Implanted device for limiting food flow in the duodenum

Abstract

This invention provides an implantable device for restricting the flow of food in the duodenum, relating to the field of medical devices. It includes a stent, a stent membrane tube, and a valve mandrel membrane tube. The stent includes a stent body and anchors disposed on the stent body. The stent membrane tube covers the outside of the stent, and the anchors protrude from the stent membrane tube and are located outside the stent membrane tube. The stent membrane tube is connected to the valve mandrel membrane tube, and a fluid channel is provided between the stent membrane tube and the valve mandrel membrane tube. A valve mandrel balloon is disposed on the valve mandrel membrane tube, and the valve mandrel balloon is connected to a gas generating component capable of generating gas under preset conditions and inputting the gas into the valve mandrel balloon. This application utilizes the gas generating component to realize the opening action of the balloon, facilitating implantation while avoiding the cumbersome operation and inconvenience of secondary inflation methods. This simplifies the treatment process, reduces additional trauma and pain to the patient, and also lowers the risk of infection and the probability of other complications.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to an implantable device that restricts the flow of food in the duodenum. Background Technology

[0002] Bariatric surgery has been proven effective in treating morbid obesity and associated type 2 diabetes. However, surgery is not suitable for all obese patients. On one hand, some patients are unsuitable for surgery due to their physical condition; on the other hand, even those who meet the surgical criteria may hesitate to choose surgery due to concerns about risks and postoperative recovery. In recent years, endoscopic bariatric and metabolic therapies (EBMT, such as intragastric balloon catheterization and duodenojejunal cannulation) have emerged as non-surgical weight loss methods, demonstrating excellent efficacy and gaining recognition in the field.

[0003] A previous study described the endoscopic placement of the SatiSphere device, consisting of a nickel wire and several mesh balls. While the device conforms to the structure of the duodenum and self-anchors, its displacement rate is as high as 47.6%, and the mesh balls significantly hinder the ease of insertion. Therefore, there is an urgent need to develop a more efficient, safe, and stable treatment method to provide better treatment options for obese patients. Summary of the Invention

[0004] The present invention aims to provide an implantable device that restricts the flow of food in the duodenum, which overcomes the problem of inconvenient implantation of an intracavitary device composed of nickel wire and several mesh balls.

[0005] The embodiments of the present invention can be implemented as follows:

[0006] In a first aspect, the present invention provides an implantable device for restricting the flow of food in the duodenum, comprising a stent, a stent membrane tube, and a valve spindle membrane tube. The stent includes a stent body and an anchor disposed on the stent body. The stent membrane tube covers the outside of the stent, and the anchor protrudes from the stent membrane tube and is located outside the stent membrane tube. The stent membrane tube is connected to the valve spindle membrane tube, and a fluid channel is provided between the stent membrane tube and the valve spindle membrane tube.

[0007] The valve core diaphragm tube is provided with a valve core air bladder, and the valve core air bladder is connected to a gas generating component that can generate gas under preset conditions and input the gas into the valve core air bladder.

[0008] In an optional embodiment, there are two or more valve core air bladders, which are arranged sequentially along the valve core shaft diaphragm tube. Each valve core air bladder is connected to the valve core shaft diaphragm tube through an air injection hole, and the outlet end of the gas generating component is connected to the valve core shaft diaphragm tube.

[0009] Alternatively, there may be two or more valve core airbags, which are arranged sequentially along the valve core shaft diaphragm tube, and each valve core airbag is provided with a corresponding gas generating component;

[0010] In an optional embodiment, the valve core airbag is streamlined.

[0011] In an optional embodiment, the valve core diaphragm tube is made of at least one of the following materials: polyurethane (PU), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyamide (PA), polyvinyl alcohol (PVA) freeze-thaw film, expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene copolymer (FEP), and silicone.

[0012] And / or, the material of the valve core airbag is selected from at least one of polyvinyl alcohol (PVA) freeze-thaw film, silicone, polyurethane (PU), low-density polyethylene (LDPE), and linear low-density polyethylene (LLDPE).

[0013] In an optional embodiment, a weak connection is used between the valve core air bladder and the valve core shaft diaphragm tube;

[0014] And / or, the valve core diaphragm tube includes a diaphragm tube section connected in sequence through a valve core air bladder, and a diaphragm is provided inside the diaphragm tube section that is connected to the valve core air bladder at both ends.

[0015] In an optional embodiment, the gas generating assembly includes a first chamber for holding a first reactant and a second chamber for holding a second reactant. The first chamber and the second chamber are separated by a second isolation device that can dissolve under preset conditions. The first reactant and the second reactant can react and generate gas upon contact.

[0016] In an optional embodiment, the first reactant is a liquid, the second reactant is a solid, and the gas outlet of the gas generating component is located on the second chamber;

[0017] And / or, the outlet end of the gas generating component is provided with a breathable membrane or breathable holes;

[0018] And / or, the second isolation device is a disintegrating suture or a disintegrating clip that is soluble in intestinal fluid.

[0019] In an optional embodiment, the first reactant is selected from at least one of citric acid solution and acetic acid, and the second reactant is selected from at least one of sodium bicarbonate and potassium bicarbonate.

[0020] And / or, the first reactant is a solvent, and the second reactant is a first tablet and a second tablet that are soluble in the solvent.

[0021] In an optional embodiment, an arc-shaped diverter is provided at the end of the valve spindle diaphragm tube near the support;

[0022] And / or, the support membrane tube and the valve spindle membrane tube are connected by a connecting membrane, and the fluid channels are symmetrically arranged along the valve spindle membrane tube.

[0023] In an optional embodiment, the material of the connecting membrane is selected from one or more of the following: polyurethane (PU), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyamide (PA), polyvinyl alcohol (PVA) freeze-thaw film, expanded polytetrafluoroethylene (ePTFE), and fluorinated ethylene propylene copolymer (FEP).

[0024] And / or, the material of the stent membrane tube is selected from one or more of polyurethane (PU), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyamide (PA), polyvinyl alcohol (PVA) freeze-thaw film, expanded polytetrafluoroethylene (ePTFE), and fluorinated ethylene propylene copolymer (FEP).

[0025] And / or, the support is made of nickel-titanium alloy.

[0026] The beneficial effects of the implantable device for restricting the flow of food in the duodenum provided in this invention include:

[0027] This application utilizes a gas generating component to activate the airbag, facilitating implantation while avoiding the cumbersome and inconvenient procedures associated with secondary inflation. This built-in gas generating component makes the airbag activation process more convenient and efficient, greatly simplifying the treatment procedure, reducing additional trauma and pain for the patient, and lowering the risk of infection and other complications that may arise from secondary inflation. Attached Figure Description

[0028] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 A first-view structural schematic diagram of an implantable device for restricting the flow of food in the duodenum, provided in an embodiment of this application.

[0030] Figure 2 This is a schematic diagram of the support structure from a first-view perspective, provided in an embodiment of this application.

[0031] Figure 3 This is a partial structural diagram of the implantable device for restricting the flow of food in the duodenum provided in this embodiment;

[0032] Figure 4 This is a schematic diagram of the valve core airbag provided in this embodiment;

[0033] Figure 5 This is a schematic diagram of the structure of the gas generating component provided in an embodiment of this application.

[0034] Icons: 1-Support; 101-Anchor; 102-Support body; 2-Support membrane tube; 3-Connecting membrane; 4-Valve core shaft membrane tube; 401-Injection port; 5-Valve core air bladder; 6-Gas generating assembly; 601-Ventilation port; 602-Second chamber; 603-Second isolation device; 604-First chamber. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0036] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0037] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0038] In the description of this invention, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed, they are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0039] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0040] It should be noted that, where there is no conflict, the features in the embodiments of the present invention can be combined with each other.

[0041] This invention provides an implantable device for restricting the flow of food in the duodenum, such as... Figure 1-3 As shown, the device includes a support 1, a support membrane tube 2, and a valve spindle membrane tube 4. The support 1 includes a support body 102 and an anchor 101 disposed on the support body 102. The support membrane tube 2 covers the outside of the support 1, and the anchor 101 protrudes from the support membrane tube 2 and is located outside the support membrane tube 2. The support membrane tube 2 is connected to the valve spindle membrane tube 4, and a fluid channel is provided between the support membrane tube 2 and the valve spindle membrane tube 4.

[0042] The valve core diaphragm tube 4 is provided with a valve core air bladder 5, and the valve core air bladder 5 is connected to a gas generating component 6 that can generate gas under preset conditions and input the gas into the valve core air bladder 5.

[0043] In some embodiments of this application, the bracket 1 is specifically as follows: Figure 2 As shown, it is W-shaped, with an anchor 101 fixed at the top, which can penetrate the duodenal bulb to fix the bracket 1. The bracket 1 as a whole is located in the duodenal bulb to provide fixing force to the valve body, so as to resist the impact force of chyme on the valve core air bladder 5. Other structures of bracket 1 can also be used in this application. Figure 2 The stent 1, with its anchor 101 structure, can fit closely with the surrounding tissues, thereby achieving a stable and reliable fixation effect, effectively preventing the stent 1 from shifting or falling off in the body, and providing a stable foundation for subsequent treatment.

[0044] In some embodiments of this application, the stent membrane tube 2 is as follows: Figure 3 As shown, it has a double-layer structure, covering all areas of the support 1 except for the rivets of the support 1. The lower part is connected to the valve core diaphragm tube 4, and a fluid channel is provided between it and the valve core diaphragm tube 4 for the passage of chyme.

[0045] The valve core shaft in this application is equipped with a valve core air bladder 5 and a gas generating component 6 capable of inflating the valve core air bladder 5. Before the implantable device restricting the flow of food in the duodenum is implanted, the gas generating component 6 does not generate gas, and the valve core air bladder 5 is not inflated, occupying a small volume, which facilitates the rapid and smooth implantation of the implantable device restricting the flow of food in the duodenum. After implantation, the implantable device restricting the flow of food in the duodenum is in the duodenal environment. Preset conditions such as pH can trigger the gas generating component 6 to start generating gas, thereby inflating the valve core air bladder 5, thus achieving the purpose of hindering the flow of chyme and prolonging the residence time of chyme in the body. It should be noted that the gas generated in the gas generating component in this application needs to be a non-toxic gas to the human body, such as carbon dioxide, because leakage may occur.

[0046] This application utilizes a gas generating component 6 to activate the airbag, facilitating implantation while avoiding the cumbersome and inconvenient procedures associated with secondary inflation. This built-in gas generating component 6 makes the airbag activation process more convenient and efficient, greatly simplifying the treatment procedure, reducing additional trauma and pain for the patient, and lowering the risk of infection and other complications that may result from secondary inflation.

[0047] In an optional embodiment, there are two or more valve core air bladders 5, which are sequentially arranged along the valve core shaft diaphragm tube 4. Each valve core air bladder 5 is connected to the valve core shaft diaphragm tube 4 through an injection hole 401. The outlet end of the gas generating component 6 is connected to the valve core shaft diaphragm tube 4. Figure 4 As shown;

[0048] Alternatively, there may be two or more valve core air bladders 5, which are arranged sequentially along the valve core shaft diaphragm tube 4, and each valve core air bladder 5 is provided with a corresponding gas generating component 6.

[0049] The valve core shaft membrane tube 4, after inflation, becomes a hollow circular tube. The upper part is welded to the connecting membrane 3, and several valve core air bladders 5 are scattered in the middle. The two ends of the valve core air bladders 5 are welded to the outer side of the valve core membrane tube. The valve core shaft membrane tube 4 has an air injection hole 401 corresponding to the middle area of ​​the valve core air bladders 5, which is used to inflate the valve core air bladders 5. After all the valve core air bladders 5 are inflated, they together with the inner wall of the duodenum form a ring-shaped multi-stage throttling valve group, which slows down the speed of chyme passage, thereby slowing down the gastric and duodenal emptying time, and indirectly reducing the amount of food intake.

[0050] In an optional embodiment, the valve core airbag 5 is streamlined, which helps to reduce the frictional resistance of the chyme passing through and guides the chyme to flow sequentially through the annular gap between the valve core airbag 5 and the intestine, thereby reducing the risk of blockage.

[0051] In an optional embodiment, the valve core diaphragm tube 4 is made of at least one of polyurethane (PU), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyamide (PA), polyvinyl alcohol (PVA) freeze-thaw film, expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene copolymer (FEP), and silicone.

[0052] And / or, the material of the valve core airbag 5 is selected from at least one of polyvinyl alcohol (PVA) freeze-thaw film, silicone, polyurethane (PU), low-density polyethylene (LDPE), and linear low-density polyethylene (LLDPE).

[0053] In an optional embodiment, a weak connection is used between the valve core air bladder 5 and the valve core shaft diaphragm tube 4;

[0054] In this way, when blockage occurs, the distal balloon can be sacrificed like a rocket to preserve the remaining balloon, which can greatly reduce adverse reactions for patients during implantation.

[0055] It should be noted that the weak connection can be formed by gelling and molding the raw material liquid for preparing the valve core airbag 5 on the valve core shaft membrane tube 4, thereby achieving the connection between the valve core airbag 5 and the valve core shaft membrane tube 4. Because the connection between the valve core airbag 5 and the valve core shaft membrane tube 4 is weak, the valve core airbag 5 and the valve core shaft membrane tube 4 connected to it can separate when blockage occurs and encounters significant resistance.

[0056] In an optional embodiment, the valve core shaft diaphragm tube 4 includes shaft tube sections connected in sequence through valve core airbags 5, and a diaphragm is provided inside the shaft tube sections that are connected to the valve core airbags 5 at both ends.

[0057] Since the air injection port 401 may leak after the valve core airbag 5 and the valve core shaft diaphragm tube 4 connected to it are separated, causing the airbag to deflate, a diaphragm is provided in the shaft tube section to prevent the remaining valve core airbag 5 from leaking and to prolong the residence time of the device in the body.

[0058] In alternative implementations, such as Figure 5 As shown, the gas generating assembly 6 includes a first chamber 604 for holding a first reactant and a second chamber 602 for holding a second reactant. The first chamber 604 and the second chamber 602 are separated by a second isolation device 603 that can dissolve under preset conditions. The first reactant and the second reactant can react and generate gas after contact.

[0059] The reactants of the gas generating component 6 are separated by a second isolation device 603, preventing the first and second reactants from contacting each other. When the gas generating component 6 enters the duodenum, the second isolation device 603 dissolves under these conditions, allowing the first and second reactants to come into contact and generate gas. The gas is directly injected into the valve core air bladder 5 or injected into the valve core shaft membrane tube 4 and then enters the valve core air bladder 5 through the gas injection hole 401 on the valve core shaft membrane tube 4.

[0060] It should be noted that the ratio and dosage of the first reactant and the second reactant in this application, as well as the size of the valve core bladder 5, need to be adjusted according to the specific condition of the patient's duodenum so that the air pressure in the valve core bladder 5 and the valve core shaft membrane tube 4 is maintained at a certain value, thereby ensuring that the valve core bladder 5 maintains a certain rigidity while not overstimulating the duodenum and causing adverse reactions.

[0061] This application allows for convenient adjustment of the balloon size by precisely controlling the dosage of solid and liquid reactants. Given the individual differences in the physiological structure of the duodenal bulb among patients, this invention provides multiple product models, each corresponding to different combinations of reactant dosages. In actual treatment, medical personnel can accurately select the appropriate model based on the specific dimensions of the patient's duodenal bulb, thereby achieving a personalized and precise treatment plan. This personalized treatment approach not only significantly improves treatment efficacy but also effectively reduces problems such as excessive pressure on the duodenal tissue or poor fit caused by unsuitable balloon size, thus minimizing adverse reactions during treatment, such as pain, inflammation, and gastrointestinal dysfunction, promoting rapid postoperative recovery, and improving the patient's quality of life and treatment experience.

[0062] In an optional embodiment, the first reactant is a liquid, the second reactant is a solid, and the gas outlet of the gas generating component 6 is located on the second chamber 602.

[0063] And / or, the outlet end of the gas generating component 6 is provided with a breathable membrane or a breathable hole 601;

[0064] And / or, the second isolation device 603 is a disintegrating binding thread or a disintegrating clip that is soluble in intestinal fluid.

[0065] The second isolation device 603 is separated by the standard that liquid cannot pass through, while the venting membrane or venting hole 601 can be separated by the standard that solids, which are the second reactants, cannot pass through or only a small amount can pass through without affecting the expansion of the capsule.

[0066] In an optional embodiment, the first reactant is selected from at least one of citric acid solution and acetic acid, and the second reactant is selected from at least one of sodium bicarbonate and potassium bicarbonate.

[0067] And / or, the first reactant is a solvent, and the second reactant is a first tablet and a second tablet that are soluble in the solvent.

[0068] In an optional embodiment, the valve core diaphragm tube 4 is provided with an arc-shaped diversion section at the end near the support 1, and the end of the valve core diaphragm tube 4 is roughly circular, which helps to reduce the resistance of the chyme passing through and guide the chyme to flow to the outside of the valve core.

[0069] In an optional embodiment, the support diaphragm tube 2 and the valve spindle diaphragm tube 4 are connected by a connecting membrane 3, and the fluid channels are symmetrically arranged along the valve spindle diaphragm tube 4. The connecting membrane 3 provides a connection force between the rear valve body portion and the support 1. Simultaneously, the surface of the connecting membrane 3 has several irregularly shaped holes that can serve as fluid channels. The symmetrical arrangement of the fluid channels along the valve spindle diaphragm tube 4 facilitates uniform force distribution on the support 1. The ends of the connecting membrane 3 and the valve spindle diaphragm tube 4 can be connected by welding.

[0070] In an optional embodiment, the material of the connecting membrane 3 is selected from one or more of polyurethane (PU), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyamide (PA), polyvinyl alcohol (PVA) freeze-thaw film, expanded polytetrafluoroethylene (ePTFE), and fluorinated ethylene propylene copolymer (FEP).

[0071] And / or, the material of the stent membrane tube 2 is selected from one or more of polyurethane (PU), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), polyamide (PA), polyvinyl alcohol (PVA) freeze-thaw film, expanded polytetrafluoroethylene (ePTFE), and fluorinated ethylene propylene copolymer (FEP).

[0072] And / or, the material of the bracket 1 is nickel-titanium alloy.

[0073] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. An implantable device for limiting the flow of food within the duodenum, comprising: The device includes a support, a support membrane tube, and a valve spindle membrane tube. The support includes a support body and anchors disposed on the support body. The support membrane tube covers the outside of the support, and the anchors protrude from the support membrane tube and are located outside the support membrane tube. The support membrane tube is connected to the valve spindle membrane tube, and a fluid channel is provided between the support membrane tube and the valve spindle membrane tube. A valve core air bladder is provided on the valve core shaft diaphragm tube, and the valve core air bladder is connected to a gas generating component that can generate gas under preset conditions and input the gas into the valve core air bladder. The valve core airbag and the valve core shaft membrane tube are connected by a weak connection. The weak connection is formed by gelling and molding the raw material liquid for preparing the valve core airbag on the valve core shaft membrane tube to achieve the connection between the valve core airbag and the valve core shaft membrane tube.

2. An implantable device for restricting the flow of food within the duodenum according to claim 1, wherein, There are two or more valve core air bladders, and the two or more valve core air bladders are arranged sequentially along the valve core shaft diaphragm tube. Each valve core air bladder is connected to the valve core shaft diaphragm tube through an air injection hole. The gas outlet of the gas generating component is connected to the valve core shaft diaphragm tube. Alternatively, there may be two or more valve core air bladders, which are arranged sequentially along the valve core shaft diaphragm tube, and each valve core air bladder is provided with a corresponding gas generating component.

3. An implantable device for restricting the flow of food within the duodenum according to claim 1, wherein, The valve core airbag is streamlined.

4. The implantable device for restricting the flow of food in the duodenum according to claim 1, characterized in that, The valve core diaphragm tube is made of at least one of polyurethane, low-density polyethylene, linear low-density polyethylene, polyamide, polyvinyl alcohol freeze-thaw film, expanded polytetrafluoroethylene, fluorinated ethylene propylene copolymer and silicone. And / or, the material of the valve core airbag is selected from at least one of polyvinyl alcohol freeze-thaw film, silicone, polyurethane, low-density polyethylene and linear low-density polyethylene.

5. The implantable device for restricting the flow of food within the duodenum according to claim 2, wherein, The valve core shaft diaphragm tube includes shaft tube sections connected in sequence through valve core air bladders, and a diaphragm is provided inside the shaft tube sections that are connected to the valve core air bladders at both ends.

6. The implantable device for restricting the flow of food within the duodenum of Claim 1, wherein, The gas generating assembly includes a first chamber for holding a first reactant and a second chamber for holding a second reactant. The first chamber and the second chamber are separated by a second isolation device that can dissolve under preset conditions. The first reactant and the second reactant can react and generate gas after contact.

7. An implantable device for restricting the flow of food within the duodenum according to claim 6, wherein, The first reactant is a liquid, the second reactant is a solid, and the gas outlet of the gas generating component is located on the second chamber; And / or, the outlet end of the gas generating component is provided with a breathable membrane or breathable holes; And / or, the second isolation device is a disintegrating suture or a disintegrating clip that is soluble in intestinal fluid.

8. The implantable device for restricting the flow of food within the duodenum according to claim 6, wherein, The first reactant is selected from at least one of citric acid solution and acetic acid, and the second reactant is selected from at least one of sodium bicarbonate and potassium bicarbonate; And / or, the first reactant is a solvent, and the second reactant is a first tablet and a second tablet that are soluble in the solvent.

9. The implantable device for restricting the flow of food within the duodenum according to claim 1, wherein, An arc-shaped flow divider is provided at the end of the valve core diaphragm tube near the support; And / or, the support membrane tube and the valve spindle membrane tube are connected by a connecting membrane, and the fluid channels are symmetrically arranged along the valve spindle membrane tube.

10. The implantable device for restricting the flow of food within the duodenum according to claim 9, wherein, The material of the connecting membrane is selected from one or more of polyurethane, low-density polyethylene, linear low-density polyethylene, polyamide, polyvinyl alcohol freeze-thaw film, expanded polytetrafluoroethylene, and fluorinated ethylene propylene copolymer. And / or, the material of the stent membrane tube is selected from one or more of polyurethane, low-density polyethylene, linear low-density polyethylene, polyamide, polyvinyl alcohol freeze-thaw film, expanded polytetrafluoroethylene, and fluorinated ethylene propylene copolymer; And / or, the support is made of nickel-titanium alloy.

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