An expansion device for a conduit in a human body

Abstract

The utility model relates to an extension device, which comprises a catheter main body, which is designed to be capable of being inserted into two organs of a human or mammal and having a passage connected between the two organs, and has a guide part, an extension part and a perfusion part, the extension part comprises an extension sac, the extension sac is designed to be capable of expanding the passage between the two organs, and the extension device further comprises a limiting element, which is capable of limiting or controlling the size of the expansion of the extension sac to keep it within a limited size, so that the rupture of the extension sac under high pressure can be reduced, the expansion size of the pipeline is consistent, and the accuracy and precision of operation are increased.

Description

Technical Field

[0001] This utility model belongs to the field of medical devices, and in particular relates to a device for expanding the channel between two organs within an individual. Background Technology

[0002] The following background information is merely a general overview and does not constitute any limitation on this invention.

[0003] Currently, devices for widening the passage between two organs in an individual, such as a human or mammal, are a necessary prerequisite for some surgeries, especially when surgical treatment or drug delivery is required to treat lesions within the same organ. The passage between the two organs is often very narrow, and widening it is desirable to facilitate the procedure. Alternatively, if the passage connecting two organs is blocked, widening the passage is also necessary to achieve the therapeutic goal.

[0004] For example, the bladder and prostate are prone to disease in middle-aged and elderly people, especially benign prostatic hyperplasia (BPH), which is a common disease. Currently, treatment for patients can be achieved by expanding the urinary catheter (the passage between the two organs) through a catheter and the placement of a dilator.

[0005] However, the above-mentioned expansion still has some shortcomings, which requires improvement of the existing expansion device to better expand the channel and reduce damage to organs or channels, while making it easier for operators or doctors to operate. Utility Model Content

[0006] To address some problems with traditional technologies, this utility model provides a dilation device, comprising: a catheter body having a guide portion, an expansion portion, and an irrigation portion; the expansion portion includes an expansion sac, which is configured to expand the passage between two organs.

[0007] In some designs, the expansion portion is an expandable sac that, in its natural state, covers the surface of the expansion portion, either directly or indirectly. When the sac is filled with gas or liquid, its volume increases, thus expanding the conduit. This conduit includes the urethra, such as the urethra between the bladder and prostate, the urethra in the genitals, and passages between other organs. In some designs, since it is a sac and can expand, it is generally an elastic membrane that is initially in a relaxed, unexpanded state. When filled with gas or liquid under pressure, its volume increases, thus increasing the size of the conduit. For example, a balloon has a small internal cavity when deflated, but expands when inflated, increasing the volume of its inner cavity.

[0008] In some embodiments, the device also includes a limiting element that maintains a relatively stable size of the expansion bladder as its volume or size increases. "Stable" here is generally understood to mean that when the expansion bladder is filled with gas or liquid, its size increases compared to its natural state—for example, its volume, diameter, or circumference increases—and the limiting element maintains the increased size of the expansion bladder within a stable range, such as preventing size changes or fluctuations within a certain range. In other words, when the expansion bladder volume increases to a certain extent, the limiting element prevents further volume increases or maintains the volume within a relatively stable range.

[0009] This is because the expansion bladder has this property: it's made of an elastic material, and increasing its size means increasing the channel size. To increase the channel size, a certain pressure needs to be applied inside the expansion bladder. This pressure must be greater than the pressure of the gas or liquid itself, requiring external pressure, such as maintaining the pressure inside the expansion bladder above one atmosphere (e.g., 1.5, 2, 2.5, 3, 3.5 atmospheres) for a certain period, such as 20 seconds, 1 minute, or 10 minutes. The applied pressure and the duration depend on the specific characteristics of the tube and the desired expansion size. If it's an elastic material, maintaining pressure above atmospheric pressure requires continuous pressure application, such as continuously filling with gas or liquid. However, with continuous filling, the elastic material changes volume as pressure increases. In this case, although pressure is applied to expand the channel, the required expansion size cannot be well controlled; the pressure keeps increasing, making it impossible to determine the specific expansion size. Furthermore, as pressure increases, the elastic material-constructed bladder may rupture if possible. Once ruptured, air or liquid inside the bladder leaks out, reducing pressure and preventing successful expansion, leading to surgical failure. This invention addresses this technical deficiency by incorporating a control element that maintains the expanded bladder at a stable size. Even with increased pressure and prolonged duration, the bladder's pressure increases, but its volume or size remains relatively stable. This allows for continuous expansion force on the channel while ensuring stable expansion dimensions, meeting the requirements for different channel expansion sizes without causing surgical failure or damage to the expansion channel.

[0010] In some embodiments, the limiting element is located outside the expansion bladder, thus limiting the stable size of the expansion bladder's expansion. In some embodiments, the limiting element can be a mesh, a film, or a film or mesh of a non-elastic material. In some embodiments, the limiting element can enclose the entire expansion bladder or include a portion of it. Preferably, it includes the entire expansion bladder. In some embodiments, in its natural state, the limiting element has a fixed size and does not deform, while the expansion bladder has two states: natural and inflated or liquid-filled. For example, in its natural state, the expansion bladder 11 has almost no gas or liquid inside, and its internal surfaces are in contact with each other or directly or indirectly covering the conduit surface. Once it is inflated or liquid-filled, or its size or volume increases after inflation or liquid filling, it will naturally expand. However, because the limiting element limits its inherent size or volume from the outside, the expansion bladder can only expand within the volume or size limited by the limiting element. This can stably maintain the volume and size of the expansion bladder, including a constant pressure (even if the pressure increases) applied to the conduit for expansion, keeping the expansion bladder within a safe range without rupture. The fixed size of the limiting element is the desired expansion size of the tube, or the maximum size. For example, if the urethra is desired to be expanded by 2 cm in diameter, then the fixed diameter of the limiting element is 2 cm. The maximum expansion size of the internal expansion bladder is 2 cm, regardless of the pressure inside the expansion bladder.

[0011] In some embodiments, the defining element covers the outer surface of the expansion bladder, and it is also bladder-shaped, but this bladder is non-elastic. The bladder does not need to be inflated or sealed. For example, the defining bladder can be a mesh, fibrous material, or a non-elastic material, but it is flexible but not elastic. Elastic bladders are generally gas-tight or airtight, and while they are also made of flexible material, they are elastic, undergoing elastic deformation and increasing in volume or size when filled with gas or liquid. In some embodiments, the defining element is flexible but inelastic, not substantially elastic. The term "covering" in this invention can be understood as including direct or indirect contact, such as the defining element including the expansion bladder, or the defining element wrapping the expansion bladder, or the defining element partially covering or including a portion of the expansion bladder.

[0012] Of course, in some methods, the limiting element can also be elastic, but not necessarily flexible. For example, a wire mesh can be placed outside the expansion bladder. The mesh has a fixed size, but its elastic strain performance is worse than that of the expansion bladder. In other words, when the expansion bladder is filled with gas or liquid, its expansion size is constant under a given pressure. However, generally, as the pressure increases, the size also increases until it bursts. While the limiting element is elastic, its size may increase with increasing pressure, but below a certain point, its size will not substantially change, maintaining a relatively constant size. Alternatively, it can be understood that when the pressure inside the expansion bladder increases to a certain level, the expansion bladder will rupture, and similarly, the limiting bladder will rupture if the pressure inside increases to a certain level—the so-called maximum rupture pressure value. That is, the maximum rupture pressure value of the limiting bladder is greater than that of the expansion bladder. This is also a solution of this invention. The pressure can be achieved by inflating with gas or liquid.

[0013] In some methods, when the expansion bladder is filled with gas or liquid, the expansion bladder expands to increase its volume, and the limiting element keeps the volume of the expansion bladder within a constant range. In some methods, the limiting element is a limiting bladder that covers the outer surface of the expansion bladder. In some methods, under the same pressure, the expansion size of the limiting bladder is smaller than that of the expansion bladder. In some methods, the limiting bladder is made of a non-elastic material. In some methods, the limiting bladder is made of a non-elastic but flexible material. The flexible material allows the limiting bladder to also cover the surface of the expansion bladder when the internal expansion bladder expands; because it is flexible, it will not cause mechanical damage to the pipe when in contact with it, allowing for smooth expansion of the pipe. In some methods, the size of the limiting bladder is a fixed size, such as a width with 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. This diameter represents the size of the internal expansion sac, or the desired size of the expansion channel. Therefore, in some embodiments, the defined sac includes the expansion sac.

[0014] In some embodiments, the expansion capsule is made of an elastic material and, without being filled with gas or liquid, covers the surface of the catheter.

[0015] In some embodiments, the dilation portion of the catheter includes a first positioning capsule and a second positioning capsule, which, along with the dilation capsule, are independently connected to the perfusion portion. The first and second positioning capsules primarily serve a positioning function, remaining fixed in position as the dilation capsule expands the conduit. In some embodiments, during use, the first positioning capsule is located within one organ, the second positioning capsule within another organ, and the conduit portion between the two positioning capsules is located within the conduit between the organs. In some embodiments, the first positioning capsule is located near the guide portion, and the second positioning capsule is located away from the guide portion or near the perfusion portion. In some embodiments, during use, the first and second positioning capsules are located within two separate organs.

[0016] In some embodiments, a suitable distance is maintained between the first and second positioning capsules, said suitable distance being set within a conduit between the two organs. In other embodiments, the suitable distance is a portion of the catheter, on which the expansion capsule and defining element are disposed, such that the expansion capsule and positioning element are also located on the surface of the catheter, from the inside out being the expansion capsule and the defining element, for example, the defining capsule.

[0017] In some embodiments, the expansion device further includes a first positioning bladder and a second positioning bladder, with the expansion bladder containing both the first and second positioning bladders. That is, when the defining element is a bladder, it defines the expansion dimension of the expansion bladder; when the first and second fiber bladders are located within the expansion bladder, they also effectively define the expansion dimensions of the first and second positioning bladders. This ensures that each bladder (first, second positioning bladder, expansion bladder) on the expansion section of this expansion device has a fixed maximum expansion dimension, preventing inconsistencies in the maximum expansion inch of the first positioning bladder and the second fiber bladder due to operational errors by different external operators.

[0018] In some methods, the infusion section at the end of the catheter has multiple independent channels, each independently connected to a first positioning balloon, a second positioning balloon, and an expansion balloon, for independently inflating or infusing fluid to increase their volume. In some methods, pressure can be applied to each balloon, for example, a pressure greater than one atmosphere. In some methods, the expansion balloon is inflated or filled with fluid through the channels to a pressure greater than one atmosphere, such as 1, 1.5, 2.5, 3, or 3.5 times the pressure of one atmosphere. Pressure is applied using a syringe connected to a pressure gauge for inflation or filling; this is a readily available commercial tool, such as the disposable balloon inflation pressure pump branded "Fervid".

[0019] In some embodiments, the infusion section has a first channel, a second channel, and a third channel, wherein the first channel communicates with a first positioning bladder, the second channel communicates with a second positioning bladder, and the third channel communicates with an expansion bladder. The first positioning bladder, the second positioning bladder, and the expansion bladder are independent of each other and are not interconnected.

[0020] In some methods, the infusion site also includes a guidewire channel through which the guidewire passes, allowing the catheter to enter the body along the guidewire. The two organs mentioned are the bladder and the prostate. The tube mentioned is the urethra, which includes the urethra of the bladder and prostate, as well as the urethra of the reproductive organs.

[0021] Therefore, the catheter body also contains a guidewire channel, which is designed to allow the guidewire to pass through, thereby enabling the catheter body to enter the internal organs of the individual from the outside. In some embodiments, the end of the guide portion is open, so that when the end enters the bladder, urine can be drained through the guidewire channel.

[0022] In some embodiments, a protective film is also applied to the outside of the tube body, covering the surface of the defining element to protect it. In some embodiments, the protective film is also elastic and adheres tightly to the defining element. In some embodiments, the covering film is a flexible elastic film. In some embodiments, the protective film covers the surface of the guide rod body, serving a smoothing function to allow the catheter to smoothly enter the internal organs along the guidewire. Beneficial effects

[0023] This invention provides a positioning element, positioned outside the expansion capsule, which effectively controls the expansion size of the capsule. Especially when increasing pressure, it prevents the expansion capsule from expanding indefinitely, ensuring a stable position under high internal pressure. This allows for accurate expansion of the required channels, reducing trauma. Furthermore, it ensures that different devices from the same batch achieve consistently stable expansion sizes for different channels, maintaining surgical consistency. Additionally, it increases the controllability of the surgeon's operation, resulting in a uniquely stable outcome. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the expansion device (without expansion) in a specific embodiment of this utility model.

[0025] Figure 2 This is a schematic diagram (assembly) of the expansion device in a specific embodiment of this utility model.

[0026] Figure 3 This is a schematic diagram of the structure of the expansion device in a specific embodiment of this utility model (the first positioning bladder is inflated).

[0027] Figure 4 This is a schematic diagram of the expansion device (second positioning bladder expansion) in a specific embodiment of this utility model.

[0028] Figure 5 This is a schematic diagram of the expansion device (expansion bladder expansion) in a specific embodiment of this utility model.

[0029] Figure 6 This is a schematic diagram (assembly diagram) of the expansion device in a specific embodiment of this utility model.

[0030] Figure 7 This is a schematic diagram of the expansion device (fully expanded) in a specific embodiment of this utility model.

[0031] Figure 8A This is a schematic diagram of the expansion device during the expansion process in a specific embodiment of this utility model (the first positioning bladder expands).

[0032] Figure 8B This is a schematic diagram of the expansion device during the expansion process in a specific embodiment of this utility model (the second positioning bladder expands).

[0033] Figure 8C This is a schematic diagram of the structure of the expansion device during the expansion process in a specific embodiment of this utility model (expansion bladder expansion). Detailed Implementation

[0034] The following description further explains the structures involved in this utility model and the technical terms used therein. Unless otherwise specified, they shall be understood and interpreted in accordance with the general terms commonly used in the art.

[0035] This utility model provides a catheter that is inserted into the body, with one part inserted inside and the other part outside. The catheter includes an insertable end and an infusion section outside the body. The insertable end and the infusion section are connected by a catheter. The catheter can actually be a flexible tube, such as a plastic tube, with an opening 80 at the insertable end and an infusion section 70 at the tail end. One end of the opening 80 is for insertion into the body, and the infusion section also connects multiple tubes to the interior of the catheter. In some embodiments, such as... Figure 6As shown, the irrigation section has an inlet channel 4 for inserting a guidewire, through which the catheter body enters the body. When the catheter is introduced into the body, the guidewire can be withdrawn from the inlet channel 4 or not. Generally, the guidewire is first inserted into the body through an external opening. For example, when the catheter needs to enter the bladder through the urethra, a thin metal guidewire is first inserted into the urethra through the urethral opening of the genitals, then through the prostate, and then into the bladder. The guidewire can be inserted under CT, ultrasound, or X-ray guidance for easy positioning and monitoring. Then, one end of the catheter, opening 80, enters the guidewire channel through the external guidewire, then along the guidewire into the urethra of the genitals, through the prostate, and into the urethra between the prostate and the bladder, finally entering the bladder. Since the bladder usually contains urine, once urine flows out from the guidewire channel 4, it indicates that the inserted end has entered the bladder. At this point, fluid can be injected through the external inlet channel for flushing or other procedures.

[0036] In this invention, the catheter has an extension portion 60. This extension portion expands the urethra (the passage between the bladder and prostate), increasing its size. This expansion reduces pressure in the prostatic urethra and consequently, in the bladder. With a larger urethra and reduced pressure, urination becomes easier and smoother. Alternatively, it can expand the passage between other internal organs to facilitate fluid flow. This is likely one of the main causes of difficulty urinating in the elderly due to muscle atrophy and urethral narrowing as they age. Therefore, this device is particularly suitable for the elderly.

[0037] To facilitate tubing expansion, the catheter includes an expansion section 60, typically located near the catheter inlet 81. When the catheter is inserted into the body, it is desirable for the expansion section to be positioned within or pass through the tubing requiring expansion, thus facilitating expansion. In some embodiments, the expansion section 60 includes an expansion bladder 11 made of an elastic material, such as nylon or Pebax. When the bladder 11 is inflated with air or liquid, it expands, increasing its volume or size (e.g., diameter) from its natural, non-inflated, non-liquid state. This increased size acts on the tubing, thereby expanding the tubing through the expansion of the expansion bladder. Therefore, in some embodiments, the expansion sac 11 covers the outer surface of the expanded portion of the conduit. When the sac is filled with air or liquid, it expands radially outward along the central axis of the conduit, forming a cylinder or sphere with an increased diameter. The purpose of this size increase is to increase the size of the conduit and overcome the muscular force of the surrounding muscles.

[0038] However, in practical use, since the bladder 11 is made of an elastic material (both elastic and flexible), when inflating it with air or injecting liquid, it is desirable for the bladder 11 to maintain a pressure higher than atmospheric pressure for a period of time. This allows the bladder 11 to exert a relatively large expansion force on the channel for a sustained period. Increasing the pressure is achieved by continuously adding gas or liquid to the expansion bladder, thus increasing its pressure. However, as the pressure increases, the size of the expansion bladder will inevitably increase. When a relatively high pressure is required, the bladder material may not be able to withstand such pressure (the bladder's maximum rupture pressure), causing it to rupture and rendering the expansion of the channel ineffective, requiring a repeat procedure. Generally, medical-grade elastic materials are chosen, and affordability is a priority. Different elastic materials have a limit to their maximum pressure resistance. For example, under fixed natural conditions, when the elastic material and its dimensions are fixed, the pressure required for expansion and rupture due to internal liquid filling or the increase in internal pressure is constant (maximum burst or rupture pressure value). For instance, some materials have a maximum rupture pressure of 1.5 atmospheres, but if the actual pressure required for tube expansion is 2.5 atmospheres, such materials cannot be used because they will rupture during use, leading to surgical failure. This limits the choice of bladder material. Only materials with an expansion-to-rupture pressure exceeding 2.5 atmospheres can be selected. Furthermore, the pressure applied to the expansion bladder 11 varies or fluctuates depending on the operator. For example, the specified pressure is 2.5 atmospheres, but the actual applied pressure may be 2 or even higher, such as 3 atmospheres. Higher pressure will inevitably cause unnecessary damage to the tube; for example, increased pressure causing greater tube expansion will inevitably lead to damage. In some cases, it is desirable to expand the pipe to a desired size, which is a relatively fixed size, such as expanding from the original 0.5 mm to 1, 2, 3, or 4 cm. This expansion size is desired to be stable and fixed, such as fixed at 1 cm, fixed at 2 cm, fixed at 4 cm, etc.

[0039] To address the above issues, this invention creatively incorporates an external limiting element into the expansion bladder, allowing it to maintain a relatively constant volume after expansion to a certain level. However, the internal pressure can be continuously increased, reaching the desired pressure or even exceeding the pressure required for rupture. This allows for a wider range of material choices for the expansion bladder. Furthermore, since the expansion bladder's volume and dimensions are constant, the expansion dimensions of the pipeline are also constant, avoiding errors caused by different operators. Sometimes, the pipeline expansion may be larger than designed, causing unnecessary damage.

[0040] In some embodiments, the limiting element includes a limiting bladder 12, which contains the expansion bladder 11. In some embodiments, the limiting bladder is made of a flexible but inelastic material, such as nonwoven fabrics, cotton, mesh, or ultra-thin white nylon textiles. In some embodiments, the limiting bladder 12 has a fixed size in its natural state, for example, a volume of 120 ml or a fixed diameter, so that even when the internal expansion bladder is subjected to pressure and expands, its maximum expansion size is controlled by the limiting bladder. This keeps the expansion size of the expansion bladder 11 relatively constant, and even if the internal pressure increases above the pressure that would cause the expansion bladder to rupture, the expansion bladder will not break due to the protective effect of the external limiting bladder. The limiting bladder 12 can be made of any flexible but inelastic material, such as a metal mesh. The "bladder" in the limiting bladder can be breathable and liquid-permeable, such as a mesh cover, and can be made of plastic, cloth, silk, or fiber materials forming a bladder-like shape. An expansion sac 11 is disposed inside the limiting sac 12. The expansion sac 11, along with the "sacs" in the first positioning sac 31 and the second positioning sac 21 described later, is generally made of a non-air-permeable or non-liquid-permeable material. It can be a flexible but also elastic material. In its natural state, it covers the surface of the expansion catheter. When inflated with air or liquid, its volume increases, thereby expanding or limiting the position. Examples include nylon film, elastic plastic film, and any other elastic material, especially medical elastic materials suitable for insertion into the human body, which possess relatively good sealing properties.

[0041] In some embodiments, the expansion device includes a first positioning bladder 31 and a second positioning bladder 21. The first positioning bladder is near the insertion end of the catheter 31, and the second positioning bladder 21 is 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 bladder 31 and the second positioning bladder 21 are located in the expansion bladder 11, which in turn is located in the restraint bladder 12. For example, ... Figure 1-5As shown, the expansion bladder 11 is located on the expansion portion, and the expansion bladder 11 includes a first positioning bladder 31 and a second positioning bladder 21. When the first and second bladders are filled with liquid or gas, they form an enlarged first bladder cavity 300 and a second bladder cavity 200. When the expansion bladder 11 is filled with liquid or gas, it forms an enlarged expansion bladder cavity 100. For example, in the initial state, the first positioning bladder 31 and the second positioning bladder 21 cover the periphery of the catheter or cover the outer surface of the catheter, while the expansion bladder 11 covers the surfaces of the first and second bladders, and the restraining bladder 12 covers the outer surface of the expansion bladder. The first, second, and expansion bladders each have an independently connected infusion tube for inflating or filling the first, second, or expansion bladders with gas or liquid. Therefore, in some embodiments, the first positioning bladder has a first through hole 30 inside, the second positioning bladder has a second hole 20 inside, and the expansion bladder has a third through hole 10 inside, which is located outside the first and second positioning bladders. These through-holes are all located on the catheter wall, each independently within the sac and each independently connected to the channel on the infusion section.

[0042] The first positioning sac 31 expands to form a first positioning cavity 300, the second positioning sac 21 expands to form a second cavity 200, and the expansion sac 11 expands to form an expansion cavity 100. The limiting sac can be flexible but inelastic, and the volume of its formed limiting cavity 120 is constant or substantially unchanged.

[0043] For example, such as Figure 5 As shown, this is the state of all the expansion balloons 11, the first 31, and the second positioning balloon 21 inflated with fluid. Normal operation involves inserting the catheter into the bladder 301 ( Figure 8AFirst, liquid is injected into the first dilation sac 31 to inflate it and form an enlarged positioning sac cavity 300. Then, the first positioning sac is gently withdrawn outward, close to the bladder outlet. Next, liquid is injected into the second positioning sac 21 to inflate it and form an enlarged sac cavity 200. At this time, the second positioning sac is located in the prostate 302. When the second positioning sac touches the prostate, the expansion section of the catheter is locked in a fixed position. During expansion, due to the positioning of the first and second positioning sacs, the catheter maintains a fixed position in the channel. At this point, the outer surface of the expanding sac 11 indirectly contacts the conduit 303 (urethral wall) through the surface of the restricting sac 12. Then, liquid is injected into the expanding sac 11, increasing its internal pressure and causing it to expand. Gradually, the internal cavity 100 of the expanding sac 11 increases to at least 2.5 atmospheres. Because of the presence of the restricting sac 12, the maximum size or volume of the expanding sac 11 is limited, maintaining a constant size. This effectively increases the internal pressure, preventing the internal cavity 100 from continuing to expand and rupture. The increased pressure effectively expands the conduit 303. Therefore, while the restricting sac 12 does not expand, it limits the expansion size of the expanding sac 11. This ensures that the size of the expanded conduit remains consistent with the size of the restricting sac 12; for example, if the diameter of the restricting sac is 2 cm, the final size of the expanded conduit will be 2 cm.

[0044] Furthermore, in this embodiment, since the first 31 and the second positioning capsule 21 are actually located inside the positioning capsule 12 (e.g., Figure 5As shown, when the first and second positioning sacs are filled with liquid, their maximum expansion size is also controlled. When the positioning sac 12 is a uniform cylinder, its maximum diameter is fixed. Thus, the maximum diameter of the first and second positioning sacs is limited by the limiting sac, which effectively restricts the expansion size of the first sac, the second sac, and the expansion sac. This has the following advantages: First, although the first and second positioning sacs do not expand the channel, they are needed for positioning. When liquid is filled into the first positioning sac 31, it generally reaches its maximum size (controlled by the limiting sac 12), indicating that the first positioning sac is full of liquid. Even if greater pressure is applied subsequently, the first positioning sac will not rupture, thus ensuring the success of the experiment. Similarly, the maximum expansion size of the second positioning sac 21 (located in the prostate) is also limited by the limiting sac 12, which can reduce damage to the prostate. Different maximum expansion sizes can be set for different people, ensuring that the diameter or volume of the first sac 31 and the second positioning sac 21 in each batch of products remains consistent, and that the expansion volume is not different due to different operators. Without the presence of the limiting sac 12, the maximum size of the expansion of the first 31 and the second positioning 21 would be inconsistent for each individual, with some diameters being too large, causing compression or even damage to the glands. Secondly, since the first 31 and the second 21 positioning sacs, as well as the expansion sac 11, are all restricted by the limiting sac 12, in the final expansion step, a shape is formed that is constrained by the limiting sac as a whole, achieving a constant size expansion of the tube.

[0045] In some ways, for example Figure 6-7 As shown, the expansion bladder 11 is located between the first positioning bladder 31 and the second positioning bladder 21. The expansion bladder 11, located between them, is actually inside the pipe, enabling pipe expansion. The first positioning bladder 31 and the second positioning bladder 21 at both ends lock the position of the expansion bladder 11, preventing movement during expansion and effectively positioning the pipe during expansion. In this case, simply adding a limiting bladder 12 to the outside of the expansion bladder 11 achieves the same effect as this invention.

[0046] In some methods, to easily distinguish the positions and operating sequence of the first positioning bladder 31, the second positioning bladder 21, and the expansion bladder 11, the channel 3 connecting to the first positioning bladder 31 is generally the shortest, while the channel 2 connecting to the expansion bladder 11 is the longest, and the channel 1 connecting to the second positioning bladder 21 is of medium length. This indicates the operating sequence: the shortest channel 3 first fills the first positioning bladder 31 with liquid (through hole 30) to expand it, then fills the second positioning bladder 21 with liquid through the medium-length catheter 1, and finally fills the expansion bladder with liquid through catheter 2 to expand it. Catheter 4 is used for the guidewire to pass through. Each channel is independently connected to the through hole; for example, channel 3 connects to through hole 30, channel 2 connects to through hole 10, and channel 1 connects to through hole 20 (as shown in the figure). The outlets of these channels are connected to the through holes inside the bladders, while the inlets are located at the infusion section 70 or extend outwards.

[0047] The tube of this invention is a channel that needs to be widened through an expansion sac, such as the urethra, for example, the urethra directly between the bladder and prostate, or the urethra of the genitals, or other tubes. These tubes are usually formed by muscle tissue and have a contractile function. When the tube needs to be expanded, the contractile force of the muscle tissue needs to be overcome to increase its size. For example, if the original tube is 0.5 mm, it needs to be expanded to 1, 2, or 3 cm. While filling the expansion sac with liquid, pressure needs to be increased. The pressure acts on the inner wall of the tube to expand it. Here, the pressure can be 1.5, 2, 2.5, 3, or 3.5 times the atmospheric pressure.

[0048] Manufacturing process This invention provides a manufacturing process. First, a catheter is provided with openings at both ends. The insertion end communicates with the inside of the bladder, while the other end is an irrigation section. Four channels are provided in the irrigation section. One channel, 4, 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 arranged from proximal to distal on the catheter wall of the extension section 60 near the insertion end. After this arrangement, a flexible first elastic sheath is provided, which is fitted onto the outer wall of the catheter through the insertion end. Then, a fixing element is used in the middle 40 of the catheter, between the first hole 30 and the second hole 20, to divide the flexible catheter into two segments, with the two segments sealed and impermeable to air or liquid. The elastic sheath is tightly fitted to the catheter surface between the first hole 30 and the second hole 20. Simultaneously, using the same method, the two ends 63 and 64 of the sheath are tightly fitted and sealed to the catheter, thus forming a first positioning capsule 31 and a second positioning capsule 21. Each capsule independently communicates with the first hole 30 and the second hole 20. The first hole 30 communicates with the third conduit 3 of the infusion section, and the second hole 20 communicates with the second conduit 1 of the infusion section. Then, a second elastic sleeve, longer than the first elastic sleeve, is provided and inserted into the extension 60 of the catheter from the insertion end. The first positioning bladder 31 and the second positioning bladder 21 are located within this second sleeve, and the third hole 10, located outside the second and first positioning bladders, is located within the second elastic conduit. The two ends 61 and 62 of this elastic conduit are sealed and only adhere to the catheter closure, thus forming the expansion bladder 11. At this time, a restrictive bladder 12 (flexible but non-elastic) is also provided. This restrictive bladder is also tubular, but the diameter of its internal cavity is approximately 1-2 cm, or a volume of 100-200 ml. The extension 60 passes through the restrictive conduit, and the two ends of the restrictive conduit are sealed. The sealing position can be the same as the sealing position of the two ends 61 and 62 of the expansion bladder, allowing the expansion bladder to be located within the restrictive bladder 12. Thus, the expansion bladder 11 is located within the restrictive bladder 12, and the first 31 and the second positioning bladder 21 are also located within the expansion bladder 11. (like Figure 2 Of course, similar methods can be used to create things like... Figure 6 The structure shown.

[0049] For better implementation, a flexible elastic protective film is added outside the restrictive capsule 12. This protective film has a smooth surface. One function is to protect the restrictive capsule 12 (when the surface of the restrictive capsule is a rough fabric or mesh) from damage or direct contact with the catheter, thus preventing damage. Simultaneously, the smooth surface of the elastic film serves two purposes: firstly, it facilitates catheter insertion into the body by providing lubrication; secondly, it needs to expand when the expansion capsule 11, the first 31, and the second positioning capsule 21 are inflated. Of course, the maximum expansion size is controlled by the internal restrictive capsule 12 (e.g., ...). Figure 5This protective film can cover the extension section or the entire surface of the catheter from the insertion end to the irrigation section. All patents and publications mentioned in this specification represent publicly available technology that can be used with this invention. All patents and publications cited herein are also listed in the references as if each publication were individually referenced. This invention can be implemented in the absence of any one or more elements, or one or more limitations, without specific indication herein. For example, the terms “comprising,” “substantially consisting of,” and “consisting of” in each instance herein may be replaced by the other two terms. The term “an” herein simply means “one” and does not exclude the inclusion of only one, but may also indicate the inclusion of two or more. The terminology and expressions used herein are descriptive in nature and are not intended to be limiting, nor is there any intention to suggest that the terms and interpretations described herein exclude any equivalent features; however, it is understood that any suitable changes or modifications may be made within the scope of this invention and the claims. It is understood that the embodiments described in this utility model are preferred embodiments and features. Any person skilled in the art can make some modifications and variations based on the essence of this utility model. These modifications and variations are also considered to fall within the scope of this utility model and the scope limited by the independent claims and appended claims.

Claims

1. An extension device, comprising: The catheter is designed to be inserted into two organs in the human body, with the two organs connected by a tube. It has a guide section, an expansion section, and an injection section; the expansion section includes an expansion bladder, which is configured to expand the tube, and the expansion device also includes a limiting element, which can limit or control the expansion size of the expansion bladder to keep it within a limited size.

2. The apparatus according to claim 1, wherein, The defining element is located outside the expansion capsule.

3. The apparatus according to claim 1, wherein, The defining element covers the outer surface of the expansion capsule.

4. The apparatus according to claim 3, wherein, When the expansion bladder is filled with gas or liquid, the expansion bladder expands and its volume increases as it is filled with gas or liquid. The limiting element enables the volume of the expansion bladder to be kept within a constant range.

5. The apparatus according to claim 1, wherein, The limiting element is a limiting capsule, and the expansion capsule is located inside the limiting capsule.

6. The apparatus according to claim 5, wherein, Under the same pressure, the size of the confined cyst expansion is smaller than that of the expanded cyst.

7. The apparatus according to claim 5, wherein, The defined capsule is made of a non-elastic material.

8. The apparatus according to claim 5, wherein, The size of the defined capsule is a fixed size.

9. The apparatus according to claim 5, wherein, The defined capsule is made of a flexible, non-elastic material.

10. The apparatus according to claim 1, wherein, The expansion capsule is made of elastic material and covers the surface of the catheter when there is no gas or liquid filling it.

11. The apparatus according to any one of claims 1-10, wherein, The expansion bladder also includes a first positioning bladder and a second positioning bladder, and the first and second positioning bladders and the expansion bladder are independently connected to the infusion section.

12. The apparatus according to claim 11, wherein, The first positioning capsule is close to the guide section, and the second positioning capsule is far away from the guide section.

13. The apparatus according to claim 12, wherein, When in use, the first positioning capsule and the second positioning capsule are located inside the two organs respectively.

14. The apparatus according to claim 13, wherein, The first positioning capsule and the second positioning capsule are at a suitable distance, which is set in the channel between the two organs.

15. The apparatus according to any one of claims 1-10, wherein, The extension device also includes a first positioning bladder and a second positioning bladder, with the extension bladder located between the first positioning bladder and the second positioning bladder.

16. The apparatus according to claim 11 or 15, wherein, The first positioning capsule, the second positioning capsule, and the expansion capsule are each independently connected to the infusion section.

17. The apparatus according to claim 16, wherein, The infusion section 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.

18. The apparatus according to claim 1, wherein, The two organs mentioned are the bladder and the prostate, and the duct is the urethra.

19. The apparatus according to claim 11 or 15, wherein, The expansion capsule, the first and second positioning capsules are made of elastic film. When inflated with air or liquid, the capsule will expand and increase in volume.

20. The apparatus according to claim 1, wherein, The tube body is covered by a protective film, which is also an elastic film covering the surface of the defining element.

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