Support and annuloplasty device

Abstract

The present invention provides a support member, comprising a first base, a plurality of support rods arranged at circumferential intervals around the first base, a plurality of connecting rods arranged corresponding to the plurality of support rods, and an adjustment rod that movably passes through the first base; wherein the proximal end of each support rod is relatively gathered at the first base, an anchor is correspondingly arranged at the distal end of a support rod; one end of a connecting rod is correspondingly connected to a support rod in rotation; and the adjustment rod is rotatably connected to the other end opposite to each connecting rod. The first base, the plurality of support rods, the plurality of connecting rods and the adjustment rod of the support member form a connecting rod structure, so that the adjustment rod can drive each connecting rod to expand the corresponding support rod when it moves axially, and the plurality of support rods are opened into an umbrella shape relative to the adjustment rod. When the position of the adjustment rod is relatively fixed, the position of each support rod is also fixed, thereby providing a stable support force for the plurality of anchors arranged at the distal end of each support rod. The present invention also provides a valve ring forming device including the support member.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a support member and an annuloplasty device. Background Art

[0002] Mitral regurgitation is one of the most common valvular diseases today. Causes include mitral annular dilatation, chordae tendineae insufficiency, myxomatous mitral valve degeneration, leaflet prolapse, rheumatic valvular heart disease, and ischemic lesions. Open mitral valvuloplasty and prosthetic valve replacement are the most effective treatments for mitral regurgitation. However, because these procedures require extracorporeal circulation, they are relatively traumatic and carry a high risk of complications and mortality in elderly patients and those with multiple comorbidities.

[0003] In recent years, medical personnel and researchers from various countries have conducted many explorations into transcatheter mitral valve repair technologies. Among them, transcatheter annuloplasty is a relatively effective interventional treatment method. The main purpose of annuloplasty is to reduce the size of the valve annulus and maintain the shape of the valve annulus after reduction.

[0004] Prior art uses an expandable nickel-titanium stent for ring contraction. Several anchors are embedded in the stent's edge, anchored to the mitral annulus. The stent then contracts to achieve ring contraction. Because the heart continues to beat during anchoring, the stent relies on the elastic memory of the nickel-titanium metal material to provide support for the anchors. However, this support is weak and unstable, making it difficult to ensure that the anchors are accurately, completely, and securely anchored in the corresponding position of the annulus. Summary of the Invention

[0005] In view of the deficiencies of the prior art, the present invention provides a support member and an annuloplasty device, which can provide a stable supporting force for the anchor, thereby ensuring that the anchor can be accurately, completely and securely anchored into the corresponding position of the annulus.

[0006] In order to solve the above technical problems, the present invention provides a support member for providing support for multiple anchors to be anchored into human tissue, the support member comprising a first base, a plurality of support rods arranged at circumferential intervals around the first base, a plurality of connecting rods arranged corresponding to the plurality of support rods, and an adjustment rod that movably passes through the first base; wherein, the proximal end of each of the support rods is relatively gathered at the first base, and one of the anchors is correspondingly arranged at the distal end of one of the support rods; one end of one of the connecting rods is correspondingly rotatably connected to one of the support rods; the adjustment rod is rotatably connected to the other end opposite to each of the connecting rods; the adjustment rod moves axially to drive each of the connecting rods to open the corresponding support rod, and the multiple support rods are opened into an umbrella shape relative to the adjustment rod.

[0007] The present invention also provides a valve ring forming device, comprising the above-mentioned support member, a plurality of anchors correspondingly arranged at the distal end of each of the support rods, and a flexible shrink ring member passing through the proximal ends of the plurality of anchors.

[0008] The support member and valve ring forming device provided by the present invention include a first base, multiple support rods, multiple connecting rods and an adjusting rod, and an anchor is provided at the distal end of each support rod. The first base, multiple support rods, multiple connecting rods and the adjusting rod form a connecting rod structure, and the adjusting rod moves axially to drive each connecting rod to open the corresponding support rod. The multiple support rods are opened into an umbrella shape relative to the adjusting rod. When the position of the adjusting rod is relatively fixed, the connecting rod structure fixes the position of the multiple support rods, thereby providing a stable supporting force for the multiple anchors provided at the distal ends of the multiple support rods, to ensure that the multiple anchors can be accurately, completely and firmly anchored in the corresponding positions of the valve ring. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0010] Figure 1 It is a schematic diagram of the three-dimensional structure of the annuloplasty device provided by the first embodiment of the present invention housed in a sheath.

[0011] Figure 2 yes Figure 1 Schematic diagram of the three-dimensional structure of the annuloplasty device when the support member extends out of the sheath.

[0012] Figure 3 yes Figure 2 Schematic diagram of the three-dimensional structure of the annuloplasty device in the state where the support members are expanded.

[0013] Figure 4 yes Figure 2 A simplified structural diagram of the support members in the folded state.

[0014] Figure 5 yes Figure 4 A simplified structural diagram of the support members in the expanded state.

[0015] Figure 6 It is a simplified structural diagram of another embodiment in which the support member is in a folded state.

[0016] Figure 7 yes Figure 6 A simplified structural diagram of the support member in the expanded state.

[0017] Figure 8 yes Figure 3 Schematic diagram of the three-dimensional decomposition of the support parts.

[0018] Figure 9 yes Figure 8 Schematic diagram of the enlarged portion IX.

[0019] Figure 10 yes Figure 8 Schematic diagram of the connection between the middle support rod and the connecting rod.

[0020] Figure 11 yes Figure 10 An enlarged schematic diagram of part XI.

[0021] Figure 12 yes Figure 8 An enlarged schematic diagram of part XII.

[0022] Figure 13 yes Figure 3 Schematic diagram of the connection between the support rod and the anchor nail.

[0023] Figure 14 yes Figure 13 Axial cross-sectional view.

[0024] Figure 15 yes Figure 13 Schematic diagram of three-dimensional decomposition.

[0025] Figure 16 and Figure 17 This is a schematic diagram of the process of using the annuloplasty device.

[0026] Figure 18 1 is a schematic diagram of a partial structure of an annuloplasty device provided in a second embodiment of the present invention.

[0027] Figure 19 yes Figure 18 Axial cross-sectional view of the first base in FIG.

[0028] Figure 20 yes Figure 19 A schematic structural diagram of the first base and the proximal end of the support rod in the retracted state.

[0029] Figure 21 yes Figure 19 A schematic structural diagram of the first base and the proximal end of the support rod in the expanded state.

[0030] Figure 22 3D is a schematic diagram of the three-dimensional structure of the annuloplasty device provided in the third embodiment of the present invention.

[0031] Figure 23 yes Figure 22Schematic diagram of the three-dimensional structure of the support rod.

[0032] Figure 24 yes Figure 23 Partial cross-sectional view of section XXIV. DETAILED DESCRIPTION

[0033] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0034] In the description of the present invention, it should be noted that the terms "upper," "lower," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," etc., etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0035] In describing the present invention, it is important to note that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator. Axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device in its natural state. The above definitions are for convenience only and are not to be construed as limitations of the present invention.

[0036] Please also refer to Figures 1 to 3 The present invention provides an annuloplasty device 1000, comprising a delivery catheter 100, a support member 200 connected to the distal end of the delivery catheter 100, a plurality of anchors 300 correspondingly disposed at the distal ends of respective support rods 220 of the support member 200, and a flexible shrink ring member 400 threaded through the proximal ends of the plurality of anchors 300. The support member 200 is configured to provide support for the plurality of anchors 300 to be anchored into the annular tissue.

[0037] Specifically, the support member 200 includes a first base 210, a plurality of support rods 220 arranged at circumferential intervals around the first base 210, a plurality of connecting rods 230 arranged corresponding to the plurality of support rods 220, and an adjusting rod 240 that movably passes through the first base 210; wherein, the proximal end of each of the support rods 220 is relatively gathered at the first base 210, and an anchor 300 is correspondingly arranged at the distal end of one of the support rods 220; one end of one of the connecting rods 230 is correspondingly rotatably connected to one of the support rods 220; and the adjusting rod 240 is rotatably connected to the other end opposite to each of the connecting rods 230. In the present invention, the first base 210 of the support member 200, multiple support rods 220, multiple connecting rods 230 and the adjusting rod 240 form a connecting rod structure, so that the axial movement of the adjusting rod 240 can drive each connecting rod 230 to open the corresponding support rod 220, and the multiple support rods 220 are opened into an umbrella shape relative to the adjusting rod 240. It can be understood that when the position of the adjusting rod 240 is relatively fixed, the connecting rod structure is fixed, and the positions of the multiple support rods 220 are also fixed, thereby providing a stable supporting force for the multiple anchors 300 provided at the distal ends of the multiple support rods 220, to ensure that the multiple anchors 300 can be accurately, completely and firmly anchored into the corresponding positions of the valve ring tissue.

[0038] It should be noted that the annuloplasty device 1000 is movably disposed within the sheath 2000 to enter the human heart through the lumen of the sheath 2000. The adjustment rod 240 passes through the first base 210 and then movably disposed within the lumen of the delivery catheter 100. It then extends outside the patient's body and connects to a corresponding drive control element (not shown) on the operating handle. The drive control element controls the relative position of the adjustment rod 240, thereby expanding and securing the multiple support rods 220, thereby providing stable support force.

[0039] Specifically, if Figure 3 As shown, the support member 200 also includes a second base 250, which is fixedly connected to the distal end of the adjusting rod 240, and the other end of each connecting rod 230 opposite to the end of the support rod 220 corresponding to the rotational connection is rotationally connected to the second base 250. When the adjusting rod 240 moves axially in the first base 210 and the delivery catheter 100, the second base 250 follows the adjusting rod 240 and moves axially to move away from or closer to the first base 210. The second base 250 drives each connecting rod 230 to push or pull the corresponding support rod 220 to move, and the support rod 220 opens or closes relative to the adjusting rod 240 with its end gathered relative to the first base 210 as the rotation base point. For details, please refer to Figure 4 and Figure 5 In this embodiment, the overall structure of the support member 200 is configured as follows: when the support rod 220 is retracted relative to the adjustment rod 240, that is, when the support member 200 is in the retracted state, Figure 4 As shown, the axial distance between the second base 250 and the first base 210 is greater than the axial distance between the end of the connecting rod 230 connected to the corresponding support rod 220 and the first base 210. Figure 5 As shown, when the adjusting rod 240 moves axially toward the proximal end, the second base 250 approaches the first base 210, and the second base 250 drives each of the connecting rods 230 to expand the corresponding support rod 220, so that each of the support rods 220 is expanded relative to the adjusting rod 240. The second base 250 and the adjusting rod 240 can be an integral structure or a non-integrated structure. In this embodiment, the second base 250 and the adjusting rod 240 are non-integrated structures but are fixedly connected to each other.

[0040] like Figure 6 As shown, in other embodiments, the overall structure of the support member 200 may also be configured such that when the support rod 220 is retracted relative to the adjustment rod 240, the axial distance between the second base 250 and the first base 210 is smaller than the axial distance between the end of the connecting rod 230 connected to the corresponding support rod 220 and the first base 210. Figure 7 As shown, when the adjusting rod 240 moves axially toward the distal end, the second base 250 moves away from the first base 210, and the second base 250 drives each of the connecting rods 230 to open the corresponding support rod 220, and each of the support rods 220 opens into an umbrella shape relative to the adjusting rod 240.

[0041] It will be appreciated that in any of the above-described embodiments, when the support member 200 is initially in the collapsed state, the adjustment rod 240 can be moved axially by different distances, thereby causing each support rod 220 to have a different opening angle relative to the adjustment rod 240. Consequently, the radial distances (i.e., distances in a direction perpendicular to the axial direction of the adjustment rod 240) between the corresponding anchors 300 disposed at the distal ends of the support rods 220 and the adjustment rod 240 are different. Consequently, after the anchors 300 are anchored into the annular tissue, the radii of the circular rings formed by the anchors 300 are also different. In other words, by controlling the axial movement distance of the adjustment rod 240, the opening angle of the support member 200 can be adjusted, such that the radius of the circular ring formed by the anchors 300 disposed on the support member 200 can adapt to different annular sizes.

[0042] Furthermore, when the expansion angle of the support member 200 is adjusted by controlling the axial movement distance of the adjusting rod 240 so that the radius of the circular ring formed by the multiple anchors 300 provided on the support member 200 is at an appropriate radius value, the position of the adjusting rod 240 can be controlled to be relatively fixed by the driving control member as described above. Under the action of the first base 210, multiple support rods 220, multiple connecting rods 230 and the connecting rod structure formed by the second base 250 and the adjusting rod 240, the position of the multiple support rods 220 is fixed, thereby providing a stable supporting force for the multiple anchors 300 provided at the distal ends of the multiple support rods 220, so as to ensure that the multiple anchors 300 can be accurately, completely and firmly anchored into the corresponding positions of the valve ring tissue.

[0043] The first base 210 , the plurality of support rods 220 , the plurality of connecting rods 230 and the adjusting rod 240 may be connected to each other in different connection ways to form a connecting rod structure.

[0044] In order to ensure that the support member 200 has sufficient rigidity and the connecting rod structure is stable, each component is preferably made of metal materials such as stainless steel.

[0045] For details, please refer to Figures 8 to 10 In this embodiment, the proximal end of the support rod 220 is rotatably connected to the first base 210. The first base 210 is generally in the shape of a pancake, and a plurality of first connecting grooves 211 are circumferentially spaced apart on the outer circumference of the first base 210. Each first connecting groove 211 receives a corresponding first connecting buckle 510, which is rotatably connected to the first base 210. The proximal end of each support rod 220 is connected to a corresponding first connecting buckle 510.

[0046] In this embodiment, the first connecting groove 211 is a U-shaped groove that passes through both end surfaces of the first base 210, with the opening of the U-shaped groove facing the outer periphery of the first base 210. The first connecting buckle 510 includes a circular ring 511 and a flat connecting body 513 connected to the outer periphery of the circular ring 511. The connecting body 513 is provided with a through-hole 515. The outer periphery of the first base 210 is provided with a circumferential first annular groove 213 that is connected to the plurality of first connecting grooves 211. A first annular hoop 215 is embedded in the first annular groove 213. The first annular hoop 215 is connected to the through-hole 515 of each first connecting buckle 510, so that the plurality of first connecting buckles 510 are movably mounted on the first annular hoop 215, and the connecting body 513 of the first connecting buckle 510 is accommodated in the first connecting groove 211. The opposing inner walls of the first connecting groove 211 abut against the opposing outer walls of the connecting body 513 of the first connecting buckle 510, allowing the first connecting buckle 510 to rotate only up and down around the first annular hoop 215. The first connecting groove 211 extends through both end surfaces of the first base 210, providing space for the first connecting buckle 510 to rotate up and down. Thus, each support rod 220 can be rotatably connected to the first base 210 via a first connecting buckle 510, allowing multiple support rods 220 to converge or diverge relative to each other with the first base 210 as a node.

[0047] The proximal end of the support rod 220 and the first connecting buckle 510 can be fixedly connected by threaded connection or laser welding. In this embodiment, laser welding is preferred.

[0048] A first connecting portion 260 is further provided on the proximal surface of the first base 210 , and the first connecting portion 260 is used to connect with the distal end of the delivery catheter 100 so as to deliver the support member 200 through the delivery catheter 100 .

[0049] The first base 210 is provided with a through hole along the axial direction, and the through hole is communicated with the inner cavity of the first connecting portion 260 for the adjustment rod 240 to pass through.

[0050] For further information, please also refer to Figure 10 and Figure 11 One end of each connecting rod 230 is correspondingly connected to a second connecting buckle 520, and each second connecting buckle 520 is correspondingly sleeved on a supporting rod 220, thereby rotatably connecting a supporting rod 220 with a connecting rod 230.

[0051] Specifically, in this embodiment, the second connecting buckle 520 is located between the proximal end and the distal end of the support rod 220, and the second connecting buckle 520 is fixedly mounted on the support rod 220 by laser welding or crimping.

[0052] It should be noted that the second connecting buckle 520 has a similar structure to the first connecting buckle 510, except that a pair of spaced connectors are fixedly connected to the annular body of the second connecting buckle 520, forming a connecting groove between the pair of connectors. One end of the connecting rod 230 is accommodated in the connecting groove and is rotatably connected to the second connecting buckle 520 via a pin. In this embodiment, the connecting rod 230 is a flat rod with connecting holes 231 at both ends, and both ends are rounded.

[0053] For further information, please also refer to Figure 8 and Figure 12 The other end of each connecting rod 230 opposite to one end of the supporting rod 220 corresponding to the rotational connection is rotationally connected to the second base 250.

[0054] like Figure 12 As shown, in this embodiment, the structure of the second base 250 is similar to that of the first base 210. Specifically, the second base 250 is generally in the shape of a pancake, and a plurality of U-shaped second connecting grooves 252 are circumferentially spaced apart on the outer circumference of the second base 250, penetrating through both end surfaces thereof. A circle of second annular grooves 254 are circumferentially formed on the outer circumference of the second base 250, which are in communication with the plurality of second connecting grooves 252. A second annular hoop 256 is embedded in the second annular groove 254, which is inserted into the connecting hole 231 of each connecting rod 230, so that the other end of each connecting rod 230 is movably sleeved on the second annular hoop 256. As a result, the other end of each connecting rod 230 is rotatably connected to the second base 250, and the plurality of connecting rods 230 can be relatively gathered or diverged with the second base 250 as a node.

[0055] The proximal end surface of the second base 250 is provided with a connection hole along the axial direction, and the distal end of the adjustment rod 240 is fixedly connected to the connection hole. The fixed connection method includes but is not limited to threaded connection and laser welding, and laser welding is preferred.

[0056] It should be noted that, in the present invention, the first annular hoop 215 and the second annular hoop 256 can each be formed of a single metal wire, which is threaded through the multiple first connecting buckles 510 or the multiple connecting rods 230, and then secured at both ends of the metal wire by welding, crimping, or inserting the wire into a connecting sleeve to form an integrated annular hoop. The metal wire includes, but is not limited to, biocompatible metal wires such as stainless steel wire and nickel-titanium wire. Of course, the first annular hoop 215 and the second annular hoop 256 can also be made of a polymer material.

[0057] As described above, the first base 210, the multiple support rods 220, the multiple connecting rods 230 correspondingly connected to the multiple support rods 220, the second base 250 and the adjusting rod 240 form a connecting rod structure. When the adjusting rod 240 is driven to move axially, the multiple support rods 220 will be driven to exhibit an opening and closing movement relative to the adjusting rod 240. When the position of the adjusting rod 240 is fixed (controlled by the aforementioned drive control component), the opening and closing angles of the multiple support rods 220 will also be fixed to form a lock, thereby realizing the rigid support function of the anchor 300 corresponding to the distal end of each support rod 220, to ensure that each anchor 300 can be accurately, completely and firmly anchored into the corresponding position of the valve ring tissue.

[0058] Furthermore, in the present invention, the support member 200 also includes a plurality of telescopic structures arranged corresponding to the plurality of support rods 220, and one of the telescopic structures is used to adjust the axial distance between the proximal end of the anchor 300 and the first base 210 (i.e., the distance along the axial direction of the adjustment rod 240).

[0059] For details, please refer to Figure 3 、 Figures 13 to 15 In this embodiment, the support rod 220 is a hollow rod having a cross-sectional shape including, but not limited to, circular, oblate, rectangular, and polygonal shapes, with a circular shape being preferred. An anchor control rod 310 and an anchor connector 330 fixedly connected to the distal end of the anchor control rod 310 are movably disposed within the inner cavity of the support rod 220. The anchor connector 330 is detachably connected to the anchor 300. The anchor control rod 310 and the anchor connector 330 constitute the telescopic structure. The anchor 300 follows the axial movement of the anchor control rod 310 to change the axial distance between the proximal end of the anchor 300 and the first base 210. The anchor 300 rotates in response to the rotation of the anchor control rod 310 to anchor into the valve annulus tissue.

[0060] The distal end diameter of the anchor joint 330 is larger than the inner diameter of the support rod 220 , so that the anchor 300 is located outside the distal end of the support rod 220 .

[0061] The anchor control rod 310 can extend outside the patient's body through the lumen of the delivery catheter 100 and connect to a corresponding control mechanism (not shown) on the operating handle. The control mechanism can then control the axial movement of the anchor control rod 310 to drive the anchors 300 to extend or retract from the distal end of the support rod 220. When the support member 200 is in the expanded state, the control mechanism can control each anchor 300 to extend to a different distance relative to the distal end of the support rod 220. This allows the anchors 300 to adapt to the unevenness of different areas of the annular tissue when anchored in the annular tissue. After the anchors 300 are anchored in different areas of the annular tissue, the flexible ring-retracting member 400 disposed proximally to the proximal ends of the anchors 300 does not lie in a flat surface, but rather adapts to the saddle-shaped, 3D physiological structure of the annular tissue, achieving a better ring-retracting effect.

[0062] Please refer again Figures 1 to 3 In the annuloplasty device 1000 provided by the present invention, the support member 200 is connected to the distal end of the delivery catheter 100 so that when the support member 200 is in a collapsed state, the support member 200 is pushed through the delivery catheter 100. As previously mentioned, the adjustment rod 240 of the support member 200 and the anchor control rod 310 extend out of the body through the inner cavity of the delivery catheter 100. Specifically, in this embodiment, the delivery catheter 100 is a multi-lumen catheter, comprising a main lumen extending axially and a plurality of secondary lumens spaced circumferentially around the main lumen. The main lumen is used for the adjustment rod 240 to pass through, and each of the secondary lumens is used for the anchor control rod to pass through.

[0063] like Figure 3 As shown, the flexible shrink ring member 400 is simultaneously passed through the proximal ends of multiple anchors 300 at the distal end of the support member 200. After the multiple anchors 300 are anchored into the valve ring tissue, the flexible shrink ring member 400 can be tightened to shrink the valve ring to an appropriate degree.

[0064] Among them, the flexible ring shrinking member 400 can be a closed-loop structure or an open-loop structure. Preferably, the flexible ring shrinking member 400 adopts a closed-loop structure. The flexible ring shrinking member 400 with a closed-loop structure forms a closed ring for shrinking the ring after tightening. When shrinking the valve ring, the force is more uniform, and the shape fixing effect of the valve opening is better.

[0065] The flexible shrink ring member 400 includes but is not limited to a flexible wire, a flexible strip or a flexible belt, and the cross-sectional shape of the flexible strip or the flexible belt includes but is not limited to an oblate circle, a rectangle, etc.

[0066] Please also refer to Figure 16 and Figure 17The use process of the annuloplasty device 1000 provided in this embodiment is as follows: First, in the initial state where the support rods 220 of the support member 200 are relatively gathered and the flexible shrink ring member 400 is retracted, the delivery catheter 100 pushes the support member 200 to pass through the channel established by the sheath tube 2000 (the figure shows the outer sheath tube passing through the femoral vein, inferior vena cava, right atrium, atrial septum, and left atrium as an example) until the support member 200 passes through the sheath tube 2000, so that the distal end of the support member 200 is provided. The multiple anchors 300 are close to the mitral valve annulus; then, the adjusting rod 240 is driven to move axially through the driving control part of the operating handle to drive each support rod 220 to open into an umbrella shape, and then the anchor control rod 310 passing through each of the support rods 220 is rotated one by one or simultaneously through the control mechanism of the operating handle to drive each of the anchors 300 to rotate, so that each of the anchors 300 is anchored into the valve annulus tissue; finally, the flexible shrinking ring part 400 passing through the multiple anchors 300 is tightened to complete the shrinking ring.

[0067] In the process of anchoring each anchor 300, each anchor control rod 310 can also be driven to move axially through the control mechanism of the operating handle to change the axial distance between the proximal end of each anchor 300 and the first base 210, so that after the multiple anchors 300 are anchored, the proximal ends of the anchors are on different horizontal planes, thereby making the flexible shrinking ring parts 400 passing through the proximal ends of the multiple anchors 300 not in the same plane, which is conducive to adapting to the real 3D physiological structure of the valve ring tissue similar to the saddle shape, and achieving a better shrinking ring effect.

[0068] The annuloplasty device 1000 provided in this embodiment has the following beneficial effects during the annuli shrinkage process: 1. The support member 200 can provide reliable rigid support for the multiple anchors 300, so that the multiple anchors 300 can be stably anchored into the annular tissue; 2. The multiple anchors 300 are simultaneously delivered to the mitral valve annulus, making the operation more convenient; 3. By controlling the distance that the adjusting rod 240 moves in the axial direction, the degree to which each support rod 220 is stretched can be adjusted, so that the multiple anchors provided at the distal end of each support rod 220 can be stably anchored into the annular tissue; The circular rings formed by the nails 300 have different radii, which can adapt to the physiological and anatomical conditions of the valve rings of different individuals; 4. The flexible shrinking ring member 300 adopts a closed-loop structure to form a closed ring for shrinking the ring after tightening. It is more evenly stressed than an open ring when shrinking the valve ring, and has a better effect on fixing the shape of the valve orifice; 5. The setting of the retractable structure can enable multiple anchor nails 300 to complete anchoring. The flexible shrinking ring member 400 passed through their proximal ends can adapt to the real 3D physiological structure of the valve ring tissue similar to a saddle shape, thereby achieving a better ring shrinking effect.

[0069] Please also refer to Figures 18 to 21The structure of the annuloplasty device provided in the second embodiment of the present invention is similar to that of the annuloplasty device 1000 in the first embodiment, except that: in the second embodiment, a plurality of receiving cavities 212 are circumferentially spaced apart on the first base 210b, which pass through the proximal and distal surfaces of the first base 210b. The proximal end of each support rod 220 is movably inserted into a corresponding receiving cavity 212. The receiving cavity 212 includes a proximal limiting section, and the axis of the proximal limiting section gradually moves away from the axis of the first base 210b from the proximal end to the distal end.

[0070] Specifically, in this embodiment, the distal portion of the receiving cavity 212 simultaneously passes through the distal end surface and the distal end portion of the outer peripheral surface of the first base 210b, so that the receiving cavity 212 has a larger movable space at the distal end. When the adjusting rod 240 (not shown in the figure) moves axially to drive each of the connecting rods 230 (not shown in the figure) to expand the corresponding support rod 220, the support rod 220 tends to move radially outward along the first base 210b, and the proximal end of the support rod 220 abuts against the inner wall of the proximal limit section. At this time, if the connecting rod 230 further expands the support rod 220, the proximal end of the support rod 220 no longer moves radially under the stop of the proximal limit section, but the support rod 220 The part of 20 away from the proximal end continues to move outward under the push of the connecting rod 230, so that the support rod 220 will be opened relative to the adjusting rod 240 with its proximal end as the rotation base point, and the distal end of the accommodating cavity 212 provides sufficient space for the opening and closing movement of the support rod 220, and finally the support rod 220 is opened to a certain angle relative to the adjusting rod 240, and multiple support rods 220 are opened into an umbrella shape, thereby providing support for the multiple anchor nails 300 at the distal ends of the multiple support rods 220.

[0071] The first base 210 b is provided with a through hole 214 along the axial direction for the adjusting rod 240 to pass through.

[0072] It is understandable that, under the restriction of the connecting rod and the second connecting buckle, each of the support rods 220 will not be separated from the receiving cavity 212 .

[0073] In this embodiment, the proximal end of each support rod 220 is movably inserted into the receiving cavity 212 of the first base 210b, and the first connecting buckle 510 and the first annular hoop 215 in the first embodiment are not required, so that the structure of the support member and the entire valve ring forming device is simpler and easier to install.

[0074] Please also refer to Figures 22 to 24The structure of the annuloplasty device 1000c provided in the third embodiment of the present invention is similar to that of the annuloplasty device in the second embodiment, except that: in the third embodiment, no anchor control rod and anchor joint are provided, and the anchor 300 is directly and detachably connected to the distal end of the support rod 220c. The support rod 220c is provided with an external thread extending along its axial direction, and an internal thread is provided in the second connecting buckle 520c. Each second connecting buckle 520c is correspondingly threadedly sleeved on one of the support rods 220c, and the second connecting buckle 520c and the external thread on the support rod 220c constitute the telescopic structure. When the support rod 220c stops opening relative to the adjustment rod, when the support rod 220c rotates, since the second connecting buckle 520c does not move axially, the anchor 300 rotates synchronously with the rotation of the support rod 220c and moves axially along the support rod 220c to change the axial distance between the proximal end of the anchor 300 and the first base 210c (i.e., the distance along the axial direction of the first base 210c).

[0075] Specifically, in this embodiment, the support rod 220c is a solid rod body, and a slot 350 is provided at its distal end. The proximal end of the anchor 300 is plugged into the slot 350, so that the rotation of the support rod 220c can drive the anchor 300 to rotate.

[0076] Among them, the second connecting buckle 520c is threadedly sleeved on the support rod 220c, and the second connecting buckle 520c is also rotatably connected to a corresponding connecting rod 230. When the support rod 220c rotates, since the second connecting buckle 520c is limited by the connecting rod 230, the support rod 220c can move along its own axial direction relative to the second connecting buckle 520c, thereby driving the distal anchor 300 to move along the axial direction of the support rod 220c.

[0077] It should be noted that the proximal end of the support rod 220c is movably arranged in the receiving cavity 212 of the first base 210c, and the proximal end of the support rod 220c can be connected to a corresponding control mechanism (such as a snake tube, etc.) through the secondary sub-cavity of the delivery catheter 100. The support rod 220c can be rotated by the control mechanism, and under the pulling of the control mechanism, the proximal end of the support rod 220c will not detach from the receiving cavity 212.

[0078] It can be understood that in this embodiment, when each support rod 220c is expanded into an umbrella shape, the control mechanism controls different support rods 220c to rotate different numbers of circles relative to their corresponding threaded second connecting buckles 520c, which can drive multiple anchors 300 to undergo different degrees of axial expansion and contraction, so that when multiple anchors 300 are anchored into the annular tissue, they can adapt to the concave and convex conditions of different areas of the annular tissue. After the multiple anchors 300 are anchored into different areas of the annular tissue, the flexible shrinking ring parts 400 passed through the proximal ends of the multiple anchors 300 are not on a plane, but can adapt to the real 3D physiological structure of the annular tissue similar to a saddle shape, thereby achieving a better shrinking ring effect.

[0079] In other embodiments, in conjunction with reference Figure 22 、 Figure 23 and Figure 8 , when a plurality of first connecting grooves 211 are provided on the outer circumferential surface of the first base 210c at intervals in the circumferential direction, the proximal end of each support rod 220c is rotatably connected to the first base 210c through a first connecting buckle, in order to prevent the first connecting buckle from hindering the rotation of the support rod 220c, an internal thread is correspondingly provided in the first connecting buckle, and the proximal end of each support rod 220c is correspondingly screwed to the first connecting buckle 510c, so that when the support rod 220c is driven to rotate by the control mechanism, the support rod 220c is simultaneously relative to the The first connecting buckle and the second connecting buckle 520c move along their own axial directions, thereby driving the anchor 300 at the distal end of the support rod 220c to move along the axial direction of the support rod 220c. The axial distance between the proximal end of each anchor 300 and the first base 210c can also be changed, so that after multiple anchors 300 are anchored into the valve ring tissue, the flexible shrinking ring member 400 passed through the proximal ends of the multiple anchors 300 is not on a plane, but can adapt to the real 3D physiological structure of the valve ring tissue similar to a saddle shape, so as to achieve a better shrinking ring effect.

[0080] The above is an implementation of the embodiment of the present invention. It should be pointed out 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. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A support member for valve repair, used to provide support for multiple anchors anchored into human tissue, characterized in that: include: First Plinth; A plurality of support rods are arranged at intervals around the circumference of the first base, the proximal end of each support rod is relatively gathered at the first base, and one anchor is correspondingly arranged at the distal end of one support rod; a plurality of connecting rods provided corresponding to the plurality of support rods, one end of each connecting rod being rotatably connected to a corresponding support rod; and an adjusting rod movably passing through the first base, the adjusting rod being rotatably connected to the other end opposite to each of the connecting rods; The adjusting rod moves axially to drive each of the connecting rods to open the corresponding support rod, and the multiple support rods are opened into an umbrella shape relative to the adjusting rod; In which, the proximal end of the support rod is rotatably connected to the first base; or, a plurality of receiving cavities that pass through the proximal end surface and the distal end surface of the first base are provided on the first base at circumferential intervals, and the proximal end of the support rod is movably arranged in a corresponding receiving cavity, and the receiving cavity includes a proximal limiting section, and the axis of the proximal limiting section gradually moves away from the axis of the first base from the proximal end to the distal end.

2. The support member according to claim 1, wherein It also includes a plurality of telescopic structures corresponding to the plurality of support rods, wherein one of the telescopic structures is used to correspondingly adjust the axial distance between the proximal end of the anchor and the first base.

3. The support member according to claim 2, wherein: The distal end of the adjusting rod is fixedly connected to the second base, and the other opposite end of each connecting rod is rotatably connected to the second base.

4. The support member according to claim 3, wherein: When the support rod is retracted relative to the adjustment rod, the axial distance between the second base and the first base is smaller than the axial distance between the end of the connecting rod connected to the corresponding support rod and the first base.

5. The support member according to claim 3, wherein: When the support rod is retracted relative to the adjustment rod, the axial distance between the second base and the first base is greater than the axial distance between the end of the connecting rod connected to the corresponding support rod and the first base.

6. The support member according to claim 3, wherein: When the proximal end of the support rod is rotatably connected to the first base, a plurality of first connecting grooves are circumferentially spaced on the outer surface of the first base, and a first connecting buckle is correspondingly accommodated in each of the first connecting grooves. The first connecting buckle is rotatably connected to the first base, and the proximal end of the support rod is correspondingly connected to each of the first connecting buckles.

7. The support member according to claim 6, wherein: A first annular groove connected to the plurality of first connecting grooves is circumferentially provided on the outer peripheral surface of the first base, a first annular hoop is embedded in the first annular groove, and the plurality of first connecting buckles are movably sleeved on the first annular hoop.

8. The support member according to claim 3, wherein: A plurality of second connecting grooves are provided on the outer peripheral surface of the second base at circumferential intervals. One end of a connecting rod is rotatably connected to a second connecting buckle. A second connecting buckle is correspondingly sleeved on a supporting rod. The other end of each connecting rod is rotatably connected to the second base.

9. The support member according to claim 8, wherein A second annular groove connected to the plurality of second connecting grooves is circumferentially provided on the outer peripheral surface of the second base, a second annular hoop is embedded in the second annular groove, and the other end opposite to each connecting rod is movably sleeved on the second annular hoop.

10. The support member according to claim 8, wherein The second connecting buckle is located between the proximal end and the distal end of the support rod, and the second connecting buckle is fixedly sleeved on the support rod.

11. The support member according to any one of claims 2 to 10, characterized in that: The support rod is a hollow rod body, and an anchor control rod and an anchor joint fixedly connected to the distal end of the anchor control rod are movably inserted into the inner cavity of the support rod, and the anchor joint is detachably connected to the anchor; the anchor control rod and the anchor joint constitute the telescopic structure, and the anchor follows the axial movement of the anchor control rod to change the axial distance between the proximal end of the anchor and the first base, and the anchor rotates following the rotation of the anchor control rod.

12. The support member according to claim 8, wherein The support rod is provided with an external thread extending along its axial direction, and a plurality of first connecting grooves are provided on the outer peripheral surface of the first base at circumferential intervals. A first connecting buckle is correspondingly accommodated in one of the first connecting grooves, and the first connecting buckle is rotatably connected to the first base. An internal thread is provided in the first connecting buckle, and the proximal end of the support rod is correspondingly screwed to the first connecting buckle.

13. The support member according to claim 8, wherein The support rod is provided with an external thread extending along its axial direction, and a plurality of receiving cavities penetrating the proximal end surface and the distal end surface of the first base are provided on the first base at circumferential intervals, and the proximal end of the support rod is movably arranged in a corresponding receiving cavity; the receiving cavity includes a proximal limiting section, and the axis of the proximal limiting section gradually moves away from the axis of the first base from the proximal end to the distal end.

14. The support member according to claim 12 or 13, characterized in that An internal thread is provided in the second connecting buckle, and a corresponding second connecting buckle is threadedly sleeved on one of the support rods. The second connecting buckle and the external thread on the support rod constitute the telescopic structure. The anchor nail rotates synchronously with the rotation of the support rod and moves along the axial direction of the support rod to change the axial distance between the proximal end of the anchor nail and the first base.

15. The support member according to claim 14, wherein The distal end of the support rod is provided with a groove extending along its axial direction, and the proximal end of the anchor nail is plugged into the groove, so that the rotation of the support rod drives the anchor nail to rotate.

16. An annuloplasty device, characterized in that: The invention comprises the support member according to any one of claims 1 to 15, a plurality of anchors correspondingly arranged at the distal end of each of the support rods, and a flexible shrink ring member passing through the proximal ends of the plurality of anchors.

17. The annuloplasty device according to claim 16, wherein: The flexible ring-shrinking member is a closed-loop structure or an open-loop structure.

18. The annuloplasty device according to claim 16, wherein: It also includes a delivery catheter, the first base is fixedly connected to the distal end of the delivery catheter, and the adjustment rod is movably arranged in the delivery catheter.

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