Valve delivery device and valve delivery system

By adopting a combined structure of guide and flexible locking members in the heart valve prosthesis delivery system, the problem of early fall off of the heart valve prosthesis during delivery is solved, and the stability and flexibility are improved, reducing the risk of surgery.

CN119097475APending Publication Date: 2024-12-10SUZHOU JIECHENG MEDICAL INC
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Patent Information

Application Number
CN202411448112.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-16
Publication Date
2024-12-10

AI Technical Summary

Technical Problem

The existing heart valve prosthesis delivery system can easily cause the heart valve prosthesis to fall off early when transported in the blood vessels, resulting in the failure of the device.

Method used

A valve delivery device is designed, adopting a combined structure of a guide member and a flexible locking member. Through the penetration part of the guide member and the multiple penetration and outgoing design of the flexible locking member, it ensures that the heart valve stent is stable and fixed during the delivery process, and Release the locked state after being in place to release the valve.

Benefits of technology

It improves the stability of the heart valve prosthesis during delivery, avoids premature shedding, enhances the flexibility and safety of operation, and reduces the risk of surgery.

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Abstract

The invention relates to the technical field of heart valve prosthesis implantation instruments, in particular to a valve conveying device and a valve conveying system. The valve conveying device is used for conveying heart valves and comprises a guide part, a valve conveying part and a valve conveying part, and a plurality of penetrating parts are arranged on the side wall of the guide part; and the flexible locking piece extends along the inner cavity of the guide piece, and after penetrating out of the guide piece from one penetrating part, the flexible locking piece penetrates back into the guide piece from the other penetrating part and then penetrates through the matching piece. According to the valve conveying device, the flexible locking piece penetrates through the matching piece on the matching structure to lock the matching structure, stable locking can be kept all the time in the moving process, locking of the flexible locking piece and the matching piece cannot be relieved before the flexible locking piece is pulled, the stability of the valve conveying device in the using process can be improved, and the valve conveying device is convenient to use. And the heart valve stent is prevented from falling off in advance.
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Description

Technical Field

[0001] The present invention relates to the technical field of heart valve prosthesis implantation instruments, and in particular to a valve delivery device and a valve delivery system. Background Art

[0002] Artificial heart valves are used to replace damaged or diseased heart valves. In vertebrates, the heart is a muscular organ with four pumping chambers: the left atrium, the right atrium, the left ventricle, and the right ventricle. Each of the left atrium, the right atrium, the left ventricle, and the right ventricle is equipped with its own one-way valve. When there is a problem with the valve, it will cause diseases such as insufficient blood supply to the heart and heart failure. In the prior art, heart valve prosthesis replacement is usually used to treat it.

[0003] Traditional heart valve replacement surgery involves accessing the heart within the patient's chest cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcing the two opposing halves of the rib basket apart, allowing access to the chest cavity and heart. The patient is then placed on cardiopulmonary bypass, which involves stopping the heart to allow access to the internal chambers. This open-heart surgery is particularly invasive and involves a long and difficult recovery period.

[0004] In order to reduce the damage to the human body during the implantation of the heart valve prosthesis, the heart valve prosthesis is implanted through an interventional method. When the heart valve prosthesis is implanted, the positioning piece on the heart valve prosthesis is fixed by the buckle structure on the delivery system through the card slot. Driven by the delivery system, after the heart valve prosthesis is positioned, the buckle structure is pushed to the far end to make the positioning piece fall off from the delivery system and release. However, since the buckle-type connection structure has high requirements for the coordination of the parts in the delivery system, when the delivery system passes through the tortuous blood vessels, the bending of the locking mechanism will cause the straight length of the locking mechanism to change, and it is easy for the locking mechanism to be released from the positioning piece before release, resulting in device failure. Summary of the invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the defect of premature detachment of the heart valve prosthesis when the heart valve prosthesis is transported in a blood vessel by the heart valve prosthesis delivery system in the prior art, thereby providing a valve delivery device and a valve delivery system.

[0006] In order to solve the above technical problems, the present invention provides a valve delivery device for delivering a heart valve. The heart valve is provided with a matching structure, and the matching structure is provided with a matching piece. The valve delivery device comprises:

[0007] A guide member, a side wall of which is provided with a plurality of penetration portions;

[0008] The flexible locking piece extends along the inner cavity of the guide piece. After passing through the guide piece from one through-hole, the flexible locking piece passes back into the guide piece from another through-hole, and then passes through the matching piece.

[0009] Optionally, two penetration portions are provided, and the flexible locking member is built into the guide member after passing through the fitting member.

[0010] Optionally, after passing through the matching piece, the flexible locking piece passes out of the guide piece, and then passes back into the guide piece through another penetration portion.

[0011] Optionally, three penetration portions are provided, and after the flexible locking member passes through the matching member, it passes through the end of the guide member to the outside of the guide member, and then passes through another penetration portion back into the guide member.

[0012] Optionally, after the flexible locking member passes through the matching member, it passes through another penetration portion to the outside of the guide member;

[0013] After the flexible locking piece passes through the matching piece, it passes through the end of the guide piece to the outside of the guide piece.

[0014] Optionally, four through-holes are provided, including a first through-hole, a second through-hole, a third through-hole and a fourth through-hole, a center line connecting the first through-hole and the second through-hole is parallel to the extension direction of the guide member, and a center line connecting the third through-hole and the fourth through-hole is parallel to the extension direction of the guide member;

[0015] Or, the through-hole includes a first through-hole, a second through-hole, a third through-hole and a fourth through-hole, a center line connecting the first through-hole and the second through-hole is parallel to the extension direction of the guide member, and a center line connecting the third through-hole and the fourth through-hole intersects with the extension direction of the guide member;

[0016] Or, the through-hole includes a first through-hole, a second through-hole, a third through-hole and a fourth through-hole, the center line of the first through-hole and the second through-hole intersects with the extension direction of the guide member, and the center line of the third through-hole and the fourth through-hole is parallel to the extension direction of the guide member;

[0017] Or, the through-hole includes a first through-hole, a second through-hole, a third through-hole and a fourth through-hole, the center line of the first through-hole and the second through-hole intersects with the extension direction of the guide member, and the center connection of the third through-hole and the fourth through-hole intersects with the extension direction of the guide member.

[0018] Optionally, after the flexible locking piece passes through the guide piece from the second through hole, it passes back into the guide piece from the first through hole, then passes through the matching piece, then passes out of the guide piece from the third through hole, and finally passes back into the guide piece from the fourth through hole.

[0019] Optionally, the first through hole and the third through hole are arranged close to the end of the guide member, and the first through hole and the third through hole are arranged flush along the circumferential direction of the guide member;

[0020] Or, the second through hole and the fourth through hole are arranged away from the end of the guide member, and the second through hole and the fourth through hole are arranged flush along the circumferential direction of the guide member;

[0021] Or, the first through hole and the third through hole are arranged near the end of the guide member, and the first through hole and the third through hole are arranged staggered along the circumferential direction of the guide member;

[0022] Alternatively, the second through hole and the fourth through hole are arranged away from the end of the guide member, and the second through hole and the fourth through hole are arranged in an offset manner along the circumferential direction of the guide member.

[0023] Optionally, a center line between the first through hole and the third through hole intersects with a center axis of the guide member;

[0024] Or, a center line between the first through hole and the third through hole and a center axis of the guide member are skew lines;

[0025] Or, a center line between the second through hole and the fourth through hole intersects with a center axis of the guide member;

[0026] Alternatively, a center line between the second through hole and the fourth through hole and a center axis of the guide member are skew lines.

[0027] Optionally, the length of the first through hole and / or the third through hole in the axial direction of the guide member is greater than the length of the second through hole and / or the fourth through hole in the axial direction of the guide member;

[0028] Or, the length of the first through hole and / or the third through hole in the axial direction of the guide member is smaller than the length of the second through hole and / or the fourth through hole in the axial direction of the guide member;

[0029] Alternatively, the length of the first through hole and / or the third through hole in the axial direction of the guide member is equal to the length of the second through hole and / or the fourth through hole in the axial direction of the guide member.

[0030] Optionally, there are no less than five penetration parts, and the flexible locking piece penetrates into or out of the guide piece multiple times at different penetration parts.

[0031] Optionally, the cross-sectional shape of the mating structure perpendicular to the axial direction is polygonal, U-shaped hole, arc, circle, ellipse, oblong, star, cross, semicircle, heart, crescent or cross, and the cross-sectional shape of the inner cavity of the guide member is polygonal, U-shaped hole, arc, circle, ellipse, oblong, star, cross, semicircle, heart, crescent or cross.

[0032] Optionally, the guide member includes a square tube segment and a round tube segment connected in sequence, and the matching member is suitable for matching and plugging with the inner cavity of the square tube segment, or the matching member is suitable for matching and plugging with the inner cavity of the round tube segment;

[0033] Or, the guide member is a circular tube with uniform radial direction as a whole;

[0034] Or, the guide member is a square tube with uniform radial direction as a whole;

[0035] Or, the guide member includes a first circular tube segment and a second circular tube segment connected in sequence, the inner diameter of the first circular tube segment is smaller than the inner diameter of the second circular tube segment, and the matching member is suitable for matching with the first circular tube segment or the matching member is suitable for matching with the second circular tube segment;

[0036] Or, the guide member includes a first square tube segment and a second square tube segment connected in sequence, the inner diameter of the first square tube segment is smaller than the inner diameter of the second square tube segment, and the fitting member is suitable for fitting with the first square tube segment or the fitting member is suitable for fitting with the second square tube segment.

[0037] Optionally, the through-hole is a U-shaped hole, a polygonal hole, a circular hole, an oblong hole, a semicircular hole, a cross hole, a star-shaped hole, a heart-shaped hole, a crescent-shaped hole, an arc-shaped hole, an elliptical hole or a cross-line hole.

[0038] Optionally, the angle between the flexible locking member passing through the through-portion and the axis of the guide member is 0° to 60°;

[0039] And / or, the penetration portion is provided with a chamfer, and the angle of the chamfer is 0 to 80 degrees.

[0040] Optionally, the fitting member is adapted to extend into the guide member; or, the fitting member is adapted to be arranged outside the guide member.

[0041] The present invention also provides a valve delivery system, comprising the valve delivery device of the present invention, and also comprising a heart valve, wherein a matching structure is arranged on the heart valve, and a matching piece is arranged on the matching structure.

[0042] Optionally, the fitting extends into the guide member.

[0043] Optionally, the matching structure is a positioning piece extending toward one side of the heart valve, and the matching piece is a positioning hole provided on the positioning piece.

[0044] The technical solution of the present invention has the following advantages:

[0045] 1. The valve delivery device provided by the present invention is used for delivering a heart valve. A matching piece is arranged on the heart valve. The valve delivery device comprises: a guide piece having a plurality of through-parts arranged on its side wall; a flexible locking piece extending along the inner cavity of the guide piece. After the flexible locking piece passes through the guide piece from one through-part, it passes back into the guide piece from another through-part and then passes through the matching piece.

[0046] When the heart valve stent with a matching structure is transported into the human body, one end of the flexible locking piece is inserted into the lumen of the guide member, and then passes through the guide member from one of the penetration parts, and then passes back into the guide member from the other penetration part. The matching piece extends into the guide member, and the flexible locking piece passes through the matching piece on the matching structure in the guide member to fix the matching structure. The end of the flexible locking piece that passes through the matching piece can be built into the guide member or extend from the guide member. During the transportation process, the matching structure is fixed by the cooperation of the guide member and the flexible locking piece, and then the heart valve stent is driven to be transported along the transportation direction of the guide member. When the heart valve stent is in place, the flexible locking piece can be withdrawn by pulling one end of the flexible locking piece, so that the locking state between the flexible locking piece, the guide member and the matching structure can be released, thereby releasing the heart valve stent. During the release process, the flexible positioning member and the guide member will not exert force on the mating structure, so that the heart valve stent can be stably positioned after release. The flexible locking member passes through the mating member on the mating structure to lock the mating structure. During the movement between the heart valves driven by the guide member, the stable locking between the flexible locking member and the mating member can always be maintained. Before the flexible locking member is pulled out, the locking between the flexible locking member and the mating member will not be released, which can improve the stability of the valve delivery device during use and prevent the heart valve prosthesis from falling off prematurely.

[0047] 2. In the valve delivery device provided by the present invention, the flexible locking piece passes through the matching piece, then passes out of the guide piece, and then passes back into the guide piece from another through-hole. When the flexible locking piece passes out of the guide piece after passing through the matching piece, it can pass out from the end of the guide piece, or from another through-hole on the guide piece. By making the flexible locking piece that passes through one side of the matching piece pass out of the guide piece and pass back into the guide piece again, the friction force of the flexible locking piece is increased, and the stability of the locking fit between the matching structure and the flexible locking piece during the movement of the heart valve stent is improved.

[0048] 3. The valve delivery device provided by the present invention comprises a through portion including a first through hole, a second through hole, a third through hole and a fourth through hole. The center line between the first through hole and the second through hole is parallel to the extension direction of the guide member, and the center connection between the third through hole and the fourth through hole is parallel to the extension direction of the guide member, so as to facilitate the flexible locking member to pass through the through portion and pass through the guide member.

[0049] The center line of the first through hole and the second through hole is parallel to the extension direction of the guide member, and the center connection of the third through hole and the fourth through hole intersects with the extension direction of the guide member; the intersection design of the third through hole and the fourth through hole and the extension direction of the guide member provides a non-linear motion trajectory for the flexible locking member, which helps to achieve more precise adjustment and positioning in specific surgical operations, increases the flexibility of operation, and helps the flexible locking member avoid obstacles in the complex environment of the human body, and smoothly penetrate into and out of the through part, reducing surgical risks.

[0050] The center line of the first through hole and the second through hole intersects with the extension direction of the guide, and the center line of the third through hole and the fourth through hole is parallel to the extension direction of the guide; the intersection design of the first through hole and the second through hole with the extension direction of the guide increases the complexity of the path of the flexible locking member and improves the stability of the flexible locking member in the subsequent locking operation with the heart valve. The parallel design of the third through hole and the fourth through hole with the extension direction of the guide ensures that the flexible locking member can move out along a stable path during the unlocking process, reducing the risk of accidents caused by path changes.

[0051] The center line of the first through hole and the second through hole intersects with the extension direction of the guide member, and the center line of the third through hole and the fourth through hole intersects with the extension direction of the guide member. The positions and directions of the first through hole, the second through hole, the third through hole and the fourth through hole can be determined according to surgical requirements, patient anatomical structure and doctor's operating habits, so as to better adapt to various surgical conditions.

[0052] 4. In the valve delivery device provided by the present invention, the length of the first through hole and / or the third through hole in the axial direction of the guide member is greater than the length of the second through hole and / or the fourth through hole in the axial direction of the guide member; or, the length of the first through hole and / or the third through hole in the axial direction of the guide member is less than the length of the second through hole and / or the fourth through hole in the axial direction of the guide member; or, the length of the first through hole and / or the third through hole in the axial direction of the guide member is equal to the length of the second through hole and / or the fourth through hole in the axial direction of the guide member. The friction force received by the flexible locking member when it is released from the long slot is smaller, and it is easier to release, which reduces the force applied to the guide member when the flexible locking member is unlocked, improves the stability of the heart valve position when the flexible locking member is unlocked, and facilitates unlocking. The friction force received by the flexible locking member when it is released from the short slot is greater, and it is not easy to release, which improves the stability of the flexible locking member when locking the heart valve. When the first through hole and the second through hole located upstream of the matching member are set as long slots or one of the two is set as a long slot, it is convenient for the flexible locking member to pass through the first through hole and the second through hole, and the difficulty of passing through the flexible locking member is reduced. When the first through hole and the second through hole located upstream of the matching piece are both set as short slots, the friction between the flexible locking piece and the guide piece can be increased, the stability of the flexible locking piece when the flexible locking piece is connected to the matching piece can be improved, and the connection difficulty of the flexible locking piece and the matching piece inside the guide piece can be reduced. When the third through hole and the fourth through hole located downstream of the matching piece are set as long slots or one of the two is set as a long slot, the force required to withdraw the internal flexible locking piece when unlocking the heart valve can be reduced, which facilitates unlocking. When the third through hole and the fourth through hole located downstream of the matching piece are both set as short slots, the stability of the flexible locking piece when it is locked and connected with the heart valve can be increased.

[0053] 5. The valve delivery device provided by the present invention has a cross-sectional shape of the matching structure perpendicular to the axial direction that is polygonal, U-shaped, arc-shaped, circular, elliptical, oblong, star-shaped, cross-shaped, semicircular, heart-shaped, crescent-shaped or cross-shaped, and a cross-sectional shape of the inner cavity of the guide piece that is polygonal, U-shaped, arc-shaped, circular, elliptical, oblong, star-shaped, cross-shaped, semicircular, heart-shaped, crescent-shaped or cross-shaped. By matching the special-shaped matching structure with the special-shaped inner cavity of the guide piece, the corners of the matching structure can be positioned with the corners of the inner cavity of the guide piece, which can prevent the structure from rotating in the guide piece and reduce the risk of failure in releasing the heart valve stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0055] Figure 1 It is a schematic structural diagram of a valve delivery device provided in an embodiment of the present invention.

[0056] Figure 2 It is a schematic diagram of a flexible locking member provided in an embodiment of the present invention passing through a guide member.

[0057] Figure 3 It is a schematic diagram of the flexible locking member provided in the embodiment of the present invention being installed in cooperation with the matching structure in the guide member.

[0058] Figure 4 This is a schematic diagram of the structure of the valve delivery device after assembly provided in an embodiment of the present invention.

[0059] Figure 5 It is a schematic structural diagram of the coordinated installation of the flexible locking member and the guide member provided in an embodiment of the present invention.

[0060] Figure 6 It is a schematic diagram of the distribution structure of the penetration portion on the guide member provided in an embodiment of the present invention.

[0061] Figure 7 It is a schematic diagram of another distribution structure of the penetration portion on the guide member provided in an embodiment of the present invention.

[0062] Figure 8 It is a schematic structural diagram of a guide member provided in an embodiment of the present invention.

[0063] Fig. 9 It is a top view of a guide member provided in an embodiment of the present invention.

[0064] Fig.10 It is a schematic diagram of the angle between the flexible locking member and the guide member provided in an embodiment of the present invention.

[0065] Fig.11 It is a schematic diagram of the chamfer on the through portion provided in an embodiment of the present invention.

[0066] Fig.12 It is a schematic structural diagram of a guide member provided in another embodiment of the present invention.

[0067] Fig.13It is a schematic structural diagram of a guide member provided in another embodiment of the present invention.

[0068] Fig.14 It is a schematic structural diagram of a guide member provided in another embodiment of the present invention.

[0069] Fig.15 It is a schematic diagram of the distribution of the penetration portion on the guide member provided in another embodiment of the present invention.

[0070] Fig.16 It is a schematic structural diagram of the coordinated installation of a flexible locking member and a guide member provided in another embodiment of the present invention.

[0071] Explanation of the accompanying drawings: 1. Flexible locking member; 2. Guide member; 3. Positioning member; 4. Penetrating portion; 41. First through hole; 42. Second through hole; 43. Third through hole; 44. Fourth through hole; 5. Matching member; 6. Heart valve. DETAILED DESCRIPTION

[0072] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0073] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0074] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0075] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0076] Example 1

[0077] Figures 1 to 11 The figure shows a valve delivery device for delivering a heart valve 6 provided in this embodiment. A matching structure is provided on the heart valve 6. The matching structure can be a valve stent or a positioning member 3 on the valve stent. In this embodiment, the matching structure is the positioning member 3 on the valve stent.

[0078] The positioning member 3 is provided with a matching member 5. The matching member 5 can be any structure that can be connected with the wire, such as a hook or a hole. In this embodiment, the matching member 5 is a matching hole. Figure 1 As shown, the valve delivery device includes: a guide member 2 and a flexible locking member 1 used in conjunction with the guide member 2. The guide member 2 can be any structure such as a tube body, a guide rod, etc. that can guide the movement of the flexible locking member 1. The guide member 2 in this embodiment uses a guide tube. The flexible locking member 1 in this embodiment uses non-absorbable polymer lines such as cotton thread, polypropylene, polyethylene, Teflon, polyamide, nylon, polybutylene terephthalate, polyester resin, Gore-Tex, etc. In some other embodiments, the flexible locking member 1 can also use absorbable polymer lines such as catgut, chemical synthetic line, pure natural collagen suture line, or metal lines such as stainless steel wire, nickel titanium wire, etc.

[0079] A plurality of through-portions 4 are provided on the side wall of the guide member 2, and the positioning member 3 is adapted to extend into the guide member 2. Figures 2 to 4 As shown, the flexible locking member 1 extends along the inner cavity of the guide member 2. After the flexible locking member 1 passes through the guide member 2 from one through-portion 4 thereof, it passes back into the guide member 2 from the other through-portion 4, and then passes through the matching member 5. In order to facilitate the operation of the flexible locking member 1 when the flexible locking member 1 is withdrawn, at least one end of the flexible locking member 1 extends from the end of the guide member 2 away from the positioning member 3 to the outside of the guide member 2. In some other embodiments, the end of the flexible locking member 1 can also be built into the guide tube serving as the guide member 2, or the positioning member 3 is provided outside the guide member 2, and the positioning member 3 is matched and connected with the flexible locking member 1 outside the guide member 2.

[0080] In this embodiment, after the flexible locking member 1 passes through the matching member 5, it passes out from another through-portion 4 to the outside of the guide member 2, and then passes back into the guide member 2 from another through-portion 4. Specifically, the through-portion 4 is provided with four, namely, the first through-hole 41, the second through-hole 42, the third through-hole 43 and the fourth through-hole 44. In this embodiment, after the flexible locking member 1 passes out of the guide member 2 from the second through-hole 42, it passes back into the guide member 2 from the first through-hole 41, then passes through the matching member 5, then passes out from the third through-hole 43 to the outside of the guide member 2, and finally passes back into the guide member 2 from the fourth through-hole 44. The center line of the first through-hole 41 and the second through-hole 42 is parallel to the extension direction of the guide member 2, and the center connection of the third through-hole 43 and the fourth through-hole 44 is parallel to the extension direction of the guide member 2. In some other embodiments, the center line of the first through-hole 41 and the second through-hole 42 is parallel to the extension direction of the guide member 2, and the center connection of the third through-hole 43 and the fourth through-hole 44 intersects with the extension direction of the guide member 2. Or, the center line of the first through hole 41 and the second through hole 42 intersects with the extension direction of the guide member 2, and the center connection of the third through hole 43 and the fourth through hole 44 is parallel to the extension direction of the guide member 2; or, the center line of the first through hole 41 and the second through hole 42 intersects with the extension direction of the guide member 2, and the center connection of the third through hole 43 and the fourth through hole 44 intersects with the extension direction of the guide member 2.

[0081] The first through hole 41 and the third through hole 43 are arranged near the end of the guide member 2, and the second through hole 42 and the fourth through hole 44 are arranged away from the end of the guide member 2. Figure 5As shown, the first through hole 41 and the third through hole 43 are arranged flush along the circumference of the guide member 2; the second through hole 42 and the fourth through hole 44 are arranged staggered along the circumference of the guide member 2. In this embodiment, the center line between the first through hole 41 and the third through hole 43 intersects with the central axis of the guide member 2, and the center line between the second through hole 42 and the fourth through hole 44 intersects with the central axis of the guide member 2, that is, the centers of the first through hole 41, the second through hole 42, the third through hole 43 and the fourth through hole 44 are located in the same plane, the center of the first through hole 41 coincides with the center of the third through hole 43 after rotating 180° around the circumference of the guide member 2, and the center of the third through hole 43 coincides with the center of the fourth through hole 44 after rotating 180° around the circumference of the guide member 2. In some other embodiments, the center line between the first through hole 41 and the third through hole 43 is a skew line with the center axis of the guide member 2, that is, the first through hole 41 and the third through hole 43 are rotated a certain angle in the circumferential direction and are not arranged directly opposite each other, and the center of the first through hole 41 coincides with the center of the third through hole 43 after rotating around the guide member 2 at a predetermined angle other than 180°; or, the center line between the second through hole 42 and the fourth through hole 44 is a skew line with the center axis of the guide member 2, that is, the second through hole 42 and the fourth through hole 44 are rotated a certain angle in the circumferential direction and are not arranged directly opposite each other, and the center of the third through hole 43 coincides with the center of the fourth through hole 44 after rotating around the guide member 2 at a predetermined angle other than 180°.

[0082] like Figure 6 As shown, one end of the guide member 2 that is connected to the heart valve 6 is the top, and the other end is the bottom. The two staggered second through holes 42 and fourth through holes 44 are located at the bottom of the guide member 2. The second through hole 42 on the left is at the bottom, and the fourth through hole 44 on the right is at the top. When the flexible locking member 1 passes back into the guide member 2 from the fourth through hole 44 at the bottom on the right side, it does not contact the flexible locking member 1, thereby reducing the friction when the flexible locking member 1 is withdrawn, making it easier to unlock. In some other embodiments, such as Figure 7 As shown, the two staggered second through holes 42 and fourth through holes 44 are located below the guide member 2, with the second through hole 42 on the left side being located above and the fourth through hole 44 on the right side being located below. When the flexible locking member 1 passes back into the guide member 2 from the fourth through hole 44 on the lower right side, it contacts the flexible locking member 1, thereby increasing the friction force when the flexible locking member 1 is withdrawn and improving the stability when locking the positioning member 3.

[0083] In this embodiment, the length of the first through hole 41 and the third through hole 43 in the axial direction of the guide member 2 is greater than the length of the second through hole 42 and the fourth through hole 44 in the axial direction of the guide member 2. In some other embodiments, the length of the first through hole 41 and / or the third through hole 43 in the axial direction of the guide member 2 is less than the length of the second through hole 42 and / or the fourth through hole 44 in the axial direction of the guide member 2; or, the length of the first through hole 41 and / or the third through hole 43 in the axial direction of the guide member 2 is equal to the length of the second through hole 42 and / or the fourth through hole 44 in the axial direction of the guide member 2.

[0084] In this embodiment, the cross-section of the positioning member 3 perpendicular to the axial direction is a square. Figure 8 and Fig. 9 As shown, the cross-section of the inner cavity of the guide member 2 is also square. The inner cavity on the guide member 2 is set as a square groove, and the positioning member 3 is also set as a rectangle accordingly. The square groove can better cooperate with the positioning member 3. The square positioning member 3 will rotate in the guide member 2 with a round hole due to stress. When the rotation angle is too large, the flexible locking member 1 will be stuck, resulting in an increase in the friction force when the flexible locking member 1 is withdrawn. When the friction force is greater than the breaking force of the flexible locking member 1's own pull line, the positioning member 3 may fail to release. The square groove can prevent the positioning member 3 from rotating in the guide member 2, reducing the risk of release failure. In some other embodiments, the cross-sectional shape of the positioning member 3 perpendicular to the axial direction can also be other polygons such as a triangle, a pentagon, a hexagon, or a U-shaped hole, an arc, a circle, an ellipse, an oblong, a star, a cross, a semicircle, a heart, a crescent, or a cross shape in which one or more of the above shapes are connected end to end or cross-matched with each other; the cross-section of the inner cavity of the guide member 2 is other polygons such as a triangle, a pentagon, a hexagon, or a U-shaped hole, an arc, a circle, an ellipse, an oblong, a star, a cross, a semicircle, a heart, a crescent, or a cross shape in which one or more of the above shapes are connected end to end or cross-matched with each other.

[0085] In this embodiment, the guide member 2 is composed of circular tubes at both ends, the head of the guide member 2 is a circular tube with a smaller diameter, and the rest of the guide member 2 is a circular tube with a larger diameter.

[0086] The penetration portion 4 can be a U-shaped hole, a polygonal hole, a round hole, an oblong hole, a semicircular hole, a cross hole, a star-shaped hole, a heart-shaped hole, a crescent-shaped hole, an arc-shaped hole, an elliptical hole or a cross-shaped hole. In this embodiment, the second through hole 42 and the fourth through hole 44 are oblong holes, the first through hole 41 and the third through hole 43 are round holes, and the inner diameter of the penetration portion 4 is 0.5 to 3 mm. The flexible locking member 1 extends from the round hole of the guide member 2 and extends from the long slot of the guide member 2 during loading. The proximal end of the flexible locking member 1 is soft, and the friction force of the flexible locking member 1 when released in the oblong hole is smaller, making it easier to release. In some other embodiments, when the first through hole 41 and the second through hole 42 located upstream of the matching member 5 are set as long slots or one of the two is set as a long slot, it is convenient for the flexible locking member 1 to pass through the first through hole 41 and the second through hole 42, thereby reducing the difficulty of passing through the flexible locking member 1. When the first through hole 41 and the second through hole 42 located upstream of the fitting 5 are both set as short slots, the friction between the flexible locking member 1 and the guide member 2 can be increased, the stability of the flexible locking member 1 when the flexible locking member 1 is connected to the fitting 5 can be improved, and the connection difficulty of the flexible locking member 1 and the fitting 5 inside the guide member 2 can be reduced. When the third through hole 43 and the fourth through hole 44 located downstream of the fitting 5 are set as long slots or one of the two is set as a long slot, the force required to withdraw the internal flexible locking member 1 when unlocking the heart valve 6 can be reduced, which is convenient for unlocking. When the third through hole 43 and the fourth through hole 44 located downstream of the fitting 5 are both set as short slots, the stability of the flexible locking member 1 when it is locked and connected with the heart valve 6 can be increased. Among them, the inner diameter of the long slot and the short slot is set according to actual needs, the inner diameter size or arrangement direction between different long slots can be the same or not, and the inner diameter size of different short slots can be the same or different.

[0087] like Fig.10 As shown, the length of the through-portion 4 will affect the angle between the flexible locking member 1 and the side wall of the guide member 2 when the flexible locking member 1 passes through the side wall of the guide member 2. The size of the angle will affect the friction force when the flexible locking member 1 is released. In theory, the smaller the angle, the smaller the friction force. The angle α between the flexible locking member 1 passing through the through-portion 4 and the axis of the guide member 2 is 0° to 60°. In actual use, it is optimal to keep the angle α at 10° to 20°.

[0088] like Fig.11 As shown, the opening of the through-portion 4 can be a straight opening or an oblique opening. The angle of the oblique opening will affect the friction force. The larger the angle, the smaller the friction force. In this embodiment, the through-portion 4 is provided with a chamfer to form an oblique opening. The chamfer angle θ is 0 to 80°. In practical applications, the effect is best when the chamfer angle θ is 45 to 60°. The through-portion 4 with a tapered opening facilitates the withdrawal and unlocking of the flexible locking member 1 and facilitates limiting the relative position between the flexible locking member 1 and the through-portion 4 during operation.

[0089] In this embodiment, a flexible locking member 1 with a taper at the front end and pre-shaped is selected. The shape of the flexible locking member 1 can be L-shaped, C-shaped, S-shaped, J-shaped, etc. The proximal end of the flexible locking member 1 is thick, with a diameter of 0.3-1.0 mm, and the distal end is thin, with a diameter of 0.1-0.3 mm. The proximal end is thick, which can have a good push shape, and the distal end is thinner and softer, which can reduce the friction when released. The middle is tapered, and the end of the transition end is close to the upper mouth of the guide member 2, with a distance of 2-10 mm, preferably 2-3 mm. The tension for releasing the flexible locking member 1 is 5-30 N. The flexible locking member 1 and the guide member 2 are components of the valve delivery device. The flexible locking member 1 is loaded in the guide member 2, and the distal end of the flexible locking member 1 passes through the oblong hole on the lower side of the guide member 2, and then passes through the circular hole on the top.

[0090] The present embodiment provides a valve delivery device, wherein a positioning member 3 is provided on the heart valve 6, and the positioning member 3 is a square pin. When used clinically, the doctor loads the heart valve 6 stent on the operating table, pushes the distal end of the flexible locking member 1 out of the circular hole of the guide member 2 by tweezers, inserts the positioning member 3 into the guide member 2, aligns the matching member 5 on the positioning member 3 with the circular hole on the guide member 2, inserts the flexible locking member 1 into the corresponding circular hole from the outside of the guide member 2, fixes the positioning member 3 and the guide member 2 by the flexible locking member 1, and finally bends the distal end of the flexible locking member 1 and inserts it into another oblong hole on the guide member 2, so that the flexible locking member 1 returns to the guide member 2. Multiple positioning members 3 can be provided on the heart valve 6, and the multiple positioning members 3 are fixed to different guide members 2 in turn. The positioning member 3 is put into the sheath by pulling back the guide member 2, and the loading of the heart valve 6 stent delivery device is completed.

[0091] As an alternative embodiment, the guide member 2 includes a square tube section and a round tube section connected in sequence. Fig.12 As shown, the square tube section is arranged at the head of the round tube end, and the positioning member 3 is plugged into the inner cavity of the square tube section. Fig.13 As shown, the round tube section is arranged at the head of the square tube section, and the positioning member 3 is plugged into the inner cavity of the round tube section. Fig.14 As shown, the guide member 2 is a square tube as a whole, or a round tube as a whole. The guide member 2 can be a tube with uniform diameter, or a thin tube at the head and a thick tube at the rest, or a thick tube at the head and a thin tube at the rest.

[0092] As an alternative embodiment, the first through hole 41 and the third through hole 43 are arranged flush along the circumference of the guide member 2, and the second through hole 42 and the fourth through hole 44 are arranged flush along the circumference of the guide member 2, such as Fig.15 and Fig.16As shown. Alternatively, the first through hole 41 and the third through hole 43 are staggered along the circumference of the guide member 2; the second through hole 42 and the fourth through hole 44 are flush along the circumference of the guide member 2. Alternatively, the first through hole 41 and the third through hole 43 are staggered along the circumference of the guide member 2; the second through hole 42 and the fourth through hole 44 are staggered along the circumference of the guide member 2. The first through hole 41 and the third through hole 43 can be arranged horizontally relative to each other in the circumferential direction, and the first through hole 41 and the third through hole 43 can also be rotated a certain angle in the circumferential direction and are not arranged directly opposite. The second through hole 42 and the fourth through hole 44 can be arranged horizontally relative to each other in the circumferential direction, and the second through hole 42 and the fourth through hole 44 can also be rotated a certain angle in the circumferential direction and are not arranged directly opposite.

[0093] As an alternative embodiment, the through-hole structure 4 can also be a through-hole structure with a cross bar in the middle, and the flexible locking member 1 passes through the side wall of the guide member 2 from the through-hole on one side of the cross bar, and then passes through the through-hole on the other side of the cross bar. The cross bar can be arranged horizontally, vertically or obliquely in the through-hole. Specifically, the first through-hole 41 and the second through-hole 42 are parts of the upper and lower sides separated by a large through-hole by a cross bar, or the third through-hole 43 and the fourth through-hole 44 are parts of the upper and lower sides separated by a large through-hole by a cross bar, or the first through-hole 41 and the third through-hole 43 are parts of the left and right sides separated by a large through-hole by a vertical bar, or the second through-hole 42 and the fourth through-hole 44 are parts of the left and right sides separated by a large through-hole by a vertical bar.

[0094] As an alternative embodiment, the number of through-portions 4 can also be any number such as 2, 3, 5, 6, etc. In practical application, the number of through-portions 4 can be determined according to the friction force required for the flexible locking member 1 to maintain stability during transportation. When the number of through-portions 4 is two, only the first through-hole 41 and the second through-hole 42 are provided, and the third through-hole 43 and the fourth through-hole 44 are omitted, so that the flexible locking member 1 is directly bent downward and built into the guide member 2 after passing through the matching hole, and is locked by the friction between the flexible locking member 1 inside the guide member 2 and the friction between the flexible locking member 1 and the inner wall of the guide member 2. When the number of through-portions 4 is three, only the first through-hole 41, the second through-hole 42 and the fourth through-hole 44 are provided, and the third through-hole 43 is omitted. After the flexible locking member 1 passes through the matching hole on the positioning member 3, it extends from the end of the guide member 2 to the outside of the guide member 2, and then passes back into the guide member 2 from the fourth through-hole 44. When the number of through-holes 4 is greater than four, in addition to setting the first through-hole 41, the second through-hole 42, the third through-hole 43 and the fourth through-hole 44, additional through-holes are set so that the flexible locking member 1 can penetrate the guide member 2 multiple times, thereby improving the locking friction between the flexible locking member 1 and the guide member 2.

[0095] Example 2

[0096] This embodiment provides a valve delivery system, which has the valve delivery device and the heart valve 6 described in embodiment 1. A positioning member 3 as a matching structure is provided on the heart valve 6, and a positioning hole as a matching member 5 is provided on the positioning member 3. The positioning member 3 is a square pin. When used clinically, the doctor loads the heart valve 6 stent on the operating table, pushes the distal end of the flexible locking member 1 out of the circular hole of the guide tube as the guide member 2 by tweezers, inserts the positioning member 3 into the guide member 2, aligns the matching hole matching member 5 on the positioning member 3 with the circular hole on the guide member 2, inserts the flexible locking member 1 into the corresponding circular hole from the outside of the guide member 2, fixes the positioning member 3 and the guide member 2 by the flexible locking member 1, and finally bends the distal end of the flexible locking member 1 and inserts it into another oblong hole on the guide member 2, so that the flexible locking member 1 returns to the guide member 2. Multiple positioning members 3 can be provided on the heart valve 6, and the multiple positioning members 3 are fixed to different guide members 2 in turn. The positioning member 3 is put into the sheath tube by pulling back the guide member 2, and the loading of the heart valve 6 delivery device is completed.

[0097] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A valve delivery device, characterized in that: Used for conveying a heart valve (6), the heart valve (6) is provided with a matching structure, the matching structure is provided with a matching piece (5), and the valve conveying device comprises: A guide member (2) having a plurality of penetration portions (4) disposed on its side wall; A flexible locking member (1) extends along the inner cavity of the guide member (2). After the flexible locking member (1) passes through the guide member (2) from one through-hole (4), it passes back into the guide member (2) from another through-hole (4) and then passes through the matching member (5).

2. The valve delivery device according to claim 1, characterized in that: The penetration parts (4) are provided with two, and the flexible locking member (1) is built into the guide member (2) after passing through the matching member (5).

3. The valve delivery device according to claim 1, characterized in that: After passing through the matching piece (5), the flexible locking piece (1) passes out of the guide piece (2) and then passes back into the guide piece (2) through another penetration portion (4).

4. The valve delivery device according to claim 3, characterized in that: The penetration parts (4) are provided with three, and after the flexible locking member (1) passes through the matching member (5), it passes out from the end of the guide member (2) to the outside of the guide member (2), and then passes back into the guide member (2) from another penetration part (4).

5. The valve delivery device according to claim 3, characterized in that: After passing through the matching piece (5), the flexible locking piece (1) passes through another through-hole (4) to the outside of the guide piece (2); Alternatively, after the flexible locking member (1) passes through the matching member (5), it passes through the end of the guide member (2) to the outside of the guide member (2).

6. The valve delivery device according to claim 5, characterized in that: The through-hole (4) is provided with four holes, including a first through-hole (41), a second through-hole (42), a third through-hole (43) and a fourth through-hole (44); the center line of the first through-hole (41) and the second through-hole (42) is parallel to the extension direction of the guide member (2); the center line of the third through-hole (43) and the fourth through-hole (44) is parallel to the extension direction of the guide member (2); Alternatively, the through-hole (4) is provided with four through-holes, including a first through-hole (41), a second through-hole (42), a third through-hole (43) and a fourth through-hole (44); a center line connecting the first through-hole (41) and the second through-hole (42) is parallel to the extension direction of the guide member (2); and a center line connecting the third through-hole (43) and the fourth through-hole (44) intersects with the extension direction of the guide member (2); Alternatively, the through-hole (4) is provided with four through-holes, including a first through-hole (41), a second through-hole (42), a third through-hole (43) and a fourth through-hole (44); a center line connecting the first through-hole (41) and the second through-hole (42) intersects with an extension direction of the guide member (2); a center line connecting the third through-hole (43) and the fourth through-hole (44) is parallel to the extension direction of the guide member (2); Alternatively, the through-hole (4) is provided with four, including a first through-hole (41), a second through-hole (42), a third through-hole (43) and a fourth through-hole (44); a center line connecting the first through-hole (41) and the second through-hole (42) intersects with the extension direction of the guide member (2); a center line connecting the third through-hole (43) and the fourth through-hole (44) intersects with the extension direction of the guide member (2).

7. The valve delivery device according to claim 6, characterized in that: After the flexible locking member (1) passes through the second through hole (42) out of the guide member (2), it passes back into the guide member (2) through the first through hole (41), then passes through the matching member (5), then passes out of the guide member (2) through the third through hole (43), and finally passes back into the guide member (2) through the fourth through hole (44).

8. The valve delivery device according to claim 6 or 7, characterized in that: The first through hole (41) and the third through hole (43) are arranged close to the end of the guide member (2), and the first through hole (41) and the third through hole (43) are arranged flush along the circumference of the guide member (2); Or, the second through hole (42) and the fourth through hole (44) are arranged away from the end of the guide member (2), and the second through hole (42) and the fourth through hole (44) are arranged flush along the circumference of the guide member (2); Or, the first through hole (41) and the third through hole (43) are arranged close to the end of the guide member (2), and the first through hole (41) and the third through hole (43) are arranged in a staggered manner along the circumferential direction of the guide member (2); Alternatively, the second through hole (42) and the fourth through hole (44) are arranged away from the end of the guide member (2), and the second through hole (42) and the fourth through hole (44) are arranged in an offset manner along the circumference of the guide member (2).

9. The valve delivery device according to claim 6 or 7, characterized in that: A center line between the first through hole (41) and the third through hole (43) intersects with a center axis of the guide member (2); Or, a center line between the first through hole (41) and the third through hole (43) and a center axis of the guide member (2) are skew lines; Or, a center line between the second through hole (42) and the fourth through hole (44) intersects with a center axis of the guide member (2); Alternatively, a center line connecting the second through hole (42) and the fourth through hole (44) and a center axis of the guide member (2) are skew lines.

10. The valve delivery device according to claim 6 or 7, characterized in that: The length of the first through hole (41) and / or the third through hole (43) in the axial direction of the guide member (2) is greater than the length of the second through hole (42) and / or the fourth through hole (44) in the axial direction of the guide member (2); Or, the length of the first through hole (41) and / or the third through hole (43) in the axial direction of the guide member (2) is smaller than the length of the second through hole (42) and / or the fourth through hole (44) in the axial direction of the guide member (2); Alternatively, the length of the first through hole (41) and / or the third through hole (43) in the axial direction of the guide member (2) is equal to the length of the second through hole (42) and / or the fourth through hole (44) in the axial direction of the guide member (2).

11. The valve delivery device according to claim 5, characterized in that: The penetration parts (4) are provided with no less than five, and the flexible locking member (1) penetrates into or out of the guide member (2) multiple times at different penetration parts.

12. The valve delivery device according to any one of claims 1 to 11, characterized in that: The cross-sectional shape of the matching structure perpendicular to the axial direction is polygonal, U-shaped hole, arc, circle, ellipse, oblong, star, cross, semicircle, heart, crescent or cross, and the cross section of the inner cavity of the guide member (2) is polygonal, U-shaped hole, arc, circle, ellipse, oblong, star, cross, semicircle, heart, crescent or cross.

13. The valve delivery device according to any one of claims 1 to 12, characterized in that: The guide member (2) comprises a square tube section and a round tube section connected in sequence, and the matching member (5) is suitable for matching and plugging with the inner cavity of the square tube section, or the matching member (5) is suitable for matching and plugging with the inner cavity of the round tube section; Or, the guide member (2) is a circular tube with uniform radial direction as a whole; Alternatively, the guide member (2) is a square tube with uniform radial direction as a whole; Or, the guide member (2) comprises a first circular tube segment and a second circular tube segment connected in sequence, the inner diameter of the first circular tube segment is smaller than the inner diameter of the second circular tube segment, and the matching member (5) is suitable for matching with the first circular tube segment or the matching member (5) is suitable for matching with the second circular tube segment; Alternatively, the guide member (2) comprises a first square tube segment and a second square tube segment connected in sequence, the inner diameter of the first square tube segment is smaller than the inner diameter of the second square tube segment, and the fitting member (5) is suitable for fitting with the first square tube segment or the fitting member (5) is suitable for fitting with the second square tube segment.

14. The valve delivery device according to any one of claims 1 to 13, characterized in that: The through-hole (4) is a U-shaped hole, a polygonal hole, a round hole, an oblong hole, a semicircular hole, a cross hole, a star-shaped hole, a heart-shaped hole, a crescent-shaped hole, an arc-shaped hole, an elliptical hole or a cross-shaped hole.

15. The valve delivery device according to any one of claims 1 to 14, characterized in that: The angle between the flexible locking member (1) and the axis of the guide member (2) at the point where the flexible locking member (1) passes through the penetration portion (4) is 0° to 60°; And / or, the penetration portion (4) is provided with a chamfer, and the angle of the chamfer is 0 to 80°.

16. The valve delivery device according to any one of claims 1 to 15, characterized in that: The matching piece (5) is suitable for extending into the guide piece (2); or, the matching piece (5) is suitable for being arranged outside the guide piece (2).

17. A valve delivery system, characterized in that: The valve delivery device comprises the valve delivery device according to any one of claims 1 to 16, and further comprises a heart valve (6), wherein a matching structure is arranged on the heart valve (6), and a matching piece (5) is arranged on the matching structure.

18. A valve delivery system according to claim 17, characterized in that: The matching piece (5) extends into the guide piece (2); or, the matching piece (5) is arranged outside the guide piece (2).

19. A valve delivery system according to claim 17 or 18, characterized in that: The matching structure is a positioning piece (3) extending toward one side of the heart valve (6), and the matching piece (5) is a positioning hole provided on the positioning piece (3).