Anchors, implants, transcatheter cardiac repair systems, and uses thereof

Abstract

The application discloses an anchor, an implant, a transcatheter heart repair system and application thereof. The anchor comprises a connecting part, an anchoring part and a threading part. The anchoring part comprises at least one anchoring strut fixedly connected to the connecting part; the anchoring strut is configured to be self-expanded from a contracted state to an expanded state; compared with the contracted state, at least one section of the anchoring strut in the expanded state is expanded in the radial direction of the anchor; the threading part comprises a threading hole located outside the connecting part. The anchor can ensure that the distance between adjacent anchors can be smoothly adjusted, thereby improving the success rate of transcatheter heart repair surgery. The implant comprises a linear member, a plurality of the above-mentioned anchors and a line collector. The transcatheter heart repair system comprises a first sheath tube, a second sheath tube and the above-mentioned implant, and the distal end of the first sheath tube is sharp.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an anchor, implant, transcatheter cardiac repair system and its application. Background Technology

[0002] Mitral regurgitation and tricuspid regurgitation are common heart diseases. In recent years, minimally invasive interventional treatment of mitral and tricuspid regurgitation has gradually become a research hotspot. Among them, for secondary mitral or tricuspid regurgitation caused by factors such as annular dilation and ventricular enlargement, annuloplasty is an effective interventional repair procedure: several anchors connected by sutures are implanted in the mitral or tricuspid valve annulus, and the sutures are used to reduce the distance between the anchors to reduce the size of the valve annulus, thereby reducing blood regurgitation.

[0003] In existing technologies, anchors are typically spiral anchors with thread-passing structures for sutures and other linear components to pass through. Because spiral anchors need to be inserted into the valve annulus tissue by rotation, linear components can easily become entangled in the anchor, hindering the adjustment of the spacing between adjacent anchors and potentially leading to surgical failure. Summary of the Invention

[0004] In a first aspect, this application proposes an anchoring member. The anchoring member, used for anchoring into a target tissue, includes a connecting portion, an anchoring portion, and a threading portion. The anchoring portion includes at least one anchoring strut fixedly connected to the connecting portion; the anchoring strut is configured to expand from its contracted state to its expanded state; compared to the contracted state, at least a portion of the anchoring strut in the expanded state expands radially within the anchoring member; the threading portion includes a threading hole located outside the connecting portion.

[0005] Secondly, this application also provides an implant, including a linear member, a plurality of the aforementioned anchoring members, and a take-up device. The plurality of anchoring members are connected in series via the linear member. The threaded hole of the first anchoring member for anchoring into the target tissue defines a first position of the linear member, and the linear member is slidably passable through the threaded holes of the other anchoring members for anchoring into the target tissue. The take-up device defines a second position of the linear member to tighten the linear member.

[0006] Thirdly, this application also provides a transcatheter cardiac repair system, including a first sheath, a second sheath, and the aforementioned implant. The distal end of the first sheath is pointed, and the connecting portion of the anchor is detachably connected to the distal end of the second sheath and movably inserted into the first sheath. The first sheath is used to deliver the anchor and the linear component to the target tissue, and the distal end of the first sheath punctures the target tissue before the anchor portion. The second sheath cooperates with the first sheath so that the anchoring strut is exposed outside the distal end of the first sheath, thereby allowing the anchoring strut to expand from its contracted state to anchor into the target tissue.

[0007] Fourthly, this application also provides an application of the transcatheter cardiac repair system as described above. The transcatheter cardiac repair system is used to shrink the valve annulus during annuloplasty or to reduce ventricular volume during ventricular volume reduction surgery.

[0008] The anchoring element, implant, and transcatheter cardiac repair system provided in this application, because the anchoring strut is configured to expand from its contracted state to its expanded state, by axially pushing the anchoring element, the anchoring strut expands from its contracted state, and at least a portion of the anchoring strut expands radially in the anchoring element to achieve anchoring into the target tissue. This avoids the situation of linear parts getting entangled in the anchor pin, which is caused by rotating the anchor pin to achieve anchoring into the target tissue, as in the prior art. It also ensures that the spacing between adjacent anchoring elements can be smoothly adjusted, improving the success rate of transcatheter cardiac repair surgery. Attached Figure Description

[0009] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below only illustrate some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0010] Figure 1 This is a three-dimensional structural diagram of the anchoring element retracting into the first sheath in a transcatheter cardiac repair system provided in one embodiment of this application;

[0011] Figure 2 yes Figure 1 A cross-sectional schematic diagram of the transcatheter cardiac repair system shown;

[0012] Figure 3 yes Figure 1 The diagram shows the connection between the anchor and the second sheath in the transcatheter cardiac repair system.

[0013] Figure 4This is a schematic diagram of the mitral valve annulus after the implant is inserted into the transcatheter cardiac repair system provided in one embodiment of this application and the linear component is tightened.

[0014] Figure 5 This is a schematic diagram of the transcatheter cardiac repair system provided in one embodiment of this application after the implant is inserted into the tricuspid valve annulus and the linear component is tightened;

[0015] Figure 6A This is a three-dimensional structural diagram of the anchoring member provided in an embodiment of this application in an expanded state;

[0016] Figure 6B yes Figure 6A An exploded three-dimensional view of the anchoring component shown.

[0017] Figure 7 This is a schematic diagram of the structure of the anchoring rod in the expanded state in an anchoring component provided in one embodiment of this application;

[0018] Figure 8 This is a schematic diagram of the structure of the anchoring member provided in one embodiment of this application in the expanded state;

[0019] Figure 9A This is a schematic diagram of the structure of the anchoring member provided in one embodiment of this application in the expanded state;

[0020] Figure 9B This is a schematic diagram of the structure of the anchoring member provided in one embodiment of this application in the expanded state;

[0021] Figure 9C This is a schematic diagram of the structure of the anchoring member provided in one embodiment of this application in the expanded state;

[0022] Figure 10 This is a schematic diagram of the structure of the anchoring member provided in one embodiment of this application in the expanded state;

[0023] Figure 11A This is a three-dimensional structural diagram of the connecting part in the anchoring member provided in one embodiment of this application;

[0024] Figure 11B yes Figure 11A Schematic diagram of the cross-sectional structure of the middle connecting part;

[0025] Figure 12A This is a three-dimensional structural diagram of the connecting part in the anchoring member provided in one embodiment of this application;

[0026] Figure 12B This application provides an embodiment with... Figure 12A A schematic diagram of the anchoring member connecting the linear component of the connection part shown;

[0027] Figure 13This is a three-dimensional structural diagram of the connecting part in the anchoring member provided in one embodiment of this application;

[0028] Figure 14A This is a three-dimensional structural diagram of the connecting part in the anchoring member provided in one embodiment of this application;

[0029] Figure 14B This application provides an embodiment with... Figure 14A A schematic diagram of the anchoring member connecting the linear component of the connection part shown;

[0030] Figure 15A This is a three-dimensional structural diagram of the anchoring member provided in an embodiment of this application in an expanded state;

[0031] Figure 15B yes Figure 15A A schematic diagram showing the anchoring component with the connecting part separated from the other parts;

[0032] Figure 16A This is a three-dimensional structural diagram of the anchor (connecting part not shown) provided in an embodiment of this application in an expanded state;

[0033] Figure 16B yes Figure 16A A side view of the anchoring component shown.

[0034] Figure 16C yes Figure 16A A schematic diagram of the anchor in the retracted state;

[0035] Figure 17 This is a schematic diagram of the structure of the first sheath in a transcatheter cardiac repair system provided in one embodiment of this application;

[0036] Figure 18 This is a schematic diagram of the first sheath inserted into the guide sheath 40 in a transcatheter cardiac repair system provided in one embodiment of this application;

[0037] Figure 19 This is a schematic diagram of the structure of the stop provided in one embodiment of this application;

[0038] Figures 20A-20D This is a schematic diagram illustrating the process of implanting an anchor into target tissue using a transcatheter cardiac repair system according to one embodiment of this application;

[0039] Figure 21A This is a schematic diagram of the structure of a take-up device provided in one embodiment of this application;

[0040] Figure 21B yes Figure 21A A schematic diagram of the retractor with its proximal portion removed from its casing;

[0041] Figure 21C yes Figure 21A A partial structural diagram of the take-up device in the image;

[0042] Figure 22 yes Figure 21A An axial sectional view showing the connection between the take-up device and the adjusting device in the middle.

[0043] Figure 23 This is a schematic diagram of a push rod push interval member provided in one embodiment of this application;

[0044] Figures 24A-24C This is a schematic diagram of the process of applying the transcatheter cardiac repair system provided in one embodiment of this application to mitral valve annulus repair surgery;

[0045] Figures 25A-25B This is a schematic diagram of the transcatheter cardiac repair system provided in one embodiment of this application applied to tricuspid valve annulus repair.

[0046] The following detailed description, in conjunction with the accompanying drawings, will further illustrate this application. Detailed Implementation

[0047] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0048] Furthermore, the following descriptions of various embodiments are based on the accompanying illustrations and are used to illustrate specific embodiments that can be implemented in this application. Directional terms used in this application, such as "up," "down," "front," "back," "left," "right," "inner," "outer," and "side," are merely for reference to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of this application, and are not intended to 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 this application.

[0049] It should be noted that the defining terms "proximal" and "distal" used in this application are conventional terms in the field of interventional medical devices. Specifically, "distal" refers to the end furthest from the operator during the surgical procedure, and "proximal" refers to the end closest to the operator during the surgical procedure. Axial direction refers to the direction parallel to the line connecting the centers of the distal and proximal ends of the instrument or component; radial direction refers to the direction perpendicular to the axial direction; and circumferential direction refers to the direction around the axial direction. The central axis of the instrument or component refers to a straight line located at the center of the instrument or component and about which the instrument or component can rotate, or a straight line approximately located at the center of the instrument or component and about which the instrument or component can rotate. The instrument or component can be an axisymmetric or non-axisymmetric object.

[0050] It is worth noting that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "starting end," "end," "both ends," "free end," "upper end," and "lower end" is not limited to a head, endpoint, or end face, but also includes a portion extending axially and / or radially from the head, endpoint, or end face on the element to which the head, endpoint, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The conventional terminology used in this application's specification is for the purpose of describing particular embodiments only and should not be construed as limiting this application.

[0051] Please see Figures 1-5 This application provides a transcatheter cardiac repair system, which can be used to perform transcatheter annuloplasty by implanting multiple anchors 12 connected by linear elements 14 (including but not limited to silk, thread, rope, band, etc., such as medical sutures) into target cardiac tissues such as the mitral or tricuspid valve annulus. By tightening the linear elements 14, the distance between any two adjacent anchors 12 is reduced, thereby directly reducing the valve annulus and thus treating mitral or tricuspid regurgitation. It can also be used to perform transcatheter ventricular volume reduction by implanting multiple anchors 12 connected by linear elements 14 into target cardiac tissues such as the left or right ventricular wall. By tightening the linear elements 14, the distance between any two adjacent anchors 12 is reduced, thereby narrowing the ventricle and reducing the ventricular volume, thus treating heart failure and valvular regurgitation caused by ventricular dysfunction.

[0052] Combination Figures 1-6B and Figures 17-18The transcatheter cardiac repair system of this application includes an implant 10, a first sheath 20, and a second sheath 30. The implant 10 includes multiple anchors 12 and linear elements 14, with the anchors 12 connected in series via the linear elements 14. The anchors 12 are used to anchor into target tissues, such as the mitral valve annulus, tricuspid valve annulus, left ventricular wall, and right ventricular wall. The distal end of the first sheath 20 is pointed. The anchors 12 are detachably connected to the distal end of the second sheath 30 and can be movably inserted into the first sheath 20. The first sheath 20 is used to deliver the anchors 12 and linear elements 14 to the target tissue. The second sheath 30 cooperates with the first sheath 20 to drive the anchors 12 into the target tissue. It can be understood that, combined with... Figure 24A or Figure 25A The transcatheter cardiac repair system also includes at least one guide sheath 40 for establishing an interventional pathway from outside the patient to the heart. A first sheath 20 can deliver an anchor 12 and a linear element 14 into the heart via the guide sheath 40. In some embodiments, the guide sheath 40 includes a first guide sheath and a second guide sheath inserted therein, the second guide sheath extending distally from the first guide sheath. The first sheath 20 extends distally from the second guide sheath and uses its pointed distal end to puncture target tissue. Preferably, both the first and second guide sheaths are adjustable bend sheaths. In other embodiments, the guide sheath 40 may also be a single adjustable bend sheath.

[0053] Please see Figure 4 , Figure 5 and Figures 6A to 10 In some embodiments, the anchoring member 12 is used to anchor into the annulus valve (i.e., the target tissue). The anchoring member 12 includes an anchoring portion 120, a connecting portion 124, and a threading portion 126. The anchoring portion 120 includes at least one anchoring rod 121 fixedly connected to the connecting portion 124. When the anchoring rod 121 is retracted into the first sheath 20, it is compressed to its contracted state. Axially pushing the second sheath 30, it pushes the anchoring member 12, allowing the anchoring rod 121 to expand from its contracted state to its expanded state when it extends beyond the distal end of the first sheath 20. Figure 2 , Figure 3 and Figures 20A-20D As shown, compared to the contracted state, at least a portion of the anchoring rod 121 in the expanded state (e.g., Figure 6B The section 1213 shown expands radially in the anchoring member 12 to achieve anchoring into the petal ring. The threading portion 126 includes a threading hole 127 located outside the connecting portion 124. The threading hole 127 is used for threading the linear member 14, in conjunction with... Figure 4 and Figure 5As shown, the linear member 14 passes through each wire hole 127 to connect each anchor member 12 in series. By tightening the linear member 14, the distance between any two adjacent anchor members 12 is reduced, thereby achieving a ring shrinkage.

[0054] In the aforementioned anchor 12, implant 10, and transcatheter cardiac repair system, the anchoring strut 121 is configured to expand from its contracted state to its expanded state. By pushing the second sheath 30 axially to push the anchor 12, the anchoring strut 121 can expand from its contracted state. At least a portion of the anchoring strut 121 expands radially in the anchor 12 to anchor into target tissues such as the valve annulus. This avoids the linear component entanglement of the anchor caused by rotating the anchor to achieve anchoring into the target tissue, as is the case in the prior art. It ensures that the spacing between adjacent anchors 12 can be smoothly adjusted, thereby improving the success rate of transcatheter cardiac repair surgery. In addition, the operation of pushing the anchor 12 is simpler and more time-saving than the operation of rotating the anchor in the prior art.

[0055] Reference Figure 6A and Figure 6B As shown, the starting end of the anchoring rod 121 connected to the connecting part 124 is considered as the starting end, and the other end as the ending end; the orientation closer to the proximal end E1 of the connecting part 124 in the axial direction along the axis OO of the anchoring member 12 is considered as upper, and the orientation closer to the distal end E2 of the connecting part 124 is considered as lower; the orientation closer to the axis OO in the radial direction is considered as inner, and the orientation farther from the axis OO is considered as outer. In some embodiments, such as Figure 6A , Figure 6B , Figure 9A As shown, the anchoring member 12 includes only one anchoring rod 121. The anchoring rod 121 includes a first section 1211, a second section 1213, and a third section 1215 connected in sequence. The first section 1211 is fixedly connected to the connecting portion 124, the third section 1215 is adjacent to the end of the anchoring rod 121, and the second section 1213 is located between the first section 1211 and the third section 1215. In the expanded state of the anchoring rod 121, the first section 1211 extends downward at least along the axial direction of the anchoring member 12, the second section 1213 extends outward at least radially in the anchoring member 12, and the third section 1215 extends radially inward from the outermost part OT of the anchoring rod 121.

[0056] Specifically: the starting end of the anchoring rod 121 can be fixedly connected to the connecting part 124 by means of welding, interference fit, etc., and the distal end of the connecting part 124 can have a slot 1241 for receiving the starting end. The first section 1211 can extend downward only along the axial direction of the anchoring member 12, or it can extend radially outward while extending downward axially. The second section 1213 can be as follows: Figure 6BAs shown, it extends outward only radially in a straight line shape, or it can be like... Figure 7 The section extends radially outward and axially upward in a curved, preferably arc-shaped form. Further, a first, preferably arc-shaped, receiving section 1212 may be provided between the first section 1211 and the second section 1213 to provide a smooth and gentle transition between them. The third section 1215 extends radially inward and axially upward from the outermost portion OT, from the outermost portion OT to the end of the anchoring rod 121. The radial distance between the third section 1215 and the first section 1211 gradually narrows axially upward. Furthermore, a preferred arc-shaped second receiving section 1214 can be provided between the second section 1213 and the third section 1215 to transition and connect them. This second receiving section 1214 changes from extending radially outward to extending radially inward, allowing the second section 1213 to connect smoothly and gently to the third section 1215, and providing a basis for the directional change of the third section 1215. In addition, the arrangement of the first receiving section 1212 and the second receiving section 1214 helps reduce stress concentration and improve the fatigue resistance of the anchoring rod 121. The outermost part OT of the anchoring rod 121 is located at the radially outermost part of the flipped section of the second receiving section 1214. The end of the anchoring rod 121, which is also the end of the third section 1215, is a pointed tip T to facilitate the anchoring rod 121's insertion into the target tissue. Further, the pointed tip T may, but is not limited to, be shaped like... Figures 6A-8 as well as Figure 10 , Figure 12B , Figures 14B-16C The pointed shape shown, such as Figures 9A-9C The pointed shapes shown are conical and pyramidal. Furthermore, the angle A1 of the pointed tip T is preferably in the range of [10°, 45°], and the angle A2 of the cone tip T is preferably in the range of [5°, 30°], so that the tip T is sharp enough to facilitate puncturing the target tissue.

[0057] Anchoring part 120 can be as Figure 6A or Figure 9A The diagram shows only one anchoring rod 121, but it can also be shown as follows: Figure 8 , Figures 9B-10 , Figure 12B , Figures 14B to 15B The diagram shows multiple anchoring rods 121, such as two, three, four, five, six, eight, etc. Preferably, the multiple anchoring rods 121 are evenly distributed in the circumferential direction of the anchoring member 12, and the anchoring part 120 is generally in the shape of a ship's anchor. After the multiple anchoring rods 121 penetrate the target tissue and expand on their own, they can generate a relatively uniform and stable anchoring force on the target tissue in all directions.

[0058] When the anchoring part 120 includes only one anchoring rod 121, the anchoring rod 121 can be made of a sheet of shape memory alloy, such as... Figures 6A-7 As shown, after the anchoring rod 121 is made from a shape memory alloy sheet with a preferably rectangular cross-section through heat setting, the starting end of the anchoring rod 121 is inserted into the slot 1241 at the distal end of the connecting part 124 and fixed by welding or other means. It is understood that when the anchoring part 120 includes multiple anchoring rods 121, such as... Figure 8 As shown, each anchoring rod 121 can also be made of shape memory alloy sheet, as long as the plurality of anchoring rods 121 are arranged circumferentially and the starting end of each anchoring rod 121 is fixedly connected to the distal end of the connecting part 124. Optionally, when the anchoring part 120 includes a plurality of anchoring rods 121, such as Figure 9B , Figure 9C As shown, each anchoring rod 121 is made of shape memory alloy wire, preferably with a circular cross-section. Multiple wires are heat-set to form multiple anchoring rods 121. The starting end of each anchoring rod 121 is fixedly connected to the distal end of the connecting part 124, and each anchoring rod 121 is evenly distributed circumferentially around the anchoring member 12; or as shown... Figure 10 As shown, multiple anchoring rods 121 are manufactured from shape memory alloy tubing through processes such as cutting and heat setting. In this case, the connecting part 124 can be integrally formed with the anchoring part 120, which includes multiple anchoring rods 121. Each anchoring rod 121 is evenly distributed in the circumferential direction of the anchoring member 12. The shape memory alloy can be, but is not limited to, a nickel-titanium alloy or other metal alloy with shape memory function and biocompatibility. The anchoring rod 121 can expand from its contracted state to its expanded state by means of the shape memory function and / or its own elasticity.

[0059] In the above embodiments, the thickness (for anchor rods with rectangular cross-sections) or diameter (for anchor rods with circular cross-sections) of the anchor rod 121 can range from 0.30 mm to 0.80 mm to ensure that the anchor rod has sufficient strength.

[0060] like Figure 6BAs shown, the preferred angle range of A3 between the first segment 1211 and the second segment 1213, or between the tangents at various points on the second segment 1211 and the tangents at various points on the second segment 1213, is [30°, 150°]. The preferred angle range of A4 between the second segment 1213 and the third segment 1215, or between the tangents at various points on the second segment 1213 and the tangents at various points on the third segment 1215, is [30°, 60°]. This achieves the third segment 1215 extending radially inward from the outermost point OT while simultaneously extending axially upward, and the radial distance between the third segment 1215 and the first segment 1211 gradually narrows as the axial distance increases, i.e., the third segment 1215 gradually tapers inward or bends inward. It is worth noting that the second segment 1213, extending radially outward, already has an anchoring function. Based on this, referring to... Figure 20D and Figure 24B The third section 1215 gradually tapers inward or bends inward, which makes the structure between the first section 1211, the second section 1213 and the third section 1215 more compact, and the structure is difficult to detach from the taper or bend opening, thereby significantly improving the anchoring reliability.

[0061] It is understood that, in addition to the above-mentioned structural form, the anchoring rod 121 may only include the first section 1211 and the second section 1213. On this basis, the first receiving section 1212 may be selectively provided, as long as the second section 1213 extends outward at least in the radial direction of the anchoring member 12. Alternatively, the anchoring rod 121 may only include the first section 1211, the second section 1213 and the third section 1215. On this basis, the first receiving section 1212 or / and the second receiving section 1215 may be selectively provided, as long as the section of the anchoring rod 121 adjacent to its end extends inward in the radial direction from the outermost radial part OT of the anchoring rod 121.

[0062] See Figure 2 , Figure 3 , Figure 6B and Figure 20DIn some embodiments, an S-shaped buckle is provided at the proximal end E1 of the connecting portion 124. This S-shaped buckle is used to engage and mate with another S-shaped buckle located at the distal end of the second sheath 30. The rest of the connecting portion 124 is generally cylindrical or cylindrical in shape. When the two S-shaped buckles are engaged and covered by the first sheath 20, the distal ends of the connecting portion 124 and the second sheath 30 remain connected. By pushing the second sheath 30 axially towards the distal end, the anchoring member 12 can be driven to pierce the target tissue, thereby anchoring the anchoring portion 120 into the target tissue. It can be understood that when the first sheath 20 is withdrawn axially towards the proximal end to expose the engagement point of the two S-shaped buckles, the distal ends of the connecting portion 124 and the second sheath 30 can be separated, thereby separating the anchoring member 12 from the second sheath 30. Of course, in other embodiments, the distal ends of the connecting portion 124 and the second sheath 30 can also be connected by a detachable connection method such as a locking block and slot engagement or a threaded connection.

[0063] See Figure 6A , Figure 6B , Figures 8 to 10 In some embodiments, the threading portion 126 is fixedly connected to the connecting portion 124. Wherein, combined with Figure 11A , Figure 11B As shown, the threading portion 126 includes a base ring 1261 and a threading block 1263 fixedly protruding from the base ring 1261. The threading hole 127 is formed on the threading block 1263. Specifically, the base ring 1261 is a circular ring coaxial with the connecting portion 124, and the base ring 1261 can be fixedly connected to the distal end of the connecting portion 124 by welding, bonding, interference fit, or other methods. The threading block 1263 protrudes radially beyond the base ring 1261, and the axial direction of the threading hole 127 is parallel to the axial direction of the connecting portion 124. Furthermore, the lowest axial portion of the thread hole 127, or the distal end face of the thread block 1263, is located above the lowest axial portion of the base ring 1261, or the distal end face of the base ring 1261. The advantage of this arrangement is that when each anchoring portion 120 is anchored into the target tissue and the linear member 14 passes through each thread hole 127 to connect each anchoring member 12, the distal end face of the base ring 1261 will press against the surface of the target tissue, while the lowest axial portion of the thread hole 127 will be higher than the surface of the target tissue. The linear member 14 will not be pressed by the thread hole 127 to the point of hindering the tightening of the linear member 14, thereby making the operation of tightening the linear member 14 to reduce the distance between any adjacent anchoring members 12 easier and more stable.

[0064] See Figure 12A and Figure 12BIn some embodiments, the threading block 1263 protrudes axially beyond the base ring 1261. Preferably, the threading block 1263 is fixedly connected to the outer peripheral surface of the base ring 1261 and extends axially upward to protrude from the proximal end face of the base ring 1261. The axial direction of the threading hole 127 is parallel to the radial direction of the base ring 1261, i.e., the radial direction of the connecting portion 124, and the lowest radial portion of the threading hole 127 is located above the proximal end face of the base ring 1261. Obviously, in this embodiment, the linear member 14 will not be pressed by the threading hole 127 to the point of hindering the tightening of the linear member 14.

[0065] See Figure 13 In some embodiments, the threading block 1263 protrudes from the base ring 1261 in both the radial and axial directions. The axial direction of the threading hole 127 is perpendicular to the axial and radial directions of the base ring 1261 or the axial and radial directions of the connecting portion 124. Furthermore, the lowest radial part of the threading hole 127 is located above the lowest axial part of the threading portion 126, i.e., the far end face of the base ring 1261. This also prevents the wire member 14 from being pressed by the threading hole 127 to the point that it hinders the tightening of the wire member 14.

[0066] See Figure 14A and Figure 14B In some embodiments, the threading portion 126 includes a base ring 1261 and a threading ring 1265 movably connected to the base ring 1261, the threading ring 1265 having the threading hole 127. Specifically, the base ring 1261 can be fixedly connected to the distal end of the connecting portion 124 by welding, bonding, interference fit, etc. The threading ring 1265 movably passes through a through hole located radially outside the base ring 1261. The threading ring 1265 can rotate with its overlapping part as a base point to move closer to or away from the central axis of the base ring 1261. This arrangement can reduce the overall radial dimension of the anchor 12, which is beneficial for the delivery of the anchor 12 and the selection of a guide sheath 40 with a smaller diameter. In addition, the linear member 14 passes through the threading hole 127 formed by the threading ring 1265. The threading ring 1265 has a large degree of freedom, allowing for more flexible adjustment of the linear member 14, so that the linear member 14 can adapt to the physiological and anatomical morphology of the target tissue to a greater extent.

[0067] Regardless of the structural form of the threading section 126 described above, see [link to documentation]. Figure 15A and Figure 15BIn other embodiments, the threading portion 126 is movably sleeved on a portion of the connecting portion 124, and the connecting portion 124 can selectively restrict the axial movement of the threading portion 126 along the anchor 12. Specifically, a circumferentially protruding flange 1243 is fixed between the distal and proximal ends of the connecting portion 124, and the base ring 1261 is movably sleeved on the portion of the connecting portion 124 below the flange 1243. When the base ring 1261 moves axially upward to abut the distal end face of the flange 1243, the flange 1243 restricts the base ring 1261 from continuing to move axially upward. When the anchor 12 is anchored into the target tissue, the distal end face of the base ring 1261 abuts the surface of the target tissue, and the proximal end face is restricted by the flange 1243. Thus, the threading portion 126 can be positioned in the axial direction but can rotate in the circumferential direction. It is worth noting that after each anchoring part 120 is anchored into the target tissue and the linear member 14 passes through each threading hole 127 to connect each anchoring part 12, during the tightening of the linear member 14, the threading part 126 can rotate adaptively to conform to the direction of the linear member 14 and reduce the obstruction to the tightening of the linear member 14.

[0068] The anchoring part 120 is not limited to being generally anchor-shaped; please refer to [link / reference]. Figure 16A and Figure 16B In some embodiments, the anchoring portion 120 is generally cage-shaped. In these embodiments, the anchoring portion 120 includes a plurality of anchoring struts 121 evenly distributed circumferentially on the anchoring member 12, and a plurality of skeleton struts 1201 evenly distributed circumferentially. In the expanded state, starting from the connecting portion 124, the skeleton struts 1201 first extend downward along the axial direction of the anchoring member 12 while gradually extending outward in the radial direction, and then transition to extending downward along the axial direction while gradually extending inward in the radial direction. The angle A6 at the transition point can be 20° to 60°; an anchoring strut 121 protrudes correspondingly from a skeleton strut 1201. Compared to the contracted state, in the expanded state, at least a portion of the anchoring strut 121 expands radially on the anchoring member 12, and the portion of the anchoring strut 121 near its end extends radially inward from the outermost radial portion OT of the anchoring strut 121. Specifically, compared with the other embodiments described above, in these embodiments, the anchoring rod 121 omits the first section 1211 and the first receiving section 1212, and only provides the second section 1213, the third section 1215 and the second receiving section 1214. The included angle A5 between the second section 1213 and the third section 1215 can be 50° to 80°. The structure of each section can be referred to the previous relevant description, which will not be repeated here.

[0069] Furthermore, in combination Figure 16CThe skeleton rod 1201 is provided with a receiving groove 1203. The starting end of the second section 1213 is fixed in the receiving groove 1203. In the contracted state, the skeleton rod 1201 and the anchoring rod 121 are basically bound to a straight state. The anchoring rod 121 can be accommodated in the receiving groove 1203, which can reduce the overall radial dimension of the anchoring member 12 to facilitate transportation.

[0070] In addition, the anchoring member 12 may also include a plurality of auxiliary anchoring rods 1205 evenly distributed in the circumferential direction. In the expanded state, an auxiliary anchoring rod 1205 protrudes from a skeleton rod 1201, and the auxiliary anchoring rod 1205 is located on the axially opposite side of the anchoring rod 121. The skeleton rod 1201 is also provided with an auxiliary receiving groove 1207. The starting end of the auxiliary anchoring rod 1205 is fixed in the auxiliary receiving groove 1207. In the expanded state, the auxiliary anchoring rod 1205 extends axially downward and radially inward from the starting end, and then flips to extend axially upward and radially outward. Its end is also a pointed tip. The angle A7 at the flip point can be 50° to 80°. The setting of the auxiliary anchoring rod 1205 helps to further enhance the anchoring reliability of the anchoring part 120 to the target tissue. In the contracted state, the skeleton rod 1201, the anchoring rod 121, and the auxiliary anchoring rod 1205 are basically bound to a straight state (e.g., Figure 16C As shown, the anchoring rod 121 can be accommodated in the receiving groove 1203, and the auxiliary anchoring rod 1205 can be accommodated in the auxiliary receiving groove 1207, which can reduce the overall radial dimension of the anchoring member 12 to facilitate transportation.

[0071] The cage-shaped anchoring part 120 can be used with the connecting part and threading part of any of the above structural forms. The connecting part and threading part will not be described again here.

[0072] In the above embodiments, the anchoring part 120 is preferably made of a shape memory alloy such as nickel-titanium, the connecting part 124 is preferably made of a shape memory alloy such as nickel-titanium or stainless steel, and the threading part 126 is also preferably made of a shape memory alloy such as nickel-titanium or stainless steel.

[0073] Please see Figure 1 , Figure 2 , Figure 17 , Figure 18 ,and Figures 20A-20DIn the transcatheter cardiac repair system provided in this application, the first sheath 20 is used to deliver the anchor 12 and the linear component 14 to the target tissue. The distal end of the first sheath 20 is specially designed to be sharp. During cardiac repair surgery, the distal end of the first sheath 20 is controlled to puncture the target tissue before the anchoring portion 120 of the anchor 12. Then, the second sheath 30 is controlled to cooperate with the first sheath 20 so that the anchoring strut 121 is exposed outside the distal end of the first sheath 20, thereby allowing the anchoring strut 121 to expand from its contracted state to puncture and anchor into the target tissue. The distal end of the first sheath 20 is preferably, but not limited to, a beveled tip 21 with a beveled surface 211. During the puncture of the target tissue by the tip 21 of the first sheath 20, each anchoring rod 121 of the anchoring member 12 is contained and bound within the first sheath 20 in a retracted state. Then, each anchoring rod 121 moves distally relative to the tip 21 along the area punctured by the tip 21 until it protrudes beyond the tip 21 and undergoes self-expansion. Compared to using the anchoring rod 121 alone for puncture, the prior puncture by the tip 21 of the first sheath 20 ensures the feasibility of the anchoring rod 121 puncturing the target tissue while significantly reducing the difficulty of puncturing the anchoring rod 121.

[0074] Specifically, the movement of each anchoring rod 121 relative to the tip 21 distally can be achieved by pushing the second sheath 30 distally and / or retracting the first sheath 20 proximally.

[0075] Preferably, the angle B between the oblique cut surface 211 and the axial direction of the first sheath 20 is preferably in the range of 15°≤B≤40°, and the wall thickness of the first sheath 20 is preferably in the range of [0.10mm, 0.50mm], to ensure that the tip 21 is sharp enough to easily puncture the target tissue. Preferably, the length L1 of the oblique cut surface 211 in the axial direction of the first sheath 20 is less than the thickness L2 of the target tissue, such as the valve annulus, to avoid puncturing the target tissue. Preferably, as... Figure 20B and Figure 20C As shown, during the process of the second sheath 30 cooperating with the first sheath 20 to expose the anchoring rod 121 beyond the distal end of the first sheath 20, at least one anchoring rod 121 is adjacent to the starting end of the oblique section 211. The anchoring rod 121 adjacent to the starting end of the oblique section 211 can be exposed, self-expanded and puncture the target tissue when the relative movement distance between the second sheath 30 and the first sheath 20 is small, thus achieving anchoring first. After the anchoring rod 121 is anchored, the other anchoring rods 121 can be exposed, self-expanded and puncture the target tissue by retracting the first sheath 20 axially towards the proximal end.

[0076] In some implementations, such as Figure 12B , Figures 20A-20D , Figure 24C and Figure 25B As shown, the linear member 14 is a double-stranded wire with its two free ends fixed by a pressure tube or steel sleeve. The distal end of the linear member 14 passes through the thread hole 127 of the first anchor member 12 anchored into the target tissue to define a first position of the linear member 14; the linear member 14 continues to slidably pass through the thread holes 127 of other anchor members 12 used for anchoring into the target tissue; see also Figure 4 , Figure 5 , Figures 21A-21C , Figure 24C and Figure 25B In some embodiments, the implant 10 further includes a take-up device 18, which includes a housing 182 and a winding shaft 184 rotatably disposed within the housing 182. The proximal end of the linear member 14 passes through each of the thread holes 127 and then movably passes through the housing 182 and the winding shaft 184. The winding shaft 184 rotates relative to the housing 182 to wind the linear member 14. When the winding shaft 184 stops rotating, the linear member 14 is fixed in the radial space between the winding shaft 184 and the housing 182, thereby the take-up device 18 defines a second position for the linear member 14 to tighten the linear member 14.

[0077] Please see Figure 1 ,and Figures 20A-20D In some embodiments, the wall of the first sheath 20 has a through groove 222 extending proximally from the starting end of the oblique section 211. The through groove 222 communicates with the inner cavity of the first sheath 20, and the distal end of the through groove 222 has an opening. When the anchor 12 is inserted into the first sheath 20, the threading block 1263 of the threading part 126 passes through the through groove 222 and is located outside the first sheath 20. The width of the threading block 1263 is adapted to the width of the through groove 222, and the threading block 1263 can move axially along the through groove 222. When the tip of the first sheath 20 pierces the target tissue, the anchor 12 is driven to move by pushing the second sheath 30 distally along the axial direction to pierce, expand, and anchor into the target tissue. During this process, the through groove 222 restricts and guides the threading block 1263, that is, it restricts and guides the entire anchor 12, ensuring that the anchor 12 moves smoothly along the axial direction.

[0078] Please see Figure 19 , combined Figure 1 and Figures 20A-20DIn some embodiments, the transcatheter cardiac repair system further includes a stop 24, which is movably disposed in the region of the first sheath 20 near the proximal end of the oblique section 211. The stop 24 is used to selectively close the opening of the through slot 222. It is understood that the stop 24 is movable to open or close the opening of the through slot 222 to facilitate the insertion of the anchor 12 or the connecting wire 14. When the anchor 12 is inserted into the first sheath 20 and connected to the wire 14, the anchoring portion 120 of the anchor 12 is received within the inner cavity of the first sheath 20. The anchoring portion 120 is separated from the wire 14 by the stop 24, so that the distal portion of the wire 14 extending from its connection with the suture hole 127 of the anchor 12 is located outside the first sheath 20, thereby preventing the wire 14 from tangling with the anchoring portion 120, avoiding the risk of tangling, and facilitating the smooth implantation of the anchor 12. The portion of the linear member 14 extending proximally from its connection with the thread hole 127 can be located either within the inner cavity of the first sheath 20 or outside the first sheath 20. Furthermore, for example... Figure 15A and Figure 15B In the embodiment shown, the threading part 126 is movably sleeved on a portion of the connecting part 124. The stop part 24 can also prevent the threading part 126 from coming out of the first sheath tube 20 before the anchor 12 is implanted. When the anchor 12 needs to be implanted, the stop part 24 needs to be operated to open the opening of the through groove 222.

[0079] Specifically, the stop portion 24 is an elongated component, and at least its distal portion is made of a material with shape memory function (such as, but not limited to, nickel-titanium alloy). That is, the distal end of the stop portion 24 is made of a material with shape memory function, or the entire stop portion 24 is made of a material with shape memory function. Preferably, the distal end of the stop portion 24 is a non-closed ring in its natural state, which improves the guiding properties of the stop portion 24, makes it easy to retract, increases the travel distance of the stop portion 24, and ensures that the distal end of the stop portion 24 can pass over the through groove 222 to form a blocking effect. The opening of the closed through groove 222 is securely and stably sealed, and the stop portion 24 has sufficient strength and is not easily broken. Of course, the distal end of the stop portion 24 in its natural state can also be a circumferential arc segment adapted to the first sheath 20. It should be noted that the natural state refers to the stop portion 24 being unaffected by any external force. In one feasible embodiment, the stop 24 can be a stop wire, which can be made of nickel-titanium wire, with its distal end forming a non-closed loop through heat setting. A stop wire channel is provided circumferentially on the corresponding area of ​​the first sheath 20, with the distal end of the stop wire movably inserted into the stop wire channel, and the proximal end of the stop wire movably extending axially within the wall or inner cavity of the first sheath 20. It is understood that the distal end of the stop wire closes the opening of the through groove 222 when not subjected to external force, preventing the anchor 12 from detaching from the first sheath 20 during transport. In the above embodiment, the distance the stop wire can be pulled and moved must be greater than the width of the through groove 222 so that the opening of the through groove 222 can be fully opened, thus not hindering the threaded part 126 and the anchor 12 from sliding out of the through groove 222.

[0080] Please refer to it again. Figure 4 , Figure 5 , Figure 24C and Figure 25B In some embodiments, the implant 10 further includes at least one spacer 16, which is fitted onto the linear member 14 and positioned between two adjacent anchors 12. It is understood that the spacer 16 prevents the linear member 14 from becoming too tight, causing damage to target tissues such as the valve annulus due to insufficient distance between adjacent anchors 12. Simultaneously, the spacer 16 acts as a buffer, dispersing the tightening force on the anchors 12 and contributing to the stability of the anchors 12 implantation. The spacer 16 may be a cylindrical member of a certain length, preferably made of a biocompatible material. The spacer 16 may be covered with a membrane to reduce the risk of damage to target tissues such as the valve annulus by the spacer 16.

[0081] Optionally, a spacer 16 may be provided between any two adjacent anchors 12 among the plurality of anchors 12 of the implant 10, or a spacer 16 may be provided every two or more anchors 12, without limitation.

[0082] As previously described, in some embodiments, the implant 10 further includes a take-up device 18, which includes a housing 182 and a winding shaft 184 rotatably disposed within the housing 182. By controlling the rotation of the winding shaft 184 relative to the housing 182, the linear member 14 can be wound around, causing the linear member 14 to continuously tighten to reduce the spacing between the plurality of anchors 12. When the rotation of the winding shaft 184 stops, the linear member 14 is fixed in the radial space between the winding shaft 184 and the housing 182, a second position of the linear member 14 is defined, and the length of the linear member 14 between the first position and the second position is fixed. The take-up device 18 winds and locks the linear member 14, resulting in a good locking effect. The take-up device 18 may be made of a biocompatible material, such as stainless steel, and is not limited thereto.

[0083] It should be noted that when the target tissue is a valve annulus, the linear component 14 is wound around the winding shaft 184 at least three times. The friction between the linear component 14 and the winding shaft 184 can counteract the tension generated by the movement of the valve leaflets, ensuring that the linear component 14 is not pulled. The linear component 14 maintains a certain length on the valve annulus that allows the valve annulus to contract.

[0084] Specifically, such as Figures 21A-21CAs shown, the housing 182 includes a bottom shell 1822 and an outer shell 1824. The outer shell 1824 has openings at both its proximal and distal ends, and the bottom shell 1822 is fixedly connected to the distal end of the outer shell 1824 to form an installation space. The take-up coil 18 also includes a limiting post 186, an anti-rotation wheel 188, and an elastic element 181. The limiting post 186, elastic element 181, anti-rotation wheel 188, and winding shaft 184 are disposed within the installation space of the housing 182. The winding shaft 184 has a winding hole 1844 along its radial direction, and the outer shell 1824 has threaded holes 1826 on both sides of the winding shaft 184, both threaded holes 1826 communicating with the winding hole 1844 of the winding shaft 184. When the take-up coil 18 is threaded onto the wire member 14, the wire member 14 first enters the mounting space of the housing 182 through one threading hole 1826, then passes through the winding hole 1844 of the winding shaft 184, and finally exits the housing 182 through the other threading hole 1826. Preferably, the central axis of the two threading holes 1826 and the central axis of the winding hole 1844 are in the same plane. The winding shaft 184 can be rotated so that the central axis of the winding hole 1844 is collinear with the central axis of the two threading holes 1826. This facilitates the smooth passage of the wire member 14 through the two threading holes 1826 and the winding hole 1844. The distal end of the limiting post 186 is fixedly connected to the bottom shell 1822. The anti-rotation wheel 188 is axially movable and fitted onto the limiting post 186, preventing rotation relative to the limiting post 186. The elastic element 181 abuts against the bottom shell 1822 and the anti-rotation wheel 188. The winding shaft 184 is rotatably fitted onto the limiting post 186. The proximal end of the anti-rotation wheel 188 is provided with a plurality of first helical teeth 1882 along the circumferential direction, and the distal end of the winding shaft 184 is provided with a plurality of second helical teeth 1846 along the circumferential direction. The second helical teeth 1846 are in unidirectional rotational engagement with the first helical teeth 1882. The anti-rotation wheel 188 has a limiting boss 1884 at its proximal end, and a corresponding limiting groove 1828 at the distal end of the outer casing 1824. The anti-rotation wheel 188 is sleeved on the limiting post 186, and the limiting boss 1884 is engaged in the corresponding limiting groove 1828. This restricts the rotation of the anti-rotation wheel 188 relative to the limiting post 186, while the anti-rotation wheel 188 can move axially along the limiting post 186. The distal end face of the winding shaft 184 also has a groove (not shown in the figure) that mates with the proximal end of the limiting post 186. The proximal part of the limiting post 186 is received in the groove at the distal end of the winding shaft 184, and the proximal end face of the limiting post 186 contacts the distal end face of the winding shaft 184. Thus, together with the proximal end of the outer casing 1824, the winding shaft 184 is restricted from axial displacement in the installation space, so that the winding shaft 184 can only rotate. The elastic element 181 is located between the anti-rotation wheel 188 and the bottom shell 1822. One end of the elastic element abuts against the bottom shell 1822, and the other end abuts against the anti-rotation wheel 188. The elastic element 181 provides elastic force to the anti-rotation wheel 188, so that the first helical tooth 1882 of the anti-rotation wheel 188 engages with the second helical tooth 1846 of the winding shaft 184. The elastic element 181 can be, but is not limited to, a spring, a tubular spring sheet, and an elastic bellows.When the winding shaft 184 rotates clockwise relative to the housing 182 and the anti-rotation wheel 188, the second helical tooth 1846 slips on the first helical tooth 1882, causing the anti-rotation wheel 188 to move further away. After the winding shaft 184 rotates through the angle of one helical tooth relative to the anti-rotation wheel 188, the anti-rotation wheel 188, under the elastic force of the elastic element 181, moves closer to the end, causing the first helical tooth 1882 and the second helical tooth 1846 to re-engage, allowing the winding shaft 184 to continue rotating relative to the housing 182 and the anti-rotation wheel 188. When the winding shaft 184 is to be rotated in the opposite direction, the second helical tooth 1846 cannot move the anti-rotation wheel 188 further away due to the obstruction of the first helical tooth 1882, preventing the winding shaft 184 from reversing. Therefore, when the winding shaft 184 stops rotating, the linear element 14 is fixed in the radial space between the winding shaft 184 and the housing 182. It should be noted that the radial space refers to the space enclosed by the winding shaft 184 and the housing 1824, and the radial space is part of the installation space.

[0085] In other embodiments, a locking pin can be inserted along the linear member 14 to lock the tightened linear member 14, so that the linear member 14 remains in the tightened state, and the excess part of the linear member 14 can be cut off.

[0086] Please see Figure 1 , Figure 12B , Figure 14B , Figure 24C and Figure 25B In some embodiments, the transcatheter cardiac repair system delivery device 30 further includes a delivery line 36, the distal end of which is connected to the proximal end of the linear member 14, and the proximal end of the delivery line 36 extends outside the body. In this way, the anchoring member 12, spacer 16, suture retractor 18, etc., can be threaded onto the linear member 14 via the delivery line 36, allowing for the selection of an appropriate implantation length for the linear member 14. This eliminates the need for in-vivo trimming of the linear member 14, preventing the shedding of suture particles and improving surgical safety. The linear member 14 has a certain axial length and is flexible; similarly, the delivery line 36 also has a certain axial length and is flexible. The radial cross-sectional shape of both the linear member 14 and the delivery line 36 can be, but is not limited to, circular, oval, rectangular, square, or other shapes.

[0087] In some embodiments, the proximal end of the linear member 14 is folded into a U-shape, and the delivery line 36 passes through the fold of the linear member 14 to achieve a detachable connection. After multiple anchors 12 and spacers 16 are implanted into the target tissue, such as the valve annulus, the suture retractor 18 is threaded onto the linear member 14 along the delivery line 36. The suture retractor 18 is then used to tighten and fix the linear member 14, maintaining it at a certain length on the valve annulus. The delivery line 36 can then be withdrawn, releasing the linear member 14 and completing the annulus reduction to alleviate blood reflux. It is understood that by using the delivery line 36 to thread the suture retractor 18 onto the linear member 14 and to smoothly release the linear member 14, it is not necessary to pre-implant the suture retractor 18 into the patient, simplifying the surgical procedure, reducing surgical difficulty, and shortening the surgical time.

[0088] Please see Figure 23 In some embodiments, the transcatheter cardiac repair system also includes a push rod 50 for pushing the spacer 16. Specifically, the distal end of the push rod 50 has a guide hole 52 for the passage of the delivery line 36. After the spacer 16 is inserted onto the delivery line 36, the delivery line 36 passes through the guide hole 52 of the push rod 50, and the push rod 50 pushes the spacer 16 along the delivery line 36 into the guide sheath 40. Then, a first sheath 20 is inserted into the guide sheath 40 to push the spacer 16 in the guide sheath 40, such that the spacer 16 is inserted along the delivery line 36 onto the linear member 14.

[0089] Understandably, after the first anchor 12 is implanted into the target tissue, such as the valve annulus, the first sheath 20 and the second sheath 30 are withdrawn. A spacer 16 is then inserted proximally into the delivery line 36, and the delivery line 36 is passed through the guide hole 52 of the push rod 50 in direction a. The push rod 50 then pushes the spacer 16 along the delivery line 36 in direction b into the guide sheath 40. Then, the push rod 50 is removed, and the second anchor 12, which is inserted into the first sheath 20, is inserted into the delivery line 36 through its thread hole 127 exposed outside the first sheath 20. The first sheath 20 is further inserted into the guide sheath 40, with the spacer 16 located on the distal side of the first sheath 20. Thus, the first sheath 20 moves axially distally within the guide sheath 40, allowing the spacer 16 and the second anchor 12 to be threaded onto the linear member 14 along the delivery line 36. The spacer 16 is then pushed to the target tissue. The first sheath 20 first punctures the target tissue, and then the second sheath 30 is manipulated to move relative to the first sheath 20, causing the second anchor 12 to protrude from the first sheath 20 and anchor into the target tissue. The spacer 16 is positioned between the two anchors 12. This process is repeated to implant multiple anchors 12 sequentially, with the spacer 16 interposed between each pair or more anchors 12. The distance between the anchoring points of adjacent anchors 12 must be greater than the axial length of the spacer 16.

[0090] Please see Figure 22 In some embodiments, the transcatheter cardiac repair system further includes an adjustment device 60, with a take-up coil 18 detachably connected to the distal end of the adjustment device 60. The adjustment device 60 is used to drive the take-up coil 18 to tighten the filament 14. Specifically, the adjustment device 60 includes a threaded rod 62, a rotating tube 64, and an outer sheath 66 arranged from the inner to the outer sheath. In the take-up coil 18, the proximal end of the winding spindle 184 extends from the proximal opening of the housing 1824, and the proximal end of the winding spindle 184 has a threaded hole 1842 along its axial direction. The distal end of the outer sheath 66 engages with the housing 182 to restrict the rotation of the housing 182; the distal end of the rotating tube 64 is sleeved on the proximal end of the winding spindle 184, and the rotating tube 64 and the winding spindle 184 are anti-rotating relative to each other; the threaded rod 62 is threadedly connected to the threaded hole 1842 to maintain the connection between the rotating tube 64 and the winding spindle 184. Therefore, rotating the rotating tube 64 can drive the winding shaft 184 to rotate, thereby winding the wire member 14 and tightening it. In some embodiments, the outer shell 1824 of the housing 182 is provided with a slot 1821, and the distal end of the outer sheath tube 66 is provided with a claw 662 corresponding to the slot 1821. Through the engagement of the claw 662 and the slot 1821, the outer sheath tube 66 is connected to the housing 182. The outer wall of the rotating tube 64 is also provided with a first boss 642. After the claw 662 engages with the slot 1821 and the distal end of the rotating tube 64 is sleeved on the proximal end of the winding shaft 184, the first boss 642 can press the claw 662 against the housing 182 to restrict the movement of the outer sheath tube 66 towards the proximal end, so that the outer sheath tube 66 remains connected to the housing 182. The inner wall of the rotating tube 64 is further provided with a second boss 644, and the outer wall of the threaded rod 62 is provided with a third boss 622. After the distal end of the rotating tube 64 is sleeved on the proximal end of the winding shaft 184 and the threaded rod 62 is screwed into the threaded hole 1842, the third boss 622 can press the second boss 644 against the winding shaft 184 to restrict the rotating tube 64 from moving towards the proximal end, so that the rotating tube 64 and the winding shaft 184 remain connected. At this time, the outer sheath tube 66 restricts the rotation of the housing 182. Rotating the rotating tube 64 can drive the threaded rod 62 and the winding shaft 184 to rotate synchronously, so that the winding shaft 184 rotates relative to the housing 182 and winds the wire member 14 to tighten the wire member 14, thereby realizing the ring shrinkage.

[0091] The following will combine Figure 4 , Figures 20A-20D and Figures 24A-24C This paper uses the application of a transcatheter cardiac repair system in mitral valve annulus repair (mitral valve shrinkage) as an example to illustrate the usage process and working principle of the transcatheter cardiac repair system according to the embodiments of this application. The surgical path is as follows: via femoral vein - inferior vena cava - right atrium (RA) - interatrial septum (AS) - left atrium (LA) - mitral valve (MV) annulus.

[0092] The first step is to establish a pathway via femoral vein puncture, connecting the femoral vein, inferior vena cava, right atrium, interatrial septum, left atrium, and mitral valve annulus.

[0093] The second step is to insert the guide sheath 40 until its distal end passes through the foramen ovale to reach the left atrium and is delivered to the vicinity of the mitral valve annulus.

[0094] Step 3, see Figure 24A The threading hole 127 of the first anchor 12 is fixedly connected to the distal end of the linear member 14, and the proximal end of the linear member 14 is detachably connected to the distal end of the delivery line 36. First, the first anchor 12 is detachably connected to the second sheath 30 and inserted into the distal end of the first sheath 20, wherein the threading hole 127 of the first anchor 12, the linear member 14, and the delivery line 36 are located outside the first sheath 20; then, the first sheath 20 is moved axially distally in the guide sheath 40 until its distal end abuts the predetermined anchoring point of the mitral valve annulus.

[0095] Step four, as Figures 20A-20D As shown, the first sheath 20 is first manipulated so that its distal tip 21 pierces the mitral valve annulus. Then, the second sheath 30, which is inserted into the inner cavity of the first sheath 20, pushes the first anchor 12 axially distally. Each anchoring strut 121 of the anchor 12 expands from a contracted state to an expanded state to anchor into the mitral valve annulus. Then, the first sheath 20 is withdrawn proximally so that the first anchor 12 is completely detached from the first sheath 20, and the connection between the second sheath 30 and the first anchor 12 is released.

[0096] Fifth step, as Figure 24B As shown, after the first anchor 12 is implanted, the second sheath 30 and the first sheath 20 are withdrawn, and the spacer 16 is introduced into the guide sheath 40 via the delivery line 36. Then, the proximal end of the delivery line 36 is passed through the thread hole 127 of the second anchor 12 (the second anchor 12 is already connected to the distal end of the second sheath 30 and inserted into the first sheath 20), and the first sheath 20 is pushed through the guide sheath 40. The forward pushing of the first sheath 20 transports the first spacer 16 and the second anchor 12 along the delivery line 36 to be inserted onto the linear member 14 and transported to the vicinity of the mitral valve annulus, with the spacer 16 positioned between the first and second anchors 12. Under ultrasound and digital subtraction angiography (DSA) equipment, the position of the second anchor 12 is adjusted according to the size of the diseased mitral valve annulus by controlling the guide sheath 40 and the first sheath 20, and the second anchor 12 is implanted.

[0097] Step 6: Repeat step 5, sequentially implanting the anchor 12 and spacer 16 from the anterior triangle of the mitral valve along the posterior annulus to the posterior triangle or in the opposite direction, so that the anchor 12 and spacer 16 are evenly distributed on the mitral valve annulus. After implanting a sufficient number of anchors 12, remove the second sheath 30 and the first sheath 20.

[0098] Step 7, see Figure 24C First, the proximal end of the delivery line 36 is passed through the take-up coil 18 at the distal end of the adjustment device 60, and the take-up coil 18 is fed onto the linear member 14 along the delivery line 36. Then, the rotating tube 64 of the adjustment device 60 is rotated forward, causing the winding shaft 184 of the take-up coil 18 to rotate and wind the linear member 14, thereby adjusting the length of the linear member 14 on the mitral valve annulus to reduce the spacing between the multiple anchors 12, and thus causing the mitral valve annulus to contract. After achieving a good annulus contraction effect, the rotating tube 64 stops rotating, the take-up coil 18 locks the linear member 14, and then the threaded rod 62 is reversed to disengage the take-up coil 18 from the adjustment device 60 so that the adjustment device 60 can be withdrawn, leaving the implant 10 on the mitral valve annulus (e.g., Figure 4 (As shown), the ring reduction surgery is completed.

[0099] It is understood that the transcatheter cardiac repair system provided in this application can also be applied to tricuspid valve annulus repair (tricuspid valve shrinking). The following will combine... Figure 5 , Figures 20A-20D ,and Figures 25A-25B This paper uses the application of a transcatheter cardiac repair system in tricuspid valve annulus repair as an example to illustrate the usage process and working principle of the transcatheter cardiac repair system according to the embodiments of this application. The surgical path is: via the femoral vein – inferior vena cava – right atrium (RA) – tricuspid valve (TV) annulus.

[0100] The first step is to establish a track from the femoral vein to the inferior vena cava, the right atrium, and the tricuspid valve annulus via femoral vein puncture.

[0101] The second step is to insert the guide sheath 40 until its distal end reaches the right atrium and is delivered to the vicinity of the tricuspid valve annulus.

[0102] Step 3, see Figure 25A The threading hole 127 of the first anchor 12 is fixedly connected to the distal end of the linear member 14, and the proximal end of the linear member 14 is detachably connected to the distal end of the delivery line 36. First, the first anchor 12 is detachably connected to the second sheath 30 and inserted into the distal end of the first sheath 20, wherein the threading hole 127 of the first anchor 12, the linear member 14, and the delivery line 36 are located outside the first sheath 20; then, the first sheath 20 is moved axially distally in the guide sheath 40 until its distal end abuts the predetermined anchoring point of the tricuspid valve annulus.

[0103] Step four, as Figures 20A-20DAs shown, the first sheath 20 is first manipulated so that its distal tip 21 pierces the mitral valve annulus. Then, the second sheath 30, which is inserted into the inner cavity of the first sheath 20, pushes the first anchor 12 axially distally. Each anchoring strut 121 of the anchor 12 expands from a contracted state to an expanded state to anchor into the mitral valve annulus. Then, the first sheath 20 is withdrawn proximally so that the first anchor 12 is completely detached from the first sheath 20, and the connection between the second sheath 30 and the first anchor 12 is released.

[0104] Fifth, after implanting the first anchor 12, the second sheath 30 and the first sheath 20 are withdrawn. The spacer 16 is introduced into the guide sheath 40 via the delivery line 36. Then, the proximal end of the delivery line 36 is passed through the thread hole 127 of the second anchor 12 (the second anchor 12 is already connected to the distal end of the second sheath 30 and inserted into the first sheath 20), and the first sheath 20 is pushed into the guide sheath 40. The forward pushing of the first sheath 20 transports the first spacer 16 and the second anchor 12 along the delivery line 36 to be inserted onto the linear member 14 and transported to the vicinity of the tricuspid valve annulus, with the spacer 16 positioned between the first anchor 12 and the second anchor 12. Under ultrasound and digital subtraction angiography, the position of the second anchor 12 is adjusted according to the size of the diseased tricuspid valve annulus by controlling the guide sheath 40 and the first sheath 20, and the second anchor 12 is implanted.

[0105] Step 6: Repeat step 5, sequentially inserting the anchor 12 and spacer 16 from the anterior septal junction of the tricuspid valve along the anterior annulus, posterior annulus to the posterior septal junction or in the opposite direction, so that the anchor 12 and spacer 16 are evenly distributed on the tricuspid valve annulus. After inserting a sufficient number of anchors 12, remove the second sheath 30 and the first sheath 20.

[0106] Step 7, see Figure 24C First, the proximal end of the delivery line 36 is passed through the take-up coil 18 at the distal end of the adjusting device 60, and the take-up coil 18 is fed onto the linear member 14 along the delivery line 36. Then, the rotating tube 64 of the adjusting device 60 is rotated forward, causing the winding shaft 184 of the take-up coil 18 to rotate and wind the linear member 14, thereby adjusting the length of the linear member 14 on the tricuspid valve annulus to reduce the spacing between the multiple anchors 12, and thus causing the tricuspid valve annulus to retract. After achieving a good annulus retraction effect, the rotating tube 64 stops rotating, the take-up coil 18 locks the linear member 14, and then the threaded rod 62 is reversed to disengage the take-up coil 18 from the adjusting device 60 so that the adjusting device 60 can be withdrawn, leaving the implant 10 on the tricuspid valve annulus (e.g., Figure 5 (As shown), the ring reduction surgery is completed.

[0107] Furthermore, the transcatheter cardiac repair system provided in this application can also be used to implant multiple anchors 12 connected in series by linear elements 14 into target tissues such as the left or right ventricular wall. By tightening the linear elements 14, the distance between the multiple anchors 12 is reduced, thereby reducing ventricular volume. That is to say, the implant 10 can be implanted not only directly on the valve annulus on the atrial side, but also under the valve annulus, i.e., the implant 10 can also be implanted in the left ventricular wall under the mitral valve annulus or the right ventricular wall under the tricuspid valve annulus. Among these, implantation of the implant 10 in the left ventricular wall is particularly suitable for treating heart failure caused by left ventricular dysfunction and functional mitral regurgitation. Specifically, the guiding sheath 40 can be punctured from the femoral artery, retrogradely enter the left ventricle through the aortic valve, and implant the implant 10 into the left ventricular wall through the first sheath 20 and the second sheath 30. After the linear elements 14 are tightened, left ventricular dilation is directly inhibited. In other words, the transcatheter cardiac repair system of this application can be used not only to shrink the valve annulus during annuloplasty, but also to reduce ventricular volume during ventricular volume reduction surgery. Its specific usage process is basically similar to that of the above-mentioned mitral valve annuloplasty or tricuspid valve annuloplasty, and will not be described in detail here.

[0108] In summary, the transcatheter repair system of this application can be used to anchor multiple anchoring elements 12 connected in series by linear elements 14 into target tissues such as the mitral valve annulus, tricuspid valve annulus, left ventricular wall, and right ventricular wall. The linear elements 14 reduce the distance between the multiple anchoring elements 12, thereby achieving the treatment of heart failure caused by mitral regurgitation, tricuspid regurgitation, or ventricular dysfunction.

[0109] In the description of this specification, the references to terms such as "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0110] Although embodiments of this application have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the claims and their equivalents.

Claims

1. An anchor for anchoring into target tissue, comprising: The anchor portion comprises at least one anchor strut fixedly connected to the connecting portion; the anchor strut is configured to be self-expandable from a contracted state to an expanded state; at least a segment of the anchor strut in the expanded state is expanded in a radial direction of the anchor member compared to the contracted state; the threading portion comprises a threading hole located outside the connecting portion; The anchor portion comprises at least one anchor strut fixedly connected to the connecting portion; the anchor strut is configured to be self-expandable from a contracted state to an expanded state; at least a segment of the anchor strut in the expanded state is expanded in a radial direction of the anchor member compared to the contracted state; the threading portion comprises a threading hole located outside the connecting portion; The threading portion comprises a base ring and a threading block fixedly provided on the base ring, and the threading hole is provided on the threading block; The axial direction of the threading hole is parallel to the axial direction of the connecting portion, and the lowest part of the axial direction of the threading hole is located above the distal end surface of the base ring; or the axial direction of the threading hole is parallel to the radial direction of the connecting portion, or perpendicular to the axial direction and the radial direction of the connecting portion, and the lowest part of the radial direction of the threading hole is located above the distal end surface of the base ring.

2. The anchor of claim 1 wherein, In the expanded state, the segment adjacent to the end of the anchor strut extends inward in the radial direction from the outermost part of the anchor strut in the radial direction.

3. The anchor of claim 2 wherein, The anchor strut comprises a first segment, a second segment and a third segment connected in sequence, the first segment is connected to the connecting portion, and the third segment is adjacent to the end; in the expanded state, the first segment extends downward at least along the axial direction of the anchor member, the second segment extends outward at least in the radial direction, and the third segment extends inward in the radial direction from the outermost part of the anchor strut.

4. The anchor of claim 3 wherein, The third segment of the anchor strut extends upward in the axial direction while extending inward in the radial direction from the outermost part of the anchor strut.

5. The anchor of claim 4 wherein, The anchor strut further comprises a receiving segment transitionally connecting the second segment and the third segment, and in the expanded state, the receiving segment is flipped from extending outward in the radial direction to extending inward in the radial direction, and the outermost part of the anchor strut is located on the receiving segment.

6. The anchor of claim 3 wherein, The second segment has a linear shape or a curved shape.

7. The anchor of claim 1 wherein, The end of the anchor strut is sharp.

8. The anchor of claim 6 wherein, The included angle between the second segment and the third segment, or the included angle between the tangent lines of each part on the second segment and the tangent lines of each part on the third segment, ranges from 30° to 60°.

9. The anchor of claim 2 wherein, In the expanded state, the anchor portion is generally in the shape of an anchor, comprising a plurality of anchor struts uniformly distributed in the circumferential direction of the anchor member.

10. The anchor of claim 2 wherein, In the expanded state, the anchor portion is generally in the shape of a cage, comprising a plurality of anchor struts uniformly distributed in the circumferential direction of the anchor member and a plurality of framework struts uniformly distributed in the circumferential direction; from the connecting portion, the framework struts first extend downward along the axial direction of the anchor member while gradually extending outward in the radial direction, and then transitionally change to extend downward along the axial direction while gradually extending inward in the radial direction; one anchor strut is provided on one framework strut.

11. The anchor of claim 10 wherein, The framework struts are provided with accommodation grooves; in the contracted state, the anchor struts can be accommodated in the accommodation grooves.

12. The anchor of claim 10 wherein, The plurality of auxiliary anchoring struts are uniformly distributed in the circumferential direction; in the expanded state, one of the auxiliary anchoring struts is provided on one of the framework struts, and the auxiliary anchoring strut is first extended downward along the axial direction and inward along the radial direction on the side of the framework strut where no anchoring strut is provided, and then turned to extend upward along the axial direction and outward along the radial direction.

13. The anchor of any one of claims 1-12, wherein, The cross-sectional shape of the anchoring strut is rectangular or circular.

14. The anchor of claim 13, wherein, The anchoring strut is made of a sheet, wire or tube of shape memory alloy.

15. The anchor of any one of claims 1-12, wherein, The threading part is fixedly connected to the connecting part; or the threading part is movably sleeved on a part of the connecting part, and the connecting part selectively limits the movement of the threading part along the axial direction of the anchor.

16. An implant, characterized in that, The implant comprises a linear member, a plurality of anchors according to any one of claims 1-15, and a retractor; the plurality of anchors are connected in series by the linear member, the threading hole of a first anchor for anchoring into the target tissue defines a first position of the linear member, and the linear member is slidably threaded through the threading hole of other anchors for anchoring into the target tissue, and the retractor defines a second position of the linear member to tighten the linear member.

17. A transcatheter cardiac repair system, comprising: The implant comprises a first sheath, a second sheath, and the anchor according to claim 16, a distal end of the first sheath is sharp, the connecting part is detachably connected to a distal end of the second sheath and movably sleeved in the first sheath, the first sheath is used to deliver the anchor and the linear member to the target tissue, and the distal end of the first sheath pierces the target tissue before the anchoring part, the second sheath cooperates with the first sheath to expose the anchoring struts outside the distal end of the first sheath, so that the anchoring struts are self-expanded from the contracted state to anchor into the target tissue.

18. The transluminal cardiac repair system of claim 17, wherein, The distal end of the first sheath is a beveled tip with a beveled surface, and the angle between the beveled surface and the axial direction of the first sheath ranges from 15° to 40°.

19. The transluminal cardiac repair system of claim 18, wherein, The length of the beveled surface in the axial direction of the first sheath is less than the thickness of the target tissue.

20. The transluminal cardiac repair system of claim 18, wherein, During the process in which the second sheath cooperates with the first sheath to expose the anchoring struts outside the distal end of the first sheath, at least one of the anchoring struts is adjacent to the starting end of the beveled surface.

21. The transluminal cardiac repair system of claim 17, wherein, The implant further comprises a delivery wire, and the delivery wire is detachably connected to the linear member. The cross-sectional shape of the anchoring strut is rectangular or circular. The anchoring strut is made of a sheet, wire or tube of shape memory alloy. The threading part is fixedly connected to the connecting part; or the threading part is movably sleeved on a part of the connecting part, and the connecting part selectively limits the movement of the threading part along the axial direction of the anchor. The implant comprises a linear member, a plurality of anchors according to any one of claims 1-15, and a retractor; the plurality of anchors are connected in series by the linear member, the threading hole of a first anchor for anchoring into the target tissue defines a first position of the linear member, and the linear member is slidably threaded through the threading hole of other anchors for anchoring into the target tissue, and the retractor defines a second position of the linear member to tighten the linear member. The implant comprises a first sheath, a second sheath, and the anchor according to claim 16, a distal end of the first sheath is sharp, the connecting part is detachably connected to a distal end of the second sheath and movably sleeved in the first sheath, the first sheath is used to deliver the anchor and the linear member to the target tissue, and the distal end of the first sheath pierces the target tissue before the anchoring part, the second sheath cooperates with the first sheath to expose the anchoring struts outside the distal end of the first sheath, so that the anchoring struts are self-expanded from the contracted state to anchor into the target tissue. The distal end of the first sheath is a beveled tip with a beveled surface, and the angle between the beveled surface and the axial direction of the first sheath ranges from 15° to 40°. The length of the beveled surface in the axial direction of the first sheath is less than the thickness of the target tissue. During the process in which the second sheath cooperates with the first sheath to expose the anchoring struts outside the distal end of the first sheath, at least one of the anchoring struts is adjacent to the starting end of the beveled surface. The implant further comprises a delivery wire, and the delivery wire is detachably connected to the linear member.

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