A mitral valve annulus constriction device and system

Abstract

This invention provides a mitral valve annulus retraction device and system, relating to the field of medical device technology. The mitral valve annulus retraction device includes multiple connecting tubes, which are sequentially connected through annulus retraction nodes to form a forming tube. Both ends of the forming tube are provided with annulus retraction nodes. Each annulus retraction node includes an annulus retraction locking component and a positioning puncture component. The positioning puncture component includes a locking block. The annulus retraction locking component includes a locking sleeve, the sidewall of which has at least one locking groove spaced circumferentially. The locking block is disposed within the locking sleeve and engaged within the locking groove, which restricts unidirectional movement of the locking block within the locking sleeve. This invention solves the problem in existing technologies where the annulus retraction ring cannot effectively counteract ventricular contraction forces for a long period, resulting in the inability to maintain the therapeutic effect for an extended period. It provides stable positioning and can maintain the therapeutic effect for a longer time.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a mitral valve annulus retraction device and system. Background Technology

[0002] Mitral valve disease ranks first in prevalence among heart valve diseases. Mitral valve diseases mainly include mitral regurgitation, mitral stenosis, and mitral valve prolapse. Among them, mitral regurgitation accounts for 65%, mainly due to mitral valve lesions caused by the mitral valve leaflets, annulus, papillary muscles, chordae tendineae, etc., which cause the mitral valve to not close tightly during heart contraction, allowing blood to flow from the left ventricle into the left atrium.

[0003] Mitral valve repair and mitral valve replacement are two main surgical procedures used in cardiac surgery to treat mitral valve disease. Previously, artificial valve replacement was the primary surgical method for treating mitral valve disease. However, according to relevant studies, mitral valve repair, which preserves the valve and subvalvular structures, can effectively maintain the morphology and function of the left ventricle, significantly reduce the mortality rate, and prevent the risk of long-term anticoagulation after surgery. Literature reports that the mortality rate of mitral valve replacement is 1.8%–18.1%, higher than that of mitral valve repair (0%–6.1%). Mitral valve repair now accounts for 41% of all mitral valve surgeries. Therefore, it is increasingly widely used in cardiac surgery. Currently, the number of mitral valve repair surgeries is increasing year by year.

[0004] The annuloplasty rings commonly used in mitral valve repair cannot effectively counteract the contractile force of the ventricles for a long period, resulting in the inability to maintain the treatment effect for an extended period. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the defect that the annular ring in the prior art cannot effectively resist the contraction force of the ventricle for a long time, resulting in the inability to maintain the therapeutic effect for a long time, thereby providing a mitral valve annular constriction device and system.

[0006] To address the aforementioned problems, this invention provides a mitral valve annulation device, comprising multiple connecting tubes connected sequentially via annulation nodes to form a forming tube. Each of the forming tubes has annulation nodes at both ends. Each annulation node includes an annulation locking component and a positioning puncture component. Except for the connecting tubes at the beginning and end, the first end of the remaining connecting tubes is connected to the annulation locking component, and the second end is connected to the positioning puncture component. The positioning puncture component of one connecting tube is inserted into the annulation locking component of another connecting tube to connect the two connecting tubes. The positioning puncture component includes a locking block. The annulation locking component includes a locking sleeve, the sidewall of which has at least one locking groove spaced circumferentially. The locking block is disposed within the locking sleeve and engaged within the locking groove.

[0007] Optionally, the locking groove is provided with at least two locking sections along the axial direction of the forming tube. The distance between the two sides of the locking section gradually decreases along the axial direction to form a conical structure. Multiple locking sections are arranged in the same direction, and adjacent locking sections form an anti-reverse step surface. The locking sections are suitable for restricting the locking block to move unidirectionally within the locking sleeve.

[0008] Optionally, the angle between the anti-retraction step surface and the circumferential contraction direction is less than or equal to 90°.

[0009] Optionally, the locking groove extends through the locking sleeve.

[0010] Optionally, the connecting tube includes a movable traction line located in the middle, the traction line passing through the forming tube; the positioning and puncture assembly includes a puncture needle limited by the traction line, the puncture needle being connected to an elastic element, and when the traction line is pulled out of the annular contraction node, the puncture needle is adapted to be released under the action of the elastic element and puncture and position.

[0011] Optionally, the locking block includes a locking block body, the locking block body having a limiting hole with at least one end penetrating through the locking block body, a piercing needle and an elastic element disposed in the limiting hole, and the opening of the limiting hole being connected to any corresponding locking groove.

[0012] Optionally, the puncture needle is provided with a first threading hole, and the locking block body is provided with a second threading hole. The first threading hole and the second threading hole are connected to each other, and the traction wire passes through the first threading hole and the second threading hole at the same time. When the traction wire is pulled out of the first threading hole and the second threading hole, it is suitable to release the puncture needle.

[0013] Optionally, the outer peripheral wall of the puncture needle is provided with several barbs that are spaced apart from the puncture direction.

[0014] Optionally, the annular locking assembly includes a limiting sleeve sleeved on the locking sleeve, wherein the side wall of the limiting sleeve is provided with a piercing channel along the axial direction, and the piercing channel is connected to any one of the locking grooves.

[0015] Optionally, the first end of the puncture needle is provided with a limiting flange, one end of the elastic element abuts against the limiting flange, and the other end abuts against the inner wall of the limiting sleeve.

[0016] Optionally, the positioning and puncture assembly includes a plug, which includes a cylindrical plug body, an elastic element disposed within the plug body, and a bottom plate or an inwardly extending second protrusion at the bottom of the plug body, the bottom plate or the second protrusion constituting a limiting protrusion.

[0017] Optionally, the puncture needle is hollow, and the plug body is fitted inside the puncture needle. The upper end of the plug body is provided with a first protruding edge extending outward, which abuts against the upper end of the puncture needle.

[0018] Optionally, the width of the puncture channel is greater than the diameter of the puncture needle but less than the width of the first convex edge.

[0019] Optionally, the locking block includes a connecting post disposed on the locking block body, the connecting post extending axially along the locking sleeve, and the first end of the connecting post and the connecting tube being fixedly connected.

[0020] Optionally, the connecting tube includes a flexible layer disposed outside the traction line and a protective layer disposed outside the flexible layer.

[0021] Optionally, the connecting post of the connecting pipe is provided with external threads, and a nut is threaded onto the connecting post. The first end of the protective layer is fixedly connected between the nut and the connecting post.

[0022] Optionally, the inner wall of the end of the locking sleeve opposite to the direction of annular contraction is provided with an anti-detachment protrusion, and the second end of the connecting tube is provided with an anti-detachment flange that mates with the anti-detachment protrusion, with the anti-detachment protrusion abutting against the anti-detachment flange.

[0023] Optionally, the second end of the protective layer is fixedly connected to the anti-detachment protrusion.

[0024] Optionally, the protective layer includes a mesh fabric.

[0025] Optional, the flexible layer may include silicone.

[0026] Another aspect of the present invention provides a mitral valve replacement system, including the mitral valve annulus device of any of the above technical solutions.

[0027] The present invention has the following advantages:

[0028] 1. Utilizing the technical solution of this invention, multiple connecting tubes are connected to form a molded tube via an annular constriction node. Since the annular constriction node is equipped with an annular constriction locking component and a positioning puncture component, the position of the annular constriction node is fixed after puncture by the positioning puncture component, thus achieving annular constriction of the mitral valve annulus. The positioning puncture component cooperates with the locking sleeve in the annular constriction locking component via a locking block. Because the locking block is locked in the locking groove, the molded tube after annular constriction can maintain a long-term annular constriction force, effectively counteracting the ventricular contraction force, thereby maintaining the therapeutic effect for a long time.

[0029] 2. The locking groove is provided with at least two locking sections along the axial direction. The anti-retraction step surface of the locking block restricts the locking block to move only in one direction within the locking sleeve. On the one hand, it can adjust the degree of annular contraction of the mitral valve by the molding tube according to different physiological structures. On the other hand, since the locking block cannot retract, it further improves the support and stability of the mitral valve annular contraction device, enhances the ability to resist the contraction force of the ventricle, and further prolongs the duration of the therapeutic effect.

[0030] 3. The mitral valve annular constriction device provided by the present invention has a connecting tube made of flexible material and an annular constriction node made of metal material. Compared with a fully rigid ring, the connecting tube is more flexible and easier to bend, which is beneficial to matching the physiological curvature of the mitral valve annulus and is easy to fold, reducing the delivery diameter. Compared with a fully flexible ring, the annular constriction node can improve the support strength of the mitral valve annular constriction device after surgery, which is beneficial to resist the contraction force of the heart and maintain the treatment effect. Attached Figure Description

[0031] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0032] Figure 1 This diagram shows the structure of the mitral valve annulus retraction device provided in Embodiment 1 of the present invention in the working state;

[0033] Figure 2 A schematic diagram of the connection structure between individual connecting pipes and annular joints, excluding the two ends, is shown.

[0034] Figure 3 It shows Figure 2 Side view;

[0035] Figure 4 It shows Figure 2 A cross-sectional view along the axial direction;

[0036] Figure 5 A cross-sectional view is shown showing the connection between adjacent connecting pipes via a circumferential joint;

[0037] Figure 6 It shows Figure 1 Partial sectional view;

[0038] Figure 7 It shows Figure 6 A magnified view of a portion of the image;

[0039] Figure 8 A three-dimensional structural schematic diagram of the locking sleeve is shown;

[0040] Figure 9 A side view of the locking sleeve from a first perspective is shown;

[0041] Figure 10 A side view of the locking sleeve from a second perspective is shown;

[0042] Figure 11 A schematic diagram of the limiting sleeve is shown;

[0043] Figure 12 An exploded view of the positioning and puncture assembly is shown;

[0044] Figure 13 A three-dimensional structural diagram of the locking block is shown;

[0045] Figure 14 A cross-sectional view of the plug is shown;

[0046] Figure 15 A radial cross-sectional view of the annular junction is shown;

[0047] Figure 16 A cross-sectional view of the formed tube along the axial direction is shown.

[0048] Explanation of reference numerals in the attached figures:

[0049] 10. Connecting tube; 20. Ring-shaped node; 100. Formed tube; 1. Ring-shaped locking assembly; 11. Locking sleeve; 111. Locking groove; 1111. Locking section; 1112. Anti-retraction step surface; 1113. Anti-detachment protrusion; 12. Limiting sleeve; 121. Puncture channel; 2. Positioning puncture assembly; 21. Locking block; 211. Locking block body; 2111. Limiting hole; 2112. Second threading hole; 212. Connecting post; 22. Puncture needle; 221. First threading hole; 222. Barb; 23. Elastic element; 24. Plug; 241. Plug body; 242. First protrusion; 243. Second protrusion; 25. Nut; 26. Connecting sleeve; 3. Traction line; 101. Flexible layer; 102. Protective layer; 103. Anti-detachment protrusion. Detailed Implementation

[0050] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0051] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0052] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0053] Furthermore, 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.

[0054] To facilitate the introduction of the technical solution of the present invention, the following detailed description is provided in conjunction with the accompanying drawings and specific embodiments, but the embodiments should not be regarded as limitations on the present invention.

[0055] Example 1

[0056] A mitral valve annulus retraction device, as described in the following text Figures 1-16 The system includes multiple connecting tubes 10, which are connected sequentially through annular nodes 20 to form a molded tube 100. Annular nodes 20 are provided at both ends of the molded tube 100. The annular node 20 includes an annular locking component 1 and a positioning piercing component 2. Except for the connecting tubes 10 at both ends, the first end of the remaining connecting tubes 10 is connected to the annular locking component 1, and the second end is connected to the positioning piercing component 2. The positioning piercing component 2 of one connecting tube 10 is inserted into the annular locking component 1 of another connecting tube 10 to achieve the connection of the two connecting tubes 10. The positioning piercing component 2 includes a locking block 21. The annular locking component 1 includes a locking sleeve 11. The side wall of the locking sleeve 11 is provided with at least one locking groove 111 at intervals along the circumference. The locking block 21 is provided in the locking sleeve 11 and is engaged in the locking groove 111.

[0057] Using the technical solution of this invention, multiple connecting tubes 10 are connected to form a molded tube 100 via annular constriction nodes 20. Since the annular constriction node 20 is equipped with an annular constriction locking component 1 and a positioning puncture component 2, the position of the annular constriction node 20 is fixed after puncture by the positioning puncture component 2, thus achieving annular constriction of the mitral valve annulus. The positioning puncture component 2 cooperates with the locking sleeve 11 in the annular constriction locking component 1 via a locking block 21. Because the locking block 21 is locked in the locking groove 111, the annular molded tube 100 can maintain a long-term annular constriction force, effectively counteracting the contractile force of the ventricle, thereby maintaining the therapeutic effect for a long time.

[0058] Optionally, the locking groove 111 is provided with at least two locking sections 1111 along the axial direction of the forming tube 100. The distance between the two sides of the locking section 1111 gradually decreases along the axial direction to form a conical structure. Multiple locking sections 1111 are arranged in the same direction, and adjacent locking sections 1111 form an anti-retraction step surface 1112. The locking section 1111 is suitable for restricting the locking block 21 to move unidirectionally within the locking sleeve 11.

[0059] Optional, refer to Figures 8-10 The distance between the two sides of the locking segment 1111 gradually decreases along the axial direction of the locking sleeve 11, forming a conical structure. That is, the distance between the two sides of the first end of the locking segment 1111 is greater than the distance between the two sides of the second end. Because the locking segment 1111 has a conical structure and multiple locking segments 1111 are arranged in the same direction, each locking segment 1111 faces the same direction, and the distance between the two sides of the locking segment 1111 gradually decreases. That is, the first end of the first locking segment 1111 connects to the second end of the second locking segment 1111, and the distance between the two sides of the first end of the locking segment 1111 is greater than the distance between the two sides of the second end of the locking segment 1111. Thus, an anti-reverse step surface 1112 is formed between adjacent locking segments 1111. When the locking block 21 moves within the locking groove 111, the locking block 21 can only move unidirectionally from the first end of the locking segment 1111 towards the second end. Because the locking section 1111 has a conical structure and its two side walls are inclined, the locking block 21 can press against the side wall of the locking groove 111 along the side wall of the locking section 1111 as it moves from the first end to the second end of the locking section 1111. This causes the locking groove 111 to deform, allowing the locking block 21 to smoothly enter the next locking section 1111. The end face of the locking block 21 will abut against the anti-retraction step surface 1112, achieving unidirectional circumferential contraction and locking.

[0060] The locking groove 111 is provided with at least two locking sections 1111 along the axial direction. The anti-retraction step surface 1112 of the locking block 21 restricts the locking block 21 to move only in one direction within the locking sleeve 11. On the one hand, it can adjust the degree of annular contraction of the mitral valve by the molding tube 100 according to different physiological structures. On the other hand, since the locking block 21 cannot retract, it further improves the support and stability of the mitral valve annular contraction device, enhances the ability to resist the contraction force of the ventricle, and further prolongs the duration of the therapeutic effect.

[0061] Optionally, the angle between the anti-retraction step surface 1112 and the circumferential contraction direction is less than or equal to 90°. In this embodiment, the anti-retraction step surface 1112 is perpendicular to the axial direction of the locking sleeve 11. Of course, it can be understood that when the angle between the anti-retraction step surface 1112 and the axial direction of the locking sleeve 11 is an acute angle, it can also play the role of preventing the locking block 21 from retracting.

[0062] Optional, refer to Figures 8-10 The locking groove 111 penetrates the locking sleeve 11.

[0063] Optionally, the structure of the locking block 21 is matched with the locking groove 111, and the axial cross section of the locking block 21 is a tapered shape adapted to the structure of the locking section 1111.

[0064] Optional, refer to Figure 4 The connecting tube 10 includes a movable traction line 3 located in the middle, which passes through the forming tube 100. The positioning and puncture assembly 2 includes a puncture needle 22 limited by the traction line 3. The puncture needle 22 is connected to an elastic element 23. When the traction line 3 is pulled out of the annular contraction node 20, the puncture needle 22 is adapted to be released under the action of the elastic element 23 and puncture and position. Optionally, the traction line 3 is made of steel wire, which can improve the support and stability of the forming tube 100.

[0065] Optional, refer to Figure 12 and Figure 13 The locking block 21 includes a locking block body 211. The locking block body 211 has a limiting hole 2111 with at least one end penetrating through it. A puncture needle 22 and an elastic element 23 are disposed within the limiting hole 2111. The opening of the limiting hole 2111 is connected to either locking groove 111. When only one end of the limiting hole 2111 penetrates the locking block body 211, the opening of the limiting hole 2111 is connected to either locking groove 111. Specifically, in this embodiment, there are two locking grooves 111. The two locking grooves 111 are symmetrically arranged circumferentially along the locking sleeve 11. The opening of the limiting hole 2111 is connected to one of the locking grooves 111 for release of the puncture needle 22. In this embodiment, the limiting hole 2111 penetrates both ends of the locking block body 211.

[0066] Optionally, the puncture needle 22 has a first threading hole 221, and the locking block body 211 has a second threading hole 2112. The first threading hole 221 and the second threading hole 2112 are connected to each other, and the traction wire 3 passes through both the first threading hole 221 and the second threading hole 2112 simultaneously. When the traction wire 3 is pulled out of the first threading hole 221 and the second threading hole 2112, it is suitable for releasing the puncture needle 22. (Refer to...) Figure 7 The traction wire 3 passes through the second threading hole 2112 and the first threading hole 221, confining the puncture needle 22 within the limiting hole 2111 of the locking block 21. It can be understood that when the traction wire 3 is pulled out, the traction wire 3 disengages from the first threading hole 221, and the puncture needle 22 can be released from the limiting hole 2111 of the locking block 21.

[0067] Optional, refer to Figure 12The outer peripheral wall of the puncture needle 22 is provided with a number of barbs 222 that are spaced apart from the puncture direction. The barbs 222 on the puncture needle 22 can make the puncture needle 22 firmly fixed in the punctured human tissue, prevent dislodgement, and maintain the effectiveness of the mitral valve annulus retraction surgery.

[0068] Optionally, the annular locking assembly 1 includes a limiting sleeve 12 sleeved on the locking sleeve 11. The side wall of the limiting sleeve 12 has a puncture channel 121 axially connected to any locking groove 111. Thus, when the traction wire 3 is withdrawn, the puncture needle 22 located in the limiting hole 2111 is released, passing sequentially through the locking groove 111 and the puncture channel 121 before finally puncturing into human tissue. Because the locking groove 111 has multiple locking segments 1111, the length of the puncture channel 121 is not less than the movable stroke of the puncture needle 22, ensuring that the puncture needle 22 can be released whenever it moves with the locking block 21 into any locking segment 1111 within the locking groove 111.

[0069] Optionally, as one embodiment, the first end of the puncture needle 22 is provided with a limiting flange, one end of the elastic member 23 abuts against the limiting flange, and the other end abuts against the inner wall of the limiting sleeve 12. The limiting sleeve can provide a limit for the first end of the elastic member 23.

[0070] Optional, refer to Figure 7 , Figure 12 , Figure 14 and Figure 15 The puncture needle 22 has a hollow structure. The positioning puncture assembly 2 includes a plug 24. The plug 24 includes a cylindrical plug body 241. An elastic element 23 is disposed inside the plug body 241. The bottom of the plug body 241 is provided with a base plate or an inwardly extending second protrusion 243. The base plate or the second protrusion 243 constitutes a limiting protrusion.

[0071] Specifically, in this embodiment, the puncture needle 22 is a hollow structure, and the plug body 241 is fitted inside the puncture needle 22. The upper end of the plug body 241 has an outwardly extending first protruding edge 242, which abuts against the upper end of the puncture needle 22. Making the puncture needle 22 a hollow structure reduces weight and the burden on the heart. Furthermore, placing the plug body 241 within the inner cavity of the puncture needle 22 reduces the radial dimension of the positioning puncture assembly 2, thereby reducing the delivery size of the forming tube 100 and improving the convenience of the surgery. The plug body 241 is a cylindrical structure, providing axial restraint for the elastic element 23.

[0072] The first protruding edge 242 is used to provide a point of force for the elastic force of the elastic member 23 when the traction line 3 is pulled out. The elastic force of the elastic member 23 is applied to the first protruding edge 242, and the first protruding edge 242 abuts against the puncture needle 22. Thus, under the action of the elastic force of the elastic member 23, the first protruding edge 242 can push the puncture needle 22 to release.

[0073] The second protrusion 243 is used to limit the second end of the elastic member 23, that is, the elastic member 23 is limited between the limiting sleeve 12 and the second protrusion 243 of the plug 24. In this way, the elastic member 23 is in a compressed state when the puncture needle 22 is in the limiting hole 2111, and the elastic member 23 can provide the release force for the puncture needle 22 when the puncture needle 22 is not restricted by the traction line 3.

[0074] Since the puncture channel 121 is for the puncture needle 22 to pass through, the width of the puncture channel 121 is greater than the diameter of the puncture needle 22 body. Optionally, refer to... Figure 15 The width of the puncture channel 121 of the limiting sleeve 12 is smaller than the width of the first protruding edge 242 of the plug 24. In this embodiment, the first protruding edge 242 is an annular protruding edge, meaning the width of the puncture channel 121 is smaller than the diameter of the first protruding edge 242. The first end of the puncture needle 22 is fixedly connected to the first protruding edge 242. Thus, when the puncture needle 22 is released, it can pass through the puncture channel 121, while the first protruding edge 242 of the plug 24 cannot pass through the puncture channel 121, preventing the puncture needle 22 from dislodging. Therefore, when the puncture needle 22 punctures human tissue, it remains connected to the locking block 21.

[0075] Optional, refer to Figure 12 The locking block 21 includes a connecting post 212 disposed on the locking block body 211. The connecting post 212 extends axially along the locking sleeve 11, and the connecting post 212 is fixedly connected to the first end of the connecting pipe 10.

[0076] Optionally, the connecting tube 10 includes a flexible layer 101 disposed outside the traction wire 3 and a protective layer 102 disposed outside the flexible layer 101. Specifically, the flexible layer 101 includes silicone filler. By providing the flexible layer 101, the delivery diameter can be reduced, which improves the convenience of the surgical procedure and reduces weight, thus reducing the burden on the heart. The protective layer 102 includes a mesh fabric.

[0077] Optionally, the connecting post 212 of the connecting tube 10 is provided with external threads, and a nut 25 is threadedly connected to the connecting post 212. The first end of the protective layer 102 is fixedly connected between the nut 25 and the connecting post 212. By providing the connecting post 212 and the nut 25, it is easy to connect the connecting tube 10 and the locking block 21.

[0078] Optionally, a connecting sleeve 26 is fitted between the nut 25 and the connecting post 212. Both the inner and outer walls of the connecting sleeve 26 are threaded. The connecting sleeve 26 is threadedly connected to the connecting post 212 and the nut 25. The first end of the protective layer 102 can be connected between the nut 25 and the connecting sleeve 26, or between the connecting sleeve 26 and the connecting post 212.

[0079] Optional, refer to Figure 4 and Figure 7 The inner wall of the locking sleeve 11 at the end opposite to the annular contraction direction is provided with an anti-detachment protrusion 1113, and the second end of the connecting tube 10 is provided with an anti-detachment flange 103 that mates with the anti-detachment protrusion 1113. The anti-detachment protrusion 1113 and the anti-detachment flange 103 abut against each other. The engagement of the anti-detachment protrusion 1113 and the anti-detachment flange 103 prevents the intermediate tube and the annular contraction locking assembly 1 from disengaging during the annular contraction process, improving reliability. Furthermore, the anti-detachment protrusion 1113 and the anti-detachment flange 103 form a limiting point, providing an installation point for the connection of the protective layer 102. Optionally, the second end of the protective layer 102 is fixedly connected to the anti-detachment flange 103, and the second end of the protective layer 102 can be fixed to the anti-detachment flange 103 by binding or sewing.

[0080] Optionally, the annular constriction node 20 is supported by a metal material, providing high support strength. In the mitral valve annular constriction device provided by this invention, the connecting tube 10 is made of a flexible material, while the annular constriction node 20 is made of a metal material. Compared to a fully rigid ring, the connecting tube 10 is more flexible and easier to bend, which is beneficial for matching the physiological curvature of the mitral valve annulus and facilitates folding, reducing the delivery diameter. Compared to a fully flexible ring, the annular constriction node 20 can improve the support strength of the mitral valve annular constriction device after surgery, which is beneficial for resisting the contractile force of the heart and maintaining the treatment effect.

[0081] Example 2

[0082] A mitral valve replacement system includes the mitral valve annulus device described in Example 1.

[0083] Specifically, the mitral valve replacement system also includes a delivery system. The mitral valve annulus device is installed in the delivery system, at which time the forming tube 100 is in the delivery state.

[0084] The procedure for using a mitral valve replacement system includes the following steps:

[0085] S01: Puncture the femoral vein on one side of the patient, insert the guidewire and puncture sheath into the right atrium, puncture the interatrial septum, and enter the left ventricle;

[0086] S02: The mitral valve annulus device is installed into the corresponding delivery system and sent into the left ventricle along the guidewire;

[0087] S03: Under the guidance of transesophageal ultrasound and digital subtraction angiography (DSA), the first annular constriction node 20 at the end of the shaping tube 100 is released at the root of the mitral valve annulus. The first annular constriction node 20 is positioned by releasing the positioning needle through the traction line 3.

[0088] S04: Under the guidance of transesophageal ultrasound and digital subtraction angiography (DSA), the delivery system tightens the first annular constriction node 20 along the mitral valve annulus and continues to pull the traction line 3 to release the second annular constriction node 20. The puncture needle 22 is released by pulling the traction line 3, ensuring that the relative position between the first annular constriction node 20 and the second annular constriction node 20 remains unchanged. At this time, by pulling the connecting tube 10, the locking block 21 slides along the locking groove 111 to achieve annular constriction. The third, fourth and so on annular constriction nodes 20 are released in sequence and annular constriction is achieved in the same way until the last annular constriction node 20 is released.

[0089] S05: The mitral valve delivery system is withdrawn to the left atrium, and the atrial septal occluder is inserted along the delivery system to block the atrial septum, completing the procedure.

[0090] Surgical procedure: The femoral vein is punctured through the interatrial septum, the anchoring portion is released, the loop is closed, the delivery system is withdrawn, and the surgery is completed.

[0091] The forming tube 100 is ultimately formed by the ends approaching each other to form a ring with a notch.

[0092] Based on the above description, this patent application has the following advantages:

[0093] 1. Since the locking block 21 is locked in the locking groove 111, the annularly contracted forming tube 100 can maintain a long-term annular contraction force, effectively counteracting the contraction force of the ventricle, thereby maintaining the therapeutic effect for a long time.

[0094] 2. The locking groove 111 is equipped with a locking section 1111, which allows the locking block 21 to move only in one direction and not backward. On the one hand, it can adjust the degree of annular constriction of the mitral valve by the molding tube 100 according to different physiological structures. On the other hand, since the locking block 21 cannot be moved backward, it further improves the support and stability of the mitral valve annular constriction device, enhances the ability to resist the contraction force of the ventricle, and further prolongs the duration of the therapeutic effect.

[0095] 3. The mitral valve annulus retraction device provided by the present invention has a connecting tube 10 made of flexible material and an annulus retraction node 20 made of metal material. Compared with a fully rigid ring, the connecting tube 10 is more flexible and easier to bend, which is conducive to matching the physiological curvature of the mitral valve annulus and is easy to fold, reducing the delivery diameter. Compared with a fully flexible ring, the annulus retraction node 20 can improve the support strength of the mitral valve annulus retraction device after surgery, which is conducive to resisting the contraction force of the heart and maintaining the treatment effect.

[0096] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A mitral annuloplasty device, characterized by, It includes multiple connecting pipes (10), which are connected in sequence through annular shrinkage nodes (20) to form a molded pipe (100). The annular shrinkage nodes (20) are provided at both ends of the molded pipe (100). The annular node (20) includes an annular locking component (1) and a positioning puncture component (2). Except for the connecting tubes (10) at both ends, the first end of the remaining connecting tubes (10) is connected to the annular locking component (1), and the second end is connected to the positioning puncture component (2). The positioning puncture component (2) of one connecting tube (10) is inserted into the annular locking component (1) of another connecting tube (10) to realize the connection of the two connecting tubes (10). The connecting pipe (10) includes a movable traction line (3) located in the middle. The positioning puncture assembly (2) includes a locking block (21), and the positioning puncture assembly (2) includes a puncture needle (22) limited by the traction line (3). The puncture needle (22) is connected to an elastic element (23). The locking block (21) also includes a locking block body (211). The locking block body (211) is provided with a limiting hole (2111) through which at least one end of the locking block body (2111) passes. The puncture needle (22) and the elastic element (23) are disposed in the limiting hole (2111). The opening of the limiting hole (2111) is connected to any locking groove (111). The annular locking assembly (1) includes a locking sleeve (11), the side wall of the locking sleeve (11) is provided with at least one locking groove (111) at intervals along the circumference, and the locking block (21) is disposed in the locking sleeve (11) and engaged in the locking groove (111).

2. The mitral annuloplasty device of claim 1, wherein, The locking groove (111) is provided with at least two locking sections (1111) along the axial direction of the forming tube (100). The distance between the two sides of the locking section (1111) gradually decreases along the axial direction to form a conical structure. Multiple locking sections (1111) are arranged in the same direction. Adjacent locking sections (1111) form an anti-retraction step surface (1112). The locking section (1111) is adapted to restrict the locking block (21) from moving unidirectionally within the locking sleeve (11).

3. The mitral annuloplasty device of claim 2, wherein, The angle between the anti-retraction step surface (1112) and the annular contraction direction is less than or equal to 90°, and / or the locking groove (111) penetrates the locking sleeve (11).

4. The mitral annuloplasty device according to any one of claims 1-3, characterized in that, The traction line (3) passes through the forming tube (100); when the traction line (3) is pulled out of the annular node (20), the puncture needle (22) is adapted to be released under the action of the elastic element (23) and puncture and position.

5. The mitral valve annulus retraction device according to claim 1, characterized in that, The puncture needle (22) is provided with a first thread hole (221), and the locking block body (211) is provided with a second thread hole (2112). The first thread hole (221) and the second thread hole (2112) are connected to each other. The traction line (3) passes through the first thread hole (221) and the second thread hole (2112) at the same time. When the traction line (3) is pulled out of the first thread hole (221) and the second thread hole (2112), it is suitable to release the puncture needle (22).

6. The mitral valve annulus retraction device according to claim 1 or 5, characterized in that, The outer peripheral wall of the puncture needle (22) is provided with a number of barbs (222) that are opposite to the puncture direction.

7. The mitral valve annulus retraction device according to claim 1 or 5, characterized in that, The annular locking assembly (1) includes a limiting sleeve (12) sleeved on the locking sleeve (11). The side wall of the limiting sleeve (12) is provided with a puncture channel (121) along the axial direction. The puncture channel (121) is connected to any of the locking grooves (111) for the puncture needle (22) to pass through.

8. The mitral valve annulus retraction device according to claim 7, characterized in that, The first end of the puncture needle (22) is provided with a limiting protrusion, one end of the elastic element (23) abuts against the limiting protrusion, and the other end abuts against the inner wall of the limiting sleeve (12).

9. The mitral valve annulus retraction device according to claim 8, characterized in that, The positioning and puncture assembly (2) includes a plug (24), the plug (24) includes a cylindrical plug body (241), the elastic element (23) is disposed inside the plug body (241), the bottom of the plug body (241) is provided with a base plate or an inwardly extending second protrusion (243), the base plate or the second protrusion (243) constitutes the limiting protrusion.

10. The mitral valve annulus retraction device according to claim 9, characterized in that, The puncture needle (22) is a hollow structure. The plug body (241) is sleeved inside the puncture needle (22). The upper end of the plug body (241) is provided with an outwardly extending first protrusion (242), which abuts against the upper end of the puncture needle (22).

11. The mitral valve annulus retraction device according to claim 10, characterized in that, The width of the puncture channel (121) is greater than the diameter of the puncture needle (22) and less than the width of the first convex edge (242).

12. The mitral valve annulus retraction device according to claim 1 or 5, characterized in that, The locking block (21) includes a connecting post (212) disposed on the locking block body (211), the connecting post (212) extending along the axial direction of the locking sleeve (11), and the connecting post (212) and the first end of the connecting tube (10) are fixedly connected.

13. The mitral valve annulus retraction device according to claim 12, characterized in that, The connecting tube (10) includes a flexible layer (101) disposed outside the traction line (3) and a protective layer (102) disposed outside the flexible layer (101).

14. The mitral valve annulus retraction device according to claim 13, characterized in that, The connecting post (212) of the connecting pipe (10) is provided with external thread, and a nut (25) is threadedly connected to the connecting post (212). The first end of the protective layer (102) is fixedly connected between the nut (25) and the connecting post (212).

15. The mitral valve annulus retraction device according to claim 13, characterized in that, The inner wall of the locking sleeve (11) at the end opposite to the annular contraction direction is provided with an anti-detachment protrusion (1113), and the second end of the connecting pipe (10) is provided with an anti-detachment ridge (103) that cooperates with the anti-detachment protrusion (1113). The anti-detachment protrusion (1113) abuts against the anti-detachment ridge (103).

16. The mitral valve annulus retraction device according to claim 15, characterized in that, The second end of the protective layer (102) is fixedly connected to the anti-detachment protrusion (103).

17. A mitral valve replacement system, characterized in that, The device includes the mitral valve annulus device as described in any one of claims 1-16.

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