Expansion device for pipeline in human body

Abstract

The invention relates to a dilation device, which comprises a catheter main body which is set to be capable of being inserted into two organs in a human body or a mammal body, and the two organs are communicated through a channel; the filling part is provided with a guide part, an expansion part and a filling part; the expanding part comprises an expanding bag, the expanding bag is set to be capable of expanding a channel between two organs, the expanding device further comprises a limiting element, and the limiting element can limit or control the expanding size of the expanding bag so that the expanding size of the expanding bag can be kept within the limited size. The fracture of the expansion bag under high pressure can be reduced, the expansion size of the pipeline is consistent, and the accuracy and precision requirements of operation are improved.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a device for expanding a channel between two organs in an individual. Background Art

[0002] The following background technology introduction is merely an introduction to some background common sense and does not constitute any limitation to the present invention.

[0003] Currently, devices that expand the passageway between two organs in individuals, such as humans or mammals, are essential for certain surgeries. This is especially true when a lesion within an organ requires surgical treatment or medication, and the passageway between the two organs is already small, making expansion of the passageway a desirable option to facilitate surgery. Alternatively, if the passageway connecting two organs is blocked, expansion is also necessary to achieve the desired treatment.

[0004] For example, for middle-aged and elderly people, the bladder and prostate are prone to lesions, especially prostate hyperplasia, which is a common disease. At present, the ureter (the channel between the two organs) is expanded by setting an expansion balloon in the catheter to achieve treatment for the patient.

[0005] However, the above expansion still has some defects, which requires the existing expansion device to be improved to better expand the channel and reduce damage to the organ or channel, while making it more convenient for the operator or doctor to operate. Summary of the Invention

[0006] In order to solve some problems in traditional technologies, the present invention provides an expansion device, including: a catheter body, having a guide part, an expansion part and an infusion part; the expansion part includes an expansion balloon, and the expansion balloon is configured to expand the pipeline between two organs.

[0007] In some embodiments, the expansion portion is an expansion capsule, which covers the surface of the expansion portion in its natural state, and the covering is directly or indirectly covering the outer surface of the tube body of the expansion portion. When the interior of the capsule is filled with gas or liquid, the volume of the capsule increases, thereby achieving the expansion of the conduit. The conduit here includes the urethra, such as the urethra between the bladder and the prostate, the urethra on the genitals, and the channel between two other organs. In some embodiments, since it is a capsule and can expand, it is generally an elastic film. The initial state is in a natural relaxed state and does not expand. When the interior is filled with gas or liquid under a certain pressure, its volume increases, and the size also increases, thereby making the size of the conduit larger. For example, when a balloon is not inflated, the volume of the internal cavity is very small. Once inflated, it expands and the volume of the inner wall cavity increases.

[0008] In some embodiments, the device further includes a restraining element that maintains a relatively stable size of the expansion bladder as it expands in volume or size. "Stable" here generally means that when the expansion bladder is filled with gas or liquid, its dimensions increase compared to its natural state, such as increasing in volume, diameter, or circumference. The restraining element maintains the expanded bladder within a stable size range, such as maintaining dimensional change or fluctuation within a certain range. In other words, when the volume of the expansion bladder reaches a certain point, the restraining element prevents the volume of the expansion bladder from increasing, or maintains the volume within a relatively stable range.

[0009] This is because the expansion bladder has this property. Made of an elastic material, increasing its size increases the channel's size. This requires applying a certain pressure within the bladder, which must be greater than the pressure of the gas or liquid itself. Similarly, external pressure is required, for example, to maintain a pressure above 1 atmosphere within the bladder—for example, 1.5, 2, 2.5, 3, 3.5 atmospheres—for a period of time, such as 20 seconds, 1 minute, or 10 minutes. The applied pressure and duration depend on the specific conditions of the pipe and the desired expansion size. If the material is elastic, maintaining a pressure above atmospheric pressure requires continuous application of pressure, such as by continuously filling the bladder with gas or liquid. However, as the bladder is elastic, its volume changes with increasing pressure. In this case, while pressure is applied to expand the channel, it is difficult to effectively control the desired channel expansion size. As pressure continues to increase, it is impossible to determine the specific channel expansion size. Furthermore, as pressure increases, the elastic material balloon may rupture. Once ruptured, the air or liquid within the balloon leaks out, reducing pressure and preventing successful expansion, leading to surgical failure. The present invention addresses this technical shortcoming by providing a control element that maintains the expanded balloon at a stable size. In this case, even if greater pressure is applied to the balloon for a longer period of time, the balloon's volume or dimensions remain relatively stable. This allows for a continuous expansion force to be applied to the expanded tube, while also stabilizing the expanded tube's dimensions. This ensures that the desired expansion dimensions are met without causing surgical failure or damaging the expanded channel.

[0010] In some embodiments, the limiting element is located outside the expansion bladder, thereby limiting the expansion of the expansion bladder to a stable size. In some embodiments, the limiting element can be in the form of a mesh, a film, or a film or mesh made of an inelastic material. In some embodiments, the limiting element can enclose the entire expansion bladder or a portion of the expansion bladder. Preferably, the limiting element encompasses the entire expansion bladder. In some embodiments, in its natural state, the limiting element has fixed dimensions and does not deform, while the expansion bladder has two states: a natural state and an inflated state or a liquid-filled state. For example, in its natural state, the expansion bladder 11 contains almost no gas or liquid, and its internal surfaces are in contact with each other or directly or indirectly cover the surface of the catheter. Once the interior is inflated with gas or liquid, or its size or volume increases after inflation, it will naturally expand. However, because the limiting element externally limits its inherent size or volume, the expansion bladder can only expand within the volume or dimensions defined by the limiting element. This ensures that the volume and size of the expansion bladder are stably maintained, and even when the pressure is constant (even if it increases), the expansion pressure applied to the catheter remains within a safe range and does not rupture. The fixed size of the limiting element is the size of the expanded tube, or the maximum size. For example, if the urethra is expected to be expanded to a diameter of 2 cm, the fixed diameter of the limiting element is 2 cm. The maximum expansion size of the internal expansion bag is 2 cm, no matter how high the pressure inside the expansion bag is.

[0011] In some embodiments, the limiting element covers the outer surface of the expansion capsule, which is also in the shape of a capsule, but the capsule is a non-elastic elastic capsule. The interior of the capsule does not need to be inflated, nor does it need to have sealing properties. For example, the limiting capsule can be a mesh, or a fiber material, a non-elastic material, but it is also flexible but not elastic. The elastic capsule here is generally airtight or sealed. The capsule is also made of a flexible material, but it is elastic, inflated with gas or liquid, and undergoes elastic deformation to increase in volume or size. In some embodiments, the limiting element is flexible, but non-elastic, and is not actually elastic. The "covering" of the present invention can be understood to include direct or indirect contact, such as the limiting element includes the expansion capsule, or the limiting element wraps the expansion capsule, or the limiting element partially covers or includes part of the expansion capsule.

[0012] Of course, in some embodiments, the limiting element can be elastic, but not necessarily flexible. For example, a wire mesh covering the expansion bladder has a fixed size, but its elastic strain capacity is inferior to that of the expansion bladder. That is, when the expansion bladder is filled with gas or liquid, its expanded size remains constant under a certain pressure. However, as the pressure increases, its size generally increases with the pressure, until it bursts. While the limiting element is elastic, its size may increase with increasing pressure. However, beyond a certain pressure level, it does not substantially change with increasing pressure, maintaining a relatively constant size. It can also be understood that when the pressure inside the expansion bladder increases to a certain level, the expansion bladder will rupture, while when the pressure inside the limiting bladder increases to a certain level, the bladder will also rupture, the so-called maximum rupture pressure. In other words, the maximum rupture pressure of the limiting bladder is greater than the maximum rupture pressure of the expansion bladder. Such a situation is also a solution of the present invention. Pressure can be achieved by filling with gas or liquid.

[0013] In some embodiments, when the expansion bladder is filled with gas or liquid, causing the bladder to expand and increase in volume, the limiting element is capable of maintaining the volume of the expansion bladder within a constant range. In some embodiments, the limiting element is a limiting bladder that covers the outer surface of the expansion bladder. In some embodiments, under the same pressure, the expanded size of the limiting bladder is smaller than the expanded size of the expansion bladder. In some embodiments, the limiting bladder is made of a non-elastic material. In some embodiments, the limiting bladder is made of a non-elastic but flexible material. The flexible material allows the limiting bladder to cover the surface of the expansion bladder as the internal expansion bladder expands. Due to its flexibility, when contacting the pipeline, it does not cause mechanical damage to the pipeline, allowing smooth expansion of the pipeline. In some embodiments, the limiting bladder has a fixed size, such as a diameter of 1, 2, 3, 4, 5, 6, 7, or 8 cm, or a fixed volume, such as 50, 80, 100, 200, 300, 400, or 800 ml. The diameter represents the size of the internal expansion capsule, and can also represent the size of the expansion channel that is desired to be expanded. Therefore, in some embodiments, the expansion capsule is included in the limiting capsule.

[0014] In some embodiments, the expansion balloon is made of elastic material, and when not filled with gas or liquid, the expansion balloon covers the surface of the catheter.

[0015] In some embodiments, the expansion portion of the catheter further includes a first positioning balloon and a second positioning balloon, and the first and second and expansion balloons are independently connected to the perfusion portion. The first and second positioning balloons mainly play a positioning role, and when the expansion balloon expands the pipeline, the position is fixed and does not move. In some embodiments, when in use, the first positioning balloon is located in one organ, the second positioning balloon is located in another organ, and the catheter part between the two positioning balloons is located in the pipeline between the organs. In some embodiments, the first positioning balloon is close to the guide portion, and the second positioning balloon is away from the guide portion or close to the perfusion portion. In some embodiments, when in use, the first positioning balloon and the second positioning balloon are respectively located in the two organs.

[0016] In some embodiments, a suitable distance is defined between the first and second positioning balloons, the suitable distance being defined within the conduit between the two organs. In some embodiments, the suitable distance is defined as a portion of a catheter, and the expansion balloon and the limiting element are positioned on the portion of the catheter. The expansion balloon and the positioning element are also positioned on the surface of the catheter, with the expansion balloon and the limiting element, such as the limiting balloon, positioned from the inside out.

[0017] In some embodiments, the expansion device further includes a first positioning capsule and a second positioning capsule, wherein the expansion capsule includes the first and second positioning capsules. That is, when the limiting element is a capsule, it limits the expansion size of the expansion capsule. When the first and second fiber capsules are located within the expansion capsule, they also effectively limit the expansion size of the first and second positioning capsules. This ensures that each capsule (the first and second positioning capsules, and the expansion capsule) on the expansion portion of the expansion device has a fixed maximum expansion size, preventing the maximum expansion size of the first positioning capsule and the second fiber capsule from being inconsistent due to operational errors by different external operators.

[0018] In some embodiments, the infusion portion at the distal end of the catheter is provided with a plurality of independent channels, each of which is independently connected to the first positioning balloon, the second positioning balloon, and the expansion balloon, for independently inflating or infusing the balloon with liquid to increase their volume. In some embodiments, pressure can be applied to each balloon, such as a pressure greater than one atmosphere. In some embodiments, the expansion balloon is inflated with gas or liquid through the channels and the internal pressure is made greater than one atmosphere, such as 1, 1.5, 2.5, 3, or 3.5 times the atmospheric pressure. The pressure is applied using a syringe connected to a pressure gauge to inflate or fill the balloon. This is a readily available commercial tool that can be purchased, such as the disposable balloon inflation pressure pump marketed as "Fervid" for inflation or filling.

[0019] In some embodiments, the perfusion portion has a first channel, a second channel, and a third channel, wherein the first channel is connected to the first positioning bladder, the second channel is connected to the second positioning bladder, and the third channel is connected to the expansion bladder. The first positioning bladder, the second positioning bladder, and the expansion bladder are independent of each other and do not communicate with each other.

[0020] In some embodiments, the infusion site is further provided with a guidewire channel for passing a guidewire, which allows the tube to enter the human body along the guidewire. The two organs are the bladder and the prostate. The tube is the urethra, including the urethra of the bladder and prostate, as well as the urethra of the genitals.

[0021] Therefore, the catheter body also has a guidewire channel, which is configured to allow a guidewire to pass through, thereby allowing the tube body to enter an organ inside the individual from outside the individual through the guidewire. In some embodiments, the end of the guide portion is open, so that when the end enters the bladder, urine can be discharged through the guidewire channel.

[0022] In some embodiments, the tube body is covered with a protective film that covers the surface of the limiting element to protect it. In some embodiments, the protective film is also elastic and fits snugly over the limiting element. In some embodiments, the covering film is a flexible elastic film. In some embodiments, the protective film covers the main surface of the guide rod, providing a lubricating effect, allowing the catheter to smoothly follow the guidewire into the internal organs of the human body.

[0023] Beneficial effects

[0024] The present invention provides a positioning element, disposed on the exterior of the expansion bladder, that effectively controls the expansion size of the bladder. Specifically, when the bladder is pressurized, the bladder is prevented from expanding indefinitely, maintaining a stable position under internal high pressure. This allows for precise expansion of the desired tube, minimizing trauma. Furthermore, different devices from the same batch can achieve the same stable expansion size for different tubes, maintaining surgical consistency. Furthermore, the surgeon's operation is more controllable, resulting in a unique and stable result. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic structural diagram of an expansion device in a specific embodiment of the present invention (not expanded).

[0026] Figure 2 It is a structural schematic diagram (assembly) of an expansion device in a specific embodiment of the present invention.

[0027] Figure 3 It is a schematic structural diagram of an expansion device in a specific embodiment of the present invention (the first positioning balloon is expanded).

[0028] Figure 4 It is a schematic structural diagram of the expansion device in a specific embodiment of the present invention (the second positioning balloon is expanded).

[0029] Figure 5 It is a schematic structural diagram of an expansion device (expansion of the expansion sac) in a specific embodiment of the present invention.

[0030] Figure 6 It is a structural schematic diagram (assembly diagram) of an expansion device in a specific embodiment of the present invention.

[0031] Figure 7 It is a structural schematic diagram of the expansion device in a specific embodiment of the present invention (fully expanded).

[0032] Figure 8A It is a structural schematic diagram of the expansion device during the operation (the first positioning balloon is expanded) in a specific embodiment of the present invention.

[0033] Figure 8B It is a structural schematic diagram of the expansion device during the operation (the second positioning balloon is expanded) in a specific embodiment of the present invention.

[0034] Figure 8C It is a structural schematic diagram of the expansion device during operation (expansion of the expansion sac) in a specific embodiment of the present invention. Detailed description

[0035] The following is a further explanation of the structures involved in the present invention or the technical terms used. If not otherwise specified, they will be understood and interpreted according to the general terms commonly used in the art.

[0036] catheter

[0037] The present invention provides a catheter that is inserted into the body, with one portion inserted into the body and another portion outside the body. The catheter includes an insertion end portion and an infusion portion outside the body, and the insertion end portion and the infusion portion are connected through the catheter. The catheter here can actually be a flexible tube, such as a plastic tube, with an opening 80 at the insertion end portion and an infusion portion 70 at the tail end portion. One end of the opening 80 is used to be inserted into the body, and the infusion portion is also connected to multiple pipes and communicated with the interior of the catheter. In some embodiments, such as Figure 6As shown, the infusion section has an introduction channel 4, which is used to insert a guide wire (a guide wire) through which the catheter body enters the body. When the catheter is introduced into the body, the guide wire can be withdrawn from the introduction channel 4 or not. Generally, the guide wire is first inserted into the body through an external opening. For example, when the catheter needs to pass through the urethra to enter the bladder, a relatively thin metal guide wire is first inserted through the genital urethra through the genital urethra, then passes through the prostate, and then enters the bladder through the prostate. The guide wire can be introduced under CT, B-ultrasound, or X-ray to facilitate positioning and status monitoring. Then, one end of the catheter is allowed to enter the guide wire channel of the catheter through the external guide wire, and then along the guide wire into the genital urethra, through the prostate, and the urethra between the prostate and the bladder, and into the bladder. Since the bladder generally contains urine, once urine flows out of the guide wire channel 4, it indicates that the insertion end has entered the bladder. At this time, liquid can be injected through the external introduction channel for cleaning and other tasks.

[0038] Extension Department

[0039] In the present invention, the catheter is provided with an expansion portion 60, the function of which is to expand the conduit (urethra) between the bladder and the prostate, making it larger than the original size. The purpose of the expansion is to reduce the pressure of the prostatic urethra and also to reduce the pressure of the bladder. When the urethra becomes larger, the pressure is reduced, which makes urination more convenient and smoother. Of course, it can also be an expansion of the conduit directly pressed by two other organs in the body to allow the liquid to flow smoothly. This may be one of the main diseases that cause difficulty in urination in the elderly due to muscle degeneration and narrowing of the urethra as they age. Therefore, the device of the present invention is particularly suitable for the elderly.

[0040] In order to facilitate the expansion of the pipeline, the catheter includes an expansion portion 60, which is generally located near the catheter introduction end 81. When the catheter is inserted into the body, it is desired that the expansion portion is located in the pipeline to be expanded, or passes through the pipeline, so as to facilitate the expansion of the pipeline. In some embodiments, an expansion capsule 11 is provided on the expansion portion 60. The capsule 11 is made of elastic material, such as nylon or Pebax. When the capsule 11 is inflated or perfused with liquid, it will expand, allowing the capsule 11 to expand from its natural non-inflated or non-liquid-filled state and increase in volume or size, such as diameter. By relying on the enlarged size to act on the pipeline, it is hoped that the pipeline can be expanded by the expansion of the expansion capsule. Therefore, in some methods, the expansion balloon 11 is covered on the outer surface of the expanded part of the catheter. When the inside is inflated with air or liquid, it expands radially around the central axis of the catheter to form a cylinder or sphere with an increased diameter. The purpose of this size increase is to increase the size of the pipeline and overcome the force of the muscles around the pipeline to become larger.

[0041] However, in actual use, since the balloon 11 is made of an elastic material (elastic and flexible), when inflating or perfusing liquid, it is desirable to maintain a pressure higher than atmospheric pressure in the balloon 11 for a period of time, so that the balloon 11 exerts a relatively large expansion force on the tube and maintains it for a period of time. The way to increase the pressure is to continuously add gas or liquid to the expansion balloon to increase the pressure. However, as the pressure increases, the size of the expansion balloon will inevitably increase. When a relatively high pressure is required, the balloon may rupture because the material cannot withstand such pressure (the maximum pressure value of the balloon ruptures), thereby causing the expansion tube to fail and requiring reoperation. Medical elastic materials are generally chosen, and they are often inexpensive. However, different elastic materials have a limit to their maximum pressure resistance. For example, when an elastic material is fixed under natural conditions and has a fixed size, the pressure at which it expands and ruptures (maximum pressure for bursting or rupture) is constant when filled with liquid or when the liquid increases the internal pressure. For example, some materials have a maximum pressure of 1.5 times atmospheric pressure, but when the actual pressure required to expand the tube is 2.5 times atmospheric pressure, such materials cannot be used because they may rupture during use, causing the operation to fail. This limits the choice of material for the bladder. Only materials with a pressure of 2.5 times atmospheric pressure or above can be selected as the bladder material. Furthermore, when different operators operate the bladder, the pressure applied to the expansion bladder 11 may vary or fluctuate. For example, if the specified pressure is 2.5 times atmospheric pressure, but the actual pressure applied is 2 or even higher, such as 3, the higher pressure will inevitably cause unnecessary damage to the tube. For example, the increased pressure will cause the tube to expand further, which will inevitably cause damage. Especially in some cases, we hope that the pipeline can be expanded to a desired size, and this size is a relatively fixed size, such as expanding from the original 0.5 mm to 1, 2, 3, or 4 cm. We hope that this expanded size can be stable and fixed, such as 1 cm, 2 cm, or 4 cm.

[0042] In order to solve the above problems, the present invention creatively provides a limiting element on the outside of the expansion sac, so that when the expansion sac 11 expands to a certain volume, it can be maintained at a certain relatively constant volume, but the internal pressure can continue to increase, and can be increased to a desired pressure, or even increased to a pressure above the pressure of expansion-induced rupture, thereby making the choice of materials for the expansion sac wider. In addition, since the volume of the expansion sac is constant, the size is also constant, and the size of the expansion of the pipeline is also a constant size, avoiding errors caused by different operators. Sometimes the pipeline expansion is larger than the design, causing unnecessary damage.

[0043] In some embodiments, the restraining element includes a restraining bladder 12, which contains the expansion bladder 11. In some embodiments, the restraining bladder is made of a flexible but inelastic material, such as non-woven fabrics, cotton fabrics, silk screens, or ultra-thin white nylon fabrics. In some embodiments, the restraining bladder 12 has a fixed size in its natural state, such as a volume of 120 ml or a fixed diameter. This allows the restraining bladder 12 to expand when pressure is applied to the internal expansion bladder, but its maximum expansion size is controlled by the restraining bladder. This keeps the expansion size of the expansion bladder 11 relatively constant. Even if the internal pressure increases above the rupture pressure of the expansion bladder, the expansion bladder will not rupture due to the protective effect of the external restraining bladder. The restraining bladder 12 can be made of any flexible but inelastic material, such as a metal mesh. The "bladder" within the restraining bladder can be air-permeable or liquid-permeable, such as a mesh with a grid. It can be made of plastic, cloth, silk, or a bladder-like shape made of fiber material. An expansion bladder 11 is disposed within the limiting bladder 12. The "bladder" in the expansion bladder 11 and the first positioning bladder 31 and second positioning bladder 21 described below is generally made of a non-air-permeable or non-liquid-permeable material. The material can be flexible yet elastic. The elastic material, which covers the surface of the expansion catheter in its natural state and expands in volume when inflated with air or liquid, achieves expansion or restriction. Examples include nylon film, elastic plastic film, or any other elastic material, particularly medical elastic materials suitable for human body use, and having good sealing properties.

[0044] In some embodiments, the expansion device includes a first positioning capsule 31 and a second positioning capsule 21. The first positioning capsule 31 is close to the insertion end of the catheter, and the second positioning capsule 21 is far away from the insertion end, but both are located on the expansion portion 60. The expansion portion 60 on the catheter is close to the insertion end. In some embodiments, the first positioning capsule 31 and the second positioning capsule 21 are located in the expansion capsule 11, and the expansion capsule 11 is located in the restriction capsule 12. For example, Figure 1-5As shown, the expansion capsule 11 is located on the expansion portion, and the expansion capsule 11 includes a first positioning capsule 31 and a second positioning capsule 21. When the first and second capsules are filled with liquid or inflated with air, an enlarged first capsule cavity 300 and a second capsule cavity 200 are formed. When the expansion capsule 11 is filled with liquid or inflated with air, an enlarged expansion capsule cavity 100 is formed. For example, in the initial state, the first positioning capsule 31 and the second positioning capsule 21 are covered around the catheter, or on the outer surface of the catheter, while the expansion capsule 11 is covered on the surface of the first and second capsules, and the limiting capsule 12 is covered on the outer surface of the expansion capsule. The first, second and expansion capsules all have a pipeline that is independently connected to the perfusion part, which is used to inflate or fill the first, second or expansion capsule with air or liquid. Therefore, in some embodiments, the first positioning capsule has a first through hole 30 inside, the second positioning capsule has a second hole 20 inside, and the expansion capsule has a third through hole 10 inside, and the third through hole 10 is arranged outside the first and second positioning capsules. These through holes are all provided on the catheter wall, are independently located in the bag and are independently communicated with the channel on the perfusion part.

[0045] The first positioning capsule 31 expands to form the first positioning capsule cavity 300, the second positioning capsule 21 expands to form the second capsule cavity 200, and the expansion capsule 11 expands to form the expansion capsule cavity 100. The limiting capsule may be flexible but inelastic, and the volume of the limiting capsule cavity 120 formed by it is constant or substantially constant.

[0046] For example, Figure 5 As shown, this is the state where all the expansion bladders 11, the first 31 and the second positioning bladder 21 are filled with liquid. The general operation is that when the catheter is inserted into the bladder 301 ( Figure 8A), first inject liquid into the first expansion balloon 31 to allow it to expand to form an enlarged positioning balloon cavity 300, then gently pull the first positioning balloon outward, close to the outlet of the bladder, and then fill the second positioning balloon 21 with liquid to allow it to expand, forming an enlarged balloon cavity 200. At this time, the second positioning balloon is located in the prostate 302, and the second positioning balloon hits, allowing the expansion part of the catheter to lock in a fixed position. During expansion, due to the positioning of the first and second positioning balloons, the catheter remains fixed in the channel. At this point, the outer surface of the expansion sac 11 indirectly contacts the conduit 303 (urethral wall) through the surface of the limiting sac 12. At this point, the expansion sac 11 is further filled with liquid, causing its internal pressure to increase and expand, gradually increasing the size of the cavity 100 inside the expansion sac 11 to at least 2.5 atmospheres. At this point, due to the presence of the limiting sac 12 outside the expansion sac 11, the maximum size or volume of the expansion sac 11 is limited by the limiting sac 11, and its size remains constant, effectively increasing the internal pressure, thereby preventing the cavity 100 inside the expansion sac 11 from continuing to expand and causing rupture. The increase in pressure effectively expands the conduit 303. Therefore, the limiting sac 12 does not expand, but limits the size of the expansion sac 11. This allows the size of the conduit to remain consistent, consistent with the size of the limiting sac 12. For example, if the diameter of the limiting sac is 2 cm, the final size of the conduit expansion is 2 cm.

[0047] In addition, in this embodiment, since the first and second positioning capsules 31 and 21 are actually located inside the positioning capsule 12 (eg Figure 5As shown in FIG. 1 , when the first and second positioning bladders are filled with liquid, the maximum expansion size of the first and second positioning bladders is actually controlled. When the positioning bladder 12 is a uniform cylinder, the maximum diameter is fixed. In this way, the maximum diameter of the first and second positioning bladders is limited by the limiting bladder. In this way, the expansion size of the first bladder, the second bladder, and the expansion bladder is actually limited. This has the following advantages: First, although the first and second positioning bladders do not expand the tube, they do need to be positioned. When the first positioning bladder 31 is filled with liquid, it generally reaches its maximum size (controlled by the limiting bladder 12), indicating that the first positioning bladder is full of liquid. Even if greater pressure is applied subsequently, the first positioning bladder will not rupture, ensuring the success of the experiment. Similarly, the maximum expansion size of the second positioning bladder 21 (located in the prostate) is also limited by the limiting bladder 12, which can reduce damage to the prostate. Different maximum expansion sizes can be set for different people, so that the expanded diameter or volume of the first 31 and second positioning bladder 21 in each product of a single batch remains consistent, and the expansion volume will not be different due to different operators. Without the limiting capsule 12, the maximum expansion size of the first and second positioning capsules 31 and 21 would vary from person to person, with some diameters being too large, potentially squeezing or even damaging the gland. Furthermore, because the first and second positioning capsules 31 and 21, as well as the expansion capsule 11, are all constrained by the limiting capsule 12, the final expansion step creates a unified shape, defined by the limiting capsule, ensuring a constant expansion of the duct.

[0048] In some methods, such as Figure 6-7 As shown, the expansion capsule 11 is located between the first and second positioning capsules 31 and 21. The expansion capsule 11 located between the first and second positioning capsules 31 and 21 is actually located inside the pipe, enabling expansion of the pipe. The first and second positioning capsules 31 and 21 at the ends lock the expansion capsule 11 in place, preventing it from moving during expansion, effectively positioning the pipe for expansion. In this case, simply placing the limiting capsule 12 outside the expansion capsule 11 is sufficient, and the effects of the present invention can still be achieved.

[0049] In some embodiments, in order to conveniently distinguish the positions and operation sequences of the first positioning capsule 31, the second positioning capsule 21, and the expansion capsule 11, the channel 3 connecting the first positioning capsule 31 is generally the shortest, the channel 2 connecting the expansion capsule 11 is the longest, and the length of the channel 1 connecting the second positioning capsule 21 is in the middle, indicating the operation sequence. The shortest channel 3 first fills the first positioning capsule 31 with liquid (through hole 30) to expand it, and then fills the catheter 1 of the middle length with liquid to fill the second positioning capsule 21 with liquid, and finally fills the expansion capsule with liquid through the catheter 2 to expand it. The catheter 4 is a channel for the guide wire to pass through. Each channel is independently connected to the through hole, for example, channel 3 is connected to the through hole 30, channel 2 is connected to the through hole 10, and channel 1 is connected to the through hole 20 (as shown in the figure). The outlets of these channels are each connected to the through hole in the capsule, and the inlet is located at the position of the perfusion part 70, or extends outward.

[0050] pipeline

[0051] The conduit of the present invention is a channel whose width needs to be increased through the expansion capsule, such as the urethra, such as the urethra directly between the bladder and the prostate, or the urethra on the genitals, and of course other conduits. These conduits are usually formed by muscle tissue, and the conduits have a contraction effect. When the conduit needs to be expanded, it is necessary to overcome the contraction force of the muscle tissue to increase its size. For example, the original conduit is 0.5 mm and needs to be expanded to 1, 2, or 3 cm. While filling the expansion capsule with liquid, the pressure needs to be increased. The pressure acts on the inner wall of the conduit to make it expand. The pressure here can be 1.5, 2, 2.5, 3, or 3.5 times the atmospheric pressure.

[0052] Production process

[0053] The present invention provides a manufacturing process. First, a catheter is provided with openings at both ends. The opening at the insertion end communicates with the interior of the bladder, while the other end serves as an infusion section. Four channels are provided in the infusion section, one of which is for a guidewire to pass through the entire catheter body, allowing the catheter to enter the body, for example, through the prostate and into the bladder. Three holes 30, 20, and 10 are sequentially formed from proximal to distal in the catheter wall of an extension portion 60 near the insertion end. After these holes are formed, a flexible first elastic sleeve is provided and sleeved onto the outer wall of the catheter through the insertion end. A fastener is then applied to the middle portion 40 of the catheter, also between the first and second holes 30 and 20, to separate the flexible catheter into two sections. The two sections are sealed to prevent air or liquid permeability, and the elastic sleeve is tightly attached to the catheter surface between the first and second holes 30 and 20. Simultaneously, using the same method, the ends 63 and 64 of the sleeve are tightly attached to the catheter, thereby forming a first positioning pocket 31 and a second positioning pocket 21, each of which independently communicates with the first and second holes 30 and 20. The first hole 30 is connected to the third conduit 3 of the infusion section, and the second hole 20 is connected to the second conduit 1 of the infusion section. A second elastic sleeve, longer than the first, is then provided and inserted into the catheter's expansion section 60 from the insertion end. The first and second positioning bladders 31 and 21 are positioned within this second sleeve, and the third hole 10, located outside the second and first positioning bladders, is positioned within the second elastic tube. The ends 61 and 62 of the elastic tube are sealed and adhere only to the catheter, thus forming the expansion bladder 11. At this point, a restriction bladder 12 (flexible but non-elastic) is also provided. This restriction bladder is also tubular, but with an internal cavity diameter of approximately 1-2 cm, or a volume of 100-200 ml. The expansion section 60 is passed through the restriction bladder, and the ends are sealed at the same locations as the ends 61 and 62 of the expansion bladder, allowing the expansion bladder to be positioned within the restriction bladder 12. This allows the expansion bladder 11 to be positioned within the restriction bladder 12, while also allowing the first and second positioning bladders 31 and 21 to be positioned within the expansion bladder 11. (like Figure 2 ). Of course, a similar method can be used to make Figure 6 The structure shown.

[0054] For a better way, a layer of flexible elastic protective film is put on the outside of the limiting capsule 12. The protective film has a smooth surface. One function is to protect the limiting capsule 12 (when the surface of the limiting capsule is a rough cloth or mesh) 2 without damaging or directly contacting the pipe to cause damage. At the same time, the smooth surface of the elastic film plays a role in facilitating the insertion of the catheter into the body and playing a lubricating role. On the other hand, when the expansion capsule 11, the first 31 and the second positioning capsule 21 are expanded, the protective film also needs to expand. Of course, the maximum size of the expansion is controlled by the internal limiting capsule 12 (such as Figure 5The protective film may cover the expansion portion or the entire surface of the catheter from the insertion end to the perfusion portion.

[0055] The following embodiment is also one of the present invention:

[0056] A dilation device includes: a catheter configured to be inserted into two organs in the human body, with the two organs connected via a tube; the catheter comprises a guide portion, an expansion portion, and an infusion portion; the expansion portion includes an expansion sac configured to expand the tube, wherein:

[0057] The expansion device further includes a limiting element, which can limit or control the expanded size of the expansion sac to keep it within a limited size.

[0058] In some embodiments, the limiting element is located outside the expansion bladder. In some embodiments, the limiting element covers the outer surface of the expansion bladder. In some embodiments, when the expansion bladder is filled with gas or liquid, the gas or liquid causes the expansion bladder to expand and increase in volume, and the limiting element can maintain the volume of the expansion bladder within a constant range. In some embodiments, the limiting element is a limiting bladder, and the expansion bladder is located within the limiting bladder. In some embodiments, under the same pressure, the expanded size of the limiting bladder is smaller than the expanded size of the expansion bladder. In some embodiments, the limiting bladder is made of a non-elastic material. In some embodiments, the size of the limiting bladder is fixed. In some embodiments, the limiting bladder is made of a flexible non-elastic material. In some embodiments, the expansion bladder is made of an elastic material and, when not filled with gas or liquid, covers the surface of the catheter. In some embodiments, the expansion bladder further includes a first positioning bladder and a second positioning bladder, each of which is independently connected to the perfusion portion. In some embodiments, the first positioning bladder is located near the guide portion, and the second positioning bladder is located farther away from the guide portion. In some embodiments, when in use, the first positioning capsule and the second positioning capsule are respectively located in the two organs. In some embodiments, there is a suitable distance between the first positioning capsule and the second positioning capsule, and the suitable distance is set in the pipeline between the two organs. In some embodiments, the expansion device also includes 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. In some embodiments, the first positioning capsule, the second positioning capsule and the expansion capsule are independently connected to the perfusion part. In some embodiments, the perfusion part has a first channel, a second channel and a third channel, wherein,

[0059] The first channel is connected to the first positioning sac, the second channel is connected to the second positioning sac, and the third channel is connected to the expansion sac. In some embodiments, the two organs are the bladder and the prostate, and the tube is the urethra. In some embodiments, the expansion sac, the first and second positioning sacs are made of an elastic film. When inflated with air or liquid, the sacs expand and increase in volume. In some embodiments, the tube body is covered with a protective film, which covers the surface of the limiting element and is also an elastic film. In some embodiments, the maximum rupture pressure of the limiting sac is greater than the maximum rupture pressure of the expansion sac.

[0060] All patents and publications cited in this specification are intended to indicate that they are state of the art and that the present invention may be used. All patents and publications cited herein are incorporated by reference in their entirety, as if each publication were specifically incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, unless otherwise specified. For example, in each instance, the terms "comprising," "consisting essentially of," and "consisting of" may be replaced with either of the other two terms. The term "a" or "an" herein simply means "one" and does not exclude the inclusion of only one or more. The terms and expressions used herein are intended to be descriptive, not limiting, and are not intended to exclude any equivalent features. However, it is understood that any suitable changes or modifications may be made within the scope of the present invention and the appended claims. It is understood that the embodiments described herein are preferred embodiments and features, and that modifications and variations can be made by persons of ordinary skill in the art based on the spirit of the present invention. Such modifications and variations are considered to be within the scope of the present invention and the scope of the independent and appended claims.

Claims

1. An expansion device comprising: A catheter is designed to be inserted into two organs in the human body, with the two organs connected through a tube; It has a guide part, an expansion part and an infusion part; the expansion part includes an expansion bag, which is set to expand the duct, wherein the expansion device also includes a limiting element, which can limit or control the size of the expansion bag 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 bag.

4. The device according to claim 3, wherein When the expansion capsule is filled with gas or liquid, the expansion capsule is filled with gas or liquid so as to expand and increase its volume. The limiting element can keep the volume of the expansion capsule within a constant range.

5. The device according to any one of claims 1 to 4, wherein: The corresponding limiting element is a limiting capsule, and the expansion capsule is located in the limiting capsule.

6. The device according to claim 5, wherein Under the same pressure conditions, the expanded size of the limiting bladder is smaller than the expanded size of the expansion bladder.

7. The device according to claim 5, wherein The limiting bag is made of 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 flexible non-elastic material.

10. The device according to claim 1-9, wherein The expansion bag is made of elastic material. When there is no gas or liquid filled inside, the expansion bag covers the surface of the catheter.

11. The device according to claims 1-10, wherein: The expansion sac also includes a first positioning sac and a second positioning sac. The first and second positioning sacs and the expansion sac are independent of each other and are communicated with the perfusion part respectively.

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 away from the guide portion.

13. The device according to claim 12, wherein When in use, the first positioning capsule and the second positioning capsule are respectively located in the 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 also includes 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.

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