Valve annuloplasty apparatus, surgical apparatus, and valve annuloplasty system

Abstract

The present disclosure relates to an annuloplasty device configured for implantation within a subject's body, the annuloplasty device including: a contraction bridge element; a plate-shaped member provided with a rotatable connection mechanism and connected to the contraction bridge element; and a tissue anchor configured to secure the plate-shaped member to valve annulus tissue via the rotatable connection mechanism, the tissue anchor having an anchor head portion and a helical tissue-connecting element whose proximal end is fixed to the anchor head portion and configured to be rotated and driven into the valve annulus tissue, the rotatable connection mechanism being configured to be at least partially rotatable relative to the plate-shaped member such that when the proximal end of the helical tissue-connecting element contacts the rotatable connection mechanism, the helical tissue-connecting element can be further rotated relative to the plate-shaped member. In this manner, a gap between the plate-shaped member and the valve annulus tissue can be eliminated or reduced, reducing the risk of disengagement of the tissue anchor.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 119,551, filed on November 30, 2020, which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to the field of annuloplasty, and more particularly to annuloplasty devices, surgical devices for performing annuloplasty, and annuloplasty systems including annuloplasty devices and surgical devices.

Background Art

[0003] Currently, there are many devices and methods for treating mitral valve regurgitation. These devices and methods mainly involve replacing or repairing the mitral valve. The replacement of the mitral valve is generally performed through the apex or the septum. The repair of the mitral valve generally includes four types: valve leaflet clips, direct annuloplasty, indirect annuloplasty, and chordae tendineae repair. Both direct and indirect annuloplasty are related to eliminating mitral valve insufficiency and preventing the occurrence of regurgitation by reshaping the subject's mitral annulus and / or left ventricle so as to accurately join the anterior valve leaflet and the posterior valve leaflet. For the application of a certain annuloplasty, an implant ring is implanted near the mitral annulus, and the purpose of the implant ring is to prevent the occurrence of regurgitation by reducing the circumference of the mitral annulus so as to bring the anterior valve leaflet and the posterior valve leaflet closer. The tricuspid valve can also be replaced or repaired by similar devices and methods.

[0004] In some techniques for repairing the mitral valve, it is necessary to fix an implant in the human body with an anchor. In the prior art, in order to transport the anchor to an accurate target position, the anchor is enclosed by a guide, and an anchor placement tool needs to transport the anchor to the desired position in the human body by the guidance of the guide and fix the implant to the anchor. The anchor placement tool needs to reliably connect, guide, and release the anchor within an appropriate program time.

[0005] When fixing an implant, anchors are connected to the implant in various ways. One way is to provide a crossbar at the anchoring position of the implant, and the helical tissue-connecting element of the anchor advances into the tissue around the crossbar until the proximal end of the helical tissue-connecting element contacts the crossbar. After anchoring is complete, it may not be possible to ensure that the implant and the tissue are in close contact. [Overview of the Initiative]

[0006] One of the objectives of this invention is to provide a valve ring forming apparatus that can mitigate or eliminate the above-mentioned technical defects.

[0007] Another objective of this disclosure is to provide a surgical device for easily implanting tissue anchors into valve annular tissue.

[0008] A valve ring forming apparatus configured to be suitable for implantation within a body, according to a first aspect of this disclosure, Contraction bridge element, A rotatable connection mechanism is provided, and a plate-shaped member is connected to the retractable bridge element, A tissue anchor configured to fix the plate-shaped member to the valve annular tissue via the rotatable connecting mechanism, comprising: an anchor head portion; and a helical tissue connecting element whose proximal end is fixed to the anchor head portion and which is configured to rotate and be driven into the valve annular tissue; The valve ring forming apparatus provides a valve ring forming apparatus in which at least a portion of the rotatable connecting mechanism is configured to be rotatable with respect to the plate-shaped member, thereby enabling the helical structure connecting element to be further rotated with respect to the plate-shaped member when the proximal end of the helical structure connecting element contacts the rotatable connecting mechanism.

[0009] A surgical apparatus for performing annuloplasty, according to a second aspect of this disclosure, A tissue anchor having a longitudinal central axis and configured to define a passage extending along the longitudinal central axis and penetrating the tissue anchor, the tissue anchor including a helical tissue connecting element that defines a part of the passage of the tissue anchor and has a proximal end and a distal end, An anchor placement tool comprising: a catheter having a distal end; and a rotary drive body having a proximal end, a distal end, and a longitudinal through-hole extending from the proximal end to the distal end, the proximal end of which is connected to the distal end of the catheter; An elongated guide configured to extend and pass through the longitudinal through-hole of the catheter and the rotary drive body, Includes, The present invention provides a surgical apparatus in which the rotational drive body is configured to extend into the passage of the helical tissue connecting element and guide the tissue anchor during the period in which the tissue anchor is rotated and anchored to the valve annular tissue.

[0010] A third aspect of this disclosure relates to a valve annulus forming system, A valve ring forming apparatus according to a first embodiment, wherein the tissue anchor has a longitudinal central axis and is configured to define a passage extending along the longitudinal central axis and penetrating the tissue anchor, and the helical tissue connecting element defines a part of the passage of the tissue anchor, An anchor placement tool comprising: a catheter having a distal end; and a rotary drive body having a proximal end, a distal end, and a longitudinal through-hole extending from the proximal end to the distal end, the proximal end of which is connected to the distal end of the catheter; An elongated guide is configured to extend and pass through the longitudinal through-holes of the catheter and the rotary drive body, and is detachably connected to the rotatable connection mechanism, Includes, The rotational drive body is configured to extend into the passage of the helical tissue connecting element and guide the tissue anchor during the period in which the tissue anchor is rotated and anchored to the annular tissue, thereby providing an annular valve forming system.

[0011] This disclosure will be described in more detail below with reference to the drawings. [Brief explanation of the drawing]

[0012] A more detailed description of the exemplary embodiments shown below with reference to the drawings will provide a clearer understanding of the features and advantages of the above embodiments of the present disclosure, which illustrate exemplary embodiments of the present disclosure in a non-limiting exemplary form.

[0013] [Figure 1] This is a schematic diagram of a valve ring forming apparatus according to one exemplary embodiment of the present disclosure. [Figure 2A] This is a schematic diagram of a valve ring forming apparatus according to another exemplary embodiment of the present disclosure. [Figure 2B] Figure 2A is a schematic diagram of a valve annulus forming device anchored to the valve annulus tissue. [Figure 3] This is a perspective view of the tissue anchor used in the valve ring forming apparatus according to this disclosure. [Figure 4A] Figure 1 or Figure 2A is a perspective view of an example of a plate-shaped member used as a valve ring forming apparatus, and a partial cross-sectional view shows the rotatable connection mechanism. [Figure 4B] Figure 4A is a perspective view of the plate-shaped body of the plate-shaped member shown. [Figure 4C] Figure 4A is a perspective view of a rotatable part of a type of rotatable connection mechanism. [Figure 4D] ~ [Figure 4E] Figure 4A is an exploded view of a rotatable part of a rotatable connection mechanism. [Figure 5A] ~ [Figure 5M] Different embodiments of the rotatable connection mechanism are shown. [Figure 6A] This is a perspective view of the surgical apparatus used to perform annuloplasty. [Figure 6B] and [Figure 6C] Figure 6A shows the anchor placement tool for the surgical apparatus, whereas Figure 6B is a partial cross-sectional view showing the cross-section of the rotational drive body of the anchor placement tool. [Figure 7A] and [Figure 7B] It is a perspective schematic view of transporting an anchor. However, FIG. 7A shows that the anchor head portion is located at the proximal end of the rotary drive body of the anchor placement tool, and FIG. 7B shows that the anchor head portion is located at the distal end of the rotary drive body of the anchor placement tool. [Figure 8A] It shows the initial rotational position of the anchor. [Figure 8B] and [Figure 8C] They are a schematic view and a cross-sectional view showing that the distal end tab of the rotary drive body contacts the crossbar of the rotatable connection mechanism respectively. [Figure 8D] It is a schematic view showing that the distal end tab of the rotary drive body contacts the crossbar of the rotatable connection mechanism, and the rotary drive body continues to rotationally drive the anchor. [Figure 9A] It is a schematic view showing that the proximal end of the spiral tissue connecting element of the anchor begins to contact the crossbar of the rotatable connection mechanism. However, the anchor head portion and the rotatable connection mechanism are shown in an enlarged view. [Figure 9B] It is a schematic view showing that after the proximal end of the spiral tissue connecting element of the anchor begins to contact the crossbar of the rotatable connection mechanism, the rotary drive body continues to rotationally drive the anchor. However, the anchor head portion and the rotatable connection mechanism are shown in an enlarged view. [Figure 9C] It is a schematic view showing that the anchor is rotated to the final appropriate position. However, the gap between the plate-shaped implant and the valve ring tissue has already been removed or reduced, and here, the anchor head portion and the rotatable connection mechanism are shown in an enlarged view. [Figure 10A] It is a cross-sectional view showing that the anchor is rotated to the final appropriate position. [Figure 10B] It is a cross-sectional view showing that the guide is removed after the anchor is rotated to the appropriate position. [Figure 10C] It is a cross-sectional view showing the situation immediately before the distal end tab of the rotary drive body of the anchor placement tool separates from the anchor. [Figure 10D]This is a schematic perspective view showing that the distal end tab of the rotational drive body of the anchor placement tool has already been separated from the anchor. [Modes for carrying out the invention]

[0014] Illustrative embodiments of the present disclosure will be described in detail below with reference to the drawings. It should be understood that embodiments having other arrangements can be adopted without departing from the scope of the present disclosure. Therefore, the following detailed description should not be considered to limit the scope of the present disclosure. The scope of the present disclosure is limited by the appended claims and their equivalents. In all drawings, the same reference numerals indicate elements that have similar or equivalent functions.

[0015] Annuloplasty devices are used to prevent regurgitation by reshaping the mitral annulus and / or left ventricle of a patient to precisely join the anterior and posterior lobes. Annuloplasty devices are generally fixed to the annular tissue via tissue anchors, and by reducing the circumference of the annuloplasty device, the circumference of the mitral annulus is reduced, bringing the anterior and posterior lobes closer together to prevent regurgitation. Annuloplasty devices can also be applied to tricuspid valves to reshape and repair the tricuspid valve.

[0016] Figure 1 shows a block-type annular forming apparatus 10 according to an exemplary embodiment of the present disclosure. The annular forming apparatus 10 includes a plate-like member 101, two plate-like members 103, which are respectively placed inside the body by a catheter, an anchor 50 for anchoring the plate-like members 101 and 103, and a tension member 102. The plate-like members 101 and 103 are independent members and are each fixed to the annular tissue via at least one tissue anchor 50. The plate-like member 101 has an elongated flattened structure, which is slightly curved to match the anatomical structure of the mitral annulus at the position where the plate-like member 101 is anchored. A loop feature 104 is provided at the end of the plate-like member 101. The plate-like member 103 has a butterfly-shaped flattened structure and includes four petal portions extending radially outward from its central portion. The number of petals may be more than four, or fewer than four, or there may be no petals at all, resulting in an overall butterfly-shaped, flattened structure. A loop feature (not shown) is provided at the tip of the plate-like member 103. For example, two tension members 102 connect the plate-like members 101 and 103 to each other via their corresponding loop features.

[0017] Preferably, the outer surfaces of the plate-like members 101 and 103 are coated with polyethylene terephthalate (PET) to contribute to the inward growth of the tissue.

[0018] When implanting the valve annulus forming device 10, first, a catheter (not shown) is introduced into the left atrium of the heart. Then, the plate-shaped member 101 is positioned in the left atrium using the catheter, and the plate-shaped member 101 is anchored to the posterior side of the mitral valve annulus in the left atrium via the anchor 50. Next, the plate-shaped member 103 is positioned using the catheter, and the plate-shaped member 103 is anchored to the anterior side of the mitral valve annulus in the left atrium via the anchor 50. After that, a flexible tension member 102 is positioned using the catheter, and the tension member 102 is attached to the corresponding loop features of both the plate-shaped members 101 and 103. Then, tension is applied to the tension member 102 to pull the plate-shaped members 101 and 103 together, bringing the posterior and anterior sides of the mitral valve annulus closer together.

[0019] Figure 2A shows an integral valve ring forming apparatus 20 according to another embodiment of the present disclosure. As shown in Figure 2A, the valve ring forming apparatus 20 includes a forming ring 21 and a plurality of anchors 50. The forming ring 21 is a complete ring and includes plate members 201, 202, 203, expandable elements 204, 206, and a selectable interconnecting element 205. The plate members 201, 202, 203 can be connected to each other via the corresponding expandable elements 204, 206. The forming ring 21 may be formed into a closed, substantially annular shape by further connecting the plate members 202, 203 via the interconnecting element 205. The expandable elements 204, 206 are connected to the corresponding plate members by their corresponding free ends hooking onto the corresponding rings 2011, 2021, and 2031 of the plate members 201, 202, 203. The interconnecting element 205 can interconnect the plate members 202 and 203 by having its corresponding free end hook onto the corresponding rings 2021 and 2031 of the plate members 202 and 203. Alternatively, or in addition to the above, the free ends of expandable elements or selectable interconnecting elements may be further welded to the corresponding rings.

[0020] The forming ring 21 further includes two adjustment wires 210, 212 and two tightening devices 214, 216. The tightening devices 214, 216 are each provided with a housing 2144, 2164 fixed to the plate-shaped member 201, and reels 2142, 2162 rotatably mounted on the housings 2144, 2164, respectively. One end of the adjustment wire 210 is connected to the ring 2021 of the plate-shaped member 202, and the other end extends through a thread-through hole (not shown) provided in the housing 2144 and is connected to the reel 2142 of the tightening device 214. One end of the adjustment wire 212 is connected to the ring 2031 of the plate-shaped member 203, and the other end extends through a thread-through hole (not shown) provided in the housing 2162 and is connected to the reel 2162 of the tightening device 216.

[0021] Reel 2142 can be driven to rotate in both the winding and unwinding directions. When reel 2142 of the tightening device 214 is driven to rotate in the winding direction, the adjustment wire 210 is wound onto reel 2142 as it rotates, shortening the length of the adjustment wire 210 and thereby attracting the plate members 201 and 202 to each other. Similarly, rotating reel 2162 of the tightening device 216 shortens the length of the adjustment wire 212, thereby attracting the plate members 201 and 203 to each other. This reduces the ring surface of the annular forming ring 21. Since the plate members 201, 202, and 203 are connected to the annulus via tissue anchors, the annulus shrinks as the ring surface of the forming ring 21 shrinks, reducing the circumference of the annulus and bringing the anterior and posterior lobes closer to each other. In this way, the reflux phenomenon caused by insufficient closure of the anterior and posterior lobes can be resolved.

[0022] Adjustment wire 210 extends into the cavity defined by the expansion joint 204, and adjustment wire 212 extends into the cavity defined by the expansion joint 206. Alternatively, adjustment wires 210 and 212 may be configured such that at least a portion of them extend into the cavities defined by the corresponding expansion joints. For example, if the expansion joint is a coiled element, adjustment wires 210 and 212 may alternately pass through the coils of the coiled element. The advantage of this arrangement is that the coiled element can be brought closer to the annular tissue. Alternatively, adjustment wires 210 and 212 may extend outside the expansion joints.

[0023] The interconnection element 205 may include a linear element, such as a wire, made of a shape memory material. Preferably, the interconnection element 205 is composed of an inclined flattened coil element, and the coil element can be configured to be inclined with respect to the longitudinal centerline of the interconnection element 205, thereby allowing the interconnection element 205 to move closer to the surface of the valve annular tissue. Preferably, the expandable elements 204 and 206 are composed of inclined flattened coil elements.

[0024] As shown in Figure 2B, the molded ring 21 covered with woven fabric 218 is fixed to the annular tissue via anchors 50, and the tightening devices 214, 216 are adjusted until the adjustment wires 210, 212 obtain the appropriate tension and / or the annular tissue is in close proximity.

[0025] As shown in Figures 1 and 2A, in valve annular forming devices 10 and 20 configured by connecting plate-like members via shrinkage bridge elements (tensile members 102 or expansion / contraction elements 204, 206), plate-like members 101, 103, 201 to 203 are anchored to the valve annular tissue via tissue anchors 50 shown in Figure 3. Furthermore, the number of anchors 50 used in Figures 1 and 2A is merely illustrative, and other appropriate numbers of anchors 50 may be used to anchor the plate-like members 101, 103, 201 to 203. In the following description, the term "plate-like implant" is used to illustratively refer to the plate-like members 101, 103, 201, 202 and / or 203.

[0026] As shown in Figure 3, the anchor 50 may be a helical tissue anchor and includes an anchor head portion 502 and a helical tissue connecting element 504 whose proximal end is fixed to the anchor head portion 502 and whose distal end has a sharp tip to facilitate insertion into the valve annular tissue. A non-circular joining opening 506 is provided in the center of the proximal end face of the anchor head portion 502, extending along the longitudinal central axis of the anchor 50 and penetrating the anchor head portion 502. The non-circular joining opening 506 may be a polygonal hole such as a triangle, square, pentagon, or hexagon. Preferably, the non-circular joining opening 506 is square. The non-circular joining opening of the anchor head portion 502 is used to be drivably joined to a rotary drive body 6024 having a suitable cross-sectional shape, as described below, in order to rotate the anchor 50 and drive it into the valve annular tissue. Details of the rotary drive body 6024 will be described later.

[0027] Figure 4A shows a perspective view of the plate-shaped implant 30, with a partial cross-sectional view showing the rotatable connection mechanism 4. Figure 4B shows a perspective view of the plate-shaped body 32 of the plate-shaped implant 30, Figure 4C shows a perspective view of the rotatable part 40 in the rotatable connection mechanism 4, and Figures 4D and 4E show exploded perspective views of the rotatable part 40.

[0028] As shown in Figures 4A and 4B, the plate-shaped implant 30 may have an elongated, flattened structure and includes a first surface 302, a second surface 304 opposite the first surface 302, and three circular through-holes 306 extending from the first surface 302 to the second surface 304. The specific shape of the elongated, flattened structure of the plate-shaped implant 30 and the number of circular through-holes 306 can be appropriately adjusted according to the anatomical characteristics of the annular tissue into which it is expected to be implanted. For example, the plate-shaped member 101 shown in Figure 1 can have five circular through-holes 306. The plate-shaped members 202 and 203 shown in Figure 2A can have only two circular through-holes 306, and the plate-shaped member 201 shown in Figure 2A can have three circular through-holes 306. Furthermore, the spacing between the circular through-holes can be appropriately adjusted according to actual needs.

[0029] Continuing with reference to Figure 4A and then to Figures 5A through 5M, the plate-shaped implant 30 can be provided with a rotatable connection mechanism 4, which includes a fixed portion 42 fixedly attached to the plate-shaped body 32 and a rotatable portion 40 configured to be rotatable relative to the plate-shaped body 32. In this way, when the proximal end of the helical tissue connecting element 504 of the tissue anchor 50 contacts the connection portion of the rotatable portion 40 of the rotatable connection mechanism 4 (for example, the crossbars 408, 40'-1, 40''-1, 40'''-1), the tissue anchor 50 is allowed to rotate further relative to the plate-shaped implant 30, thereby eliminating or reducing the gap between the plate-shaped implant 30 and the tissue.

[0030] In the preferred embodiment shown in Figures 4A to 4E, the rotatable connection mechanism 4 may include a rotatable portion 40 and a fixed portion 42. The rotatable portion 40 may include a tubular body 404 having a proximal end and a distal end, and the tubular body 404 may be positioned within a circular through-hole 306 of a plate-shaped implant 30. The fixed portion 42 may consist of a portion 424 of a plate-shaped body 32 that defines the circular through-hole 306. The outer diameter of the tubular body 404 may be equal to or slightly smaller than the circular through-hole 306, so that the outer surface of the tubular body 404 can slidably fit with the inner surface of the circular through-hole 306, thereby allowing the tubular body 404 to rotate within the circular through-hole 306. As shown in Figure 4A, when the tube 404 is positioned within the circular through-hole 306, the proximal and distal ends of the tube 404 can protrude from the first surface 302 and the second surface 304 of the plate-shaped implant 30, respectively. The rotatable portion 40 may further include a top ring 402 and a bottom ring 406. For the top ring 402 and the bottom ring 406, their outer diameters may be larger than the inner diameter of the circular through-hole 306, and their inner diameters may be equal to or smaller than the inner diameter of the circular through-hole 306. The top ring 402 can be fixed around the tube 404 to the proximal end of the tube 404, and the bottom ring 406 can be fixed around the tube 404 to the distal end of the tube 404, thereby defining an annular circumferential groove 412 extending along the circumferential direction of the tube 404 between the top ring 402, the tube 404, and the bottom ring 406.

[0031] Alternatively, the top ring 402 and bottom ring 406 do not have to be positioned around the tube 404. For example, when the tube 404 is positioned within the circular through hole 306, the proximal and distal ends of the tube 404 may be substantially aligned with the first surface 302 and second surface 304 of the plate-shaped implant 30. In this case, the inner diameters of the top ring 402 and bottom ring 406 are substantially the same as or slightly larger than the inner diameter of the tube 404, but smaller than the outer diameter of the tube 404, and the outer diameters of the top ring 402 and bottom ring 406 may be larger than the inner diameter of the circular through hole 306. Thus, the top ring 402 and bottom ring 406 can be positioned substantially concentrically with the tube 404 at the proximal and distal end faces, respectively, thereby similarly defining the annular circumferential groove 412.

[0032] When assembling the top ring 402, the tube 404, and the bottom ring 406 to the plate-shaped body 32, the portion 424 of the plate-shaped body 32 defining the circular through hole 306 can be housed within the annular circumferential groove 412 defined by the top ring 402, the tube 404, and the bottom ring 406, thereby allowing the rotatable portion 40 to rotate relative to the portion 424, and therefore relative to the plate-shaped body 32. The top ring 402, the tube 404, and the bottom ring 406 can be fixed together by welding, thereby allowing them to rotate as a single unit relative to the plate-shaped implant 30.

[0033] In the embodiments shown in Figures 4D and 4E, the top ring 402, the tube 404, and the bottom ring 406 are separate elements. However, one of the top ring 402 and the bottom ring 406 may be formed integrally with the tube 404. For example, the top ring 402 may be formed integrally with the tube 404, and after assembling the integrated tube 404 and top ring 402 into the circular through hole 306, the bottom ring 406 can be fixed (e.g., welded) to the distal end of the tube 404 around the distal end of the tube 404, thereby defining an annular circumferential groove 412 of the rotatable portion 40, and the portion 424 is housed within the circumferential groove 412.

[0034] The top ring 402 may include a connecting portion, and the tissue anchor 50 can fix the plate-shaped implant 30 to the annular tissue via the helical tissue connecting element 504 and the connecting portion. In the example shown in Figures 4D and 4E, the connecting portion may be a crossbar 408 fixed radially to the inner circumferential wall of the top ring 402. In this case, the crossbar 408 can be formed integrally with the top ring 402 on the inner circumferential wall of the top ring, or it can be fixed to the inner circumferential wall of the top ring by welding.

[0035] The connection portion is not limited to the crossbar 408 shown in the figure, and other embodiments or shapes may be adopted, as long as the helical tissue connecting element 504 of the tissue anchor 50 can fix the plate-shaped implant 30 to the annular tissue via the connection portion. For example, the connection portion can take the form of a fan-shaped suspension wall (not shown) that extends inward from the inner circumferential surface of the top ring 402, substantially parallel to the distal end face of the top ring 402, and passes through the center of the top ring 402. The fan-shaped suspension wall occupies a portion of the inner circumferential surface of the top ring 402 along the circumferential direction of the top ring 402, such that it defines an opening that allows the helical tissue connecting element 504 of the helical tissue anchor 50 to pass between the fan-shaped suspension wall and the inner circumferential surface of the top ring 402. The fan-shaped suspension wall may be a top wall located at the proximal end of the inner surface of the top ring 402, a bottom wall located at the distal end of the inner surface of the top ring 402, or an intermediate wall located between the proximal and distal ends of the inner surface of the top ring 402. Furthermore, a screw hole may be provided in the portion of the fan-shaped suspension wall located at the center of the top ring 402 for detachable connection to the male screw 6042 at the distal end of the elongated guide 604 described below. The fan-shaped suspension wall may occupy 1 / 6 to 5 / 8 or other proportions of the circumference of the inner surface of the top ring 402, and the opening between the fan-shaped suspension wall and the inner surface of the top ring 402 should allow the passage of the helical structure connecting element 504.

[0036] Alternatively, the crossbar 408 may be fixed radially to the proximal or distal end face of the top ring 402. In this case, preferably, the proximal or distal end face of the top ring 402 is provided with two radially opposing grooves (not shown) for accommodating the crossbar 408. Preferably, after the crossbar 408 is positioned in these two grooves (not shown), the crossbar 408 is fixed to these grooves, for example, by welding.

[0037] Preferably, the proximal end face of the tube 404 may be provided with two radially opposing grooves 4042 configured to accommodate the crossbar 408. In this case, the distal end face of the tube 404 may be provided with a plurality of grooves 4044 configured to accommodate a plurality of projections 4062 provided radially inward on the inner circumferential surface of the bottom ring 406. Figures 4D and 4E show four projections 4062 and four corresponding grooves 4044. However, for example, two, three, four or more other numbers of projections 4062 and a corresponding number of grooves 4044 may be provided.

[0038] More preferably, as shown in Figure 4C, when the crossbar 408 is housed in the groove 4042, the proximal end faces of the top ring 402 and the crossbar 408 are aligned with the proximal end face of the tubular body 404.

[0039] Alternatively, the crossbar 408 may be radially fixed to the inner circumferential wall of the tube 404 between its proximal and distal ends. In this case, the top ring 402 can have the same structure as the bottom ring 406, i.e., it can be provided with a plurality of projections (not shown) projecting radially inward from the inner circumferential surface of the top ring 402. The proximal end of the tube 404 can have the same structure as the distal end, i.e., it can be provided with a corresponding number of grooves (not shown) for accommodating the plurality of projections of the top ring 402.

[0040] As shown in Figures 4D and 4E, a guide joint is provided in the center of the crossbar 408 for detachable connection to the elongated guide 604. Preferably, the guide joint is a screw hole 410 that is detachably connected to a male screw 6042 provided at the distal end of the guide 604.

[0041] In the embodiment of the rotatable connection mechanism 4 described above, the rotatable portion 40 of the rotatable connection mechanism 4 is composed of three separate elements, namely a top ring 402, a tubular body 404, and a bottom ring 406. The fixed portion 42 of the rotatable connection mechanism 4 is composed of a portion 424 of a plate-shaped body 32 that defines a circular through hole 306. Here, the portion 424 is housed in an annular circumferential groove 412 defined by the top ring 402, the tubular body 404, and the bottom ring 406, thereby enabling the rotatable portion 40 to rotate relative to the fixed portion 42 (part 424 in this embodiment), and therefore relative to the plate-shaped implant 30.

[0042] In another embodiment, as shown in Figures 5A to 5C, the rotatable portion 40 of the rotatable connection mechanism 4 may be composed of an annular ring 40' similar to the top ring 402 shown in Figure 4D. Specifically, the annular ring 40' may include a connecting portion, and the tissue anchor 50 can fix the plate-shaped implant 30 to the annular tissue via the helical tissue connecting element 504 and the connecting portion. In the example shown in Figures 5A to 5C, the connecting portion may be a crossbar 40'-1 fixed radially to the inner circumferential wall of the annular ring 40'. In this case, the crossbar 40'-1 may be formed integrally with the annular ring 40' on the inner circumferential wall of the annular ring, or it may be fixed to the inner circumferential wall of the annular ring by welding.

[0043] Alternatively, the crossbar 40'-1 may be radially fixed to the proximal or distal end face of the annulus 40'. In this case, preferably, the proximal or distal end face of the annulus 40' is provided with two radially opposing grooves (not shown) for accommodating the crossbar 40'-1. More preferably, after the crossbar 40'-1 is positioned in these two grooves (not shown), it is fixed to these grooves, for example, by welding. Similarly, the center of the crossbar 40'-1 is provided with a guide joint, such as a screw hole 40'-2, for detachable connection to an elongated guide 604. The crossbar 40'-1 may also be replaced with the fan-shaped suspension wall (not shown) described above.

[0044] Referring further to Figures 5A to 5C, the fixed portion 42 of the rotatable connection mechanism 4 may include a portion 424 of a plate-shaped body 32 defining a circular through hole 306, and a top plate 422 having a circular through hole 4220, which can be fixedly laminated (for example by welding) to the portion 424 such that the circular through hole 306 and the circular through hole 4220 are substantially concentric. The inner circumferential wall of the circular through hole 4220 of the top plate 422 is provided with an L-shaped first circumferential groove 4222 extending along the circumferential direction, and the inner circumferential wall of the circular through hole 306 of the plate-shaped body 32 is provided with an L-shaped second circumferential groove 4242 extending along the circumferential direction, and both the first circumferential groove 4222 and the second circumferential groove 4242 define a U-shaped annular circumferential groove 420. Since the ring 40' constituting the rotatable portion 40 is slidably housed within the annular circumferential groove 420, the ring 40' can rotate relative to the fixed portion 42 and, therefore, relative to the plate-shaped implant 30.

[0045] Preferably, as shown in Figure 5C, the top plate 422 may have at least one projection 4224 (two are shown in Figure 5C) on the end face facing the plate-shaped body 32, and the projection 4224 may be housed in a corresponding groove 308 provided in the plate-shaped body 32. After housing the projection 4224 in the corresponding groove 308, the top plate 422 can be fixed to the plate-shaped body 32 by welding.

[0046] In the embodiments shown in Figures 5A to 5C, the annular circumferential groove 420 is composed of an L-shaped first circumferential groove 4222 and an L-shaped second circumferential groove 4242. However, the annular circumferential groove 420 may consist only of an L-shaped circumferential groove (not shown) provided on the top plate 422 or portion 424. Also, Figures 5A to 5C show a top plate 422 with a circular external shape. However, the disclosure is not limited thereto, and the top plate 422 may have other external shapes, such as a square shape.

[0047] Figures 5D to 5G show further embodiments of the rotatable connection mechanism 4. In these embodiments, the rotatable portion 40 of the rotatable connection mechanism 4 is composed of an annular ring 40'' similar to the top ring 402 shown in Figure 4D. Specifically, the annular ring 40'' may include a connecting portion, and the tissue anchor 50 can fix the plate-shaped implant 30 to the annular tissue via the helical tissue connecting element 504 and the connecting portion. In the examples shown in Figures 5D to 5G, the connecting portion may be a crossbar 40''-1 fixed radially to the inner circumferential wall of the annular ring 40''. In this case, the crossbar 40''-1 may be formed integrally with the annular ring 40'' on the inner circumferential wall, or it may be fixed to the inner circumferential wall of the annular ring by welding. Alternatively, the crossbar 40''-1 may be replaced with the above-mentioned fan-shaped suspension wall (not shown).

[0048] Alternatively, the crossbar 40''-1 may be radially fixed to the proximal or distal end face of the annulus 40''. In this case, preferably, the proximal or distal end face of the annulus 40'' is provided with two radially opposing grooves (not shown) for accommodating the crossbar 40''-1. More preferably, after the crossbar 40''-1 is positioned in these two grooves (not shown), it is fixed to these grooves, for example, by welding. Similarly, the center of the crossbar 40''-1 is provided with a guide joint, for example, a screw hole 40''-2, for detachable connection to an elongated guide 604.

[0049] The fixed portion 42 of the rotatable connection mechanism 4 may be fixed to the plate-shaped body 32, for example by welding, with at least a portion of it housed within a circular through-hole 306 of the plate-shaped body 32. In this embodiment, the fixed portion 42 may include a top plate 426 having a circular through-hole 4262 and a circular base 428 having a stepped circular through-hole 4282, wherein the large diameter hole 42821 of the stepped circular through-hole 4282 and the top plate 426 define a substantially U-shaped circumferential groove 430. The annular ring 40'' may be housed within the circumferential groove 430, thereby allowing it to rotate relative to the fixed portion 42 and, therefore, relative to the plate-shaped implant 30.

[0050] Preferably, the outer peripheral wall of the circular base 428 is provided with at least one projection 4284 which can be accommodated in a corresponding groove 308 provided in the inner peripheral wall of the circular through hole 306 of the plate-shaped body 32.

[0051] Referring to Figures 5F and 5G, the fixing portion 42 is a separate fixing base including the top plate 426 and the base 428, and Figure 5E shows the boundary line between the top plate 426 and the base 428, indicated by reference numeral 432. After the ring 40'' is placed in the U-shaped circumferential groove 430, the top plate 426 is fixed to the base 428, for example by welding, and then the fixing portion 42, which is composed of the top plate 426 and the base 428, is placed in the through hole 306 and fixed to the plate-shaped body 32, for example by further welding.

[0052] Figures 5E and 5G show a fixing portion 42 having a circular shape (i.e., a top plate 426 and a base 428), but the disclosure is not limited thereto. For example, Figure 5H shows a fixing portion 42 having another shape (e.g., a square). Accordingly, the plate-shaped body 32 is provided with through holes (not shown) whose shape corresponds to the other shape of the fixing portion 42. Reference numeral 432' indicates the boundary line 432' between the top plate 426' and the base 428'. Except for the external shape, the other structures of the top plate 426' and base 428' are the same as those of the top plate 426 and base 428.

[0053] Figures 5I to 5M show a rotatable connection mechanism 4 according to another embodiment. The only difference between the rotatable connection mechanism 4 according to this embodiment and the rotatable connection mechanism shown in Figures 5D to 5G is the fixed seat 423 that constitutes the fixed part 42, while the ring 40''' and its connection part that constitute the rotatable part 40 are the same as the ring 40''' and its connection part. For example, the connection part of the ring 40''' may include a crossbar 40'''-1 fixed radially to the inner circumferential wall of the ring 40''', and a guide joint, such as a screw hole 40'''-2, may be provided in the center of the crossbar 40'''-1 for detachable connection to an elongated guide 604. Alternatively, the crossbar 40'''-1 can be replaced with the above-mentioned fan-shaped suspension wall (not shown).

[0054] As shown in Figure 5K, the fixed seat 423 includes a circular through hole 4231, and the inner circumferential wall of the circular through hole 4231 is provided with an annular circumferential groove 4232 extending along the circumferential direction, and the ring 40''' can be slidably housed in the circumferential groove 4232, thereby allowing it to rotate relative to the fixed seat 432.

[0055] As shown in Figure 5M, the fixed seat 423 may include a left fixed seat half 423L having a left circumferential groove 4232L and a right fixed seat half 423R having a right circumferential groove 4232R. When the left fixed seat half 423L and the right fixed seat half 423R are joined together to form a separate fixed seat 423, the left circumferential groove 4232L and the right circumferential groove 4232R form a complete annular circumferential groove 4232. After the ring 40''' is housed in the left circumferential groove 4232L and the right circumferential groove 4232R, the left fixed seat half 423L and the right fixed seat half 423R are joined together and fixed to each other, for example, by welding.

[0056] Figure 5K shows a U-shaped circumferential groove 4232. Alternatively, as shown in Figure 5L, the circumferential groove 4232 may be a circumferential groove 4232' having a semicircular cross-section. Accordingly, the annule 40''' also has a semicircular cross-section so that it can be slidably accommodated within the circumferential groove 4232'.

[0057] Preferably, the outer peripheral walls of the left fixed seat half 423L and / or the right fixed seat half 423R are provided with at least one projection 4233 that can be accommodated in a corresponding groove 308 (see Figure 5J) in the inner peripheral wall of the circular through hole 306 of the plate-shaped body 32.

[0058] Figure 5M shows a separate fixing seat 423 comprising two semicircular fixing seat halves 423L and 423R, with an external shape of circular. However, the separate fixing seat 423 may have other external shapes (e.g., square), and accordingly, the plate-shaped body 32 may have through holes 306 whose shape corresponds to the other external shape (e.g., square) of the separate fixing seat 423.

[0059] In the embodiments shown in Figures 5D to 5F and Figures 5I to 5J, when the base 428 and / or fixing seat 423 are attached to the through hole 306 of the plate-shaped body 32, the distal end surface of the base 428 and / or fixing seat 423 is preferably aligned with the second surface 304 of the plate-shaped body 32, thereby bringing the second surface 304 of the plate-shaped implant 30 and the annular tissue closer together, thereby reducing the gap between them.

[0060] In the examples above, it has been explained that the rotatable connection mechanism includes both a rotatable part and a fixed part. However, this is not intended to limit the present disclosure, but merely to facilitate explanation. For example, the rotatable connection mechanism may include only the rotatable part as described above. In this case, the fixed part as described above can be separately provided on the plate-shaped member (e.g., the plate-shaped body 32).

[0061] The following explanation will continue with reference to Figure 3. The tissue anchor 50 shown in Figure 3 can fix the plate-shaped implant 30 to the annular tissue via the connection portion (e.g., crossbars 408, 40'-1, 40''-1, 40''-1) of the rotatable connection mechanism 4 provided on the plate-shaped implant 30. In the end program in which the anchor 50 penetrates the tissue by torque, the proximal end of the helical tissue connecting element 504 of the tissue anchor 50 comes into contact with the connection portion. If the connection portion is directly and fixedly provided in a non-rotatable manner within the circular through hole 306 of the plate-shaped body 32, the tissue anchor 50 cannot be further rotated after the proximal end of the helical tissue connecting element 504 contacts the connection portion. This can cause a gap to form between the implant 30 and the annular tissue, potentially leading to displacement and even detachment of the tissue anchor 50. In the plate-shaped implant 30 of this disclosure, since the plate-shaped implant 30 is provided with a rotatable connection mechanism 4, after the proximal end of the helical tissue connecting element 504 of the tissue anchor 50 abuts against the connection part, the anchor 50 can still be rotated, causing the helical tissue connecting element 504 to continue rotating and advance into the annular tissue, thereby eliminating or reducing the gap between the plate-shaped implant 30 and the annular tissue, and making the anchor fixation more stable.

[0062] The surgical apparatus for driving the tissue anchor 50 to fix the plate-shaped implant 30 to the annular tissue will be described below with reference to Figures 6A, 6B, and 6C. In the following description, the rotatable connection mechanism 4 shown in Figures 4A to 4E will be used as an example to explain how the plate-shaped implant 30 is anchored to the annular tissue. However, it will be recognized by those skilled in the art that the same function and effect can be achieved similarly by the rotatable connection mechanism shown in Figures 5A to 5M.

[0063] Figure 6A shows a surgical apparatus 60 for performing annuloplasty, and Figures 6B and 6C show the anchor placement tool 602 of the surgical apparatus 60.

[0064] As shown in Figure 6A, the surgical apparatus 60 may include a tissue anchor 50 as shown in Figure 3, an anchor placement tool 602, and an elongated guide 604. The tissue anchor 50 has a longitudinal central axis (not shown) and defines a passage extending along the longitudinal central axis and penetrating the tissue anchor, with the anchor head portion 502 and the helical tissue connecting element 504 both defining this passage. The anchor placement tool 602 may include a catheter 6022 having a proximal end and a distal end, and a rotary drive body 6024 having a proximal end, a distal end, and a longitudinal through-hole 60242 extending from the proximal end to the distal end, the proximal end of which is connected to the distal end of the catheter 6022.

[0065] The elongated guide 604 extends and passes through the longitudinal through-hole 60242 of the catheter 6022 and the rotary drive body 6024, and has a male thread 6042 at its distal end, which is used to removably connect to a screw hole 410 provided in the center of the crossbar 408 of the rotatable part 40.

[0066] The rotary drive body 6024 is elongated, and the shape of all its cross-sections along its longitudinal length conforms to the shape of the non-circular joint opening 506 of the anchor head portion 502. In this way, when the tissue anchor 50 is externally mounted on the rotary drive body 6024, the rotary drive body 6024 can transmit torque to the anchor 50 during rotation, that is, it can drive the anchor 50 to rotate. Since the shape of all its cross-sections along its longitudinal length conforms to the shape of the non-circular joint opening 506 of the anchor head portion 502, the anchor 50 slides along the rotary drive body 6024 toward the distal end, and the rotary drive body 6024 can always transmit torque to the anchor 50 by rotational motion, thereby driving the anchor 50 into the valve annular tissue.

[0067] The vertical through-hole 60242 is provided within the rotary drive body 6024 along the vertical direction. Preferably, the distal end of the rotary drive body 6024 includes a branching body 60246. In the examples shown in Figures 6B and 6C, the branching body 60246 includes two support legs, but may include three or more support legs.

[0068] A tab 60248 projecting radially outward may be provided at the distal end of the branched body 60246. The branched body 60246 can be made of a shape memory material such as nitinol. The natural state of the tab 60248 can be set to naturally separate but have a tendency to aggregate. An elongated guide 604 can be inserted between the tabs 60248 to keep them separated at all times. When the elongated guide 604 is removed from between the tabs 60248, the tabs 60248 can move inward toward each other when subjected to force. When the external force is removed, the tabs 60248 can maintain their natural separated state. Preferably, the natural separated state of the tabs 60248 can be set to curve inward toward each other. In some embodiments, an elongated guide 604 is inserted between the tabs 60248 to cause the tabs 60248 to abut against the elongated guide 604 and push outward, thereby preventing the tabs 60248 from passing through the non-circular joint opening 506 of the anchor head portion 502 of the tissue anchor 50. When the elongated guide 604 between the tabs 60248 is removed, the tabs 60248 move inward toward each other, allowing the tabs 60248 to pass through the non-circular joint opening 506 of the anchor head portion 502 of the tissue anchor 50. Hereinafter, the separated state of the tabs 60248 will be described as the natural separated state.

[0069] As shown in Figures 6B and 6C, the anchor placement tool 602 further includes a catheter connector 606 located at the proximal end of the rotary drive body 6024. The catheter connector 606 integrally connects the proximal end of the rotary drive body 6024 and the distal end of the catheter 6022, and can define a longitudinal passage (not shown) that connects the cavity of the catheter 6022 to a longitudinal through-hole 60242 of the rotary drive body 6024. In the example shown in Figures 6B and 6C, the catheter connector 606 is a cylindrical element integrated with the proximal end of the rotary drive body 6024, and the distal end of the catheter 6022 is inserted into the cylindrical element and welded to the catheter connector 606 via a plurality of process holes 6062 provided in the outer circumferential wall of the cylindrical element. The lateral dimension of the catheter connection portion 606 is preferably larger than the cross-sectional dimension (e.g., the length or width of the cross-section) of the rotary drive body 6024, thereby allowing the tissue anchor 50 to be pushed toward the distal end.

[0070] As shown in Figure 7A, when the tissue anchor 50 is enclosed on the rotary drive body 6024, when the proximal end of the catheter 6022 is manipulated from outside the human body, the rotary drive body 6024 can be moved or rotated, further enabling the transport and driving of the tissue anchor 50.

[0071] As shown in Figures 7A and 7B, the distal male thread 6042 of the guide 604 (see Figure 6A) can be removably screwed to a threaded hole 410 (see Figure 4C) in the crossbar 408 of the rotatable portion 40 provided on the plate-shaped implant 30. The anchor placement tool 602 can be fitted onto the guide 604, and the anchor 50 can be fitted onto the rotary drive body 6024 of the anchor placement tool 602. The anchor 50 is axially movable between the catheter connection portion 606 and the tab 60248. As shown in Figure 7B, the guide 604 is inserted between the distal tabs 60248, thereby preventing the anchor 50 from detaching from the rotary drive body 6024 distally by keeping the tabs 60248 separated at all times. As shown in Figure 7A, when the proximal end face of the anchor head portion 502 of the anchor 50 contacts the catheter connection portion 606, the anchor placement tool 602 can bias the anchor 50 with thrust to move it toward the plate-shaped implant 30. In this way, when the guide 604 is curved, the thrust of the anchor placement tool 602 and the auxiliary guiding action of the rotational drive body 6024 allow the anchor 50 to smoothly reach the target anchor position. As shown in Figures 10B to 10D, when the guide 50 is removed from between the distal tabs 60248, the tabs 60248 can move closer to the middle, allowing the tabs 60248 to separate from the anchor 50. In this way, the anchor placement tool 602 and the anchor 50 can be separated effectively and reliably.

[0072] In the process of the anchor placement tool 602 and guide 604 working together to transport the anchor 50, the anchor head portion 502 can be positioned at any location between the catheter connection portion 606 and the tab 60248. In some cases, the catheter connection portion 606 biases the anchor head portion 502 with thrust to drive the anchor 50 to slide against the plate implant 30. In other cases, the anchor 50 slides automatically against the plate implant 30 guided by the rotational drive body 6024 of the anchor placement tool 602, and the tab 60248 contacts the anchor head portion 502 to restrict the anchor 50 from continuing to move toward the distal end, and only when the anchor placement tool 602 is further moved toward the plate implant 30 can the anchor 50 continue to move toward the plate implant 30. In yet another case, the anchor placement tool 602 can be driven by the tab 60248 to move the anchor 50 toward the proximal end.

[0073] The cooperation of the anchor placement tool 602 and the guide 604 in transporting the anchor 50 ensures that the anchor 50 and the rotary drive body 6024 have a high degree of concentricity because the rotary drive body 6024 is positioned between the anchor 50 and the guide 604 (in other words, the rotary drive body 6024 extends and passes through the passage of the anchor 50), and because the gap between the helical inner surface of the helical structure connecting element 504 of the anchor 50 and the apex of the cross-section of the rotary drive body can be set to be small. At the same time, the diameter of the guide 604 matches the diameter of the vertical through hole 60242 of the rotary drive body 6024, and thus ensures that the guide 604 is concentric with the rotary drive body 6024, thereby ensuring that the anchor 50 and the guide 604 have a high degree of concentricity. Furthermore, the elongated rotary drive body 6024 increases the length for guiding the anchor 50. Therefore, the rotary drive body 6024 not only transmits torque to drive the anchor 50, but also plays a role in guiding the anchor 50.

[0074] Figures 7A to 10D schematically show an example of the process by which the anchor placement tool 602 and the guide 604 cooperate to transport the anchor 50, screw the anchor 50 into the tissue, and separate it from the tissue.

[0075] As shown in Figures 7A and 8A, the anchor placement tool 602 and the guide 604 work together, and the pushing action of the catheter connection portion 606 causes the anchor 50 to slide along the elongated guide 604 toward the distal end until the distal end of the helical tissue connecting element 504 of the anchor 50 contacts the proximal end surface (upper surface in Figure 8A) of the crossbar 408 of the rotatable portion 40. Figures 8A to 10D show the process from when the distal end of the helical tissue connecting element 504 contacts the upper surface of the crossbar 408 until the anchor placement tool 602 and the guide 604 separate from the anchor 50.

[0076] As shown in Figure 8A, the distal end of the helical tissue connecting element 504 of the anchor 50 has already reached the upper surface of the rotatable section 40. By maneuvering the proximal end of the catheter 6022, the anchor placement tool 602 is driven to advance along the guide 604, and the anchor placement tool 602 is rotated to helically advance the helical tissue connecting element 504 of the anchor 50 around the crossbar 408 of the rotatable section 40 until the distal end of the tab 60248 reaches the upper surface of the crossbar 408 (see Figures 8B and 8C). At this point, the distal end of the helical tissue connecting element 504 has reached at least the lower surface of the rotatable section 40 (i.e., at least contact with the tissue). Alternatively, the distal end of the helical tissue connecting element 504 may already be in the tissue at this point. As shown in Figures 8B and 8C, the distal end of the tab 60248 has already reached the upper surface of the rotatable section 40. At this time, as shown in Figure 8D, the anchor placement tool 602 is driven to continue rotating, the helical tissue linking element 504 continues to spiral forward around the crossbar 408, and the anchor 50 slides distally along the elongated rotary drive body 6024 of the anchor placement tool 602, thereby further screwing the anchor 50 into the tissue.

[0077] Figures 9A to 9C illustrate the schematic process of rotating the anchor placement tool 602 as the proximal end of the helical tissue linking element 504 contacts the crossbar 408. As shown in Figure 9A, the proximal end of the helical tissue linking element 504 begins to contact the crossbar 408. As shown in Figure 9B, the anchor placement tool 602 is continued to rotate so that the proximal end of the helical tissue linking element 504 rotates together with the crossbar 408 after contact. As shown in Figure 9C, the anchor placement tool 602 is continued to rotate so that the helical tissue linking element 504 enters the tissue further.

[0078] As can be seen by comparing Figures 9A to 9C (referring to the circumferential position of the crossbar 408), after the proximal end of the helical tissue connecting element 504 contacts the crossbar 480, a rotatable connection mechanism is provided on the plate-shaped implant 30. This allows the helical tissue connecting element 504 of the anchor 50 to rotate further relative to the plate-shaped implant 30. This eliminates or reduces the gap that occurs between the plate-shaped implant 30 and the tissue during the screwing-in process of the anchor 50, thereby strengthening the fixation of the anchor 50 and effectively preventing the anchor 50 from detaching from the tissue.

[0079] Figures 10A to 10D show the entire process of the anchor placement tool 602 separating from the anchor 50 and the plate-shaped implant 30. As shown in Figure 10A, the anchor 50 is anchored in place (i.e., the gap between the implant and the tissue is eliminated or reduced). As shown in Figure 10B, the guide 604 has already been removed from between the distal end tabs 60248 of the anchor placement tool 602. At this point, the tabs 60248 return to their natural separated state as shown in Figure 10B. As shown in Figure 10C, the anchor placement tool 602 is moved proximal by maneuvering the proximal end of the catheter, causing the tabs 60248 to move inward toward each other due to the action of the opening wall of the non-circular joint opening 506 of the anchor head portion 502, allowing the tabs 60248 to pass through the opening 506. As shown in Figure 10D, the tabs 60248 separate from the anchor 50, i.e., the anchor placement tool 602 separates from the anchor 50.

[0080] Preferably, after the guide 604 is removed from between the distal end tabs 60248 of the anchor placement tool 602, the tabs 60248 return to a state where they are close to each other and facing inward, thereby allowing the tabs 60248 to pass through the opening 506.

[0081] When the anchor placement tool 602 and the guide 604 work together to anchor the anchor 50, the distal end of the guide 604 is maintained to be substantially perpendicular to the plate-shaped implant 30. The elongated rotary drive body 6024 extends into the passage of the anchor 50 during the anchoring process to guide the anchor 50 while simultaneously driving it, and the diameter of the guide 604 matches the longitudinal through-hole of the elongated rotary drive body 6024, so that the elongated drive body 6024, the guide 604 and the anchor 50 are substantially concentric, thereby ensuring that the anchor placement tool 602 screws the anchor 50 into the tissue substantially perpendicularly.

[0082] Specific embodiments of the valve ring forming apparatus and surgical apparatus according to the embodiments of this disclosure have been described above with reference to the drawings. However, these descriptions are intended only to illustrate the basic principles and applications of this disclosure and do not limit the scope of this disclosure. The scope of this disclosure is limited by the appended claims and their equivalents. Those skilled in the art can imagine many different embodiments from the viewpoint of this disclosure. [Note 1] A valve ring forming device configured to be suitable for implantation into the body of a target, A retractable bridge element, A rotatable connection mechanism is provided, and a plate-shaped member is connected to the retractable bridge element, A tissue anchor configured to fix the plate-shaped member to the valve annular tissue via the rotatable connecting mechanism, comprising: an anchor head portion; and a helical tissue connecting element whose proximal end is fixed to the anchor head portion and which is configured to rotate and be driven into the valve annular tissue; The rotatable connection mechanism is configured such that at least a portion of it is rotatable relative to the plate-shaped member, allowing the tissue anchor to rotate further relative to the plate-shaped member when the proximal end of the helical tissue connecting element contacts the rotatable connection mechanism. Valve annulus molding device. [Note 2] The rotatable connecting mechanism includes a fixed portion fixedly provided to the plate-shaped member and a rotatable portion. The aforementioned tissue anchor can fix the plate-shaped member to the valve ring tissue via the rotatable portion. An annular circumferential groove is provided in one of the rotatable portion and the fixed portion, and the other portion is rotatably housed within the annular circumferential groove relative to the one portion. The valve ring forming apparatus described in Appendix 1. [Note 3] The plate-like member includes a first surface, a second surface opposite to the first surface, and a circular through-hole extending from the first surface to the second surface, The rotatable portion includes a tubular body having a proximal end and a distal end, a top ring, and a bottom ring, the top ring and the bottom ring being provided at the proximal and distal ends of the tubular body, respectively, and defining the annular circumferential groove extending along the outer circumference of the tubular body. The fixing portion is the part of the plate-shaped member that defines the circular through hole, and the portion is housed within the annular circumferential groove. The valve ring forming apparatus described in Appendix 2. [Note 4] The rotatable portion further includes a connecting portion provided on one of the top ring, the tubular body, and the bottom ring, and the tissue anchor fixes the plate-shaped member to the valve ring tissue via the connecting portion. The valve ring forming apparatus described in Appendix 3. [Note 5] The connecting portion is a crossbar radially fixed to the inner circumferential wall of the top ring, or to the proximal or distal end face of the top ring, and the proximal end face of the tubular body is provided with two radially opposing grooves configured to accommodate the crossbar. The valve ring forming apparatus described in Appendix 4. [Note 6] The distal end surface of the tube is provided with a plurality of grooves configured to accommodate a plurality of protrusions provided radially inward on the inner circumferential surface of the bottom ring. The valve ring forming apparatus described in Appendix 5. [Note 7] The connecting portion is a crossbar radially fixed to the inner circumferential wall of the bottom ring, or to the proximal or distal end face of the bottom ring, and the distal end face of the tubular body is provided with two radially opposing grooves for accommodating the crossbar. The valve ring forming apparatus described in Appendix 4. [Note 8] The proximal end face of the tube is provided with a plurality of grooves configured to accommodate a plurality of protrusions provided radially inward on the inner circumferential surface of the top ring. The valve ring forming apparatus described in Appendix 7. [Note 9] The center of the crossbar is provided with a screw hole that is detachably connected to the distal end male thread of a guide for guiding the tissue anchor. A valve ring forming apparatus as described in any one of the appendices 5 to 8. [Note 10] One of the top ring and the bottom ring is formed integrally with the tubular body. The valve ring forming apparatus described in Appendix 3. [Note 11] The plate-like member includes a first surface, a second surface opposite to the first surface, and a circular through-hole extending from the first surface to the second surface. The fixing portion comprises the portion of the plate-shaped member that defines the circular through hole, The invention includes a top plate having a circular through-hole, the top plate being fixed to the first surface such that the circular through-hole and the circular through-hole of the plate-like member are substantially concentric, wherein the annular circumferential groove is provided along the circumferential direction on the inner circumferential surface of the circular through-hole of the plate-like member and / or the top plate, and The rotatable portion includes a ring rotatably housed in the annular circumferential groove. The valve ring forming apparatus described in Appendix 2. [Note 12] The plate-like member includes a first surface, a second surface opposite to the first surface, and a through hole extending from the first surface to the second surface. The fixing portion includes a separate fixing seat that is fixed within the through hole and is configured such that a circular through hole is defined. The annular circumferential groove is provided within the inner circumferential surface of the circular through hole along the circumferential direction, The rotatable portion includes a ring rotatably housed within an annular circumferential groove of the separate fixed seat. The valve ring forming apparatus described in Appendix 2. [Note 13] The aforementioned ring is provided with a connecting portion. The aforementioned tissue anchor fixes the plate-shaped member to the valve annular tissue via the connecting portion. A valve ring forming apparatus as described in Appendix 11 or 12. [Note 14] The connecting portion is a crossbar that is radially fixed to the inner circumferential wall of the ring, or to the proximal or distal end face of the ring. The center of the crossbar is provided with a screw hole that is detachably connected to the distal end male thread of a guide for guiding the tissue anchor. The valve ring forming apparatus described in Appendix 13. [Note 15] When the separate fixing seat is fixed within the through hole of the plate-shaped member, its distal end surface aligns with the second surface of the plate-shaped member. The valve ring forming apparatus described in Appendix 12. [Note 16] A surgical device for performing annuloplasty, A tissue anchor having a longitudinal central axis and configured to define a passage extending along the longitudinal central axis and penetrating the tissue anchor, the tissue anchor including a helical tissue connecting element that defines a part of the passage of the tissue anchor and has a proximal end and a distal end, An anchor placement tool comprising: a catheter having a distal end; and a rotary drive body having a proximal end, a distal end, and a longitudinal through-hole extending from the proximal end to the distal end, the proximal end of which is connected to the distal end of the catheter; An elongated guide configured to extend and pass through the longitudinal through-hole of the catheter and the rotary drive body, Includes, The rotational drive body is configured to extend into the passage of the helical tissue connecting element and guide the tissue anchor during the period in which the tissue anchor is rotated and anchored to the valve ring tissue. Surgical equipment. [Note 17] The tissue anchor further includes an anchor head portion, which is fixed to the proximal end of the helical tissue connecting element and is configured to define a non-circular bonding opening that extends along the longitudinal central axis and penetrates the anchor head portion, the non-circular bonding opening defining another portion of the passage of the tissue anchor. The rotational drive body has a non-circular cross-section perpendicular to its longitudinal direction, and the non-circular cross-section is configured to fit the non-circular joint opening along the entire longitudinal direction of the rotational drive body and to be removably joined thereto, so that the tissue anchor rotates when the rotational drive body rotates, thereby allowing the tissue anchor to slide along the rotational drive body toward the distal end and to be anchored to the valve annular tissue. Surgical devices as described in Appendix 16. [Note 18] The distal end of the rotary drive body includes a branching body, and tabs are provided on the radially outer side of the distal end of the branching body. The branching body is configured such that when the guide is inserted between the tabs, the tabs are pushed radially outward by the guide, preventing them from passing through the non-circular joint opening of the anchor head portion. However, when the guide between the tabs is removed, the tabs return to a naturally separated state or to a state where they are close to each other facing inward, allowing them to pass through the non-circular joint opening of the anchor head portion. Surgical devices as described in Appendix 17. [Note 19] The anchor placement tool further includes a catheter connector located at the proximal end of the rotary drive body for connecting to the distal end of the catheter, the catheter connector being further configured to drive the tissue anchor toward the distal end together with the rotary drive body when the proximal end of the catheter is driven from outside the target to transport the tissue anchor. Surgical devices as described in Appendix 18. [Note 20] The length of the rotational drive body is such that, when the distal end of the tab cannot move further toward the distal end, the distal end of the helical tissue connecting element of the tissue anchor is in contact with the valve annular tissue. The surgical device described in Appendix 19. [Note 21] The branched body is formed of a shape memory material. Surgical devices as described in Appendix 18. [Note 22] A valve annulus plasty system, A valve ring forming apparatus as described in any one of the appendices 1 to 15, wherein the tissue anchor has a longitudinal central axis and is configured to define a passage that extends along the longitudinal central axis and penetrates the tissue anchor, and the helical tissue connecting element defines a part of the passage of the tissue anchor, An anchor placement tool comprising: a catheter having a distal end; and a rotary drive body having a proximal end, a distal end, and a longitudinal through-hole extending from the proximal end to the distal end, the proximal end of which is connected to the distal end of the catheter; An elongated guide is configured to extend and pass through the longitudinal through-holes of the catheter and the rotary drive body, and is detachably connected to the rotatable connection mechanism, Includes, The rotational drive body is configured to extend into the passage of the helical tissue connecting element and guide the tissue anchor during the period in which the tissue anchor is rotated and anchored to the valve ring tissue. Valve annulus repair system. [Note 23] The tissue anchor further includes an anchor head portion, which is fixed to the proximal end of the helical tissue connecting element and is configured to define a non-circular bonding opening that extends along the longitudinal central axis and penetrates the anchor head portion, the non-circular bonding opening defining another portion of the longitudinal passage of the tissue anchor. The rotational drive body has a non-circular cross-section perpendicular to its longitudinal direction, and the non-circular cross-section is configured to fit the non-circular joint opening along the entire longitudinal direction of the rotational drive body and to be removably joined thereto, so that the tissue anchor rotates when the rotational drive body rotates, thereby allowing the tissue anchor to slide along the rotational drive body toward the distal end and to be anchored to the valve annular tissue. The valve annulus repair system described in Appendix 22. [Note 24] The distal end of the rotary drive body includes a branch body, and tabs are provided on the radially outward side of the distal end of the branch body. The branch body is configured such that when the guide is inserted between the tabs, the tabs are pushed radially outward by the guide, preventing them from passing through the non-circular joint opening of the anchor head portion of the tissue anchor; however, when the guide between the tabs is removed, the tabs return to a naturally separated state or to a state where they are inwardly close to each other, allowing them to pass through the non-circular joint opening of the anchor head portion. The valve annulus shaping system described in Appendix 23. [Note 25] The anchor placement tool further includes a catheter connector located at the proximal end of the rotary drive body for connecting the distal end of the catheter, the catheter connector being further configured to drive the tissue anchor toward the distal end together with the rotary drive body when the proximal end of the catheter is driven from outside the target to transport the tissue anchor. The valve annulus repair system described in Appendix 24. [Note 26] The length of the rotational drive body is such that, if the distal end of the tab cannot move further toward the distal end, the distal end of the helical tissue connecting element of the tissue anchor is in contact with the valve annular tissue. The valve annulus repair system described in Appendix 25.

Claims

1. A valve ring forming device configured to be suitable for implantation into the body of a target, A retractable bridge element, A rotatable connection mechanism is provided, and a plate-shaped member is connected to the retractable bridge element, A tissue anchor configured to fix the plate-shaped member to the valve annular tissue via the rotatable connecting mechanism, comprising: an anchor head portion; and a helical tissue connecting element whose proximal end is fixed to the anchor head portion and which is configured to rotate and be driven into the valve annular tissue; The rotatable connection mechanism is configured such that at least a portion of it is rotatable with respect to the plate-shaped member, and that when the proximal end of the helical structure connecting element contacts the rotatable connection mechanism, the structure anchor can be further rotated with respect to the plate-shaped member. The rotatable connecting mechanism includes a fixed portion fixedly provided to the plate-shaped member and a rotatable portion. The aforementioned tissue anchor can fix the plate-shaped member to the valve ring tissue via the rotatable portion. An annular circumferential groove is provided in one of the rotatable portion and the fixed portion, and the other portion is rotatably housed within the annular circumferential groove relative to the one portion. Valve annulus molding device.

2. The plate-like member includes a first surface, a second surface opposite to the first surface, and a circular through-hole extending from the first surface to the second surface, The rotatable portion includes a tubular body having a proximal end and a distal end, a top ring, and a bottom ring, the top ring and the bottom ring being provided at the proximal and distal ends of the tubular body, respectively, and defining the annular circumferential groove extending along the outer circumference of the tubular body. The fixing portion is the part of the plate-shaped member that defines the circular through hole, and the portion is housed within the annular circumferential groove. The valve ring forming apparatus according to claim 1.

3. The rotatable portion further includes a connecting portion provided on one of the top ring, the tubular body, and the bottom ring, and the tissue anchor fixes the plate-shaped member to the valve ring tissue via the connecting portion. The valve ring forming apparatus according to claim 2.

4. The connecting portion is a crossbar radially fixed to the inner circumferential wall of the top ring, or to the proximal or distal end face of the top ring, and the proximal end face of the tubular body is provided with two radially opposing grooves configured to accommodate the crossbar. The valve ring forming apparatus according to claim 3.

5. The distal end surface of the tube is provided with a plurality of grooves configured to accommodate a plurality of protrusions provided radially inward on the inner circumferential surface of the bottom ring. The valve ring forming apparatus according to claim 4.

6. The connecting portion is a crossbar fixed radially to the inner circumferential wall of the bottom ring, or to the proximal or distal end face of the bottom ring, and the distal end face of the tubular body is provided with two radially opposing grooves for accommodating the crossbar. The valve ring forming apparatus according to claim 3.

7. The proximal end face of the tube is provided with a plurality of grooves configured to accommodate a plurality of protrusions provided radially inward on the inner circumferential surface of the top ring. The valve ring forming apparatus according to claim 6.

8. The center of the crossbar is provided with a screw hole that is detachably connected to the distal end male thread of a guide for guiding the tissue anchor. The valve ring forming apparatus according to any one of claims 4 to 7.

9. One of the top ring and the bottom ring is formed integrally with the tubular body. The valve ring forming apparatus according to claim 2.

10. The plate-like member includes a first surface, a second surface opposite to the first surface, and a circular through-hole extending from the first surface to the second surface. The fixing portion comprises the portion of the plate-shaped member that defines the circular through hole, The invention includes a top plate having a circular through-hole, the top plate being fixed to the first surface such that the circular through-hole and the circular through-hole of the plate-like member are substantially concentric, wherein the annular circumferential groove is provided along the circumferential direction on the inner circumferential surface of the circular through-hole of the plate-like member and / or the top plate, and The rotatable portion includes a ring rotatably housed in the annular circumferential groove. The valve ring forming apparatus according to claim 1.

11. The plate-like member includes a first surface, a second surface opposite to the first surface, and a through hole extending from the first surface to the second surface. The fixing portion includes a separate fixing seat that is fixed within the through hole and is configured such that a circular through hole is defined. The annular circumferential groove is provided within the inner circumferential surface of the circular through hole along the circumferential direction, The rotatable portion includes a ring rotatably housed within an annular circumferential groove of the separate fixed seat. The valve ring forming apparatus according to claim 1.

12. The aforementioned ring is provided with a connecting portion. The aforementioned tissue anchor fixes the plate-shaped member to the valve annular tissue via the connecting portion. The valve ring forming apparatus according to claim 10 or 11.

13. The connecting portion is a crossbar that is radially fixed to the inner circumferential wall of the ring, or to the proximal or distal end face of the ring. The center of the crossbar is provided with a screw hole that is detachably connected to the distal end male thread of a guide for guiding the tissue anchor. The valve ring forming apparatus according to claim 12.

14. When the separate fixing seat is fixed within the through hole of the plate-shaped member, its distal end surface aligns with the second surface of the plate-shaped member. The valve ring forming apparatus according to claim 11.

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