Sectional type gastric bypass stent conveying and releasing system

Abstract

The invention discloses a sectional type gastric bypass stent conveying and releasing system, and relates to the technical field of medical instruments. The sectional type gastric bypass stent conveying and releasing system comprises a sectional type stent and a conveying and releasing mechanism, the sectional bracket comprises an upper bracket, a lower bracket, a connecting rope and a membrane tube, the upper bracket and the lower bracket are connected through the connecting rope, and one end, far away from the upper bracket, of the lower bracket is connected with the membrane tube; the lower support and the membrane pipe are both contained in a containing pipe of the conveying and releasing mechanism, the membrane pipe is connected with the releasing small ball, the lower support makes contact with the support pushing block, the connecting rope is led out of the rope passing groove, and the upper support is contained in a gap between a conveying pipe of the conveying and releasing mechanism and an outer sleeve. The sectional stent provided by the invention reduces the incidence rate of gastrointestinal tract events (vomiting, nausea, stomachache and the like) and stent displacement, reduces the occurrence rate of gastric retention or obstruction, and is not easy to form pressure ulcer. The sectional type support and the conveying and releasing mechanism are high in matching performance, and the conveying and releasing effects are better.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a segmented gastric bypass stent delivery and release system. Background Technology

[0002] The gastric bypass stent system applies the principles of Roux-en-Y gastric bypass (RYGB) in a minimally invasive manner. This device uses an endoscope to insert a shunt into the upper duodenum and jejunum, isolating chyme from the intestinal wall while allowing digestive juices to flow normally outside the shunt. This design achieves the effects of surgical gastric bypass without altering the physiological structure of the gastrointestinal tract, thereby reducing nutrient absorption in the duodenum and most of the jejunum, leading to weight loss and improvement of metabolic diseases.

[0003] There are two existing technical solutions: one is a single stent fixed in the duodenal bulb, and the other is a double stent, with the upper stent fixed at the pylorus and the lower stent placed in the duodenal bulb. Both single and double stents are delivered using conventional delivery mechanisms. Among these, existing gastric bypass stent devices and delivery systems are more suitable for single-stent use. However, when used with double stents, these devices and delivery systems suffer from poor compatibility and delivery difficulties.

[0004] In view of this, the present invention is proposed. Summary of the Invention

[0005] The purpose of this invention is to provide a segmented gastric bypass stent delivery and release system.

[0006] This invention is implemented as follows: In a first aspect, the present invention provides a segmented gastric bypass stent delivery and release system, which includes a segmented stent and a delivery and release mechanism; The segmented support includes an upper support, a lower support, a connecting rope, and a membrane tube. The upper support and the lower support are connected by the connecting rope, and the end of the lower support away from the upper support is connected to the membrane tube. The delivery and release mechanism includes a release ball, a receiving tube, a conveying tube, and a driving mechanism for releasing the release ball. The cylindrical end of the release ball is located at the end of the receiving tube, and the side wall of the receiving tube has a through-hole for passing through the rope along its axis. The two ends of the conveying tube are fixedly connected between the receiving tube and the driving mechanism. An outer tube is movably sleeved on the conveying tube, and an installation cavity for installing the upper bracket is formed between the conveying tube and the outer tube. The lower support and the membrane tube are both housed in the receiving tube. The membrane tube is connected to the release ball. The connecting rope is led out from the rope groove. The upper support is housed in the gap between the conveying tube and the outer tube.

[0007] In an optional embodiment, the upper support is teardrop-shaped and includes a top, a middle section, and a bottom. The top and the bottom of the upper support are both open and internally connected. The diameter of the top is smaller than the maximum diameter of the middle section but larger than the minimum diameter of the middle section. The diameter of the bottom is equal to the minimum diameter of the middle section. The diameter of the middle section first increases and then decreases along the direction from the top to the bottom.

[0008] In an optional embodiment, the maximum diameter of the middle portion is 50-90 mm; And / or, the height of the upper bracket is 55-100mm; And / or, the top opening size is 35-65mm, and the bottom opening size is greater than 16mm.

[0009] In an optional embodiment, the upper support is a mesh support; And / or, both the inner and outer surfaces of the upper support are provided with a silicone film.

[0010] In an optional embodiment, the connecting rope includes a first skeleton rope, an intermediate extension rope, and a second skeleton rope. The first skeleton rope consists of multiple ropes, one end of which is evenly connected to the edge of the upper support. The other ends of the first skeleton rope converge at a point and are connected to one end of the intermediate extension rope. The second skeleton rope consists of multiple ropes, one end of which is evenly connected to the edge of the lower support. The other ends of the second skeleton rope converge at a point and are connected to the other end of the intermediate extension rope. And / or, the surface of the connecting rope is coated with a silicone film; And / or, the connecting rope is made of polymer material or metal material.

[0011] In an optional embodiment, a reinforcing rib is provided on the circumference of one end of the lower support near the connecting rope; And / or, the lower support is a mesh structure; And / or, the diameter of the lower support is 35mm-65mm.

[0012] In an optional embodiment, the outer sleeve includes a receiving section, a transition section, and an operating section. The receiving section forms the mounting cavity with the delivery tube. The two ends of the transition section are respectively connected to the receiving section and the operating section. The diameter of the transition section gradually decreases along the direction from the receiving section to the operating section.

[0013] In an optional embodiment, the axial sidewall of the operating section is provided with a take-out groove to facilitate the disengagement of the operating section from the conveying pipe, and the cross-section of the operating section is C-shaped.

[0014] In an optional embodiment, a support pusher block for pushing the lower support is provided inside the storage tube; the driving mechanism includes a handle, a single-cavity tube and a handle, the handle is fixedly connected to one end of the transmission tube away from the storage tube, one end of the single-cavity tube is connected to the handle, and the other end passes through the handle and the transmission tube in sequence and extends into the storage tube to be connected to the support pusher block for pushing the support pusher block to move inside the storage tube; And / or, a connecting cap is connected to one end of the receiving tube, and the other end of the connecting cap is fixedly connected to the conveying tube.

[0015] In an optional embodiment, the delivery and release mechanism further includes an unlocking line, the handle is provided with a knob, one end of the unlocking line is connected to the release ball, and the other end is wrapped around the end of the handle and fixed by the knob.

[0016] The present invention has the following beneficial effects: The segmented gastric bypass stent delivery and release system provided by this invention features a separate upper and lower stent design, connected by a connecting rope. The upper stent is placed inside the stomach, while the lower stent is fixed to the duodenal bulb. Because the upper and lower stents are connected by the rope, food can smoothly reach the pylorus and flow into the lower stent under any circumstances, eliminating concerns about gastric retention or obstruction and avoiding severe gastrointestinal reactions. The lower stent of this invention has no anchors, preventing related bleeding and puncture ulcers. Because the upper stent is placed inside the stomach and has sufficient strength, it effectively prevents the lower stent from shifting. The lower stent is designed to mimic the physiological structure of the duodenal bulb, ensuring uniform contact between the stent and all surfaces of the bulb, reducing the likelihood of pressure ulcers. Furthermore, the delivery and release system of this invention has high compatibility with segmented stents, allowing for separate assembly and storage of each segment. The lower stent retains the original storage tube size, eliminating difficulties in inserting the storage tube into the throat. Meanwhile, the upper support is assembled around the conveying tube via a sleeve, allowing it to move smoothly together with the conveying tube. A rope groove is provided on the receiving tube, allowing the connecting rope of the segmented support to pass through. This invention changes the traditional support release method; the upper support is first released by pulling the sleeve, and then the lower support is precisely released at the pylorus, resulting in better conveying and release effects. Attached Figure Description

[0017] 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.

[0018] Figure 1 This is a schematic diagram of the segmented gastric bypass stent delivery and release system provided in an embodiment of the present invention; Figure 2 This is a schematic diagram of the segmented stent structure in the segmented gastric bypass stent delivery and release system provided in an embodiment of the present invention; Figure 3 This is a schematic diagram showing the connection between the upper and lower stents in the segmented stent delivery and release system provided in an embodiment of the present invention. Figure 4 This is a schematic diagram of the delivery and release mechanism in the segmented gastric bypass stent delivery and release system provided in an embodiment of the present invention; Figure 5 This is a schematic diagram of the receiving tube in the delivery and release mechanism of the segmented gastric bypass stent delivery and release system provided in an embodiment of the present invention; Figure 6 This is a schematic diagram of the outer sheath in the delivery and release mechanism of the segmented gastric bypass stent delivery and release system provided in an embodiment of the present invention; Figure 7 This is a cross-sectional schematic diagram of the operating section of the outer sheath in the delivery and release mechanism of the segmented gastric bypass stent delivery and release system provided in an embodiment of the present invention.

[0019] Icon: 100 - Segmented gastric bypass stent delivery and release system; 110 - Segmented support; 111 - Upper support; 1111 - Top; 1112 - Middle; 1113 - Bottom; 112 - Lower support; 1121 - Reinforcing rib; 113 - Connecting rope; 1131 - First skeleton rope; 1132 - Intermediate extension rope; 1133 - Second skeleton rope; 114 - Membrane tube; 120 - Conveying and releasing mechanism; 121 - Releasing ball; 122 - Storage tube; 1221 - Rope groove; 1222 - Connecting cap; 1223 - Support push block; 123 - Conveying tube; 124 - Handle; 1241 - Knob; 1242 - Unlocking line; 125 - Single-cavity tube; 126 - Handle; 127 - Outer tube; 1271 - Receiving section; 1272 - Transition section; 1273 - Operating section; 1274 - Removal groove. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0021] In the description of this application, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of describing this application and for 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. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0022] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "setup" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0023] This invention has revealed the following shortcomings in current single-stent and double-stent systems and their transport processes: Single-stent designs typically require barbs on the outer periphery of the metal stent for fixation. These barbs effectively prevent product displacement. The stent is fixed to the duodenal bulb by expansion force and the anchor barb design. The disadvantages of this technique are: (1) the anchor barb site is prone to scratching the patient's duodenal bulb, causing bleeding and punctate ulcers; (2) due to the single-stent design, the stent is inevitably prone to displacement when the patient experiences severe vibration and strong gastrointestinal peristalsis; (3) due to its cylindrical stent design, it does not match the anatomy of the human duodenal bulb. After the stent is removed, pressure ulcers are often found in the distal part of the patient's duodenal bulb.

[0024] Among the existing gastric bypass stents, CN108938163 discloses a design in which the stent is a double stent design, with the upper stent fixed at the pylorus and the lower stent placed in the duodenal bulb. Although this technique can improve bleeding and ulcers, it also has certain disadvantages: (1) The upper stent is fixed at the pylorus, which interferes with the normal closure frequency of the pylorus, causing the pylorus to accelerate peristalsis and fail to close, thus leading to bile and pancreatic juice reflux; (2) The upper stent stimulates the pylorus for a long time, and patients will have strong gastrointestinal reactions after stent implantation, including nausea, vomiting and abdominal pain; (3) The lower stent is designed to be small and has no reinforcement design, so the stent is easy to flip back into the stomach under reverse peristalsis of the intestine.

[0025] Among the existing gastric bypass stents, (CN110755189 and CN104546248) disclose a segmented stent with a double-stent structure. The upper stent is placed in the antrum of the stomach, and the lower stent is placed below the pylorus. The upper and lower stents are connected by a membrane tube. CN110755189 uses titanium clips to fix the upper stent in the stomach. The disadvantages are: (1) The upper stent structure is rigid. After being fixed to the stomach wall, it will affect the peristalsis of the antrum when used. (2) With the increase of the insertion time, the titanium clip will fall off within 1-3 months. The fall-off time is less than the insertion time of the stent in the human body, which will affect its stability when used. (3) When the titanium clip falls off, the stent is unstable. The irregular movement in the stomach will cause the first membrane tube to be rotated and tightened. Once the first membrane tube is rotated and tightened multiple times, food will not be able to flow from the stomach to the intestine, which will lead to gastric retention and intestinal obstruction.

[0026] CN104546248 also features a dual-stent design. The shortcomings of this design are: (1) The first stent cannot fit snugly against the pyloric antrum depending on the body's posture (standing, sitting, or lying down), allowing food chyme to pass through the side of the first stent and reach the pylorus. Furthermore, because the diameter of the duodenal bulb stent (the second stent) is smaller than the diameter of the duodenal bulb, the second stent cannot fit snugly against the duodenal bulb. This design inevitably allows some food chyme to pass through the outside of the stent, failing to completely isolate food from the duodenum. (2) Since the stent is placed in the pyloric antrum only by expansion force, the circumferential direction of the stent is unstable. Irregular movement within the stomach causes the tubular membrane to rotate and tighten. Once the tubular membrane rotates and tightens multiple times, food cannot flow from the stomach to the intestines, leading to gastric retention and intestinal obstruction.

[0027] Among the existing gastric bypass stents, CN106667620 discloses a design with the following shortcomings: (1) the metal stent is fixed at the pylorus, which interferes with the normal closing frequency of the pylorus, causing the pylorus to accelerate peristalsis and fail to close, thus leading to bile and pancreatic juice reflux; (2) the metal stent stimulates the pylorus for a long time, and patients will have strong gastrointestinal reactions after stent implantation, including nausea, vomiting and abdominal pain. In existing single-stent gastric bypass stent devices and delivery systems, the covered stent is folded and placed in a cylindrical receiving tube. The front end of the covered stent's membrane tube is connected to a spherical release ball, which is placed into the opening at the front end of the receiving tube. Both the release ball and the receiving tube (see patent CN109152570) of existing delivery systems are designed with side holes. During use, a guidewire is first inserted into the pylorus under endoscopic guidance, then the endoscope is withdrawn. Finally, the side holes of the release ball and receiving tube are engaged with the guidewire to ensure that the receiving tube of the delivery system enters the pylorus along the guidewire during insertion. The release ball serves two purposes: (1) locking the stent's membrane tube; and (2) guiding the delivery device into the pylorus and ensuring the stent is fully deployed.

[0028] The current segmented bracket (see patent CN108938163) also uses the above-mentioned bracket device and release system, with both the upper and lower brackets folded and stored in a storage tube.

[0029] However, this device and release system have many drawbacks when used in conjunction with a segmented support: (1) Both the upper and lower supports are folded inside the storage tube, which inevitably increases the length of the storage tube. Since the storage tube is made of rigid material, an excessively long storage tube cannot pass smoothly through the patient's throat in clinical practice, or may even be unusable.

[0030] (2) When both the upper and lower stents are folded into the storage tube, the stacking order is that the upper stent is closer to the connecting cap end. In clinical use, the lower stent will be released first and then the upper stent will be released. When the upper and lower stents are stacked together during release, it is not easy for clinicians to judge the release position, which may easily cause the lower stent to be misaligned.

[0031] Based on the above research, please refer to Figure 1 The present invention provides a segmented gastric bypass stent delivery and release system 100, which includes a segmented stent 110 and a delivery and release mechanism 120. By improving the segmented stent 110 and the delivery and release mechanism 120 respectively, the present invention not only improves the defects of the current single stent and double stent, but also makes them more compatible with the delivery and release mechanism 120, which is more conducive to delivery.

[0032] Next, the present invention will describe in detail the structure of the segmented support 110, the structure of the conveying and releasing mechanism 120, and the assembly and conveying methods between the segmented support 110 and the conveying and releasing mechanism 120.

[0033] (1) Structure of segmented support 110 (see Figure 2 and Figure 3 ).

[0034] The segmented support 110 includes an upper support 111, a lower support 112, a connecting rope 113, and a membrane tube 114. The upper support 111 and the lower support 112 are connected by the connecting rope 113, and the end of the lower support 112 away from the upper support 111 is connected to the membrane tube 114.

[0035] In this invention, the upper stent 111 is placed in the stomach after being delivered into the body. In this embodiment, the upper stent 111 is teardrop-shaped and is a mesh stent, comprising a top 1111, a middle portion 1112, and a bottom 1113. Both the top 1111 and the bottom 1113 of the upper stent 111 are open and internally connected. The diameter of the top 1111 is smaller than the maximum diameter of the middle portion 1112 but larger than the minimum diameter of the middle portion 1112. The diameter of the bottom 1113 is equal to the minimum diameter of the middle portion 1112. The diameter of the middle portion 1112 first increases and then decreases along the direction from the top 1111 to the bottom 1113. Specifically, the maximum diameter of the middle portion 1112 is 50-90 mm; the height of the upper stent 111 is 55-100 mm; the opening size of the top 1111 is 35-65 mm; and the lower opening size of the bottom 1113 is greater than 16 mm. Since the size of the upper support 111 of the present invention is larger than the size of the pylorus, and the structure of the upper support 111 gives it a certain strength, it can effectively prevent the lower support 112 from shifting. Even if the lower support 112 moves downward, the upper support 111 will be blocked by the pylorus, thereby preventing the lower support 112 from continuing to move.

[0036] The upper support 111 of the present invention is designed in the shape of a water droplet, which can control the speed at which chyme flows from the stomach to the duodenum, and can appropriately slow down the gastric emptying rate of obese patients, increase the patient's feeling of fullness, and thus control the eating speed and amount.

[0037] In this invention, the lower stent 112 has a mesh structure and is located in the duodenal bulb after being delivered into the body. The lower stent 112 of this invention has no anchors, thus avoiding related bleeding and puncture ulcers. The diameter of the lower stent 112 is 35mm-65mm, which is larger than the diameter of the duodenal bulb, allowing it to conform to the duodenal bulb. In this invention, the lower stent is made of nickel-titanium alloy, which has a certain degree of elasticity, with the core being shape memory effect and superelasticity. Its elasticity far exceeds that of ordinary alloys, enabling it to maintain a certain degree of elasticity and expansion force within the intestine, sufficient to ensure that the lower stent 112 remains in continuous contact with the duodenum, preventing food from passing through the outside of the stent and thus hindering weight loss. The lower stent 112 of this invention is designed to mimic the physiological structure of the duodenal bulb, ensuring more uniform contact between the stent and all surfaces of the bulb, making it less prone to pressure ulcers. The upper circumference of the lower stent 112 is designed with a reinforced dense mesh stent as a reinforcing rib 1121, which can effectively prevent the lower stent 112 from flipping back / refluxing into the stomach when subjected to reverse peristaltic force.

[0038] Since the upper stent 111 is located in the stomach and the lower stent 112 is located in the duodenal bulb, in this embodiment, a connecting rope 113 is used to connect the upper stent 111 and the lower stent 112 through the pylorus, thus avoiding the strong gastrointestinal reaction that is easily caused by the prior art.

[0039] The connecting rope 113 is made of polymer or metal. The connecting rope 113 includes a first skeleton rope 1131, an intermediate extension rope 1132, and a second skeleton rope 1133. The first skeleton rope 1131 consists of multiple ropes, one end of which is evenly connected to the edge of the upper support 111. The other ends of the first skeleton rope 1131 converge at one point and are connected to one end of the intermediate extension rope 1132. The second skeleton rope 1133 consists of multiple ropes, one end of which is evenly connected to the edge of the lower support 112. The other ends of the second skeleton rope 1133 converge at one point and are connected to the other end of the intermediate extension rope 1132. As can be seen, the first skeleton rope 1131 and the second skeleton rope 1133 form a structure similar to the ribs of an umbrella. There is a gap between any two adjacent first skeleton ropes 1131 or any two adjacent second skeleton ropes 1133. Under any circumstances, food can smoothly reach the pylorus and flow into the lower stent 112 without worrying about gastric retention or obstruction. This can effectively avoid the gastric retention and intestinal obstruction caused by the current technology (using a membrane tube 114 or a tubular membrane to connect the upper stent 111 and the lower stent 112) due to irregular movement in the stomach, which causes the membrane tube 114 or the tubular membrane to be in a rotated and tightened state.

[0040] In this embodiment, the connecting rope 113 is bound to the upper support 111 and the lower support 112 by a braiding method.

[0041] In this embodiment, the inner and outer surfaces of the upper stent 111 are coated with a silicone film, and similarly, the surface of the connecting rope 113 is also coated with a silicone film. The silicone film is soft and corrosion-resistant, friendly to the human digestive tract, and will not fail. It protects the patient's digestive tract from damage and prevents the stent itself from being corroded.

[0042] The membrane tube 114 is connected to one end of the lower support 112. It can be deployed in the human intestine by the release ball 121. The lower support 112 and the membrane tube 114 are connected together by a coating process / thermal fusion method.

[0043] (2) Structure of the conveying and releasing mechanism 120 (see [reference]) Figure 4 ).

[0044] The delivery and release mechanism 120 includes a release ball 121, a receiving tube 122, a conveying tube 123, and a drive mechanism. The cylindrical end of the release ball 121 is located at the end of the receiving tube 122, and the release ball 121 and the receiving tube 122 are in clearance fit.

[0045] Please see Figure 5 The side wall of the storage tube 122 is provided with a through-rope groove 1221 that is arranged along its axis. The end of the storage tube 122 is connected to a connecting cap 1222. A support push block 1223 for pushing the lower support 112 is provided inside the storage tube 122. The support push block 1223 can move inside the storage tube 122.

[0046] The delivery tube 123 is a hollow tubular structure. Both ends of the delivery tube 123 are fixedly connected between the receiving tube 122 and the handle 124. Specifically, one end of the delivery tube 123 is fixedly connected to the connecting cap 1222, and the other end is fixedly connected to the handle 124 of the drive mechanism. An outer sleeve 127 is movably fitted onto the delivery tube 123, and a mounting cavity for mounting the upper bracket 111 is formed between the delivery tube 123 and the outer sleeve 127.

[0047] Please see Figure 6 and Figure 7 The outer sleeve 127 includes a receiving section 1271, a transition section 1272, and an operating section 1273. The receiving section 1271 forms an installation cavity with the delivery pipe 123. The two ends of the transition section 1272 are connected to the receiving section 1271 and the operating section 1273, respectively. The diameter of the transition section 1272 gradually decreases along the direction from the receiving section 1271 to the operating section 1273. The axial sidewall of the operating section 1273 has a take-out groove 1274 to facilitate the disengagement of the operating section 1273 from the delivery pipe 123. The operating section 1273 has a C-shaped cross-section.

[0048] And / or, the outer tube 127 is made of silicone or soft polymer material.

[0049] Any driving mechanism capable of releasing the release ball 121 can be used as the driving mechanism of this invention. For example, the release ball can be released by a push rod or by locking the release ball with a hook. This invention does not limit the specific structure of the driving mechanism. This embodiment provides a typical but non-limiting example, in which the driving mechanism includes a handle 124, a single-cavity tube 125, and a handle 126.

[0050] The handle 124 is located between the transmission tube 123 and the handle 126 for the operator to hold. The handle 124 includes a knob 1241 and an unlocking line 1242. One end of the unlocking line 1242 is connected to the release ball 121, and the other end is wrapped around the end of the handle 124 and fixed by the knob 1241.

[0051] The single-cavity tube 125 is a slender tube. One end of the single-cavity tube 125 is connected to the handle 126, and the other end passes through the handle 124 and the transmission tube 123 in sequence and extends into the storage tube 122 to be connected to the support push block 1223 for pushing the support push block 1223 to move in the storage tube 122.

[0052] (3) Assembly method between the segmented support 110 and the conveying and releasing mechanism 120 (see [reference]). Figure 1 ).

[0053] The lower support 112 and the membrane tube 114 are both housed in the receiving tube 122. The membrane tube 114 is connected to the release ball 121. The lower support 112 is in contact with the support push block 1223. The connecting rope 113 is led out from the rope groove 1221. The upper support 111 is housed in the gap between the conveying tube 123 and the outer tube 127.

[0054] The membrane tube 114 and the release ball 121 are connected by a soluble inner core. Before the inner core dissolves, the release ball 121 is connected to the stent to drive the membrane tube 114 on the stent to unfold in the human intestine. After the inner core dissolves, the release ball 121 detaches from the stent, facilitating the subsequent recovery of the release ball 121.

[0055] The contact between the lower support 112 and the support push block 1223 is a clearance fit. The support push block 1223 can push the lower support 112 to move, thereby causing the lower support 112 to disengage from the storage tube 122.

[0056] In this embodiment, the storage tube 122 is different from the existing storage tube 122. Its side wall has a rope groove 1221, and the connecting rope 113 is led out from the rope groove 1221. The setting of the rope groove 1221 can realize the separate release of the upper support 111 and the lower support 112, and at the same time facilitate the smooth recovery of the storage tube 122 after the lower support 112 is released.

[0057] In this embodiment, the upper support 111 is evenly distributed around the circumference of the conveying tube 123 and then covered with the outer sleeve 127, which realizes the storage and fixation of the upper support 111.

[0058] (4) Delivery method.

[0059] In use, under endoscopic guidance, a guidewire is first inserted into the pylorus. The guidewire is then used to guide portions of the receiving tube 122 and delivery tube 123 of the segmented gastric bypass stent delivery and release system 100 into the stomach. Once the receiving tube 122 is inserted into the patient's duodenal bulb, delivery is stopped, and the handle 124 is fixed to prevent further movement of the receiving tube 122. At this point, the outer tube 127 of the upper stent 111 is inside the stomach. Subsequently, the outer tube 127 is retracted, allowing it to move along the delivery tube 123. After the outer tube 127 has retracted sufficiently, the upper stent 111 exits from the outer tube 123. Release within 27, thus enabling the upper stent 111 to be released within the stomach; readjust the position of the receiving tube 122 to adjust the position of the lower stent 112; then rotate the knob 1241 on the handle 124 to free the unlocking line 1242, use the handle 126 to push the single-lumen tube 125, the single-lumen tube 125 moves within the handle 124 and the delivery tube 123 and pushes the stent pusher 1223 to move within the receiving tube 122, thereby pushing the lower stent 112 to disengage from the receiving tube 122, and finally retract the receiving tube 122 to achieve precise release of the lower stent 112.

[0060] The lower stent 112 of this invention is housed in the receiving tube 122 before release. The size of the receiving tube 122 is no different from that of currently available single stents, so the receiving tube 122 will not obstruct the smooth entry of this product into the patient's throat. Meanwhile, because the upper stent 111 is designed to be flexible, it is assembled around the delivery tube 123 via an outer tube 127, which is also made of flexible material. Therefore, the upper stent 111 can move smoothly together with the delivery tube 123. The segmented gastric bypass stent delivery and release system 100 provided by this invention will not obstruct the smooth passage of the product through the patient's throat.

[0061] In summary, the segmented gastric bypass stent delivery and release system 100 provided by this invention features a separate design for the upper stent 111 and the lower stent 112, connected by a connecting rope 113. The upper stent 111 is placed inside the stomach, while the lower stent 112 is fixed to the duodenal bulb. Because the upper stent 111 and the lower stent 112 are connected by the connecting rope 113, food can smoothly reach the pylorus and flow into the lower stent 112 under any circumstances, eliminating concerns about gastric retention or obstruction and avoiding severe gastrointestinal reactions. The lower stent 112 of this invention has no anchors, preventing related bleeding and puncture ulcers. Because the upper stent 111 is placed inside the stomach and has sufficient strength, it effectively prevents the lower stent 112 from shifting. The lower stent 112 is designed to mimic the physiological structure of the duodenal bulb, ensuring uniform contact between the stent and all surfaces of the bulb, reducing the likelihood of pressure ulcers. Meanwhile, the delivery and release system of this invention is highly compatible with the segmented support 110, enabling separate assembly and storage of the segmented support 110. The lower support 112 retains the original dimensions of the storage tube 122, eliminating the difficulty of the storage tube 122 entering the throat. Simultaneously, the upper support 111 is assembled around the delivery tube 123 via a sleeve, allowing the upper support 111 to move smoothly together with the delivery tube 123. A rope groove 1221 is provided on the storage tube 122, allowing the connecting rope 113 of the segmented support 110 to pass through. This invention changes the traditional support release method, first releasing the upper support 111 by pulling the sleeve, and then precisely releasing the lower support 112 at the pylorus, resulting in better delivery and release effects.

[0062] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0063] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A segmented gastric bypass stent delivery and release system, characterized in that, It includes a segmented support structure and a conveying and releasing mechanism; The segmented support includes an upper support, a lower support, a connecting rope, and a membrane tube. The upper support and the lower support are connected by the connecting rope, and the end of the lower support away from the upper support is connected to the membrane tube. The delivery and release mechanism includes a release ball, a receiving tube, a conveying tube, and a driving mechanism for releasing the release ball. The cylindrical end of the release ball is located at the end of the receiving tube, and the side wall of the receiving tube has a through-hole for passing through the rope along its axis. The two ends of the conveying tube are fixedly connected between the receiving tube and the driving mechanism. An outer tube is movably sleeved on the conveying tube, and an installation cavity for installing the upper bracket is formed between the conveying tube and the outer tube. The lower support and the membrane tube are both housed in the receiving tube. The membrane tube is connected to the release ball. The connecting rope is led out from the rope groove. The upper support is housed in the gap between the conveying tube and the outer tube.

2. The segmented gastric bypass stent delivery and release system according to claim 1, characterized in that, The upper support is teardrop-shaped and includes a top, a middle and a bottom. The top and the bottom are both open and internally connected. The diameter of the top is smaller than the maximum diameter of the middle and larger than the minimum diameter of the middle. The diameter of the bottom is equal to the minimum diameter of the middle. The diameter of the middle first increases and then decreases along the direction from the top to the bottom.

3. The segmented gastric bypass stent delivery and release system according to claim 2, characterized in that, The maximum diameter of the middle section is 50-90 mm; And / or, the height of the upper bracket is 55-100mm; And / or, the top opening size is 35-65mm, and the bottom opening size is greater than 16mm.

4. The segmented gastric bypass stent delivery and release system according to any one of claims 1-3, characterized in that, The upper support is a mesh support; And / or, both the inner and outer surfaces of the upper support are provided with a silicone film.

5. The segmented gastric bypass stent delivery and release system according to claim 1, characterized in that, The connecting rope includes a first skeleton rope, an intermediate extension rope, and a second skeleton rope. The first skeleton rope consists of multiple ropes, one end of which is evenly connected to the edge of the upper support. The other ends of the first skeleton rope converge at a point and are connected to one end of the intermediate extension rope. The second skeleton rope consists of multiple ropes, one end of which is evenly connected to the edge of the lower support. The other ends of the second skeleton rope converge at a point and are connected to the other end of the intermediate extension rope. And / or, the surface of the connecting rope is coated with a silicone film; And / or, the connecting rope is made of polymer material or metal material.

6. The segmented gastric bypass stent delivery and release system according to claim 1, characterized in that, The lower support is provided with a reinforcing rib at one end of the circumference near the connecting rope; And / or, the lower support is a mesh structure; And / or, the diameter of the lower support is 35mm-65mm.

7. The segmented gastric bypass stent delivery and release system according to claim 1, characterized in that, The outer sleeve includes a receiving section, a transition section, and an operating section. The receiving section forms the mounting cavity with the conveying tube. The two ends of the transition section are connected to the receiving section and the operating section, respectively. The diameter of the transition section gradually decreases along the direction from the receiving section to the operating section.

8. The segmented gastric bypass stent delivery and release system according to claim 7, characterized in that, The axial sidewall of the operating section is provided with a take-out groove to facilitate the operation section's separation from the conveying pipe, and the cross-section of the operating section is C-shaped.

9. The segmented gastric bypass stent delivery and release system according to claim 1, characterized in that, The storage tube is provided with a support push block for pushing the lower support; the driving mechanism includes a handle, a single-cavity tube and a handle. The handle is fixedly connected to the end of the transmission tube away from the storage tube. One end of the single-cavity tube is connected to the handle, and the other end passes through the handle and the transmission tube in sequence and extends into the storage tube to be connected to the support push block for pushing the support push block to move in the storage tube. And / or, a connecting cap is connected to one end of the receiving tube, and the other end of the connecting cap is fixedly connected to the conveying tube.

10. The segmented gastric bypass stent delivery and release system according to claim 9, characterized in that, The delivery and release mechanism also includes an unlocking line. The handle is equipped with a knob. One end of the unlocking line is connected to the release ball, and the other end is wrapped around the end of the handle and fixed by the knob.

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