Delivery System for Artificial Heart Valve

Abstract

The present invention provides a delivery system for an artificial valve, comprising an outer tube, an inner tube, an inflatable balloon, a first stopper and a second stopper. Both the first stopper and the second stopper include a fixing portion and a stopping portion. The stopping portion is a circumferentially closed annular structure. The fixing portion is connected to the inner tube. A first fluid passage or a second fluid passage is provided on the side wall of the first stopper; a first fluid passage is provided on the side wall of the second stopper; the first fluid passage axially penetrates through the stopping portion in the inner tube; the second fluid passage axially penetrates from one end of the stopping portion of the first stopper away from the fixing portion to the end of its fixing portion away from the stopping portion in the inner tube; the ends of the two stopping portions can axially limit the artificial valve. The present invention can make the expansion medium flow more smoothly in the initial stage of the inflation of the inflatable balloon, which is beneficial to the rapid progress of interventional treatment and better prevents the axial displacement of the artificial valve during the inflation of the inflatable balloon.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a delivery system for an artificial valve. Background Art

[0002] The heart is an important organ of the human body, providing power for the blood circulation of the human body. The valves inside the heart control the blood flow direction and play a crucial role in ensuring sufficient blood supply flow through the cardiovascular system. When the autologous valve is damaged, it will cause serious cardiovascular damage and even death, and artificial heart valves can be used to treat heart valve diseases. Currently, the process of implanting a transcatheter interventional artificial heart valve into the body usually relies on a catheter interventional delivery system to deliver the artificial heart valve to a predetermined position for release.

[0003] The delivery system in the prior art includes an outer tube, an inner tube passing through the distal end of the outer tube, and an inflatable balloon located at the distal part of the inner tube. In order to prevent the artificial valve from shifting on the inflatable balloon during delivery, two stoppers are fixed on the inner tube. These two stoppers are located inside the inflatable balloon. One end of the inflatable balloon is fixed to the distal end of the outer tube, and the other end is fixed to the outer wall of the stopper at the distal end of the inner tube. When the delivery system is delivering, the inflatable balloon is in a contracted state, and the compressed artificial valve is installed on the outer periphery of the inflatable balloon and located between the two stoppers.

[0004] In the above delivery system, the diameters of the two stoppers need to be larger than the inner diameter of the artificial valve in the compressed state at the relative parts. Therefore, the radial dimensions of the two stoppers are relatively large. When the delivery system carries the artificial valve to the treatment position, the inflation medium flows into the proximal region of the inflatable balloon, and then flows to the middle region and the distal region. However, in the existing stopper structure, when the inflatable balloon is in a compressed state, the gap between its outer peripheral wall and the two stoppers is too small, so that the inflation medium can only make the proximal region of the inflatable balloon inflated relatively large first, and then can increase the gap between the stopper and the inflatable balloon, so that the inflation medium flows to the middle region and the distal region of the inflatable balloon. Obviously, the inflation interval time at each part of the inflatable balloon is too long, affecting the time of the entire interventional treatment; and the inflation method with a large interval time at each part may cause the artificial valve to be axially inclined relative to the inner tube during the inflation process of the inflatable balloon, because in some regions, especially the proximal region, it may expand to make the inner wall of the artificial valve located outside the stopper, while the distal region has not started to expand or the inflation medium has not reached yet. At this time, the proximal end of the artificial valve is not axially blocked by the stopper, and may be axially inclined relative to the inner tube as the proximal region of the inflatable balloon expands, resulting in possible axial displacement of the artificial valve, affecting the accurate position of the artificial valve placement and reducing the surgical quality and success rate. Summary of the Invention

[0005] Based on the above situation, the main object of the present invention is to provide a delivery system for an artificial valve to solve the problem of too slow flow of the inflation medium in the prior art.

[0006] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] The present invention provides a delivery system for an artificial valve, including an outer tube, an inner tube disposed inside the outer tube and extending from the distal end of the outer tube, an inflatable balloon, a first stopper and a second stopper located inside the inflatable balloon and fixed to the inner tube. One end of the inflatable balloon is installed in the distal region of the outer tube, and the other end is installed in the distal region of the inner tube; the first stopper is closer to the distal end of the outer tube than the second stopper;

[0008] A gap is left between the first stopper and the outer tube; both the first stopper and the second stopper include an axially arranged fixing portion and a stopping portion. The fixing portion has a cylindrical tubular structure and is inserted and connected to the inner tube; the stopping portion is located in the section where the first stopper and the second stopper are close to each other and has a circumferentially closed annular structure. The maximum radial dimension from at least the outer edge of the end of the stopping portion to the axis of the fixing portion is greater than the radius of the fixing portion;

[0009] The side wall of the first stopper is provided with a first fluid passage or a second fluid passage; the side wall of the second stopper is provided with a first fluid passage; wherein, the first fluid passage penetrates through the stopping portion in the axial direction of the inner tube; the second fluid passage penetrates from one end of the first stopper to the other end in the axial direction of the inner tube;

[0010] When the inflatable balloon is in a contracted state, the part of the inflatable balloon located between the two stopping portions and the two stopping portions enclose a receiving space for the artificial valve, so that when the artificial valve in a compressed state is located in the receiving space, the ends of the two stopping portions axially limit the artificial valve.

[0011] Preferably, the first stopper is provided with a first fluid passage; the stopping portion has a conical tubular structure, and the small end of the stopping portion is connected to the fixing portion; the first fluid passage penetrates from the inner wall surface to the outer wall surface of the stopping portion.

[0012] Preferably, the axis of the first fluid passage is parallel to the axis of the inner tube, or the end of the first fluid passage located on the inner wall surface is farther from the inner tube than the other end.

[0013] Preferably, the included angle between the axis of the first fluid passage and the axis of the inner tube is 0° to 30°.

[0014] Preferably, the stopping part has a straight cylindrical structure, the extending direction of the side wall of the stopping part is parallel to the axis of the stopping part, and there is a gap between the inner wall surface of the stopping part and the inner tube; the first fluid passage penetrates from one end surface of the stopping part far away from the fixing part to the other end surface.

[0015] Preferably, at least one of the first stopper and the second stopper further includes a connecting part in the shape of a conical tube, the large-diameter end of the connecting part is connected to the stopping part, and the small-diameter end is connected to the fixing part.

[0016] Preferably, the first stopper and the second stopper are provided with a plurality of fluid passages along their respective circumferences.

[0017] Preferably, the annular structure includes a plurality of convex structures arranged circumferentially, and the concave areas between two adjacent convex structures form a concave structure. The convex structure is formed by the inner ring surface and the outer ring surface of the annular structure protruding towards the outside of the annular structure at the same time, and the concave structure is formed by the inner ring surface and the outer ring surface of the annular structure recessing towards the inside of the annular structure at the same time.

[0018] Preferably, the first fluid passage is arranged in the convex structure; the second fluid passage is partially arranged in the concave structure.

[0019] Preferably, each of the concave structures is a V-shaped groove, the adjacent groove walls of two adjacent V-shaped grooves form the convex structure, and the included angle at the wave crest of the convex structure is smaller than the included angle at the wave trough of the concave structure.

[0020]

Beneficial effects

[0021] In the conveying system of the present invention, the stop parts of the first stopper and the second stopper are closed structures in the circumferential direction. By setting the first fluid channel and the second fluid channel, when the expansion medium flows out from the annular cavity between the inner tube and the outer tube, it can not only flow from the proximal area of the inflatable balloon to the middle and distal areas through the gap between the inflatable balloon and the outer circumferential surfaces of the first stopper and the second stopper, but also the expansion medium can flow into the middle area of the inflatable balloon through the first fluid channel or the second fluid channel on the first stopper, and then flow into the distal area of the inflatable balloon through the first fluid channel on the second stopper. Since the medium flow channel formed by the first fluid channel and the second fluid channel is always in a connected state, the middle area of the inflatable balloon, especially the distal area, does not need to wait for the proximal area to expand to a sufficient size before the medium can flow smoothly. In other words, the expansion medium can basically reach the proximal area, middle area and distal area of the inflatable balloon at the same time. , shortening the inflation time of the inflatable balloon, which is conducive to the rapid implementation of interventional treatment; and by adopting the delivery system of the present application, each area of the inflatable balloon can basically be gradually inflated at the same time, so that each part of the artificial valve will be expanded to the same extent as the inflatable balloon gradually expands, and the artificial valve will not be tilted, thereby avoiding the axial displacement of the artificial valve during the expansion of the inflatable balloon as much as possible, thereby improving the placement accuracy of the artificial valve in the patient's body, and increasing the quality and success rate of the operation; at the same time, since the fluid channel is set on the side walls of the first stopper and the second stopper, the strength of the stopper may be reduced, and the end face of the artificial valve may be pressed against the stopper during the transmission process, causing the stopper to deform, resulting in the displacement of the artificial valve during the delivery process, and the present invention improves the strength of the stopper by setting the stopper as a circumferentially closed annular structure, which can avoid the axial displacement of the artificial valve during the delivery process as much as possible.

[0022] Other beneficial effects of the present invention will be explained in the specific implementation manner through the introduction of specific technical features and technical solutions. Through the introduction of these technical features and technical solutions, those skilled in the art should be able to understand the beneficial technical effects brought about by the technical features and technical solutions. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The preferred embodiment of the delivery system of the artificial valve of the present invention will be described below with reference to the accompanying drawings.

[0024] Figure 1 It is a structural schematic diagram of a preferred embodiment of the conveying system of the present invention;

[0025] Figure 2 A partial cross-sectional view of a preferred embodiment of the delivery system of the present invention;

[0026] Figure 3In the conveying system of the present invention, a schematic structural diagram of a preferred embodiment of the first stopper and the second stopper;

[0027] Figure 4 For Figure 3 A longitudinal sectional view of the illustrated embodiment;

[0028] Figure 5 In the conveying system of the present invention, a schematic structural diagram of another preferred embodiment of the first stopper and the second stopper;

[0029] Figure 6 For Figure 5 A longitudinal sectional view of the illustrated embodiment;

[0030] Figure 7 In the conveying system of the present invention, a schematic structural diagram of still another preferred embodiment of the first stopper and the second stopper;

[0031] Figure 8 For Figure 7 A longitudinal sectional view of the illustrated embodiment;

[0032] Figure 9 In the conveying system of the present invention, a schematic structural diagram of still another preferred embodiment of the first stopper and the second stopper;

[0033] Figure 10 For Figure 9 A longitudinal sectional view of the illustrated embodiment;

[0034] Figure 11 A cross-sectional view of a preferred embodiment of the stopper in the conveying system of the present invention.

[0035] In the figure,

[0036] 10. Outer tube;

[0037] 20. Inner tube;

[0038] 30. Expandable balloon;

[0039] 40. First stopper; 41. Stopper part; 411. Protrusion structure; 412. Concave structure; 42. Fixing part; 421. Process hole; 43. Connecting part; 44. First fluid channel; 45. Second fluid channel;

[0040] 50. Second stopper;

[0041] 60. Guide;

[0042] 70. Operating handle;

[0043] 80. Adjustable bending connecting pipe;

[0044] 90. Three-way pipe. Detailed implementation manners

[0045] The present invention will be described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid obscuring the essence of the present invention, well-known methods, processes, procedures, and components are not described in detail.

[0046] In addition, those of ordinary skill in the art should understand that the drawings provided herein are for illustrative purposes only, and the drawings are not necessarily drawn to scale.

[0047] Unless the context clearly requires otherwise, the words such as "including", "comprising" and the like in the whole specification and claims should be interpreted in an inclusive sense rather than an exclusive or exhaustive sense; that is, it is the meaning of "including but not limited to".

[0048] In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, the meaning of "a plurality" is two or more.

[0049] It should be noted that in the description of the present invention, the distal end and the proximal end are relative to the operator of the delivery system. The proximal end refers to the end close to the operator, and the distal end refers to the end far from the operator. That is, for the same component, if only a part of it extends into the patient's body, the end extending into the patient's body is the distal end, and the end located outside the body close to the operator is the proximal end.

[0050] The present invention provides a delivery system for an artificial valve, which is used to deliver artificial organs or stents such as artificial valves or artificial stents to the treatment position of a patient. As Figures 1-11 shown, the delivery system includes an outer tube 10, an inner tube 20 disposed inside the outer tube and extending from the distal end of the outer tube 10, an expandable balloon 30, a first stopper 40 and a second stopper 50 located inside the expandable balloon 30 and fixed to the inner tube 20. One end of the expandable balloon 30 is installed in the distal region of the outer tube 10 and can be connected by bonding, welding or the like, and the other end is installed in the distal region of the inner tube 20; the first stopper 40 is closer to the distal end of the outer tube 10 than the second stopper 50. Specifically, the inner tube 20 is inserted into the outer tube 10, and an annular cavity is formed therebetween for the expansion medium to flow through. The inner tube 20 extends out of the distal end of the outer tube 10, and the first stopper 40 and the second stopper 50 are installed in the region where the inner tube 20 extends out of the outer tube 10.

[0051] There is a gap between the first stopper 40 and the outer tube 10. That is to say, the proximal end of the first stopper 40 does not contact the end face of the outer tube 10. In this way, the expansion medium in the annular cavity can flow out from the gap between the outer tube 10 and the first stopper 40. Both the first stopper 40 and the second stopper 50 include an axially arranged fixing portion 42 and a stopping portion 41. The fixing portion 42 is connected to the inner tube 20. Specifically, the fixing portion 42 has a cylindrical tubular structure and is inserted and connected to the inner tube 20. The stopping portion 41 is located in the section where the first stopper 40 and the second stopper 50 are close to each other. That is to say, axially, for the first stopper 40, its stopping portion 41 is closer to the second stopper 50 than its fixing portion 42, and for the second stopper 50, its stopping portion 41 is closer to the first stopper 40 than its fixing portion 42. Among them, each stopping portion 41 has a circumferentially closed annular structure. That is to say, the annular belt of the annular structure is continuous in the circumferential direction, as Figure 11 shown. Among them, the maximum radial dimension from at least the outer edge of the end of the stopping portion 41 to the axis of the fixing portion 42 is greater than the radius of the fixing portion 42. In the axial projection along the fixing portion 42, at least the projection contour of the end of the stopping portion 41 is located outside the projection contour of the fixing portion 42. Among them, the side wall of the first stopper 40 is provided with a first fluid passage 44 or a second fluid passage 45, and the side wall of the second stopper 50 is provided with a first fluid passage 44. The first fluid passage 44 and the second fluid passage 45 form a medium flow passage for the expandable medium to flow. Specifically, the first fluid passage 44 penetrates the stopping portion 41 axially along the inner tube 20, and the second fluid passage 45 penetrates the entire first stopper 40 axially along the inner tube 20, penetrating from one end of the first stopper 40 to the other end, that is, from the end of the first stopper 40 where the stopping portion 41 is far from the fixing portion 42 to the end of its fixing portion 42 where it is far from the stopping portion 41. That is to say, the first fluid passage 44 is only located in the stopping portion 41 and axially penetrates the stopping portion 41; the second fluid passage 45 is partially located in the stopping portion 41 and partially located in the fixing portion 42. When including a connecting portion 43 (detailed below), it is also located in the connecting portion 43, that is, the second fluid passage 45 is provided on the entire first stopper 40. As Figure 1 shown, the second stopper 50 only provides a medium flow passage on its stopping portion 41. The first stopper 40 can only provide a medium flow passage on its stopping portion 41, or can also provide a medium flow passage on both the stopping portion 41 and the fixing portion.

[0052] When the inflatable balloon 30 is in the contracted state, the portion of the inflatable balloon 30 located between the two stoppers 41 and the two stoppers 41 define a receiving space for the artificial valve, so that when the artificial valve in the compressed state is located in the receiving space, the ends of the two stoppers 41 achieve axial limitation on the artificial valve. That is to say, the inflatable balloon 30 has a contracted state and an inflated state. By filling the inflatable balloon 30 with an inflation medium, the inflatable balloon 30 can be inflated at least in the radial direction, so as to place the artificial valve located thereon into the patient's body; in the contracted state, the artificial valve can be installed on the outside of the inflatable balloon 30. At this time, the two end faces of the artificial valve are substantially in contact with the end faces of the two stoppers 41.

[0053] When the above-mentioned delivery system works, the artificial valve in the compressed state is located on the receiving space. When the delivery system delivers the artificial valve to the treatment position of the patient, an inflation medium is introduced. The inflation medium flows into the gap between the first stopper 40 and the distal end of the outer tube 10 through the annular cavity between the inner tube 20 and the outer tube 10 and flows out, and enters the proximal region of the inflatable balloon 30, and enters the middle region of the inflatable balloon 30 through the first fluid passage 44 or the second fluid passage 45 of the first stopper 40, and then enters the distal region of the inflatable balloon 30 through the first fluid passage 44 of the second stopper 50. Of course, during this process, part of the inflation medium may also seep into the gap between the outer peripheral surfaces of the first stopper 40 and the second stopper 50 and the inflatable balloon 30 and then flow into the middle region and the distal region.

[0054] In the above-mentioned conveying system, the stop portion 41 of the first stopper 40 and the second stopper 50 is a closed structure in the circumferential direction. By setting the first fluid channel 44 and the second fluid channel 45, when the expansion medium flows out from the annular cavity between the inner tube 20 and the outer tube 10, it can not only flow from the proximal area of the inflatable balloon 30 to the middle and distal areas through the gap between the inflatable balloon 30 and the first stopper 40 and the second stopper 50, but also the expansion medium can flow into the middle area of the inflatable balloon 30 through the first fluid channel 44 or the second fluid channel 45 on the first stopper 40, and then flow into the distal area of the inflatable balloon 30 through the first fluid channel 44 on the second stopper 50. Since the medium flow channel formed by the first fluid channel 44 and the second fluid channel 45 is always in a connected state, Therefore, the middle area of the inflatable balloon 30, especially the distal area, does not need to wait for the proximal area to expand to a sufficient size before the medium can flow. That is to say, the expansion medium can basically reach the proximal area, the middle area and the distal area of the inflatable balloon 30 at the same time, thereby shortening the expansion time of the inflatable balloon 30 and facilitating the rapid implementation of interventional treatment. Moreover, by adopting the delivery system of the present application, each area of the inflatable balloon 30 can basically be gradually expanded at the same time. Therefore, various parts of the artificial valve will expand to the same extent as the inflatable balloon gradually expands, and the artificial valve will not be tilted, thereby avoiding axial displacement of the artificial valve during the expansion of the inflatable balloon as much as possible, thereby improving the placement accuracy of the artificial valve in the patient's body and increasing the quality and success rate of the operation.

[0055] The expandable balloon 30 includes a first region near its distal end, a second region near its proximal end, and a middle region between the first region and the second region. When the expandable balloon 30 is expanded, the first region and the second region are substantially in a conical structure, and the middle region is in a cylindrical structure. In a compressed state, the artificial valve is located in the middle region. Therefore, preferably, the first stopper 40 is located in the range covered by the second region, and the second stopper 50 is located in the range covered by the first region.

[0056] In some embodiments, in order to enable the expansion medium to reach each region of the expandable balloon 30 substantially simultaneously, the stopper 41 is provided as a plurality of finger-like structures, that is, the fixing part 42 is simultaneously connected to a plurality of spaced-apart finger-like structures. In this way, the expansion medium can also flow through the gaps between the two elastic fingers to the middle region and the distal region of the expandable balloon 30. However, in this structure, the finger-like structures are separated from each other and are cantilever structures, with a large degree of freedom in all directions. During transportation and other processes, they are prone to shaking, and even affected by vibrations, etc., they may be deformed, resulting in poor limiting accuracy of the artificial valve during later use; when the artificial valve is installed in the delivery system and before entering the patient or during transmission in the patient's body, the plurality of finger-like structures are also prone to shaking and deformation in the circumferential and axial directions, causing the artificial valve to slide; and the strength of this finger-like structure is weak, and it is also prone to deformation when pressed by the end of the artificial valve, affecting the limiting accuracy of the artificial valve. In the present invention, a stopper with a circumferentially closed annular structure, and a first fluid passage 44 and a second fluid passage 45 provided on the side wall of the stopper, improve the strength of the stopper 41, which can not only avoid the reduction of the strength of the stopper 41 caused by the setting of the fluid passages on the side walls of the first stopper 40 and the second stopper 50, and affect the displacement of the artificial valve during transmission, but also enable the expansion medium to reach each region of the expandable balloon 30 as simultaneously as possible.

[0057] Considering that the distal end of the expandable balloon 30 still needs to be connected to the distal region of the inner tube 20 during the expansion process, and does not need to be expanded, and the sealing needs to be ensured here. Therefore, the opening of the distal region of the expandable balloon 30 is often set relatively small. The stopper 41 of the present application is an elastic part with radial elasticity, which can form an elastic member through the structural setting, or can be processed from a material with elastic properties, such as block polyether amide resin (PEBAX). When the latter is selected, for the convenience of processing, the entire first stopper 40 and the second stopper 50 can be made of this material with elastic properties; the stopper 41 can also improve its radially compressible elastic ability through the selection of its own structure and material. By setting the stopper 41 as an elastic part, it is beneficial for the inner tube 20 on which the first stopper 40 and the second stopper 50 are installed to be installed from the distal opening of the expandable balloon 30. And when installing the artificial valve, in order to make the artificial valve in a better contracted state, a tooling fixture for compressing the artificial valve may radially compress the stopper 41 together. Through the radially compressible stopper 41 of the present application, the stopper 41 can be compressed together with the compression of the artificial valve and will not hinder the compression process of the artificial valve.

[0058] Among them, the stop portion 41 can be a conical tube structure, a straight tube structure or other special-shaped structures. As long as the end faces have an overlapping area in the axial direction of the fixing portion 42, axial limitation of the artificial valve can be achieved.

[0059] In a preferred embodiment, the stop portion 41 is in a conical tube structure. The side wall of the stop portion 41 extends in a direction inclined relative to the axis of the fixing portion 42. That is to say, the maximum radial dimensions from each part of the stop portion 41 in the axial direction to the axis of the fixing portion 42 are different. It has opposite inner wall surfaces and outer wall surfaces. The extending directions of the inner wall surfaces and the outer wall surfaces are both inclined relative to the axis of the inner tube 20. The generatrices of the inner wall surfaces and the outer wall surfaces are straight lines, and the straight lines form a non-zero angle with the axis of the inner tube. The cross-section of the stop portion 41 can be an annular surface or other special-shaped structures. Refer to Figure 3 、 Figure 4 As shown, the small end of the stop portion 41 is connected to the fixing portion 42. In this embodiment, the outer contour of the large end (i.e., the end portion) of the stop portion 41 is located outside the fixing portion 42. It is possible that the outer contours of both the inner and outer walls are located outside the fixing portion 42, and the small end coincides with the outer periphery of the fixing portion 42. With this structure, more space can be left between the proximal region of the expandable balloon 30 and the first stopper 40, so that the expansion medium can enter each first fluid channel 44 or the second fluid channel 45 more quickly.

[0060] In another embodiment, the stop portion 41 is in a straight tube structure. The side wall of the stop portion 41 extends in a direction parallel to the axis of the fixing portion 42. As Figures 5-10 shown, the maximum radial dimensions from each part of the stop portion 41 in the axial direction to the axis of the fixing portion 42 are the same. The stop portion 41 also has inner wall surfaces and outer wall surfaces. The extending directions of the inner wall surfaces and the outer wall surfaces are both parallel to the axis of the inner tube 20, and their generatrices are both parallel to the axis of the inner tube 20. In this embodiment, the outer contours of all parts of the stop portion 41 in the entire axial direction are located outside the fixing portion 42. In order to make the stop portion 41 easier to be radially compressed, a gap is left between the inner wall surface of the straight tube structure and the inner tube 20. With this straight tube structure, the strength of the stop portion 41 in the axial direction can be further increased, and the axial limiting effect of the stop portion on the artificial valve can be better improved. Whether the stop portion 41 is in a conical tube structure or a straight tube structure, one opening of the first fluid channel 44 can be arranged on the end face of the stop portion 41 away from the fixing portion 42, or can also be arranged on the inner wall surface of the stop portion 41. When the stop portion 41 is in a conical tube structure, the first fluid channel 44 penetrates from the inner wall surface of the stop portion 41 to the outer wall surface, as Figure 3 、 Figure 4As shown, that is, one opening of the first fluid passage 44 is provided on the inner wall surface of the stopper portion 41, and the other opening is provided on the outer wall surface. That is to say, the first fluid passage 44 penetrates the side wall of the stopper portion 41, and its penetration direction can be perpendicular to the thickness direction of the side wall, or can form a certain angle with the thickness direction, but it also forms an angle with the generatrix of the stopper portion 41 (including the generatrix of the outer wall surface and the generatrix of the inner wall surface). With this structure, the side wall of the conical tube structure does not need to be too thick. In this way, the radial compressibility of the stopper portion 41 is easier, which further facilitates the installation of the inner tube 20 of the first stopper 40 and the second stopper 50 and the installation of the expandable balloon 30.

[0061] In the embodiment where the stopper portion 41 has a conical tube structure, preferably, the axis of the first fluid passage 44 is parallel to the axis of the inner tube 20, as Figure 3 、 Figure 4 shown; or the axis of the first fluid passage 44 is inclined with respect to the axis of the inner tube 20. One end of the first fluid passage 44 located on the inner wall surface is farther from the inner tube 20 than the other end. The opening of the first fluid passage 44 located on the inner wall surface is farther from the inner tube 20 than the opening located on the outer wall surface. In this way, the expansion medium ejected from the first fluid passage 44 of the first stopper 40 can flow towards the second stopper 50 faster; and since there is an artificial valve surrounding the middle region of the expandable balloon 30, the force required during expansion is greater than that in the distal region and the proximal region. And with the first fluid passage 44 arranged in this inclined manner, since the ejection direction of the first fluid passage 44 is towards the middle region of the expandable balloon 30, therefore, a certain ejection effect can be formed on this area, and then this area can expand better. Further, the angle between the axis of the first fluid passage 44 and the axis of the inner tube 20 is 0° to 30°, such as 0°, 5°, 10°, 15°, 20°, 25°, 28°, 30°, etc., so as to better increase the ejection effect of the first fluid passage 44 on the middle region of the expandable balloon 30, and it is more beneficial to the expansion of the middle region of the expandable balloon 30.

[0062] When the stopper portion 41 has a straight cylindrical structure, such as when the first stopper 40 or the second stopper 50 is a stepped structure, if the first fluid passage 41 penetrates the stopper portion 41 in the thickness direction of the side wall, the gap between the outer wall surface of the stopper portion 41 and the expandable balloon 30 is relatively small, which is not conducive to the rapid entry of the expansion fluid into the first fluid passage 41. In a preferred embodiment of the present invention, the first fluid passage 44 penetrates from one end surface of the stopper portion 41 away from the fixing portion 42 to the other end surface. One opening of the first fluid passage 44 is located at the end surface of the stopper portion 41 away from the fixing portion 42, and the other opening is located on the stepped surface of the stepped structure. In this way, when the expandable medium flows to the outer periphery of the fixing portion 42, it can quickly enter the first fluid passage 44. Specifically, the axis of the first fluid passage 44 may be parallel to the axis of the inner tube 20, that is, the first fluid passage 44 extends along the generatrix direction parallel to the outer wall surface (or the generatrix direction of the inner wall surface), that is, the axis of the first fluid passage 44 is parallel to the axis of the inner tube 20; or the axis of the first fluid passage 44 may form a certain angle with the axis of the inner tube 20, that is, the axis of the first fluid passage 44 is inclined with respect to the axis of the fixing portion 42. The latter is preferred, and the first fluid passage 44 is farther away from the inner tube 20 at the end of the stopper portion 41 away from the fixing portion 42 than at the other end, as Figure 6 shown. In this way, it will neither increase the side wall thickness of the stopper portion 41 due to the setting of the first fluid passage 44 too much, nor can the expansion medium enter the first fluid passage 44 faster, and it can form a jetting effect on the middle region of the expandable balloon 30, thereby overcoming the binding force of the artificial valve on the expansion of the middle region and making this region easier to expand. Of course, the first fluid passage 44 can also be arranged such that the end of the stopper portion 41 away from the fixing portion 42 is closer to the inner tube 20 than the other end.

[0063] When the stopper portion 41 has a straight cylindrical structure, the first stopper 40 may also be provided with a second fluid passage 45. If the first stopper 40 is provided with the second fluid passage 45, the second fluid passage 45 penetrates from the end surface of the stopper portion 41 away from the fixing portion 42 to the end surface of the fixing portion 42 away from the stopper portion 41, as Figure 8 , Figure 10 shown. In this embodiment, the axis of the second fluid passage 45 may be parallel to the axis of the fixing portion 42. Preferably, the axis of the second fluid passage 45 is inclined with respect to the axis of the fixing portion 42, and one end of the second fluid passage 45 is farther away from the axis of the fixing portion 42 than the other end, that is, the opening of the second fluid passage 45 in the stopper portion 41 is farther away from the inner tube 20 in the radial direction than the other opening. In this way, the expansion medium ejected from the second fluid passage 45 of the first stopper 40 can form a certain jetting effect on the middle region of the expandable balloon 30 (that is, the region where the artificial valve is installed), and this jetting force can also overcome the compression force of the artificial valve, so that this region can expand better.

[0064] It should be noted that the structures of the stop portions 41 of the first stopper 40 and the second stopper 50 may be the same or different. For example, the stop portions 41 of the two may both be conical cylindrical structures or straight cylindrical structures; for another example, the stop portion 41 of the first stopper 40 may be a conical cylindrical structure, and the stop portion 41 of the second stopper 50 may be a straight cylindrical structure; for another example, the stop portion 41 of the first stopper 40 may be a straight cylindrical structure, and the stop portion 41 of the second stopper 50 may be a conical cylindrical structure. However, when the stopper 41 of the first stopper 40 is a tapered cylindrical structure, since the cross section of the stopper 41 gradually decreases in the direction close to the fixing portion 42, and the fixing portion 42 is mainly used to fix with the inner tube 20, the outer diameter of the fixing portion 42 is often set to be smaller. In a preferred embodiment, the first stopper 40 is only provided with the first fluid channel 41, and the first fluid channel 41 passes through from the inner wall surface of the stopper 41 to the outer wall surface. With this structure, the first fluid channel 44 makes it easier for the expansion medium to quickly enter the space between the inner wall surface of the tapered cylindrical structure and the inner tube 20, and then quickly reach various areas of the expandable balloon 30. When the stopper 41 of the first stopper 40 is a straight cylindrical structure, the first stopper 40 can be provided with the first fluid channel 44 or the second fluid channel 45.

[0065] When the stopper 41 is a straight cylindrical structure, since the stopper 41 needs to play an axial limiting role on the artificial valve, its outer diameter is set relatively large, while the fixing part 42 only needs to be fixedly connected to the inner tube 20, and its outer diameter can be set relatively small. In this way, the direct transition from a larger radial dimension to a smaller radial dimension is likely to cause the first stopper 40 or the second stopper 50 to break. In order to avoid the above-mentioned problem as much as possible, in a preferred embodiment of the present invention, at least one of the first stopper 40 and the second stopper 50 further includes a connecting portion 43 connected between its stopper 41 and the fixing portion 42, such as Figure 9 , Figure 10 As shown, only the first stopper 40 may include the mutually connected stopper 41, the connecting portion 43 and the fixing portion 42, while the second stopper 50 may include the mutually connected stopper 41 and the fixing portion 42; or only the second stopper 50 may include the mutually connected stopper 41, the connecting portion 43 and the fixing portion 42, while the first stopper 40 may include the mutually connected stopper 41 and the fixing portion 42; or both may include the mutually connected stopper 41, the connecting portion 43 and the fixing portion 42. By adding the connecting portion 43, a transition effect is played on the stopper 41 and the fixing portion 42, the fracture resistance of the first stopper 40 or the second stopper 50 can be improved, and the reliability of the entire transmission system can be improved.

[0066] Specifically, the connecting portion 43 may be a circular tubular structure, i.e., its cross section is annular. In this case, half of the outer diameter of the circular tubular structure is less than the maximum radial distance between the stopper 41 and the axis of the inner tube 20, and is greater than half of the outer diameter of the fixing portion 42. There may be a gap between the inner wall surface of the circular tubular structure and the inner tube 20, or they may be directly fitted. For ease of assembly, there is a gap between the connecting portion 43 and the inner tube 20, i.e., only the fixing portion 42 of the first stopper 40 and the second stopper 50 is in contact with and connected to the inner tube 20. In another embodiment, as Figure 9 , Figure 10 As shown, the connecting portion 43 is a conical tubular structure, the cross section of the connecting portion 43 is annular, the inner and outer rings are circular, the large diameter end of the connecting portion 43 is connected to the stopper 41, and the small diameter end is connected to the fixing portion 42, that is, the outer wall surface of the connecting portion 43 is a conical surface, and the inner wall surface is also a conical surface. The connecting portion 43 is set as a conical tubular structure, which can not only well realize the transition between the stopper 41 and the fixing portion 42, but also reduce the damage to the blood vessel wall during transmission in the patient's body. Of course, the connecting portion 43 can also be a pyramidal tubular structure, that is, the inner wall surface and the outer wall surface are both pyramidal surfaces.

[0067] Regardless of which of the above-mentioned embodiments the first stopper 40 and the second stopper 50 adopt, the first stopper 40 can be provided with a plurality of first fluid channels 44 or second fluid channels 45 along the circumferential direction; the second stopper 50 can be provided with a plurality of first fluid channels 44 along the circumferential direction, so as to further enable the expansion medium to reach various axial regions of the inflatable balloon 30 more quickly, and enable the inflatable balloon 30 to receive a more uniform force applied by the expansion medium at various locations in the circumferential direction.

[0068] Among them, the cross-section of the stop portion 41 can be a circular ring structure, that is, the inner ring and the outer ring of the cross-section of the stop portion 41 are both circular. When the stop portion 41 is a straight cylindrical structure, its outer ring surface and the inner ring surface are both cylindrical surfaces; when the stop portion 41 is a conical cylindrical structure, its outer ring surface and the inner ring surface are both conical surfaces. In order to better increase the radial compressibility of the stop portion 41, in a preferred embodiment of the present invention, the annular structure includes a plurality of protruding structures 411 arranged along the circumferential direction, and the recessed area between two adjacent protruding structures 411 forms a recessed structure 412. The recessed structure 412 penetrates the entire stop portion 41 along the axial direction, and may be penetrated in a direction parallel to the axial direction (such as when the stop portion 41 is a straight cylindrical structure), or may be penetrated in a direction inclined to the axial direction (such as when it is a conical cylindrical structure). The protruding structure 411 is formed by the inner annular surface and the outer annular surface of the annular structure protruding in a direction away from the inner tube 20 at the same time, and the recessed structure 412 is formed by the inner annular surface and the outer annular surface of the annular structure being recessed in a direction close to the inner tube 20 at the same time, such as Figure 11As shown, the cross-section of the stopping part 41 is a ring-shaped structure similar to a wave shape, with the convex structures 411 and the concave structures 412 arranged at intervals, so that either the convex structures 411 or the concave structures 412 are present in the entire circumference of the stopping part 41. When the stopping part 41 is in a straight cylindrical structure, the dimensions from the peaks of the convex structures 411 to the axis of the stopping part 41 (i.e., the axis of the inner tube 20) are equal at all points along the axis. That is to say, the straight line (or line segment) or tangent plane formed by the peaks of the convex structures 411 is parallel to the axis of the stopping part 41. When the stopping part 41 is in a conical cylindrical structure, the straight line or tangent plane formed by the peaks of the convex structures 411 forms an angle with the axis of the stopping part 41, so that the entire stopping part 41 has a petal-shaped structure. It should be noted that in this embodiment, in the axial projection along the inner tube 20, the outer contour of the fixing part 42 is located inside the contour formed by the bottom of the concave structures 412. That is to say, the fixing part 42 does not extend beyond the concave structures 412. When the connecting part 43 is provided, the outer contour of the connecting part 43 is also located inside the contour formed by the bottom of the concave structures 412.

[0069] Among them, when the stopping part 41 is in a straight cylindrical structure, the dimensions from the peaks of the convex structures 411 to the axis of the stopping part 41 are equal at all points along the axis. That is to say, the straight line (or line segment) or tangent plane formed by the peaks of the convex structures 411 is parallel to the axis of the stopping part 41. Similarly, the dimensions from the troughs of the concave structures 412 to the axis of the stopping part 41 are equal at all points along the axis. That is to say, the straight line (or line segment) or tangent plane formed by the troughs of the concave structures 412 is parallel to the axis of the stopping part 41. When the stopping part 41 is in a conical cylindrical structure, the dimensions from the peaks of the convex structures 411 to the axis of the stopping part 41 are gradually changing at all points along the axis. That is to say, the straight line (or line segment) or tangent plane formed by the peaks of the convex structures 411 is inclined to the axis of the stopping part 41. Similarly, the dimensions from the troughs of the concave structures 412 to the axis of the stopping part 41 are gradually changing at all points along the axis. That is to say, the straight line (or line segment) or tangent plane formed by the troughs of the concave structures 412 is inclined to the axis of the stopping part 41.

[0070] By setting the cross-section of the stop portion 41 into the above-mentioned wavy structure, on the one hand, the stop portions 41 of the first stopper 40 and the second stopper 50 form a closed structure in the circumferential direction, and are provided with the convex structure 411 and the concave structure 412, so that the stop portion 41 has a certain radial elastic force, which can not only achieve radial compression, and its respective convex structures 411 and concave structures 412 are connected to each other in the circumferential direction, so that the stop portion 41 affects each other and restricts each other to a certain extent during the compression process, the compressed state or the free state, avoiding large-angle free shaking of a single convex structure 411 or concave structure 412. In this way, the stop portion 41 can maintain a stable structure without being subjected to a large external force, and the conveying system has higher stability whether during the transportation process, before entering the patient or during the transmission process in the patient's body. Therefore, the limit accuracy of the artificial valve during the conveying process can be greatly improved.

[0071] The convex direction of each convex structure 411 can be the radial direction of the stop portion 41 or can form an angle with the radial direction. In a preferred embodiment, the wave crests of the convex structures 411 on the same cross-section of the stop portion 41 are located on the same circumference, and the bottoms of the concave structures 412 are located on the same circumference. At this time, the contour formed by the wave crests of the convex structures 411 is a circumference, and the contour formed by the bottoms of the concave structures 412 is a circumference; wherein, the cross-section refers to the section perpendicular to the axial direction, that is to say, the convex heights of the convex structures 411 in the radial direction are equal. Further, each convex structure 411 protrudes along its respective radial direction. By adopting this structure, the radial elastic forces at various positions of the entire stop portion 41 in the circumferential direction are basically equal, which is convenient for controlling the stop portion 41 during the process of installing the inner tube 20 on the expandable balloon 30 and the process of installing the artificial valve on the expandable balloon 30, and is more likely to achieve radial compression.

[0072] The convex structure 411 can be an inverted V-shaped structure, a semi-circular ring structure, an arc-shaped ring structure, an n-shaped structure, etc., and the concave structure 412 can be a V-shaped groove, a semi-circular groove, an arc-shaped groove, a U-shaped groove, etc., and the shapes of the convex structure 411 and the concave structure 412 can be freely combined. In a preferred embodiment of the present invention, such as Figure 11As shown, the recessed structure 412 is a V-shaped groove, and the adjacent side walls of two adjacent recessed structures 412 form a convex structure 411, so that the convex structure 411 is approximately triangular. The angle of the convex structure 411 at the wave crest can be equal to or different from the angle of the V-shaped groove at the groove bottom. Preferably, the former is less than or equal to the latter, that is, the angle at which the two sides of the V-shaped groove diverge is larger, while the angle formed by the adjacent side walls of two adjacent V-shaped grooves is smaller. In this way, when the stopper 41 is subjected to a radial extrusion force, the recessed structure 412 can provide a larger deformation space for the deformation of the convex structure 411, so that the convex structure 411 is more likely to achieve radial compression, which is conducive to the inner tube 20 being inserted into the expandable balloon 30 and the artificial valve being installed in the accommodating space; and with this structure, the distance between the bottoms of two adjacent V-shaped grooves is relatively large, making the V-shaped structure more stable, and thus having a better limiting effect.

[0073] When the convex structure 411 of the V-shaped structure is sharp at the wave crest, during the insertion process of the inner tube 20 and the installation process of the artificial valve, it may scratch the expandable balloon 30 or even cause rupture. Preferably, the convex structure 411 is arc-shaped at the wave crest. The bottom of the V-shaped groove can also be set as an arc-shaped structure or other smoothly transitioning structures. The recessed structure 412 can also be set as an arc-shaped structure or other smoothly transitioning structures at the wave trough.

[0074] When the recessed structure 412 is a V-shaped groove, further preferably, the angle of the convex structure 411 at the wave crest is 45° - 90°, such as 45°, 50°, 55°, 60°, 65°, 70°, 80°, 87°, 90°, etc.; the angle of the V-shaped groove is preferably 90° - 150°, such as 90°, 93°, 98°, 105°, 110°, 120°, 130°, 135°, 140°, 145°, 150°, etc. Using this range can better ensure the radial compressibility of the stopper 41 and improve its axial anti-extrusion ability, which is convenient for the installation of the inner tube 20 and the expandable balloon and the installation of the artificial valve on the expandable balloon 30, and can also provide sufficient axial limiting effect on the artificial valve during its transportation in the patient's body.

[0075] When the stopper 41 includes the convex structure 411, the first fluid channel 44 can be located in the convex structure 411 or in the recessed structure 412. Preferably, it is the former, such as Figure 3 、 Figure 5As shown, this method is particularly applicable when the stop portion 41 has a conical cylindrical structure, especially when the stop portion 41 of the first stopper 40 adopts this method. Since when the stop portion 41 has an overall petal-like structure, the expansion medium can flow through the recessed structure 412 of the first stopper 40 to the middle region and the distal region of the expandable balloon 30. Therefore, when the first fluid channel 44 is arranged on the raised structure 411, fluid channels can be formed on both the raised structure 411 and the recessed structure 412, thereby minimizing the time for the expansion medium to reach each region of the expandable balloon 30 and improving the uniformity of expansion at each location. When the stop portion 41 has a straight cylindrical structure, the wall thickness of the stop portion located inside the recessed structure 412 can also be increased. That is, the annular structure includes a support ring located on the inner circle, a raised structure 411 and a recessed structure 412 arranged outside the support ring. For example, the annular structure includes two radially arranged parts. The part located inside is in the form of a cylindrical tube structure (i.e., the support ring), and the part located outside includes a raised structure 411 and a recessed structure 412. At this time, the first fluid channel 44 can be arranged on the support ring.

[0076] When the stop portion 41 includes a raised structure 411, if the first stopper 40 is provided with a second fluid channel 45, preferably, part of the second fluid channel 45 is arranged in the recessed structure 412, such as Figure 7 , Figure 9 As shown, considering that in the radial direction, the recessed structure 412 is closer to the fixing portion 42 than the raised structure 411, arranging the part of the second fluid channel 45 located on the stop portion 41 on the recessed structure 412 can reduce the wall thickness of the stop portion 41 and enable the outer diameter of the fixing portion 42 to be set not too large.

[0077] It should be noted that regardless of the structure adopted by the stop portion 41, in the axial direction of the inner tube 20, the projections of the two end walls of the two artificial valves respectively and the projections of the ends of the stop portions 41 adjacent to them at least have an overlapping area. If the projection of the end face of the artificial valve close to the first stopper 40 is recorded as the first projection, the projection of the end face close to the second stopper 50 is recorded as the second projection, the projection of the end face of the stop portion 41 of the first stopper 40 is recorded as the third projection, and the projection of the end face of the stop portion 41 of the second stopper 50 is recorded as the fourth projection, then, the first projection and the third projection have an overlapping area, and the second projection and the fourth projection have an overlapping area. For example, at least part of the end of the outer ring surface exceeds the inner wall of the artificial valve in the compressed state. When each part of the end of the outer ring surface in the circumferential direction exceeds the outer wall of the artificial valve in the compressed state, at least part of the end of the inner ring surface has to exceed the inner wall of the artificial valve in the compressed state. In this way, it can prevent the artificial valve from entering the internal space of the stop portion 41.

[0078] Specifically, the connection between the fixing part 42 and the inner tube 20 can be an insertion connection. In a preferred embodiment, the fixing part 42 is provided with a process hole 421 that penetrates radially, that is, the process hole penetrates from the outer wall of the fixing part 42 to its inner wall. When the first stopper 40 and the second stopper 50 are inserted into place with the inner tube 20, the fixing part 42 can be bonded and fixed to the inner tube 20 by applying glue to the process hole 421, so as to improve the connection reliability between the first stopper 40, the second stopper 50 and the inner tube 20. Further, along the axial direction of the fixing part 42, a plurality of process holes 421 can be provided, or one, two, or more process holes can be provided along the circumferential direction of the fixing part 42. The fixing part 42 can also be connected to the inner tube 20 by means of heat melting or the like.

[0079] In addition, the delivery system further includes a guide member 60, such as Figure 2 shown, in the direction from the distal end to the proximal end of the guide member 60, its cross-section gradually increases. Specifically, the guide member 60 can be a conical structure (i.e., the generatrix is a straight line), or a conical structure with an arc-shaped generatrix, or a structure with a hyperbolic or other curved or polyline-shaped generatrix, so as to play a guiding role in the transmission of the delivery system in the patient's body. Along the axial projection of the inner tube 20, the outer contour of the guide member 60 is located within the outer contour of the stop portion 41.

[0080] In one embodiment, the second stopper 50 further includes a mounting portion having a mounting hole, and a part of the guide member 60 is inserted into the mounting hole. That is to say, the mounting portion is inserted and connected to the guide member 60. In this embodiment, the inner tube 20 can be connected only to the fixing part 42 of the second stopper 50, that is, the distal end of the inner tube 20 is located within the fixing part 42 of the second stopper 50.

[0081] In another embodiment, the guide member 60 has an axially penetrating connection hole, and the distal end of the inner tube 20 extends out of the second stopper 50 and is inserted and connected to the connection hole; the end face of the fixing portion 42 of the second stopper 50 is in contact connection with the end face of the guide member 60. By adopting this end-face contact method, the second stopper 50 does not need to be provided with a special installation portion. In this way, the processing difficulty can be reduced, the length of the second stopper 50 can be reduced, the axial dimension of the entire conveying system at the distal end can be reduced, and the material cost can be reduced; furthermore, compared with the structure in which the guide member 60 is inserted into the installation hole, in this structure, the guide member 60 does not need to be deliberately made smaller than the size of the installation hole, that is, the guide member 60 does not necessarily need to be provided with a stepped shaft structure, and the second stopper 50 does not need to be provided with a thin-walled installation portion, and the connection can be realized directly through end-face bonding, further reducing the processing difficulty. In this embodiment, the distal end of the expandable balloon 30 is connected to the distal end region of the inner tube 20 through at least one of the fixing portion 42 of the second stopper 50 and the guide member 60. That is to say, the distal end of the expandable balloon 30 can be directly connected to the fixing portion 42 of the second stopper 50, or directly connected to the outer wall surface of the guide member 60, or can be simultaneously connected to the fixing portion 42 and the outer wall surface of the guide member 60. Preferably, the distal end of the expandable balloon 30 is simultaneously connected to the fixing portion 42 of the second stopper 50 and the outer wall surface of the guide member 60. By adopting this structure, the connection reliability of the expandable balloon 30 can be increased, and the connection reliability between the guide member 60 and the second stopper 50 can be increased. Further preferably, the outer diameter of the fixing portion 42 is equal to the maximum outer diameter of the guide member 60. In this way, when the expandable balloon 30 is simultaneously connected to the fixing portion 42 and the guide member 60, a stepped connection structure will not be formed, thereby avoiding affecting the sealing performance of the expandable balloon 30 due to the existence of the stepped structure.

[0082] In yet another embodiment, the guide member 60 is provided with a connection hole; one end of the fixing portion 42 of the second stopper 50 away from the stopping portion 41 is inserted and connected to the connection hole, and the distal end of the expandable balloon 30 passes through the outer wall surface of the guide member 60, such as Figure 1 shown. That is to say, the expandable balloon 30 is connected to the distal end region of the inner tube 20 through the guide member 60. By adopting this inserted connection structure, both the overall length after the assembly of the guide member 60 and the second stopper 50 can be reduced, and the sealing performance of the expandable balloon 30 at the distal end can be ensured. Further, the connection hole 61 can be a stepped hole, and the fixing portion 42 of the second stopper 50 is inserted into the large hole of the connection hole. In this embodiment, the distal end of the inner tube 20 can be only inserted into the fixing portion 42 of the second stopper 50, or the distal end of the inner tube 20 can extend out of the second stopper 50 and be inserted and connected to the small hole of the stepped hole. That is to say, the inner tube 20 is not only connected to the fixing portion 42 of the second stopper 50, but also connected to the guide member 60. In this way, the connection reliability between the second stopper 50 and the guide member 60 can be further increased.

[0083] It should be noted that when the guiding member 60 is connected to the second stop member 50, the axial stability of the second stop member 50 relative to the inner tube 20 can be increased, thereby further improving the reliability of the second stop member 50 in limiting the artificial valve.

[0084] In an embodiment where the guiding member 60 and the fixing portion 42 are in an inserted connection, in the overlapping area of the two, a radially penetrating process hole is also provided on the one located on the outer side. After the two are inserted and installed, glue can be applied through this process hole to achieve the connection between the two.

[0085] The delivery system further includes a developing member, and the developing member can be arranged on the inner tube 20, or the first stop member 40, the second stop member 50. Of course, it can also be arranged on other components to facilitate the operator to observe the delivery situation of the artificial valve in the patient's body.

[0086] Continue to refer to Figure 1 , the delivery system further includes an operating handle 70, an adjustable bending connecting pipe 80 extending from the distal end of the operating handle 70, and a three-way pipe 90. The proximal ends of the outer tube 10 and the inner tube 20 are connected to the three-way pipe 90 so that the expansion medium enters the annular cavity between the outer tube 10 and the inner tube 20 through the three-way pipe. The distal ends extend from the proximal end of the operating handle 70 and pass through the distal end of the adjustable bending connecting pipe 80; the operating handle 70 can adjust the bending degree of the distal part of the adjustable bending connecting pipe 80, and can also adjust the relative positions of the outer tube 10, the inner tube 20, and the expandable balloon 30 relative to the adjustable bending connecting pipe 80 to precisely adjust the position of the artificial valve entering the patient's body.

[0087] It should be noted that in the present invention, the axes of the first stop member 40, the second stop member 50, the axis of the stop portion, the axis of the fixing portion, and the axis of the inner tube 20 can be considered as the same axis, and the above-mentioned axial direction also refers to the direction where the same axis of these several is located. And although the radial and radial dimensions are described in many places above, the present invention is not limited to the components corresponding to the radial and radial dimensions must be a cylindrical structure, a conical structure, etc. It only represents the direction perpendicular to the axial direction or the dimension in this direction.

[0088] Those skilled in the art can understand that on the premise of no conflict, the above-mentioned preferred solutions can be freely combined and superimposed.

[0089] It should be understood that the above embodiments are merely exemplary and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions made by those skilled in the art to the above details will be included within the scope of the claims of the present invention.

Claims

1. A delivery system for an artificial valve, comprising an outer tube, an inner tube disposed inside the outer tube and extending from the distal end of the outer tube, an inflatable balloon, a first stopper and a second stopper located inside the inflatable balloon and fixed to the inner tube. One end of the inflatable balloon is mounted on the distal region of the outer tube, and the other end is mounted on the distal region of the inner tube; the first stopper is closer to the distal end of the outer tube than the second stopper; characterized in that, a gap is left between the first stopper and the outer tube; both the first stopper and the second stopper include an axially arranged fixing portion and a stopping portion. The fixing portion has a cylindrical tubular structure and is inserted and connected to the inner tube; the stopping portion is located in the section where the first stopper and the second stopper are close to each other and has a circumferentially closed annular structure. The maximum radial dimension from at least the outer edge of the end of the stopping portion to the axis of the fixing portion is greater than the radius of the fixing portion; the side wall of the first stopper is provided with a first fluid passage or a second fluid passage; the side wall of the second stopper is provided with a first fluid passage; wherein, the first fluid passage penetrates through the stopping portion in the axial direction of the inner tube; the second fluid passage penetrates from one end to the other end of the first stopper in the axial direction of the inner tube; when the inflatable balloon is in a contracted state, the portion of the inflatable balloon between the two stopping portions and the two stopping portions enclose a receiving space for the artificial valve, so that when the artificial valve in a compressed state is located in the receiving space, the ends of the two stopping portions axially limit the artificial valve; the annular structure includes a plurality of protruding structures arranged circumferentially, and a concave structure is formed in the concave area between two adjacent protruding structures. The protruding structure is formed by the inner ring surface and the outer ring surface of the annular structure protruding towards the outside of the annular structure at the same time, and the concave structure is formed by the inner ring surface and the outer ring surface of the annular structure recessing towards the inside of the annular structure at the same time.

2. The conveying system according to claim 1, wherein, the first stopper is provided with a first fluid passage; the stopping portion has a conical tubular structure, and the small end of the stopping portion is connected to the fixing portion; the first fluid passage penetrates from the inner wall surface of the stopping portion to the outer wall surface.

3. The conveying system according to claim 2, characterized in that, the axis of the first fluid passage is parallel to the axis of the inner tube, or the end of the first fluid passage located on the inner wall surface is farther from the inner tube than the other end.

4. The conveying system according to claim 3, characterized in that, the included angle between the axis of the first fluid passage and the axis of the inner tube is 0° to 30°.

5. The conveying system according to claim 1, characterized in that, the stopping portion has a straight tubular structure, the extending direction of the side wall of the stopping portion is parallel to the axis of the stopping portion, and a gap is left between the inner wall surface of the stopping portion and the inner tube; the first fluid passage penetrates from one end surface of the stopping portion far from the fixing portion to the other end surface of the stopping portion.

6. The conveying system according to claim 5, characterized in that, at least one of the first stopper and the second stopper further includes a connecting portion in the shape of a conical tube, the large diameter end of the connecting portion is connected to the stopping portion, and the small diameter end is connected to the fixing portion.

7. The conveying system according to any one of claims 1-6, characterized in that, the first stopper and the second stopper are provided with a plurality of fluid passages along their respective circumferences.

8. The conveying system according to any one of claims 1-6, characterized in that, The first fluid passage is disposed in the convex structure; the second fluid passage is partially disposed in the concave structure.

9. The conveying system according to claim 8, wherein Each of the concave structures is a V-shaped groove, and the adjacent groove walls of two adjacent V-shaped grooves form the convex structure, and the angle at the wave crest of the convex structure is smaller than the angle at the wave trough of the concave structure.

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