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WO1998001169A2 - Dispositif a contenant doseur, notamment pour l'administration de solutions medicamenteuses - Google Patents

Dispositif a contenant doseur, notamment pour l'administration de solutions medicamenteuses Download PDF

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Publication number
WO1998001169A2
WO1998001169A2 PCT/EP1997/003579 EP9703579W WO9801169A2 WO 1998001169 A2 WO1998001169 A2 WO 1998001169A2 EP 9703579 W EP9703579 W EP 9703579W WO 9801169 A2 WO9801169 A2 WO 9801169A2
Authority
WO
WIPO (PCT)
Prior art keywords
application device
closure element
container
dosing
metering
Prior art date
Application number
PCT/EP1997/003579
Other languages
German (de)
English (en)
Other versions
WO1998001169A3 (fr
Inventor
Volker Lang
Original Assignee
Volker Lang
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE19702362A external-priority patent/DE19702362A1/de
Application filed by Volker Lang filed Critical Volker Lang
Publication of WO1998001169A2 publication Critical patent/WO1998001169A2/fr
Publication of WO1998001169A3 publication Critical patent/WO1998001169A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum

Definitions

  • the invention relates to an application device, in particular for dispensing medicament solutions, with one or more dosing containers.
  • the application device has one or more dosing containers, one dosing container each defining a space which is delimited on at least one side by a closure element. Means are also provided by which detachment, opening or destruction of the closure element can be achieved.
  • Such a device enables targeted therapy or drug addition, in which the different drugs can be delivered to the patient in precisely determinable individual portions with different strengths. Consequently medication dosing that is easily adaptable to the individual needs of the patient is possible without the use of pumps.
  • the device according to the invention also has the advantage that it is simple in construction and therefore inexpensive to manufacture and easy to handle. It is possible to dispense medication or chemical substances in exact quantities to the desired application site by emptying the dosing containers at predeterminable intervals directly or by means of a carrier liquid which flows continuously, for example, from a storage container.
  • the means by which the closure element can be detached, opened or destroyed can be arranged in the space defined by the metering container. This results in a particularly compact design of the application device according to the invention.
  • the closure element comprises a film or a membrane. It is of particular importance that the film or membrane is dimensioned such that it can be detached, opened or destroyed, for example due to pressure and / or temperature changes or by suitable means, in order to enable the reagents to be released safely.
  • the closure element can have wax and / or plastic and / or metal. The choice of material depends on the type of reagent taken up and the type of opening or destruction by the means provided.
  • the means for detaching, opening or destroying the closure element comprise an electrical resistance heating element.
  • the operation of such a heating element leads to the fact that the pressure in the dosing container is increased by the fact that the liquid therein is heated, whereby a gas phase is formed which contributes to a corresponding pressure increase.
  • the resistance heating element can also be arranged in such a way that the temperature increase acts directly on the closure element, as a result of which the latter is detached, opened or destroyed, for example by melting or shrinking.
  • the means according to the invention can further comprise at least two electrodes which are arranged such that the electrolysis of a liquid surrounding the electrodes can be carried out. Due to the direct current supplied, the liquid is split electrically with the development of detonating gas, as a result of which the total pressure in the metering container increases. The pressure increase can be supported by an electrically triggered micro-gas explosion of the oxyhydrogen gas, which likewise causes the closure element to be detached or opened or destroyed. A moderately gas-permeable membrane can be arranged between the electrodes and communicates with the surrounding atmosphere.
  • the closure element is provided with electrical conductor tracks.
  • Such an arrangement has the advantage that an unintentional destruction of a closure element by the current flow thus interrupted can be signaled directly by appropriate display instruments. In this case, the user can immediately stop the further application of medication. Shut-off means can also be provided, which prevent further metering in this case.
  • the means for detaching, opening or destroying the closure element are connected in series with the electrical conductor tracks of the closure element. In this way, the operation of the means according to the invention in safely avoided in those cases in which emptying of the corresponding metering container has either been desired or has occurred due to incorrect manufacture of the closure element, which can lead to uncontrolled emptying of the metering container.
  • the dosing containers of the application device according to the invention can be cylindrical or honeycomb-shaped. While the cylindrical design simplifies the manufacture of the dosing containers, the honeycomb arrangement and design has the advantage that numerous dosing containers can be arranged even in a small space.
  • the dosing containers each have a closure element. This ensures that the opening of a dosing container does not in any way impair the function of the closure element of another, adjacent dosing container.
  • An individual closing of the dosing container with one closure element each has the advantage that the dimensions and nature of the closure elements can be adapted to the individual requirements of the respective medication application.
  • the dosing containers are an integral part of a dosing cassette or can be accommodated therein.
  • a unit made up of different dosing containers with medications that can be selected in different ways can be combined in a unit that can be administered to the patient on an outpatient basis or at home.
  • a container can be provided in which one or more dosing containers or the dosing cassettes can be accommodated, and which has a space which adjoins the closure element of the dosing containers.
  • the drugs or reagents dispensed in the space of the container are absorbed, for example, by an infusion liquid, or act on certain skin areas of the patient for transdermal therapy.
  • the container is fixed on the patient's skin, it is furthermore possible for the dosing cassette to be detached from the container in a simple manner and to be replaced accordingly by a new cassette, for example with a modified medicament composition. It is also possible to remove the container finally to be provided with an inlet connection when drug solutions are introduced for the purpose of transdermal therapy.
  • the container can have an inlet and an outlet.
  • the means for detaching, opening or destroying the closure element are arranged on a plate which is adjacent to the space defined by the dosing container.
  • the plate can be detachably connected to the dosing containers and is placed in this case after filling the container in such a way that each of the dosing containers has at least one means for detaching, opening or destroying the closure element or is in connection therewith.
  • the plate has connecting lines for the means and / or logic elements according to the invention and / or a connecting cable.
  • the electrical connection of the means according to the invention and the associated control and regulating elements can be arranged on the plate of the application device.
  • the means according to the invention and / or the logic elements and / or the connecting cable can also be arranged on the closure element.
  • the plate has no such elements and thus serves mainly to limit the space of the dosing containers.
  • the interruption of the electrical energy supply of the means according to the invention can be coupled with a destruction of electrical conductor tracks in the closure element.
  • a separation membrane is provided in the space delimited by the metering containers, which separates this space into two areas, the closure element being arranged in one of the areas and the other area containing the means according to the invention for detaching, opening or destroying the closure element has or is in connection with these. It is thus possible for the substance to be metered to be arranged on one side of the separating membrane, while a medium is provided on the other side, already causes a large change in pressure when the temperature rises. If the pressure is increased to a predeterminable level, the closure element is also detached, opened or destroyed, as a result of which the medicament arranged on the corresponding side of the separating membrane is released. According to the invention, the released content can either be used directly for transdermal application, or it is taken up by an infusion agent that flows through a corresponding area that receives the dispensed medicament or reagent.
  • the separating membrane can be fastened to the wall of the metering container in the region of the closure element.
  • the area separated by the separating membrane which has the means for detaching, opening or destroying the closure element or is in connection therewith, can be filled with water or a water-containing solution.
  • the use of water is recommended on the one hand for cost reasons, and on the other hand the choice of the materials used for the application device is unproblematic in this case
  • a storage vessel for receiving an infusion solution can be provided, which can be connected to an inlet of the container of the application device, a metering device being arranged in the connecting line.
  • devices for subcutaneous, percutaneous or intravenous use are provided which can be connected to the drain of the container of the application device. It is thus possible to carry out transdermal therapy with the same arrangement, for example after the drain connector has been closed, or to carry out a subcutaneous or intravenous treatment after connecting the appropriate devices.
  • tug substances e.g. Dimethyl suifoxide, added from one or more of the dosing containers to promote absorption of the medication into the skin.
  • the container of the application device can be fixed directly onto the patient's skin by means of a liquid-tight adhesive layer.
  • a fixation can take place in that the adhesive layer is arranged on a ring provided on both sides with adhesives, which can be fixed on the container of the application device according to the invention.
  • a storage unit for recording and reproducing the application data and control electronics are provided, with which the application device can be connected.
  • the storage unit and the control electronics are integral components of the application device.
  • the exact specification of dosing times, dosing quantities, dosing intervals and type of medication can be specified and can be stored and called up in the storage unit.
  • the control electronics control and regulate the release of medication from the micro containers.
  • the storage unit can contain further data, e.g. have the batch number, the type and quantity of a medication, code numbers for increased safety and error and function documentation available.
  • a control unit with a power supply which can be connected to the application device.
  • Application or patient data can be entered into the control device and are passed on to the application device by means of a connection to the application device.
  • the control device can simultaneously take over the power supply of the application device.
  • the control unit with a power supply can be connected directly to it, for example, worn on a belt or put in a pocket.
  • the control unit can also be used to provide the patient with current data about the quantities already dosed or about the medications still to be administered. It is also possible for the control unit to transfer, for example, metering intervals and times to the application device after appropriate programming.
  • the individual dosing containers can be controlled one after the other by the control unit with a power supply and the respective total current can be compared with a predeterminable value, from which safety-relevant conclusions about the operating states and functions of the individual dosing containers are signaled optically and acoustically. the.
  • This data can also be recorded in the memory module according to the invention, which enables a later error function analysis.
  • the control unit with power supply can be provided with a receiver and / or transmitter, in particular for infrared radiation, whereby data can be transmitted to the control unit or called up by the control unit by means of an evaluation unit.
  • the attending physician can, for example, transmit data to the control unit from a computer or other evaluation device in practice and thus adapt the medication administration individually and monitor the therapy by data transfer from the control unit to the evaluation device.
  • a spectral photometer which has a space serving as a cuvette, which adjoins the closure element of the dosing container of the application device.
  • a space serving as a cuvette, which adjoins the closure element of the dosing container of the application device.
  • Such a device permits the immediate analysis of the drugs or reagents released from the dosing containers before they are administered to the patient. This means that enzymatic and chemical microanalyses can be carried out very easily on site.
  • the dosing containers of the application device have openings for adding the media to be analyzed or to be administered.
  • a reaction space is present in which the medium discharged from the metering containers can be analyzed by means of electrochemical sensors.
  • Such sensors can be used to measure the electrical conductivity, the change in the relative dielectric constant or the hydrogen ion concentration.
  • a further precise analysis of the reagents or also the liquids containing enzymes which have been released from the metering containers can be achieved in this way.
  • Fig. 3 a schematic section through two dosing containers.
  • the container (left) is filled with medication, closed; the container (right) is shown in the infusion solution during the electro-thermally triggered emptying process;
  • Fig. 4 a schematic section of two dosing containers, each with a tightly inserted plastic bulge (separating membrane) as a medication container (left: closed; right: placed under electro-thermal or electrolytic steam or gas evolution and emptied into the infusion solution flowing through);
  • FIG. 5 a perspective view of an application device for percutaneous therapy consisting of containers with dosing containers, a removable control power supply unit and an adhesive sealing ring for fixing on the patient's skin;
  • FIG. 7 shows a schematic illustration of an exemplary embodiment of the application device for intravenous, subcutaneous and transdermal therapy
  • FIG. 1 an application device is shown in exploded perspective view in perspective. It can be seen that this consists of a rectangular bowl-shaped container 1, which shows an inlet hose connector 2 and an outlet hose connector 3 for the infusion solution.
  • the dosing cassette 4 is tightly, non-detachably connected, fitted.
  • This dosing cassette 4 contains ten cylindrical dosing containers 5, which are sealed by the plate 6 (with its integrated electrical resistance heating elements, connecting lines, logic elements and visible connecting cable 7) and a sealing plate or film 8.
  • Fig. 2 shows in section (section plane I - I, Fig. 1) the completely assembled application device.
  • a gap 10 is formed, into which the dosing container 5 can empty and which is infused with infusion solution.
  • FIG. 3 shows schematically, in section, two dosing containers closed by the plate 6 and their electrical resistance heating elements 9 projecting into the containers.
  • the dosing container 11 on the left is filled with a medicament 12 (symbolized by crosses) and is tightly closed by the closure film 13.
  • the dosing container 14, on the right in the picture, shows a blown-open closure 15, from which the medicament solution is emptied under vapor pressure 16 (symbolized by rings) into the gap space 10, through which the infusion solution flows (indicated by arrows).
  • Fig. 4 shows schematically in section a further embodiment of the dosing container.
  • two dosing containers are shown closed by the plate 6 with the electrical resistance heating elements 9.
  • the left-hand dosing container 11 is now filled to a maximum of 1/3 of its volume with water 17 (dotted symbolized), while the other at least 2/3 fills a plastic bulge 18 filled with a medication (functioning as a rolling membrane), which with the Opening of the metering container and the closure film 13 is tightly connected.
  • the dosing container 19 shown on the right in the picture steam bubbles 16 (symbolized by rings) can be seen in the water. This steam development by the activated electrical resistance heating element 9 causes the plastic bulge 20 to protrude and empty into the infusion solution flowing through the gap space 10.
  • FIG. 5 shows in simplified form, in perspective, an application device for percutaneous therapy. It consists of the cylindrical container 21 with translucent dosing containers 5 drawn through the plate 6 and a hat-shaped fastening ring 2 for applying the adhesive ring 23 coated with adhesive on both sides and provided with protective film for airtight and moisture-proof fixing on the patient's skin 24. Before use on the patient, this container 21 is used to connect the electronic control power supply unit 25, which is shown in simplified form as a thick disk, with its manually operable fastening elements 26 and electrical connecting elements (not shown) attached to its underside.
  • FIG. 6 shows in section (section plane II - II, according to FIG. 5) the completely assembled application device for the percutaneous therapy fixed on the skin 24 of the patient.
  • the container with three dosing containers 5 is filled with the medication 16 and sealed by the plate 6 and the sealing film 13.
  • a gap 26 between the patient's skin 24 and the sealing film 13 can be clearly seen.
  • the medicaments are emptied out of the dosing containers 5 according to the program entered into the control power supply unit 25 and then absorbed through the skin 24 of the patient.
  • FIG. 7 schematically shows as an example an arrangement for intravenous, subcutaneous and transdermal medication application using the application device 33 and the electronic, programmable control power supply unit 34.
  • This arrangement consists of a reservoir 27 filled with infusion solution and under largely constant pressure (stretched elastomer bladder ) in a protective housing 28 with injection 29 and outlet connector 30.
  • a coarse metering device 32 (capillary, capillary tube) is inserted via a microlumen line 31. It works a fixed constant infusion flow (error 10-20%).
  • the therapeutically interesting range is about 0.5 - 5 ml / hour. Downstream of this coarse metering device is the application device 33 with control power supply unit 34.
  • the special devices which in turn are provided with standard connectors 36 and connecting hose 37, can now be connected via a subsequent standard hose connector 35.
  • Hollow needles bent at right angles may be used with special cut 38 for subcutaneous and port infusions, butterfly hollow needles 39 for intravenous applications.
  • the flat, cylindrical, wide rim for gluing onto the skin, provided with inflow connector 41, is also part of the new inventive system and is used for transdermal medication application.
  • the above-mentioned system consists of the small battery-operated control power supply device 43, which contains a micro-controller, a real-time oscillator and an infrared transmitter and receiver unit and is worn on the patient's belt. It is used to supply power to the application device and to trigger the dosing container safely and in a controlled manner.
  • the disposable application device 44 which contains the programmable, permanent, electronic memory module (EEPROM) and the control electronics for the dosing container (both addressable via a serial bus), is carried by the patient on the body, as in Fig. 7 is shown schematically.
  • the batch number, the type of medication or medications, their dosing range, their desired dosing intervals and any desired bolus administered by the patient himself are permanently stored.
  • the control electronics of the cassette ensure that medication is released from the dosing containers.
  • an electronic communication adapter 42 which is connected to a commercially available personal computer 41, for example via a conventional RS 232 interface
  • the attending physician can, in practice, after the installation of a special dosing container pharmacotherapy software on the PC, the desired patient medication on the screen are displayed, entered, checked and then documented and transmitted via infrared via the communication adapter 42 to the control power supply device 42, which in turn confirms correct data reception, and then the connected application device or dosing cassette is put into operation in a controlled manner.
  • 9 shows schematically as an exemplary embodiment a spectrophotometer measuring cuvette to form a unit connected to the programmable application device as a component of a one-time use microanalysis system.
  • the spectrophotometer measuring cuvette 45 with an entrance window 46 and exit window 47 which is permeable to the spectral light 48 has here as a tight, firmly connected lid the programmable dosing cassette 49 already described, which, however, here has dosing containers 50 filled with reagents and additionally via a piercing opening 51 for filling in the Analysis sample and a connector 52 for the electronic control and evaluation system integrated in the spectrophotometer.
  • this programmable application system can be used to implement simple, portable, automatic analysis devices.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif destiné notamment à administrer des solutions médicamenteuses et comportant un ou plusieurs contenants doseurs. Un dispositif d'application de médicaments adapté à une utilisation individuelle en soins ambulatoires et soins à domicile est obtenu par le fait que chaque contenant doseur détermine un espace, délimité d'un côté au moins par un obturateur, et en ce que des moyens sont prévus pour permettre le détachement, l'ouverture ou la destruction de l'obturateur.
PCT/EP1997/003579 1996-07-07 1997-07-07 Dispositif a contenant doseur, notamment pour l'administration de solutions medicamenteuses WO1998001169A2 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DE19627152 1996-07-07
DE19627152.5 1996-07-07
DE19629395 1996-07-20
DE19629395.2 1996-07-20
DE19702362A DE19702362A1 (de) 1996-07-07 1997-01-23 Programmierbares Mikrobehälter-Applikationssystem für intravenöse, subcutane und transdermale Therapie mit besonderer Eignung für Home Care Patienten und die chemische Analytik
DE19702362.2 1997-01-23

Publications (2)

Publication Number Publication Date
WO1998001169A2 true WO1998001169A2 (fr) 1998-01-15
WO1998001169A3 WO1998001169A3 (fr) 1998-05-07

Family

ID=27216427

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1997/003579 WO1998001169A2 (fr) 1996-07-07 1997-07-07 Dispositif a contenant doseur, notamment pour l'administration de solutions medicamenteuses

Country Status (1)

Country Link
WO (1) WO1998001169A2 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1099132B (de) * 1958-08-02 1961-02-09 Leitz Ernst Gmbh Injektionsspritze
DE2461272A1 (de) * 1974-12-23 1976-07-01 Baumgartner Injektionseinrichtung
US5368570A (en) * 1991-11-12 1994-11-29 Imed Corporation Apparatus for infusing medical solutions
US5304128A (en) * 1992-09-22 1994-04-19 Habley Medical Technology Corporation Gas powered self contained syringe
US5308322A (en) * 1993-04-19 1994-05-03 Tennican Patrick O Central venous catheter access system

Also Published As

Publication number Publication date
WO1998001169A3 (fr) 1998-05-07

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