WO2023124540A1

WO2023124540A1 - Implant capable of accelerating endothelialization and transcatheter cardiac repair system

Info

Publication number: WO2023124540A1
Application number: PCT/CN2022/130084
Authority: WO
Inventors: 匡经旭; 郭荣辉; 张庭超
Original assignee: 杭州德晋医疗科技有限公司
Priority date: 2021-12-31
Filing date: 2022-11-04
Publication date: 2023-07-06
Also published as: CN116407349A

Abstract

An implant (100) capable of accelerating endothelialization and a transcatheter cardiac repair system. The implant (100) comprises a plurality of anchoring assemblies (10), a plurality of spacers (20), and a tightening wire (30). The anchoring assemblies (10) are used for anchoring into cardiac tissue. The spacers (20) have elasticity in axial directions thereof. The plurality of anchoring assemblies (10) and the plurality of spacers (20) are alternately penetratingly mounted on the tightening wire (30), and a distal end of the tightening wire (30) is connected to a first anchoring assembly (10) that is used for anchoring into the cardiac tissue. In the implant (100), when the first anchoring assembly (10) thereof is anchored into the cardiac tissue, the other anchoring assemblies (10) and the plurality of spacers (20) can be delivered to the cardiac tissue along the tightening wire (30) that is connected to the first anchoring assembly (10). After the anchoring assemblies (10) are all anchored into the cardiac tissue, all of the spacers (20) and all of the anchoring assemblies (10) can be brought into close proximity along the tightening wire (30) by means of pulling the tightening wire (30), each of the spacers (20) and the adjacent anchoring assemblies (10) thereof being pressed to be compressed in an axial direction. Thus, when the implant (100) is implanted into the cardiac tissue, gaps between the anchoring assemblies (10) and the spacers (20) are eliminated.

Description

Implants and transcatheter cardiac repair systems that accelerate endothelialization

This application claims the priority of the Chinese patent application with the application number 202111671786.6 and the title of “Endothelialization Accelerated Implant and Transcatheter Cardiac Repair System” submitted to the China Patent Office on December 31, 2021, all of which The contents are incorporated by reference in this application.

technical field

The present application relates to the technical field of medical devices, in particular to an implant capable of accelerating endothelialization and a transcatheter heart repair system.

Background technique

Mitral regurgitation (abbreviation: MR) is a common heart valve disease, including primary mitral regurgitation and secondary mitral regurgitation. Primary mitral regurgitation is due to abnormal mitral valve leaflets, chordal rupture or papillary muscle insufficiency leading to poor anastomosis of the anterior and posterior leaflets of the mitral valve, resulting in blood regurgitation; secondary mitral regurgitation is due to Annulus expansion, left atrium and left ventricle enlargement lead to poor anastomosis of the anterior and posterior leaflets of the mitral valve, resulting in blood regurgitation. Therefore, the mitral annulus can be constricted or the left ventricle can be narrowed to reduce secondary mitral regurgitation.

The prior art discloses a transcatheter left ventricular repair system, as shown in Figure 1, which alternately wears several anchors 1b and several spacers 1c on a thread 1a, wherein each anchor 1b can be implanted Left ventricular wall 1d. After each anchor 1c is implanted in the left ventricle wall 1d, the silk thread 1a is pulled toward the proximal end (as shown in the L0 direction in Figure 1), and several spacers 1c and several anchors 1b implanted in the left ventricle wall 1d are along the silk thread 1a. Close to each other to achieve the contraction of the left ventricle, and then treat mitral regurgitation.

However, in the process of implanting the anchor 1b into the left ventricle wall 1d, it is difficult to ensure that the distance between adjacent anchors 1b is uniform, and it is impossible to ensure that the central axis of each anchor 1b implanted in the left ventricle wall 1d is uniform. Perpendicular to the left ventricular wall 1d; and, during the process of pulling the wire 1a proximally to contract the left ventricle, several anchors 1a implanted in the left ventricular wall 1d will be inclined relative to the left ventricular wall 1d and mutually along the wire 1a Closer, the spacing between adjacent anchors 1b is more difficult to ensure the same. In this way, when the wire 1a is pulled toward the proximal end to constrict the left ventricle, one end surface or even two end surfaces of part of the spacer 1c do not fit with the anchor 1b, and there is a certain gap between the anchor 1b and the spacer 1c. Gaps lead to prolonged endothelialization time, increasing the risk of postoperative period.

Contents of the invention

In order to solve the above technical problems, the present application provides an implant that can accelerate endothelialization and a transcatheter heart repair system.

The present application firstly provides an implant capable of accelerating endothelialization, which includes multiple anchor components, multiple spacers and tightening wires. An anchor assembly is used to anchor into cardiac tissue. The spacer is elastic in its axial direction. A plurality of anchor components and a plurality of spacers are alternately worn on the tightening wire, and the distal end of the tightening wire is connected with the first anchor component for anchoring into the heart tissue.

The above-mentioned implant that can accelerate endothelialization, when the first anchoring component is anchored into the heart tissue, other anchoring components and multiple spacers can be delivered to the heart along the tightening wire connected to the first anchoring component organization office. After each anchoring component is anchored into the heart tissue, by tightening the tightening wire, the alternately distributed spacers and anchoring components can be made close to each other along the tightening wire, and the space between multiple anchoring components can be narrowed to further Restriction of the annulus or narrowing of the ventricles to reduce backflow of blood. Since each spacer has elasticity in its axial direction, each spacer is squeezed and compressed in the axial direction by the two anchor components adjacent to it, so that the end surface of each spacer along its axial direction is in line with its corresponding Adjacent anchoring components fit together, eliminating the gap between the anchoring component and the spacer, accelerating the endothelialization of the implant after it is implanted into the heart tissue, and reducing the risk in the later stage of the operation.

The present application also provides a transcatheter heart repair system, which includes a delivery device, an anchoring device and the above-mentioned implant capable of accelerating endothelialization. The delivery device includes a delivery sheath. The anchoring device is movably installed in the lumen of the delivery sheath, the anchoring assembly is installed in the distal end of the delivery sheath, the anchoring assembly is detachably connected to the distal end of the anchoring device, and the delivery sheath is used to The anchor component is delivered to the heart tissue, and the anchor device is used to drive the anchor component to anchor into the heart tissue.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings that need to be used in the embodiments. Apparently, the drawings in the following description are some embodiments of the present application, which are common to those skilled in the art. Technical personnel can also obtain other drawings based on these drawings without paying creative work.

Fig. 1 is a schematic diagram of the structure of the left ventricle narrowed by the transcatheter left ventricle repair system provided by the prior art.

Fig. 2 is a schematic structural view of the implant provided in the embodiment of the present application.

Fig. 3 is a schematic structural view of the implant provided in the embodiment of the present application in a tightened state.

FIG. 4 is a schematic structural view of the spacer (with the film omitted) in FIG. 3 in a natural state.

Fig. 5 is an exploded schematic view of the spacer in Fig. 3 in a natural state.

Fig. 6 is a cross-sectional view of the spacer in Fig. 5 after being assembled along its axial direction.

FIG. 7 is a schematic structural view of the spacer (with the film omitted) in FIG. 3 in a fully compressed state.

FIG. 8 is an enlarged view of part VIII in FIG. 3 .

FIG. 9 is a schematic structural view of the spacer (with the film omitted) in FIG. 3 in an incompletely compressed state.

Fig. 10 is an enlarged view of part X in Fig. 3 .

FIG. 11 is a schematic structural view of another embodiment of the spacer (with the film omitted) in FIG. 3 in a natural state.

Fig. 12 is a schematic structural view of the spacer in Fig. 11 in a compressed state.

Fig. 13 is a structural schematic diagram of the anchor assembly in Fig. 3 .

Fig. 14 is a schematic structural diagram of the wire take-up in Fig. 3 .

Fig. 15 is a structural schematic diagram of the section along XV-XV after the wire take-up in Fig. 14 cooperates with the tightening wire.

Fig. 16 is a schematic structural view of the wire take-up (with the shell omitted) in Fig. 14 .

Fig. 17 is a partial cross-sectional view of the wire take-up and the adjustment tool in Fig. 14 assembled.

Fig. 18 is a partial structural schematic diagram of a transcatheter heart repair system provided by an embodiment of the present application.

Fig. 19 is a schematic structural view of the assembled anchoring device and anchoring assembly provided in the embodiment of the present application.

Fig. 20 is a schematic diagram showing the anchoring device of Fig. 19 separated from the anchoring assembly.

Fig. 21 is a cross-sectional view of Fig. 19 taken along the central axis of the drive tube.

Fig. 22 is a structural schematic diagram of the assembled tightening wire, anchor assembly, anchor device and delivery sheath in Fig. 18 .

23 to 28 are schematic views of the application process of the transcatheter heart repair system provided by the embodiment of the present application in mitral annuloplasty; wherein, FIG. 24 is an enlarged view of part XXIV in FIG. 23 .

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the application, not all of them. Based on the implementation manners in this application, all other implementation manners obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

In addition, the following descriptions of the various embodiments refer to the attached drawings to illustrate specific embodiments that the application can be used to implement. The directional terms mentioned in this application, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., only is to refer to the direction of the attached drawings. Therefore, the direction terms used are for better and clearer description and understanding of the present application, rather than indicating or implying that the referred device or element must have a specific orientation, and must have a specific orientation. construction and operation, therefore should not be construed as limiting the application.

Definition of orientation: For clarity of description, the end close to the operator is referred to as the "proximal end" and the end far away from the operator is referred to as the "distal end" during the operation. The central axis of "part A" refers to the geometric centerline of "part A". The connection between "part A" and "part B" may be a direct contact connection between "part A" and "part B", or an indirect connection between "part A" and "part B" through "part C". The above definitions are only for the convenience of expression, and should not be understood as limitations on the present application.

It is worth noting that regardless of "near end", "distal end", "one end", "another end", "first end", "second end", "initial end", "end end", "both ends" , "free end", "upper end", "lower end" and other words, "end" is not limited to the end, end point or end face, but also includes from the end, end point, or end face at the end, end point, or The portion of the element to which the end face belongs extends an axial distance and/or a radial distance.

Please refer to FIG. 2 and FIG. 3, the embodiment of the present application provides an implant 100 that can accelerate endothelialization, which can be applied to annuloplasty or ventricular volume reduction, and it can be implanted and left in the mitral valve Ring 1, tricuspid valve ring, left ventricle wall or right ventricle wall and other heart tissues, to directly shrink the valve ring or reduce the volume of the ventricle by narrowing the ventricle to achieve the purpose of shrinking the valve ring, so as to achieve mitral regurgitation or tricuspid regurgitation treatment. In addition, volume reduction of the left ventricle can also treat ischemic heart failure. It should be noted that the implant 100 is generally C-shaped or ring-shaped after being implanted in the annulus or the wall of the ventricle. In the examples shown in FIG. 2 and FIG. 3 , the heart tissue is the mitral valve ring 1 , and the mitral valve ring 1 is shown in a straight line to make the illustration more intuitive. For convenience of description, heart tissue is used as the mitral valve annulus 1 below, and the implant 100 is implanted and left on the mitral valve annulus 1 to shrink the mitral valve annulus 1 and realize the treatment of mitral regurgitation Take as an example for specific description.

Specifically, the implant 100 includes a plurality of anchor assemblies 10 , a plurality of spacers 20 and tightening wires 30 . The anchoring assembly 10 is used for anchoring into cardiac tissue (ie the mitral valve annulus 1). The spacer 20 has elasticity in its axial direction. A plurality of anchoring assemblies 10 and a plurality of spacers 20 are alternately worn on the tightening wire 30, and the distal end of the tightening wire 30 is connected to the first anchoring assembly 10 for anchoring into the heart tissue (as shown in FIG. 2 ). The anchor assembly 10a) is connected. In this application, the spacer 20 is threaded on the tightening wire 30 along its axial direction. "The first anchor assembly 10" refers to the anchor assembly 10 that is first delivered to the heart tissue in chronological order among the plurality of anchor assemblies 10, and the "last anchor assembly 10" refers to the anchor assembly 10 of the plurality of anchor assemblies 10. Among them, the anchoring components 10 that are finally delivered to the heart tissue in chronological order, "the second anchoring component 10", "the third anchoring component 10" and so on can be understood similarly; 20", "the second spacer 20", "the last spacer 20" and other descriptions can be understood similarly.

When the above-mentioned implant 100 is anchored into the mitral valve annulus 1 by its first anchoring component 10, other anchoring components 10 and a plurality of spacers 20 can be tightened along the joint connected to the first anchoring component 10. The wire 30 is delivered to the annulus 1 of the mitral valve. After each anchoring assembly 10 is anchored into the mitral valve annulus 1, by tightening the tightening wire 30, the alternately distributed spacers 20 and anchoring assemblies 10 can be made to approach each other along the tightening wire 30, and by shrinking more The spacing between the two anchoring components 10 further shrinks the mitral annulus 1 to reduce blood regurgitation. Since each spacer 20 has elasticity in its axial direction, each spacer 20 is squeezed by the two anchor assemblies 10 adjacent to it and compressed in the axial direction, so that the end surface of each spacer 20 along the axial direction Adjacent anchoring components 10 fit together, eliminating the gap between the anchoring components 10 and the spacer 20 , accelerating the endothelialization of the implant 100 after it is implanted in the mitral annulus 1 , and reducing the risk in the later stage of the operation.

In addition, such a design greatly reduces the requirement for the distance between adjacent anchor components 10 when they are implanted, and the distance between adjacent anchor components 10 during implantation does not need to be uniform, which reduces the difficulty of operation and is conducive to improving surgical efficiency. The spacer 20 can prevent the excessive tightening of the tightening wire 30 from causing the distance between two adjacent anchoring assemblies 10 to be too short and damage the mitral valve annulus 1. At the same time, the spacer 20 can play a buffer role and disperse the anchoring The pulling force received by the component 10 ensures that the anchor component 10 is anchored stably.

In the examples of FIGS. 2 and 3 , the number of anchor components 10 is only three, which are respectively anchor component 10a, anchor component 10b and anchor component 10c; the number of spacers 20 is only two, They are the spacer 20a and the spacer 20b respectively. Generally, the number of the anchor assembly 10 is more than three, and the number of the spacer 20 is more than two. In practical applications, the number of anchoring components 10 is at least three, and the number of spacers 20 is at least two. The application does not specifically limit the number of anchoring components 10 and spacers 20 .

Please refer to Fig. 2, the anchoring assembly 10a is connected with the distal end of the tightening wire 30, and the distal end of the tightening wire 30 is delivered to the mitral annulus 1 along with the anchoring assembly 10a; when the anchoring assembly 10a is anchored into the mitral After the valve annulus 1, the spacer 20a is inserted from the proximal end of the tightening wire 30 and delivered to the mitral annulus 1 along the tightening wire 30; then the anchor assembly 10b is inserted from the proximal end of the tightening wire 30 And delivered along the tightening wire 30 and anchored into the mitral annulus 1; similarly, the spacer 20b and the anchoring assembly 10c are delivered to the mitral annulus 1 in sequence, and the anchoring assembly 10c is then anchored into the mitral annulus Ring 1. Then, by tightening the tightening wire 30, the anchoring assembly 10a, the anchoring assembly 10b, and the anchoring assembly 10c anchored into the mitral valve annulus 1 approach each other along the tightening wire 30, and the mitral valve annulus 1 can be tightened. Ring retraction is performed to relieve mitral regurgitation.

Please refer to FIG. 3 , when the tightening wire 30 is tightened, the anchor assembly 10a and the anchor assembly 10b approach each other and squeeze the spacer 20a, so that the spacer 20a is compressed along its axial direction, and the spacer 20a is compressed along its axial direction. The opposite end faces of the anchoring assembly 10a and the anchoring assembly 10b are attached respectively; the anchoring assembly 10b and the anchoring assembly 10c approach each other and press the spacer 20b, so that the second spacer 21 is compressed along its axial direction, and the spacer The opposite ends of the member 20b along the axial direction are attached to the anchoring component 10b and the anchoring component 10c respectively. Thus, the gap between the anchoring assembly 10 and the spacer 20 is eliminated, the speed of endothelialization is greatly accelerated, and the risk in the later stage of the operation is reduced.

In some embodiments, spacer 20 may be a compression spring. When the compression spring is compressed along its axial direction, the two opposite end surfaces of the compression spring in the axial direction can be attached to the two anchor assemblies 10 respectively, so that the gap between the compression spring and the anchor assembly 10 can be eliminated, To reduce the time for implant 100 to endothelialize.

Please refer to FIGS. 3 to 12 together. In some embodiments, the spacer 20 also has elasticity in its radial direction. When the spacer 20 is compressed along its axial direction, the spacer 20 expands along its radial direction to make the spacer 20 The outer peripheral surface of the valve body is attached to the heart tissue (that is, the mitral valve annulus 1). It can be understood that due to irresistible factors such as manual operation, the anchoring depths of all anchoring components 10 into the mitral annulus 1 cannot be guaranteed to be all the same. When tightening the tightening wire 30 to shrink the mitral annulus , resulting in a small or no contact area between the outer peripheral surface of part of the spacer 20 and the mitral annulus 1 , which is not conducive to the endothelialization of the implant 100 . In this embodiment, since the spacer 20 has elasticity in its radial direction, when the tightening wire 30 is tightened to shrink the mitral valve annulus 1, the spacer 20 is compressed along its axial direction and at the same time The radial expansion makes the outer peripheral surface of the spacer 20 have a larger contact area with the mitral annulus 1, which further shortens the time for endothelialization and reduces the risk in the later stage of the operation.

Specifically, the spacer 20 includes a main body 21 having an axial inner cavity 211 , and the main body 21 is made of a shape memory material. The main body portion 21 is compressed in its axial direction so that the main body portion 21 expands in its radial direction. It can be understood that the axial direction of the spacer 20 is the same as the axial direction of the main body 21 , the axial cavity 211 runs through the opposite end surfaces of the main body 21 in the axial direction, and the tightening wire 30 can pass through the axial inner portion of the main body 21 . The lumen 211 thus threads the spacer 20 over the cinch wire 30 . In this way, when the spacer 20 is compressed in the axial direction, that is, the main body 21 is compressed in the axial direction and expands in the radial direction, so that the end surface of the spacer 20 in the axial direction is in close contact with the anchor assembly 10 adjacent to it. At the same time, since the main body 21 is made of shape memory material, the main body 21 can adapt to the shape of different structural tissues and deform, so that there is a larger contact area between the outer peripheral surface of the spacer 20 and the mitral annulus 1 , further shortening the time of endothelialization. Optionally, the shape memory material may be Ti—Ni-based shape memory alloy, copper-based shape-memory alloy, iron-based shape-memory alloy, shape-memory polymer, etc., such as nickel-titanium alloy, which is not limited in this application.

Please refer to FIG. 4 and FIG. 11 , in some embodiments, in a natural state, the radial dimension of the main body portion 21 gradually decreases from the middle to both ends along its axial direction, in other words, the axial length of the main body portion 21 The radial dimension A1 at the middle position is the largest. In this way, when the main body portion 21 is compressed along its axial direction, the main body portion 21 will only expand outwardly along its radial direction, and will not be squeezed inward, so as to ensure that the outer peripheral surface of the spacer 20 is in contact with the mitral valve annulus 1 (such as As shown in Figure 3) can be in stable contact. Moreover, such a main body portion 21 is evenly stressed and easy to deform. It should be noted that the natural state refers to the state where the main body 21 is not subjected to any external force, that is, the main body 21 is not deformed.

In the examples of FIG. 4 and FIG. 11 , when the main body portion 21 is in a natural state, the main body portion 21 is an elliptical cylinder. It can be understood that the main body 21 can also be an ellipsoid. In other embodiments, the main body 21 can also be an elongated water droplet, that is to say, when the main body 21 is in a natural state, the two ends of the radial dimension of the main body 21 are small, the middle is large, and the maximum radial dimension Off-axis mid-position.

Please refer to FIG. 3 to FIG. 12 , in some embodiments, the spacer 20 further includes two fixing pieces 22 , the fixing pieces 22 are provided with a wire passing hole 221 along its axial direction, and the two fixing pieces 22 are respectively arranged on the main body portion 21 The two ends in the axial direction, the wire passing hole 221 communicates with the axial inner chamber 211 . It can be understood that when the spacer 20 is worn on the tightening wire 30, the tightening wire 30 passes through the wire passing hole 221 of one fixing member 22, the axial inner cavity 211 of the main body 21 and the opening of the other fixing member 22 in sequence. Wire hole 221 . When the tightening wire 30 is tightened, the two anchor assemblies 10 adjacent to the spacer 20 approach each other and press the two fixing members 22, and the two fixing members 22 approach each other along the axial direction of the main body portion 21, and the main body portion 21 is axially compressed. The design of the fixing member 22 ensures that the main body 21 can be evenly stressed, which is beneficial to the deformation of the main body 21 .

3 to 6, in some embodiments, the spacer 20 further includes a rigid member 23, the rigid member 23 is provided with a threading hole 231 along its axial direction, the rigid member 23 is accommodated in the axial cavity 211 and is located on both sides. Between the two fixing pieces 22, the threading hole 231 is connected to the threading hole 221. When the main body 21 is in a natural state, there is an axial distance between the rigid part 23 and at least one fixing part 22. In this way, the tightening wire 30 passes through the wire passing hole 221 of one fixing member 22 along the axial direction of the main body portion 21 and penetrates into the axial inner cavity 211, and then passes through the wire passing hole 231 from the wire passing hole of the other fixing member 22. 221, the spacer 20 can be worn on the tightening line 30. When the main body 21 is in a natural state, there is an axial distance between the rigid member 23 and at least one fixing member 22 to ensure that when the tightening wire 30 is tightened, the main body 21 can be compressed in the axial direction.

It can be understood that when the spacer 20 is subjected to an axial force, the two fixing members 22 approach each other along the axial direction of the main body 21 and press against the rigid member 23, the main body 21 is axially compressed, and the rigid member 23 can limit the main body. 21, so as to prevent the main body 21 from being over-compressed and crushed, causing the main body 21 to lose its elastic force in the radial direction. In addition, when the rigid member 23 is accommodated in the axial cavity 211, it can move freely. In some examples, the rigid member 23 is a steel pipe with an inner diameter smaller than the outer diameter of the fixing member 22 and an outer diameter larger than the inner diameter of the fixing member 22, so that when the spacer 20 is subjected to excessive axial force, the rigid member can be guaranteed 23 is always located in the axial cavity 211 of the main body 21 , and the fixing part 22 can press the rigid part 23 stably.

Please refer to Fig. 3 to Fig. 10, in some embodiments, the main body 21 is a mesh structure, the fixing member 22 includes an outer casing 222 and an inner casing 223 sleeved in the axial direction, and the free end of the mesh structure is extruded It is accommodated between the outer sleeve 222 and the inner sleeve 223 . It can be understood that the main body 21 of the mesh structure has high elasticity and good flexibility, and is easy to deform, so that when the main body 21 expands in the radial direction, it is beneficial for the outer peripheral surface of the spacer 20 to better align with the mitral annulus 1. The contact area between the outer peripheral surface of the spacer 20 and the mitral annulus 1 is further increased, and the endothelialization time is further shortened.

Specifically, the main body 21 is woven into a mesh structure by a plurality of nickel-titanium wires, which is shaped after heat treatment and has an elliptical cylinder appearance. When the main body 21 is heat-set, the nickel-titanium wires at both axial ends (i.e. the free ends) are folded and aggregated toward the axial inner cavity 211 of the main body 21, and the nickel-titanium wires at both ends are squeezed and accommodated in a fixing member 22 respectively. Between the outer casing 222 and the inner casing 223. Taking the nickel-titanium wire at one end as an example, the nickel-titanium wire at one end is folded and gathered into the lumen 224 of the outer sleeve 222 of a fixing member 22, and then the inner sleeve 223 is squeezed along the main body The axial direction of part 21 is squeezed into the lumen 224, and the nickel-titanium wire at the end is fixed by the friction force between it and the outer sleeve 222 and the inner sleeve 223, so that the nickel-titanium wire at the end is squeezed and accommodated in the outer sleeve 222 and the outer wall of the inner sleeve 223.

In this embodiment, the lumen of the inner sleeve 223 is the wire passing hole 221 of the fixing member 22, that is to say, when the spacer 20 is worn on the tightening wire 30, the tightening wire 30 passes through it sequentially. The lumen of the inner sleeve 223 of one fixing member 22 , the axial lumen 211 of the main body 21 and the lumen of the inner sleeve 223 of the other fixing member 22 . The material of the outer casing 222 and the inner casing 223 is SUS316Lvm, that is, both are stainless steel pipes. In other embodiments, the material of the outer sleeve 222 and the inner sleeve 223 may also be other materials, which are not specifically limited in this application.

In addition, since the nickel-titanium wires at the axial ends (i.e., free ends) of the main body 21 are folded and aggregated toward the axial inner cavity of the main body 21, the fixing member 22 is located in the axial inner cavity 211 of the main body 21 as a whole, and the spacer 20 The two ends along the axial direction are meshed nickel-titanium wires, and the nickel-titanium wires have good elasticity. When the spacer 20 is axially compressed, the two ends of the spacer 20 along the axial direction better fit the adjacent anchor assembly 10 .

Referring to FIG. 11 and FIG. 12 , in some embodiments, the main body 21 includes a plurality of support bars 212 distributed at intervals, the fixing member 22 is a fixing tube, and the plurality of support bars 212 are arranged around the circumference of the fixing tube 22 . It can be understood that, in a natural state, the middle portion of each support bar 212 protrudes outward along the radial direction of the spacer 20 , so that the radially middle dimension A1 of the main body portion 21 is larger than the end portion thereof. In this way, when the spacer 20 is squeezed along its axial direction, the support bar 212 will expand outward along the radial direction of the main body 21, which is beneficial to the contact between the outer peripheral surface of the spacer 20 and the heart tissue (ie, the mitral valve annulus 1) Touch and fit. In addition, due to the relatively small width and thickness of the support strip 212 itself, when the spacer 20 contacts the mitral valve annulus 1 and the support strip 212 is subjected to radial pressure, the support strip 212 can also be deformed to be in contact with the mitral valve. The fit of the ring 1 increases the contact area between the spacer 20 and the mitral valve ring 1, which is beneficial to further shorten the time for endothelialization. In the example of FIG. 11 , in a natural state, the main body portion 21 is in the shape of an elliptical cylinder.

In some embodiments, the main body 21 and the two fixing members 22 of the spacer 20 can be made of a tube made of a shape memory material, such as a nickel-titanium tube. Specifically, a whole piece of nickel-titanium tube can be cut and processed, and then placed in a specific mold for heat setting.

Please refer to FIG. 5 and FIG. 6 , in some embodiments, the spacer 20 further includes a covering film 24 , the covering film 24 is elastic, and the covering film 24 covers the outside of the main body portion 21 and is fixedly connected with the main body portion 21 . It can be understood that due to the elasticity of the coating 24 , when the main body 21 is compressed in the axial direction and expands in the radial direction, the coating 24 covering the main body 21 can adapt to the deformed main body 21 . The covering film 24 plays a role of protection, preventing the main part 21 from rubbing against the mitral valve annulus 1 and causing damage to the mitral valve annulus 1 .

In the example shown in FIG. 6 , the covering film 24 can be fixedly connected with the main body portion 21 having a mesh structure by means of sutures. Optionally, the covering film 24 is made of a polymer material with good biocompatibility, such as PET (Polyethylene Glycol Terephthalate, polyethylene terephthalate), PTFE (Poly tetra Fluoroethylene, polytetrafluoroethylene), etc. , which is not limited in this application. Of course, the main body portion 21 surrounded by a plurality of support bars 212 (as shown in FIG. 11 ) can also be covered with a coating film 24 .

In the example of FIG. 3 , when the tightening wire 30 is tightened, the spacer 20a is squeezed by the anchoring component 10a and the anchoring component 10b, and its opposite ends in the axial direction are in contact with the anchoring component 10a and the anchoring component respectively. 10b, at the same time, its radial dimension becomes larger and fits with the mitral valve annulus 1; the spacer 20b is squeezed by the anchoring assembly 10b and the anchoring assembly 10c, and its opposite ends in the axial direction are respectively It fits with the anchoring component 10b and the anchoring component 10c, and at the same time, its radial dimension becomes larger and fits with the mitral valve annulus 1 . In this way, the anchoring assembly 10a, the spacer 20a, the anchoring assembly 10b, the spacer 20b, the anchoring assembly 10c and the mitral valve ring 1 are connected together in terms of positional relationship.

It should be noted that when the anchoring assembly 10 is implanted into the mitral valve annulus 1, the traction force of the tightening wire 30 should be smaller than the anchoring force of the anchoring assembly 10 on the mitral valve annulus 1, thus tightening When the wire 30 is tightened, the anchor assembly 10 will not break away from the mitral valve annulus 1, ensuring that the implant 100 can stably shrink the mitral valve annulus 1. In addition to the traction force of the tightening wire 30, the contraction amount of the mitral annulus 1 also depends on the tissue stiffness of the mitral annulus 1 itself. It can be understood that the tissue hardness at different positions of the mitral valve annulus 1 is different, among which, the hardness of the anterior trigone and the posterior trigone is the hardest. As shown in Figure 3, when the annulus tissue between the anchor assembly 10a and the anchor assembly 10b is soft, and when the annulus tissue between the anchor assembly 10b and the anchor assembly 10c is relatively hard, tighten the tightening wire 30 to shrink the mitral valve annulus 1, at this time, the shrinkage of the valve ring tissue between the anchoring assembly 10a and the anchoring assembly 10b is greater than the shrinkage of the valve ring tissue between the anchoring assembly 10b and the anchoring assembly 10c, in other words, The distance between the anchor component 10a and the anchor component 10b is smaller than the distance between the anchor component 10b and the anchor component 10c.

As shown in Figures 7 and 8, the anchoring assembly 10a and the anchoring assembly 10b squeeze the spacer 20a, and the spacer 20a is completely compressed due to the large contraction of the annulus tissue between the anchoring assembly 10a and the anchoring assembly 10b. Compression (such as the spacer 20 shown in FIG. 7), its main body 21 can no longer be compressed along its axial direction, and the spacer 20a is rigid in its axial direction. As shown in Figures 9 and 10, the anchoring assembly 10b and the anchoring assembly 10c press the spacer 20b, and the spacer 20b is not compressed due to the small contraction of the annulus tissue between the anchoring assembly 10b and the anchoring assembly 10c. When fully compressed (as shown in the spacer 20 in FIG. 8 ), its main body 21 can continue to compress along its axial direction, and the spacer 20b still has elasticity in its axial direction. It can be understood that the radial dimension of the spacer 20 a at its axial middle position is larger than the radial dimension of the spacer 20 b at its axial middle position.

If the mitral valve regurgitation is still serious at this time, it is necessary to continue to tighten the tightening wire 30 to shrink the ring, and each anchor assembly 10 is increased by the pulling force of the tightening wire 30, and the spacer 20a and the spacer are continuously compressed. 20b. Since the spacer 20a is rigid and cannot be further compressed, the pulling force received by the anchoring component 10a and the anchoring component 10b will be distributed to the remaining anchoring components 10, such as the anchoring component 10c, so that the anchoring component 10b and the anchoring component 10c The space between the components 10c will continue to be narrowed, and the spacer 20b will be further compressed until the ideal effect on the constriction of the mitral annulus 1 is achieved, that is, mitral valve regurgitation is weakened or disappeared.

When the number of anchor assemblies 10 exceeds three and the number of spacers 20 exceeds two, if the spacers 20b are fully compressed and become rigid, the constriction of the mitral annulus 1 has not yet achieved the desired effect, and may Continue to tighten the tightening wire 30, the pulling force continues to increase, and the pulling force received by the anchor assembly 10b and the anchor assembly 10c will be partially transmitted to the next anchor assembly 10, so as to further strengthen the next spacer 20. Compression, and so on until the mitral valve regurgitation weakens or disappears.

Therefore, when the mitral valve annulus 1 is contracted by the implant 100 of this embodiment, each anchor assembly 10 receives approximately the same pulling force from the tightening wire 30, but since the anchor assembly 10 is implanted in Different locations of the mitral annulus 1, and the tissue at each location of the mitral annulus 1 itself varies in softness and hardness. In places where the hardness of the annulus tissue is softer, the amount of contraction is greater, and two adjacent anchors The axial compression amount of the spacer 20 between the components 10 is relatively large; where the annulus tissue hardness is relatively hard, the contraction amount is small, and the spacer 20 between two adjacent anchoring components 10 is squeezed. The pressure is less, and its axial compression is less. Compared with the spacer 20 at the harder part of the annulus, the spacer 20 at the softer part of the annulus is easier to be completely compressed and becomes rigid, and the two adjacent anchor components 10 can disperse the excess pulling force to other anchor components 10, so as to facilitate further compression deformation of other spacers 20, and achieve the ideal effect of shrinking rings. Since the axial length of the spacer 20 itself is long and it can expand radially, in the implant 100 implanted in the mitral valve annulus 1, the spacer 20 and the two adjacent anchor assemblies 10 And the mitral annulus 1 has a larger contact area, which eliminates the gap as much as possible, which is beneficial to the endothelialization of the implant 100 better and faster.

Please refer to Fig. 2, Fig. 3 and Fig. 13 together. In some embodiments, the anchoring assembly 10 includes an anchor 11 and a threading structure 12 arranged on the anchor 11, and the distal end of the tightening wire 30 is used for anchoring. The threading structure 12 of the first anchoring assembly (such as the anchoring assembly 10a in Figure 2) that enters the heart tissue (i.e. the mitral valve annulus 1) is connected, and the other parts of the tightening wire 30 slide through for anchoring into the heart The threading structure 12 of the other anchoring assembly 10 of the tissue.

In the example shown in FIG. 13 , the anchor 11 includes a nail base 111 and a helical nail 112 fixedly connected to the distal end of the nail base 111 . The nail seat 111 is used for connecting with external instruments, so as to deliver the anchor assembly 10 to the mitral annulus 1 (as shown in FIG. 2 ). The helical nail 112 is used for anchoring into heart tissues such as the mitral annulus 1 . Specifically, the tip of the distal end of the helical nail 112 can penetrate into the mitral annulus 1 , and the helical nail 112 is driven to rotate by rotating the nail seat 111 to be anchored into the mitral annulus 1 . Although the part where the anchor 11 is anchored into the heart tissue is exemplified as a helical nail, in other embodiments, it may have another suitable configuration that enables the anchor 11 to engage with the heart tissue and be substantially fixed to the heart tissue. , such as but not limited to barbs, hooks, tines, etc.

The distal end of the tightening wire 30 can realize the connection with the first anchoring component (as shown in FIG. Connection of the threading structure 12 of the anchor assembly 10a).

In some embodiments, the threading structure 12 includes a threading ring 121 and a connecting piece 122, the connecting piece 122 is movably sleeved on the anchor 11, the threading ring 121 is movably connected to the connecting piece 122, and the threading ring 121 is used to connect the tightening wire 30 ( as shown in picture 2). Preferably, the connecting member 122 is sleeved on the nail base 111 and can rotate relative to the central axis of the nail base 111 . Because the connecting piece 122 can rotate relative to the central axis of the nail seat 111, when the screw 112 rotates with the nail seat 111 and is anchored in the mitral valve annulus 1 (as shown in FIG. The tightening wire 30 winds around the anchor 11 with the rotation of the nail seat 111 , thereby affecting the anchoring of the anchor 11 into the mitral annulus 1 . At the same time, because the connecting piece 122 can rotate around the central axis of the nail seat 111, and the threading ring 121 can move relative to the connecting piece 122, so a plurality of anchoring assemblies 10 anchored into the mitral annulus 1 are respectively connected and tightened through the threading ring 121 After the thread 30, when the tightening thread 30 is tightened, the threading ring 121 of the anchor assembly 10 can move to the state after the tightening thread 30 is tightened under the action of the pulling force of the tightening thread 30, each anchor The threading ring 121 of the assembly 10 can be moved so that the threading direction is along the circumferential direction of the mitral annulus 1, thereby greatly reducing the resistance of the tightening wire 30 during tightening, and the tightening wire 30 has no bending The situation and the tightening is stable and smooth, so that the stability of the shrinking ring can be guaranteed, and the effect of the shrinking ring is good. Furthermore, since the resistance of the tightening wire 30 in the tightening direction is greatly reduced, the pulling force is reduced and the force distributed by the pulling force on each anchor component 10 is more uniform, so that each anchor component The pulling force of 10 is greatly reduced, reducing the force of each anchoring component 10 on the mitral valve annulus 1, reducing the risk of damage to the mitral valve annulus 1, while avoiding the occurrence of a single anchoring component The fact that the pulling force on 10 is relatively large reduces the risk of the anchoring component 10 falling off, and the implantation is safer.

In other embodiments, the threading structure 12 may be a threading ring 121 movably sleeved on the anchor 11 . Preferably, the threading ring 121 is movably sleeved on the nail seat 111 of the anchor 11; of course, the threading ring 121 can also be movably sleeved on the screw 112 of the anchor 11 to ensure that the threading ring 121 does not fall off from the anchor 11 just drop. The threading structure 12 can also be a perforation provided on the nail base 111 , the central axis of the perforation is perpendicular to the central axis of the nail base 111 , and the anchor assembly 10 is mounted on the tightening wire 30 through the perforation.

Please refer to FIG. 3 and FIG. 14 to FIG. 17 together. In some embodiments, the implant 100 further includes a wire retractor 40, and the wire retractor 40 includes a housing 41 and a coil rotatably arranged in the housing 41. Spool 42. The tightening wire 30 moves through the housing 41 and the winding shaft 42 , and the winding shaft 42 rotates relative to the housing 41 to wind the tightening wire 30 . When the winding shaft 42 stops rotating, the tightening wire 30 is locked in the radial space 43 between the winding shaft 42 and the casing 41 .

Thus, when a plurality of anchoring assemblies 10 are sequentially implanted into the mitral valve annulus 1, a plurality of anchoring assemblies 10 and a plurality of spacers 20 are alternately worn on the tightening wire 30, at this time the tightening wire can be 30 passes through the casing 41 and the winding shaft 42, so that the wire take-up device 40 can be movably worn on the tightening wire 30, and the wire take-up device 40 is transported to the mitral annulus 1 along the tightening wire 30, and is anchored with the last one The assembly 10 or the last spacer 20 is in contact. By controlling the winding shaft 42 to rotate relative to the casing 41, the tightening wire 30 can be wound, so that the tightening wire 30 is continuously tightened to shrink the mitral valve annulus 1 until the mitral valve regurgitation weakens or disappears. Rotate the bobbin 42, at this time the tightening wire 30 is locked in the radial space 43 between the bobbin 42 and the housing 41, and the tightening wire 30 maintains a certain length on the mitral annulus 1. It can be understood that the locking effect of the tightening wire 30 is good when the mitral annulus 1 is retracted by winding and locking the tightening wire 30 with the wire retractor 40 . Moreover, if after a period of time, the patient's mitral valve annulus 1 expands again and causes regurgitation to recur, the wire take-up device 40 can be directly controlled to further coil the tightening wire 30 to reduce the valve annulus so that the regurgitation weakens or disappears, avoiding two The operation caused great harm to the patient. The wire take-up 40 can be made of 316L stainless steel, or other biocompatible materials, which is not limited in this application.

It should be noted that the tightening wire 30 is wound at least three times on the winding shaft 42, and the frictional force between the tightening wire 30 and the winding shaft 42 can offset the pulling force generated by the movement of the mitral valve leaflets, ensuring that the tightening wire 30 Not pulled by the pulling force created by leaflet activity.

Please refer to FIG. 16 and FIG. 17 , the wire take-up 40 also includes a limiting post 44 , a rotation stop wheel 45 and an elastic member 46 . The housing 41 includes a bottom shell 411 and an outer shell 412 , the proximal end and the distal end of the shell 412 are open, and the bottom shell 411 is fixedly connected to the distal end of the shell 412 to form an installation space 413 . The installation space 413 is used for accommodating the winding shaft 42 , the limiting post 44 , the anti-rotation wheel 45 and the elastic member 46 . The winding shaft 42 is provided with a through hole 421 along its radial direction, and the shell 412 is provided with two wire holes 4121 on both sides of the winding shaft 42 , and the two wire holes 4121 are connected to the through hole 421 of the winding shaft 42 . When threading the wire take-up device 40 on the tightening wire 30, the tightening wire 30 first passes through a wire hole 4121 into the installation space 413 of the housing 41, then passes through the through hole 421 of the bobbin 42, and then passes through another wire hole 4121. A wire hole 4121 passes through the casing 41 . Preferably, the central axis of the two wire holes 4121 is in the same plane as the central axis of the through hole 421, and the rotatable bobbin 42 makes the central axis of the through hole 421 collinear with the central axis of the two wire holes 4121, which is conducive to the collection The tight wire 30 passes through the two wire holes 4121 and the through hole 421 smoothly. The distal end of the limiting post 44 is fixedly connected to the bottom case 411 , and the anti-rotation wheel 45 is sheathed on the limiting post 44 and can move axially along the limiting post 44 . The near-end surface of the anti-rotation wheel 45 is provided with some first helical teeth 451 along the circumferential ring, and the far-end surface of the winding shaft 42 is provided with some second helical teeth 422 along the circumferential ring, and the winding shaft 42 is sleeved on the limit post 44, so that the second The helical tooth 422 can cooperate with the first helical tooth 451 to rotate in one direction. The elastic member 46 is located between the anti-rotation wheel 45 and the bottom shell 411, one end is against the bottom case 411, and the other end is against the anti-rotation wheel 45. A helical tooth 451 engages with the second helical tooth 422 of the winding shaft 42 . When the bobbin 42 rotated forward, the second helical tooth 422 slipped on the first helical tooth 451 to make the anti-rotation wheel 45 move to the far end. The rotating wheel 45 will move proximally after receiving the elastic force given by the elastic member 46 , so that the first helical teeth 451 and the second helical teeth 422 are reattached, and the bobbin 42 can continue to rotate relative to the stop wheel 45 . When the bobbin 42 is to be rotated in the reverse direction, the second helical tooth 422 cannot move the anti-rotation wheel 45 to the distal end, and the second helical tooth 422 cannot pass over any one of the first helical teeth 451 so that the bobbin 42 cannot reverse. Therefore, when the winding shaft 42 stops rotating, the take-up wire 30 can be locked in the radial space 43 between the winding shaft 42 and the casing 41 . It should be noted that, in the illustrated embodiment, the radial space 43 refers to the space formed by the winding shaft 42 and the casing 412 , and the radial space 43 is a part of the installation space 413 .

The far end surface of the bobbin 42 is also provided with a groove 423 that cooperates with the proximal end of the limit post 44. The proximal surface of the limit post 44 contacts the far end surface of the bobbin 42, and the proximal end of the housing 412 jointly limits the winding. The axial displacement of the bobbin 42 in the installation space 413 makes the bobbin 42 only rotatable. The near-end of the anti-rotation wheel 45 is also provided with a limiting boss 452, and the far-end of the shell 412 is provided with a limiting groove, and the limiting boss 452 is stuck in the limiting groove, which can limit the rotation of the anti-rotating wheel 45, so that the anti-rotating wheel 45 It can only move along the axial direction of the limit post 44 .

In other embodiments, as shown in FIG. 2 , after the mitral annulus 1 is implanted with a plurality of anchor assemblies 10 and spacers 20, the tightening wire 30 is pulled to shrink the annulus to weaken mitral valve regurgitation. Or after disappearing, can send into lock nail (not shown in the figure) along the tightening line 30 and lock the tightening line 30 after tightening, make the tightening line 30 keep the state after tightening, the tightening line 30 is superfluous The part can be cut out.

Please refer to FIG. 2 , FIG. 3 , and FIG. 18 to FIG. 21 . The embodiment of the present application also provides a transcatheter cardiac repair system 1000 , which includes a delivery device 200 , an anchoring device 300 and the aforementioned implant 100 . The delivery device 200 includes a delivery sheath 201, the anchoring device 300 is movably worn in the lumen 2011 of the delivery sheath 201, the anchor assembly 10 is worn in the distal end lumen of the delivery sheath 201, and the anchor assembly 10 and The distal end of the anchoring device 300 is detachably connected. The delivery sheath 201 is used to deliver the anchor assembly 10 to the heart tissue (ie, the mitral annulus 1 ), and the anchor device 300 is used to drive the anchor assembly 10 to anchor into the heart tissue.

It can be understood that when the anchoring assembly 10 is delivered to the mitral annulus 1 , the anchoring device 300 and the anchoring assembly 10 need to be inserted into the lumen 2011 of the delivery sheath 201 first. Specifically, firstly, the distal end of the anchoring device 300 can be passed through the distal end of the delivery sheath 201 along the lumen 2011 of the delivery sheath 201, and then the anchor assembly 10 is connected with the anchoring device 300, and the The anchoring device 300 is withdrawn until the anchoring assembly 10 is worn in the distal lumen of the delivery sheath 201 . Afterwards, the delivery sheath 201 is pushed to deliver the anchoring device 300 and the anchoring assembly 10 to the annulus 1 of the mitral valve, and the anchoring device 300 drives the anchoring assembly 10 to be anchored into the annulus 1 of the mitral valve. It should be noted that the lumen 2011 of the delivery sheath 201 runs through the two opposite ends of the delivery sheath 201 along the axial direction, and the distal lumen refers to the space where the lumen 2011 is located at the distal end of the delivery sheath 201 .

Referring to FIGS. 19 to 21 , in some embodiments, the anchoring device 300 includes a driving tube 301 and a connecting rod 302 mounted in the driving tube 301 , and the proximal end of the anchoring component 10 is provided with a first connecting portion 113 , The distal end of the driving tube 301 is provided with a second connecting part 303 that is detachably connected to the first connecting part 113, and the connecting rod 302 is passed through the first connecting part 1013 and the second connecting part that are mated and connected along the axial direction of the driving tube 301. 303 to maintain the connection between the driving tube 301 and the anchoring assembly 10, and the driving tube 301 is used to drive the anchoring assembly 10 to anchor into the heart tissue (ie, the mitral annulus 1 as shown in FIG. 3 ). In this way, the connection between the driving tube 301 and the anchor assembly 10 can be maintained by the connecting rod 302 passing through the first connecting part 113 and the second connecting part 303, and the driving can be released by withdrawing the connecting rod 302 towards the proximal end. The connection between the pipe 301 and the anchor assembly 10 is easy to operate and easy to assemble and disassemble.

Specifically, the first connecting part 113 is an S-shaped buckle protruding from the proximal end of the nail seat 111 of the anchor 11, the second connecting part 303 is an S-shaped buckle protruding from the distal end of the driving tube 301, and the two S Type buckles can be buckled correspondingly. When the first connecting part 113 and the second connecting part 303 are correspondingly engaged, the connecting rod 302 passes through the first connecting part 113 and the second connecting part 303 along the axial direction of the drive tube 301 and presses against the nail base 111. 302 can keep the fastening between the first connecting part 113 and the second connecting part 303 , so that the anchoring assembly 10 and the anchoring device 300 are kept connected. At this time, by rotating the driving tube 301 , the anchor 11 can be driven to rotate and be anchored into the mitral annulus 1 (as shown in FIG. 3 ), that is, the anchor assembly 10 is anchored into the mitral annulus 1 . Then, withdraw the connecting rod 302 toward the proximal end until the connecting rod 302 no longer passes through the connection position between the first connecting part 113 and the second connecting part 303. Anchor assembly 10 connection. In this embodiment, both the driving tube 301 and the connecting rod 302 are made of stainless steel 304V, of course, they can also be made of other materials, which is not limited in this application.

Please refer to FIG. 22 , in some embodiments, the wall of the delivery sheath 201 is provided with a through groove 2012 communicating with its lumen 2011 , the through groove 2012 is in the shape of a straight line and extends to the delivery sheath along the axial direction of the delivery sheath 201 The distal end of the tube 201 , the channel 2012 has an opening at the distal end of the delivery sheath 201 . After the anchoring device 300 passes through the distal end of the delivery sheath 201 and is connected with the anchoring assembly 10, the anchoring device 300 is retracted toward the proximal end, and the threading ring 121 of the anchoring assembly 10 is withdrawn with the withdrawal of the anchoring device 300. penetrate into the through groove 2012 , and move toward the proximal end along the through groove 2012 until the anchor assembly 10 is inserted into the lumen 2011 of the delivery sheath 201 along with the anchor device 300 .

It can be understood that the threading ring 121 is exposed to the outside of the delivery sheath 201 from the through groove 2012. Such a design facilitates the passage of the tightening wire 30 and facilitates the anchoring assembly 10 to be worn on the tightening wire 30; The tightening wire 30 is located outside the delivery sheath 201, during the process of anchoring the anchor assembly 10 into the mitral annulus 1 (as shown in FIG. 3 ), this can prevent the tightening wire 30 from wrapping around the anchor 11 and avoid affecting the anchor. Anchoring of the fixed assembly 10. Preferably, the opening of the through groove 2012 is provided with chamfers or rounded corners, which facilitates the insertion of the anchor assembly 10 into the through groove 2012, facilitates assembly, and improves operation efficiency.

Further, the distal end of the delivery sheath 201 is further provided with a stopper 2013 , and the stopper 2013 is used to close or open the opening of the channel 2012 at the distal end of the delivery sheath 201 . When the anchor assembly 10 is worn, the stopper 2013 is operated to open the opening of the through groove 2012 , so that the threading ring 121 of the anchor assembly 10 can enter the through groove 2012 from the opening. After the anchor assembly 10 is installed in the lumen 2011 of the delivery sheath 201, the stopper 2013 is operated to close the opening of the channel 2012, preventing the tightening wire 30 outside the delivery sheath 201 from falling into the delivery channel 2012. The inner cavity 2011 of the sheath tube 201 is entangled with the anchor 11 (as shown in FIG. 21 ). At the same time, the threading ring 121 of the anchoring assembly 10 cannot slide out from the opening of the through groove 2012 , which also prevents the anchoring assembly 10 from detaching from the delivery sheath 201 during delivery.

Referring to FIG. 18 , in some embodiments, the delivery device 200 further includes a delivery wire 202 , the distal end of the delivery wire 202 is connected to the proximal end of the tightening wire 30 . In this way, a sufficiently long conveying line 202 can be used, and correspondingly, a shorter tightening line 30 can be used. After the tightening line 30 is locked, there is no need to cut the tightening line 30 . The delivery wire 202 is connected to the tightening wire 30 , and after the first anchoring assembly 10 connected to the distal end of the tightening wire 30 is delivered to the mitral annulus 1 , the delivery wire 202 can be extended outside the human body. The anchor assembly 10 , the spacer 20 , and the wire retractor 40 to be implanted later can be slid on the tightening wire 30 through the delivery wire 202 outside the body. After the implant 100 is implanted and left at the mitral annulus 1, the delivery wire 202 can be disconnected from the tightening wire 30, and the delivery wire 202 can be taken out from the human body.

It should be noted that the tightening wire 30 has a certain axial length and is flexible, and the radial cross-sectional shape of the tightening wire 30 can be circular, oblate, rectangular, square or other shapes; With a certain axial length and flexibility, the radial cross-sectional shape of the conveying line 202 can also be circular, oblate, rectangular, square or other shapes; The shape is not specifically limited. When the delivery device 200 omits the delivery wire 202, the length of the cinch wire 30 is long enough to extend outside the patient's body. After the tightening line 30 is tightened and the shrinking ring is completed, no matter whether the tightening line 30 is locked and kept tightened by the wire take-up device 40 or locked and kept tightened by a locking nail (not shown in the figure), redundant Tighten the thread 30 for cutting and taking out.

Referring to FIG. 18 , in some embodiments, the transcatheter cardiac repair system 1000 further includes an introducing sheath 500 . The guide sheath 500 is used to establish an intervention channel from the outside of the patient's body to the mitral valve annulus 1 (as shown in FIG. As shown in Figure 26) to the mitral annulus 1. In the example of FIG. 18 , the transcatheter cardiac repair system 1000 includes two guiding sheaths 500 , which are respectively a first guiding sheath 501 and a second guiding sheath worn in the first guiding sheath 501 502, the second guide sheath 502 can protrude from the distal end of the first guide sheath 501 and fit on the mitral valve annulus 1, thereby establishing an intervention channel from the outside of the human body to the mitral valve annulus 1 . Preferably, both the first guiding sheath 501 and the second guiding sheath 502 are adjustable curved sheaths, so that the bending angle and direction of the distal end of the guiding sheath 500 can be better adjusted, which in turn facilitates the introduction of the guiding sheath. The distal end of the tube 500 is adjusted to fit the angle of the mitral annulus 1 . Certainly, in other embodiments, only one adjustable bendable guiding sheath 500 may also be used. The adjustable sheath tube is a commonly used guide device in interventional surgery in the prior art, and will not be described in detail here.

Please refer to FIG. 18 and FIG. 26 , in some embodiments, the transcatheter cardiac repair system 1000 further includes a push rod 600 , the distal end of the push rod 600 is provided with a guide hole 601 , and after the spacer 20 is worn on the delivery wire 202 , the delivery line 202 moves through the guide hole 601, the push rod 600 pushes the spacer 20 along the delivery line 202 and enters the guide sheath 500, and the delivery sheath 201 is movably worn in the guide sheath 500 so that the guide sheath The spacer 20 is pushed in the tube 500 so that the spacer 20 is threaded on the take-up line 30 along the delivery line 202 .

It can be understood that, as shown in FIG. 26 and FIG. 27, after the first anchoring assembly 10 is implanted in the mitral valve annulus 1 (as shown in FIG. 3 ), the delivery sheath 201 and the anchoring device 300 are withdrawn. The part 20 can be worn outside the body on the delivery line 202, the proximal end of the delivery line 202 passes through the guide hole 601 of the push rod 600, and the push rod 600 can push the spacer 20 into the guide sheath 500 along the delivery line 202 . Then, the push rod 600 is taken out, and the second anchor assembly 10 installed in the delivery sheath tube 201 is threaded on the delivery line 202 through the threading ring 121 exposed outside the delivery sheath tube 201, and the delivery sheath tube 201 is further threaded. Installed in the introducing sheath 500 , the spacer 20 is located on the distal side of the delivery sheath 201 . Thus, the delivery sheath 201 moves axially and distally in the guide sheath 500, so that the spacer 20 and the anchor assembly 10 can be threaded on the tightening wire 30 along the delivery line 202, and the spacer 20 is pushed to the mitral annulus 1, and then the anchoring device 300 pushes the second anchor assembly 10 out of the delivery sheath 201 and anchors the second anchor assembly 10 into the mitral annulus 1, so that the spacer 20 is located between the two anchor assemblies 10 . The same steps are repeated, and multiple anchor assemblies 10 are implanted into the mitral valve annulus 1 sequentially, while multiple spacers 20 are sequentially inserted between every two anchor assemblies 10 .

Please refer to FIG. 17 and FIG. 18 , in some embodiments, the transcatheter heart repair system 1000 further includes an adjustment tool 400, the wire retractor 40 is detachably connected to the distal end of the adjustment tool 400, and the adjustment tool 400 is used to drive the wire retractor 40 tightens up the tightening line 30 (as shown in Figure 15).

Specifically, the adjustment tool 400 includes an outer sheath tube 401 , a rotating tube 402 and a threaded rod 403 that are sheathed sequentially from outside to inside. The outer sheath tube 401 is connected with the housing 41 of the wire take-up 40 to limit the rotation of the housing 41, the rotating tube 402 is clamped with the proximal end of the winding shaft 42, and the threaded rod 403 is screwed with the winding shaft 42 to press the rotating tube 402 so that The rotating tube 402 remains connected to the bobbin 42 . Therefore, the winding shaft 42 can be driven to rotate by rotating the rotating tube 402 to wind the tightening wire 30 to tighten the tightening wire 30 .

In some embodiments, the shell 412 of the housing 41 is provided with a slot 4122, and the distal end of the outer sheath tube 401 is provided with a claw 4011 corresponding to the slot 4122. Through the cooperation between the claw 4011 and the slot 4122, the outer sheath The pipe 401 is connected with the casing 41 . The proximal end of the bobbin 42 protrudes from the proximal opening of the housing 412 , and the proximal end of the bobbin 42 is provided with a threaded hole 424 along its axial direction. A first boss 4021 protrudes from the inner wall of the rotating tube 402 , and a second boss 4031 protrudes from the outer wall of the threaded rod 403 . After the rotating tube 402 is clamped with the winding shaft 42, the threaded rod 403 is screwed with the threaded hole 424, that is, the threaded rod 403 is screwed with the winding shaft 42, so that the first boss 4021 presses against the winding shaft 42 and the second boss 4031 Between, the rotating tube 402 is kept connected with the winding shaft 42 . At this time, the outer sheath tube 401 restricts the rotation of the housing 41, and the rotation of the rotating tube 402 can drive the threaded rod 403 and the bobbin 42 to rotate synchronously, so that the bobbin 42 rotates relative to the casing 41 to wind the tightening wire 30 (as shown in Figure 15 shown) and the tightening line 30 is tightened.

Please refer to FIG. 18 and FIG. 23 to FIG. 28 together. Taking the application of the transcatheter cardiac repair system 1000 in mitral valve annuloplasty as an example, the usage process and working principle:

S1. As shown in Figure 23, puncture through the femoral vein (not shown) through a puncture device (not shown in the figure), and then establish a transfemoral vein-inferior vena cava 2-right atrium through a guide wire (not shown in the figure) 3-atrial septum 4-left atrium 5-the track of mitral valve annulus 1; introduce the guide sheath 500 along the guide wire until the distal end of the guide sheath 500 is delivered to the mitral valve annulus 1 along the guide wire Once in proximity, withdraw the guidewire.

S2. As shown in FIGS. 24 and 25 , implant the first anchor component 10 connected to the distal end of the tightening wire 30 (the anchor component 10 a shown in FIG. 28 ). Specifically, firstly, the anchoring device 300 is worn in the delivery sheath 201 and passed out from the distal end of the delivery sheath 201 to connect with the first anchoring assembly 10; then, the anchoring device 300 is withdrawn toward the proximal end , driving the first anchoring assembly 10 into the delivery sheath 201, at this time, the threading ring 121 of the first anchoring assembly 10 is exposed to the outside of the delivery sheath 201 from the through groove 2012, and the threading ring 121 connected with The tightening line 30 and the delivery line 202 connected with the tightening line 30 are located outside the delivery sheath tube 201; then, the delivery sheath tube 201 is pushed into the guide sheath tube 500 and delivered along the guide sheath tube 500 until the first The anchoring assembly 10 is delivered to the vicinity of the mitral valve annulus 1 and reaches a predetermined treatment site; finally, the driving tube 301 is rotated to anchor the first anchoring assembly 10 into the mitral valve annulus 1 .

S3. As shown in FIGS. 26 and 27, after implanting the first anchoring assembly 10, withdraw the anchoring device 300 and the delivery sheath 201 to the outside of the body and carry out the first spacer 20 (as shown in FIG. 28 ). Implantation of the spacer 20a) and the second anchor component 10 (such as the anchor component 10b shown in FIG. 28). First, wear the first spacer 20 at the proximal end of the delivery line 202, pass the proximal end of the delivery line 202 through the guide hole 601 of the push rod 600 (direction L1 as shown in Figure 26); then, push Push the rod 600 until the first spacer 20 is pushed into the guide sheath 500 (L2 direction as shown in FIG. 26 ), withdraw the push rod 600 and separate the delivery wire 202 toward the proximal end; then, pull the delivery wire The proximal end of 202 passes through the threading loop 121 of the second anchor assembly 10 (the second anchor assembly 10 has been connected to the distal end of the anchoring device 300 and is located in the delivery sheath 201) and in the guide sheath 500 towards Push the delivery sheath 201 distally (L3 direction as shown in FIG. 27 ), and through the pushing of the delivery sheath 201, the first spacer 20 and the second anchor assembly 10 are worn along the delivery line 202 and tightened. Wire 30 and delivered to the mitral valve annulus 1 (as shown in FIG. 28 ); finally, the second anchor assembly 10 is anchored into the mitral valve annulus 1 .

S4. Repeat step S3. As shown in FIG. 28, the rest of the spacer 20 and the anchor assembly 10 are driven into the posterior triangle from the anterior triangle of the mitral annulus 1 along its posterior annulus (or with it) opposite direction), so that the anchoring assemblies 10 and the spacers 20 are alternately and evenly distributed on the mitral annulus 1, wherein each spacer 20 is located between every two anchoring assemblies 10.

S5. As shown in FIG. 18 and FIG. 28 , after implanting a sufficient number of anchor components 10 and spacers 20 , withdraw the delivery sheath 201 and the anchor device 300 toward the proximal end, and use the wire take-up device 40 for coiling And tighten the tightening line 30 to realize shrinkage. First, pass the proximal end of the delivery line 202 through the wire retractor 40 connected to the distal end of the adjustment tool 400; then, in the guiding sheath 500, thread the wire retractor 40 on the tightening wire along the delivery line 202 30, and delivered to the last anchor assembly 10 or the last spacer 20 on the tightening line 30; turn the rotating tube 402 of the adjustment tool 400 to drive the winding shaft 42 to rotate, so that the tightening line 30 is wound around the winding Tighten the spool 42 until the mitral valve regurgitation weakens or disappears and stops rotating the rotating tube 402. At this time, due to the anti-rotation effect of the anti-rotation wheel 45 of the take-up device 40, the tightening line 30 is locked on the spool 42 and the radial space 43 between the housing 41, the tightening wire 30 maintains a certain length on the mitral valve annulus 1; finally, the connection between the adjustment tool 400 and the wire retractor 40 and the connection between the delivery wire 202 and the retractor 40 are released. Tighten the connection of the wire 30, withdraw the adjustment tool 400, the delivery wire 202 and the guide sheath 500 from the body, and leave the wire take-up device 40 at the mitral annulus 1 along with the tightening wire 30, so as to shrink the ring so that the two The goal of treatment is the reduction or disappearance of cusp regurgitation.

It should be understood that, in addition to being directly implanted on the valve annulus (mitral valve annulus 1, tricuspid valve annulus) on the side of the atrium, the implant 100 can also be implanted under the valve annulus, that is, the implant 100 can also be implanted into the wall of the left ventricle below the mitral annulus or the wall of the right ventricle below the tricuspid annulus. Wherein, implanting the implant 100 on the wall of the left ventricle is especially suitable for treating heart failure and functional mitral regurgitation caused by abnormal function of the left ventricle. The guide sheath 500 can be punctured from the femoral artery, retrogradely enters the left ventricle through the aortic valve, and the implant 100 is implanted on the wall of the left ventricle through the delivery device 200 and the anchoring device 300, and the tightening wire 30 is tightened and directly The reduction of the mitral valve annulus is achieved by inhibiting the expansion of the left ventricle. This subannular annulus can preserve the natural structure of the mitral valve. That is to say, the transcatheter heart repair system 1000 of the present application is not only used for shrinking the valve ring during annuloplasty, but also can be used for reducing the volume of the ventricle during ventricular volume reduction. The use process of valve annuloplasty is basically similar and will not be repeated here.

In the description of this specification, descriptions with reference to the terms "some embodiments", "exemplary embodiments", "examples", "specific examples", or "some examples" mean that the specific embodiments described in conjunction with the embodiments or examples A feature, structure, material, or characteristic is included in at least one embodiment or example of the present application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the described specific features, structures, materials or characteristics may be combined in any suitable manner in any one or more embodiments or examples.

Although the embodiments of the present application have been shown and described, those skilled in the art can understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principle and spirit of the present application. The scope of the application is defined by the claims and their equivalents.

Claims

An implant capable of accelerating endothelialization, comprising:

a plurality of anchor assemblies for anchoring into cardiac tissue;

a plurality of spacers having elasticity in their axial direction; and

Tightening wires, the plurality of anchoring components and the plurality of spacers are alternately worn on the tightening wires, the distal ends of the tightening wires are connected with the first one for anchoring into the heart tissue The anchor assembly is connected.
The implant capable of accelerating endothelialization according to claim 1, wherein the spacer also has elasticity in its radial direction, and when the spacer is compressed along its axial direction, the spacer along its Radial expansion conforms the outer peripheral surface of the spacer to the cardiac tissue.
The implant capable of accelerating endothelialization according to claim 2, wherein the spacer comprises a main body, the main body has an axial lumen, and the main body is made of a shape memory material;

The body portion is compressed in its axial direction so that the body portion expands in its radial direction.
The implant capable of accelerating endothelialization according to claim 3, characterized in that, in a natural state, the radial dimension of the main body portion gradually decreases from the middle portion to both ends along its axial direction.
The implant capable of accelerating endothelialization according to claim 3, wherein the spacer further comprises two fixing parts, and the fixing parts are provided with wire holes along the axial direction, and the two fixing parts The parts are respectively arranged at the two axial ends of the main body part, and the wire passing hole communicates with the axial inner cavity.
The implant capable of accelerating endothelialization according to claim 5, wherein the spacer further comprises a rigid member, the rigid member is provided with a threading hole along its axial direction, and the rigid member is accommodated in the In the axial cavity and between the two fixing parts, the threading hole communicates with the threading hole;

When the main body is in a natural state, there is an axial distance between the rigid member and at least one of the fixing members.
The implant capable of accelerating endothelialization according to claim 5, wherein the main body part is a mesh structure, the fixing member includes an outer sleeve and an inner sleeve axially sleeved, and the mesh The free end of the structure is squeezed and accommodated between the outer sleeve and the inner sleeve.
The implant capable of accelerating endothelialization according to claim 5, wherein the main body part includes a plurality of supporting bars distributed at intervals, the fixing member is a fixing tube, and a plurality of the supporting bars surround the Circumferential arrangement of fixed pipes.
The implant capable of accelerating endothelialization according to any one of claims 3-8, characterized in that, the spacer further includes a covering film, the covering film is elastic, and the covering film covers the The outside of the main body is fixedly connected with the main body.
The accelerated endothelialization implant according to claim 1, wherein the spacer is a compression spring.
The implant capable of accelerating endothelialization according to any one of claims 1-8, wherein the anchor component comprises an anchor and a threading structure provided on the anchor, and the tightening thread The distal end of the tightening wire is connected to the threading structure of the first anchor assembly for anchoring into the heart tissue, and the other part of the tightening wire slides through the other anchors for anchoring into the heart tissue The threading structure of the given component.
The implant capable of accelerating endothelialization according to any one of claims 1-8, characterized in that, the implant further comprises a wire take-up, the wire take-up includes a housing and is rotatably arranged on The winding shaft in the housing, the tightening wire moves through the housing and the winding shaft, the winding shaft rotates relative to the housing to wind the tightening wire, the winding shaft When the rotation stops, the tightening wire is locked in the radial space between the winding shaft and the housing.
A transcatheter heart repair system, characterized in that the transcatheter heart repair system comprises a delivery device, an anchoring device, and the implant capable of accelerating endothelialization according to any one of claims 1-12;

The delivery device includes a delivery sheath, the anchoring device is movably worn in the lumen of the delivery sheath, the anchor assembly is worn in the distal lumen of the delivery sheath, the An anchoring assembly is detachably connected to the distal end of the anchoring device, the delivery sheath is used to deliver the anchoring assembly to the heart tissue, and the anchoring device is used to drive the anchoring assembly to anchor into the cardiac tissue.
The transcatheter heart repair system according to claim 13, wherein the anchoring device comprises a driving tube and a connecting rod pierced in the driving tube, and the proximal end of the anchoring assembly is provided with a first A connecting part, the distal end of the driving tube is provided with a second connecting part that is detachably connected to the first connecting part, and the connecting rod passes through the first connecting part that is mated and connected along the axial direction of the driving tube. The connecting portion and the second connecting portion are used to maintain the connection between the driving tube and the anchoring assembly, and the driving tube is used to drive the anchoring assembly to anchor into the heart tissue.
The transcatheter heart repair system according to claim 13, wherein the delivery device further comprises a delivery wire, the distal end of the delivery wire is connected to the proximal end of the tightening wire.
The transcatheter heart repair system according to claim 15, characterized in that, the transcatheter heart repair system further comprises a guide sheath and a push rod, the distal end of the push rod is provided with a guide hole, and the interval After a piece is worn on the delivery line, the delivery line moves through the guide hole, the push rod pushes the spacer along the delivery line into the guide sheath, and the delivery The sheath tube is movably threaded in the guiding sheath to push the spacer in the guiding sheath so that the spacer is threaded on the tightening line along the delivery line.