Delivery catheter and implant delivery system

By designing a delivery catheter with a special structure, the problems of axial movement and stability of the bulbar dilatation valve during delivery and release were solved, achieving stable deployment and safe release of the artificial valve and reducing the risk of damage to the delivery system.

CN223773905UActive Publication Date: 2026-01-09JIANGSU TRULIVE MEDTECH CO LTD
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Patent Information

Application Number
CN202323104899.5
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2023-11-16
Publication Date
2026-01-09
Estimated Expiration
2033-11-16

AI Technical Summary

Technical Problem

In existing balloon dilation valve replacement techniques, the artificial valve may experience axial movement during delivery and release, leading to risks such as incomplete release, asymmetrical expansion, or damage to the delivery system.

Method used

A delivery catheter was designed, including a catheter, a guidewire lumen, a proximal support, a distal support, a balloon body, and a distal structure. Through the special design of the proximal and distal supports, the implant is ensured to be axially limited during delivery to avoid movement, and the risk of balloon body rupture is reduced by the combination of elastic elements and materials with different stiffnesses.

Benefits of technology

This effectively prevents the implant from shifting axially in the delivery system, ensuring the stable deployment and release of the artificial valve, reducing the risk of damage to the delivery system, and improving the accuracy and safety of the release process.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model provides a delivery catheter and implant delivery system.The delivery catheter comprises a catheter body, a guide wire cavity tube, a near-end supporting piece, a far-end supporting piece, a balloon body and a far-end structure, the guide wire cavity tube is arranged in the catheter body in a penetrating mode, the far end of the guide wire cavity tube extends out of the far end of the catheter body, the near-end supporting piece is arranged at the far-end end of the catheter body, and the balloon body is arranged in the far-end structure. The near-end supporting piece is arranged at the near-end part of the guide wire cavity tube, the far-end structure is arranged at the far-end part of the far-end supporting piece, the balloon body is arranged on the outer sides of the near-end supporting piece, the far-end supporting piece and the far-end structure in a sleeving manner, and the implant is arranged on the balloon body and is axially limited between the near-end supporting piece and the far-end supporting piece in the conveying process; the wall thickness of the near-end supporting piece at the far-end end is the thickest, and / or the wall thickness of the far-end supporting piece at the near-end end is the thickest, so that the near-end supporting piece can better abut against an implant, and axial movement and even movement of the implant are avoided.
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Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a delivery catheter and implant delivery system. Background Technology

[0002] Heart valves are membranous structures in the organs of humans and some animals that can open and close. Each person's heart has four valves: the aortic valve (connecting the left ventricle and aorta), the pulmonary valve (connecting the right ventricle and pulmonary artery), the mitral valve (connecting the left atrium and left ventricle), and the tricuspid valve (connecting the right atrium and right ventricle). These heart valves act as one-way valves, maintaining a specific direction of blood flow throughout the body to establish effective blood circulation. However, due to congenital factors, inflammation, or degenerative aging, these heart valves can fail, leading to circulatory disorders, severe cardiovascular and organ damage, and even death. Currently, the most effective treatment in medicine is surgical repair or replacement of the valves using the patient's own tissue. Traditional surgical valve repair is highly invasive, requiring a long recovery period and increasing the risk of complications. Interventional valve surgery, which uses major blood vessels in the body as delivery channels, can implant valve repair materials or artificial heart valve replacements into the location of the autologous valve with less invasiveness to achieve the therapeutic effect.

[0003] Transcatheter aortic valve replacement (TAVR) is a novel minimally invasive valve replacement technique developed internationally in recent years. Its principle involves loading a prosthetic valve into a delivery system and delivering it into the body via a catheter to replace the degenerated original valve, thereby improving the patient's heart function. This technique can treat valvular disease without open-chest surgery and without stopping the heart, eliminating the significant trauma caused by traditional open-chest surgery and cardiac arrest. Currently, the prosthetic valves used in common transcatheter aortic replacement surgery (TAVR) are mainly divided into two categories: self-expanding valves and balloon-expanding valves. Both types require pre-loading into the delivery system through compression before intervention. During release, self-expanding valves utilize the phase change of a special metal (such as nickel-titanium) stent material at different temperatures to automatically expand and replace the original valve. Balloon-expanding valves, on the other hand, use balloons or other expansion tools to expand the prosthetic valve with external force to replace the original valve.

[0004] Compared to self-expanding valves, bulbar expansion valves offer better radial support and roundness after deployment. However, because external force is required for deployment, the delivery system demands stricter control to ensure proper integration with the artificial valve. While bulbar expansion valve replacement technology is rapidly advancing, challenges remain in the design of delivery systems. For example, the accuracy and stability of the artificial valve during delivery and deployment. Current designs may experience axial movement of the artificial valve within the delivery system during transport and deployment, potentially leading to incomplete or asymmetrical deployment, damage to the delivery system, or even valve expulsion during deployment. Utility Model Content

[0005] The purpose of this invention is to provide a delivery catheter and implant delivery system, which helps to solve the risks of implant movement along the axial direction of the delivery system and the risks during implant deployment when the implant is delivered and released.

[0006] To address the aforementioned problems, this utility model provides a delivery catheter, comprising a catheter, a guidewire lumen, a proximal support, a distal support, a balloon body, and a distal structure. The guidewire lumen is inserted within the catheter, with its distal end extending beyond the distal end of the catheter. The proximal support is disposed at the distal end of the catheter, the distal support is disposed at the distal end of the guidewire lumen, and the distal structure is disposed at the distal end of the distal support. The balloon body is fitted over the proximal support, the distal support, and the distal structure. An implant is positioned on the balloon body and axially positioned between the proximal and distal support during delivery. The proximal support has the thickest wall at its distal end, and / or the distal support has the thickest wall at its proximal end.

[0007] Optionally, both the proximal support and the distal support are tubular structures with openings at both ends, and the proximal end of the proximal support is connected to the conduit.

[0008] Furthermore, the outer diameter of the proximal support remains constant from the proximal end to the distal end, then gradually increases, while the inner diameter of the proximal support remains constant from the proximal end to the distal end; and / or,

[0009] The outer diameter of the distal support remains constant from the distal end to the proximal end, and then gradually increases, while the inner diameter of the distal support remains constant from the distal end to the proximal end.

[0010] Furthermore, the outer diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases, and finally tends to remain constant; the inner diameter of the proximal support remains constant from the proximal end to the distal end; and / or,

[0011] The outer diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases, and finally tends to remain constant. The inner diameter of the distal support remains constant from the distal end to the proximal end.

[0012] Furthermore, the outer diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and then gradually increases a second time. The inner diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases during the second increase in outer diameter. The slope of the outer diameter during the first increase is greater than or equal to the slope during the second increase, and the slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the increase; and / or,

[0013] The outer diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases for the first time, and then gradually increases for the second time. The inner diameter of the distal support remains constant from the distal end to the proximal end, and gradually increases in the area where the outer diameter increases for the second time. The slope of the outer diameter during the first increase is greater than or equal to the slope of the outer diameter during the second increase, and the slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the increase.

[0014] Furthermore, the outer diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and then gradually increases again. Similarly, the inner diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and then gradually increases again. The slope of the outer diameter during the first increase is greater than or equal to the slope of the outer diameter during the second increase, the slope of the outer diameter during the first increase is greater than the slope of the inner diameter during the first increase, and the slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the second increase; and / or,

[0015] The outer diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases for the first time, and then gradually increases for the second time. The inner diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases for the first time, and then gradually increases for the second time. The slope of the outer diameter during the first increase is greater than or equal to the slope of the outer diameter during the second increase. The slope of the outer diameter during the first increase is greater than the slope of the inner diameter during the first increase. The slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the second increase.

[0016] Among them, in the proximal support and the distal support, the region where the outer diameter remains unchanged and the region where the inner diameter remains unchanged are located in the same region along the radial direction, the region where the outer diameter increases for the first time and the region where the inner diameter increases for the first time are located in the same region along the radial direction, and the region where the outer diameter increases for the second time and the region where the inner diameter increases for the second time are located in the same region along the radial direction.

[0017] Furthermore, both the proximal support and the distal support are elastic elements.

[0018] Furthermore, both the proximal support and the distal support are divided into a proximal portion and a distal portion from the proximal end to the distal end. The proximal and distal portions of the proximal support are made of different materials, and the stiffness of the proximal portion of the proximal support is greater than that of the distal portion of the proximal support. Similarly, the proximal and distal portions of the distal support are made of different materials, and the stiffness of the distal portion of the distal support is greater than that of the proximal portion of the distal support.

[0019] Furthermore, a number of first recesses are provided on the outer peripheral surface of the proximal support member, which are evenly distributed in the circumferential direction, and each of the first recesses extends in the axial direction; a number of second recesses are provided on the outer peripheral surface of the distal support member, which are evenly distributed in the circumferential direction, and each of the second recesses extends in the axial direction.

[0020] Furthermore, at least one flow channel is provided on the outer peripheral wall of both the proximal support and the distal support. The flow channel on the proximal support penetrates the outer peripheral wall of the proximal support, and the flow channel on the distal support penetrates the outer peripheral wall of the distal support. All the flow channels of the proximal support are evenly distributed circumferentially on the outer peripheral surface of the proximal support, and all the flow channels of the distal support are evenly distributed circumferentially on the outer peripheral surface of the distal support.

[0021] On the other hand, this invention provides an implant delivery system, including the aforementioned delivery catheter.

[0022] Compared with the prior art, the present invention has at least the following beneficial effects:

[0023] 1. By having the thickest wall at the distal end of the proximal support and / or the thickest wall at the proximal end of the distal support, the implant can be better supported, preventing axial movement or even displacement of the implant.

[0024] 2. Both the proximal and distal support components are elastic components, which is beneficial for assembling the balloon body.

[0025] 3. The proximal and distal portions of the proximal support are made of different materials, and the stiffness of the proximal portion of the proximal support is greater than that of the distal portion of the proximal support. The proximal and distal portions of the distal support are made of different materials, and the stiffness of the distal portion of the distal support is greater than that of the proximal portion of the distal support. This reduces the contact force between the proximal and distal supports on the balloon body, effectively preventing rupture. Attached Figure Description

[0026] Figures 1a-1c This is a schematic diagram of the structure of a delivery catheter according to an embodiment of the present invention;

[0027] Figures 2a-2d This is a partial structural schematic diagram of a delivery catheter according to an embodiment of the present invention;

[0028] Figure 3 This is a schematic diagram of the structure of an inflatable balloon provided in an embodiment of the present invention.

[0029] Explanation of reference numerals in the attached figures:

[0030] 1-Delivery catheter; 10-Artificial valve; 110-Proximal support; 111, 1211-Flow channel; 112, 1212-Recess; 121-Distal support; 122-Connector; 123-Conical tip; 130-Inflatable balloon; 131-First segment; 132-Second segment; 133-Third segment; 134-Groographed strip; 1341-Groograph; 140-Balloon body; 210-Guidewire lumen; 220-Catheter. Detailed Implementation

[0031] The following is a further detailed description of a delivery catheter and implant delivery system according to the present invention. The present invention will now be described in more detail with reference to the accompanying drawings, which illustrate preferred embodiments of the present invention. It should be understood that those skilled in the art can modify the present invention described herein while still achieving its advantageous effects. Therefore, the following description should be understood as being of general knowledge to those skilled in the art and is not intended to limit the present invention.

[0032] For clarity, not all features of the actual embodiments are described. In the following description, well-known functions and structures are not detailed in detail, as they would confuse the present invention with unnecessary detail. It should be understood that in the development of any actual embodiment, numerous implementation details must be made to achieve the developer's specific goals, such as changes from one embodiment to another according to limitations related to the system or business. Furthermore, it should be understood that such development work may be complex and time-consuming, but is merely routine work for those skilled in the art.

[0033] To make the objectives and features of this utility model clearer and easier to understand, the specific embodiments of this utility model will be further described below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise ratios, and are only used to facilitate and clearly illustrate the purpose of the embodiments of this utility model. In this document, the term "or" is generally used to include the meaning of "and / or" unless otherwise expressly stated. The terms "inner," "outer," and similar expressions used herein are for illustrative purposes only and do not represent the only possible embodiments. In this document, the terms "distal" and "proximal" refer to the relative orientation, position, or direction of elements or actions relative to each other from the perspective of the physician using the medical device. Although "distal" and "proximal" are not restrictive, "proximal" generally refers to the end of the medical device closer to the operator during normal operation, and "distal" generally refers to the end closer to the patient's heart.

[0034] like Figures 1a-1c As shown, this embodiment provides an implant delivery system, which includes a delivery catheter. The implant delivery system is used to deliver implants, and the implants include artificial valves, specifically, for example, bulbar valves.

[0035] The delivery catheter 2201 includes a catheter 220, a guidewire lumen 210, a proximal support 110, a distal support 121, a balloon body 140, and a distal structure. The guidewire lumen is inserted into the catheter, with its distal end extending beyond the distal end of the catheter. The proximal support 110 is located at the distal end of the catheter 220, the distal support 121 is located at the distal end of the guidewire lumen 210, and the distal structure is located at the distal end of the distal support 121. The balloon body 140... The 0 is sleeved on the outside of the proximal support 110, the distal support 121 and the distal structure, and sleeved on the guide wire lumen between the proximal support 110 and the distal support 121. The implant is placed on the balloon body 140 and is axially limited between the proximal support 110 and the distal support 121 during delivery. The wall thickness of the proximal support 110 is the thickest at the distal end, and / or the wall thickness of the distal support 121 is the thickest at the proximal end.

[0036] In this embodiment, the proximal support 110 has the thickest wall at the distal end, and the distal support 121 has the thickest wall at the proximal end, which can better support the implant and prevent axial movement or even displacement of the implant.

[0037] The diameter of the guidewire lumen 210 is smaller than that of the catheter 220, allowing filling fluid to flow in from the proximal end of the catheter 220 outside the guidewire lumen 210 and out from the distal end. The proximal support 110 can be fixedly connected to the catheter 220 by welding, bonding, or integral injection molding.

[0038] like Figures 2a-2c As shown, both the proximal support 110 and the distal support 121 are tubular structures with openings at both ends, so that the proximal end of the proximal support 110 is connected to the conduit 220. At least one flow channel is provided on the outer peripheral surface of both the proximal support 110 and the distal support 121. The flow channel 111 on the proximal support 110 penetrates the outer peripheral wall of the proximal support 110, allowing the internal and external environments of the proximal support 110 to communicate. The flow channel 1211 on the distal support 121 penetrates the outer peripheral wall of the distal support 121, allowing the internal and external environments of the distal support 121 to communicate. Thus, after the filling fluid flows in from the proximal end of the conduit 220, it first flows in from the proximal end of the proximal support 110 and flows out from the distal port of the proximal support 110 and the flow channel 111 of the proximal support 110 to the proximal end of the balloon body 140, and then flows in from the proximal end of the distal support 121 to the distal support 121, and finally flows out from the flow channel 1211 of the distal support 121 to the distal end of the balloon body 140.

[0039] All the flow channels 111 of the proximal support 110 are evenly distributed circumferentially on the outer peripheral surface of the proximal support 110, so that the filling fluid can flow into the proximal end of the balloon body 140 evenly in the radial direction; all the flow channels 1211 of the distal support 121 are evenly distributed circumferentially on the outer peripheral surface of the distal support 121, so that the filling fluid can flow into the distal end of the balloon body 140 evenly in the radial direction, thereby allowing the filling fluid to evenly inflate the balloon body 140.

[0040] Among them, the flow channels 111 and 1211 can be through holes, slots, or other conventional shapes, and there are no restrictions here.

[0041] like Figure 2a As shown, in the first embodiment, the outer diameter of the proximal support 110 remains constant from the proximal end to the distal end and then gradually increases, while the inner diameter of the proximal support 110 remains constant from the proximal end to the distal end, which makes the wall thickness of the proximal support 110 the thickest at the distal end; and / or, the outer diameter of the distal support 121 remains constant from the distal end to the proximal end and then gradually increases, while the inner diameter of the distal support 121 remains constant from the distal end to the proximal end, which makes the wall thickness of the distal support 121 the thickest at the proximal end.

[0042] like Figure 2bAs shown, in the second embodiment, the outer diameter of the proximal support 110 remains constant from the proximal end to the distal end, then gradually increases, and finally tends to remain constant. The inner diameter of the proximal support 110 remains constant from the proximal end to the distal end, which makes the wall thickness of the proximal support 110 the thickest at the distal end. And / or, the outer diameter of the distal support 121 remains constant from the distal end to the proximal end, then gradually increases, and finally tends to remain constant. The inner diameter of the distal support 121 remains constant from the distal end to the proximal end, which makes the wall thickness of the distal support 121 the thickest at the proximal end.

[0043] like Figure 2c As shown, in the third embodiment, the outer diameter of the proximal support 110 remains constant from the proximal end to the distal end, then gradually increases for the first time, and finally gradually increases for the second time. The inner diameter of the proximal support 110 remains constant from the proximal end to the distal end, and gradually increases in the region where the outer diameter increases for the second time. The slope of the outer diameter during the first increase is greater than or equal to the slope during the second increase, and the slope during the second increase is greater than the slope during the increase of the inner diameter. This results in the proximal support 110 having the thickest wall at the distal end. And / or, the outer diameter of the distal support 121 remains constant from the distal end to the proximal end, then gradually increases for the first time, and finally gradually increases for the second time. The inner diameter of the distal support 121 remains constant from the distal end to the proximal end, and gradually increases in the region where the outer diameter increases for the second time. The slope of the outer diameter during the first increase is greater than or equal to the slope during the second increase, and the slope during the second increase is greater than the slope during the increase of the inner diameter. This results in the proximal support 110 having the thickest wall at the distal end. Preferably, the flow channels on the proximal support 110 are distributed in the region of increased inner diameter, and the flow channels on the distal support 121 are distributed in the region of increased inner diameter.

[0044] In the fourth embodiment, the outer diameter of the proximal support 110 initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and finally gradually increases for the second time. Similarly, the inner diameter of the proximal support 110 initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and finally gradually increases for the second time. The regions where the outer diameter and inner diameter remain constant are located radially in the same area. The regions where the outer diameter increases for the first time are located radially in the same area as the regions where the inner diameter increases for the first time, and the regions where the outer diameter increases for the second time are located radially in the same area. Furthermore, the slope of the outer diameter during the first increase is greater than or equal to the slope during the second increase, and the slope of the outer diameter during the first increase is greater than the slope of the inner diameter during the first increase. This results in a wall thickness of the proximal support 110 at the distal end. The thickest part of the wall is located at the distal end of the proximal support 110. The outer diameter of the distal support 121 remains constant from the distal end to the proximal end, then gradually increases for the first time, and finally gradually increases for the second time. The inner diameter of the distal support 121 also remains constant from the distal end to the proximal end, then gradually increases for the first time, and finally gradually increases for the second time. The region where the outer diameter remains constant and the region where the inner diameter remains constant are located radially in the same region. The region where the outer diameter increases for the first time and the region where the inner diameter increases for the first time are located radially in the same region. The region where the outer diameter increases for the second time and the region where the inner diameter increases for the second time are located radially in the same region. Furthermore, the slope of the outer diameter during the first increase is greater than or equal to the slope of the outer diameter during the second increase, the slope of the outer diameter during the first increase is greater than the slope of the inner diameter during the first increase, and the slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the second increase. This results in the proximal support 110 having the thickest wall at the distal end.

[0045] Optionally, both the proximal support 110 and the distal support 121 are elastic components, which facilitates the assembly of the balloon body 140. For example, materials with a certain degree of elasticity can be used, such as... Figure 2d As shown, a number of recesses 112 are provided on the outer peripheral surface of the proximal support 110, which are evenly distributed along the circumference and each recess 112 extends along the axial direction; a number of recesses 1212 are provided on the outer peripheral surface of the distal support 121, which are evenly distributed along the circumference and each recess 1212 extends along the axial direction.

[0046] Before inflation, the balloon body 140 is subjected to significant pressure from the implant. Due to the compression of the implant, the balloon contacts the distal ends of the proximal support 110 and the proximal ends of the distal support 121. When the balloon body 140 begins to inflate, it experiences significant contact forces from both ends of the implant at this location, making it prone to rupture. Therefore, preferably, the proximal support 110 is divided into a proximal portion and a distal portion, with the stiffness of the proximal portion differing from that of the distal portion. Furthermore, the proximal portion of the proximal support 110 utilizes a high-stiffness elastic material, while the distal portion uses a low-stiffness elastic material, resulting in a greater stiffness in the proximal portion than in the distal portion. Similarly, the distal support 121 is divided into a proximal portion. The stiffness of the proximal portion of the distal support 121 differs from that of the distal portion of the proximal support 110. Furthermore, the distal portion of the distal support 121 uses a high-stiffness elastic material, while the proximal portion uses a low-stiffness elastic material. This results in the distal portion of the distal support 121 having a higher stiffness than its proximal portion. Consequently, the contact force between the proximal support 110 and the distal support 121 on the balloon body 140 is reduced, effectively preventing rupture.

[0047] In this embodiment, the structures of the proximal support 110 and the distal support 121 can be completely the same or not exactly the same. For example, the proximal support 110 and the distal support 121 may have different shapes. Specifically, the proximal support 110 may adopt a different shape than the distal support 121. Figure 2a The tubular structure shown has a distal support member 121 made of, for example Figure 2b The tubular structure shown, or the shape and / or size of the flow channel 111 of the proximal support 110 is different from the shape and / or size of the flow channel 1211 of the distal support 121; or the materials of the proximal support 110 and the distal support 121 are different.

[0048] The distal structure includes a connecting portion 122 and a conical head 123 connected sequentially from proximal to distal. The proximal end of the connecting portion 122 is connected to the distal end of the distal support 121, and the distal end of the connecting portion 122 is connected to the proximal end of the conical head 123. The diameter of the conical head 123 gradually decreases from proximal to distal to facilitate the delivery of the catheter 2201 into the blood vessel. The proximal end of the balloon body is fixed to the outer wall of the catheter, and the distal end of the balloon body is fixed to the outer wall of the distal structure. Preferably, the distal end of the balloon body 140 is fixed to the outer wall of the proximal end of the conical head 123. The conical head 123 has an axially oriented lumen. Both the distal support 121 and the connecting part 122 can be tubular structures with openings at both ends. The outer diameter of the connecting part 122 is smaller than the outer diameter of the distal support 121, and the inner diameter of the connecting part 122 is smaller than the inner diameter of the distal support 121 and slightly larger than the outer diameter of the guidewire lumen 210. The outer surface of the guidewire lumen 210 is bonded to the inner surface of the connecting part 122 and ends at the distal end of the connecting part 122. The guidewire lumen 210 is coaxially arranged with the inner lumen so that the guidewire can pass through smoothly.

[0049] Optionally, the delivery catheter 220 also includes an inflatable balloon 130, which is fitted over the outside of the guidewire lumen 210. The proximal end of the inflatable balloon 130 passes through the proximal support 110, and the distal end of the inflatable balloon 130 passes through the distal structure. The distal end of the inflatable balloon 130 is fixedly connected to the distal outer wall of the guidewire lumen 210 by welding, bonding, or other means to seal the inflatable balloon 130 at the distal end of the distal structure. The proximal end of the inflatable balloon 130 can pass through the catheter 220, and the proximal end of the inflatable balloon 130 is fixedly connected to the distal inner wall of the catheter 220 by welding, bonding, or anchoring, so that the filling fluid entering the catheter 220 can enter the proximal end of the inflatable balloon 130 through the flow channel 111 of the proximal support 110 and flow to the distal end.

[0050] The inflatable balloon 130 can be elongated, specifically, for example, cylindrical, gourd-shaped, or cuboid, and the axial direction of the inflatable balloon 130 is the same as the axial direction of the second guidewire lumen 210. Preferably, the inflatable balloon 130 is cylindrical. The inflatable balloon 130 can be made of polymer materials, such as PA, PE, PP, PEBAX, or silicone. Preferably, the inflatable balloon 130 is made of PA material.

[0051] like Figure 3 As shown, the inflatable balloon 130 includes a first segment 131, a second segment 132, and a third segment 133 connected sequentially from proximal to distal. The second segment 132 is located between the proximal support 110 and the distal support 121. The first segment 131 passes through the proximal support 110, and the third segment 133 passes through the distal structure. Please refer to [link / reference]. Figure 1aIn the constricted state (i.e., without inflatable fluid), the artificial valve 10 is fitted against the outside of the proximal support 110, the distal support 121, the distal structure, and the second segment 132, thus maintaining the surface shape of the proximal support 110, the distal structure, and the second segment 132. The artificial valve 10 is fitted over the balloon body 140 of the second segment 132. Since the diameters of the proximal support 110 and the distal support 121 are both larger than the diameter of the inflatable balloon 130, the compressed artificial valve 10 can be stably embedded in the second segment 132 between the proximal support 110 and the distal support 121, thereby axially limiting the artificial valve 10 between the proximal support 110 and the distal support 121 and preventing axial movement of the artificial valve 10 during delivery and release.

[0052] Both the first segment 131 and the third segment 133 have at least one groove 134 on their outer walls of the inflatable balloon 130. Preferably, both segments 131 and 133 have 2 to 6 grooves 134 on their outer walls. All grooves 134 in the first segment 131 are located radially inside all flow channels 111 of the proximal support 110, and all grooves 134 in the third segment 133 are located radially inside all flow channels 1211 of the distal support 121. All grooves 134 in the first segment 131 and all grooves 134 in the third segment 133 are evenly distributed circumferentially, and the axial direction of the grooves 134 is the same as the axial direction of the inflatable balloon 130.

[0053] Each grooved strip 134 includes at least one groove 1341. All grooves 1341 of each grooved strip 134 are spaced apart, and the spacing between adjacent grooves 1341 is small enough that the inflation process can connect adjacent grooves 1341 of each grooved strip 134. The thickness of the bottom of the groove 1341 is smaller than the thickness of the inflation balloon 130, making the inflation balloon 130 easily rupture under the impact of a large pressure inflation fluid. This allows the internal and external environments of the inflation balloon 130 to be interconnected, so that when the artificial valve 10 is released, it can form a microstructure to slightly expand the valve, thereby connecting the proximal and distal internal environments of the balloon body 140. This allows for simultaneous inflation of the proximal and distal ends of the balloon body 140, preventing the artificial valve 10 from dislodging due to sequential inflation of the proximal and distal ends of the balloon body 140. The groove 1341 can be formed by laser etching, chemical etching or physical etching, etc.; the groove 1341 can be a regular shape such as a circular groove or a square groove.

[0054] When using it, firstly, as Figure 1aAs shown, the artificial valve 10 is pressed onto the balloon body 140 by external force. At this time, the balloon body 140 is in a contracted state, and there is no filling fluid in the inflated balloon 130 (i.e., a non-inflated state). Therefore, the artificial valve 10 is in a fully compressed state and is fitted to the outside of the balloon structure. The artificial valve 10 is axially limited between the proximal support 110 and the distal structure. The wall thickness of the proximal support 110 is the thickest at the distal end, and the wall thickness of the distal support 121 is the thickest at the proximal end, avoiding the risk of axial movement or even displacement of the artificial valve 10 in the axial direction of the delivery system during delivery and release. Then, as... Figures 1b-1c As shown, filling fluid is introduced from the proximal end of catheter 220 at a lower pressure. After passing through catheter 220, the filling fluid enters the balloon body 140 evenly through the flow channels of proximal support 110 and distal support 121. At this time, because the stiffness of the distal part and the proximal part of proximal support 110 are different, and the stiffness of the distal part is less than that of the proximal part, and the stiffness of the distal part and the proximal part of distal support 121 are different, and the stiffness of the proximal part is less than that of the distal part, the balloon body 140 is prevented from rupturing.

[0055] In summary, this utility model provides a delivery catheter and implant delivery system. The delivery catheter includes a catheter, a guidewire lumen, a proximal support, a distal support, a balloon body, and a distal structure. The guidewire lumen is inserted into the catheter, with its distal end extending beyond the distal end of the catheter. The proximal support is disposed at the distal end of the catheter, the distal support is disposed at the distal end of the guidewire lumen, and the distal structure is disposed at the distal end of the distal support. The balloon body is sleeved on the outside of the proximal support, the distal support, and the distal structure. The implant is disposed on the balloon body and is axially positioned between the proximal and distal support during delivery. The proximal support has the thickest wall at its distal end, and / or the distal support has the thickest wall at its proximal end. This invention utilizes a proximal support with the thickest wall at the distal end and a distal support with the thickest wall at the proximal end, which provides better support against the implant and prevents axial movement or even displacement of the implant. Both the proximal and distal supports are elastic components, facilitating balloon assembly. The proximal and distal portions of the proximal support are made of different materials, and the stiffness of the proximal portion is greater than that of the distal portion. Similarly, the distal portion of the distal support is made of different materials and has greater stiffness than that of the proximal portion. This reduces the contact force exerted on the balloon by the proximal and distal supports, effectively preventing rupture.

[0056] Furthermore, it should be noted that, unless otherwise specified or indicated, the terms "first" and "second" in the specification are used only to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical or sequential relationships between the various components, elements, steps, etc.

[0057] It is understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the present invention without departing from the scope of the present invention, or equivalent embodiments can be modified based on the disclosed technical content. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A delivery catheter, characterized in that, The device includes a catheter, a guidewire lumen, a proximal support, a distal support, a balloon body, and a distal structure. The guidewire lumen is inserted within the catheter, with its distal end extending beyond the distal end of the catheter. The proximal support is located at the distal end of the catheter, the distal support is located at the distal end of the guidewire lumen, and the distal structure is located at the distal end of the distal support. The balloon body is fitted over the proximal support, distal support, and distal structure. An implant is positioned on the balloon body and axially positioned between the proximal and distal support during delivery. The proximal support has the thickest wall at its distal end, and / or the distal support has the thickest wall at its proximal end.

2. The delivery catheter as claimed in claim 1, characterized in that, Both the proximal support and the distal support are tubular structures with openings at both ends, and the proximal end of the proximal support is connected to the conduit.

3. The delivery catheter as described in claim 2, characterized in that, The outer diameter of the proximal support remains constant from the proximal end to the distal end, then gradually increases; the inner diameter of the proximal support remains constant from the proximal end to the distal end; and / or, The outer diameter of the distal support remains constant from the distal end to the proximal end, and then gradually increases, while the inner diameter of the distal support remains constant from the distal end to the proximal end.

4. The delivery catheter as claimed in claim 2, characterized in that, The outer diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases, and finally tends to remain constant; the inner diameter of the proximal support remains constant from the proximal end to the distal end; and / or, The outer diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases, and finally tends to remain constant. The inner diameter of the distal support remains constant from the distal end to the proximal end.

5. The delivery catheter as claimed in claim 2, characterized in that, The outer diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and then gradually increases again. The inner diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases during the second increase in outer diameter. The slope of the outer diameter during the first increase is greater than or equal to the slope during the second increase, and the slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the increase; and / or, The outer diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases for the first time, and then gradually increases for the second time. The inner diameter of the distal support remains constant from the distal end to the proximal end, and gradually increases in the area where the outer diameter increases for the second time. The slope of the outer diameter during the first increase is greater than or equal to the slope of the outer diameter during the second increase, and the slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the increase.

6. The delivery catheter as claimed in claim 2, characterized in that, The outer diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and then gradually increases again. Similarly, the inner diameter of the proximal support initially remains constant from the proximal end to the distal end, then gradually increases for the first time, and then gradually increases again. Furthermore, the slope of the outer diameter during the first increase is greater than or equal to the slope of the outer diameter during the second increase, the slope of the outer diameter during the first increase is greater than the slope of the inner diameter during the first increase, and the slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the second increase; and / or, The outer diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases for the first time, and then gradually increases for the second time. The inner diameter of the distal support remains constant from the distal end to the proximal end, then gradually increases for the first time, and then gradually increases for the second time. The slope of the outer diameter during the first increase is greater than or equal to the slope of the outer diameter during the second increase. The slope of the outer diameter during the first increase is greater than the slope of the inner diameter during the first increase. The slope of the outer diameter during the second increase is greater than the slope of the inner diameter during the second increase. Among them, in the proximal support and the distal support, the region where the outer diameter remains unchanged and the region where the inner diameter remains unchanged are located in the same region along the radial direction, the region where the outer diameter increases for the first time and the region where the inner diameter increases for the first time are located in the same region along the radial direction, and the region where the outer diameter increases for the second time and the region where the inner diameter increases for the second time are located in the same region along the radial direction.

7. The delivery catheter as claimed in claim 2, characterized in that, Both the proximal support and the distal support are elastic components.

8. The delivery catheter as claimed in claim 7, characterized in that, Both the proximal support and the distal support are divided into a proximal portion and a distal portion from the proximal end to the distal end. The proximal and distal portions of the proximal support are made of different materials, and the stiffness of the proximal portion of the proximal support is greater than that of the distal portion of the proximal support. Similarly, the proximal and distal portions of the distal support are made of different materials, and the stiffness of the distal portion of the distal support is greater than that of the proximal portion of the distal support.

9. The delivery catheter as claimed in claim 2, characterized in that, A plurality of first recesses are provided on the outer peripheral surface of the proximal support member, which are evenly distributed in the circumferential direction, and each of the first recesses extends in the axial direction; a plurality of second recesses are provided on the outer peripheral surface of the distal support member, which are evenly distributed in the circumferential direction, and each of the second recesses extends in the axial direction.

10. The delivery catheter as claimed in claim 2, characterized in that, At least one flow channel is provided on the outer peripheral wall of both the proximal support and the distal support. The flow channel on the proximal support penetrates the outer peripheral wall of the proximal support, and the flow channel on the distal support penetrates the outer peripheral wall of the distal support. All the flow channels of the proximal support are evenly distributed circumferentially on the outer peripheral surface of the proximal support, and all the flow channels of the distal support are evenly distributed circumferentially on the outer peripheral surface of the distal support.

11. An implant delivery system, characterized in that, Includes the delivery catheter as described in any one of claims 1 to 10.