A leaflet anchor secured to leaflet

Abstract

The invention provides a leaflet anchor for securing to a leaflet. The leaflet anchor includes an anchor body and a suture. The anchor body defines a threading hole extending through the anchor body, a distal end of the suture is attached to the anchor body, and at least two extending ends of the suture extend from the distal end and penetrate through the threading hole. Wherein the wire passing hole is configured to be used for allowing the at least two extending ends to penetrate out of the anchor body side by side in the long axis direction of the anchor body, the at least two extending ends penetrate out of the anchor body, then extend towards the near end and can move relatively to drive the anchor body to move, and then the long axis direction of the anchor body is changed. According to the leaflet anchor provided by the invention, the bearing area of the leaflet is effectively increased, and the possibility of collision between the leaflet and the opposite leaflet when the leaflet is closed is further avoided, so that the safety of repairing the leaflet is guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a leaflet anchor for fixing to a leaflet. Background Art

[0002] The atrioventricular valves of the heart (such as the mitral valve and tricuspid valve) are one-way valves located between the atria and ventricles. Healthy atrioventricular valves can control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. However, when the leaflets, chordae tendineae, or valve rings of the atrioventricular valves and other related structures become diseased and cause blood to flow back to the atria, it is very easy to cause mitral valve regurgitation or tricuspid valve regurgitation. Clinically, repairing the atrioventricular valves through interventional minimally invasive surgery has become increasingly common.

[0003] Taking artificial chord implantation and edge-to-edge repair as examples, when performing artificial chord implantation, one end of the suture can be fixed to the leaflet and the other end can be fixed to the ventricular tissue to form an artificial chord, thereby replacing the function of the diseased or broken natural chord; when performing edge-to-edge repair, two or three groups of sutures can be fixed to the leaflets of the mitral valve or tricuspid valve respectively, and then all the sutures can be fixed together using a locking piece to complete the edge-to-edge repair. In the prior art, in order to ensure the effective fixation of the suture at the leaflet end and prevent the leaflet from being torn due to the suture cutting the leaflet, one end of the suture is generally attached with a slender anchor to support the leaflet and disperse stress. However, after the slender anchor in the prior art is fixed to the leaflet, its long axis is likely to be perpendicular to the edge of the leaflet, which not only fails to ensure the effective supporting area of ​​the leaflet, but also is very likely to collide with the contralateral leaflet when the leaflet is closed, thereby causing the risk of damage to the contralateral leaflet. Summary of the invention

[0004] An object of the present invention is to provide a leaflet anchor for fixing to a leaflet, which not only ensures the effective supporting area of ​​the leaflet, but also further reduces the damage to the leaflet, thereby greatly ensuring the safety of repairing the leaflet.

[0005] In order to achieve the above objectives, in a first aspect, the present invention provides a leaflet anchor for fixing to a leaflet, the leaflet anchor comprising:

[0006] an anchor body, the anchor body defining a wire hole extending through the anchor body; and

[0007] A suture, wherein the distal end of the suture is attached to the anchor body, and at least two extending ends of the suture extend from the distal end and pass through the suture hole;

[0008] Among them, the wire hole is configured to allow the at least two extension ends to pass through the anchor body side by side along the long axis direction of the anchor body; after passing through the anchor body, the at least two extension ends extend toward the proximal end and can move relative to each other to drive the anchor body to move, thereby changing the long axis direction of the anchor body.

[0009] In a second aspect, the present invention also provides an anchor for fixing to a tissue, the anchor comprising:

[0010] an anchor body, the anchor body defining a wire-passing hole extending through the anchor body;

[0011] A buffer member, the buffer member being disposed on at least a portion of the surface of the wire hole to reduce the hardness of the surface of the wire hole; and

[0012] A suture thread, wherein the suture thread can pass through the thread hole and the hollow channel surrounded by the buffer component.

[0013] Compared with the prior art, the present invention designs the thread hole of the anchor body so that at least two extension ends of the suture thread pass through the anchor body side by side along the long axis direction of the anchor body. Therefore, under the continuous beating of the heart or the pulling of external force, the at least two extension ends will move relative to each other in order to maintain balance, thereby driving the anchor body to move so that the long axis direction of the anchor body changes, and finally switches to a state of extending roughly horizontally to be parallel to the edge of the leaflet to effectively support the leaflet. Therefore, the leaflet anchor provided by the present invention not only ensures the effective supporting area of ​​the leaflet, but also further avoids the possibility of collision with the opposite leaflet when the leaflet is closed, thereby greatly ensuring the safety of repairing the leaflet. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0015] Figure 1 A schematic diagram is shown of a state in which the leaflet anchor vertically extends to the leaflet in some embodiments, and the state diagram shows a side cross-sectional view of the leaflet.

[0016] Figure 2 Shows Figure 1 The schematic diagram of the state in which the leaflet anchor is horizontally extended to the leaflet is shown, and the state diagram shows a front view of the leaflet.

[0017] Figure 3 A schematic diagram showing a state in which the leaflet anchor is fixed to the leaflet using a puncture needle.

[0018] Figure 4-9 The diagrams show the structure of the anchor body with different thread holes and the different states of the anchor body connected with the suture.

[0019] Fig.10 A schematic structural diagram of a leaflet anchor having four elastic extension arms is shown.

[0020] Figure 11-12 They are shown respectively Fig.10 The diagram shows a radially contracted state where the leaflet anchor is housed in the puncture needle and a radially expanded state where the leaflet anchor is released from the puncture needle.

[0021] Fig.13 A schematic structural diagram of a leaflet anchor having two elastic extension arms is shown.

[0022] Fig.14 Shows Fig.13 A schematic diagram of the leaflet anchor is shown in a radially contracted state.

[0023] Fig.15 A three-dimensional schematic diagram of the leaflet anchor in a first slender rod structure is shown.

[0024] Figure 16-17 They are shown respectively Fig.15 The diagram shows the state where the leaflet anchor is housed in the puncture needle and released to the leaflet.

[0025] Figure 18-20 A schematic diagram showing the leaflet anchor being in a second elongated rod structure is shown.

[0026] Figure 21-22 They are shown respectively Fig.18 The diagram shows the valve leaflet anchor being housed in the puncture needle and released to the valve leaflet.

[0027] Figure 23-25 A schematic diagram showing a leaflet anchor in the form of a slender tubular structure is shown.

[0028] Fig.26 A schematic diagram showing the state of transcatheter artificial chord implantation by implanting a valve leaflet anchor into the mitral valve using a suturing instrument.

[0029] Fig. 27 Shows the use of Fig.26 Schematic diagram of the structure of the puncture needle of the suturing instrument puncturing the valve leaflet.

[0030] Fig.28 Shows the use of Fig. 27 Schematic diagram of the structure in which the pusher pushes the leaflet anchor out of the distal end of the puncture needle.

[0031] Fig.29 A schematic diagram showing the state of completion of artificial chord implantation.

[0032] Fig.30 The schematic diagram shows a state in which the leaflet anchors extend vertically to the ventricular side of the leaflets.

[0033] Figure 31-34 Various schematic diagrams of anchor structures with different buffers are shown. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] In addition, the following descriptions of the embodiments are made with reference to the attached diagrams to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0036] It should be noted that, in order to more clearly describe a leaflet anchor fixed to a leaflet provided by the present invention, the limiting terms "proximal end" and "distal end" described in the specification of the present invention are all conventional terms in the medical field. Specifically, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end close to the operator during the surgical operation; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius. It is worth noting that the "end" in the terms such as "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end" and "lower end" is not limited to the end, end point or end face, but also includes a portion extending from the end, end point, or end face on the element to which the end, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by technicians in the technical field of the present invention. The conventional terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not to be construed as limiting the present invention.

[0037] Please combine Figure 1 to Figure 2 , an embodiment of the present invention provides a leaflet anchor 100 for fixing to a leaflet 40, so as to treat or repair cardiac tissue. Specifically, the leaflet anchor 100 includes an anchor body 20 and a suture 30, wherein the anchor body 20 defines a thread hole 21 extending through the anchor body 20, such as extending radially and penetrating the anchor body 20 or extending axially and penetrating the anchor body 20. The suture 30 has a distal end 31, a proximal end 32, and at least two extending ends 33 extending between the distal end 31 and the proximal end 32, wherein the distal end 31 of the suture 30 is an end close to the anchor body 20, and the proximal end 32 of the suture 30 is an end away from the anchor body 20. After the distal end 31 of the suture 30 is attached to the anchor body 20, at least two extending ends 33 of the suture 30 pass through the thread hole 21 and extend toward the proximal end 32, so as to complete the overall penetration and connection of the suture 30 on the anchor body 20. Furthermore, the thread hole 21 is configured to allow at least two extension ends 33 of the suture thread 30 to pass through the anchor body 20 side by side along the long axis direction A of the anchor body 20. After passing through the anchor body 20, the at least two extension ends 33 can move relative to each other and drive the anchor body 20 to move, such as rotating around the at least two extension ends 33, thereby changing the long axis direction A of the anchor body 20, such as freely moving the long axis direction A of the anchor body 20. Figure 1 The first direction shown is extended to switch to Figure 2 The shown extending in the second direction.

[0038] Please continue reading Figure 3 Specifically, the leaflet anchor 100 can be pre-removably carried in the puncture needle 50, and the puncture needle 50 has a sharp distal end 51. After the leaflet anchor 100 is delivered to the target position of the leaflet 40 by the puncture needle 50 and the leaflet 40 is punctured by the sharp distal end 51, the anchor body 20 can be released from the distal end of the puncture needle 50 and rotated relative to the puncture needle 50 to be set at an angle (for example, 90 degrees) with at least two extension ends 33 of the suture 30 to be fixed to the leaflet 40. Then, when the long axis direction A of the anchor body 20 is as shown in FIG. Figure 1 When the anchor body 20 extends in a first direction and abuts against the leaflet 40, such as extending in a non-horizontal direction and abutting against the leaflet 40, the at least two extension ends 33 located in the puncture hole 401 will be arranged side by side on the leaflet 40 along the long axis direction A of the anchor body 20 (such as passing through the puncture hole 401 side by side) and in an unbalanced state stacked on each other, that is, stacked on each other through the puncture hole 401 of the leaflet 40. Given that the size of the puncture hole 401 on the leaflet 40 must be larger than the total diameter of the suture 30, the at least two extension ends 33 of the suture 30 can move freely in the puncture hole 401. Therefore, under the continuous beating of the heart or the pulling of external force, in order to maintain balance, the at least two extension ends 33 will move relative to each other in the puncture hole 401 of the leaflet 40 until they are as shown. Figure 2 At the same time, the anchor body 20 will rotate around the puncture hole 401 of the leaflet 40 driven by the at least two extension ends 33 until the long axis direction A of the anchor body 20 is switched to the balanced state shown in FIG. Figure 2 As shown, it extends in a second direction, such as a state of extending basically horizontally. At this time, the long axis direction A of the anchor body 20 is parallel to the leaflet edge 400 in the natural state, so as to horizontally support the leaflet 40, thereby increasing the supporting area of ​​the leaflet anchor 100 for the leaflet 40. In view of the fact that the leaflet edge 400 extends horizontally when the leaflet 40 is in the natural state, the leaflet anchor 100 provided by the present invention can ensure that the long axis direction A (i.e., the axial direction) of the anchor body 20 is basically parallel to the leaflet edge 400 after implantation, which not only effectively increases the supporting area of ​​the leaflet anchor 100 supporting the leaflet 40, which helps to ensure the treatment effect of the operation, but also further avoids the possibility of collision with the opposite leaflet when the leaflet 40 is closed, thereby ensuring the safety of the leaflet anchor 100 in repairing the leaflet 40.

[0039] In some embodiments, Figure 4 and Figure 7 As shown, the number of the wire hole 21 is one, and the cross section of the wire hole 21 forms a structure with a major axis and a minor axis, including but not limited to the following: Figure 4 a-4b and Figure 7 The oval structure shown in a-7b, or Figure 4 c-4d and Figure 7 In the racetrack-shaped structure of c-7d, at least two extended ends 33 of the suture 30 pass through the thread hole 21 side by side along the long axis of the thread hole 21. Specifically, the long axis of the thread hole 21 can be as follows: Figure 4 The anchor body 20 extends in the longitudinal direction A in the manner shown, or in the manner shown in FIG. Figure 7 The anchor body 20 extends in the radial direction B as shown, and the radial direction B is the extension direction of the at least two extension ends 33 of the suture 30 after passing through the thread hole 21 (see FIG. Fig. 9 a). In some embodiments, in order to ensure that the at least two extension ends 33 of the suture thread 30 can smoothly pass through the long axis of the thread hole 21 side by side, the absolute value of the difference between the short axis dimension W of the thread hole 21 and the diameter D of a single extension end 33 is ≤ 0.1 mm, and the long axis dimension L of the thread hole 21 is greater than the sum of the diameters D of all the extension ends 33. 总 The absolute value of the difference between them is ≤0.1mm, where D 总=nD, n is the number of extension ends 33 accommodated in the thread hole 21, the preferred range of n is a natural number of 2-5 for accommodating up to 5 extension ends 33, and D is the diameter of a single extension end 33 or the diameter of a single suture 30. Taking the thread hole 21 accommodating two sutures 30 as an example, at this time, the preferred range of the major axis dimension L of the thread hole 21 is 0.2mm-2.1mm, and the preferred range of the minor axis dimension W is 0.1mm-1.05mm. Then, when the diameter D of a single extension end 33 is 0.4mm, the preferred minor axis dimension W of the thread hole 21 of the present invention is 0.45mm, and the major axis dimension L is 0.9mm. For example, if the thread hole 21 just accommodates the suture thread 30, that is, the absolute value of the above-mentioned difference is 0, then the ratio W:D of the short axis dimension W of the thread hole 21 and the diameter D of a single extension end 33 is 1:1; the preferred range of the ratio L:D of the long axis dimension L of the thread hole 21 and the diameter D of a single extension end 33 is 2:1-5:1, so as to accommodate up to 5 extension ends 33 with the same diameter D.

[0040] In other embodiments, Figure 5 a-5b and Figure 8 As shown in a-8b, the wire holes 21 have at least two and are arranged side by side at intervals, for example, Figure 5 The anchor bodies 20 are arranged side by side and spaced apart in the manner shown in FIG. Figure 8 The manner shown is arranged side by side and spaced along the radial direction B of the anchor body 20. Preferably, the number of the thread holes 21 is 2-5, so as to accommodate a maximum of 5 extension ends 33. In order to ensure that each thread hole 21 is used to accommodate only one extension end 33 and pass smoothly, the cross section of each thread hole 21 is roughly circular, and the absolute value of the difference between the diameter d of each thread hole 21 and the diameter D of a single extension end 33 is ≦0.1mm. For example, if the thread hole 21 just accommodates the suture 30, that is, the absolute value of the above difference is 0, then the ratio d:D of the diameter d of each thread hole 21 and the diameter D of a single extension end 33 is 1:1.

[0041] It is understandable that if Figure 6 and Fig. 9As shown, the thread hole 21 has a first opening 211, a second opening 212, and a closed suture channel 213 extending from the first opening 211 to the second opening 212, wherein the first opening 211 is opened at a substantially middle position on the side wall of the anchor body 20. The distal end 31 of the suture 30 is limited outside the second opening 212 to achieve the attachment of the suture 30 to the anchor body 20, and the at least two extended ends 33 thereof can pass through the anchor body 20 side by side along the long axis direction A of the anchor body 20 from the first opening 211 after entering from the second opening 212 and passing through the suture channel 213. In particular, the at least two extended ends 33 of the suture 30 can selectively switch between parallel to the long axis direction A of the anchor body 20 and perpendicular to the long axis direction A of the anchor body 20 along the first opening 211, so as to achieve the switching of the leaflet anchor 100 between the accommodation state of the puncture needle 50 and the release state of the puncture needle 50.

[0042] In some embodiments, Figure 6 As shown in a-6b, the thread hole 21 radially penetrates the anchor body 20, and the radial direction is set at an angle, such as perpendicular to the long axis direction A of the anchor body 20. Specifically, two opposite first openings 211 and second openings 212 are formed on the side wall of the anchor body 20, and a suture channel 213 is radially formed between the first opening 211 and the second opening 212 to form a single radially penetrating thread hole 21, such as an elliptical thread hole 21. At this time, the long axis of the elliptical thread hole 21 extends along the long axis direction A of the anchor body 20, so that at least two extension ends 33 of the suture 30 can pass through the thread hole 21 side by side along the long axis of the thread hole 21. Preferably, the suture 30 is at least two sutures. Taking two sutures 30 as an example, when the sutures 30 need to be attached to the anchor body 20, the two distal ends 31 of the two sutures 30 are manipulated to enter from the first opening 211 of the anchor body 20, and pass through the suture channel 213 and then pass through the second opening 212, and further the two distal ends 31 are knotted to form at least one knot 300. At this time, the distal end 31 of the suture 30 is attached to the anchor body 20 by restricting the knot 300 outside the second opening 212. Inevitably, the size of the knot 300 needs to be larger than the size of the second opening 212 to ensure that the distal end 31 of the suture 30 can always be restricted outside the anchor body 20, thereby avoiding the risk of the distal end 31 of the suture 30 detaching from the anchor body 20 and causing the fixation failure of the suture 30.

[0043] In other embodiments, Fig. 9As shown in a-9b, the thread hole 21 axially penetrates the anchor body 20. Specifically, a side opening (i.e., a first opening 211) is formed on the side wall of the anchor body 20, for example, two first openings 211 are formed and arranged side by side along the long axis direction A. The thread hole 21 axially penetrates and extends from the two distal openings (i.e., the two second openings 212) of the anchor body 20 along the long axis direction A to the two first openings 211, so as to form a suture channel 213 connecting the first opening 211 and the second opening 212 for at least two extended ends 33 of the suture 30 to pass through. The two thread holes 21 are arranged side by side along the radial direction B of the anchor body 20 and form a substantially L-shaped extension length, so that at least two extended ends 33 of the suture 30 can pass through the anchor body 20 from the two first openings 211 side by side along the long axis direction A of the anchor body. Preferably, there is one suture 30. When the suture 30 needs to be attached to the anchor body 20, the suture 30 is folded in half to form two extension ends 33, and two thread holes 21 are respectively provided. At this time, the distal end 31 of the suture 30 is attached and restricted outside the two second openings 212 by winding back, so as to attach the distal end 31 of the suture 30 to the anchor body 20. Of course, when there is one thread hole 21, the suture 30 is provided with at least two and connected in parallel. Figure 6 The distal end 31 is connected by tying a knot.

[0044] In the embodiment of the present invention, the anchor body 20 is made of metal material or high-hardness polymer material, such as nickel titanium, stainless steel and other metal materials that can be implanted in the human body. Therefore, it is not easy to deform and has good support. Even if a smaller anchor body 20 is used, it can meet the support force of the leaflet 40, thereby avoiding the risk of deformation or bending of the leaflet 40 caused by long-term bearing and causing secondary regurgitation. At the same time, the anchor body 20 can be various slender structures of different shapes, such as Figure 6 The cross-section of the flat strip shown is a square elongated structure, which can be as follows Fig.10 and Fig.13 The elastic elongated structure with the extension arm shown can be as follows Fig.15 and Fig.18 The slender rod structure shown in FIG. Fig.23 Of course, in some embodiments, the anchor body 20 may also have other features, for example, it may include a first embedded wire portion for accommodating at least a portion of the extended end 33 of the suture 30, a second embedded wire portion for accommodating the distal end 31 of the suture 30, and / or a hollow portion for reducing the weight of the anchor body 20, etc. The specific structure of the anchor body 20 provided by various embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings.

[0045] In such Figure 10-14In the elastic elongated structure shown, the anchor body 20a includes a main body 22a and extension arms 23a and 24a extending from the main body 22a. The extension arms 23a and 24a are symmetrically arranged in a divergent shape from the circumference of the main body 22a and at least the radial portion thereof is elastic so as to switch between a radially contracted state and a radially expanded state. Fig.10 As shown in FIG. 1 , four slender extension arms 23a extend outward at an angle to the long axis direction A of the anchor body 20a, respectively, to form a slender anchor body 20a that is symmetrical in both the axial direction and the radial direction and is generally in an inverted X shape; at this time, the angle between two slender extension arms 23a spaced apart along the long axis direction A of the anchor body 20a is greater than 90 degrees and less than 180 degrees, so that the long axis of the anchor body 20a is greater than the short axis. Or, as Fig.13 As shown in FIG. 1 , two slender extension arms 24a extend from the main body 22a toward opposite sides, such as extending along the long axis direction A of the anchor body 20a, to form a slender anchor body 20a that is substantially in the shape of an inverted figure 8. Specifically, the wire hole 21a is provided in the main body 22a, such as Fig.10 A through hole with an elliptical cross section extending in a direction perpendicular to the long axis A of the anchor body 20a as shown in a-10b and 13a-13b, or a through hole as shown in Fig.10 c-10d and 13c-13d show a through hole with a racetrack-shaped cross section, or a through hole as shown in Fig.10 The two through-holes shown in Figs. e-10f and 13e-13f have circular cross-sections. The sutures 30 are arranged side by side in the through-holes 21a along the longitudinal direction A of the anchor body 20a. Fig.11 or Fig.14 When the anchor body 20a with the suture 30 attached is loaded into the puncture needle 50 along the longitudinal direction A, at least the radial portions of the extension arms 23a and 24a are retracted inwardly into the distal end of the puncture needle 50. At this time, the anchor body 20a is in a radially retracted state and forms a generally straight-line structure. Fig.12 When the anchor body 20a is released from the distal end of the puncture needle 50, the extension arms 23a and 24a extend radially outward to expand to a natural state; at this time, the anchor body 20a switches to a radially expanded state and presents an inverted X-shaped or inverted 8-shaped structure in a natural state. The at least two extension ends 33 of the suture thread 30 will pass through the anchor body 20a side by side along the long axis direction A of the anchor body 20a, so as to drive the anchor body 20a to move freely when the at least two extension ends 33 move relative to each other. Figure 1 The first direction shown is extended to switch to Figure 2 The second direction shown extends.

[0046] In such Figure 15-17In the first elongated rod structure shown, the anchor body 20b has opposite distal and proximal ends, and further includes a first thread embedding portion 25b extending along the long axis direction A of the anchor body 20b, for embedding at least two extension ends 33 of the suture 30, thereby making the overall radial dimension of the leaflet anchor 100 much smaller than the sum of the radial dimensions of the anchor body 20b and the suture 30. At this time, the overall dimension of the puncture needle 50 will also be greatly reduced, thereby reducing the risk of tearing or other damage to the leaflet 40 due to the oversize of the puncture needle 50. Specifically, a single wire-passing hole 21b having an elliptical cross-section (i.e., a structure having a long axis and a short axis) extends through the anchor body 20b along the long axis direction A of the anchor body 20b to form a distal opening 212b. The elliptical wire-passing hole 21b has a long axis and a short axis, and is cut from the proximal end of the anchor body 20b along one end of the long axis of the wire-passing hole 21b to a position adjacent to the middle to form a side opening 211b with a cut width of W1 and a first wire-embedded portion 25b connected to the side opening 211b. For example, the long axis of the wire-passing hole 21b extends along the radial direction B of the anchor body 20b (see FIG. 21A ). Fig.17 ), the radial direction B is the extension direction of the at least two extension ends 33 of the suture 30 after passing through the first opening 211b. At this time, the side opening 211b is defined as the first opening 211b, the distal opening 212b is defined as the second opening 212b, the space formed by the second opening 212b of the anchor body 20b to the distal end of the first opening 211b is defined as the suture channel 213b, and the space formed by the proximal end of the anchor body 20b to the distal end of the first opening 211b is defined as the first buried wire portion 25b. It can be understood that the first buried wire portion 25b is connected to the first opening 211b, so that the at least two extension ends 33 of the suture 30 can selectively switch between being accommodated in the first buried wire portion 25b and being separated from the first buried wire portion 25b around the first opening 211b. Moreover, the suture channel 213b is coaxially connected with the first buried thread portion 25b to form a first elongated inner cavity 200b with an elliptical cross-section structure that runs axially from the proximal end to the distal end of the anchor body 20b. In some embodiments, the ratio H1:D of the depth H1 of the first buried thread portion 25b to the diameter D of a single extension end 33 is in the range of 1:1-5:1, so as to accommodate a maximum of five extension ends 33. Taking the accommodation of two sutures 30 as an example, at this time, the preferred outer diameter range of the anchor body 20b is 0.8mm-1.5mm, the preferred length range is 5mm-10mm, and the preferred incision width W1 range is 0.1mm-1.05mm.

[0047] Preferably, the suture 30 is attached to the anchor body 20b by forming a knot 300 at the distal end. Fig.16As shown, when the anchor body 20b with the suture 30 attached is in the received state received in the puncture needle 50, the anchor body 20b is axially loaded on the distal end of the puncture needle 50, the knot 300 at the distal end of the suture 30 is exposed and confined outside the second opening 212b, and the tail line of the suture 30 is ensured not to exceed the distal opening of the puncture needle 50; and, at least two extended ends 33 of the suture 30 are axially received behind the first embedded wire portion 25b and extend proximally to pass through the puncture needle 50. When the anchor body 20b is driven to be released from the distal opening of the puncture needle 50 to the released state and rotated, the at least two extended ends 33 of the suture 30 will be detached from the first embedded wire portion 25b along the first opening 211b, and the knot 300 at the distal end of the suture 30 is still confined outside the second opening 212b. Once the puncture needle 50 is withdrawn from the leaflet 40, as shown in FIG. Fig.17 As shown, the first opening 211b and the first buried thread portion 25b of the anchor body 20b will be arranged toward the leaflet 40, and at least two extended ends 33 of the suture 30 will extend along a direction A perpendicular to the long axis of the anchor body 20b to abut against the distal side of the first opening 211b, and the at least two extended ends 33 can be arranged side by side through the anchor body 20b along the long axis A of the anchor body 20b, and further penetrate the leaflet 40 side by side.

[0048] In such Figure 18-22 In the second elongated rod structure shown, the anchor body 20c has opposite distal and proximal ends, and includes a first embedded thread portion 25c and a second embedded thread portion 26c extending along the long axis direction A of the anchor body 20c, for respectively embedding at least two extended ends 33 and the distal end 31 of the suture 30, so as to further reduce the overall radial size of the leaflet anchor 100. Specifically, as Fig.18 and Fig.19 As shown, in order to ensure that the distal end and the proximal end of the anchor body 20c can maintain balance, a thread hole 21c with a runway-shaped cross section (i.e., a structure with a long axis and a short axis) is formed by radially penetrating the anchor body 20c along the middle position of the anchor body 20c, and the long axis of the thread hole 21c extends along the long axis direction A of the anchor body 20c, so that at least two extension ends 33 of the suture 30 can be arranged side by side along the long axis. Specifically, as shown in FIG. Fig. 20As shown, the thread hole 21c includes a first opening 211c and a second opening 212c which are arranged radially opposite to each other, and a closed suture thread channel 213c which extends vertically from the first opening 211c to the second opening 212c. Further, a portion of the anchor body 20c is radially cut from the first opening 211c and extends axially to the proximal end of the anchor body 20c to form a first thread embedding platform, thereby forming a first thread embedding portion 25c which is connected to the first opening 211c, and a portion of the anchor body 20c is radially cut from the second opening 212c and extends axially to the distal end of the anchor body 20c to form a second thread embedding platform, thereby forming a second thread embedding portion 26c which is connected to the second opening 212c. It is understandable that, since the first buried wire portion 25c is connected to the first opening 211c, and the second buried wire portion 26c is connected to the second opening 212c, the at least two extension ends 33 of the suture 30 can selectively switch between being accommodated in the first buried wire portion 25c and being separated from the first buried wire portion 25c around the first opening 211c, and the distal end 31 of the suture 30 can selectively switch between being accommodated in the second buried wire portion 26c and being separated from the second buried wire portion 26c around the second opening 212c. In addition, the first buried wire portion 25c and the second buried wire portion 26c are located on both sides of the suture channel 213c; the first buried wire portion 25c, the suture channel 213c and the second buried wire portion 26c are connected, and form a roughly Z-shaped suture extension space for accommodating the suture 30. In some embodiments, the ratio H2:D of the depth H2 of the first buried thread portion 25c and the second buried thread portion 26c to the diameter D of a single extension end 33 is in the range of 1:1-5:1, so as to accommodate a maximum of five extension ends 33. Taking accommodating two sutures as an example, at this time, the preferred outer diameter of the anchor body 20b is in the range of 0.8 mm-1.5 mm, the preferred length is in the range of 5 mm-10 mm, and the preferred depth H2 is in the range of 0.3 mm-1.2 mm.

[0049] Furthermore, in order to reduce the weight of the anchor body 20c and thus reduce the movement burden caused by long-term stay in the leaflet 40, the anchor body 20c also includes at least one pair of hollow parts 27c that penetrate in the radial direction. Each pair of hollow parts 27c is symmetrically arranged on both sides of the wire hole 21c and is respectively connected to the first buried wire part 25c or the second buried wire part 26c to ensure that the distal end and the proximal end of the anchor body 20c can maintain balance. In some embodiments, the number of the hollow parts 27c is a pair, one of which is located at the proximal side of the wire hole 21c and is connected to the first buried wire part 25c, and the other hollow part 27c is located at the distal side of the wire hole 21c and is connected to the second buried wire part 26c.

[0050] So, if Fig.21As shown, when the anchor body 20c with the suture 30 attached is in the accommodation state of the puncture needle 50, the anchor body 20c is axially loaded on the distal end of the puncture needle 50, the distal end 31 of the suture 30 is axially accommodated in the second embedded thread portion 25c, the knot 300 at the distal end is exposed and restricted outside the distal end of the second embedded thread portion 25c, and the tail of the suture 30 does not exceed the distal opening of the puncture needle 50. Meanwhile, at least two extended ends 33 of the suture 30 are axially accommodated in the first embedded thread portion 25c, and extend axially toward the proximal end to pass through the puncture needle 50. When the anchor body 20c is released from the distal opening of the puncture needle 50 to the released state and rotates, at least two extended ends 33 of the suture 30 will be separated from the first embedded thread portion 25c along the first opening 211c, and the distal end 31 of the suture 30 will be separated from the second embedded thread portion 26c along the second opening 212c, and the knot 300 at the distal end of the suture 30 will be switched to be exposed and restricted outside the second opening 212c (see FIG. Fig. 22 Once the puncture needle 50 is withdrawn from the valve leaflet 40, Fig. 22 As shown, the first opening 211c and the first buried thread portion 25c of the anchor body 20c are disposed toward the leaflets 40, and the second opening 212c and the second buried thread portion 26c are disposed away from the leaflets 40. In addition, at least two extended ends 33 of the suture 30 are disposed side by side along the long axis direction A of the anchor body 20c to pass through the anchor body 20c side by side, and further penetrate the leaflets 40 side by side.

[0051] In such Figure 23-25 In the elongated tubular structure shown, the anchor body 20d has opposite distal and proximal ends, and includes a first thread embedding portion 25d and a second thread embedding portion 26d extending along the longitudinal direction A of the anchor body 20d, so as to embed at least two extending ends 33 and the distal end 31 of the suture 30, respectively. Fig.24 As shown, the thread hole 21d radially penetrates the wall of the anchor body 20d. The thread hole 21d is set in the middle position of the anchor body 21d and extends vertically to ensure that the distal end and the proximal end of the anchor body 20d can maintain balance. Further, the cross section of the thread hole 21d forms a runway-like structure with a long axis and a short axis. The long axis of the thread hole 21d extends along the long axis direction A of the anchor body 20d, so that at least two extension ends 33 of the suture 30 can be arranged side by side along the long axis. It can be understood that since the suture 30 passes through the thread hole 21d extending radially compared to the thread hole 21b extending axially, the contact area between the suture 30 and the anchor body 21d will be greatly reduced, and the risk of suture 30 breaking due to long-term wear will be greatly reduced.

[0052] Specifically, see Fig.23 and Fig.25, a first opening 211d and a first wire embedding portion 25d with a cut width W2 are formed by axially cutting along the tube wall of the anchor body 20d from the proximal end of the anchor body 20d, and a second opening 212d and a second wire embedding portion 26d with a cut width W2 are formed by axially cutting along the opposite tube wall of the anchor body 20d from the distal end of the anchor body 20d. The first opening 211d and the second opening 212d are arranged opposite to each other on the tube wall of the anchor body 20d, the first wire embedding portion 25d extends along the axial direction and communicates with the first opening 211d, the second wire embedding portion 26d extends along the axial direction and communicates with the second opening 212d, and a suture channel 213d is vertically formed between the first opening 211d and the second opening 212d along the radial direction. At this time, the first buried wire portion 25d, the suture thread channel 213d and the second buried wire portion 26d are connected to form a second elongated inner cavity 200d extending axially from the proximal end of the anchor body 20d to the distal end, and the inner diameter of the second elongated inner cavity 200d is the inner diameter of the anchor body 20d. Preferably, the incision width W2 is equal to the short axis dimension W of the thread hole 21d, and the projection of the first opening 211d and the projection of the second opening 212d partially overlap and form the long axis dimension L of the thread hole 21d. Moreover, at least two extended ends 33 of the suture thread 30 can selectively switch between being accommodated in the first buried wire portion 25d and being separated from the first buried wire portion 25d around the first opening 211d, and the distal end 31 of the suture thread 30 can selectively switch between being accommodated in the second buried wire portion 26d and being separated from the second buried wire portion 26d around the second opening 212d. Preferably, the ratio H3:D of the depth H3 of the first buried thread portion 25d and the second buried thread portion 26d to the diameter D of the single extended end 33 is preferably in the range of 1:1-5:1. Taking the case where the thread hole 21d accommodates two sutures 30 as an example, at this time, the preferred outer diameter range of the anchor body 20d is 0.8mm-1.5mm, the preferred inner diameter range is 0.1mm-1.05mm, and the preferred length range is 5mm-10mm.

[0053] It is understandable that the leaflet anchor 100 can be used in both artificial chord implantation and edge-to-edge repair. The following uses the artificial chord implantation of the mitral valve as an example to illustrate the implantation process of the leaflet anchor 100. Figure 26-30 The leaflet anchor 100 is delivered by the suturing device 5 and delivered to the target position of the mitral valve leaflet 40 via the path provided by the delivery catheter 70. Preferably, the suturing device 5 includes a flexible and elongated suturing catheter 51, a capturer 52, a puncture needle 50, and a pusher 53. The capturer 52 is fixedly arranged at the distal end of the suturing catheter 51, the puncture needle 50 is axially reciprocated by the suturing catheter 51 and extends to the proximal end, and the pusher 53 is removably loaded in the puncture needle 50 and extends to the proximal end. Once the leaflet anchor 100 is loaded at the distal end of the puncture needle 50, as shown in FIG. Fig. 27As shown, the long axis direction A of the anchor body 20 will overlap with the axial direction of the puncture needle 50, and the pusher 53 is located at the proximal side of the anchor body 20, and extends proximally in the puncture needle 50 together with the suture 30. It should be particularly noted that the capturer 52, the puncture needle 50 and the pusher 53 can be driven by a driver or handle connected to their corresponding proximal ends to achieve the capture, puncture and release functions.

[0054] See also Fig.26 When the suturing instrument 5 carrying the leaflet anchor 100 is passed along the delivery catheter 70 into the left atrium inside the heart, and the distal end of the suturing instrument 5 is positioned at the target position of the leaflet 40, the proximal drive or handle is controlled to drive the capture device 52 to capture the leaflet 40 to limit the movement of the leaflet 40. Once the capture is completed, the proximal drive or handle is further controlled to drive the puncture needle 50 to advance axially to the distal end to exceed the distal opening of the suturing catheter 51 and the capture device 52, so as to puncture the leaflet 40 with the sharp distal end 51, for example, puncture the leaflet 40 from the atrial side of the leaflet 40 to the corresponding ventricular side, such as Fig. 27 Finally, the proximal driver or handle is controlled to drive the pusher 53 to advance axially to the distal end to push the anchor body 20 out of the distal opening of the puncture needle 50 and release it, as shown in FIG. Fig.28 As shown. At this time, the anchor body 20 will rotate under the action of gravity or to maintain balance, so as to change from a contained state parallel to the puncture needle 50 to a released state at a certain angle to the puncture needle 50. Once the leaflet anchor 100 is configured to the end of the leaflet 40 and the suturing instrument 5 is withdrawn to leave the leaflet anchor 100, another set of interventional instruments (not shown) can be further introduced to use the ventricular implant 80 to connect the other end of the suture 30 to the ventricular tissue of the mitral valve, such as the papillary muscle or the free wall, and cut it to form an artificial chord, so as to replace or supplement the natural chord inside the heart. At this time, the artificial chord between the leaflet 40 and the ventricular tissue is completed and repaired, thereby effectively preventing mitral valve regurgitation.

[0055] In addition, since the leaflet anchor 100 is positioned on the ventricular side of the leaflet 40, and the leaflet anchor 100 of the present invention is a slender metal or polymer component that is not easily deformed, the leaflet anchor 100 will be supported horizontally below the leaflet 40 after being released, thereby supporting the leaflet 40 upward and ensuring continuous support, which can not only effectively prevent the leaflet 40 from curling and stacking for a long time, but also avoid the following problems: Fig.30 The risk of contralateral leaflet damage due to vertical extension is shown.

[0056] It is understandable that, since the leaflet anchor 100 needs to stay in the human body for a long time, the anchor body 20 directly in contact with the suture 30 is made of a metal or polymer material with high hardness, and thus it is very easy to cause wear and tear on the suture 30, causing irreversible damage and the risk of breakage, and ultimately leading to the risk of secondary reflux. In order to protect the suture 30, in another embodiment of the present invention, as Figure 31-34 As shown, the leaflet anchor 100 further includes a buffer 60, which is disposed on at least a portion of the surface of the thread hole 21 to reduce the hardness of the surface of the thread hole 21; and the suture 30 can pass through the thread hole 21 and the hollow channel 10 surrounded by the buffer 60. At this time, the anchor body 20 and the thread hole 21 may include Figure 1-25 The above features may not include the above features; that is, the size and cross-sectional structure of the wire hole can be defined according to the needs of the designer, and are not limited to the following. Figure 1-25 The thread hole shown is used to pass at least one suture 30. However, the leaflet anchor 100 is not only applied to the leaflet 40, but also to the papillary muscle or other cardiac tissues. In this case, the leaflet anchor 100 can be defined as an anchor 100 for fixing to the tissue. In some embodiments, the suture 30 has a distal end, a proximal end, and at least one extended end connected between the distal end and the proximal end. By attaching the distal end of the suture 30 to the anchor body 20 and passing the extended end of the suture 30 through the hollow channel 10, a leaflet implant or an artificial chord implant with a suture attached is formed for use in edge-to-edge repair or artificial chord implantation.

[0057] The present invention takes the anchor body 20d as an example to illustrate the anchor 100 in this embodiment. Specifically, Fig.31 As shown, the buffer member 60 may be a coating applied to the surface of the wire hole 21d or a film covering the surface of the wire hole 21d, for example, a coating having a lower hardness than the anchor body 20d is applied to at least the wall surface of the anchor body 20d surrounding the wire hole 21d, or a film having a lower hardness than the anchor body 20d is attached to the above wall surface by hot pressing or other processes.

[0058] See also Figure 32-34 The buffer member 60 may also be a flexible member covering the surface of the wire hole 21d, such as a hollow sheath or a slender member. Fig.32As shown, the buffer 60 is a hollow sheath, which is configured to be at least partially accommodated in the wire hole 21d, and the hollow sheath 60 is a tubular structure with a certain wall thickness, and is formed with a hollow channel 10 for the suture 30 to pass through. In particular, the cross-sectional outer diameter of the hollow sheath 60 is configured to be substantially consistent with the cross-sectional size of the wire hole 21d, so that the hollow sheath 60 can be accommodated in the wire hole 21d, and its inner diameter is configured to be larger than the diameter of the suture 30, so that the suture 30 can pass through. In some embodiments, the hollow sheath 60 can be a cloth sheath, such as made of a cloth material with low hardness such as polyester fiber (polyester). Furthermore, the hollow sheath 60 can be fixed to the surface of the wire hole 21d by bonding or suturing, or by using medical wires 61 to fix the hollow sheath 60 to the surface of the wire hole 21d. For example, two medical wires 61 are sewed to the opposite ends of the hollow cloth sheath 60 by using a suturing needle. Specifically, the medical wires 61 are repeatedly wrapped around and wound around the wall of the corresponding anchor body 20d and then wrapped back and sewed to the side wall of the hollow cloth sheath 60. The two free ends of the medical wires 61 will form at least one knot 610 at the distal end and the proximal end of the anchor body 20d to fix the hollow sheath 60. At this time, the medical wires 61 will be wound side by side around the wall of the anchor body 20d opposite to the first opening 211d, or around the wall of the anchor body 20d opposite to the second opening 212d.

[0059] like Fig.33 As shown, the buffer 60 is a slender member such as a flexible wire, and the flexible wire 60 covers the surface of the wire hole 21d in a winding manner. For example, after one or more flexible wires 60 are wound from the distal end, the proximal end and the two side ends of the anchor body 20d toward the surface of the wire hole 21d and are wound back multiple times, the two free ends of the flexible wire 60 will form at least one knot 62 at least at the distal end, the proximal end and / or the side end of the anchor body 20d to fix the flexible wire 60. In some embodiments, as Fig.34 As shown, the anchor body 20d is further defined with a winding hole 27d, and the flexible wire 60 is wound around at least a portion of the surface of the winding hole 27d and at least a portion of the surface of the wire-passing hole 21d, so as to be wound around the surface of the wire-passing hole 21d through the winding hole 27d. Specifically, two winding holes 27d are arranged on opposite sides of the wire-passing hole 21d along the long axis direction A of the anchor body 20d. After the flexible wire 60 is wound around the surface of the wire-passing hole 21d, the surface of the winding hole 27d and the side end wall of the anchor body 20d in a clockwise or counterclockwise direction for multiple times, the two free ends of the flexible wire 60 will form at least one knot 63 in the winding hole 27d to achieve fixation. At this time, the knot 63 of the flexible wire 60 will be accommodated in the winding hole 27d to avoid friction or collision with the leaflet 40 or other tissues to cause tissue damage.

[0060] The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention. The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A leaflet anchor for fixing to a leaflet, characterized in that: The leaflet anchor comprises: an anchor body, the anchor body defining a wire hole extending through the anchor body; and A suture, wherein the distal end of the suture is attached to the anchor body, and at least two extending ends of the suture extend from the distal end and pass through the suture hole; Among them, the wire hole is configured to allow the at least two extension ends to pass through the anchor body side by side along the long axis direction of the anchor body; after passing through the anchor body, the at least two extension ends extend toward the proximal end and can move relative to each other to drive the anchor body to move, thereby changing the long axis direction of the anchor body.

2. The leaflet anchor according to claim 1, characterized in that: The at least two extending ends move relative to each other to switch from an unbalanced state in which they are stacked on each other to a balanced state in which they are not stacked on each other.

3. The leaflet anchor according to claim 1, characterized in that: There is one wire-passing hole, and a cross section of the wire-passing hole has a major axis and a minor axis. The at least two extending ends pass through the wire-passing hole side by side along the major axis of the wire-passing hole.

4. The leaflet anchor according to claim 3, characterized in that: The absolute value of the difference between the minor axis dimension of the wire passing hole and the diameter of a single extension end is ≦0.1 mm, and the absolute value of the difference between the major axis dimension of the wire passing hole and the sum of the diameters of the at least two extension ends is ≦0.1 mm.

5. The leaflet anchor according to claim 1, characterized in that: There are at least two wire-passing holes arranged side by side, the cross section of each wire-passing hole is circular, and the absolute value of the difference between the diameter of each wire-passing hole and the diameter of a single extending end is ≦0.1 mm.

6. The leaflet anchor according to claim 1, characterized in that: The wire-passing hole radially penetrates the anchor body; or, a side opening is formed on the side wall of the anchor body, and the wire-passing hole penetrates from the distal end opening of the anchor body to the side opening along the long axis direction.

7. The leaflet anchor according to claim 1, characterized in that: The anchor body comprises a main body and an extension arm extending from the main body, the wire hole is arranged in the main body, and at least a radial portion of the extension arm is elastic.

8. The leaflet anchor according to claim 1, characterized in that: The thread hole has a first opening, a second opening and a suture thread channel extending from the first opening to the second opening, and the at least two extension ends pass through the anchor body side by side from the first opening along the long axis direction of the anchor body.

9. The leaflet anchor according to claim 8, characterized in that: The anchor body further includes a first buried wire portion communicating with the first opening, and a ratio of a depth of the first buried wire portion to a diameter of a single extended end is in a range of 1:1-5:

1.

10. The leaflet anchor according to claim 9, characterized in that: The anchor body further includes a second buried wire portion communicating with the second opening, and a ratio of a depth of the second buried wire portion to a diameter of a single extended end is in a range of 1:1-5:

1.

11. The leaflet anchor according to claim 1, characterized in that: The leaflet anchor also includes a buffer component, which is disposed on at least a portion of the surface of the wire hole to reduce the hardness of the surface of the wire hole.

12. The leaflet anchor according to claim 1, characterized in that: The leaflet anchor is removably carried in a puncture needle having a sharp distal end. The anchor body can be released from the distal end of the puncture needle and rotated relative to the puncture needle to be arranged at an angle with the at least two extension ends.

13. An anchor for fixing to tissue, characterized in that The anchor comprises: an anchor body, the anchor body defining a wire-passing hole extending through the anchor body; A buffer member, the buffer member being disposed on at least a portion of the surface of the wire hole to reduce the hardness of the surface of the wire hole; and A suture thread, wherein the suture thread can pass through the thread hole and the hollow channel surrounded by the buffer component.

14. An anchor according to claim 13, characterized in that The buffer is one of a coating applied on the surface of the wire hole, a film covering the surface of the wire hole, or a flexible component covering the surface of the wire hole.

15. An anchor according to claim 14, characterized in that The anchor body further defines a wire winding hole, and the flexible member is an elongated member and surrounds at least a portion of the surface of the wire winding hole and at least a portion of the surface of the wire passing hole.

16. An anchor according to claim 15, characterized in that The flexible member has two free ends, and the two free ends form at least one knot and are received in the winding hole.

17. The anchor according to claim 14, characterized in that The flexible component is a hollow sheath, and the hollow sheath is at least partially accommodated in the wire passing hole.

18. The anchor according to claim 13, characterized in that The suture has a distal end, a proximal end, and an extended end connected between the distal end and the proximal end. The distal end of the suture is attached to the anchor body, and the extended end of the suture passes through the hollow channel.

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