINiCo magnet or AINiCo portion of the electropermanent magnet 200.
- An electrical pulse can be supplied to the electropermanent magnet 200 to magnetize the electropermanent magnet 200.
- an electrical pulse can be supplied to the electropermanent magnet 200 when a current is delivered through the conductive wire 204 in a first direction 206 for a brief period of time.
- a current generator 216 can supply the electrical pulse to the electropermanent magnet 200 by generating a current to flow through the conductive wire 204 wrapped or coiled around the semi-hard magnetic material 213.
- the current generator 216 can be a direct current (DC) generator.
- the current generator 216 can generate a current of approximately 50 mA for approximately between 1 to 2 seconds to magnetize the electropermanent magnet 200. In other examples, the current generator 216 can generate a current between approximately 50 mA and 100 mA (or a higher current) for approximately 1 to 5 seconds (or longer) to magnetize the electropermanent magnet 200.
- the semi-hard magnetic material 213 can be magnetized in a direction aligned with the direction of the temporary magnetic field generated by the solenoid or wound conductive wire 204.
- a polarity 217 of the semi-hard magnetic material 213 matches a polarity 219 of the hard magnetic material 212.
- another electrical pulse can also be applied to magnetize the semi-hard magnetic material 213 in an opposite direction.
- another current can be delivered through the conductive wire 204 in a second direction 208 opposite the first direction.
- the current generator 216 can generate another approximately 50 mA (or higher) current for approximately between 1 to 2 seconds (or longer) to de-magnetize the electropermanent magnet 200. In doing so, the semi-hard magnetic material 213 can be magnetized in a direction opposite the hard magnetic material 212.
- the magnetic flux 220 will be concentrated or circulate within the electropermanent magnet 200 and the magnetic flux outside of the electropermanent magnet 200 will be reduced or diminished to almost non-existent or insignificant levels.
- the entire electropermanent magnet 200 is considered to be de-magnetized or switched to the OFF configuration 210.
- One or more electropermanent magnets 200 can be housed within an intragastric space-filling device 100.
- the one or more electropermanent magnets 200 can be magnetized to actuate the expansion or contraction of the intragastric space-filling device 100 within the stomach of a patient.
- the one or more electropermanent magnets 200 can be de-magnetized to actuate the expansion or contraction of the intragastric space-filling device 100 within the stomach of a patient.
- multiple electropermanent magnets 200 can be housed within the intragastric space-filling device 100 to expand and/or contract the intragastric space-filling device 100.
- one electropermanent magnet 200 and one or more other types of magnets can be housed within the intragastric space-filling device 100 to expand and/or contract the intragastric space- filling device 100.
- one or more electropermanent magnets 200 can be housed within each of the plurality of intragastric space-filling devices 102. In some variations, the one or more electropermanent magnets 200 can be magnetized to cause the plurality of intragastric space-filling devices 102 to join together into a space-filling agglomeration 104. In these and other variations, the one or more electropermanent magnets 200 can be de-magnetized to cause the space-filling agglomeration 104 to break apart or separate back into the plurality of intragastric space-filling devices 102 for passage through the gastrointestinal tract of the patient.
- the electropermanent magnet 200 can have a length dimension, a width dimension, and a thickness or height dimension.
- the length dimension of the electropermanent magnet 200 can be between approximately 10.00 mm and 31.75 mm.
- the length dimension of the electropermanent magnet 200 can be approximately 12.00 mm.
- the width dimension of the electropermanent magnet 200 can be between approximately 5.00 mm and 12.70 mm.
- the width dimension of the electropermanent magnet 200 can be approximately 7.00 mm.
- the height dimension of the electropermanent magnet 200 can be between approximately 5.00 mm and 12.70 mm.
- the height dimension of the electropermanent magnet 200 can be approximately 7.00 mm.
- Fig. 3 illustrates a variation of a control unit 300 configured to control the expandable intragastric space-filling device 100, each of the plurality of intragastric spacefilling devices 102, or a combination thereof.
- the control unit 300 can be placed within the expandable intragastric space-filling device 100 or within each of the plurality of intragastric space-filling devices 102.
- the control unit 300 can also be electrically coupled to one or more electropermanent magnets 200 within the expandable intragastric space-filling device 100 or within each of the plurality of intragastric space-filling devices 102.
- the control unit 300 can comprise one or more processors 302, a memory
- a battery 310 can be coupled to and supply power to the control unit 300.
- the battery 310 can also supply power to other electronic components coupled to the control unit 300 such as the current generator 216.
- the processor 302 can be or comprise a processor chip, an embedded processor, a processor core, a microprocessor, a logic circuit, a hardware FSM, a DSP, or a combination thereof.
- the processor 302 can be a 32-bit processor such as an ARMTM processor.
- the memory 304 can be random-access memory (RAM), read-only memory (ROM), non-volatile random-access memory (NVRAM), or a combination thereof.
- the memory 304 can store instructions or firmware to be executed by the processor 302.
- the memory 304 can also store data collected by one or more sensors coupled to or in communication with the control unit 300.
- the wireless communication unit 306 can be or comprise a Bluetooth® communication module, a near-field communication (NFC) module, or a combination thereof. In some variations, the wireless communication unit 306 can be or comprise a Bluetooth® low energy (BLE) module. In other variations, the wireless communication unit 306 can be a radio-frequency identification (RFID) chip or module.
- the wireless communication unit 306 can also comprise one or more memory units such as RAM, ROM, or a combination thereof.
- the antenna of the wireless communication unit 306 can be a Bluetooth® antenna.
- the control unit 300 can be run by a processor within the wireless communication unit 306, such as a processor within a Bluetooth® module.
- the wireless communication unit 306 can be or comprise an NFC module.
- the NFC module can be coupled to the processor 302 via an I C interface or other ports.
- the antenna of the wireless communication unit 306 can be an NFC antenna.
- the NFC antenna can have a range of between approximately 15.0 cm and 20.0 cm.
- multiple NFC modules or chips can be coupled to the control unit 300 with some having shorter or longer communication ranges.
- an NFC module or chip with a communication range of between approximately 5.00 cm to 10.0 cm can be used in addition to an NFC module or chip with a communication range of between approximately 15.0 cm and 20.0 cm. This way, the same portable electronic device 400 (see Fig.
- control unit 300 can be used to track the location of the control unit 300 (and, hence, the location of the ingestible intragastric device(s)) within the body of the patient based on the signal(s) received (or not received) from the multiple NFC modules or chips.
- the battery 310 can be a cell or coin battery.
- the battery 310 can have a voltage of between approximately 1.2 V and 3.0 V.
- the battery 310 can have a voltage of approximately 1.5 V.
- the battery 310 can be a lithium- iodine battery, a lithium-manganese dioxide battery, or a lithium-carbon monofluoride battery.
- the battery 310 can be a biocompatible battery suitable for implantable medical devices.
- Fig. 4 illustrates a variation of the control unit 300 coupled to an electropermanent magnet 200 configured to receive a wireless signal from a portable electronic device 400 over a wireless communication protocol 402.
- the portable electronic device 400 can be or comprise a smartphone, a tablet computer, a laptop, a smartwatch, a personal entertainment device, or a combination thereof. In other variations not shown in Fig. 4, the portable electronic device 400 can be a desktop computer, a workstation, a handheld device, or a combination thereof.
- the portable electronic device 400 can have at least a device processor, a device memory, and a device communication unit.
- the portable electronic device 400 can transmit a wireless signal over a wireless communication protocol 402 to the wireless communication unit 306 of the control unit 300.
- the wireless communication protocol 402 can be a Bluetooth® or BLE communication protocol, an NFC communication protocol, an air- interface protocol, or a combination thereof.
- the portable electronic device 400 can transmit instructions to the control unit 300 via the wireless communication protocol 402.
- the portable electronic device 400 can instruct the control unit 300 within the ingestible intragastric devices described herein to magnetize or de-magnetize one or more electropermanent magnets 200 within the ingestible intragastric devices.
- the portable electronic device 400 can also instruct the control unit 300 to retrieve sensor data from one or more sensors within the ingestible intragastric devices.
- the portable electronic device 400 can wirelessly communicate with the control unit 300 within the ingestible intragastric devices when the ingestible intragastric devices are within the stomach of a patient and the portable electronic device 400 is outside the body of the patient.
- one portable electronic device 400 and one control unit 300 are shown in Fig. 4, it is contemplated by this disclosure that one portable electronic device 400 can wirelessly communicate with multiple control units 300 and that multiple portable electronic devices 400 can be used to wirelessly communicate with the same or different control units 300.
- Figs. 5A to 5D illustrate various mechanisms for actuating the expansion of an ingestible intragastric space-filling device 100 using a first magnetic component 500 and a second magnetic component 502.
- Figs. 5A and 5B show the first magnetic component 500 and the second magnetic component 502 as two electropermanent magnets 200.
- Fig. 5A illustrates the first magnetic component 500 in the OFF configuration 210 (de-magnetized) and the second magnetic component 502 in the ON configuration 202 (magnetized).
- the first magnetic component 500 can be positioned close to or overlapping with the second magnetic component 502 without the magnetic components magnetically repelling one another.
- the ingestible intragastric space-filling device 100 can be in a collapsed or contracted configuration for ingestion by a patient.
- a portable electronic device 400 can be used to transmit a signal to the control unit 300 to instruct one or more current generators 216 to send an electrical pulse (i.e., a short burst of current through the conductive wire 204) to demagnetize the first magnetic component 500 and to magnetize the second magnetic component 502.
- an electrical pulse i.e., a short burst of current through the conductive wire 204
- the portable electronic device 400 can be used to transmit another signal to the control unit 300 to send an additional electrical pulse via one of the current generators 216 to the first magnetic component 500.
- Fig. 5B illustrates both the first magnetic component 500 and the second magnetic component 502 in the ON configuration 202.
- the first magnetic component 500 can be in the ON configuration 202 once the portable electronic device 400 has transmitted a signal to the control unit 300 to send an additional electrical pulse via one of the current generators 216 to the first magnetic component 500.
- the additional electrical pulse to the first magnetic component 500, the polarity of the semi-hard magnetic material 213 can be flipped such that it matches the polarity of the hard magnetic material 212.
- the first magnetic component 500 and the second magnetic component 502 can be arranged such that the two magnetic components repel one another when the first magnetic component 500 and the second magnetic component 502 are both in the ON configuration 202.
- the like-poles of the first magnetic component 500 and the second magnetic component 502 can be positioned close to or abutting one another when at least one of the magnetic components is demagnetized.
- the poles of the magnetic components can be determined based on the polarity of the hard magnetic material 212 having the higher coercivity.
- the first magnetic component 500 and the second magnetic component 502 can be affixed or otherwise attached or otherwise coupled to different parts of a frame serving as a support for the ingestible intragastric space-filling device 100.
- the frame can change its shape (e.g., expand or contort) and, as a result, change the shape of the ingestible intragastric space-filling device 100.
- Fig. 5A illustrates the second magnetic component 502 as being initially in the ON configuration 202
- the second magnetic component 502 can also be switched to the OFF configuration 210 such that both the first magnetic component 500 and the second magnetic component 502 are in the OFF configuration 210 when the intragastric space-filling device 100 is ready to be ingested by the patient.
- the first magnetic component 500 and the second magnetic component 502 can both be switched to the ON configuration 202 immediately prior to the intragastric space-filling device 100 being ingested by the patient.
- the intragastric space-filling device 100 can be designed such that the frame of the device expands gradually when the first magnetic component 500 and the second magnetic component 502 are both switched to the ON configuration 202.
- At least one of the first magnetic component 500 and the second magnetic component 502 can be switched to the OFF configuration 210 when it comes time for the intragastric space-filling device 100 to shrink into a compressed or contracted configuration for passage out of the body of the patient.
- the portable electronic device 400 can be used to transmit a signal to the control unit 300 to instruct the one or more current generators 216 to send additional electrical pulses to demagnetize both the first magnetic component 500 and the second magnetic component 502.
- the first magnetic component 500 and the second magnetic component 502 can be arranged such that the opposite poles of the two magnetic components face one another.
- the first magnetic component 500 and the second magnetic component 502 can both initially be switched to the OFF configuration 210 (i.e., de-magnetized).
- the intragastric space-filling device 100 can be ingested by the patient when both the first magnetic component 500 and the second magnetic component 502 are in the OFF configuration 210.
- the intragastric space-filling device 100 can expand once within the stomach of the patient as a result of mechanical actuation means, shape-memory recovery, chemical reactions occurring within the intragastric space-filling device 100, or a combination thereof.
- Both the first magnetic component 500 and the second magnetic component 502 can be switched to the ON configuration 202 (i.e., magnetized) when it comes time for the intragastric space-filling device 100 to shrink into a compressed or contracted configuration for passage out of the body of the patient.
- the ON configuration 202 i.e., magnetized
- the opposite poles of the two magnetic components can attract one another and the two magnetic components can urge the intragastric space-filling device 100 (or a frame attached to the intragastric space-filling device 100) into the collapsed or contracted configuration.
- Figs. 5C and 5D illustrate instances where the second magnetic component
- the permanent magnet 504 is a permanent magnet 504.
- the permanent magnet 504 can be or comprise a hard magnetic material with a high coercivity.
- the permanent magnet 504 can be a neodymium iron boron (NdFeB) magnet.
- the mechanisms shown in Figs. 5C and 5D can operate similar to the mechanisms shown Figs. 5A and 5B except for the second magnetic component 502 is unable to be manipulated (i.e., unable to be electrically de-magnetized) by the control unit 300.
- One benefit of the mechanisms shown in Figs. 5C and 5D is a reduction in the cost to produce such mechanisms relative to the mechanisms shown in Figs. 5A and 5B.
- another benefit of the mechanisms shown in Figs. 5C and 5D is a reduction in the complexity of such mechanisms.
- Fig. 6A is an example of a Hoberman-style ingestible intragastric device
- the Hoberman-style ingestible intragastric device 600 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A). As shown in Fig. 6A, the Hoberman-style ingestible intragastric device 600 can comprise an expandable frame 602 covered or completely encompassed by a device covering 604.
- the expandable frame 602 can be or comprise an expandable Hoberman structure as shown in Fig. 6A.
- the expandable frame 602 can be fabricated from or comprise polyether ether ketone (PEEK) or other types of lightweight biocompatible polymers.
- PEEK polyether ether ketone
- the expandable frame 602 can be fabricated from or comprise fluoropolymers, polycarbonate, stainless steel, or a combination thereof.
- the device covering 604 can encompass or completely cover the entire expandable frame 602 and any electronic components or magnetic components attached or otherwise coupled to the expandable frame 602.
- the device covering 604 can be an intragastric balloon or another type of biocompatible expandable shell.
- the device covering 604 can be any type of balloon or covering disclosed in U.S. Patent Application No. 12/434,594, filed on May 1, 2009, the content of which is incorporated herein by reference in its entirety.
- the device covering 604 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
- the device covering 604 can be affixed or otherwise coupled to certain parts of the expandable frame 602. As such, expansion of the expandable frame 602 can cause the device covering 604 to expand.
- the device covering 604 can initially be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606.
- the device covering 604 can be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606 to maintain the Hoberman- style ingestible intragastric device 600 in the contracted configuration 606 and to prevent the device covering 604 from inadvertently expanding prior to entry into the stomach of the patient.
- the dissolvable polymeric layer can be dissolved by gastric acids within the stomach of the patient.
- the Hoberman-style ingestible intragastric device 600 can further comprise at least a first magnetic component 500, a second magnetic component 502, the control unit 300, and one or more current generators 216.
- the first magnetic component 500 and the second magnetic component 502 can be attached or otherwise coupled to parts of the expandable frame 602.
- the first magnetic component 500 and the second magnetic component 502 can be positioned or forced closer together when the Hoberman-style ingestible intragastric device 600 is compressed into the contracted configuration 606.
- at least one of the first magnetic component 500 and the second magnetic component 502 can be magnetized to actuate the expansion of the expandable frame 602.
- both the first magnetic component 500 and the second magnetic component 502 can be magnetized by the control unit 300 coupled to a part of the expandable frame 602 via the one or more current generators 216. Magnetizing both of the magnetic components can cause the like-poles of the magnetic components to repel one another and, in turn, open up or expand the expandable frame 602.
- one of the first magnetic component 500 or the second magnetic component 502 can also be a permanent magnet 504.
- the Hoberman-style ingestible intragastric device 600 can be expanded when situated within the stomach of a patient.
- a portable electronic device 400 (see Fig. 4) outside the body of the patient can be used to transmit a wireless signal to the control unit 300 within the Hoberman-style ingestible intragastric device 600 to magnetize one or more of the magnetic components and expand the Hoberman-style ingestible intragastric device 600 into the expanded configuration 608.
- the Hoberman-style ingestible intragastric device 600 can have a maximum diameter of between approximately 10.0 mm and 15.0 mm when in the contracted configuration 606.
- the Hoberman-style ingestible intragastric device 600 can have a diameter of approximately 12.0 mm when in the contracted configuration 606.
- the Hoberman-style ingestible intragastric device 600 can have a maximum diameter of between approximately 25.0 mm and 60.0 mm when in the expanded configuration 608.
- the Hoberman-style ingestible intragastric device 600 can have a diameter of approximately 30.0 mm when in the expanded configuration 608.
- the portable electronic device 400 can be used once again to transmit another wireless signal to the control unit 300 to de-magnetize one or more of the magnetic components.
- the expandable frame 602 e.g., the Hoberman structure
- the Hoberman-style ingestible intragastric device 600 can gradually collapse or shrink back into the contracted configuration 606.
- the Hoberman-style ingestible intragastric device 600 can eventually be passed out of the gastrointestinal tract of the patient.
- Hoberman-style ingestible intragastric device 600 is shown in Fig. 6A, it is contemplated by this disclosure that multiple Hoberman-style ingestible intragastric devices 600 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s).
- Fig. 6B is an example of an origami ball-style ingestible intragastric device
- the origami ball-style ingestible intragastric device 610 can be another type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
- the origami ball- style ingestible intragastric device 610 can comprise an expandable frame 602 covered or completely encompassed by a device covering 604.
- the expandable frame 602 can be or comprise a thin-layer scaffold folded into an expandable origami-style structure as shown in Fig. 6B.
- the expandable frame 602 can be folded from cellulose-based paper, biofunctionalized paper, hydrogel-laden paper scaffold, shrink film, polyester and vinyl films, or any other type of biocompatible thin sheets or films.
- the device covering 604 can encompass or completely cover the entire expandable frame 602 and any electronic components or magnetic components attached or otherwise coupled to the interior of the expandable frame 602.
- the device covering 604 can be an intragastric balloon or another type of biocompatible expandable shell.
- the device covering 604 can be any type of balloon or covering disclosed in U.S. Patent Application No. 12/434,594, filed on May 1, 2009, the content of which is incorporated herein by reference in its entirety.
- the device covering 604 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
- the device covering 604 can be affixed or otherwise coupled to certain parts of the expandable frame 602. As such, expansion of the expandable frame 602 can cause the device covering 604 to expand.
- the device covering 604 can initially be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606.
- the device covering 604 can be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606 to maintain the origami ball-style ingestible intragastric device 610 in the contracted configuration 606 and to prevent the device covering 604 from inadvertently expanding prior to entry into the stomach of the patient.
- the dissolvable polymeric layer can be dissolved by gastric acids within the stomach of the patient.
- first magnetic component 500 and the second magnetic component 502 can be attached or otherwise coupled to parts of the expandable frame 602.
- the first magnetic component 500 and the second magnetic component 502 can be positioned or forced closer together when the origami ball-style ingestible intragastric device 610 is compressed into the contracted configuration 606.
- at least one of the first magnetic component 500 and the second magnetic component 502 can be magnetized to actuate the expansion of the expandable frame 602.
- both the first magnetic component 500 and the second magnetic component 502 can be magnetized by the control unit 300 coupled to a part of the expandable frame 602 via the one or more current generators 216. Magnetizing both of the magnetic components can cause the like-poles of the magnetic components to repel one another and, in turn, open up or expand the expandable frame 602.
- one of the first magnetic component 500 or the second magnetic component 502 can also be a permanent magnet 504.
- the origami ball-style ingestible intragastric device 610 can be expanded when situated within the stomach of a patient.
- a portable electronic device 400 outside the body of the patient can be used to transmit a wireless signal to the control unit 300 within the origami ball-style ingestible intragastric device 610 to magnetize one or more of the magnetic components and expand the origami ball-style ingestible intragastric device 610 into the expanded configuration 608.
- the origami ball-style ingestible intragastric device 610 can have a maximum diameter of between approximately 10.0 mm and 15.0 mm when in the contracted configuration 606.
- the origami ball- style ingestible intragastric device 610 can have a diameter of approximately 12.0 mm when in the contracted configuration 606.
- the origami ball-style ingestible intragastric device 610 can have a maximum diameter of between approximately 25.0 mm and 60.0 mm when in the expanded configuration 608.
- the origami ball- style ingestible intragastric device 610 can have a diameter of approximately 30.0 mm when in the expanded configuration 608.
- the portable electronic device 400 can be used once again to transmit another wireless signal to the control unit 300 to de-magnetize one or more of the magnetic components.
- the expandable frame 602 e.g., the origami ball scaffold
- the origami ball scaffold can gradually collapse or shrink back into the contracted configuration 606.
- the origami ball-style ingestible intragastric device 610 is compressed or otherwise returns to the contracted configuration 606, the origami ball-style ingestible intragastric device 610 can eventually be passed out of the gastrointestinal tract of the patient.
- origami or foldable structures
- origami boxes origami stars, origami pyramids, origami-lantern structures, or a combination thereof.
- origami ball-style ingestible intragastric device 610 is shown in Fig. 6B, it is contemplated by this disclosure that multiple origami ball-style ingestible intragastric devices 610 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s).
- Fig. 7 A is an example of an intragastric assembly 700 comprising a plurality of intragastric space-filling devices 702 joined together into an intragastric space-filling agglomeration 704.
- the intragastric space-filling devices 702 shown in Figs. 7A and 7B can be one type of the intragastric space-filling devices 102 shown in Fig. IB.
- each of the intragastric space-filling devices 702 can comprise an electropermanent magnet 200, a control unit 300, and a current generator 216 (see Fig. 4).
- the electropermanent magnet 200, the control unit 300, and the current generator 216 can be contained within a device shell 706.
- the device shell 706 can be inflatable or fillable such that an interior of the device shell 706 is hollow or taken up by air, other fluids, or a fillable substance.
- the device shell 706 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, polytetrafluoroethylene (PTFE), or a combination thereof.
- the device shell 706 can comprise a frame structure (not shown in Figs. 7 A and 7B) and the electropermanent magnet 200, the control unit 300, and the current generator 216 can be coupled to the frame structure.
- the device shell 706 can be a solid structure having voids, channels, or cavities for holding the electropermanent magnet 200, the control unit 300, and the current generator 216.
- the device shell 706 can be fabricated from or comprise biocompatible polymers, elastic polymers, ceramics, or a combination thereof.
- the device shell 706 can be fabricated from PEEK, polycarbonate, medical-grade polyvinyl chloride, rubber, or a combination thereof.
- the device shell 706 can be fabricated from or comprise a thin-walled metallic material
- the electropermanent magnet 200 can be positioned or affixed near a surface of the device shell 706. This can allow the magnetic flux generated by the electropermanent magnet 200 to permeate beyond the surface of the device shell 706 and allow multiple intragastric space-filling devices 702 to magnetically join together when the electropermanent magnets 200 are magnetized.
- Fig. 7A illustrates four intragastric space-filling devices 702 joining together to form the intragastric space-filling agglomeration 704, it is contemplated by this disclosure that the intragastric assembly 700 can comprise between five and twenty intragastric space-filling devices 702.
- the intragastric assembly 700 can comprise five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, or twenty intragastric space-filling devices 702.
- the intragastric assembly 700 can comprise two intragastric space-filling devices 702 or three intragastric space-filling devices 702.
- a portable electronic device 400 can be used to transmit a wireless signal to the control unit 300 within each of the intragastric space-filling devices 702 to generate an electrical pulse (i.e., a short burst of current through the conductive wire 204) to magnetize the electropermanent magnet 200 within each of the intragastric spacefilling devices 702.
- the intragastric space-filling devices 702 can be magnetically attracted to one another and join together into the intragastric space-filling agglomeration 704.
- the intragastric space-filling devices 702 can be magnetized or switched to the ON configuration 202 before ingestion by the patient.
- the intragastric space-filling devices 702 can be magnetized or switched to the ON configuration 202 after the intragastric space-filling devices 702 are within the stomach of the patient. In this latter variation, the intragastric space-filling devices 702 can be demagnetized or switched to the OFF configuration 210 prior to ingestion by the patient.
- the intragastric space-filling agglomeration 704 can be sized to be larger than the pyloric sphincter of a patient such that the intragastric space-filling agglomeration 704 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the intragastric space-filling agglomeration 704 stays within the stomach of the patient to take up space within the stomach.
- the intragastric space-filling agglomeration 704 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
- the portable electronic device 400 can be used to transmit another wireless signal to the control unit 300 within each of the intragastric space-filling devices 702 to generate another electrical pulse (i.e., a short burst of current through the conductive wire 204) to de-magnetize the electropermanent magnet 200 within each of the intragastric space-filling devices 702.
- the intragastric space-filling devices 702 are de-magnetized or switched to the OFF configuration 210, the intragastric space-filling agglomeration 704 can break up or separate into its constituent intragastric space-filling devices 702 as shown in Fig. 7B.
- the intragastric space-filling devices 702 can be substantially shaped as spheres.
- the intragastric space-filling devices 702 can each have a diameter of between approximately 10.0 mm and 15.0 mm.
- the intragastric space-filling devices 702 can be substantially shaped as polyhedrons such as cuboids, rhomboids, pyramids, or a combination thereof.
- the intragastric space-filling devices 702 can be individually sized to allow the intragastric space-filling devices 702 to pass through the digestive system of the patient and out of the patient. For example, once the electropermanent magnets 200 within the intragastric space-filling devices 702 are de-magnetized, the intragastric space-filling devices 702 can individually pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- Fig. 8 illustrates a side cross-sectional view of an example of an intragastric space-filling vessel 800.
- the intragastric space-filling vessel 800 can comprise a vessel housing 802 comprising a bulbous portion 804, an elongate narrow portion 806, a channel 808 extending through the elongate narrow portion 806 and the bulbous portion 804, and a conduit 810 connecting the channel 808 to an external environment outside of the vessel housing 802.
- the external environment can be a gastric environment of the patient.
- the intragastric space-filling vessels 800 shown in Figs. 8, 9A, and 9B can be one type of the intragastric space-filling devices 102 shown in Fig. IB.
- the conduit 810 can be positioned along the segment of the channel 808 disposed within the elongate narrow portion 806 of the vessel housing 802. In the example variation shown in Fig. 8, the conduit 810 can be defined along a lateral surface of the elongate narrow portion 806. In other variations, the conduit 810 can be defined along a distal end surface or terminal surface of the elongate narrow portion 806.
- the intragastric space-filling vessel 800 can also comprise a magnetic component 812 translatable longitudinally within the channel 808.
- the magnetic component 812 can be or comprise a permanent magnet.
- the magnetic component 812 can be an NdFeB magnet.
- the channel 808 can house or contain an expandable filling material 814.
- the filling material 814 can absorb fluids (e.g., water, digestive fluids, etc.) entering the channel 808 through the conduit 810 and expand over time.
- fluids e.g., water, digestive fluids, etc.
- the filling material 814 can be a polymeric filling material.
- the polymeric filling material can comprise a hydrophilic gel, agar, agarose, alginate, amylopectin, carrageenan, gelatin, gellan, guar gum, other types of gums, maltodextrin, hydrophilic polyurethanes, hydroxypropyl methylcellulose, other types of cellulose, hydrophilic polyurethane polymers, pectins, hydroxyethyl cellulose, methyl cellulose, hydroxymethyl methacrylate, insoluble polysaccharides, xanthans, or combinations or mixtures thereof.
- a hydrophilic gel agar, agarose, alginate, amylopectin, carrageenan, gelatin, gellan, guar gum, other types of gums, maltodextrin, hydrophilic polyurethanes, hydroxypropyl methylcellulose, other types of cellulose, hydrophilic polyurethane polymers, pectins, hydroxyethyl cellulose, methyl
- the conduit 810 can comprise a one-way valve such that fluids (e.g., water, digestive fluids, etc.) from the external environment enter the channel 808 but the filling material 814 does not exit or flow out of the channel 808.
- fluids e.g., water, digestive fluids, etc.
- the magnetic component 812 can be configured to initially be positioned within a segment of the channel 808 disposed within the elongate narrow portion 806.
- the magnetic component 812 can be configured to initially be positioned within the segment of the channel 808 disposed within the elongate narrow portion 806 prior to or immediately upon ingestion of the intragastric space-filling vessel 800 by the patient.
- the elongate narrow portion 806 can be substantially shaped as a cylinder. In other variations, the elongate narrow portion 806 can be substantially shaped as a cuboid, a frustoconic, an ovoid, or a combination thereof.
- the channel 808 can be substantially shaped to conform to the shape of the elongate narrow portion 806.
- the channel 808 can be a substantially cylindrical channel, frustoconic channel, cuboid channel, or a combination thereof.
- the elongate narrow portion 806 of the vessel housing 802 can have a thin wall.
- the elongate narrow portion 806 of the vessel housing 802 can have a wall thickness of between approximately 0.50 mm to 2.0 mm.
- the elongate narrow portion 806 of the vessel housing 802 can have a wall thickness of approximately 1.00 mm.
- the thin wall of the elongate narrow portion 806 can allow the magnetic component 812 to exert a force on other magnetic materials or ferromagnetic materials outside of the elongate narrow portion 806 of the vessel housing 802 when the magnetic component 812 is positioned within the elongate narrow portion 806 (such as when the magnetic component 812 is positioned within the segment of the channel 808 disposed within the elongate narrow portion 806).
- the thin wall of the elongate narrow portion 806 can also allow the external magnetic field or the external magnetic flux emanating from the magnetic component 812 to permeate beyond the elongate narrow portion 806 of the vessel housing 802. [0140] As fluids gradually enter the channel 808 through the conduit 810, the filling material 814 can gradually expand.
- Expansion of the filling material 814 can push, move, or otherwise translate the magnetic component 812 longitudinally through the channel 808 toward the segment of the channel 808 disposed within the bulbous portion 804.
- the bulbous portion 804 of the vessel housing 802 can reduce the ability of the magnetic component 812 to exert a force on other magnetic materials or ferromagnetic materials outside of the bulbous portion 804 of the vessel housing 802.
- the size and shape of the bulbous portion 804 of the vessel housing 802 can prevent the magnetic component 812 from attaching to other magnetic materials or ferromagnetic materials outside of the bulbous portion 804 of the vessel housing 802 once the magnetic component 812 is within the bulbous portion 804.
- the bulbous portion 804 of the vessel housing 802 can be substantially shaped as an ellipsoid, a biconic structure (i.e., two frusto-conics attached base to base), a hemisphere or dome, an ovoid, or a combination thereof.
- the bulbous portion 804 can be substantially shaped as a hexahedron, an octahedron, a decahedron, a dodecahedron, or a combination thereof.
- the overall shape or design of the intragastric space-filling vessel 800 can be substantially mushroom-shaped, cornet- shaped, lollipop- shaped, or a combination thereof.
- the vessel housing 802 of the intragastric space-filling vessel 800 can have an end-to-end length dimension of between approximately 10.00 mm and 31.75 mm.
- the bulbous portion 804 of the vessel housing 802 can have a maximum width dimension or diameter of between approximately 5.00 mm and 12.70 mm.
- Fig. 9A illustrates a side cross-sectional view of an intragastric assembly
- each of the plurality of intragastric space-filling vessels 800 can comprise the vessel housing 802 having the bulbous portion 804 and the elongate narrow portion 806, a channel 808 extending through the bulbous portion 804 and the elongate narrow portion 806, and a magnetic component 812 and filling material 814 contained within the channel 808.
- the magnetic component 812 of each of the intragastric space-filling vessels 800 can be initially configured to be positioned within the segment of the channel 808 disposed within the elongate narrow portion 806 of the vessel housing 802.
- a method of treating obesity can involve providing the plurality of intragastric space-filling vessels 800 to be ingested (one by one) by the patient. Once within the stomach of the patient, the plurality of intragastric space-filling vessels 800 can magnetically join together into the intragastric vessel agglomeration 902 when the magnetic components 812 positioned within the elongate narrow portions 806 of the intragastric space-filling vessels 800 exert an attractive force on one another.
- intragastric space-filling vessels 800 are shown in Figs. 9A and 9B, it is contemplated by this disclosure that between four and twenty intragastric space-filling vessels 800 can be included as part of the intragastric assembly 900. Moreover, the intragastric vessel agglomeration 902 formed by the intragastric spacefilling vessels 800 can take on certain composite shapes such as spheres, disks, ellipsoids, ovoids, polyhedrons, or a combination thereof.
- the intragastric space-filling vessels 800 can be designed and sized such that the intragastric vessel agglomeration 902 formed by the intragastric space-filling vessels 800 is larger in size than the pyloric sphincter of the patient. This ensures that the intragastric vessel agglomeration 902 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This also ensures that the intragastric vessel agglomeration 902 stays within the stomach of the patient to take up space within the stomach and that the intragastric vessel agglomeration 902 can intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
- Fig. 9B illustrates a side cross-sectional view of the intragastric vessel agglomeration 902 of Fig. 9A broken up or separated into its constituent intragastric spacefilling vessels 800.
- the intragastric vessel agglomeration 902 can separate back into the plurality of intragastric space-filling vessels 800 when the magnetic attraction or the magnetic forces holding the plurality of intragastric space-filling vessels 800 close together are weakened or diminished.
- the magnetic attraction between the intragastric space-filling vessels 800 can be weakened or diminished by the movement or translation of the magnetic component 812 within each of the plurality of intragastric space-filling vessels 800 from the elongate narrow portion 806 of the vessel housing 802 to the bulbous portion 804.
- the magnetic component 812 within each of the plurality of intragastric space-filling vessels 800 can be configured to move or translate longitudinally from the segment of the channel 808 within the elongate narrow portion 806 to the bulbous portion 804 when the filling material 814 within each of the plurality of intragastric space-filling vessels 800 expands.
- the filling material 814 within the channel 808 of each of the intragastric space-filling vessels 800 can expand as fluid from the external environment flows through the conduit 810 into the channel 808 and interacts with the filling material 814.
- each of the intragastric space-filling vessels 800 can individually pass through the pylorus and duodenum into the intestines of the patient. Each of the intragastric space-filling vessels 800 can then eventually pass out of the body of the patient.
- Fig. 10 illustrates an example of an ingestible intragastric device 1000.
- the ingestible intragastric device 1000 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
- the ingestible intragastric device 1000 can comprise an expandable covering 1002 serving as the shell or casing for the ingestible intragastric device 1000.
- the expandable covering 1002 can be a balloon-type covering or shell.
- the expandable covering 1002 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
- the ingestible intragastric device 1000 can also comprise the control unit
- the pressure sensor 1004 can be configured to sense an internal pressure within the expandable covering 1002.
- the pressure sensor 1004 can also transmit a signal to the processor 302 (see Fig. 3) of the control unit 300 when the internal pressure exceeds a predetermined threshold.
- the control unit 300 can also receive a wireless signal from a portable electronic device 400.
- the portable electronic device 400 can instruct the control unit 300 to magnetize or de-magnetize certain magnetic components within the ingestible intragastric device 1000 or to electrically control certain components certain valves or regulators within the ingestible intragastric device 1000.
- the ingestible intragastric device 1000 can further comprise a first interior chamber 1006 comprising a first chemical composition 1008, a second interior chamber 1010 comprising a second chemical composition 1012, a first electronic valve coupled to the control unit 300 and serving as a remote-controllable regulator or gate between the first interior chamber 1006 and the second interior chamber 1010 and a second electronic valve 1016 coupled to the control unit 300 and serving as a remote-controllable regulator or gate between the second interior chamber 1010 and an exterior environment surrounding the expandable covering 1002.
- the first chemical composition 1008 can be or comprise a weak acid such as acetic acid, CH 3 COOH.
- the second chemical composition 1012 can be or comprise a weak base such as sodium bicarbonate, NaHC0 3 .
- the weak acid can also be contained within the second interior chamber 1010 and the weak base can be contained within the first interior chamber 1006.
- the first electronic valve 1014 and the second electronic valve 1016 can both be controlled by the control unit 300.
- each of the first electronic valve 1014 and the second electronic valve 1016 can comprise two or more electropermanent magnets 200 capable of being magnetized or de-magnetized by the control unit 300 (as explained in the preceding sections).
- the first electronic valve 1014 and the second electronic valve 1016 can comprise permanent magnets, other electrically controllable valves capable of being controlled by the control unit 300, or destructive features such as explosive components or resistors that can heat up and burn a hole in the expandable covering 1002.
- both of the electropermanent magnets 200 can be switched to the ON configuration 202 and the electropermanent magnets 200 can be positioned such that opposite poles of the two electropermanent magnets 200 face one another and are attracted to one another.
- the two electropermanent magnets 200 can be attached to one another and act as a gate to close the first electronic valve 1014 or the second electronic valve 1016.
- the two electropermanent magnets 200 can begin to separate or move away from one another and the first electronic valve 1014 or the second electronic valve 1016 can begin to open.
- the first electronic valve 1014 is opened, the first chemical composition 1008 can mix with the second chemical composition 1012 to produce a gas (e.g., carbon dioxide, C0 2 ) to inflate the expandable covering 1002.
- a gas e.g., carbon dioxide, C0 2
- the second electronic valve 1016 can be instructed to open via the same mechanisms as those discussed with respect to the first electronic valve 1014.
- control unit 300 can transmit one or more signals to the first electronic valve 1014 to close the first electronic valve 1014 to preserve the first chemical composition 1012 within the first interior chamber 1006 or preserve the second chemical composition 1012 within the second interior chamber 1010.
- the first electronic valve 1014 can be opened at a later time to further increase the size of the ingestible intragastric device 1000 at the later time.
- the gas can be evacuated from the expandable covering 1002 and the ingestible intragastric device 1000 can begin to shrink.
- the ingestible intragastric device 1000 can continue to shrink or decrease in size until the ingestible intragastric device 1000 can pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- a weight-loss regimen or method of treating obesity can involve a patient ingesting the ingestible intragastric device 1000 when both the first electronic valve 1014 and the second electronic valve 1016 are closed.
- a clinician or other medical professional can check that the ingestible intragastric device 1000 is within the stomach of the patient by using the portable electronic device 400 to transmit a signal to the control unit 300 within the ingestible intragastric device 1000 via a wireless communication protocol 402 such as an NFC protocol or a BluetoothTM protocol.
- a wireless signal can be sent from a portable electronic device 400 to open the first electronic valve 1014 and expand the ingestible intragastric device 1000.
- the ingestible intragastric device 1000 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1000 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the ingestible intragastric device 1000 stays within the stomach of the patient to take up space within the stomach.
- the ingestible intragastric device 1000 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
- the portable electronic device 400 can be used to transmit another wireless signal to the control unit 300 to open the second electronic valve 1016. Once the second electronic valve 1016 is opened, the ingestible intragastric device 1000 can shrink or decrease in size until the ingestible intragastric device 1000 is able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- acetic acid, sodium bicarbonate, and carbon dioxide are discussed in the aforementioned sections, it is contemplated by this disclosure that any type of weak acids or bases can be used as long as such weak acids or bases can be buffered by the gastric environment within the stomach of the patient. In addition, other gases besides carbon dioxide can be generated as long as such gases are not harmful to the patient.
- one ingestible intragastric device 1000 is shown in Fig. 10, it is contemplated by this disclosure that multiple ingestible intragastric devices 1000 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s).
- Fig. 11 illustrates yet another example of an ingestible intragastric device 1100.
- the ingestible intragastric device 1100 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
- the ingestible intragastric device 1100 can comprise an expandable covering 1102 serving as the shell or casing for the ingestible intragastric device 1100.
- the expandable covering 1102 can be a balloon-type covering or shell.
- the expandable covering 1102 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
- the ingestible intragastric device 1100 can also comprise the control unit
- the pressure sensor 1004 can be configured to sense an internal pressure within the expandable covering 1102.
- the pressure sensor 1004 can also transmit a signal to the processor 302 (see Fig. 3) of the control unit 300 when the internal pressure exceeds a predetermined threshold.
- the control unit 300 can also receive a wireless signal from a portable electronic device 400.
- the portable electronic device 400 can instruct the control unit 300 to magnetize or de-magnetize certain magnetic components within the ingestible intragastric device 1100 or to electrically control certain components certain valves or regulators within the ingestible intragastric device 1100.
- the ingestible intragastric device 1100 can further comprise a gas cartridge
- the pressurized gas 1106 can comprise carbon dioxide (C0 2 ), nitrogen (N 2 ) gas, oxygen (0 2 ), or a combination thereof.
- the pressurized gas 1106 can be a type of pressurized inert gas that can be released within the stomach of the patient.
- the ingestible intragastric device 1100 can also comprise a controllable valve and regulator 1108 coupled to the control unit 300.
- the controllable valve and regulator 1108 can control the release of the pressurized gas 1106 from the gas cartridge 1104.
- the controllable valve and regulator 1108 can be instructed to remain closed or open to allow the pressurized gas 1106 to remain within the gas cartridge or be released from the gas cartridge 1104, respectively.
- the ingestible intragastric device 1100 can further comprise a controllable valve 1110 separating the expandable covering 1102 from an external environment.
- the controllable valve and regulator 1108 and the controllable valve 1110 can both be controlled by the control unit 300.
- each of the controllable valve and regulator 1108 and the controllable valve 1110 can comprise two or more electropermanent magnets 200 capable of being magnetized or de-magnetized by the control unit 300 (as explained in the preceding sections).
- controllable valve and regulator 1108 and the controllable valve 1110 can comprise permanent magnets, other electrically controllable valves capable of being controlled by the control unit 300, or destructive features such as explosive components or resistors that can heat up and burn a hole in the expandable covering 1102.
- both of the electropermanent magnets 200 can be switched to the ON configuration 202 and the electropermanent magnets 200 can be positioned such that opposite poles of the two electropermanent magnets 200 face one another and are attracted to one another.
- the two electropermanent magnets 200 can be attached to one another and act as a gate to close the controllable valve and regulator 1108 and the controllable valve 1110.
- the two electropermanent magnets 200 can begin to separate or move away from one another and the controllable valve and regulator 1108 and the controllable valve 1110 can begin to open.
- the controllable valve and regulator 1108 is opened, the pressurized gas 1106 can be released and inflate the expandable covering 1102.
- the controllable valve 1110 can be instructed to open via the same mechanisms as those discussed with respect to the controllable valve and regulator 1108. Once the controllable valve 1110 is opened, the pressurized gas 1106 can be evacuated from the expandable covering 1102 and the ingestible intragastric device 1100 can begin to shrink. The ingestible intragastric device 1100 can continue to shrink or decrease in size until the ingestible intragastric device 1100 can pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- One weight-loss regimen or method of treating obesity can involve a patient ingesting the intragastric device 1100 when both the controllable valve and regulator 1108 and the controllable valve 1110 are closed.
- a clinician or other medical professional can first determine that the intragastric device 1100 is within the stomach of the patient by transmitting one or more wireless signals to certain wireless communication units 306 coupled to the control unit 300 within the intragastric device 1100. Based on the responses (or lack thereof) received from the wireless communication units 306, the clinician or other medical professional can determine whether the intragastric device 1100 is within the stomach of the patient.
- a wireless signal can be sent from a portable electronic device 400 to open the controllable valve and regulator 1108 and expand the ingestible intragastric device 1100.
- the ingestible intragastric device 1100 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1100 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the ingestible intragastric device 1100 stays within the stomach of the patient to take up space within the stomach.
- the ingestible intragastric device 1100 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
- the portable electronic device 400 can be used to transmit a wireless signal to the control unit 300 to open the controllable valve 1110. Once the controllable valve 1110 is opened, the ingestible intragastric device 1100 can shrink or decrease in size until the intragastric device 1100 is able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- An alternative weight-loss regimen or method of treating obesity can involve a patient ingesting the intragastric device 1100 when both the controllable valve and regulator 1108 and the controllable valve 1110 are open. Once the ingestible intragastric device 1100 is within the stomach of the patient, a wireless signal can be sent from a portable electronic device 400 to close the controllable valve 1110 and expand the ingestible intragastric device 1100.
- the ingestible intragastric device 1100 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1100 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient.
- the ingestible intragastric device 1100 stays within the stomach of the patient to take up space within the stomach.
- the ingestible intragastric device 1100 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
- the control unit 300 can instruct the controllable valve and regulator 1108 to close.
- the portable electronic device 400 can be used once again to transmit a wireless signal to the control unit 300 to open the controllable valve 1110.
- the controllable valve 1110 is opened, the ingestible intragastric device 1100 can shrink or decrease in size until the intragastric device 1100 is able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- controllable valve and regulator 1108 and the controllable valve 1110 can each be opened or closed multiple times to fine tune the inflation or deflation of the ingestible intragastric device 1100.
- Fig. 12 illustrates an additional example of an ingestible intragastric device 1200.
- the ingestible intragastric device 1200 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
- the ingestible intragastric device 1200 can comprise an expandable covering 1202 serving as the shell or casing for the ingestible intragastric device 1200.
- the expandable covering 1202 can be a balloon-type covering or shell.
- the expandable covering 1202 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
- the ingestible intragastric device 1200 can also comprise the control unit
- the pressure sensor 1004 can be configured to sense an internal pressure within the expandable covering 1202.
- the pressure sensor 1004 can also transmit a signal to the processor 302 (see Fig. 3) of the control unit 300 when the internal pressure exceeds a predetermined threshold.
- the control unit 300 can also receive a wireless signal from a portable electronic device 400.
- the portable electronic device 400 can instruct the control unit 300 to magnetize or de-magnetize certain magnetic components within the ingestible intragastric device 1200 or to electrically control certain components certain valves or regulators within the ingestible intragastric device 1200.
- the ingestible intragastric device 1200 can be filled with a compressed gas
- the compressed gas 1204 can comprise liquefied nitrogen (N 2 ) gas or other gases.
- the ingestible intragastric device 1200 can be filled with the compressed gas 1204 immediately before being ingested by the patient.
- liquefied nitrogen can be injected into the interior of the expandable covering 1202 through a controllable valve 1206 immediately before the intragastric device 1200 is ingested by the patient.
- the controllable valve 1206 can be instructed to close or open to allow the compressed gas 1204 to remain within or be released from the ingestible intragastric device 1200, respectively.
- the controllable valve 1206 can comprise two or more electropermanent magnets 200 capable of being magnetized or demagnetized by the control unit 300 (as explained in the preceding sections).
- the controllable valve 1206 can comprise permanent magnets, other electrically controllable valves capable of being controlled by the control unit 300, or destructive features such as explosive components or resistors that can heat up and burn a hole in the expandable covering 1202.
- both of the electropermanent magnets 200 can be attached to one another and act as a gate to close the controllable valve 1206 when the electropermanent magnets 200 are switched to the ON configuration 202.
- the electropermanent magnets 200 can be positioned such that opposite poles of the two electropermanent magnets 200 face one another and are attracted to one another.
- the two electropermanent magnets 200 can begin to separate or move away from one another and the controllable valve and regulator 1108 and the controllable valve 1206 can begin to open.
- the expandable covering 1202 can expand to a predetermined size or until the internal pressure within the expandable covering 1202 is detected to exceed a predetermined threshold.
- the controllable valve 1110 can be instructed to open and the compressed gas 1204 can be evacuated from the expandable covering 1202 and begin to shrink.
- the ingestible intragastric device 1200 can continue to shrink or decrease in size until the ingestible intragastric device 1200 can pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- One weight-loss regimen or method of treating obesity can involve a clinician or medical professional injecting the compressed gas 1204 (such as liquefied nitrogen) into the expandable covering 1202 of the ingestible intragastric device 1200 prior to the patient ingesting the ingestible intragastric device 1200.
- the patient can then ingest the intragastric device 1200 and wait for the intragastric device 1200 to reach the stomach of the patient.
- a clinician or other medical professional can determine that the intragastric device 1200 is within the stomach of the patient by transmitting one or more wireless signals to certain wireless communication units 306 coupled to the control unit 300 within the intragastric device 1200. Based on the responses (or lack thereof) received from the wireless communication units 306, the clinician or other medical professional can determine whether the intragastric device 1200 is within the stomach of the patient.
- a wireless signal can be sent from a portable electronic device 400 to the control unit 300 within the intragastric device 1200 to close the controllable valve 1206 and expand the ingestible intragastric device 1200.
- the ingestible intragastric device 1200 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1200 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the ingestible intragastric device 1200 stays within the stomach of the patient to take up space within the stomach.
- the ingestible intragastric device 1200 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
- the portable electronic device 400 can be used to transmit another wireless signal to the control unit 300 to open the controllable valve 1206. Once the controllable valve 1206 is opened, the ingestible intragastric device 1200 can shrink or decrease in size until the intragastric device 1200 is able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted. Moreover, the portable electronic device 400 can also be used to transmit a wireless signal to the control unit 300 to open the controllable valve 1206 before the patient has met his or her weight-loss goals if the size of the expanded intragastric device 1200 is causing discomfort to the patient. For example, a small amount of compressed gas 1204 can be evacuated from the expandable covering 1202 to reduce the size of the intragastric device 1200 slightly but still allow the intragastric device 1200 to remain within the stomach of the patient.
- multiple ingestible intragastric devices 1200 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s).
- the controllable valve 1206 can be opened or closed multiple times to fine tune the inflation or deflation of the ingestible intragastric device 1200.
- Fig. 13 illustrates an example of a biodegradable intragastric device 1300.
- the biodegradable intragastric device 1300 can be another type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
- the biodegradable intragastric device 1300 can be ingested when in an unexpanded configuration 1302.
- the unexpanded configuration 1302 is a state of the biodegradable intragastric device 1300 when the device 1300 has not reacted with any bodily fluids of the patient.
- the biodegradable intragastric device 1300 can be sized to be orally ingested by the patient when in the unexpanded configuration 1302.
- the biodegradable intragastric device 1300 can be expanded from the unexpanded configuration 1302 to an expanded configuration 1304 after ingestion by the patient and when the biodegradable intragastric device 1300 is within the stomach of the patient.
- the biodegradable intragastric device 1300 can expand from the unexpanded configuration 1302 to the expanded configuration 1304 when the biodegradable intragastric device 1300 has been activated by digestive acids (e.g., stomach acids) within the gastrointestinal system of the patient.
- the biodegradable intragastric device 1300 can be activated by digestive acids when the digestive acids have reacted with coatings, foams, gels, or a combination thereof contained within or on the surface of the biodegradable intragastric device 1300.
- the biodegradable intragastric device 1300 can comprise expandable polymeric materials such as hydrophilic gels, agar, agarose, alginate, amylopectin, carrageenan, gelatin, gellan, guar gum, other types of gums, maltodextrin, hydrophilic polyurethanes, hydroxypropyl methylcellulose, other types of cellulose, hydrophilic polyurethane polymers, pectins, hydroxyethyl cellulose, methyl cellulose, hydroxymethyl methacrylate, insoluble polysaccharides, xanthans, or combinations or mixtures thereof.
- expandable polymeric materials such as hydrophilic gels, agar, agarose, alginate, amylopectin, carrageenan, gelatin, gellan, guar gum, other types of gums, maltodextrin, hydrophilic polyurethanes, hydroxypropyl methylcellulose, other types of cellulose, hydrophilic polyurethane polymers,
- the biodegradable intragastric device 1300 can expand to an expanded configuration 1304 larger than the pyloric sphincter of a patient such that the biodegradable intragastric device 1300 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the biodegradable intragastric device 1300 in the expanded configuration 1304 stays within the stomach of the patient to take up space within the stomach.
- the biodegradable intragastric device 1300 in the expanded configuration 1304 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
- the polymers or other materials making up the biodegradable intragastric device 1300 can biodegrade and be shed or dissolved by gastric acids or other fluids within the body of the patient.
- the biodegradable intragastric device 1300 in the expanded configuration 13034 can shrink or decrease in size over time until the biodegradable intragastric device 1300 shrinks to a size able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
- Methods recited herein may be carried out in any order of the recited events that is logically possible, as well as the recited order of events. Moreover, additional steps or operations may be provided or steps or operations may be eliminated to achieve the desired result.
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Abstract
Disclosed are devices, assemblies, and methods for treating obesity. In one embodiment, an ingestible intragastric device is disclosed comprising an expandable frame, a device covering encompassing the expandable frame, and multiple magnetic components wherein at least one of the magnetic components is configured to be magnetized remotely by a portable electronic device. In another embodiment, an intragastric assembly is disclosed comprising a plurality of intragastric space-filling devices each having an electropermanent magnet configured to be magnetized remotely by a portable electronic device. The intragastric space-filling devices are configured to magnetically join together into an intragastric space-filling agglomeration. In another embodiment, an intragastric assembly is disclosed comprising a plurality of intragastric space-filling vessels configured to join together to form an intragastric vessel agglomeration. Each intragastric space-filling vessel comprises a magnet and a filling material configured to expand upon contact with stomach acid.
Description
INGESTIBLE AND EXPANDABLE DEVICES AND ASSEMBLIES FOR WEIGHT- LOSS AND METHODS OF USE THEREOF
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. Provisional Application No.
62/470,235 filed on March 11, 2017, which is incorporated herein by reference in its entirety. TECHNICAL FIELD
[0002] The present disclosure relates generally to the field of bariatrics; more specifically, to ingestible and expandable devices and assemblies for weight-loss and methods of use thereof.
BACKGROUND [0003] Obesity is a condition of epidemic proportions in the United States. Recent government studies have indicated that up to 40% of Americans are obese and that, among those, almost 20% are morbidly obese. Patients who are obese tend to suffer from cardiovascular disease, heart disease, stroke, diabetes, and obstructive sleep apnea. Recent studies have indicated that obesity can reduce a person's lifespan by an average of three years in adults and twenty years in children.
[0004] Many attempts have been made in the prior art to provide medications, devices, and surgical procedures for the treatment of obesity, all of which either have serious side effects or are basically ineffective. For example, various diets, supplements, and pharmaceuticals have been developed and marketed, but none have shown any significant benefits to date in the treatment of obesity with the exception of some pharmaceuticals, which have unfortunately been found to cause a number of serious, life- threatening medical conditions. To date, there are no commercially available supplements or drugs that have been proven to be effective in promoting significant weight loss and, at the same time, are free from serious adverse side effects.
[0005] Devices have been developed in the prior art aimed at providing a sense of fullness to a patient. Such devices may be configured as stents that support the stomach or the pyloric valve or that may be configured as permanent occluders. Unfortunately, these
devices are implanted in the patient on an essentially permanent basis and typically include complex mechanical or electrical features that may stop working properly over time or that may require maintenance from time to time.
[0006] Moreover, devices have been developed to date that introduce inflated balloon(s) filled with saline or air inside a patient's stomach to occupy space or reduce the rate of digestion. However, these devices suffer from several shortcomings including the need to be placed inside a patient's stomach through costly and invasive endoscopic procedures and the need to remove such devices with the same costly and invasive endoscopic procedures. Moreover, such devices are often difficult to monitor or control once they are deployed within the patient's stomach. A solution is therefore needed that is inexpensive compared to current bariatric devices, minimally invasive, and allows a user to remotely monitor and control the device when deployed within the stomach of a patient.
SUMMARY
[0007] Disclosed are ingestible and expandable devices and assemblies for weight- loss and methods of use thereof. An ingestible intragastric device is disclosed comprising an expandable frame having a first configuration and a second configuration, a device covering encompassing the expandable frame and coupled to the expandable frame such that expansion of the expandable frame expands the device covering, and a first magnetic component and a second magnetic component coupled to the expandable frame.
[0008] The first magnetic component can be configured to be magnetized remotely by a portable electronic device. The second magnetic component can be configured to be repelled by the first magnetic component when the first magnetic component is magnetized. The expandable frame can be configured to expand from the first configuration to the second configuration when the second magnetic component is repelled by the first magnetic component.
[0009] At least one of the first magnetic component and the second magnetic component can be coupled to a control unit. The control unit can comprise a wireless communication unit configured to receive a wireless signal from the portable electronic device over a wireless communication protocol. The wireless communication protocol can be at least one of a Bluetooth™ communication protocol and a near field communication (NFC) communication protocol.
[0010] The control unit can be coupled to a battery and a current generator. The current generator can be configured to supply an electrical pulse to the first magnetic component to magnetize the first magnetic component. At least one of the first magnetic component and the second magnetic component can be an electropermanent magnet. The electropermanent magnet can comprise a hard magnetic material, a semi-hard magnetic material, and a soft magnetic material. A conductive wire can be wound around the semihard magnetic material.
[0011] In some variations, the hard magnetic material can be a neodymium iron boron (NdFeB) magnet, the semi-hard magnetic material can be an aluminum nickel cobalt (AINiCo) magnet, and the soft magnetic material can be an iron magnet. The hard magnetic material can have a higher intrinsic coercivity than the semi-hard magnetic material.
[0012] The ingestible intragastric device can be configured to expand within a stomach of a patient in response to receiving a wireless signal from the portable electronic device outside of the body of the patient. The expandable frame can be configured or designed as an expandable Hoberman structure. Alternatively, the expandable frame can be configured or designed as an expandable origami ball structure.
[0013] A method of treating obesity can comprise providing an ingestible intragastric device to be ingested by a patient. The ingestible intragastric device can comprise an expandable frame having a first configuration and a second configuration. A device covering can encompass the expandable frame and be coupled to the expandable frame such that expansion of the expandable frame expands the device covering. A first magnetic component and a second magnetic component can also be coupled to the expandable frame.
[0014] The method of treating obesity can also comprise remotely magnetizing the first magnetic component with a portable electronic device when the ingestible intragastric device is within the stomach of the patient. The second magnetic component can be configured to be repelled by the first magnetic component when the first magnetic component is magnetized.
[0015] The expandable frame can be configured to expand from the first configuration to the second configuration when the second magnetic component is repelled by the first magnetic component. Remotely magnetizing the first magnetic component with the portable electronic device can comprise transmitting a wireless signal to a wireless communication unit of a control unit within the ingestible intragastric device.
[0016] The method treating obesity can further comprise supplying, using a battery and a current generator coupled to the control unit, an electrical pulse to the first magnetic component to magnetize the first magnetic component in response to the wireless signal received by the wireless communication unit. Supplying the electrical pulse to the first magnetic component can comprise delivering a current through a conductive wire wound around a portion of the first magnetic component.
[0017] An intragastric assembly for weight-loss can comprise a plurality of intragastric space-filling devices. Each of the plurality of intragastric space-filling devices can comprise an electropermanent magnet. The electropermanent magnets can be configured to be magnetized remotely by a portable electronic device. The plurality of intragastric space-filling devices can be configured to magnetically join together into an intragastric space-filling agglomeration when the electropermanent magnets are magnetized by the portable electronic device.
[0018] The plurality of intragastric space-filling devices can be between two and four intragastric space-filling devices. For example, the plurality of intragastric spacefilling devices can be four intragastric space-filling devices. Alternatively, the plurality of intragastric space-filling devices can be between four and twenty intragastric space-filling devices.
[0019] The electropermanent magnets can be configured to be de-magnetized by the portable electronic device. The intragastric space-filling agglomeration can be configured to separate back into the plurality of intragastric space-filling devices when the electropermanent magnets are demagnetized.
[0020] The plurality of intragastric space-filling devices can be substantially shaped as spheres. Alternatively, the plurality of intragastric space-filling devices can be substantially shaped as polyhedrons.
[0021] The intragastric space-filling agglomeration can be sized to be larger than the pyloric sphincter of a patient. Each of the plurality of intragastric space-filling devices can be sized to allow the intragastric space-filling device to pass through the digestive system of the patient to be excreted.
[0022] Each of the electropermanent magnets can be coupled to a control unit. The control unit can comprise a wireless communication unit configured to receive a wireless signal from the portable electronic device over a wireless communication protocol. The wireless communication protocol can be at least one of a Bluetooth™ communication
protocol and a near field communication (NFC) communication protocol. The control unit is coupled to a battery and a current generator. The current generator can be configured to supply an electrical pulse to the electropermanent magnet to magnetize the electropermanent magnet.
[0023] A method of treating obesity can comprise providing a plurality of intragastric space-filling devices to be ingested by a patient. Each of the plurality of intragastric space-filling devices can comprise an electropermanent magnet.
[0024] The method can further comprise remotely magnetizing the electropermanent magnets with a portable electronic device when the plurality of intragastric space-filling devices are within the stomach of the patient. The plurality of intragastric space-filling devices can be configured to magnetically join together into an intragastric space-filling agglomeration when the electropermanent magnets are remotely magnetized by the portable electronic device. Remotely magnetizing the electropermanent magnets with the portable electronic device can comprise transmitting a wireless signal to a wireless communication unit of a control unit coupled to each of the electropermanent magnets. The method can further comprise supplying, using a battery and a current generator coupled to the control unit of each of the electropermanent magnets, an electrical pulse to the electropermanent magnet to magnetize the electropermanent magnet in response to the wireless signal received by the wireless communication unit. Supplying the electrical pulse to the electropermanent magnet can comprise delivering a current through a conductive wire wound around a portion of the electropermanent magnet.
[0025] An intragastric assembly for weight-loss can comprise a plurality of intragastric space-filling vessels. Each of the plurality of intragastric space-filling vessels can comprise a vessel housing comprising a bulbous portion, an elongate narrow portion, a channel extending through the elongate narrow portion and the bulbous portion, and a conduit connecting the channel to an external environment outside of the vessel housing.
[0026] The channel can comprise a magnetic component translatable within the channel and an expandable filling material. The magnetic component can be initially configured to be positioned within a segment of the channel disposed within the elongate narrow portion upon ingestion of the intragastric space-filling vessel by the patient. The plurality of intragastric space-filling vessels can be configured to magnetically join together into an intragastric vessel agglomeration when the magnetic component of each of
the plurality of intragastric space-filling vessels is positioned within the segment of the channel disposed within the elongate narrow portion.
[0027] The filling material within each of the plurality of intragastric space-filling vessels can be configured to expand as fluids from the external environment flows through the conduit into the channel and interacts with the filling material. The magnetic component can be configured to translate into the segment of the channel disposed within the bulbous portion in response to an expansion of the filling material over time. The expansion of the filling material can push or otherwise physically translate the magnetic component into the segment of the channel disposed within the bulbous portion.
[0028] The intragastric vessel agglomeration can be configured to separate back into the plurality of intragastric space-filling vessels when the magnetic component of each of the plurality of intragastric space-filling vessels is translated into the segment of the channel disposed within the bulbous portion. The magnetic component can be a permanent magnet.
[0029] The bulbous portion of the vessel housing can be substantially shaped as an ellipsoid. Alternatively, the bulbous portion of the vessel housing can be substantially shaped as a biconic structure. In some variations, the elongate narrow portion of the vessel housing can be substantially shaped as a cylinder.
[0030] A method of treating obesity can comprise providing a plurality of intragastric space-filling vessels to be ingested by a patient. Each of the plurality of intragastric space-filling vessels can comprise a vessel housing comprising a bulbous portion, an elongate narrow portion, a channel extending through the elongate narrow portion and the bulbous portion, and a conduit connecting the channel to an external environment outside of the vessel housing.
[0031] The channel can further comprise a magnetic component translatable within the channel and an expandable filling material. The magnetic component can be initially configured to be positioned within a segment of the channel disposed within the elongate narrow portion upon ingestion of the plurality of intragastric space-filling vessels by the patient.
[0032] The method can further comprise allowing the plurality of intragastric space-filling vessels to magnetically join together into an intragastric vessel agglomeration within the stomach of the patient when the magnetic component of each of the plurality of intragastric space-filling vessels is positioned within the segment of the channel disposed
within the elongate narrow portion. The method can further comprise allowing the intragastric vessel agglomeration to separate back into the plurality of intragastric spacefilling vessels when a magnetic attraction between the plurality of intragastric space-filling vessels is weakened by the translation of the magnetic component of each of the plurality of intragastric space-filling vessels into the segment of the channel disposed within the bulbous portion.
[0033] The magnetic component can be configured to translate into the segment of the channel disposed within the bulbous portion in response to an expansion of the filling material. The filling material within each of the plurality of intragastric space-filling vessels can be configured to expand as fluids from the external environment flow through the conduit into the channel and interacts with the filling material.
[0034] Another ingestible intragastric device is disclosed comprising a device covering a control unit housed within the device covering and comprising a wireless communication unit configured to receive a wireless signal from a portable electronic device, a first interior chamber housed within the device covering, a second interior chamber housed within the device covering, a first electronic valve connecting an interior of the device covering to the first interior chamber and the second interior chamber, and a second electronic valve connecting the interior of the device covering with an external environment outside of the device covering
[0035] The first interior chamber can comprise a first chemical composition. The first chemical composition can be a weak acid. For example, the weak acid can be acetic acid. The second interior chamber can comprise a second chemical composition. The second chemical composition can be a weak base. For example, the weak base can be sodium bicarbonate.
[0036] The first electronic valve can be electrically coupled to and controllable by the control unit. The first electronic valve can be configured to open in response to a signal received from the control unit. The first chemical composition can be configured to mix with the second chemical composition to produce a gas within the device covering when the first electronic valve is opened. The gas can be configured to inflate the device covering. For example, the gas produced can be carbon dioxide.
[0037] The second electronic valve can be electrically coupled to and controllable by the control unit. The second electronic valve can be configured to open in response to a signal received from the control unit. The gas can be configured to be evacuated from the
interior of the device covering and deflate the device covering when the second electronic valve is opened.
[0038] An additional ingestible intragastric device is disclosed comprising a device covering, a control unit housed within the device covering, a pressure sensor electrically coupled to the control unit and configured to determine an internal pressure within the device covering, a gas cartridge housed within the device covering and comprising a pressurized gas, a first electronic valve coupled to the gas cartridge, and a second electronic valve connecting the interior of the device covering with an external environment outside of the device covering.
[0039] The control unit can further comprise a wireless communication unit configured to receive a wireless signal from a portable electronic device. The first electronic valve can be electrically coupled to and controllable by the control unit. The first electronic valve can be configured to open or close in response to a signal received from the control unit. The pressurized gas can be configured to inflate the device covering when the first electronic valve is opened. The pressurized gas can be at least one of carbon dioxide, nitrogen, and oxygen.
[0040] The second electronic valve can be electrically coupled to and controllable by the control unit. The second electronic valve can be configured to open or close in response to a signal received from the control unit when the internal pressure within the device covering is determined by the pressure sensor to exceed a predetermined threshold pressure. The pressurized gas can be configured to be evacuated from the interior of the device covering and deflate the device covering when the second electronic valve is opened.
[0041] Another ingestible intragastric device is disclosed comprising a device covering configured to contain a compressed gas, a control unit housed within the device covering and comprising a wireless communication unit configured to receive a wireless signal from a portable electronic device, a pressure sensor electrically coupled to the control unit and configured to determine an internal pressure within the device covering, and an electronic valve coupled to a surface of the device covering and connecting the interior of the device covering with an external environment outside of the device covering.
[0042] The electronic valve can be electrically coupled to and controllable by the control unit. The electronic valve can be configured to open or close in response to a signal received from the control unit when the internal pressure within the device covering is
determined by the pressure sensor to exceed a predetermined threshold pressure. The compressed gas can be configured to be evacuated from the interior of the device covering and deflate the device covering when the electronic valve is opened. In some instances, the compressed gas used can be liquefied nitrogen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] Fig. 1A illustrates an example method for treating obesity using an expandable and contractible intragastric space-filling device.
[0044] Fig. IB illustrates an example method for treating obesity using a plurality of intragastric space-filling devices configured to join together into a space-filling agglomeration and, subsequently, separate back into the plurality of intragastric spacefilling devices.
[0045] Fig. 2A illustrates an example of an electropermanent magnet switched on by a pulse of electric current sent through a conductive coil wrapped around a portion of the electropermanent magnet in a first direction.
[0046] Fig. 2B illustrates the electropermanent magnet of Fig. 2A switch off by a pulse of electric current sent through the conductive coil wrapped around the portion of the electropermanent magnet in a second direction.
[0047] Fig. 3 illustrates an example of a control unit configured to control the intragastric space-filling devices described herein.
[0048] Fig. 4 illustrates an example of a control unit coupled to an electropermanent magnet configured to receive a wireless signal from a portable electronic device over a wireless communication protocol.
[0049] Figs. 5 A to 5D illustrate various mechanisms for actuating the expansion of an ingestible intragastric space-filling device using a first magnetic component and a second magnetic component.
[0050] Fig. 6A illustrates an example of a Hoberman- style ingestible intragastric device.
[0051] Fig. 6B illustrates an example of an origami ball-style ingestible intragastric device.
[0052] Fig. 7A illustrates an example of an intragastric assembly comprising a plurality of intragastric space-filling devices joined together into an intragastric spacefilling agglomeration.
[0053] Fig. 7B illustrates an example of the intragastric space-filling agglomeration of Fig. 7A broken up into its constituent intragastric space-filling devices.
[0054] Fig. 8 illustrates a side cross-sectional view of an example of an intragastric space-filling vessel.
[0055] Fig. 9A illustrates a side cross-sectional view of a plurality of intragastric space-filling vessels joined together into an intragastric vessel agglomeration.
[0056] Fig. 9B illustrates a side cross-sectional view of the intragastric vessel agglomeration broken up or separated into its constituent intragastric space-filling vessels.
[0057] Fig. 10 illustrates another example of an ingestible intragastric device.
[0058] Fig. 11 illustrates yet another example of an ingestible intragastric device.
[0059] Fig. 12 illustrates an additional example of an ingestible intragastric device.
[0060] Fig. 13 illustrates an example of a biodegradable intragastric device
DETAILED DESCRIPTION
[0061] It is to be understood that the specific details disclosed herein are not to be interpreted as limiting, but rather as a representative basis for teaching one skilled in the art how to employ the present disclosure in virtually any detailed system, structure, or manner.
[0062] The devices, assemblies, systems, and methods disclosed herein are suited not only for the treatment of obesity but also for treating other ailments, such as improper glucose tolerance in a diabetic or pre-diabetic subject and the progression of diabetes itself by inhibiting fasting insulin secretion or glucose-stimulated insulin secretion. The devices of the present disclosure are also suited for treating other ailments deriving from obesity, including hyperphagia, dyslipidemia, Prader Willi syndrome, Froelich's syndrome, Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesen syndrome, Bardet-Biedl syndrome, or hyperlipoproteinemia, types I, II, III, and IV, etc. The devices, assemblies, and systems disclosed herein are well tolerated by the stomach and in general, by the gastrointestinal tract.
[0063] Fig. 1A illustrates an example method for treating obesity using an expandable and contractible intragastric space-filling device 100. Fig. 1A shows the expandable and contractible intragastric space-filling device 100 within the stomach of a
patient after the intragastric space-filling device 100 has been orally ingested by the patient. For example, the intragastric space-filling device 100 can have the form factor of a pill or capsule. The esophagus (shown as ES), pylorus (shown as PY) and duodenum (shown as DU) of the patient are also depicted in Fig. 1A for reference.
[0064] The intragastric space-filling device 100 can expand automatically within the stomach of the patient or expand in response to an action taken by a clinician, healthcare provider, or patient. The intragastric space-filling device 100 can be expanded through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof). The intragastric space-filling device 100 can remain in the expanded configuration for a period of time between approximately 1 month and 12 months. In other variations, the intragastric spacefilling device 100 can remain in the expanded configuration for a period of time between approximately 12 months and 36 months.
[0065] The intragastric space-filling device 100 can be configured such that the intragastric space-filling device 100 in the expanded configuration is unable to pass through the pylorus and remains within the stomach. As the patient ingests food or liquids, the stomach can contract and relax, repeatedly (through peristalsis) and the intragastric space-filling device 100 in the expanded configuration can be propelled or otherwise moved by peristaltic waves through the stomach towards the pylorus. The intragastric space-filling device 100 in the expanded configuration can take up space within the stomach of the patient. The intragastric space-filling device 100 in the expanded configuration can also intermittently obstruct the pylorus. In all such cases, the intragastric space-filling device 100 in the expanded configuration can enhance or trigger the patient's feeling of satiety and result in the patient reducing their overall level of food intake.
[0066] As depicted in Fig. 1A, the intragastric space-filling device 100 can also contract or shrink in size from the expanded configuration into a contracted configuration. The intragastric space-filling device 100 can be contracted or shrunk in size once the treatment period has ended or once the patient has met his or her weight-loss goals. The intragastric space-filling device 100 can be contracted or shrunk through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof). Once the intragastric space-filling device 100 has contracted in size from the expanded configuration into the contracted configuration, the intragastric space-filling device 100 can pass through the pylorus and
duodenum into the intestines of the patient. The intragastric space-filling device 100 in the contracted configuration can then pass out of the body of the patient.
[0067] Fig. IB illustrates an example method for treating obesity using a plurality of intragastric space-filling devices 102 configured to join together into a space-filling agglomeration 104 and, subsequently, separate back into the plurality of intragastric spacefilling devices 102. Fig. IB shows the plurality of intragastric space-filling devices 102 within the stomach of a patient after the plurality of intragastric space-filling devices 102 have been orally ingested by the patient. For example, the intragastric space-filling devices 102 can each have the form factor of a pill or capsule. The esophagus (shown as ES), pylorus (shown as PY) and duodenum (shown as DU) of the patient are also depicted in Fig. IB for reference.
[0068] The plurality of intragastric space-filling devices 102 can join together automatically within the stomach of the patient or join together in response to an action taken by a clinician, health-care provider, or patient. The plurality of intragastric space- filling devices 102 can be joined together through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof). The plurality of intragastric space-filling devices 102 can join together into the space-filling agglomeration 104 for a period of time between approximately 1 month and 12 months. In other variations, the plurality of intragastric space-filling devices 102 can join together into the space-filling agglomeration 104 for a period of time between approximately 12 months and 36 months.
[0069] The plurality of intragastric space-filling devices 102 can be configured such that the space-filling agglomeration 104 formed by the accumulated intragastric space-filling devices 102 is unable to pass through the pylorus and remains within the stomach. As the patient ingests food or liquids, the stomach can contract and relax, repeatedly (through peristalsis) and the space-filling agglomeration 104 can be propelled or otherwise moved by peristaltic waves through the stomach towards the pylorus. The spacefilling agglomeration 104 can take up space within the stomach of the patient. The spacefilling agglomeration 104 can also intermittently obstruct the pylorus. In all such cases, the space-filling agglomeration 104 can enhance or trigger the patient's feeling of satiety and result in the patient reducing their overall level of food intake.
[0070] As depicted in Fig. IB, the space-filling agglomeration 104 can also break apart or separate back into the plurality of intragastric space-filling devices 102. The spacefilling agglomeration 104 can break apart or separate back into the plurality of intragastric
space-filling devices 102 once the treatment period has ended or once the patient has met his or her weight-loss goals. The space-filling agglomeration 104 can separate or break apart through various mechanisms as described herein (including through remote wireless actuation, mechanical actuation, chemical reactions, or a combination thereof). Once the space-filling agglomeration 104 has broken apart or separated into the plurality of intragastric space-filling devices 102, each of the intragastric space-filling devices 102 can individually pass through the pylorus and duodenum into the intestines of the patient. Each of the intragastric space-filling devices 102 can then pass out of the body of the patient.
[0071] Fig. 2A illustrates a variation of an electropermanent magnet 200 switched to an ON configuration 202 by a pulse of electric current sent through a conductive wire 204 in a first direction 206. In addition, Fig. 2B illustrates that the electropermanent magnet 200 of Fig. 2A can be switched to an OFF configuration 210 by a pulse of electric current sent through the conductive wire 204 in a second direction 208. As shown in Figs. 2A and 2B, the conductive wire 204 can be wrapped or wound around a portion of the electropermanent magnet 200.
[0072] The electropermanent magnet 200 can comprise a hard magnetic material
212, a semi-hard magnetic material 213, and a soft magnetic material 214. The hard magnetic material 212 can have a greater intrinsic coercivity than the semi-hard magnetic material 213 and the soft magnetic material 214. The soft magnetic material 214 can have the lowest intrinsic coercivity of the three materials.
[0073] As shown in Figs. 2 A and 2B, the soft magnetic material 214 can connect or otherwise couple the hard magnetic material 212 to the semi-hard magnetic material 213. For example, the electropermanent magnet 200 can comprise two instances of the soft magnetic material 214 with each instance of the soft magnetic material 214 connecting or otherwise coupling the hard magnetic material 212 to the semi-hard magnetic material 213. The soft magnetic material 214 can connect or otherwise couple the poles or ends of the hard magnetic material 212 to the semi-hard magnetic material 213. In some variations, the soft magnetic material 214 can act as caps to the hard magnetic material 212 and the semihard magnetic material 213 or act as bridges between the hard magnetic material 212 and the semi-hard magnetic material 213. Although Figs. 2A and 2B illustrate the electropermanent magnet 200 shaped substantially as a stadium or oval, it is contemplated by this disclosure and it should be understood by one of ordinary skill in the art that the electropermanent magnet 200 can be substantially shaped as a cuboid or other polyhedron, a disk, an annular ring, or a combination thereof.
[0074] In some variations, the hard magnetic material 212 can be or comprise one or more neodymium iron boron (NdFeB) magnets (intrinsic coercivity of approximately 1120kA/m). The hard magnetic material 212 can be substantially shaped as a cuboid, a cylinder, a conic or frustoconic, or a combination thereof. In these and other variations, the semi-hard magnetic material 213 can be or comprise one or more aluminum nickel cobalt (AINiCo) magnets (intrinsic coercivity of approximately 50kA/m). The semi-hard magnetic material 213 can be substantially shaped as a cuboid, a cylinder, a conic or frustoconic, or a combination thereof. In some variations, the soft magnetic material 214 can be or comprise one or more iron (Fe) magnets.
[0075] The conductive wire 204 can be coiled, wrapped, or otherwise wound (as a solenoid) around the semi-hard magnetic material 213. For example, the conductive wire 204 can be or comprise copper wire. As a more specific example, the conductive wire 204 can be coiled, wrapped, or otherwise wound around the AINiCo magnet or AINiCo portion of the electropermanent magnet 200.
[0076] An electrical pulse can be supplied to the electropermanent magnet 200 to magnetize the electropermanent magnet 200. As a more specific example, an electrical pulse can be supplied to the electropermanent magnet 200 when a current is delivered through the conductive wire 204 in a first direction 206 for a brief period of time. As shown in Figs. 2A and 2B, a current generator 216 can supply the electrical pulse to the electropermanent magnet 200 by generating a current to flow through the conductive wire 204 wrapped or coiled around the semi-hard magnetic material 213. In some variations, the current generator 216 can be a direct current (DC) generator. For example, the current generator 216 can generate a current of approximately 50 mA for approximately between 1 to 2 seconds to magnetize the electropermanent magnet 200. In other examples, the current generator 216 can generate a current between approximately 50 mA and 100 mA (or a higher current) for approximately 1 to 5 seconds (or longer) to magnetize the electropermanent magnet 200.
[0077] Once the electrical pulse is applied, the semi-hard magnetic material 213 can be magnetized in a direction aligned with the direction of the temporary magnetic field generated by the solenoid or wound conductive wire 204. In addition, once the semi-hard magnetic material 213 is magnetized in the same direction as the hard magnetic material 212, a polarity 217 of the semi-hard magnetic material 213 matches a polarity 219 of the hard magnetic material 212. When the polarity 217 of the semi-hard magnetic material 213 is aligned or matches with the polarity 219 of the hard magnetic material 212, an external
magnetic field 218 or the external magnetic flux around the entire electropermanent magnet 200 is enhanced or otherwise increased and the entire electropermanent magnet 200 is magnetized or switched to the ON configuration 202.
[0078] As illustrated in Fig. 2B, another electrical pulse can also be applied to magnetize the semi-hard magnetic material 213 in an opposite direction. For example, another current can be delivered through the conductive wire 204 in a second direction 208 opposite the first direction. For example, the current generator 216 can generate another approximately 50 mA (or higher) current for approximately between 1 to 2 seconds (or longer) to de-magnetize the electropermanent magnet 200. In doing so, the semi-hard magnetic material 213 can be magnetized in a direction opposite the hard magnetic material 212. When the polarity 217 of the semi-hard magnetic material 213 is opposite the polarity 219 of the hard magnetic material 212, the magnetic flux 220 will be concentrated or circulate within the electropermanent magnet 200 and the magnetic flux outside of the electropermanent magnet 200 will be reduced or diminished to almost non-existent or insignificant levels. When the magnetic flux outside of the electropermanent magnet 200 is reduced or diminished to almost non-existent or insignificant levels, the entire electropermanent magnet 200 is considered to be de-magnetized or switched to the OFF configuration 210.
[0079] One or more electropermanent magnets 200 can be housed within an intragastric space-filling device 100. In some variations, the one or more electropermanent magnets 200 can be magnetized to actuate the expansion or contraction of the intragastric space-filling device 100 within the stomach of a patient. In other variations, the one or more electropermanent magnets 200 can be de-magnetized to actuate the expansion or contraction of the intragastric space-filling device 100 within the stomach of a patient. As will be discussed in more detail in the following sections, multiple electropermanent magnets 200 can be housed within the intragastric space-filling device 100 to expand and/or contract the intragastric space-filling device 100. In other variations, one electropermanent magnet 200 and one or more other types of magnets can be housed within the intragastric space-filling device 100 to expand and/or contract the intragastric space- filling device 100.
[0080] In other variations, one or more electropermanent magnets 200 can be housed within each of the plurality of intragastric space-filling devices 102. In some variations, the one or more electropermanent magnets 200 can be magnetized to cause the plurality of intragastric space-filling devices 102 to join together into a space-filling
agglomeration 104. In these and other variations, the one or more electropermanent magnets 200 can be de-magnetized to cause the space-filling agglomeration 104 to break apart or separate back into the plurality of intragastric space-filling devices 102 for passage through the gastrointestinal tract of the patient.
[0081] The electropermanent magnet 200 can have a length dimension, a width dimension, and a thickness or height dimension. In some variations, the length dimension of the electropermanent magnet 200 can be between approximately 10.00 mm and 31.75 mm. For example, the length dimension of the electropermanent magnet 200 can be approximately 12.00 mm. In these and other variations, the width dimension of the electropermanent magnet 200 can be between approximately 5.00 mm and 12.70 mm. For example, the width dimension of the electropermanent magnet 200 can be approximately 7.00 mm. In these and other variations, the height dimension of the electropermanent magnet 200 can be between approximately 5.00 mm and 12.70 mm. For example, the height dimension of the electropermanent magnet 200 can be approximately 7.00 mm.
[0082] Fig. 3 illustrates a variation of a control unit 300 configured to control the expandable intragastric space-filling device 100, each of the plurality of intragastric spacefilling devices 102, or a combination thereof. The control unit 300 can be placed within the expandable intragastric space-filling device 100 or within each of the plurality of intragastric space-filling devices 102. As will be discussed in the following sections, the control unit 300 can also be electrically coupled to one or more electropermanent magnets 200 within the expandable intragastric space-filling device 100 or within each of the plurality of intragastric space-filling devices 102.
[0083] The control unit 300 can comprise one or more processors 302, a memory
304, and a wireless communication unit 306 coupled to a printed circuit board (PCB) 308 or a flexible circuit board. A battery 310 can be coupled to and supply power to the control unit 300. The battery 310 can also supply power to other electronic components coupled to the control unit 300 such as the current generator 216.
[0084] The processor 302 can be or comprise a processor chip, an embedded processor, a processor core, a microprocessor, a logic circuit, a hardware FSM, a DSP, or a combination thereof. As a more specific example, the processor 302 can be a 32-bit processor such as an ARM™ processor. The memory 304 can be random-access memory (RAM), read-only memory (ROM), non-volatile random-access memory (NVRAM), or a combination thereof. The memory 304 can store instructions or firmware to be executed by
the processor 302. The memory 304 can also store data collected by one or more sensors coupled to or in communication with the control unit 300.
[0085] The wireless communication unit 306 can be or comprise a Bluetooth® communication module, a near-field communication (NFC) module, or a combination thereof. In some variations, the wireless communication unit 306 can be or comprise a Bluetooth® low energy (BLE) module. In other variations, the wireless communication unit 306 can be a radio-frequency identification (RFID) chip or module. The wireless communication unit 306 can also comprise one or more memory units such as RAM, ROM, or a combination thereof.
[0086] When the wireless communication unit 306 is a Bluetooth® module, the antenna of the wireless communication unit 306 can be a Bluetooth® antenna. In these and other variations, the control unit 300 can be run by a processor within the wireless communication unit 306, such as a processor within a Bluetooth® module.
[0087] In other variations, the wireless communication unit 306 can be or comprise an NFC module. In these variations, the NFC module can be coupled to the processor 302 via an I C interface or other ports. When the wireless communication unit 306 is an NFC module, the antenna of the wireless communication unit 306 can be an NFC antenna. The NFC antenna can have a range of between approximately 15.0 cm and 20.0 cm. In some variations, multiple NFC modules or chips can be coupled to the control unit 300 with some having shorter or longer communication ranges. For example, an NFC module or chip with a communication range of between approximately 5.00 cm to 10.0 cm can be used in addition to an NFC module or chip with a communication range of between approximately 15.0 cm and 20.0 cm. This way, the same portable electronic device 400 (see Fig. 4) can be used to track the location of the control unit 300 (and, hence, the location of the ingestible intragastric device(s)) within the body of the patient based on the signal(s) received (or not received) from the multiple NFC modules or chips.
[0088] The battery 310 can be a cell or coin battery. The battery 310 can have a voltage of between approximately 1.2 V and 3.0 V. For example, the battery 310 can have a voltage of approximately 1.5 V. In some variations, the battery 310 can be a lithium- iodine battery, a lithium-manganese dioxide battery, or a lithium-carbon monofluoride battery. In other variations, the battery 310 can be a biocompatible battery suitable for implantable medical devices.
[0089] Fig. 4 illustrates a variation of the control unit 300 coupled to an electropermanent magnet 200 configured to receive a wireless signal from a portable
electronic device 400 over a wireless communication protocol 402. The portable electronic device 400 can be or comprise a smartphone, a tablet computer, a laptop, a smartwatch, a personal entertainment device, or a combination thereof. In other variations not shown in Fig. 4, the portable electronic device 400 can be a desktop computer, a workstation, a handheld device, or a combination thereof. The portable electronic device 400 can have at least a device processor, a device memory, and a device communication unit.
[0090] The portable electronic device 400 can transmit a wireless signal over a wireless communication protocol 402 to the wireless communication unit 306 of the control unit 300. The wireless communication protocol 402 can be a Bluetooth® or BLE communication protocol, an NFC communication protocol, an air- interface protocol, or a combination thereof. The portable electronic device 400 can transmit instructions to the control unit 300 via the wireless communication protocol 402.
[0091] As will be discussed in more detail in the following sections, the portable electronic device 400 can instruct the control unit 300 within the ingestible intragastric devices described herein to magnetize or de-magnetize one or more electropermanent magnets 200 within the ingestible intragastric devices. In addition, the portable electronic device 400 can also instruct the control unit 300 to retrieve sensor data from one or more sensors within the ingestible intragastric devices. The portable electronic device 400 can wirelessly communicate with the control unit 300 within the ingestible intragastric devices when the ingestible intragastric devices are within the stomach of a patient and the portable electronic device 400 is outside the body of the patient. Although one portable electronic device 400 and one control unit 300 are shown in Fig. 4, it is contemplated by this disclosure that one portable electronic device 400 can wirelessly communicate with multiple control units 300 and that multiple portable electronic devices 400 can be used to wirelessly communicate with the same or different control units 300.
[0092] Figs. 5A to 5D illustrate various mechanisms for actuating the expansion of an ingestible intragastric space-filling device 100 using a first magnetic component 500 and a second magnetic component 502. Figs. 5A and 5B show the first magnetic component 500 and the second magnetic component 502 as two electropermanent magnets 200.
[0093] Fig. 5A illustrates the first magnetic component 500 in the OFF configuration 210 (de-magnetized) and the second magnetic component 502 in the ON configuration 202 (magnetized). In these configurations, the first magnetic component 500 can be positioned close to or overlapping with the second magnetic component 502 without the magnetic components magnetically repelling one another. For example, when the first
magnetic component 500 and the second magnetic component 502 are in these configurations, the ingestible intragastric space-filling device 100 can be in a collapsed or contracted configuration for ingestion by a patient.
[0094] For example, once the intragastric space-filling device 100 has been ingested by the patient, a portable electronic device 400 (see Fig. 4) can be used to transmit a signal to the control unit 300 to instruct one or more current generators 216 to send an electrical pulse (i.e., a short burst of current through the conductive wire 204) to demagnetize the first magnetic component 500 and to magnetize the second magnetic component 502. This can be done before the intragastric space-filling device 100 is ingested by the patient. The portable electronic device 400 can be used to transmit another signal to the control unit 300 to send an additional electrical pulse via one of the current generators 216 to the first magnetic component 500.
[0095] Fig. 5B illustrates both the first magnetic component 500 and the second magnetic component 502 in the ON configuration 202. For example, the first magnetic component 500 can be in the ON configuration 202 once the portable electronic device 400 has transmitted a signal to the control unit 300 to send an additional electrical pulse via one of the current generators 216 to the first magnetic component 500. As a more specific example, by sending the additional electrical pulse to the first magnetic component 500, the polarity of the semi-hard magnetic material 213 can be flipped such that it matches the polarity of the hard magnetic material 212.
[0096] The first magnetic component 500 and the second magnetic component 502 can be arranged such that the two magnetic components repel one another when the first magnetic component 500 and the second magnetic component 502 are both in the ON configuration 202. For example, in one variation, the like-poles of the first magnetic component 500 and the second magnetic component 502 can be positioned close to or abutting one another when at least one of the magnetic components is demagnetized. As a more specific example, when the first magnetic component 500 and the second magnetic component 502 are both electropermanent magnets 200, the poles of the magnetic components can be determined based on the polarity of the hard magnetic material 212 having the higher coercivity. As will be discussed in more detail in the following sections, the first magnetic component 500 and the second magnetic component 502 can be affixed or otherwise attached or otherwise coupled to different parts of a frame serving as a support for the ingestible intragastric space-filling device 100. When the first magnetic component 500 is repelled by the second magnetic component 502 (or vice versa), the frame can
change its shape (e.g., expand or contort) and, as a result, change the shape of the ingestible intragastric space-filling device 100.
[0097] Although Fig. 5A illustrates the second magnetic component 502 as being initially in the ON configuration 202, it is contemplated by this disclosure that the second magnetic component 502 can also be switched to the OFF configuration 210 such that both the first magnetic component 500 and the second magnetic component 502 are in the OFF configuration 210 when the intragastric space-filling device 100 is ready to be ingested by the patient.
[0098] In an alternative variation, the first magnetic component 500 and the second magnetic component 502 can both be switched to the ON configuration 202 immediately prior to the intragastric space-filling device 100 being ingested by the patient. In this variation, the intragastric space-filling device 100 can be designed such that the frame of the device expands gradually when the first magnetic component 500 and the second magnetic component 502 are both switched to the ON configuration 202.
[0099] In some variations, at least one of the first magnetic component 500 and the second magnetic component 502 can be switched to the OFF configuration 210 when it comes time for the intragastric space-filling device 100 to shrink into a compressed or contracted configuration for passage out of the body of the patient. For example, the portable electronic device 400 can be used to transmit a signal to the control unit 300 to instruct the one or more current generators 216 to send additional electrical pulses to demagnetize both the first magnetic component 500 and the second magnetic component 502.
[0100] In another alternative variation contemplated by the present disclosure, the first magnetic component 500 and the second magnetic component 502 can be arranged such that the opposite poles of the two magnetic components face one another. The first magnetic component 500 and the second magnetic component 502 can both initially be switched to the OFF configuration 210 (i.e., de-magnetized). In this variation, the intragastric space-filling device 100 can be ingested by the patient when both the first magnetic component 500 and the second magnetic component 502 are in the OFF configuration 210. The intragastric space-filling device 100 can expand once within the stomach of the patient as a result of mechanical actuation means, shape-memory recovery, chemical reactions occurring within the intragastric space-filling device 100, or a combination thereof. Both the first magnetic component 500 and the second magnetic component 502 can be switched to the ON configuration 202 (i.e., magnetized) when it comes time for the intragastric space-filling device 100 to shrink into a compressed or
contracted configuration for passage out of the body of the patient. For example, once the first magnetic component 500 and the second magnetic component 502 are switched to the ON configuration 202, the opposite poles of the two magnetic components can attract one another and the two magnetic components can urge the intragastric space-filling device 100 (or a frame attached to the intragastric space-filling device 100) into the collapsed or contracted configuration.
[0101] Figs. 5C and 5D illustrate instances where the second magnetic component
502 is a permanent magnet 504. For example, the permanent magnet 504 can be or comprise a hard magnetic material with a high coercivity. For example, the permanent magnet 504 can be a neodymium iron boron (NdFeB) magnet. The mechanisms shown in Figs. 5C and 5D can operate similar to the mechanisms shown Figs. 5A and 5B except for the second magnetic component 502 is unable to be manipulated (i.e., unable to be electrically de-magnetized) by the control unit 300. One benefit of the mechanisms shown in Figs. 5C and 5D is a reduction in the cost to produce such mechanisms relative to the mechanisms shown in Figs. 5A and 5B. Moreover, another benefit of the mechanisms shown in Figs. 5C and 5D is a reduction in the complexity of such mechanisms.
[0102] Fig. 6A is an example of a Hoberman-style ingestible intragastric device
600 in a contracted configuration 606 and subsequently enlarged to an expanded configuration 608. The Hoberman-style ingestible intragastric device 600 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A). As shown in Fig. 6A, the Hoberman-style ingestible intragastric device 600 can comprise an expandable frame 602 covered or completely encompassed by a device covering 604.
[0103] The expandable frame 602 can be or comprise an expandable Hoberman structure as shown in Fig. 6A. The expandable frame 602 can be fabricated from or comprise polyether ether ketone (PEEK) or other types of lightweight biocompatible polymers. In other variations, the expandable frame 602 can be fabricated from or comprise fluoropolymers, polycarbonate, stainless steel, or a combination thereof.
[0104] The device covering 604 can encompass or completely cover the entire expandable frame 602 and any electronic components or magnetic components attached or otherwise coupled to the expandable frame 602. The device covering 604 can be an intragastric balloon or another type of biocompatible expandable shell. For example, the device covering 604 can be any type of balloon or covering disclosed in U.S. Patent
Application No. 12/434,594, filed on May 1, 2009, the content of which is incorporated herein by reference in its entirety.
[0105] In some variations, the device covering 604 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof. The device covering 604 can be affixed or otherwise coupled to certain parts of the expandable frame 602. As such, expansion of the expandable frame 602 can cause the device covering 604 to expand.
[0106] Although not shown in the figures, the device covering 604 can initially be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606. The device covering 604 can be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606 to maintain the Hoberman- style ingestible intragastric device 600 in the contracted configuration 606 and to prevent the device covering 604 from inadvertently expanding prior to entry into the stomach of the patient. The dissolvable polymeric layer can be dissolved by gastric acids within the stomach of the patient.
[0107] As shown in Fig. 6A, the Hoberman-style ingestible intragastric device 600 can further comprise at least a first magnetic component 500, a second magnetic component 502, the control unit 300, and one or more current generators 216. The first magnetic component 500 and the second magnetic component 502 can be attached or otherwise coupled to parts of the expandable frame 602. The first magnetic component 500 and the second magnetic component 502 can be positioned or forced closer together when the Hoberman-style ingestible intragastric device 600 is compressed into the contracted configuration 606. As discussed in the preceding sections with respect to the mechanisms shown in Figs. 5A to 5D, at least one of the first magnetic component 500 and the second magnetic component 502 can be magnetized to actuate the expansion of the expandable frame 602. For example, both the first magnetic component 500 and the second magnetic component 502 can be magnetized by the control unit 300 coupled to a part of the expandable frame 602 via the one or more current generators 216. Magnetizing both of the magnetic components can cause the like-poles of the magnetic components to repel one another and, in turn, open up or expand the expandable frame 602. In some variations, one of the first magnetic component 500 or the second magnetic component 502 can also be a permanent magnet 504.
[0108] The Hoberman-style ingestible intragastric device 600 can be expanded when situated within the stomach of a patient. A portable electronic device 400 (see Fig. 4)
outside the body of the patient can be used to transmit a wireless signal to the control unit 300 within the Hoberman-style ingestible intragastric device 600 to magnetize one or more of the magnetic components and expand the Hoberman-style ingestible intragastric device 600 into the expanded configuration 608.
[0109] The Hoberman-style ingestible intragastric device 600 can have a maximum diameter of between approximately 10.0 mm and 15.0 mm when in the contracted configuration 606. For example, the Hoberman-style ingestible intragastric device 600 can have a diameter of approximately 12.0 mm when in the contracted configuration 606. In addition, the Hoberman-style ingestible intragastric device 600 can have a maximum diameter of between approximately 25.0 mm and 60.0 mm when in the expanded configuration 608. For example, the Hoberman-style ingestible intragastric device 600 can have a diameter of approximately 30.0 mm when in the expanded configuration 608.
[0110] As previously discussed, when it comes time to remove the Hoberman-style ingestible intragastric device 600 from the stomach of the patient, the portable electronic device 400 can be used once again to transmit another wireless signal to the control unit 300 to de-magnetize one or more of the magnetic components. Once the two magnetic components no longer magnetically repel one another, the expandable frame 602 (e.g., the Hoberman structure) can gradually collapse or shrink back into the contracted configuration 606. When the Hoberman-style ingestible intragastric device 600 is compressed or otherwise returns to the contracted configuration 606, the Hoberman-style ingestible intragastric device 600 can eventually be passed out of the gastrointestinal tract of the patient.
[0111] Moreover, although one Hoberman-style ingestible intragastric device 600 is shown in Fig. 6A, it is contemplated by this disclosure that multiple Hoberman-style ingestible intragastric devices 600 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s).
[0112] Fig. 6B is an example of an origami ball-style ingestible intragastric device
610 in a contracted configuration 606 and subsequently enlarged to an expanded configuration 608. The origami ball-style ingestible intragastric device 610 can be another type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A). As shown in Fig. 6B, the origami ball- style ingestible intragastric device 610 can comprise an expandable frame 602 covered or completely encompassed by a device covering 604.
[0113] The expandable frame 602 can be or comprise a thin-layer scaffold folded into an expandable origami-style structure as shown in Fig. 6B. The expandable frame 602 can be folded from cellulose-based paper, biofunctionalized paper, hydrogel-laden paper scaffold, shrink film, polyester and vinyl films, or any other type of biocompatible thin sheets or films.
[0114] The device covering 604 can encompass or completely cover the entire expandable frame 602 and any electronic components or magnetic components attached or otherwise coupled to the interior of the expandable frame 602. As previously discussed, the device covering 604 can be an intragastric balloon or another type of biocompatible expandable shell. For example, the device covering 604 can be any type of balloon or covering disclosed in U.S. Patent Application No. 12/434,594, filed on May 1, 2009, the content of which is incorporated herein by reference in its entirety.
[0115] In some variations, the device covering 604 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof. The device covering 604 can be affixed or otherwise coupled to certain parts of the expandable frame 602. As such, expansion of the expandable frame 602 can cause the device covering 604 to expand.
[0116] Although not shown in the figures, the device covering 604 can initially be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606. The device covering 604 can be coated and constrained by a dissolvable polymeric layer when in the contracted configuration 606 to maintain the origami ball-style ingestible intragastric device 610 in the contracted configuration 606 and to prevent the device covering 604 from inadvertently expanding prior to entry into the stomach of the patient. The dissolvable polymeric layer can be dissolved by gastric acids within the stomach of the patient.
[0117] As shown in Fig. 6B, the origami ball-style ingestible intragastric device
610 can further comprise at least a first magnetic component 500, a second magnetic component 502, the control unit 300, and one or more current generators 216. The first magnetic component 500 and the second magnetic component 502 can be attached or otherwise coupled to parts of the expandable frame 602. The first magnetic component 500 and the second magnetic component 502 can be positioned or forced closer together when the origami ball-style ingestible intragastric device 610 is compressed into the contracted configuration 606. As discussed in the preceding sections with respect to the mechanisms shown in Figs. 5A to 5D, at least one of the first magnetic component 500 and the second
magnetic component 502 can be magnetized to actuate the expansion of the expandable frame 602. For example, both the first magnetic component 500 and the second magnetic component 502 can be magnetized by the control unit 300 coupled to a part of the expandable frame 602 via the one or more current generators 216. Magnetizing both of the magnetic components can cause the like-poles of the magnetic components to repel one another and, in turn, open up or expand the expandable frame 602. In some variations, one of the first magnetic component 500 or the second magnetic component 502 can also be a permanent magnet 504.
[0118] The origami ball-style ingestible intragastric device 610 can be expanded when situated within the stomach of a patient. A portable electronic device 400 (see Fig. 4) outside the body of the patient can be used to transmit a wireless signal to the control unit 300 within the origami ball-style ingestible intragastric device 610 to magnetize one or more of the magnetic components and expand the origami ball-style ingestible intragastric device 610 into the expanded configuration 608.
[0119] The origami ball-style ingestible intragastric device 610 can have a maximum diameter of between approximately 10.0 mm and 15.0 mm when in the contracted configuration 606. For example, the origami ball- style ingestible intragastric device 610 can have a diameter of approximately 12.0 mm when in the contracted configuration 606. In addition, the origami ball-style ingestible intragastric device 610 can have a maximum diameter of between approximately 25.0 mm and 60.0 mm when in the expanded configuration 608. For example, the origami ball- style ingestible intragastric device 610 can have a diameter of approximately 30.0 mm when in the expanded configuration 608.
[0120] As previously discussed, when it comes time to remove the origami ball- style ingestible intragastric device 610 from the stomach of the patient, the portable electronic device 400 can be used once again to transmit another wireless signal to the control unit 300 to de-magnetize one or more of the magnetic components. Once the two magnetic components no longer magnetically repel one another, the expandable frame 602 (e.g., the origami ball scaffold) can gradually collapse or shrink back into the contracted configuration 606. When the origami ball-style ingestible intragastric device 610 is compressed or otherwise returns to the contracted configuration 606, the origami ball-style ingestible intragastric device 610 can eventually be passed out of the gastrointestinal tract of the patient. Although Fig. 6B shows a contracted origami cylinder expanded into an origami ball, it is contemplated by this disclosure that other origami (or foldable) structures
can be used such as origami boxes, origami stars, origami pyramids, origami-lantern structures, or a combination thereof.
[0121] Moreover, although one origami ball-style ingestible intragastric device 610 is shown in Fig. 6B, it is contemplated by this disclosure that multiple origami ball-style ingestible intragastric devices 610 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s).
[0122] Fig. 7 A is an example of an intragastric assembly 700 comprising a plurality of intragastric space-filling devices 702 joined together into an intragastric space-filling agglomeration 704. The intragastric space-filling devices 702 shown in Figs. 7A and 7B can be one type of the intragastric space-filling devices 102 shown in Fig. IB.
[0123] As shown in Fig. 7A, each of the intragastric space-filling devices 702 can comprise an electropermanent magnet 200, a control unit 300, and a current generator 216 (see Fig. 4). The electropermanent magnet 200, the control unit 300, and the current generator 216 can be contained within a device shell 706. In some variations, the device shell 706 can be inflatable or fillable such that an interior of the device shell 706 is hollow or taken up by air, other fluids, or a fillable substance. In these variations, the device shell 706 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, polytetrafluoroethylene (PTFE), or a combination thereof. The device shell 706 can comprise a frame structure (not shown in Figs. 7 A and 7B) and the electropermanent magnet 200, the control unit 300, and the current generator 216 can be coupled to the frame structure.
[0124] In other variations, the device shell 706 can be a solid structure having voids, channels, or cavities for holding the electropermanent magnet 200, the control unit 300, and the current generator 216. In these variations, the device shell 706 can be fabricated from or comprise biocompatible polymers, elastic polymers, ceramics, or a combination thereof. In some variations, the device shell 706 can be fabricated from PEEK, polycarbonate, medical-grade polyvinyl chloride, rubber, or a combination thereof. In alternative variations, the device shell 706 can be fabricated from or comprise a thin-walled metallic material
[0125] As depicted in Fig. 7A, the electropermanent magnet 200 can be positioned or affixed near a surface of the device shell 706. This can allow the magnetic flux generated by the electropermanent magnet 200 to permeate beyond the surface of the device shell 706 and allow multiple intragastric space-filling devices 702 to magnetically join together when the electropermanent magnets 200 are magnetized.
[0126] Although Fig. 7A illustrates four intragastric space-filling devices 702 joining together to form the intragastric space-filling agglomeration 704, it is contemplated by this disclosure that the intragastric assembly 700 can comprise between five and twenty intragastric space-filling devices 702. For example, the intragastric assembly 700 can comprise five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, or twenty intragastric space-filling devices 702. In other variations, the intragastric assembly 700 can comprise two intragastric space-filling devices 702 or three intragastric space-filling devices 702.
[0127] A portable electronic device 400 (see Fig. 4) can be used to transmit a wireless signal to the control unit 300 within each of the intragastric space-filling devices 702 to generate an electrical pulse (i.e., a short burst of current through the conductive wire 204) to magnetize the electropermanent magnet 200 within each of the intragastric spacefilling devices 702. Once the electropermanent magnets 200 are switched to the ON configuration 202, the intragastric space-filling devices 702 can be magnetically attracted to one another and join together into the intragastric space-filling agglomeration 704. In one variation, the intragastric space-filling devices 702 can be magnetized or switched to the ON configuration 202 before ingestion by the patient. In other variations, the intragastric space-filling devices 702 can be magnetized or switched to the ON configuration 202 after the intragastric space-filling devices 702 are within the stomach of the patient. In this latter variation, the intragastric space-filling devices 702 can be demagnetized or switched to the OFF configuration 210 prior to ingestion by the patient.
[0128] The intragastric space-filling agglomeration 704 can be sized to be larger than the pyloric sphincter of a patient such that the intragastric space-filling agglomeration 704 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the intragastric space-filling agglomeration 704 stays within the stomach of the patient to take up space within the stomach. The intragastric space-filling agglomeration 704 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
[0129] Once the patient has met his or her weight-loss goals, the portable electronic device 400 can be used to transmit another wireless signal to the control unit 300 within each of the intragastric space-filling devices 702 to generate another electrical pulse (i.e., a short burst of current through the conductive wire 204) to de-magnetize the electropermanent magnet 200 within each of the intragastric space-filling devices 702. Once the intragastric space-filling devices 702 are de-magnetized or switched to the OFF
configuration 210, the intragastric space-filling agglomeration 704 can break up or separate into its constituent intragastric space-filling devices 702 as shown in Fig. 7B.
[0130] As depicted in Fig. 7B, the intragastric space-filling devices 702 can be substantially shaped as spheres. In this variation, the intragastric space-filling devices 702 can each have a diameter of between approximately 10.0 mm and 15.0 mm.
[0131] In other variations, the intragastric space-filling devices 702 can be substantially shaped as polyhedrons such as cuboids, rhomboids, pyramids, or a combination thereof. The intragastric space-filling devices 702 can be individually sized to allow the intragastric space-filling devices 702 to pass through the digestive system of the patient and out of the patient. For example, once the electropermanent magnets 200 within the intragastric space-filling devices 702 are de-magnetized, the intragastric space-filling devices 702 can individually pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0132] Fig. 8 illustrates a side cross-sectional view of an example of an intragastric space-filling vessel 800. The intragastric space-filling vessel 800 can comprise a vessel housing 802 comprising a bulbous portion 804, an elongate narrow portion 806, a channel 808 extending through the elongate narrow portion 806 and the bulbous portion 804, and a conduit 810 connecting the channel 808 to an external environment outside of the vessel housing 802. When the intragastric space-filling vessel 800 has been ingested by a patient, the external environment can be a gastric environment of the patient. The intragastric space-filling vessels 800 shown in Figs. 8, 9A, and 9B can be one type of the intragastric space-filling devices 102 shown in Fig. IB.
[0133] The conduit 810 can be positioned along the segment of the channel 808 disposed within the elongate narrow portion 806 of the vessel housing 802. In the example variation shown in Fig. 8, the conduit 810 can be defined along a lateral surface of the elongate narrow portion 806. In other variations, the conduit 810 can be defined along a distal end surface or terminal surface of the elongate narrow portion 806.
[0134] The intragastric space-filling vessel 800 can also comprise a magnetic component 812 translatable longitudinally within the channel 808. In some variations, the magnetic component 812 can be or comprise a permanent magnet. For example, the magnetic component 812 can be an NdFeB magnet.
[0135] The channel 808 can house or contain an expandable filling material 814.
The filling material 814 can absorb fluids (e.g., water, digestive fluids, etc.) entering the channel 808 through the conduit 810 and expand over time.
[0136] In some variations, the filling material 814 can be a polymeric filling material. For example, the polymeric filling material can comprise a hydrophilic gel, agar, agarose, alginate, amylopectin, carrageenan, gelatin, gellan, guar gum, other types of gums, maltodextrin, hydrophilic polyurethanes, hydroxypropyl methylcellulose, other types of cellulose, hydrophilic polyurethane polymers, pectins, hydroxyethyl cellulose, methyl cellulose, hydroxymethyl methacrylate, insoluble polysaccharides, xanthans, or combinations or mixtures thereof. In these and other variations, the conduit 810 can comprise a one-way valve such that fluids (e.g., water, digestive fluids, etc.) from the external environment enter the channel 808 but the filling material 814 does not exit or flow out of the channel 808.
[0137] The magnetic component 812 can be configured to initially be positioned within a segment of the channel 808 disposed within the elongate narrow portion 806. For example, the magnetic component 812 can be configured to initially be positioned within the segment of the channel 808 disposed within the elongate narrow portion 806 prior to or immediately upon ingestion of the intragastric space-filling vessel 800 by the patient.
[0138] In one variation, the elongate narrow portion 806 can be substantially shaped as a cylinder. In other variations, the elongate narrow portion 806 can be substantially shaped as a cuboid, a frustoconic, an ovoid, or a combination thereof. The channel 808 can be substantially shaped to conform to the shape of the elongate narrow portion 806. For example, the channel 808 can be a substantially cylindrical channel, frustoconic channel, cuboid channel, or a combination thereof.
[0139] The elongate narrow portion 806 of the vessel housing 802 can have a thin wall. For example, the elongate narrow portion 806 of the vessel housing 802 can have a wall thickness of between approximately 0.50 mm to 2.0 mm. As a more specific example, the elongate narrow portion 806 of the vessel housing 802 can have a wall thickness of approximately 1.00 mm. The thin wall of the elongate narrow portion 806 can allow the magnetic component 812 to exert a force on other magnetic materials or ferromagnetic materials outside of the elongate narrow portion 806 of the vessel housing 802 when the magnetic component 812 is positioned within the elongate narrow portion 806 (such as when the magnetic component 812 is positioned within the segment of the channel 808 disposed within the elongate narrow portion 806). The thin wall of the elongate narrow portion 806 can also allow the external magnetic field or the external magnetic flux emanating from the magnetic component 812 to permeate beyond the elongate narrow portion 806 of the vessel housing 802.
[0140] As fluids gradually enter the channel 808 through the conduit 810, the filling material 814 can gradually expand. Expansion of the filling material 814 can push, move, or otherwise translate the magnetic component 812 longitudinally through the channel 808 toward the segment of the channel 808 disposed within the bulbous portion 804. Once the magnetic component 812 is positioned (e.g., positioned entirely) within the segment of the channel 808 disposed within the bulbous portion 804, the bulbous portion 804 of the vessel housing 802 can reduce the ability of the magnetic component 812 to exert a force on other magnetic materials or ferromagnetic materials outside of the bulbous portion 804 of the vessel housing 802. The size and shape of the bulbous portion 804 of the vessel housing 802 can prevent the magnetic component 812 from attaching to other magnetic materials or ferromagnetic materials outside of the bulbous portion 804 of the vessel housing 802 once the magnetic component 812 is within the bulbous portion 804.
[0141] The bulbous portion 804 of the vessel housing 802 can be substantially shaped as an ellipsoid, a biconic structure (i.e., two frusto-conics attached base to base), a hemisphere or dome, an ovoid, or a combination thereof. In other variations, the bulbous portion 804 can be substantially shaped as a hexahedron, an octahedron, a decahedron, a dodecahedron, or a combination thereof. The overall shape or design of the intragastric space-filling vessel 800 can be substantially mushroom-shaped, cornet- shaped, lollipop- shaped, or a combination thereof.
[0142] In some variations, the vessel housing 802 of the intragastric space-filling vessel 800 can have an end-to-end length dimension of between approximately 10.00 mm and 31.75 mm. In these and other variations, the bulbous portion 804 of the vessel housing 802 can have a maximum width dimension or diameter of between approximately 5.00 mm and 12.70 mm.
[0143] Fig. 9A illustrates a side cross-sectional view of an intragastric assembly
900 comprising a plurality of intragastric space-filling vessels 800 joined together into an intragastric vessel agglomeration 902. As previously discussed, each of the plurality of intragastric space-filling vessels 800 can comprise the vessel housing 802 having the bulbous portion 804 and the elongate narrow portion 806, a channel 808 extending through the bulbous portion 804 and the elongate narrow portion 806, and a magnetic component 812 and filling material 814 contained within the channel 808. The magnetic component 812 of each of the intragastric space-filling vessels 800 can be initially configured to be positioned within the segment of the channel 808 disposed within the elongate narrow portion 806 of the vessel housing 802.
[0144] A method of treating obesity can involve providing the plurality of intragastric space-filling vessels 800 to be ingested (one by one) by the patient. Once within the stomach of the patient, the plurality of intragastric space-filling vessels 800 can magnetically join together into the intragastric vessel agglomeration 902 when the magnetic components 812 positioned within the elongate narrow portions 806 of the intragastric space-filling vessels 800 exert an attractive force on one another.
[0145] Although three intragastric space-filling vessels 800 are shown in Figs. 9A and 9B, it is contemplated by this disclosure that between four and twenty intragastric space-filling vessels 800 can be included as part of the intragastric assembly 900. Moreover, the intragastric vessel agglomeration 902 formed by the intragastric spacefilling vessels 800 can take on certain composite shapes such as spheres, disks, ellipsoids, ovoids, polyhedrons, or a combination thereof.
[0146] The intragastric space-filling vessels 800 can be designed and sized such that the intragastric vessel agglomeration 902 formed by the intragastric space-filling vessels 800 is larger in size than the pyloric sphincter of the patient. This ensures that the intragastric vessel agglomeration 902 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This also ensures that the intragastric vessel agglomeration 902 stays within the stomach of the patient to take up space within the stomach and that the intragastric vessel agglomeration 902 can intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
[0147] Fig. 9B illustrates a side cross-sectional view of the intragastric vessel agglomeration 902 of Fig. 9A broken up or separated into its constituent intragastric spacefilling vessels 800. As previously discussed, the intragastric vessel agglomeration 902 can separate back into the plurality of intragastric space-filling vessels 800 when the magnetic attraction or the magnetic forces holding the plurality of intragastric space-filling vessels 800 close together are weakened or diminished. The magnetic attraction between the intragastric space-filling vessels 800 can be weakened or diminished by the movement or translation of the magnetic component 812 within each of the plurality of intragastric space-filling vessels 800 from the elongate narrow portion 806 of the vessel housing 802 to the bulbous portion 804.
[0148] The magnetic component 812 within each of the plurality of intragastric space-filling vessels 800 can be configured to move or translate longitudinally from the segment of the channel 808 within the elongate narrow portion 806 to the bulbous portion
804 when the filling material 814 within each of the plurality of intragastric space-filling vessels 800 expands. The filling material 814 within the channel 808 of each of the intragastric space-filling vessels 800 can expand as fluid from the external environment flows through the conduit 810 into the channel 808 and interacts with the filling material 814.
[0149] Once the intragastric vessel agglomeration 902 has broken apart or separated into the plurality of intragastric space-filling vessels 800, each of the intragastric space-filling vessels 800 can individually pass through the pylorus and duodenum into the intestines of the patient. Each of the intragastric space-filling vessels 800 can then eventually pass out of the body of the patient.
[0150] Fig. 10 illustrates an example of an ingestible intragastric device 1000. The ingestible intragastric device 1000 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
[0151] The ingestible intragastric device 1000 can comprise an expandable covering 1002 serving as the shell or casing for the ingestible intragastric device 1000. The expandable covering 1002 can be a balloon-type covering or shell. For example, the expandable covering 1002 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
[0152] The ingestible intragastric device 1000 can also comprise the control unit
300 (see Fig. 3 for a description of the components of the control unit 300) and a pressure sensor 1004 electrically coupled to the control unit 300. The pressure sensor 1004 can be configured to sense an internal pressure within the expandable covering 1002. The pressure sensor 1004 can also transmit a signal to the processor 302 (see Fig. 3) of the control unit 300 when the internal pressure exceeds a predetermined threshold. The control unit 300 can also receive a wireless signal from a portable electronic device 400. The portable electronic device 400 can instruct the control unit 300 to magnetize or de-magnetize certain magnetic components within the ingestible intragastric device 1000 or to electrically control certain components certain valves or regulators within the ingestible intragastric device 1000.
[0153] The ingestible intragastric device 1000 can further comprise a first interior chamber 1006 comprising a first chemical composition 1008, a second interior chamber 1010 comprising a second chemical composition 1012, a first electronic valve coupled to the control unit 300 and serving as a remote-controllable regulator or gate between the first
interior chamber 1006 and the second interior chamber 1010 and a second electronic valve 1016 coupled to the control unit 300 and serving as a remote-controllable regulator or gate between the second interior chamber 1010 and an exterior environment surrounding the expandable covering 1002.
[0154] In some variations, the first chemical composition 1008 can be or comprise a weak acid such as acetic acid, CH3COOH. In addition, the second chemical composition 1012 can be or comprise a weak base such as sodium bicarbonate, NaHC03. In other variations, other types of weak acids besides acetic acid and other types of weak bases besides sodium bicarbonate can be used. Moreover, in alternative variations, the weak acid can also be contained within the second interior chamber 1010 and the weak base can be contained within the first interior chamber 1006.
[0155] The first electronic valve 1014 and the second electronic valve 1016 can both be controlled by the control unit 300. In the variation depicted in Fig. 10, each of the first electronic valve 1014 and the second electronic valve 1016 can comprise two or more electropermanent magnets 200 capable of being magnetized or de-magnetized by the control unit 300 (as explained in the preceding sections). In other variations, the first electronic valve 1014 and the second electronic valve 1016 can comprise permanent magnets, other electrically controllable valves capable of being controlled by the control unit 300, or destructive features such as explosive components or resistors that can heat up and burn a hole in the expandable covering 1002.
[0156] In one variation, both of the electropermanent magnets 200 can be switched to the ON configuration 202 and the electropermanent magnets 200 can be positioned such that opposite poles of the two electropermanent magnets 200 face one another and are attracted to one another. In this variation, the two electropermanent magnets 200 can be attached to one another and act as a gate to close the first electronic valve 1014 or the second electronic valve 1016.
[0157] When at least one of the electropermanent magnets 200 is switched to the
OFF configuration 210 or is de-magnetized by an electrical pulse sent by the control unit 300 via the current generator 216, the two electropermanent magnets 200 can begin to separate or move away from one another and the first electronic valve 1014 or the second electronic valve 1016 can begin to open. When the first electronic valve 1014 is opened, the first chemical composition 1008 can mix with the second chemical composition 1012 to produce a gas (e.g., carbon dioxide, C02) to inflate the expandable covering 1002. When
the expandable covering 1002 is expanded to a predetermined size or when the internal pressure within the expandable covering 1002 is detected to exceed a predetermined threshold, the second electronic valve 1016 can be instructed to open via the same mechanisms as those discussed with respect to the first electronic valve 1014.
[0158] Alternatively, in some variations, the control unit 300 can transmit one or more signals to the first electronic valve 1014 to close the first electronic valve 1014 to preserve the first chemical composition 1012 within the first interior chamber 1006 or preserve the second chemical composition 1012 within the second interior chamber 1010. In these variations, the first electronic valve 1014 can be opened at a later time to further increase the size of the ingestible intragastric device 1000 at the later time.
[0159] Once the second electronic valve 1016 is opened, the gas can be evacuated from the expandable covering 1002 and the ingestible intragastric device 1000 can begin to shrink. The ingestible intragastric device 1000 can continue to shrink or decrease in size until the ingestible intragastric device 1000 can pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0160] A weight-loss regimen or method of treating obesity can involve a patient ingesting the ingestible intragastric device 1000 when both the first electronic valve 1014 and the second electronic valve 1016 are closed. A clinician or other medical professional can check that the ingestible intragastric device 1000 is within the stomach of the patient by using the portable electronic device 400 to transmit a signal to the control unit 300 within the ingestible intragastric device 1000 via a wireless communication protocol 402 such as an NFC protocol or a Bluetooth™ protocol.
[0161] Once the ingestible intragastric device 1000 is within the stomach of the patient, a wireless signal can be sent from a portable electronic device 400 to open the first electronic valve 1014 and expand the ingestible intragastric device 1000. The ingestible intragastric device 1000 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1000 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the ingestible intragastric device 1000 stays within the stomach of the patient to take up space within the stomach. The ingestible intragastric device 1000 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
[0162] Once the patient has met his or her weight-loss goals, the portable electronic device 400 can be used to transmit another wireless signal to the control unit 300 to open
the second electronic valve 1016. Once the second electronic valve 1016 is opened, the ingestible intragastric device 1000 can shrink or decrease in size until the ingestible intragastric device 1000 is able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0163] Although acetic acid, sodium bicarbonate, and carbon dioxide are discussed in the aforementioned sections, it is contemplated by this disclosure that any type of weak acids or bases can be used as long as such weak acids or bases can be buffered by the gastric environment within the stomach of the patient. In addition, other gases besides carbon dioxide can be generated as long as such gases are not harmful to the patient. Moreover, although one ingestible intragastric device 1000 is shown in Fig. 10, it is contemplated by this disclosure that multiple ingestible intragastric devices 1000 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s).
[0164] Fig. 11 illustrates yet another example of an ingestible intragastric device 1100. The ingestible intragastric device 1100 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
[0165] The ingestible intragastric device 1100 can comprise an expandable covering 1102 serving as the shell or casing for the ingestible intragastric device 1100. The expandable covering 1102 can be a balloon-type covering or shell. For example, the expandable covering 1102 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
[0166] The ingestible intragastric device 1100 can also comprise the control unit
300 (see Fig. 3 for a description of the components of the control unit 300) and a pressure sensor 1004 electrically coupled to the control unit 300. The pressure sensor 1004 can be configured to sense an internal pressure within the expandable covering 1102. The pressure sensor 1004 can also transmit a signal to the processor 302 (see Fig. 3) of the control unit 300 when the internal pressure exceeds a predetermined threshold. The control unit 300 can also receive a wireless signal from a portable electronic device 400. The portable electronic device 400 can instruct the control unit 300 to magnetize or de-magnetize certain magnetic components within the ingestible intragastric device 1100 or to electrically control certain components certain valves or regulators within the ingestible intragastric device 1100.
[0167] The ingestible intragastric device 1100 can further comprise a gas cartridge
1104 comprising a pressurized gas 1106. In some variations, the pressurized gas 1106 can comprise carbon dioxide (C02), nitrogen (N2) gas, oxygen (02), or a combination thereof. In other variations, the pressurized gas 1106 can be a type of pressurized inert gas that can be released within the stomach of the patient.
[0168] The ingestible intragastric device 1100 can also comprise a controllable valve and regulator 1108 coupled to the control unit 300. The controllable valve and regulator 1108 can control the release of the pressurized gas 1106 from the gas cartridge 1104. The controllable valve and regulator 1108 can be instructed to remain closed or open to allow the pressurized gas 1106 to remain within the gas cartridge or be released from the gas cartridge 1104, respectively.
[0169] The ingestible intragastric device 1100 can further comprise a controllable valve 1110 separating the expandable covering 1102 from an external environment. The controllable valve and regulator 1108 and the controllable valve 1110 can both be controlled by the control unit 300. In the variation depicted in Fig. 11, each of the controllable valve and regulator 1108 and the controllable valve 1110 can comprise two or more electropermanent magnets 200 capable of being magnetized or de-magnetized by the control unit 300 (as explained in the preceding sections). In other variations, the controllable valve and regulator 1108 and the controllable valve 1110 can comprise permanent magnets, other electrically controllable valves capable of being controlled by the control unit 300, or destructive features such as explosive components or resistors that can heat up and burn a hole in the expandable covering 1102.
[0170] In one variation, both of the electropermanent magnets 200 can be switched to the ON configuration 202 and the electropermanent magnets 200 can be positioned such that opposite poles of the two electropermanent magnets 200 face one another and are attracted to one another. In this variation, the two electropermanent magnets 200 can be attached to one another and act as a gate to close the controllable valve and regulator 1108 and the controllable valve 1110.
[0171] When at least one of the electropermanent magnets 200 is switched to the OFF configuration 210 or is de-magnetized by an electrical pulse sent by the control unit 300 via the current generator 216, the two electropermanent magnets 200 can begin to separate or move away from one another and the controllable valve and regulator 1108 and the controllable valve 1110 can begin to open. When the controllable valve and regulator
1108 is opened, the pressurized gas 1106 can be released and inflate the expandable covering 1102. When the expandable covering 1102 is expanded to a predetermined size or when the internal pressure within the expandable covering 1102 is detected to exceed a predetermined threshold, the controllable valve 1110 can be instructed to open via the same mechanisms as those discussed with respect to the controllable valve and regulator 1108. Once the controllable valve 1110 is opened, the pressurized gas 1106 can be evacuated from the expandable covering 1102 and the ingestible intragastric device 1100 can begin to shrink. The ingestible intragastric device 1100 can continue to shrink or decrease in size until the ingestible intragastric device 1100 can pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0172] One weight-loss regimen or method of treating obesity can involve a patient ingesting the intragastric device 1100 when both the controllable valve and regulator 1108 and the controllable valve 1110 are closed. A clinician or other medical professional can first determine that the intragastric device 1100 is within the stomach of the patient by transmitting one or more wireless signals to certain wireless communication units 306 coupled to the control unit 300 within the intragastric device 1100. Based on the responses (or lack thereof) received from the wireless communication units 306, the clinician or other medical professional can determine whether the intragastric device 1100 is within the stomach of the patient.
[0173] Once the ingestible intragastric device 1100 is determined to be within the stomach of the patient, a wireless signal can be sent from a portable electronic device 400 to open the controllable valve and regulator 1108 and expand the ingestible intragastric device 1100. The ingestible intragastric device 1100 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1100 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the ingestible intragastric device 1100 stays within the stomach of the patient to take up space within the stomach. The ingestible intragastric device 1100 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
[0174] Once the patient has met his or her weight-loss goals, the portable electronic device 400 can be used to transmit a wireless signal to the control unit 300 to open the controllable valve 1110. Once the controllable valve 1110 is opened, the ingestible intragastric device 1100 can shrink or decrease in size until the intragastric device 1100 is
able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0175] An alternative weight-loss regimen or method of treating obesity can involve a patient ingesting the intragastric device 1100 when both the controllable valve and regulator 1108 and the controllable valve 1110 are open. Once the ingestible intragastric device 1100 is within the stomach of the patient, a wireless signal can be sent from a portable electronic device 400 to close the controllable valve 1110 and expand the ingestible intragastric device 1100. The ingestible intragastric device 1100 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1100 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the ingestible intragastric device 1100 stays within the stomach of the patient to take up space within the stomach. The ingestible intragastric device 1100 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
[0176] Once the pressure sensor 1004 determines that the internal pressure within the expandable covering 1002 has reached or surpassed a predetermined pressure threshold, the control unit 300 can instruct the controllable valve and regulator 1108 to close. When the patient has met his or her weight-loss goals, the portable electronic device 400 can be used once again to transmit a wireless signal to the control unit 300 to open the controllable valve 1110. Once the controllable valve 1110 is opened, the ingestible intragastric device 1100 can shrink or decrease in size until the intragastric device 1100 is able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0177] Moreover, although one ingestible intragastric device 1100 is shown in Fig.
11, it is contemplated by this disclosure that multiple ingestible intragastric devices 1100 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s). In addition, the controllable valve and regulator 1108 and the controllable valve 1110 can each be opened or closed multiple times to fine tune the inflation or deflation of the ingestible intragastric device 1100.
[0178] Fig. 12 illustrates an additional example of an ingestible intragastric device 1200. The ingestible intragastric device 1200 can be one type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
[0179] The ingestible intragastric device 1200 can comprise an expandable covering 1202 serving as the shell or casing for the ingestible intragastric device 1200. The expandable covering 1202 can be a balloon-type covering or shell. For example, the expandable covering 1202 can be fabricated from or be composed of silicone, silicone rubber, urethanes, a thermoplastic elastomer, copolymers thereof, or a combination thereof.
[0180] The ingestible intragastric device 1200 can also comprise the control unit
300 (see Fig. 3 for a description of the components of the control unit 300) and a pressure sensor 1004 electrically coupled to the control unit 300. The pressure sensor 1004 can be configured to sense an internal pressure within the expandable covering 1202. The pressure sensor 1004 can also transmit a signal to the processor 302 (see Fig. 3) of the control unit 300 when the internal pressure exceeds a predetermined threshold. The control unit 300 can also receive a wireless signal from a portable electronic device 400. The portable electronic device 400 can instruct the control unit 300 to magnetize or de-magnetize certain magnetic components within the ingestible intragastric device 1200 or to electrically control certain components certain valves or regulators within the ingestible intragastric device 1200.
[0181] The ingestible intragastric device 1200 can be filled with a compressed gas
1204. In some variations, the compressed gas 1204 can comprise liquefied nitrogen (N2) gas or other gases. The ingestible intragastric device 1200 can be filled with the compressed gas 1204 immediately before being ingested by the patient. For example, liquefied nitrogen can be injected into the interior of the expandable covering 1202 through a controllable valve 1206 immediately before the intragastric device 1200 is ingested by the patient.
[0182] The controllable valve 1206 can be instructed to close or open to allow the compressed gas 1204 to remain within or be released from the ingestible intragastric device 1200, respectively. In the variation depicted in Fig. 12, the controllable valve 1206 can comprise two or more electropermanent magnets 200 capable of being magnetized or demagnetized by the control unit 300 (as explained in the preceding sections). In other variations, the controllable valve 1206 can comprise permanent magnets, other electrically controllable valves capable of being controlled by the control unit 300, or destructive features such as explosive components or resistors that can heat up and burn a hole in the expandable covering 1202.
[0183] In one variation, both of the electropermanent magnets 200 can be attached to one another and act as a gate to close the controllable valve 1206 when the
electropermanent magnets 200 are switched to the ON configuration 202. The electropermanent magnets 200 can be positioned such that opposite poles of the two electropermanent magnets 200 face one another and are attracted to one another. When at least one of the electropermanent magnets 200 is switched to the OFF configuration 210 or is de-magnetized by an electrical pulse sent by the control unit 300 via the current generator 216, the two electropermanent magnets 200 can begin to separate or move away from one another and the controllable valve and regulator 1108 and the controllable valve 1206 can begin to open.
[0184] When the controllable valve 1110 is closed, the expandable covering 1202 can expand to a predetermined size or until the internal pressure within the expandable covering 1202 is detected to exceed a predetermined threshold. At this point, the controllable valve 1110 can be instructed to open and the compressed gas 1204 can be evacuated from the expandable covering 1202 and begin to shrink. The ingestible intragastric device 1200 can continue to shrink or decrease in size until the ingestible intragastric device 1200 can pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0185] One weight-loss regimen or method of treating obesity can involve a clinician or medical professional injecting the compressed gas 1204 (such as liquefied nitrogen) into the expandable covering 1202 of the ingestible intragastric device 1200 prior to the patient ingesting the ingestible intragastric device 1200. The patient can then ingest the intragastric device 1200 and wait for the intragastric device 1200 to reach the stomach of the patient. A clinician or other medical professional can determine that the intragastric device 1200 is within the stomach of the patient by transmitting one or more wireless signals to certain wireless communication units 306 coupled to the control unit 300 within the intragastric device 1200. Based on the responses (or lack thereof) received from the wireless communication units 306, the clinician or other medical professional can determine whether the intragastric device 1200 is within the stomach of the patient.
[0186] Once the ingestible intragastric device 1200 is determined to be within the stomach of the patient, a wireless signal can be sent from a portable electronic device 400 to the control unit 300 within the intragastric device 1200 to close the controllable valve 1206 and expand the ingestible intragastric device 1200. The ingestible intragastric device 1200 can be expanded to be larger than the pyloric sphincter of a patient such that the ingestible intragastric device 1200 cannot pass through the pyloric sphincter into the
duodenum and intestines of the patient. This ensures the ingestible intragastric device 1200 stays within the stomach of the patient to take up space within the stomach. The ingestible intragastric device 1200 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
[0187] Once the patient has met his or her weight-loss goals, the portable electronic device 400 can be used to transmit another wireless signal to the control unit 300 to open the controllable valve 1206. Once the controllable valve 1206 is opened, the ingestible intragastric device 1200 can shrink or decrease in size until the intragastric device 1200 is able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted. Moreover, the portable electronic device 400 can also be used to transmit a wireless signal to the control unit 300 to open the controllable valve 1206 before the patient has met his or her weight-loss goals if the size of the expanded intragastric device 1200 is causing discomfort to the patient. For example, a small amount of compressed gas 1204 can be evacuated from the expandable covering 1202 to reduce the size of the intragastric device 1200 slightly but still allow the intragastric device 1200 to remain within the stomach of the patient.
[0188] Moreover, although one ingestible intragastric device 1200 is shown in Fig.
12, it is contemplated by this disclosure that multiple ingestible intragastric devices 1200 can be used in a single treatment or spread out over several treatment procedures to improve the efficacy of the treatment(s). In addition, the controllable valve 1206 can be opened or closed multiple times to fine tune the inflation or deflation of the ingestible intragastric device 1200.
[0189] Fig. 13 illustrates an example of a biodegradable intragastric device 1300.
The biodegradable intragastric device 1300 can be another type of the expandable and contractible intragastric space-filling device 100 discussed in the preceding sections (see, for example, Fig. 1A).
[0190] The biodegradable intragastric device 1300 can be ingested when in an unexpanded configuration 1302. The unexpanded configuration 1302 is a state of the biodegradable intragastric device 1300 when the device 1300 has not reacted with any bodily fluids of the patient. The biodegradable intragastric device 1300 can be sized to be orally ingested by the patient when in the unexpanded configuration 1302.
[0191] The biodegradable intragastric device 1300 can be expanded from the unexpanded configuration 1302 to an expanded configuration 1304 after ingestion by the
patient and when the biodegradable intragastric device 1300 is within the stomach of the patient. The biodegradable intragastric device 1300 can expand from the unexpanded configuration 1302 to the expanded configuration 1304 when the biodegradable intragastric device 1300 has been activated by digestive acids (e.g., stomach acids) within the gastrointestinal system of the patient. The biodegradable intragastric device 1300 can be activated by digestive acids when the digestive acids have reacted with coatings, foams, gels, or a combination thereof contained within or on the surface of the biodegradable intragastric device 1300.
[0192] In some variations, the biodegradable intragastric device 1300 can comprise expandable polymeric materials such as hydrophilic gels, agar, agarose, alginate, amylopectin, carrageenan, gelatin, gellan, guar gum, other types of gums, maltodextrin, hydrophilic polyurethanes, hydroxypropyl methylcellulose, other types of cellulose, hydrophilic polyurethane polymers, pectins, hydroxyethyl cellulose, methyl cellulose, hydroxymethyl methacrylate, insoluble polysaccharides, xanthans, or combinations or mixtures thereof.
[0193] The biodegradable intragastric device 1300 can expand to an expanded configuration 1304 larger than the pyloric sphincter of a patient such that the biodegradable intragastric device 1300 cannot pass through the pyloric sphincter into the duodenum and intestines of the patient. This ensures the biodegradable intragastric device 1300 in the expanded configuration 1304 stays within the stomach of the patient to take up space within the stomach. The biodegradable intragastric device 1300 in the expanded configuration 1304 can also intermittently block the pylorus such that food and liquids ingested by the patient stay longer in the stomach before emptying.
[0194] Once the biodegradable intragastric device 1300 has expanded into the expanded configuration 1304, the polymers or other materials making up the biodegradable intragastric device 1300 can biodegrade and be shed or dissolved by gastric acids or other fluids within the body of the patient. The biodegradable intragastric device 1300 in the expanded configuration 13034 can shrink or decrease in size over time until the biodegradable intragastric device 1300 shrinks to a size able to pass through the pyloric sphincter of the patient and into the intestines to be eventually excreted.
[0195] Each of the individual variations or embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other variations or embodiments. Modifications
may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention.
[0196] Methods recited herein may be carried out in any order of the recited events that is logically possible, as well as the recited order of events. Moreover, additional steps or operations may be provided or steps or operations may be eliminated to achieve the desired result.
[0197] Furthermore, where a range of values is provided, every intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
[0198] All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.
[0199] Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "said" and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use of a "negative" limitation. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
[0200] This disclosure is not intended to be limited to the scope of the particular forms set forth, but is intended to cover alternatives, modifications, and equivalents of the variations or embodiments described herein. Further, the scope of the disclosure fully encompasses other variations or embodiments that may become obvious to those skilled in the art in view of this disclosure.
Claims
1. An intragastric assembly for weight-loss comprising:
a plurality of intragastric space-filling devices,
wherein each of the plurality of intragastric space-filling devices comprises an electropermanent magnet,
wherein the electropermanent magnets are configured to be magnetized
remotely by a portable electronic device, and
wherein the plurality of intragastric space-filling devices are configured to magnetically join together into an intragastric space-filling agglomeration when the electropermanent magnets are magnetized by the portable electronic device.
2. The intragastric assembly of claim 1, wherein the plurality of intragastric space-filling devices is between two and four intragastric space-filling devices.
3. The intragastric assembly of claim 1, wherein the plurality of intragastric space-filling devices is four intragastric space-filling devices.
4. The intragastric assembly of claim 1, wherein the plurality of intragastric space-filling devices is between four and twenty intragastric space-filling devices.
5. The intragastric assembly of claim 1, wherein the electropermanent magnets are
configured to be de-magnetized by the portable electronic device and wherein the intragastric space-filling agglomeration is configured to separate back into the plurality of intragastric space-filling devices when the electropermanent magnets are demagnetized.
6. The intragastric assembly of claim 1, wherein the plurality of intragastric space-filling devices are substantially shaped as spheres.
7. The intragastric assembly of claim 1, wherein the plurality of intragastric space-filling devices are substantially shaped as polyhedrons.
8. The intragastric assembly of claim 1, wherein the intragastric space-filling
agglomeration is sized to be larger than the pyloric sphincter of a patient and wherein each of the plurality of intragastric space-filling devices is sized to allow the intragastric space-filling device to pass through the digestive system of the patient.
9. The intragastric assembly of claim 1, wherein each of the electropermanent magnets is coupled to a control unit, wherein the control unit comprises a wireless communication
unit configured to receive a wireless signal from the portable electronic device over a wireless communication protocol.
10. The ingestible assembly of claim 9, wherein the wireless communication protocol is at least one of a Bluetooth™ communication protocol and a near field communication (NFC) communication protocol.
11. The ingestible assembly of claim 1, wherein the control unit is coupled to a battery and a current generator and wherein the current generator is configured to supply an electrical pulse to the electropermanent magnet to magnetize the electropermanent magnet.
12. A method of treating obesity, comprising:
providing a plurality of intragastric space-filling devices to be ingested by a patient, wherein each of the plurality of intragastric space-filling devices comprises an electropermanent magnet; and
remotely magnetizing the electropermanent magnets with a portable electronic device when the plurality of intragastric space-filling devices are within the stomach of the patient,
wherein the plurality of intragastric space-filling devices are configured to
magnetically join together into an intragastric space-filling agglomeration when the electropermanent magnets are magnetized by the portable electronic device.
13. The method of claim 12, wherein remotely magnetizing the electropermanent magnets with the portable electronic device comprises transmitting a wireless signal to a wireless communication unit of a control unit coupled to each of the electropermanent magnets.
14. The method of claim 13, further comprising supplying, using a battery and a current generator coupled to the control unit of each of the electropermanent magnets, an electrical pulse to the electropermanent magnet to magnetize the electropermanent magnet in response to the wireless signal received by the wireless communication unit.
15. The method of claim 14, wherein supplying the electrical pulse to the electropermanent magnet comprises delivering a current through a conductive wire wound around a portion of the electropermanent magnet.
16. An intragastric assembly for weight-loss comprising:
a plurality of intragastric space-filling vessels,
wherein each of the plurality of intragastric space-filling vessels comprises:
a vessel housing comprising a bulbous portion, an elongate narrow
portion, a channel extending through the elongate narrow portion and the bulbous portion, and a conduit connecting the channel to an external environment outside of the vessel housing,
a magnetic component translatable within the channel, and
an expandable filling material within the channel,
wherein the magnetic component is initially configured to be positioned within a segment of the channel disposed within the elongate narrow portion upon ingestion of the plurality of intragastric space-filling vessels by the patient; and wherein the plurality of intragastric space-filling vessels are configured to
magnetically join together into an intragastric vessel agglomeration when the magnetic component of each of the plurality of intragastric space-filling vessels is positioned within the segment of the channel disposed within the elongate narrow portion.
17. The intragastric assembly of claim 16, wherein the filling material within each of the plurality of intragastric space-filling vessels is configured to expand as fluids from the external environment flows through the conduit into the channel and interacts with the filling material, wherein the magnetic component is configured to translate into the segment of the channel disposed within the bulbous portion in response to an expansion of the filling material over time, and wherein the intragastric vessel agglomeration is configured to separate back into the plurality of intragastric space-filling vessels when the magnetic component of each of the plurality of intragastric space-filling vessels is translated into the segment of the channel disposed within the bulbous portion.
18. The intragastric assembly of claim 16, wherein the magnetic component is a permanent magnet.
19. The intragastric assembly of claim 16, wherein the bulbous portion of the vessel
housing is substantially shaped as an ellipsoid.
20. The intragastric assembly of claim 16, wherein the bulbous portion of the vessel
housing is substantially shaped as a biconic structure.
21. The intragastric assembly of claim 16, wherein the elongate narrow portion of the
vessel housing is substantially shaped as a cylinder.
22. A method of treating obesity, comprising:
providing a plurality of intragastric space-filling vessels to be ingested by a patient,
wherein each of the plurality of intragastric space-filling vessels comprises: a vessel housing comprising a bulbous portion, an elongate narrow
portion, a channel extending through the elongate narrow portion and the bulbous portion, and a conduit connecting the channel to an external environment outside of the vessel housing,
a magnetic component translatable within the channel, and
an expandable filling material within the channel,
wherein the magnetic component is initially configured to be positioned within a segment of the channel disposed within the elongate narrow portion upon ingestion of the plurality of intragastric space-filling vessels by the patient; and allowing the plurality of intragastric space-filling vessels to magnetically join together into an intragastric vessel agglomeration within the stomach of the patient when the magnetic component of each of the plurality of intragastric space-filling vessels is positioned within the segment of the channel disposed within the elongate narrow portion.
23. The method of claim 22, further comprising allowing the intragastric vessel
agglomeration to separate back into the plurality of intragastric space-filling vessels when a magnetic attraction between the plurality of intragastric space-filling vessels is weakened by the translation of the magnetic component of each of the plurality of intragastric space-filling vessels into the segment of the channel disposed within the bulbous portion.
24. The method of claim 23, wherein the magnetic component is configured to translate into the segment of the channel disposed within the bulbous portion in response to an expansion of the filling material, and wherein the filling material within each of the plurality of intragastric space-filling vessels is configured to expand as fluids from the external environment flows through the conduit into the channel and interacts with the filling material.
25. An ingestible intragastric device, comprising:
an expandable frame having a first configuration and a second configuration;
a device covering encompassing the expandable frame and coupled to the expandable frame such that expansion of the expandable frame expands the device covering; and
a first magnetic component and a second magnetic component coupled to the expandable frame,
wherein the first magnetic component is configured to be magnetized remotely by a portable electronic device,
wherein the second magnetic component is configured to be repelled by the first magnetic component when the first magnetic component is magnetized, and wherein the expandable frame is configured to expand from the first configuration to the second configuration when the second magnetic component is repelled by the first magnetic component.
26. The ingestible intragastric device of claim 25, wherein at least one of the first magnetic component and the second magnetic component is coupled to a control unit, wherein the control unit comprises a wireless communication unit configured to receive a wireless signal from the portable electronic device over a wireless communication protocol.
27. The ingestible intragastric device of claim 26, wherein the wireless communication protocol is at least one of a Bluetooth™ communication protocol and a near field communication (NFC) communication protocol.
28. The ingestible intragastric device of claim 25, wherein the control unit is coupled to a battery and a current generator and wherein the current generator is configured to supply an electrical pulse to the first magnetic component to magnetize the first magnetic component.
29. The ingestible intragastric device of claim 25, wherein at least one of the first magnetic component and the second magnetic component is an electropermanent magnet.
30. The ingestible intragastric device of claim 25, wherein the electropermanent magnet comprises a hard magnetic material, a semi-hard magnetic material, and a soft magnetic material, wherein a conductive wire is wound around the semi-hard magnetic material.
31. The ingestible intragastric device of claim 30, wherein the hard magnetic material is a neodymium iron boron (NdFeB) magnet, wherein the semi-hard magnetic material is an aluminum nickel cobalt (AINiCo) magnet, and wherein the soft magnetic material is an iron magnet.
32. The ingestible intragastric device of claim 25, wherein the ingestible intragastric device is configured to expand within a stomach of a patient in response to receiving a wireless signal from the portable electronic device outside of the body of the patient.
33. The ingestible intragastric device of claim 25, wherein the expandable frame is configured as an expandable Hoberman structure.
34. The ingestible intragastric device of claim 25, wherein the expandable frame is
configured as an expandable origami ball structure.
35. A method of treating obesity, comprising:
providing an ingestible intragastric device to be ingested by a patient, wherein the
ingestible intragastric device comprises:
an expandable frame having a first configuration and a second configuration, a device covering encompassing the expandable frame and coupled to the
expandable frame such that expansion of the expandable frame expands the device covering,
a first magnetic component and a second magnetic component coupled to the expandable frame; and
remotely magnetizing the first magnetic component with a portable electronic device when the ingestible intragastric device is within the stomach of the patient,
wherein the second magnetic component is configured to be repelled by the first magnetic component when the first magnetic component is magnetized, and wherein the expandable frame is configured to expand from the first configuration to the second configuration when the second magnetic component is repelled by the first magnetic component.
36. The method of claim 35, wherein remotely magnetizing the first magnetic component with the portable electronic device comprises transmitting a wireless signal to a wireless communication unit of a control unit within the ingestible intragastric device.
37. The method of claim 36, further comprising supplying, using a battery and a current generator coupled to the control unit, an electrical pulse to the first magnetic
component to magnetize the first magnetic component in response to the wireless signal received by the wireless communication unit.
38. The method of claim 37, wherein supplying the electrical pulse to the first magnetic component comprises delivering a current through a conductive wire wound around a portion of the first magnetic component.
39. An ingestible intragastric device, comprising:
a device covering;
a control unit housed within the device covering and comprising a wireless
communication unit configured to receive a wireless signal from a portable electronic device;
a first interior chamber housed within the device covering and comprising a first
chemical composition;
a second interior chamber housed within the device covering and comprising a second chemical composition;
a first electronic valve connecting an interior of the device covering to the first interior chamber and the second interior chamber, wherein the first electronic valve is electrically coupled to and controllable by the control unit, wherein the first electronic valve is configured to open in response to a signal received from the control unit, and wherein the first chemical composition is configured to mix with the second chemical composition to produce a gas within the device covering when the first electronic valve is opened, and wherein the gas is configured to inflate the device covering; and
a second electronic valve connecting the interior of the device covering with an
external environment outside of the device covering, wherein the second electronic valve is electrically coupled to and controllable by the control unit, wherein the second electronic valve is configured to open in response to a signal received from the control unit, and wherein the gas is configured to be evacuated from the interior of the device covering and deflate the device covering when the second electronic valve is opened.
40. The ingestible intragastric device of claim 39, wherein the first chemical composition is a weak acid.
41. The ingestible intragastric device of claim 40, wherein the weak acid is acetic acid.
42. The ingestible intragastric device of claim 39, wherein the second chemical
composition is a weak base.
43. The ingestible intragastric device of claim 42, wherein the weak base is sodium
bicarbonate.
44. The ingestible intragastric device of claim 39, wherein the gas produced is carbon
dioxide.
45. An ingestible intragastric device, comprising:
a device covering;
a control unit housed within the device covering and comprising a wireless
communication unit configured to receive a wireless signal from a portable electronic device;
a pressure sensor electrically coupled to the control unit and configured to determine an internal pressure within the device covering;
a gas cartridge housed within the device covering and comprising a pressurized gas; a first electronic valve coupled to the gas cartridge, wherein the first electronic valve is electrically coupled to and controllable by the control unit, wherein the first electronic valve is configured to open or close in response to a signal received from the control unit, and wherein the pressurized gas is configured to inflate the device covering when the first electronic valve is opened; and
a second electronic valve connecting the interior of the device covering with an
external environment outside of the device covering, wherein the second electronic valve is electrically coupled to and controllable by the control unit, wherein the second electronic valve is configured to open or close in response to a signal received from the control unit when the internal pressure within the device covering is determined by the pressure sensor to exceed a predetermined threshold pressure, and wherein the pressurized gas is configured to be evacuated from the interior of the device covering and deflate the device covering when the second electronic valve is opened.
46. The ingestible intragastric device of claim 45, wherein the pressurized gas is at least one of carbon dioxide, nitrogen, and oxygen.
47. An ingestible intragastric device, comprising:
a device covering configured to contain a compressed gas;
a control unit housed within the device covering and comprising a wireless
communication unit configured to receive a wireless signal from a portable electronic device;
a pressure sensor electrically coupled to the control unit and configured to determine an internal pressure within the device covering; and
an electronic valve coupled to a surface of the device covering and connecting the interior of the device covering with an external environment outside of the device covering, wherein the electronic valve is electrically coupled to and controllable by the control unit, wherein the electronic valve is configured to open or close in response to a signal received from the control unit when the internal pressure within
the device covering is determined by the pressure sensor to exceed a predetermined threshold pressure, and wherein the compressed gas is configured to be evacuated from the interior of the device covering and deflate the device covering when the electronic valve is opened.
48. The ingestible intragastric device of claim 47, wherein the compressed gas is liquefied nitrogen.
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US201762470235P | 2017-03-11 | 2017-03-11 | |
US62/470,235 | 2017-03-11 |
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PCT/US2018/021868 WO2018169805A1 (en) | 2017-03-11 | 2018-03-09 | Ingestible and expandable devices and assemblies for weight-loss and methods of use thereof |
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US20230100738A1 (en) * | 2021-09-30 | 2023-03-30 | Appetec Inc | Intragastric Magnetic Device and Delivery System |
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