WO2023040320A1 - Prosthetic valve delivery system and stop device and stop member therefor - Google Patents

Abstract

A prosthetic valve delivery system, a stop device and a stop member therefor, and a prosthetic valve delivery device. The stop device comprises: a first blocking member (4) which comprises a first tube part (41) and a first stop part (42), the first tube part (41) being fixed to a catheter (2) in a sleeving mode and being spaced apart from the proximal end of a balloon (1), the first stop part (42) being fitted over the catheter (2), and the distal end of the first stop part (42) being used for limiting a prosthetic valve; and a second blocking member (5) which comprises a second tube part (51) and a second stop part (52), the second tube part (51) being fixed to the catheter (2) in a sleeving mode and being provided close to the distal end of the balloon (1), the second stop part (52) being fitted over the catheter (2), and the proximal end of the second stop part (52) being used for limiting the prosthetic valve. The prosthetic valve can be axially limited, and the flowing effect of fluid in the balloon (1) can be optimized, such that the conveying effect of the prosthetic valve can be improved, and the assembly efficiency is improved.

Description

Prosthetic valve delivery system and stop device and stopper therefor

Cross References to Related Applications

This application requires the invention patent submitted on September 16, 2021 with the application number 202111088663.X (invention name: artificial valve delivery system and stop device for it) and the application number 202122253299 submitted on September 16, 2021 .X (name of invention: stopper for artificial valve delivery device and artificial valve delivery device) has the priority right of utility model patent.

technical field

The present application relates to an artificial valve delivery system, in particular to a stopper for an artificial valve delivery system, an artificial valve delivery system, a stopper and an artificial valve delivery device.

Background technique

Artificial heart valves (artificial valves for short) usually refer to implantable heart valves (including aortic valve, pulmonary valve, tricuspid valve, mitral valve) that can make blood flow in one direction and have natural heart valves. Functional artificial organs.

With the continuous development of minimally invasive surgery and interventional medical equipment technology, transcatheter valve replacement is to introduce the artificial valve into the body through the artificial valve delivery system and place it at the position where it needs to be implanted. The artificial valve delivery system generally includes a valve installation part, a connection part, and an operation part. The valve installation part includes a conical head, a balloon, a catheter, etc. Adjustment button, traction device, three-way tailstock, etc., wherein the catheter runs through the entire delivery system, and the balloon is an inflatable balloon. Usually, the operating part is used as a reference, and the above-mentioned components are close to the end of the operating part along the axial direction of the catheter It is called the proximal end, and the end away from the operating part is called the distal end. During delivery, after the prosthetic valve is mounted on the balloon in a compressed state and advanced through the blood vessel to the implantation site, the balloon is inflated by injecting fluid into the balloon to deploy the prosthetic valve. The prosthetic valve release process needs to be combined with external equipment such as ultrasound, contrast imaging, etc. to observe the specific position of the prosthetic valve and the state of the balloon-expanded valve stent.

The artificial valve system usually fixes a proximal stop structure and a distal stop structure on the catheter inside the balloon, and the axial inner end of the proximal stop structure and the distal stop structure is used to accommodate the artificial valve and It is limited axially.

The existing one-type stop structure is composed of several independent elastic fingers. The elastic fingers are generally cantilever structures and each elastic finger is independent of each other, so that each elastic finger can move and deform freely. The degree is relatively large, which is prone to deformation during the delivery of the artificial valve, and the positioning accuracy of the artificial valve cannot be guaranteed, resulting in increased surgical risks.

Another type of stop structure is a cone, whose radial cross-sectional diameter gradually decreases in the direction away from the artificial valve. The cone stop structure can reduce the degree of freedom of movement and deformation to a certain extent, but there are still the following disadvantages: 1. When the balloon is in a contracted state, the balloon is almost completely wrapped on the catheter and the stop structure. Since the circumferential edge of the cone stop structure fits well with the balloon, there is a gap between the two. The gap through which the fluid passes is small, which is not conducive to the rapid passage of fluid; 2. When the valve installation part is assembled, the stop structure needs to be inserted into the balloon in advance, and the diameter of the proximal and distal openings of the balloon is limited, so it is necessary to stop The structure has a certain degree of compressibility in the radial direction, while the radial compression range of the conical structure is very limited, or even incompressible, which makes the assembly of the balloon and the stop structure more difficult. In addition, the contact area between the axial inner end surface of the cone stop structure and the axial end surface of the artificial valve is relatively large, which will increase the radial friction force of the stop structure of the artificial valve at the initial stage of balloon inflation, which may lead to The artificial valve does not expand smoothly, which increases the risk of surgery.

Contents of the invention

Based on the above-mentioned status quo, the main purpose of this application is to provide a stop device for artificial valve delivery system, artificial valve delivery system, stopper and artificial valve delivery device. In this case, the stopper can not only achieve uniform deformation during radial compression, but also provide a flow channel for the fluid when the balloon is deflated.

In order to achieve the above object, the technical scheme adopted by the application is as follows:

According to the first aspect of the present application, a stopper device for a prosthetic valve delivery system, the prosthetic valve delivery system includes a balloon for setting the prosthetic valve and a catheter passing through the balloon, the fluid flows from the proximal end of the balloon into the interior of the balloon, the stop is located within the balloon and includes:

The first stopper includes a first tube portion and a first stopper along the axial direction of the catheter, the first tube portion is sleeved on and fixed on the catheter, and is spaced apart from the proximal end of the balloon, the first The stopper is sleeved on the catheter, the proximal end of the first stopper is affixed to the distal end of the first tube, and the distal end of the first stopper is used to limit the proximal end of the artificial valve, The first stop part is an annular structure and is formed by alternately connecting several first convex parts and several first concave parts along the circumferential direction, and the inner and outer wall surfaces of the first convex part protrude outward along the radial direction of the first stop part, The inner and outer wall surfaces of the first recess are recessed inward along the radial direction of the first stopper, and the radial distance between the first protrusion and the catheter axis gradually increases from the proximal end to the distal end of the first stopper;

The second stopper includes a second tube part and a second stop part along the axial direction of the catheter, the second tube part is sleeved and fixed on the catheter, and is arranged near the distal end of the balloon, and the second stop part The moving part is sleeved on the catheter, the distal end of the second stopper is fixedly connected to the proximal end of the second pipe part, and the proximal end of the second stopper is used to limit the distal end of the artificial valve. The two stoppers are ring-shaped and formed by alternately connecting several second protrusions and second recesses along the circumferential direction. The inner and outer walls of the second protrusions protrude outward along the radial direction of the second stopper. The inner and outer walls of the two recesses are recessed inward along the radial direction of the second stopper, and the radial distance between the second protrusion and the axis of the catheter gradually decreases from the proximal end to the distal end of the second stopper;

The axial distance between the first stopper and the second stopper matches the axial length of the artificial valve;

When the balloon is in a deflated state, fluid can pass through the plurality of first recesses and the plurality of second recesses.

Preferably, the first stopper is a structure of constant wall thickness; the second stopper is a structure of constant wall thickness.

Preferably, the first pipe part is connected smoothly with the first stop part; the second pipe part is connected smoothly with the second stop part.

Preferably, the radial section of the first recess is V-shaped, several first recesses are arranged in the circumferential direction, and a first protrusion is formed between two adjacent first recesses; the radial section of the second recess It is V-shaped, several second concave parts are arranged along the circumferential direction, and a second convex part is formed between two adjacent second concave parts.

Preferably, on the distal surface of the first stopper, the radial maximum distance between the first protrusion and the catheter axis is greater than half of the inner diameter of the artificial valve in a compressed state, and the first The radial minimum distance between the recess and the catheter axis is less than half of the inner diameter of the prosthetic valve in a compressed state;

On the proximal end surface of the second stopper, the radial maximum distance between the second protrusion and the catheter axis is greater than half of the inner diameter of the artificial valve in a compressed state, and the second recess and the The radial minimum distance of the catheter axis is less than half of the inner diameter of the artificial valve under pressure.

Preferably, on the distal surface of the first stopper, the radial maximum distance between the first protrusion and the catheter axis is greater than half of the outer diameter of the artificial valve in a compressed state, and the first A minimum radial distance between a recess and the catheter axis is less than half the outer diameter of the prosthetic valve in a compressed state;

On the proximal end surface of the second stopper, the maximum radial distance between the second protrusion and the axis of the catheter is greater than half of the outer diameter of the artificial valve in a compressed state, and the second recess and The radial minimum distance of the conduit axis is less than half the outer diameter of the prosthetic valve in a compressed state.

Preferably, the maximum radial distance between the first protrusion and the catheter axis is 1.05-1.25 times half of the outer diameter of the artificial valve in a compressed state;

The maximum radial distance between the second protrusion and the catheter axis is 1.05-1.25 times half of the outer diameter of the artificial valve in a compressed state.

Preferably, the second stopper further includes a third tube portion in the axial direction, the proximal end of the third tube portion is affixed to the distal end of the second tube portion, and the distal end of the third tube portion is used for connecting with the The conical head of the delivery system is fixedly connected to the distal end of the balloon, and the outer diameter of the proximal end of the third tube part is smaller than the outer diameter of the distal end of the second tube part.

Preferably, a radially penetrating first dispensing hole is provided on the pipe wall of the first pipe part; a radially penetrating second dispensing hole is provided on the pipe wall of the second pipe part.

According to the second aspect of the present application, an artificial valve delivery system includes a balloon disposed at the distal end of the delivery system, a balloon connection tube for connecting the balloon, and a catheter inserted into the balloon connection tube , the proximal end of the balloon is connected and fixed with the distal end of the balloon connecting tube, the catheter passes through the distal end of the balloon connecting tube and penetrates into the balloon through the proximal end of the balloon, the balloon connecting tube The tube and catheter form an annular lumen within the proximal end of the balloon through which fluid used to inflate the balloon flows into or out of the interior of the balloon;

The catheter is provided with the stopping device as described in the first aspect above, and the stopping device is used for axially limiting the artificial valve in the compressed state.

In the third aspect of the present application, a stopper for an artificial valve delivery device, the artificial valve delivery device includes a balloon for setting the artificial valve and a catheter passing through the balloon, and two stoppers are arranged at intervals on the catheter pieces,

The stopper includes a sleeve part and a stop part; the sleeve part is used to be sleeved and fixed on the catheter, and one end of the sleeve part is coaxially connected with the stop part; the stop part It is used to limit the artificial valve. The stop part is an annular structure sleeved on the catheter and is formed by alternately connecting several convex parts and several concave parts along the circumferential direction. The inner and outer walls of the convex parts are all along the radial direction of the stop part. The inner and outer wall surfaces of the concave part are recessed inward along the radial direction of the stopper part, and the radial distance between the convex part and the axis of the stopper part gradually increases in the direction away from the sleeve part, and the concave part The stop part is penetrated along the axial direction of the stop part.

Preferably, the stopper is a structure of equal wall thickness.

Preferably, the sleeve part and the stop part are connected smoothly.

Preferably, the radial section of the concave portion is V-shaped, and a convex portion is formed between two adjacent concave portions.

Preferably, the highest point of the protrusion in the radial direction is arc-shaped.

Preferably, on the end face of the stopper, the maximum radial distance between the convex part and the axis of the stopper is greater than half of the inner diameter of the artificial valve in a compressed state, and the distance between the concave part and the axis of the stopper The radial minimum distance is less than half of the inner diameter of the artificial valve in a compressed state.

Preferably, the maximum radial distance between the protrusion and the axis of the stopper is greater than half of the outer diameter of the prosthetic valve in a compressed state.

Preferably, radially penetrating glue dispensing holes are provided on the tube wall of the casing part.

Preferably, the other end of the sleeve part is coaxially connected with an extension part, the extension part is in the shape of a sleeve and is sleeved and fixed on the catheter, and the outer diameter of the extension part is smaller than the outer diameter of the sleeve part.

According to the fourth aspect of the present application, an artificial valve delivery device includes a catheter, a balloon located at the distal end region of the catheter, a guide located at the distal end of the catheter, located in the balloon and arranged at intervals on the catheter. a proximal stop and a distal stop on the catheter;

The proximal stopper and the distal stopper are the stoppers described in the first aspect above, and the adjacent parts of the two are respective stoppers, and the proximal stopper and the The space between the distal stoppers forms a limiting space for accommodating the artificial valve in a compressed state; the proximal end of the balloon is spaced apart from the proximal stoppers.

The stopper device for the artificial valve delivery system of the present application, firstly, through the first stopper and the second stopper on the first stopper and the second stopper, so that it is placed on the first stopper and the second stopper The artificial valve between the two stoppers is limited in the axial direction, and the structure of the first stopper and the second stopper is designed while ensuring the stopper's effect on the artificial valve. And optimization, the radial compressibility of the first stopper and the second stopper is improved through alternately connecting convex parts and concave parts along the circumferential direction, the compressible range is improved, and the compression deformation is more uniform and stable. During the assembly process, it is convenient to insert the stop device into the balloon, which can effectively improve the assembly efficiency. Secondly, the first recess and the second recess can provide an optimized flow path for the fluid flowing in the balloon, especially when the balloon is in a contracted state, it can ensure that there is a gap between the first stopper, the second stopper and the balloon. There are enough gaps to serve as fluid flow channels, making the fluid flow in the balloon faster and smoother, thereby optimizing the fluid flow effect and improving the inflation and contraction effects of the balloon, helping to reduce operation time, Reduce surgical risk. Furthermore, by reasonably controlling the actual contact area between the distal end surface of the first stopper part and the proximal end surface of the artificial valve, and between the proximal end surface of the second stopper part and the distal end surface of the artificial valve, it is possible to avoid the balloon inflation during the initial stage of inflation. The excessive radial friction force on the artificial valve helps to reduce the expansion resistance of the artificial valve, making the process of artificial valve deployment smoother and reducing the risk of surgery.

The artificial valve delivery system of the present application adopts the above-mentioned stopping device, which can effectively limit the position of the artificial valve in the axial direction, and can improve the flow effect of the fluid in the balloon, especially when the balloon is in a contracted state. The fluid provides a flow channel that improves balloon inflation and deflation, helping to improve surgical efficiency and reduce surgical risk.

In the stopper of the artificial valve delivery device of the present application, the stopper is a circumferentially closed structure and has alternately connected convex parts and concave parts. On the one hand, the compression performance of the stopper in the radial direction is improved, so that the stopper The radial compressibility range of the radial direction increases, and the compression deformation effect of the stopper is more reasonable, and it is more convenient to put the stopper into the balloon during the assembly process, which helps to improve the assembly efficiency; on the other hand, the alternate The connected convex part and concave part restrain each other to a certain extent, so that the degree of freedom of deformation of the stop part can be reasonably controlled, so that the stop part is more stable and reliable in structure, and can ensure the limiting effect on the artificial valve. At the same time, the recess can provide an optimized flow path for the fluid in the balloon, especially when the balloon is in a contracted state, it can ensure that there is enough space between the stopper and the balloon for the fluid to pass through, making the fluid flow faster , Unobstructed, can improve the inflation and contraction effect of the balloon, help to reduce the operation time, and also reduce the operation risk.

The artificial valve delivery device of the present application can effectively limit the position of the artificial valve in the axial direction by using the above-mentioned stopper, and can improve the flow effect of the fluid in the balloon, especially when the balloon is in a contracted state. Providing a flow path for the fluid has a positive effect on improving balloon inflation and deflation.

Other beneficial effects of the present application will be explained in the specific implementation manner through the introduction of specific technical features and technical solutions, and those skilled in the art should be able to understand that the technical features and technical solutions bring beneficial technical effects.

Description of drawings

Preferred embodiments according to the present application will be described below with reference to the accompanying drawings. In the picture:

FIG. 1 is a schematic diagram of the axial structure of the stopping device used in the artificial valve delivery system of the present application;

FIG. 2 is a schematic diagram of the three-dimensional structure of the first stopper used in the artificial valve delivery system of the present application;

FIG. 3 is a schematic diagram of the three-dimensional structure of the second stopper used in the artificial valve delivery system of the present application;

Fig. 4 is a radial cross-sectional schematic view of the first stopper used in the artificial valve delivery system of the present application;

Fig. 5 is a schematic structural view of the distal region of a preferred embodiment of the artificial valve delivery device of the present application.

Explanation of reference numerals: 1 balloon, 2 catheter, 3 balloon connecting tube, 4 first stopper, 41 first tube part, 42 first stopper part, 43 first convex part, 44 first concave part, 45 first stop part Dispensing hole, 5 the second stopper, 51 the second pipe part, 52 the second stop part, 53 the second convex part, 54 the second concave part, 55 the third pipe part, 56 the second dispensing hole, 6 developing Components, 7 conical heads, 8 annular cavities.

Detailed ways

It should be noted that in the description of this application, the proximal end and the distal end are relative to the operator of the artificial valve delivery device, the proximal end refers to the end relatively close to the operator, and the distal end refers to the end relatively far away from the operator .

Example 1

Referring to Fig. 1, the present application provides a stop device for an artificial valve delivery system, the artificial valve delivery system includes a balloon 1 for setting the artificial valve and a catheter 2 passing through the balloon, the catheter 2 is provided with a developing assembly 6. The fluid used to inflate the balloon 1 flows into the interior of the balloon 1 from the proximal end of the balloon 1. Specifically, the delivery system also includes a balloon connection tube 3 for connecting the balloon 1, and the proximal end of the balloon 1 is connected to the balloon 1. The distal end of the balloon connecting tube 3 is connected and fixed. The catheter 2 passes through the distal end of the balloon connecting tube 3 and penetrates into the balloon 1 from the proximal end of the balloon 1. The balloon connecting tube 3 and the catheter 2 are in the balloon. An annular cavity 8 is formed at the proximal end of the balloon 1, and the fluid used to inflate the balloon 1 flows into or flows out of the interior of the balloon 1 through the annular cavity 8.

The stopping device is located inside the balloon 1 and includes a first stopper 4 and a second stopper 5 arranged on the catheter 2 .

Referring to FIG. 2 , the first stopper 4 includes a first tube portion 41 and a first stopper portion 42 along the axial direction of the catheter 2 . The ends are arranged at intervals, the first stopper 42 is sleeved on the catheter 2, the proximal end of the first stopper 42 is affixed to the distal end of the first tube part 41, and the distal end of the first stopper 42 is used to limit the proximal end of the prosthetic valve. The first stop portion 42 is an annular structure and is formed by alternately connecting several first convex portions 43 and several first concave portions 44 along the circumferential direction. The inner and outer walls of the first recess 44 are recessed inward along the radial direction of the first stopper 42, and the radial distance between the first protrusion 43 and the axis of the catheter 2 starts from the proximal end of the first stopper 42. gradually increases distally.

Referring to FIG. 3 , the second stopper 5 includes a second tube portion 51 and a second stopper portion 52 along the axial direction of the catheter 2 , the second tube portion 51 is sleeved and fixed on the catheter 2 , and is close to the distal end, the second stopper 52 is sleeved on the catheter 2, the distal end of the second stopper 52 is affixed to the proximal end of the second tube part 51, and the proximal end of the second stopper 52 is used for limiting The distal end of the prosthetic valve. The second stop portion 52 is an annular structure and is formed by alternately connecting a plurality of second convex portions 53 and a plurality of second concave portions 54 along the circumferential direction. The inner and outer wall surfaces of the second recess 54 are recessed inward along the radial direction of the second stopper 52, and the radial distance between the second protrusion 53 and the axis of the catheter 2 starts from the proximal end of the second stopper 52. gradually decreases distally.

It should be noted that the "radial direction" here is not limited to the radial direction of a cylinder, a cone, etc., but is used to define that the direction is a direction perpendicular to the axial direction of the catheter. Here, "outward" and "inward" " is defined with respect to the axis of the catheter as an aid to illustrate the embodiments and should not be construed as a limitation.

The axial distance between the first stopper 42 and the second stopper 52 matches the axial length of the artificial valve, thereby enabling the artificial valve to be placed between the first stopper and the second stopper And is limited in the axial direction.

When the balloon 1 is in a deflated state, the fluid can pass through several first recesses 44 and several second recesses 54, that is, when the balloon is wrapped on the circumferential outer edge of the stopper, there is a gap between the two. The gaps provided by the plurality of first recesses and the plurality of second recesses, through which fluid can pass, can help improve the flow of fluid when the balloon is in a deflated state.

As a result, the stopper implements the axial limit of the artificial valve through the first stopper and the second stopper, and the first stopper and the second stopper are alternately provided with protrusions along the circumferential direction. On the basis of ensuring structural stability and controllable degrees of freedom of movement and deformation, the compressibility and performance of the first stopper and the second stopper in the radial direction are improved, and the compression deformation effect is more Even and reasonable, it is convenient to insert the stopper into the balloon during assembly to improve assembly efficiency. Moreover, the radial dimensions of the first convex portion and the second convex portion gradually increase and decrease gradually from the proximal end to the distal end, so that the first stopper portion and the second stopper portion both present a three-dimensional petal-like structure as a whole, Wherein, the first recess and the second recess can not only provide an optimized flow path for the fluid, make the flow of the fluid in the balloon more smooth, but also increase the distance between the stopper device and the balloon when the balloon is in a contracted state. The gap in the radial direction can provide a flow channel for the fluid at the initial stage of balloon inflation, facilitate the flow of fluid in the balloon, and help improve the inflation and contraction effect of the balloon.

As an optional embodiment, the first stopper 42 is a structure of equal wall thickness, that is, the inner and outer walls of the first convex part 43 protrude radially outwards from the proximal end of the first stopper 42 to the distal end. The ends are consistent, and the variation range of the inner and outer wall surfaces of the first recess 44 inwardly recessed in the radial direction is consistent from the proximal end to the distal end of the first stopper 42 . Similarly, the second stop portion 52 is of equal wall thickness, that is, the variation range of the radial outward protrusion of the inner and outer walls of the second convex portion 53 is consistent from the distal end to the proximal end of the second stop portion 52 , Moreover, the variation range of the inner and outer wall surfaces of the second concave portion 54 radially inwardly recessed is consistent from the distal end to the proximal end of the second stop portion 52 .

Therefore, the structural changes of the first stopper and the second stopper are consistent in the circumferential direction and the axial direction, so that the compression range and compression performance in the radial direction are further optimized and improved, and the structure is more stable when compressed by an external force. Stable, more uniform deformation effect, easy to assemble with the balloon, and help to improve assembly efficiency.

As an alternative to the above embodiment, the wall thickness of the first stopper 42 can gradually increase from the proximal end to the distal end of the first stopper 42, that is, the inner and outer wall surfaces of the first convex part 43 radially outward The range of variation of the protrusions may be different, and the range of variation of the inner and outer walls of the first recess 44 radially inwardly recessed may also be different. Similarly, the wall thickness of the second stopper 52 can gradually decrease from the proximal end to the distal end of the second stopper 52, that is, the variation range of the inner and outer wall surfaces of the second protrusion 53 protruding radially outward can be different, and the change range of the inner and outer wall surfaces of the second recess 54 radially inwardly recessed may also be different. Thus, the structural strength and deformation freedom of the first stopper and the second stopper can be adjusted according to actual needs, so as to meet actual use needs.

In this embodiment, the materials of the first blocking member and the second blocking member are both polymer materials, such as PP. The first tube part and the first stop part of the first stopper can be bonded and fixed together by means of thermal fusion, but considering that interventional medical devices such as artificial valve delivery systems should minimize the impact and damage on the inner wall of the blood vessel, As a preferred embodiment, the first stopper is integrally formed, and similarly, the second stopper is also integrally formed to avoid the gap between the first tube part and the first stopper part, the second tube part and the first stopper part. The connection between the second stoppers produces structures such as sharp points or protrusions, and the first stopper and the second stopper are more compact in structure and easy to assemble.

As an optional embodiment, there is a smooth connection between the first pipe portion 41 and the first stop portion 42, and a smooth connection between the second pipe portion 51 and the second stop portion 52.

As a result, there will be no unnecessary sharp structures at the connection between the tube part and the stopper part between the first stopper and the second stopper, which can reduce the damage to the inner wall of the blood vessel during delivery, and also help to complete the smooth delivery of the artificial valve. process.

As an optional embodiment, the radial section of the first recess 44 is V-shaped, and the V-shape includes two sides in an angled shape. Several first recesses 44 are arranged in the circumferential direction, and two consecutive first recesses 44 Adjacent side edges are connected to form the first protrusion 43 . Similarly, the radial cross-section of the second recess 54 is V-shaped, and the V-shape includes two sides that are angled. Several second recesses 54 are arranged in the circumferential direction, and two consecutive second recesses 54 are adjacent to each other. The side edges of are connected to form a second convex portion 53, see FIG. 4 . Preferably, the highest portion of the first protrusion 43 in the radial direction is arc-shaped, and the highest portion of the second protrusion 53 in the radial direction is arc-shaped.

Thus, the distal end surface of the first stopper has a wave-like shape that uniformly changes in the circumferential direction, and similarly, the proximal end surface of the second stopper also has a wave-like shape that uniformly changes in the circumferential direction, so that the first The actual contact area between the distal surface of the stopper and the proximal surface of the artificial valve, and between the proximal surface of the second stopper and the distal surface of the artificial valve is reasonably controlled, which can avoid contact between the artificial valve and the first artificial valve. The radial friction force between the stopper parts and between the artificial valve and the second stopper part is too large, so that the artificial valve expands more smoothly. In addition, the crests of the first stopper and the second stopper in the circumferential direction are arc-shaped, which can avoid sharp structures on the circumferential wall surface of the first stopper and the second stopper, and reduce damage to the inner wall of the blood vessel. damage.

As an alternative to the above-mentioned embodiment, the radial section of the first convex portion 43 is arc-shaped, and the arc shape includes two ends. Several first convex portions 43 are arranged along the circumferential direction. Between two consecutive first convex portions 43 Adjacent end portions are connected to form a first concave portion 44 . Similarly, the radial cross-section of the second protrusions 53 is arc-shaped, and the arc includes two ends. Several second protrusions 53 are arranged along the circumferential direction, and the adjacent ends between two consecutive second protrusions 53 parts are connected to form a second concave part 54 .

As a result, both the distal end surface of the first stopper part and the proximal end surface of the second stopper part have a uniformly changing wave shape in the circumferential direction, and there will be no redundant sharp structures on the circumferential wall surface, which can avoid Damage to the inner wall of the blood vessel during the delivery process also helps to complete the smooth delivery process of the artificial valve.

As an optional embodiment, on the distal end surface of the first stopper portion 42, the radial maximum distance between the first convex portion 43 and the axis of the catheter 2 is greater than half of the inner diameter of the artificial valve in a compressed state, and the first concave portion 44 The radial minimum distance from the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state; similarly, on the proximal surface of the second stopper 52, the radial maximum distance from the second protrusion 53 to the axis of the catheter 2 greater than half of the inner diameter of the artificial valve in a compressed state, and the radial minimum distance between the second recess 54 and the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state.

Thus, the radially highest portion of the first protrusion exceeds the inner wall of the artificial valve in the compressed state, and the radially lowest portion of the first concave portion is lower than the inner wall of the artificial valve in the compressed state, so that the first stopper can be realized Axial limit when the artificial valve is in a compressed state. Similarly, the highest part of the second protrusion in the radial direction exceeds the inner wall of the artificial valve in the compressed state, and the lowest part of the second concave part in the radial direction is lower than the inner wall of the artificial valve in the compressed state, so that the second stopper can be realized Axial limit when the artificial valve is in a compressed state. At the same time, such a structure can also avoid that in some cases, if the radial minimum distance of the first recess is greater than half of the outer diameter of the artificial valve in a compressed state, it may cause the end portion of the artificial valve to enter the first stopper and In the gap between the catheters, it affects the normal release of the artificial valve.

As an alternative to the above-mentioned embodiment, on the distal end surface of the first stopper 42, the radial maximum distance between the first protrusion 43 and the axis of the catheter 2 is greater than half of the outer diameter of the artificial valve in a compressed state, and the first The radial minimum distance between the concave portion 44 and the axis of the catheter 2 is less than half of the outer diameter of the artificial valve in a compressed state; similarly, on the proximal surface of the second stopper 52, the diameter of the second convex portion 53 and the axis of the catheter 2 The maximum distance is greater than half of the outer diameter of the artificial valve in a compressed state, and the radial minimum distance between the second recess 54 and the axis of the catheter 2 is less than half of the outer diameter of the artificial valve in a compressed state.

Thus, the highest portion of the first protrusion in the radial direction exceeds the outer wall of the artificial valve in the compressed state, and the lowest portion of the first concave portion in the radial direction is lower than the outer wall of the artificial valve in the compressed state, so that the first stopper can be realized Axial limit when the artificial valve is in a compressed state. Similarly, the highest part of the second protrusion in the radial direction exceeds the outer wall of the artificial valve in the compressed state, and the lowest part of the second concave part in the radial direction is lower than the outer wall of the artificial valve in the compressed state, so that the second stopper can be realized Axial limit when the artificial valve is in a compressed state. Moreover, the radially highest portions of the first convex portion and the second convex portion both exceed the outer wall of the artificial valve in the compressed state, which is equivalent to being in a structure similar to an annular groove in the compressed state of the artificial valve, so that it can be transported during delivery. It can better protect the artificial valve, reduce the contact between the artificial valve and the inner wall of the blood vessel during the movement process, and prevent other components of the delivery system from touching the outer wall of the artificial valve.

As a preferred solution of the above-mentioned embodiment, the radial maximum distance between the first convex portion 43 and the axis of the catheter 2 is 1.05 to 1.25 times the half of the outer diameter of the artificial valve in a compressed state; the diameter of the second convex portion 53 and the axis of the catheter 2 The maximum distance is 1.05 to 1.25 times the half of the outer diameter of the artificial valve in a compressed state.

Thus, by limiting the size of the first convex part and the second convex part, the highest part in the radial direction of the first convex part and the second convex part is slightly higher than the outer wall of the artificial valve in the compressed state, which can realize the artificial The axial limit and circumferential protection of the valve prevents the radial dimensions of the first stopper and the second stopper from being too large, avoiding unnecessary damage to the inner wall of the blood vessel, and conveniently moving the first The stopper, the second stopper and the balloon are assembled.

As an optional embodiment, referring to Fig. 1 and Fig. 3, the second stopper 5 further includes a third tube part 55 in the axial direction, the proximal end of the third tube part 55 is affixed to the distal end of the second tube part 51, The distal end of the third tube part 55 is used for fixed connection with the tapered head 7 of the delivery system and the distal end of the balloon 1 , and the proximal outer diameter of the third tube part 55 is smaller than the distal outer diameter of the second tube part 51 .

Specifically, the distal opening of the balloon 1 is wrapped on the outer side of the distal tube wall of the third tube part 55, and the proximal end of the conical head 7 and the distal end of the third tube part 55 can be fixedly connected through the end surface or fixedly connected through an insert. .

Therefore, while the second stopper provides the position-limiting function for the artificial valve, it also provides the function of fixed connection for the conical head and the distal end of the balloon, so that the structure of the artificial valve delivery system at the distal end is more compact and simple. and reduce damage to blood vessels.

As an optional embodiment, a radially penetrating first dispensing hole 45 is provided on the pipe wall of the first pipe part 41; a radially penetrating second dispensing hole 56 is provided on the pipe wall of the second pipe part 51, by This realizes the adhesively fixed connection of the first stopper and the second stopper with the catheter.

The present application also provides an artificial valve delivery system, including a balloon 1 arranged at the distal end of the delivery system, a balloon connection tube 3 for connecting the balloon 1 and a balloon connection tube 3 inserted into the balloon connection tube 3. Catheter 2, the proximal end of the balloon 1 is connected and fixed to the distal end of the balloon connecting tube 3, the catheter 2 passes through the distal end of the balloon connecting tube 3 and penetrates into the balloon 1 from the proximal end of the balloon 1, the balloon The balloon connecting tube 3 and the catheter 2 form an annular cavity 8 at the proximal end of the balloon 1 , and the fluid used to inflate the balloon 1 flows into or out of the balloon 1 through the annular cavity 8 .

The catheter 2 is provided with the above-mentioned stopping device, which is used for axially limiting the artificial valve in the compressed state.

Thus, through the first stopper and the second stopper in the stopping device, the artificial valve support can be effectively limited in the axial direction, and the flow of fluid in the balloon can also be optimized when the balloon is inflated and deflated. The path can effectively improve the effect of fluid flow, help to improve surgical efficiency and reduce surgical risk.

The present application is used for the stop device of the artificial valve delivery system and the artificial valve delivery system, wherein, both the first stopper and the second stopper have a stopper with a continuous three-dimensional petal-shaped structure, which can effectively move the artificial valve in the axial direction. In addition to limiting, it also has good radial compressibility, and at the same time, the first concave part and the second concave part can provide an optimized flow path for the fluid, especially as a fluid channel when the balloon is in a contracted state, which helps to improve The effect of balloon expansion and contraction can improve the operation effect of the artificial valve delivery system and reduce the operation risk to a certain extent.

Example 2

Referring to FIG. 5 , the present application provides a stopper for an artificial valve delivery device. The distal region of the artificial valve delivery device includes a balloon 1 for setting the artificial valve and a catheter 2 passing through the balloon. The catheter 2 is arranged at intervals Two stoppers, the two stoppers are located inside the balloon 1 . An artificial valve is accommodated between the two stoppers. The material of the stopper is a polymer material, such as PP, PE, K resin, PTFE, block polyether amide resin (PEBAX) and the like.

Referring to Fig. 2, the stopper includes a sleeve part (such as the first pipe part 41 or the second pipe part 51) and a stopper part (such as the first stopper part 42 or the second stopper part 52), and the stopper is One-piece construction. Wherein, when the stopper is installed on the catheter 2, the sleeve part (such as the first tube part 41 or the second tube part 51) is set away from the artificial valve, and the stop part (such as the first stop part 42 or the second stop part The moving part 52) is set close to the artificial valve.

The sleeve part (such as the first tube part 41 or the second tube part 51) is used to be sleeved and fixed on the catheter 2, and one end of the sleeve part (such as the first tube part 41 or the second tube part 51) is coaxially provided with A stopper (such as the first stopper 42 or the second stopper 52). The stopper (such as the first stopper 42 or the second stopper 52) is used to limit the artificial valve, and the stopper (such as the first stopper 42 or the second stopper 52) is sleeved on the catheter The annular structure on 2 is formed by alternate connection of several convex portions (such as the first convex portion 43 or the second convex portion 53) and several concave portions (the first concave portion 44 or the second concave portion 54) along the circumferential direction, and the convex portion 43 ( For example, the inner and outer wall surfaces of the first convex portion 43 or the second convex portion 53) protrude radially outward along the stopper portion (such as the first stopper portion 42 or the second stopper portion 52), and the concave portion 44 (or 54 ) inside and outside walls are recessed inward along the radial direction of the stopper (such as the first stopper 42 or the second stopper 52), and the convex part (such as the first convexity 43 or the second convexity 53) and the stopper The radial distance of the axis of the stopper part (such as the first stopper part 42 or the second stopper part 52 ) gradually increases toward the direction away from the sleeve part.

The recess 44 (or 54) penetrates the stopper 42 (such as the first stopper 42 or the second stopper 52) along the axial direction of the stopper (such as the first stopper 42 or the second stopper 52) . When the balloon 1 is in a deflated state, the fluid can pass through several recesses (the first recess 44 or the second recess 54), that is, when the balloon 1 is almost completely wrapped in the stopper (such as the first stopper 42 or the second stopper 42). When the circumferential outer edge of the two stoppers 52) is upward, there are still gaps provided by several recesses (first recesses 44 or second recesses 54) between the balloon 1 and the stopper, and these gaps can be used as fluid passages for supplying fluid. Fluid passes through.

Thus, the artificial valve can be placed between the two stoppers, and the artificial valve can be limited in the axial direction of the catheter. The stopping part has convex parts and concave parts connected alternately along the circumferential direction. On the one hand, the radial dimension of the convex part gradually increases in the direction close to the artificial valve, so that the stopping part presents a continuous three-dimensional petal-like structure, and The concave part can provide a larger deformation space for the convex part in the radial direction, so that the radial compression performance of the stopper part can be improved. The stop part can maintain a stable structure, and its degree of freedom of deformation can be controlled when it is subjected to external force, so that the stop part can ensure its effectiveness and stability in the process of limiting the artificial valve, and also helps to improve Limit accuracy. Moreover, the recess can optimize the flow path of the fluid in the balloon, especially when the balloon is in a deflated state, it can also provide a flow channel for the fluid, so as to accelerate the flow effect and improve the inflation and contraction effect of the balloon.

As an optional embodiment, the stopper (such as the first stopper 42 or the second stopper 52) is an equal-wall thickness structure, that is, the stopper (such as the first stopper 42 or the second stopper 52) Part 52) has equal wall thickness everywhere. As a result, the structural strength of the stopping part remains consistent, and this structure leaves a certain reasonable space between the inner wall surface of the stopping part and the outer tube wall of the catheter, which can further optimize and improve its compression performance, so that The deformation effect of the stopper is more reasonable when the stopper is acted by external force, and the assembly of the stopper and the balloon is more convenient.

As an alternative to the above-mentioned embodiment, the wall thickness of the stopper (such as the first stopper 42 or the second stopper 52) can gradually increase or decrease gradually in the direction close to the artificial valve, that is, the convex part ( As the range of variation of the inner and outer walls of the first convex portion 43 or the second convex portion 53) in the above-mentioned direction can be different, the range of variation of the inner and outer walls of the concave portion 44 (the first concave portion 44 or the second concave portion 54) in the above-mentioned direction is also different. Can be different. Thus, the wall thickness variation of the stopper portion can be adjusted according to actual needs to obtain corresponding structural strength and deformation freedom.

As an optional embodiment, there is a smooth connection between the sleeve part (such as the first pipe part 41 or the second pipe part 51) and the stopper part (such as the first stopper part 42 or the second stopper part 52), That is, the stop portion (such as the first stop portion 42 or the second stop portion 52) is connected with the sleeve portion (such as the first tube portion 41 or the second tube portion 51) and the size of the end surface of the sleeve portion (such as the first tube portion 51) The radial dimensions of a pipe portion 41 or the second pipe portion 51) are kept consistent, and the stopper portion (such as the first stopper portion 42 or the second stopper portion 52) gradually extends out of the convex portion in the direction away from the sleeve portion (such as the first convex portion 43 or the second convex portion 53) and the concave portion (the first concave portion 44 or the second concave portion 54). Therefore, there will be no redundant sharp structure at the junction of the cannula part and the stop part, which can reduce the damage to the inner wall of the blood vessel during the delivery process, and also help reduce the risk during the delivery process of the artificial valve.

As an optional embodiment, the radial section of the convex portion (such as the first convex portion 43 or the second convex portion 53) can be in the shape of a semicircle, an arc, an n-type, an inverted V shape, etc., and the concave portion (the first concave portion 44 or the second concave portion 54) can be in the shape of a semicircular ring, an arc, a U shape, a V shape, etc., and the convex portion (such as the first convex portion 43 or the second convex portion 53) and the concave portion (the first The above-mentioned shapes of the concave portion 44 or the second concave portion 54) can be freely combined. As a result, the end surface of the stopper facing the artificial valve is in a wave-like shape that uniformly changes in the circumferential direction, so that the actual contact area between the stopper and the axial end surface of the artificial valve is reasonably controlled, and the artificial valve is prevented from being affected in the radial direction. If the friction force is too large, the artificial valve will unfold more smoothly.

As a preferred solution of the above-mentioned embodiment, referring to Fig. 4, the radial section of the recess (the first recess 44 or the second recess 54) is V-shaped, and several recesses (the first recess 44 or the second recess 54) are arranged circumferentially such that A convex portion (such as the first convex portion 43 or the second convex portion 53 ) is formed between two adjacent concave portions (the first concave portion 44 or the second concave portion 54 ). The V shape includes two sides that are angled, and several recesses (the first recess 44 or the second recess 54) are arranged along the circumferential direction, and the two continuous recesses (the first recess 44 or the second recess 54) are connected to each other. Adjacent sides are connected to form a convex portion, so that the convex portion (such as the first convex portion 43 or the second convex portion 53 ) forms an inverted V-shaped structure. Therefore, the V-shaped included angle of the concave part is larger than the V-shaped included angle of the convex part, so that the accommodating space of the concave part as a fluid channel is larger, and it can also provide a larger deformation space for the convex part when it is compressed and deformed in the radial direction, which is easy to stop. The moving part achieves radial compression.

As a preferred solution of the above-mentioned embodiment, the convex portion (such as the first convex portion 43 or the second convex portion 53) is arc-shaped at the highest point in the radial direction, that is, the convex portion (such as the first convex portion 43 or the second convex portion 53) The circumferential outer edge at the V-shaped angle is a smooth transition shape, which can avoid the sharp structure of the stopper on the circumferential wall surface, so as to reduce the damage to the inner wall of the blood vessel during the delivery process, and reduce the artificial valve delivery as much as possible. risks in the process.

As an optional embodiment, the end face of the stopper (such as the first stopper 42 or the second stopper 52) facing the artificial valve, the convex part (such as the first convex part 43 or the second convex part 53) and The radial maximum distance of the axis of the catheter 2 is greater than half of the inner diameter of the artificial valve in a compressed state, and the radial minimum distance between the recess (the first recess 44 or the second recess 54) and the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state.

Thus, the radially highest part of the convex portion exceeds the inner wall of the artificial valve in the compressed state, and the radially lowest portion of the concave portion is lower than the inner wall of the artificial valve in the compressed state, so that the stopper can be in a compressed state for the artificial valve When the axial limit. At the same time, by limiting the size of the convex part and the concave part in the radial direction, it is ensured that the end face of the artificial valve is in contact with the end face of the stop part, so as to realize the axial limit of the artificial valve in the compressed state, and also avoid in some cases Next, if the minimum radial distance of the recess is greater than half of the outer diameter of the artificial valve under compression, it may cause the end portion of the artificial valve to enter the gap between the stopper and the catheter, affecting the normal release of the artificial valve.

As a preferred solution of the above embodiment, the maximum radial distance between the convex portion (such as the first convex portion 43 or the second convex portion 53 ) and the axis of the catheter 2 is greater than half of the outer diameter of the artificial valve in a compressed state. Therefore, on the end surface of the stopper facing the artificial valve, the highest radial part of the protrusion is higher than the outer wall of the artificial valve in the compressed state, which is equivalent to being in a structure similar to an annular groove in the compressed state of the artificial valve. On the one hand, there is enough contact area between the stopper and the artificial valve, so as to ensure the axial limit of the artificial valve; better protection.

As an optional embodiment, the end face of the stopper (such as the first stopper 42 or the second stopper 52) facing the artificial valve, the convex part (such as the first convex part 43 or the second convex part 53) and The radial maximum distance of the axis of the catheter 2 is greater than half of the outer diameter of the artificial valve in a compressed state, and the radial minimum distance between the recess (the first recess 44 or the second recess 54) and the axis of the catheter 2 is less than half of the outer diameter of the artificial valve in a compressed state. half. That is, when the radially highest portion of the protruding portion is higher than the outer wall of the artificial valve in the compressed state, it is only necessary to ensure that the radially lowest portion of the concave portion is lower than the outer wall of the artificial valve in the compressed state, so that the stopper can achieve alignment. The axial limit of the artificial valve is equivalent to being in a structure similar to an annular groove when the artificial valve is in a compressed state, which can realize the protection of the artificial valve.

As a preferred solution of the above embodiment, the minimum radial distance between the concave portion (the first concave portion 44 or the second concave portion 54 ) and the axis of the catheter 2 is less than half of the inner diameter of the artificial valve in a compressed state. As a result, there is a sufficient contact area between the stopper and the artificial valve, thereby ensuring the axial limit of the artificial valve.

When the radial maximum distance between the convex portion (such as the first convex portion 43 or the second convex portion 53) and the axis of the catheter 2 is greater than half of the outer diameter of the prosthetic valve in the compressed state, the convex portion (such as the first convex portion 43 or the second convex portion The radial maximum distance between the portion 53) and the axis of the catheter 2 is preferably 1.05 to 1.25 times the half of the outer diameter of the artificial valve in a compressed state.

As an optional embodiment, a radially penetrating dispensing hole (the first dispensing hole 45 or the second dispensing hole 56) is set on the pipe wall of the casing part (such as the first pipe part 41 or the second pipe part 51). ), the dispensing hole (the first dispensing hole 45 or the second dispensing hole 56) at least penetrates the one-sided tube wall of the casing part (such as the first tube part 41 or the second tube part 51), thereby realizing a stop Adhesive fixation of parts and conduits.

As an optional embodiment, the axial length of the stopper part (such as the first stopper part 42 or the second stopper part 52) is the axis of the sleeve part (such as the first tube part 41 or the second tube part 51). One-third to one-half of the length. Therefore, by reasonably controlling the axial length ratio of the sleeve part and the stopper part, the stopper can have better performance in terms of structural strength and axial positioning, and the size of the structural part can be kept within a reasonable range Inside.

As an optional embodiment, referring to FIG. 3 , the other end of the casing part (such as the first tube part 41 or the second tube part 51 ) is coaxially connected with an extension part (that is, the third tube part 55 in the first embodiment). ), the extension part is sleeve-shaped, the extension part is sleeved and fixed on the catheter 2, and the outer diameter of the extension part is smaller than the outer diameter of the sleeve part (such as the first tube part 41 or the second tube part 51). When the stopper is placed close to the distal area of the balloon 1, the extension can be used to fix the connecting guide (ie, the conical head 7 in the first embodiment), specifically, the distal end of the balloon 1 is wrapped around the extension. On the outer tube wall at the distal end, the guide piece and the extension part can be fixedly connected through the end surface or fixedly connected by inserting.

As a result, the stopper provided near the distal end of the balloon can provide a position-limiting function for the artificial valve and at the same time provide an installation position for the guide and the distal end of the balloon, so that the artificial valve delivery device can be positioned at the distal end of the valve. The structure is more compact and simple, and can also reduce damage to blood vessels.

The present application also provides an artificial valve delivery device, including an artificial valve delivery system, as shown in FIG. A proximal stopper (ie, the first stopper 4 in the first embodiment) and a distal stopper (ie, the second stopper 5 in the first embodiment) are provided on the catheter 2 at intervals.

The near-end stopper and the far-end stopper are the stoppers described in the above embodiments, and the parts where the two are close to each other are respective stoppers, and the space between the proximal stopper and the far-end stopper A limited space for accommodating the artificial valve in a compressed state is formed.

As a result, the proximal stopper and the distal stopper can effectively limit the position of the artificial valve in the axial direction, and the recess on the stopper can also optimize the flow of fluid in the balloon when the balloon is inflated and deflated. The flow path, especially providing a flow channel for the fluid in the balloon deflation state, has a positive effect on improving the inflation and deflation effects of the balloon.

As an optional embodiment, the proximal end of the balloon 1 is affixed to the catheter 2, and the proximal end of the balloon 1 is spaced apart from the proximal end stopper. The tube wall of the catheter 2 is provided with several radially through openings, and the fluid used to inflate the balloon 1 flows into the interior of the balloon 1 through the openings. The opening is provided between the proximal end of the balloon 1 and the proximal stop.

When the end of the sleeve part (such as the first tube part 41 or the second tube part 51) of the distal stopper is connected coaxially to the stop part (such as the first stop part 42 or the second stop part 52) There is an extension part, the extension part is sleeve-shaped and fixed on the catheter 2, the outer tube wall of the extension part is fixedly connected to the distal end of the balloon 1, and the distal end of the extension part is fixedly connected to the guide.

As an alternative to the above embodiment, referring to Fig. 1, the artificial valve delivery device is also provided with a balloon connecting tube 3, the catheter 2 passes through the balloon connecting tube 3 and enters the inside of the balloon 1, and the proximal end of the balloon 1 is affixed On the balloon connecting tube 3, the proximal end of the balloon 1 is spaced from the proximal stopper. At this time, the distance between the balloon connecting tube 3 and the proximal stopper is also set at intervals. The balloon connecting tube 3 and The catheter 2 forms an annular lumen 8 at the proximal end of the balloon 1 , and the fluid used to inflate the balloon 1 flows into the interior of the balloon 1 through the annular lumen 8 through the space between the balloon connecting tube 3 and the proximal stopper.

In the above two embodiments, the fluid flows into the interior of the balloon from the proximal end of the balloon, so that the recess on the proximal stopper can provide a fluid channel for the fluid when the balloon is in a contracted state, so as to achieve better flow effect.

In the description of the present application, it should be understood that, unless otherwise specified, "first", "second" and other similar words are used for description purposes only, and should not be understood as indicating or implying relative importance. In addition, in the description of the present application, unless otherwise specified, the meanings of "plurality" and "several" are two or more.

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.

It should be understood that the above-mentioned implementations are only exemplary rather than limiting, and those skilled in the art can make various obvious or equivalent solutions to the above-mentioned details without departing from the basic principles of the present application. Any modification or replacement will be included in the scope of the claims of this application.

Claims (20)

A stop device for an artificial valve delivery system, the artificial valve delivery system includes a balloon for setting the artificial valve and a catheter passing through the balloon, the fluid flows into the interior of the balloon from the proximal end of the balloon, and is characterized in that , the stopper is located within the balloon and includes: The first stopper includes a first tube portion and a first stopper along the axial direction of the catheter, the first tube portion is sleeved on and fixed on the catheter, and is spaced apart from the proximal end of the balloon, the first The stopper is sleeved on the catheter, the proximal end of the first stopper is affixed to the distal end of the first tube, and the distal end of the first stopper is used to limit the proximal end of the artificial valve, The first stop part is an annular structure and is formed by alternately connecting several first convex parts and several first concave parts along the circumferential direction, and the inner and outer wall surfaces of the first convex part protrude outward along the radial direction of the first stop part, The inner and outer wall surfaces of the first recess are recessed inward along the radial direction of the first stopper, and the radial distance between the first protrusion and the catheter axis gradually increases from the proximal end to the distal end of the first stopper; The second stopper includes a second tube part and a second stop part along the axial direction of the catheter, the second tube part is sleeved and fixed on the catheter, and is arranged near the distal end of the balloon, and the second stop part The moving part is sleeved on the catheter, the distal end of the second stopper is fixedly connected to the proximal end of the second pipe part, and the proximal end of the second stopper is used to limit the distal end of the artificial valve. The two stoppers are ring-shaped and formed by alternately connecting several second protrusions and second recesses along the circumferential direction. The inner and outer walls of the second protrusions protrude outward along the radial direction of the second stopper. The inner and outer walls of the two recesses are recessed inward along the radial direction of the second stopper, and the radial distance between the second protrusion and the axis of the catheter gradually decreases from the proximal end to the distal end of the second stopper; The axial distance between the first stopper and the second stopper matches the axial length of the artificial valve; When the balloon is in a deflated state, fluid can pass through the plurality of first recesses and the plurality of second recesses. The stopper device for an artificial valve delivery system according to claim 1, characterized in that, the first stopper is a structure of equal wall thickness; the second stopper is a structure of constant wall thickness. The stopping device for the artificial valve delivery system according to claim 1, wherein the first tube part is smoothly connected with the first stopper part; the second tube part and the second stopper part are smoothly connected connect. The stopping device for an artificial valve delivery system according to claim 1, wherein the radial cross-section of the first recess is V-shaped, several first recesses are arranged in the circumferential direction, and two adjacent second recesses A first convex portion is formed between one concave portion; a radial section of the second concave portion is V-shaped, several second concave portions are arranged along the circumferential direction, and a second convex portion is formed between two adjacent second concave portions. The stopping device for an artificial valve delivery system according to claim 1, wherein, On the distal end surface of the first stopper part, the radial maximum distance between the first convex part and the axis of the catheter is greater than half of the inner diameter of the artificial valve in a compressed state, and the first concave part and the The radial minimum distance of the catheter axis is less than half of the inner diameter of the artificial valve in a compressed state; On the proximal end surface of the second stopper, the radial maximum distance between the second protrusion and the catheter axis is greater than half of the inner diameter of the artificial valve in a compressed state, and the second recess and the The radial minimum distance of the catheter axis is less than half of the inner diameter of the prosthetic valve in a compressed state. The stopping device for an artificial valve delivery system according to claim 1, wherein, On the distal end surface of the first stopper part, the radial maximum distance between the first convex part and the axis of the catheter is greater than half of the outer diameter of the artificial valve in a compressed state, and the first concave part and the The radial minimum distance of the catheter axis is less than half of the outer diameter of the prosthetic valve in a compressed state; On the proximal end surface of the second stopper, the maximum radial distance between the second protrusion and the catheter axis is greater than half of the outer diameter of the artificial valve in a compressed state, and the second recess is defined by The radial minimum distance of the catheter axis is less than half of the outer diameter of the artificial valve in a compressed state. The stopping device for an artificial valve delivery system according to claim 6, wherein, The maximum radial distance between the first protrusion and the catheter axis is 1.05 to 1.25 times half of the outer diameter of the artificial valve in a compressed state; The maximum radial distance between the second protrusion and the catheter axis is 1.05-1.25 times half of the outer diameter of the artificial valve in a compressed state. The stopping device for an artificial valve delivery system according to any one of claims 1 to 7, wherein the second blocking member further includes a third tube portion in the axial direction, and the proximal end of the third tube portion It is affixed to the distal end of the second tube part, the distal end of the third tube part is used to be affixed to the conical head of the delivery system and the distal end of the balloon, and the proximal end of the third tube part is The diameter is smaller than the outer diameter of the distal end of the second tube part. The stopping device for an artificial valve delivery system according to any one of claims 1 to 8, wherein a radially penetrating first dispensing hole is set on the tube wall of the first tube part; A radially penetrating second dispensing hole is arranged on the pipe wall of the second pipe portion. An artificial valve delivery system, characterized in that it comprises a balloon arranged at the far end of the delivery system, a balloon connecting tube for connecting the balloon and a catheter inserted into the balloon connecting tube, the balloon The proximal end of the balloon is connected and fixed with the distal end of the balloon connecting tube, and the catheter passes through the distal end of the balloon connecting tube and penetrates into the balloon through the proximal end of the balloon. The balloon connecting tube and the catheter are An annular cavity is formed at the proximal end of the balloon, through which the fluid used to inflate the balloon flows into or out of the interior of the balloon; The guide tube is provided with a stopping device according to any one of claims 1 to 9, and the stopping device is used for axially limiting the artificial valve in a compressed state. A stopper for an artificial valve delivery device, the artificial valve delivery device includes a balloon for setting the artificial valve and a catheter that runs through the balloon, and two stoppers are arranged at intervals on the catheter, it is characterized in that, The stopper includes a sleeve part and a stop part; the sleeve part is used to be sleeved and fixed on the catheter, and one end of the sleeve part is coaxially connected with the stop part; the stop part It is used to limit the artificial valve. The stop part is an annular structure sleeved on the catheter and is formed by alternately connecting several convex parts and several concave parts along the circumferential direction. The inner and outer walls of the convex parts are all along the radial direction of the stop part. The inner and outer wall surfaces of the concave part are recessed inward along the radial direction of the stopper part, and the radial distance between the convex part and the axis of the stopper part gradually increases in the direction away from the sleeve part, and the concave part The stop part is penetrated along the axial direction of the stop part. The stopper of the artificial valve delivery device according to claim 11, characterized in that, the stopper is a structure of equal wall thickness. The stopper of the artificial valve delivery device according to claim 11, wherein the sleeve part and the stopper part are connected smoothly. The stopper of the artificial valve delivery device according to claim 11, wherein the radial cross-section of the concave part is V-shaped, and a convex part is formed between two adjacent concave parts. The stopper of the artificial valve delivery device according to claim 14, wherein the highest point of the protrusion in the radial direction is arc-shaped. The stopper of the artificial valve delivery device according to claim 11, characterized in that, on the end face of the stopper part, the radial maximum distance between the convex part and the axis of the stopper part is greater than the compressed state of the artificial valve half of the lower inner diameter, and the radial minimum distance between the recess and the axis of the stopper is less than half of the inner diameter of the artificial valve in a compressed state. The stopper of the artificial valve delivery device according to claim 16, wherein the maximum radial distance between the protrusion and the axis of the stopper is greater than half of the outer diameter of the artificial valve in a compressed state. The stopper of the artificial valve delivery device according to claim 11, characterized in that, radially penetrating glue dispensing holes are arranged on the tube wall of the cannula part. The stopper of the artificial valve delivery device according to any one of claims 11 to 18, characterized in that, the other end of the sleeve part is coaxially connected with an extension part, and the extension part is sleeve-shaped and sleeved To be fixed on the catheter, the outer diameter of the extension part is smaller than the outer diameter of the sleeve part. An artificial valve delivery device is characterized in that it comprises a catheter, a balloon located at the distal end of the catheter, a guide at the distal end of the catheter, a guide located in the balloon and spaced on the catheter a proximal stop and a distal stop; The proximal stopper and the distal stopper are the stoppers described in any one of claims 11 to 19, and the adjacent parts of the two are respective stoppers, and the proximal stopper A limiting space for accommodating the artificial valve in a compressed state is formed between the stopper and the distal stopper; the proximal end of the balloon is spaced apart from the proximal stopper.

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