CN120459504A - Expansion device for human body inner pipeline - Google Patents

Abstract

The invention relates to an expanding device which comprises a catheter main body, a guiding part, an expanding part and a perfusion part, wherein the catheter main body is set to be inserted into two organs in a human body or a mammal body and is provided with a channel communicated with the two organs, the expanding part comprises an expanding bag, the expanding bag is set to expand the channel between the two organs, and the expanding device further comprises a limiting element which can limit or control the expanding size of the expanding bag to be kept within the limiting size.

Description

Expansion device for human body inner pipeline

Technical Field

The invention belongs to the field of medical appliances, and particularly relates to a device for expanding a channel between two organs in an individual.

Background

The following background description is only an illustration of some of the general background knowledge and is not intended to limit the invention in any way.

Currently, the devices for expanding the passage between two organs in an individual, such as a human or a mammal, are necessary preconditions for performing some operations, especially when a lesion is required to be treated in the same organ or when a medicine is introduced, the passage of the two organs is very small, and it is desirable to expand the passage to facilitate the treatment of the operation. Or the channel connecting two organs is blocked, and the channel is also required to be expanded to achieve the purpose of treatment.

For example, for the middle-aged and elderly people, bladder and prostate are easily diseased, and in particular, prostatic hyperplasia is a common disease, and at present, the treatment of patients is realized by expanding a urinary tract (a passage between two organs) from a catheter to an expansion bladder.

However, the above-described expansion still has some drawbacks, which require an improvement over existing expansion devices, and a better expansion of the passageway to reduce damage to the organ or passageway, while allowing for more convenient handling by the operator or physician.

Disclosure of Invention

In order to solve some problems in the prior art, the invention provides an expanding device, which comprises a catheter main body, wherein the catheter main body is provided with a guide part, an expanding part and a perfusion part, and the expanding part comprises an expanding bag which can expand a pipeline between two organs.

In some embodiments, the expansion portion is an expansion bladder that, in its natural state, is coated on the surface of the expansion portion, and the coating is directly or indirectly coated on the outer surface of the tube body of the expansion portion. When the inside of the bag is filled with gas or liquid, the volume of the bag becomes large, thereby realizing expansion of the pipe. The conduit herein includes the urethra, for example between the bladder and the prostate, as well as the urethra over the genitalia, as well as the passage between the other two organs. In some modes, since the membrane is a bag and can expand, typically a flexible membrane, the initial state is in a natural relaxed state and does not expand, and when the interior is filled with gas or liquid under a certain pressure, the volume of the membrane is increased, and the size of the membrane is increased, so that the size of the pipeline is increased. For example, the balloon may not be inflated, the volume of the interior cavity may be small, and once inflated, the volume of the interior wall cavity may be enlarged.

In some embodiments, the device further comprises a restriction element that allows the size of the expansion bladder to be in a relatively stable state when the volume of the expansion bladder is increased, or when the size of the expansion bladder is increased. "stable" is herein understood generally to mean that when the inflatable bladder is filled with a gas or liquid, its dimensions become larger than in the natural state, for example, its volume, diameter, circumference, etc., while the restriction element is such that the enlarged bladder is maintained in a stable size range, such as to maintain dimensional changes or fluctuations within a certain range. That is, when the volume of the expansion bladder becomes larger to a certain degree, the restriction member is restricted so that the volume of the expansion bladder is not increased or so that the volume is maintained within a relatively stable range.

This is because the expansion bladder is of an elastic material and the larger size is the larger the channel size, which requires a certain pressure to be applied to the interior of the expansion bladder, which must be greater than the pressure of the gas or liquid itself, as well as an applied pressure, for example, to maintain the interior of the expansion bladder at a pressure above 1 atmosphere, for example, above 1.5,2,2.5,3.3.5 atmospheres, for a period of time, for example, 20 seconds, 1 minute, or 10 minutes. The pressure applied and the time maintained are based on the specific circumstances of the particular pipeline and the size of the expansion desired. If the elastic material is an elastic material, the pressure needs to be maintained above the atmospheric pressure, such as continuous filling of gas or liquid, but continuous filling of liquid and gas, the bag is an elastic material, and the volume of the elastic material is continuously changed along with the increase of the pressure, at the moment, the pressure is applied to the expansion of the channel, but the size required by the expansion of the channel cannot be well controlled, and the continuous increase of the pressure cannot be judged. In addition, as the pressure increases, the elastic material comprising the balloon may rupture, and once ruptured, the air or liquid in the balloon leaks, the pressure decreases, and the purpose of successful expansion is not achieved, resulting in failure of the operation. The invention is characterized in that a control element is arranged on the technical defect, the control element can maintain the expanded bag in a stable size, even if larger pressure is applied in the bag for a longer time, the pressure of the bag is increased, but the volume or the size is kept stable, so that the expansion force can be continuously applied to the expansion of the pipeline, the expansion size of the pipeline is stable, the stable requirements of different expansion sizes of the pipeline can be realized, and the operation failure or the damage to the expansion channel can not be caused.

In some aspects, the defining element is located outside of the expansion balloon, which may define a stable dimension of expansion of the expansion balloon. In some embodiments, the defining element may be a mesh, a film, or a film or inelastic web of inelastic material. In some embodiments, the restriction element may wrap around the entire expansion bladder, or may comprise a portion of the expansion bladder. Preferably, the entire expansion bladder is included. In some modes, the limiting element has a fixed size without deformation in the natural state, and the expansion bladder has both a natural state and an inflated latter liquid-filled state, for example, the expansion bladder 11 has little gas or liquid inside in the natural state, the inner surfaces contact each other or directly and indirectly cover the catheter surface, and once the inside is inflated or filled with liquid, or the size or volume becomes larger after inflation or filling, the expansion bladder naturally expands, but because the limiting element externally defines the inherent size or volume, the expansion bladder can only expand to the size or volume defined by the limiting element, thus stably maintaining the volume and size of the expansion bladder, including constant pressure (even if the pressure increases), and the expansion bladder is in a safe range without rupture. The fixed dimension of the limiting element is the dimension of the conduit to be expanded, or the maximum dimension, e.g. the diameter of the urethra to be expanded by 2 cm, the fixed diameter of the limiting element is 2 inside, the maximum expanded dimension of the inner expansion balloon is 2 cm, no matter how much pressure is inside the expansion balloon.

In some embodiments, the restriction element covers the outer surface of the expandable bladder, which is also in the shape of a bladder, which is simply a non-elastic bladder, which does not require inflation of the interior of the bladder, nor does it have to have sealing properties, e.g. the restriction bladder may be a mesh, or a fibrous material, a non-elastic material, but also flexible rather than elastic. The elastic bag is generally airtight or airtight, and is also made of flexible materials, but has elasticity, and is inflated with air or liquid, and is elastically deformed to become larger in volume or size. In some aspects, the defining element is flexible, but inelastic, not substantially elastic. The term "overlying" according to the instant invention may be understood to include either direct or indirect contact, such as the inclusion of an expansion balloon within a defining element, or the wrapping of an expansion balloon by a defining element, or the partial covering of a defining element, or the inclusion of a partial expansion balloon.

Of course, in some embodiments, the limiting element may also be elastic, but not necessarily flexible, e.g. a mesh formed of wire mesh outside the expansion bladder, the mesh being of a fixed size, and the elastic strain properties being inferior to those of the expansion bladder. That is, when the expansion bladder is filled with gas or liquid, the size of the expansion is constant at a certain pressure, but the pressure is generally increased, and the size is increased with the increase of the pressure until the expansion is achieved. While the limiting element is elastic, the size of the limiting element may increase as the pressure increases, but to a certain extent the limiting element does not substantially change in size as the pressure increases, maintaining a relatively constant size. It will also be appreciated that the pressure within the inflatable bladder will rupture when the pressure within the bladder increases to a certain level, and that the pressure within the bladder will be defined to rupture if the pressure increases to a certain level, the so-called maximum burst pressure value. That is, it is also an aspect of the present invention that the maximum pressure value defining the rupture of the balloon is greater than the maximum pressure value of the rupture of the distended balloon. The pressure may be either pneumatic or hydraulic.

In some embodiments, when the expansion bladder is filled with a gas or liquid, the expansion bladder is filled with a gas or liquid to expand the expansion bladder to a volume that is increased, and the restriction element is capable of maintaining the volume of the expansion bladder within a constant range. In some aspects, the defining element is configured to define a balloon that covers an outer surface of the expandable balloon. In some aspects, the size defining the balloon expansion is smaller than the size of the expansion balloon expansion under the same pressure. In some embodiments, the defining bladder is constructed of a non-elastic material. In some aspects, the defining bladder is constructed of a non-elastic material but a flexible material. The flexible material can be used for ensuring that the limiting bag also covers the surface of the expansion bag when the expansion bag inside expands or not, and the flexible material can smoothly expand the pipeline without causing mechanical damage to the pipeline when contacting the pipeline due to the flexibility. In some embodiments, the defined bladder is sized to be a fixed size, such as a width of 1,2,3,4,5,6,7,8 cm in diameter, or a fixed volume, such as 50,80,100,200,300,400,800 milliliters. The diameter is the dimension representing the expansion of the inner expansion balloon and may also represent the dimension desired to expand the expansion channel. Thus, in some embodiments, the defined balloon includes the expansion balloon therein.

In some embodiments, the balloon is an elastic material that covers the surface of the catheter without filling with gas or liquid.

In some aspects, the catheter further comprises a first positioning balloon and a second positioning balloon on the expandable portion of the catheter, the first and second and expandable balloons being in communication with the perfused portion independently of each other. The first and second positioning bags mainly play a role in positioning, and when the expansion bag expands the pipeline, the positions are fixed and not moved. In some embodiments, when in use, the first positioning balloon is positioned within one organ, the second positioning balloon is positioned within another organ, and the portion of the catheter between the two positioning balloons is positioned in the tract between the organs. In some aspects, the first positioning balloon is proximal to the guide portion and the second positioning balloon is distal to the guide portion or proximal to the irrigation portion. In some embodiments, the first positioning balloon and the second positioning balloon are positioned within the two organs, respectively, when in use in a row.

In some aspects, the first positioning balloon and the second positioning balloon have a suitable distance therebetween, the suitable distance being set in the conduit between the two organs. In some embodiments, the appropriate distance is a portion of the catheter, and the amplification balloon and the defining element are disposed on a portion of the catheter, such that the balloon and the positioning element are also located on the surface of the catheter, from inside to outside, the balloon being an expansion balloon, and the defining element, such as a defining balloon.

In some aspects, the expansion device further comprises a first positioning balloon and a second positioning balloon, wherein the expansion balloon comprises the first positioning balloon and the second positioning balloon. That is, when the defining element is a balloon, it defines the expanded dimension of the expanded balloon, and when the first and second fibrous balloons are positioned within the expanded balloon, it also effectively defines the expanded dimension of the first and second positioning balloons. In this way, each bag (first, second positioning bag and expansion bag) on the expansion part of the expansion device has a fixed maximum expansion size, and the arrangement cannot cause the maximum expansion of the first positioning bag and the second fiber bag to be inconsistent due to the operation errors of different operators.

In some embodiments, the infusion part at the distal end of the catheter is provided with a plurality of independent channels, and the channels are respectively and independently communicated with the first positioning bag, the second positioning bag and the expansion bag and are used for respectively and independently inflating or infusing liquid so as to enlarge the volume of the infusion part. In some embodiments, pressure may be applied to each bladder, such as a pressure above one atmosphere. In some embodiments, the inflatable bladder is inflated or liquid filled through the passageway and the pressure within is allowed to be greater than one atmosphere, such as 1,1.5,2.5,3,3.5 times the atmosphere. The pressure is applied by connecting a syringe to a pressure gauge for inflation or filling, which is commercially available, for example, a single use balloon inflation pressure pump commercially available as "forede" (fervid) for inflation or filling.

In some aspects, there is a first channel in the irrigation portion, the first channel in communication with the first positioning balloon, a second channel in communication with the second positioning balloon, and a third channel in communication with the expansion balloon. The first positioning bag and the second positioning bag are independent of each other and are not communicated with each other.

In some embodiments, the infusion site is further provided with a guidewire channel through which the guidewire passes, the channel allowing the tube to pass along the guidewire into the interior of the body. The two organs are bladder and prostate. The conduit is a urethra including the urinary bladder and prostate, as well as the urethra in the genitalia.

Thus, there is a guidewire channel within the catheter body configured to pass a guidewire therethrough, thereby allowing the catheter body to be used outside the individual to the internal organs of the individual. In some versions, the end of the guide is open, so that the guidewire channel can be notified to drain urine when the end enters the bladder.

In some embodiments, the tube body is covered with a protective film that covers the surface of the defining element to protect the defining element. In some versions, the protective film is also elastic, being held against the limiting element. In some aspects, the cover film is a flexible elastic film. In some embodiments, the protective film covers the surface of the body of the guide rod to provide a smooth surface for the catheter to pass along the guidewire and into the body's internal organs.

Advantageous effects

The invention provides a positioning element which is arranged outside an expansion bag, can effectively control the expansion size of the expansion bag, and can not expand the expansion bag to a size which is stable under the condition of high internal pressure, particularly under the condition that the expansion bag is pressurized, so that the expansion of a pipeline which needs to be expanded is accurately realized, the trauma is reduced, in addition, different devices in the same batch are stable to the expansion size of different pipelines, and the consistency of operation is maintained. In addition, for doctor manipulations, the controllable properties are added, the result of which is uniquely stable.

Drawings

Fig. 1 is a schematic view of the structure of an expansion device (not inflated) in one embodiment of the present invention.

Fig. 2 is a schematic structural view (assembly) of an expansion device according to an embodiment of the present invention.

Fig. 3 is a schematic structural view of an expansion device (first positioning balloon inflation) in one embodiment of the present invention.

Fig. 4 is a schematic structural view of an expanding device (second positioning balloon inflated) in an embodiment of the present invention.

Fig. 5 is a schematic view of the structure of an expansion device (expansion balloon inflation) in one embodiment of the present invention.

Fig. 6 is a schematic structural view (assembly view) of an expansion device according to an embodiment of the present invention.

Fig. 7 is a schematic view (full expansion) of the structure of the expansion device in one embodiment of the present invention.

Fig. 8A is a schematic illustration of the deployment process (first positioning balloon inflation) of an expansion device according to one embodiment of the present invention.

Fig. 8B is a schematic illustration of the deployment process of the expansion device (inflation of the second positioning balloon) in accordance with an embodiment of the present invention.

Fig. 8C is a schematic illustration of the deployment process of the expansion device (inflation of the expansion bladder) in accordance with one embodiment of the present invention.

Detailed Description

The structures and terms of art to which the present invention pertains are further described below, as understood and interpreted in accordance with the general terms of art unless otherwise specified.

Catheter tube

The present invention provides a catheter for insertion into a body, a portion for insertion into the body, and a portion for external use, the catheter including an end portion having an insertion, and an infusion portion external to the body, the end portion having the insertion being connected to the infusion portion by the catheter. The catheter herein may in fact be a flexible tube, such as a plastic tube, with an opening 80 for the end insertion portion, a perfusion portion 70 for the tail portion, one end of the opening 80 for insertion into the body, and the perfusion portion also connecting a plurality of tubes for communication with the interior of the catheter. In some embodiments, as shown in fig. 6, the irrigation portion has an introduction channel 4, the introduction channel 4 being a guide wire (guide wire) through which the tube body is introduced into the body. The guide wire may or may not be withdrawn from the introduction channel 4 when the catheter is introduced into the body. Generally, when a guide wire is inserted into a body through an external opening, for example, when a catheter needs to be led into a bladder through a urethra, firstly, a relatively thin metal guide wire is led into the urethra of the genitals through a urine outlet of the genitals, then passes through a prostate, then enters the bladder through the prostate, and the guide wire can be led in CT, B ultrasonic and X-ray modes, so that the positioning and the state monitoring are convenient. An opening 80 in the catheter is then passed from the guidewire outside the body into the guidewire channel of the catheter and then along the guidewire into the urethra of the genitals, through the prostate, and into the urinary bladder between the prostate and the urinary bladder. Since urine is generally contained in the bladder, once urine flows out of the guide wire channel 4, the insertion end portion enters the bladder, and at this time, liquid can be injected through the external introduction channel to perform cleaning and the like.

Expansion part

In the present invention, the catheter has an expansion part 60 which expands the duct (urethra) between the bladder and the prostate, so that the size of the expansion part is larger than that of the original size, and the purpose of the expansion part is to reduce the pressure of the prostatic urethra, and also reduce the pressure of the bladder. Of course, it is also possible to expand the duct by which two organs in the body are directly pressed, so that the fluid can flow smoothly. This may be one of the major diseases in which the elderly age, with muscle degeneration, narrows the urethra, and causes difficulty in urination. Therefore, the device of the present invention is particularly suitable for the elderly.

To facilitate expansion of the tubing, an expansion portion 60 is included on the catheter, generally near the catheter lead-in 81, and when the catheter is inserted into the body, it is desirable for the expansion portion to be positioned within the tubing to be expanded, or through the tubing, so as to facilitate expansion of the tubing. In some embodiments, the expansion portion 60 is provided with an expansion bladder 11, and the bladder 11 is made of an elastic material, such as nylon, pebax. After inflation or infusion of fluid within the bladder 11, it expands, allowing nang a 11 to expand from a natural non-inflated, non-fluid-filled condition to a larger volume or size, such as a larger diameter. By virtue of the enlarged dimensions acting on the conduit, it is desirable to expand the conduit by inflation of the expansion bladder. Thus, in some embodiments, the inflatable bladder 11 is placed over the outer surface of the catheter extending over the portion of the deployment site, and when inflated or filled with fluid, expands radially around the central axis of the catheter to form a cylinder or sphere of increased diameter, which is intended to increase the size of the conduit against the force of the muscles surrounding the conduit.

In actual use, however, since the bladder 11 is of an elastic material (both elastic and flexible), when inflated and perfused with liquid, it is desirable that the bladder 11 be maintained at a pressure above atmospheric pressure for a period of time, which allows the bladder 11 to act with a relatively large expansion force against the tubing, and for a period of time. The pressure is increased by increasing the pressure of the gas or liquid to the expansion bladder, but the size of the expansion bladder is increased along with the pressure increase, and when the pressure is required to be relatively large, the expansion bladder may rupture due to the fact that the material of the bladder cannot bear the pressure (the maximum rupture pressure value of the bladder), so that the action of the expansion duct fails and the operation needs to be performed again. Medical elastic materials are generally selected and are desirably inexpensive, and there is a limit to the maximum pressure that different elastic materials have to overcome, such as when the elastic materials are fixed under natural conditions, the size is fixed, the internal filling of liquid or liquid increases its internal pressure and the pressure of the inflation to rupture is certain (the maximum pressure of the burst or rupture value), such as when the maximum pressure of some inflation to rupture is 1.5 times the atmospheric pressure, but when the pressure of the expansion of the tube is actually required to be 2.5 times the atmospheric pressure, such materials cannot be used because the burst will occur in use and the operation will fail, and the material selection of the balloon is limited. Only materials with pressures above 2.5 times the pressure at which inflation ruptures can be selected as the material for the bladder. Also, when operated by different persons, the pressure applied to the inside of the expansion bladder 11 is varied or fluctuates, for example, the prescribed pressure is 2.5 times the atmospheric pressure, but 2 or more, for example, 3 is actually applied, and the larger pressure inevitably causes unnecessary damage to the pipe, for example, the pressure increases, and the pipe expands more, inevitably causing damage. In particular, in some cases it is desirable that the conduit extends to a desired dimension which is a relatively fixed dimension, such as from an original 0.5mm to 1,2,3,4 cm, and this extended dimension is desirably a stable fixation, such as 1 cm, 2cm, 4 cm, etc.

In order to solve the above problems, the present invention provides an external device limiting element of an expansion bag, which enables the expansion bag 11 to maintain a certain constant volume when being expanded to a certain volume, but the internal pressure can be continuously increased, the desired pressure can be increased, even the pressure above the pressure of the expansion rupture can be increased, so that the selection of the material of the expansion bag is widened more widely, in addition, the expansion size of the pipeline is constant due to the constant volume and the constant size of the expansion bag, so that errors caused by different operators are avoided, and the pipeline expansion is sometimes larger than the design, so that unnecessary damage is caused.

In some embodiments, the restriction element comprises a restriction balloon 12 that includes the described expansion balloon 11 therein. In some embodiments, the restriction bladder is a flexible material, but a non-elastic material, such as some nonwoven fabrics, cotton, silk screens, ultra-thin white nylon textiles. In some embodiments, the restriction cell 12 is fixed in its natural dimensions, e.g., 120 milliliters in volume, or fixed in diameter, such that the maximum size of inflation is controlled by the restriction cell even when the inner inflation cell is inflated by the application of pressure, thus maintaining the inflation cell 11 at a relatively constant inflation size, and the inner pressure, even if increased above the pressure at which the inflation cell ruptures, is not break a rule due to the protective effect of the outer restriction cell. The restraining bladder 12 may be of any flexible but inelastic material, such as a metal mesh, and the "bladder" in the restraining bladder may be breathable, liquid-permeable, such as mesh with a mesh, plastic material, or cloth, silk, or fibrous material forming a bladder-like shape. An inflation bladder 11 is disposed within the restriction bladder 12, wherein the "bladder" of the inflation bladder 11 and the subsequently described first and second positioning bladders 31, 21 is generally a non-breathable or liquid-impermeable material, which may be a flexible but also resilient material, which is a resilient material that in its natural state covers the surface of the inflation catheter and in the case of inflation or fluid filling, expands in volume to achieve the inflation or restriction position. Such as nylon film, elastic plastic film, and any other elastic material, particularly medical elastic materials suitable for access to the human body, with comparable sealing properties.

In some embodiments, the expansion device includes a first positioning bladder 31 positioned against the insertion end of the 31 jin catheter and a second positioning bladder 21 positioned away from the insertion end but on the expansion site 60. While the expansion 60 on the catheter is located near the insertion end. In some aspects, the first positioning balloon 31 and the second positioning balloon 21 are positioned within the expansion balloon 11, and the expansion balloon 11 is positioned within the restriction balloon 12. For example, as shown in FIGS. 1-5, the inflation bladder 11 is positioned over the inflation portion and the inflation bladder 11 includes a first positioning bladder 31 and a second positioning bladder 21 that form an inflated first bladder chamber 300 and second bladder chamber 200 when the first and second bladders are filled with fluid or inflated. When the extended bladder 11 is filled with fluid or inflated, an enlarged extended bladder cavity 100 is formed. For example, in the initial state, the first positioning balloon 31, the second positioning balloon 21 is wrapped around the catheter or over the outer surface of the catheter, while the inflation balloon 11 is wrapped over the surfaces of the first and second balloons and the restriction balloon 12 is wrapped over the outer surface of the inflation balloon. The first, second and expansion bladders each have a conduit through which the irrigation portion communicates independently of each other for inflating or filling the first, second or expansion bladder, so that in some embodiments the first bladder has a first through-hole 30 therein, the second bladder has a second hole 20 therein, and the expansion bladder has a third through-hole 10 therein, the third through-hole 10 being disposed outside of the first and second positioning bladders. The through holes are all arranged on the wall of the guide tube, are respectively and independently positioned in the bag and are respectively and independently communicated with the channel on the perfusion part.

The first positioning balloon 31 is inflated to form a first positioning balloon 300, the second positioning balloon 21 is inflated to form a second balloon 200, and the expansion balloon 11 is inflated to form an expansion balloon 100. While the restriction balloon may be flexible but inelastic, the volume of the shaped restriction balloon lumen 120 is constant or substantially constant.

For example, as shown in FIG. 5, this is the state in which all of the extended bladder 11, first 31 and second positioning bladder 21 are fluid-filled and inflated. The general procedure is that when the catheter is inserted into the bladder 301 (fig. 8A), the first dilated balloon 31 is first inflated to form an enlarged positioning balloon cavity 300, then the first positioning balloon is gently withdrawn outwardly, adjacent the outlet of the bladder, and the second positioning balloon 21 is inflated to form an enlarged balloon cavity 200, with the second positioning balloon positioned in the prostate 302, the second positioning balloon contacting the fixed position in which the expanded portion of the catheter is locked, and during the expansion, the catheter remains in place in the passageway due to the positioning of the first and second positioning balloons. At this time, the outer surface of the expansion bladder 11 is indirectly contacted with the pipe 303 (urethral wall) through the surface of the restriction bladder 12, at this time, the expansion bladder 11 is inflated with liquid, the internal pressure thereof is increased and is also expanded, the internal bladder cavity 100 of the expansion bladder 11 is gradually increased to at least 2.5 atmospheres, at this time, the maximum size or volume of expansion of the expansion bladder 11 is limited by the restriction bladder 11 due to the existence of the restriction bladder 12 outside the expansion bladder 11, and the size thereof is kept at a constant size, so that the internal pressure can be effectively increased, and the bladder cavity 100 inside the expansion bladder 11 is not expanded continuously to cause rupture. By increasing the pressure, the pipeline 303 can be effectively expanded. Therefore, the restriction bladder 12 does not expand but restricts the expanded size of the expansion bladder 11, so that the expanded size of the conduit can be kept consistent with the size of the restriction bladder 12, for example, the diameter of the restriction bladder is 2 cm, and the final expanded size of the conduit is 2 cm.

In addition, in the present embodiment, since the first and second positioning bags 21 are also positioned in the interior of the positioning bag 12 (as shown in fig. 5), the maximum expansion size of the first and second positioning bags is controlled in practice when the first and second positioning bags are filled with liquid, and the maximum diameter of the first positioning bag is fixed when the positioning bag 12 is a uniform cylinder, so that the maximum diameters of the first and second positioning bags are limited by the restriction bag, and thus, the expansion sizes of the first and second positioning bags and the expansion bag are limited in practice, and there is a point that the first and second positioning bags do not expand the tube but require positioning, and the maximum size is generally reached (controlled by the restriction bag 12) when the first positioning bag is filled with liquid, and even if a larger pressure is applied later, the first positioning bag is not ruptured, and success of the experiment is ensured, and the restriction of the maximum size of the prostate is reduced by the restriction bag 21 positioned in the enlarged prostate 12. Different maximum expansion sizes can be set according to different people, so that the expansion diameters or volumes of the first 31 and the second positioning bags 21 in each product in a single batch are kept consistent, and the expansion volumes are not different due to different operators. If the presence of the restriction capsule 12 is absent, everyone is not consistent with the maximum size of the expansion of the first 31 and second 21 positioning, some diameters are too large, causing compression or even damage to the glands. Secondly, since the first 31 and second 21 positioning pockets and the expansion pocket 11 are both limited by the limiting pocket 12, in the final expansion step, a shape that is integrally limited by the limiting pocket is formed to realize constant-size expansion of the duct.

In some modes, for example, as shown in fig. 6-7, the expansion bag 11 is located between the first positioning bag 31 and the second positioning bag 21, the expansion bag 11 located between is actually located inside the pipeline, expansion of the pipeline is achieved, the first positioning bag 31 and the second positioning bag 21 located at two ends achieve locking of the position of the expansion bag 11, no movement of the position occurs during expansion, and expansion of the pipeline is effectively achieved. At this time, it is sufficient to provide the restriction bag 12 only on the outside of the expansion bag 11, and the effects of the present invention can be obtained as well.

In some aspects, to facilitate distinguishing between the position and order of operation of the first positioning bladder 31, the second positioning bladder 21, and the extended bladder 11, the passageway 3 connecting the first positioning bladder 31 is generally shortest and the passageway 2 connecting the extended bladder 11 is generally longest, while the length of the passageway 1 connecting the second positioning bladder 21 is centered, indicating the order of operation, the shortest passageway 3 is first filled with fluid (through-hole 30) into the first positioning bladder 31, inflated, then filled with fluid into the centered length of catheter 1 to allow the second positioning bladder 21 to be filled with fluid, and finally inflated through the catheter 2 to the extended bladder fluid. And the catheter 4 is a channel for passing a guide wire therethrough. Each of the channels is independently connected to the through-hole, for example, the channel 3 communicates with the through-hole 30, the channel 2 communicates with the through-hole 10, and the channel 1 communicates with the through-hole 20 (as shown). The outlets of these channels are each connected to a through hole in the bladder, while the inlets are located at the location of the pouring section 70, or extend outwardly.

Pipeline

The conduit of the present invention is a passageway through the expansion bladder that requires an increased width, such as the urethra, for example, directly between the bladder and the prostate, but may also be the urethra over the genitalia, and of course may be other conduits, which are typically formed of muscle tissue, which has a constricting effect, and when the conduit is required to be expanded, it is required to overcome the constricting force of the muscle tissue to allow it to increase in size, such as 0.5mm for the original conduit, to 1,2,3 cm for expansion, and to increase pressure on the inner wall of the conduit while filling the expansion bladder with fluid, where the pressure may be 1.5,2,2.5,3,3.5 times the atmospheric pressure.

Manufacturing process

The invention can provide a manufacturing process, firstly, a catheter is provided, two ends of the catheter are provided with openings, the openings of the insertion end are communicated with the inside of the bladder, the other end is provided with a perfusion part, 4 channels are arranged on the perfusion part, and one channel 4 is used for a guide wire to penetrate through the whole catheter body and enter the catheter into the body, for example, penetrate through the prostate and enter the bladder. The three holes 30,20,10 are sequentially arranged from near to far on the conduit wall of the expansion 60 near the insertion end of the conduit, after which a flexible first elastic sleeve is provided, which is sleeved on the outer wall of the conduit through the insertion end, and then a fixing member is adopted on the conduit 40 between the first hole 30 and the second hole 20, so that the flexible conduit is divided into two sections, and the two sections are sealed and airtight or liquid-permeable, so that the elastic sleeve is tightly attached on the conduit surface between the first hole 30 and the second hole 20. Simultaneously, the two ends 63,64 of the sleeve are respectively sealed by tightly adhering the sleeve to the catheter in the same way, so that a first positioning bag 31 and a second positioning bag 21 are formed, and the two bags are respectively communicated with the first hole 30 and the second hole 20 independently. While the first hole 30 communicates with the third conduit 3 of the pouring section and the second hole 20 communicates with the second conduit 1 of the pouring section. Then, a second elastic sleeve is provided, which is longer than the first elastic sleeve, is sleeved on the expanding part 60 of the catheter from the insertion end, and the first positioning bag 31 is arranged, the second positioning bag 21 is arranged in the second sleeve, and the third hole 10 arranged outside the second positioning and the first positioning is arranged in the second elastic pipeline, and the two ends 61 and 62 of the elastic pipeline are sealed and only stuck on the catheter, so that the expanding bag 11 is formed. At this time, a restriction cell 12 (flexible but inelastic) is also provided, which is also tubular in form, but the internal cavity has a diameter of about 1-2 cm in size, or a volume of 100-200 ml, and the expansion portion 60 is passed through the restriction tubing, sealed at both ends thereof, in the same manner as the ends 61,62 of the expansion cell, and the expansion cell is located in the restriction cell 12. Thereby positioning the expansion bladder 11 within the restriction bladder 12 and also positioning the first 31 and second 21 positioning bladders within the expansion bladder 11. (as in fig. 2.) of course, the structure as illustrated in fig. 6 can be made in a similar manner.

In order to better form, a flexible elastic protective film is further sleeved outside the limiting bag 12, the protective film has a smooth surface, one function is to protect the limiting bag 12 (when the limiting bag surface is a rough cloth or a net cover) 2 from damage or damage caused by direct contact with a pipeline, meanwhile, one function of the smooth surface of the elastic film is to facilitate the insertion of a catheter into a body for lubrication, and the other function is to expand the protective film when the expansion bag 11, the first 31 and the second positioning bag 21 are expanded, and of course, the maximum size of expansion is controlled by the limiting bag 12 (as shown in fig. 5). The protective film may cover the expansion portion or the entire surface of the catheter from the insertion end to the irrigation portion.

The following embodiment is also one of the present invention:

An expansion device comprises a catheter which is configured to be inserted into two organs in a human body and is communicated with the two organs through a pipeline, wherein the expansion device comprises a guide part, an expansion part and a perfusion part, the expansion part comprises an expansion bag, the expansion bag is configured to expand the dun pipeline,

The expanding device also comprises a limiting element which can limit or control the expansion size of the expanding bag to be kept within the limit size.

In some aspects, the restriction element is located on the exterior of the expansion bladder. In some aspects, the defining element overlies an outer surface of the expansion bladder. In some embodiments, when the expansion bladder is filled with a gas or liquid, the expansion bladder is filled with a gas or liquid to expand the expansion bladder and increase the volume, and the restriction element is capable of maintaining the volume of the expansion bladder within a constant range. In some aspects, the defining element is a defining bladder, and the expansion bladder is positioned within the defining bladder. In some aspects, the size defining the balloon inflation is smaller than the size of the expanded balloon inflation under the same pressure. In some embodiments, the defining bladder is constructed of a non-elastic material. In some embodiments, the size of the defined pocket is a fixed size. In some embodiments, the defining bladder is made of a flexible, inelastic material. In some embodiments, the balloon is an elastic material that covers the surface of the catheter without filling with gas or liquid. In some embodiments, a first positioning balloon and a second positioning balloon are also included within the dilation balloon, each of the first and second and dilation balloons being in communication with the irrigation section independently of the other. In some aspects, the first positioning bladder is proximal to the guide portion and the second positioning bladder is distal to the guide portion. In some embodiments, the first positioning balloon and the second positioning balloon are positioned within the two organs, respectively, at the time of use. In some aspects, the first positioning bladder and the second positioning bladder have a suitable distance therebetween that is set in the tract between the two organs. In some aspects, the expansion device further comprises a first positioning bladder and a second positioning bladder, wherein the expansion bladder is positioned between the first positioning bladder and the second positioning bladder. In some aspects, the first positioning balloon, the second positioning balloon, and the inflation balloon are each in communication with the irrigation portion independently of one another. In some aspects, there is a first channel, a second channel, and a third channel in the irrigation portion, wherein,

The first channel is communicated with the first positioning bag, the second channel is communicated with the second positioning bag, and the third channel is communicated with the expanding bag. In some embodiments, the two organs are the bladder and the prostate and the conduit is the urethra. In some embodiments, the bladder is expanded and the first and second localized portions of the bladder are formed of an elastic membrane that expands to a greater volume when inflated or filled. In some embodiments, the tube body is covered with a protective film, which is also an elastic film, over the surface defining the element. In some aspects, the maximum burst pressure value of the restriction bladder is greater than the maximum burst pressure value of the expansion bladder.

All patents and publications mentioned in the specification are indicative of those of ordinary skill in the art to which this invention pertains and which may be applied. All patents and publications cited herein are hereby incorporated by reference to the same extent as if each individual publication were specifically and individually indicated to be incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. For example, the terms "comprising," "consisting essentially of," and "consisting of," in each example herein, may be replaced with the remaining 2 terms of one of the two. The term "a" or "an" as used herein means "one" only, and does not exclude that only one is included, and may also mean that more than 2 are included. The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described, but it is recognized that various modifications are possible within the scope of the invention and of the claims. It is to be understood that the embodiments described herein are illustrative of the preferred embodiments and features and that modifications and variations may be made by those skilled in the art in light of the teachings of this invention and are to be considered as falling within the scope of the invention and the appended claims.

Claims (15)

1. An expansion device comprising: A catheter is configured to be inserted into two organs in the human body, and the two organs are connected via a tube; it comprises a guide portion, an expansion portion, and an infusion portion; the expansion portion includes an expansion sac, which is configured to expand the tube, wherein the expansion device also includes a limiting element, which can limit or control the size of the expansion sac to keep it within the limited size. 2. The device according to claim 1, wherein the limiting element is located outside the expansion capsule. 3. The device according to claim 1, wherein the limiting element covers the outer surface of the expansion balloon. 4. The device according to claim 3, wherein, when the expansion sac is filled with gas or liquid, the expansion sac is filled with gas or liquid so as to expand the expansion sac and increase its volume, and the limiting element can keep the volume of the expansion sac within a constant range. 5. The device according to any one of claims 1 to 4, wherein the limiting element is a limiting capsule, and the expansion capsule is located within the limiting capsule. 6. The device according to claim 5, wherein, under the same pressure condition, the expanded size of the limiting balloon is smaller than the expanded size of the expansion balloon. 7. The device according to claim 5, wherein the limiting bladder is made of a non-elastic material. 8. The device according to claim 5, wherein the size of the limiting capsule is a fixed size. 9. The device according to claim 5, wherein the limiting bag is made of a flexible non-elastic material. 10. The device according to claims 1-9, wherein the expansion balloon is made of elastic material and covers the surface of the catheter when there is no gas or liquid filled inside. 11. The device according to claims 1-10, wherein the expansion sac further comprises a first positioning sac and a second positioning sac, and the first and second positioning sacs and the expansion sac are independently connected to the perfusion part. 12. The device according to claim 11, wherein the first positioning capsule is close to the guide portion and the second positioning capsule is far from the guide portion. 13. The device according to claim 12, wherein, when in use, the first positioning balloon and the second positioning balloon are respectively located in two organs. 14. The device according to claim 13, wherein there is an appropriate distance between the first positioning balloon and the second positioning balloon, and the appropriate distance is set to be located in the channel between the two organs. 15. The device according to claims 1-10, wherein the expansion device further comprises a first positioning capsule and a second positioning capsule, and the expansion capsule is located between the first positioning capsule and the second positioning capsule.