CN113116605A

CN113116605A - Support and annuloplasty device

Info

Publication number: CN113116605A
Application number: CN201911426141.9A
Authority: CN
Inventors: 谢琦宗; 黄桥; 张庭超; 郭荣辉
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-12-31
Filing date: 2019-12-31
Publication date: 2021-07-16

Abstract

The invention provides a supporting piece which comprises a first base, a plurality of supporting rods, a plurality of connecting rods and an adjusting rod, wherein the supporting rods are arranged at intervals in the circumferential direction of the first base, the connecting rods are arranged corresponding to the supporting rods, and the adjusting rod movably penetrates through the first base; the proximal end of each support rod is relatively gathered at the first base, and an anchor is correspondingly arranged at the distal end of one support rod; one end of a connecting rod is correspondingly and rotatably connected with a supporting rod; the adjusting rod is rotatably connected with the other end of each connecting rod. Support piece's first base, a plurality of bracing pieces, a plurality of connecting rod and regulation pole form the connecting rod structure for adjusting the pole and can ordering about each connecting rod along axial displacement and strut the bracing piece that corresponds, a plurality of bracing pieces open into umbelliform for adjusting the pole, work as when the position of adjusting the pole is fixed relatively, the position of each bracing piece also can be fixed, thereby can provide stable holding power for a plurality of anchors of locating each bracing piece distal end. The invention also provides an annuloplasty device comprising the support.

Description

Support and annuloplasty device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a support and an annuloplasty device.

Background

Mitral insufficiency is one of the most common valvular lesions at present, mainly due to mitral annulus dilatation, chordae tendineae insufficiency, mitral valve mucus degeneration, leaflet prolapse, rheumatic valvular disease, ischemic lesions, etc. The open mitral valvuloplasty and the artificial valve replacement are the most effective methods for treating mitral insufficiency, but the surgery needs extracorporeal circulation technology support, so that the trauma to the human body is large, and the complications and the death rate of the elderly patients and the patients with more complications are high.

In recent years, medical staff and researchers in various countries have conducted many researches on transcatheter mitral valve repair techniques, in which transcatheter annuloplasty is a more effective interventional treatment, and the main idea of annuloplasty is to reduce the valve annulus and maintain the reduced shape of the valve annulus.

In the prior art, there is an expandable nickel-titanium stent for ring contraction, in which a plurality of anchors are embedded in the edge of the nickel-titanium stent, the anchors are respectively anchored to the mitral annulus, and the nickel-titanium stent is contracted to achieve the purpose of ring contraction. Because the heart is continuously beating during the anchoring process, the nickel-titanium stent provides supporting force for the anchor by means of the elastic memory function of the nickel-titanium metal material, however, the supporting force is small and unstable, and it is difficult to ensure that the anchor can be accurately, completely and firmly anchored in the corresponding position of the valve annulus.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides the support and the annuloplasty device, which can provide stable support force for the anchor, so as to ensure that the anchor can be accurately, completely and firmly anchored in the corresponding position of the annulus.

In order to solve the technical problem, the invention provides a support member for providing support for anchoring a plurality of ground anchors into human tissue, wherein the support member comprises a first base, a plurality of support rods arranged around the first base at intervals in the circumferential direction, a plurality of connecting rods arranged corresponding to the plurality of support rods, and an adjusting rod movably penetrating through the first base; the proximal end of each supporting rod is relatively gathered at the first base, and one anchor is correspondingly arranged at the distal end of one supporting rod; one end of the connecting rod is correspondingly and rotatably connected with the supporting rod; the adjusting rod is rotatably connected with the other end, opposite to each connecting rod, of each connecting rod; the adjusting rods move axially to drive each connecting rod to prop open the corresponding supporting rod, and the supporting rods are opened into an umbrella shape relative to the adjusting rods.

The invention also provides an annuloplasty device, which comprises the support member, a plurality of anchors correspondingly arranged at the distal ends of the support rods, and a flexible loop-retracting member arranged on the proximal ends of the anchors.

The support piece comprises a first base, a plurality of support rods, a plurality of connecting rods and an adjusting rod, wherein an anchor is arranged at the far end of each support rod, the first base, the plurality of support rods, the plurality of connecting rods and the adjusting rod form a connecting rod structure, the adjusting rod moves axially to drive each connecting rod to prop open the corresponding support rod, the plurality of support rods are unfolded into an umbrella shape relative to the adjusting rod, and when the positions of the adjusting rod are relatively fixed, the positions of the plurality of support rods can be fixed through the connecting rod structure, so that stable supporting force can be provided for the plurality of anchors arranged at the far ends of the plurality of support rods, and the plurality of anchors can be accurately, completely and firmly anchored into the corresponding positions of the valve annulus.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic perspective view of an annuloplasty device accommodated in a sheath according to a first embodiment of the present invention.

Fig. 2 is a perspective view of the annuloplasty device of fig. 1 with the support extending out of the sheath.

Fig. 3 is a perspective view of the annuloplasty device of fig. 2 in a support-expanded state.

Fig. 4 is a diagrammatic view of the support member of fig. 2 in a collapsed condition.

Figure 5 is a schematic view of the support of figure 4 in an expanded configuration.

FIG. 6 is a schematic view of another embodiment of a support member in a collapsed condition.

Fig. 7 is a schematic view of the support of fig. 6 in an open position.

Fig. 8 is an exploded perspective view of the support member of fig. 3.

Fig. 9 is an enlarged schematic view of part IX in fig. 8.

Fig. 10 is a schematic view showing the connection of the support rod and the connection rod in fig. 8.

Fig. 11 is an enlarged schematic view of a portion XI in fig. 10.

Fig. 12 is an enlarged schematic view of XII in fig. 8.

Fig. 13 is a schematic view of the connection of the support rod to the anchor in fig. 3.

Fig. 14 is an axial cross-sectional view of fig. 13.

Fig. 15 is an exploded perspective view of fig. 13.

Figures 16 and 17 are schematic views of the annuloplasty device in use.

Fig. 18 is a partial schematic view of an annuloplasty device according to a second embodiment of the present invention.

Fig. 19 is an axial cross-sectional view of the first base of fig. 18.

Fig. 20 is a schematic view of the first base of fig. 19 and the proximal end of the support rod in a collapsed state.

Figure 21 is a simplified schematic illustration of the first base of figure 19 and the proximal end of the support rod in a stretched condition.

Fig. 22 is a perspective view of an annuloplasty device according to a third embodiment of the present invention.

Fig. 23 is a perspective view of the support rod of fig. 22.

Fig. 24 is a partial sectional view of the XXIV portion in fig. 23.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device in its natural state. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 1 to 3, the present invention provides an annuloplasty device 1000, including a delivery catheter 100, a support member 200 connected to a distal end of the delivery catheter 100, a plurality of anchors 300 correspondingly disposed at distal ends of the support rods 220 of the support member 200, and a flexible loop-retracting member 400 disposed at a proximal end of the anchors 300. The support 200 is configured to provide support for the plurality of anchors 300 to anchor into the annulus tissue.

Specifically, the supporting member 200 includes a first base 210, a plurality of supporting rods 220 spaced around the circumference of the first base 210, a plurality of connecting rods 230 corresponding to the plurality of supporting rods 220, and an adjusting rod 240 movably passing through the first base 210; the proximal end of each of the supporting rods 220 is relatively gathered at the first base 210, and one of the anchors 300 is correspondingly arranged at the distal end of one of the supporting rods 220; one end of the connecting rod 230 is correspondingly and rotatably connected with the supporting rod 220; the adjustment rod 240 is rotatably connected to the opposite end of each of the connection rods 230. In the present invention, the first base 210, the plurality of support rods 220, the plurality of connecting rods 230, and the adjustment rod 240 of the support member 200 form a linkage structure, such that the axial movement of the adjustment rod 240 may drive each of the connecting rods 230 to prop open the corresponding support rod 220, and the plurality of support rods 220 are opened in an umbrella shape relative to the adjustment rod 240, it can be understood that when the position of the adjustment rod 240 is relatively fixed, the linkage structure is fixed, and the position of the plurality of support rods 220 is fixed, so as to provide a stable supporting force for the plurality of anchors 300 disposed at the distal ends of the plurality of support rods 220, so as to ensure that the plurality of anchors 300 can accurately, completely, and reliably anchor the corresponding positions of the valve annulus tissue.

It should be noted that the annuloplasty device 1000 is movably disposed through the sheath 2000 to enter the heart of the human body through the lumen of the sheath 2000. The adjusting rod 240 passes through the first base 210 and is movably inserted into the inner cavity of the delivery catheter 100, and extends to the outside of the patient body to be connected with a corresponding driving control member (not shown) on the operating handle, and the relative position of the adjusting rod 240 can be controlled by the driving control member, so that the plurality of supporting rods 220 are opened and fixed, and further a stable supporting force is provided.

Specifically, as shown in fig. 3, the supporting member 200 further includes a second base 250, the second base 250 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 rotatably connected to the corresponding supporting rod 220, is rotatably connected to the second base 250. When the adjusting rod 240 moves in the first base 210 and the conveying conduit 100 along the axial direction, the second base 250 moves along the axial direction along with the adjusting rod 240 to be far away from or close to the first base 210, the second base 250 drives each connecting rod 230 to push or pull the corresponding supporting rod 220 to move, and the supporting rod 220 is opened or closed relative to the adjusting rod 240 with one end of the supporting rod, which is closed relative to the first base 210, as a rotation base point. Specifically, referring to fig. 4 and 5, in the present embodiment, the overall structure of the supporting member 200 is configured as follows: when the supporting rods 220 are folded with respect to the adjusting rods 240, i.e., when the supporting member 200 is in a folded state, as shown in fig. 4, 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 supporting rod 220 and the first base 210. As shown in fig. 5, when the adjustment rod 240 moves axially and proximally, the second base 250 approaches the first base 210, the second base 250 drives each of the connection rods 230 to prop open the corresponding support rod 220, and each of the support rods 220 is opened relative to the adjustment rod 240. The second base 250 and the adjustment rod 240 may be an integral structure or a non-integral structure, and in this embodiment, the second base 250 and the adjustment rod 240 are non-integral structures and are fixedly connected to each other.

As shown in fig. 6, in other embodiments, the overall structure of the support member 200 may also be configured to: when the supporting rods 220 are folded with respect to the adjusting rods 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 supporting rod 220 and the first base 210. As shown in fig. 7, when the adjustment rod 240 moves axially and distally, the second base 250 moves away from the first base 210, the second base 250 drives each of the connection rods 230 to open the corresponding support rod 220, and each of the support rods 220 opens in an umbrella shape relative to the adjustment rod 240.

It is understood that, in any of the above embodiments, when the support member 200 is in the collapsed state in the initial state, the adjustment rod 240 moves different distances in the axial direction, so that the opening angle of each of the support rods 220 with respect to the adjustment rod 240 is different, and thus, the radial distance (i.e., the distance in the direction perpendicular to the axial direction of the adjustment rod 240) of the anchor rods 300 disposed at the distal ends of the support rods 220 with respect to the adjustment rod 240 is different, and the radius of the circular ring shape surrounded by the anchor rods 300 is different after the anchor rods 300 are anchored in the annular tissue. In other words, by controlling the moving distance of the adjusting rod 240 in the axial direction, the opening angle of the support member 200 can be adjusted, so that the radius of the circular ring formed by the plurality of anchors 300 arranged on the support member 200 can be adapted to different annulus sizes.

Further, when the expansion angle of the support member 200 is adjusted by controlling the moving distance of the adjusting rod 240 along the axial direction, so that the radius of the circular ring surrounded by the plurality of anchor bolts 300 disposed on the support member 200 is at a suitable radius value, the position of the adjusting rod 240 can be controlled to be relatively fixed by driving the control member as described above, and the position of the plurality of support rods 220 is fixed under the action of the connecting rod structure formed by the first base 210, the plurality of support rods 220, the plurality of connecting rods 230, the second base 250 and the adjusting rod 240, so as to provide a stable supporting force for the plurality of anchor bolts 300 disposed at the distal ends of the plurality of support rods 220, thereby ensuring that the plurality of anchor bolts 300 can be accurately, completely and reliably anchored into the corresponding positions of the annulus tissue.

The first base 210, the plurality of support rods 220, the plurality of connecting rods 230, and the adjustment rod 240 may be connected to each other by different connection methods to form a link structure.

In order to ensure sufficient rigidity of the supporting member 200 and stability of the connecting rod structure, the components are preferably made of a metal material such as stainless steel.

Specifically, referring to fig. 8 to 10, in the present embodiment, the proximal end of the supporting rod 220 is rotatably connected to the first base 210. The first base 210 is substantially in a shape of a circular cake, a plurality of first connecting grooves 211 are formed on the outer circumferential surface of the first base 210 at intervals around the circumferential direction, a first connecting buckle 510 is correspondingly accommodated in each first connecting groove 211, the first connecting buckle 510 is rotatably connected to the first base 210, and a proximal end of each supporting rod 220 is correspondingly connected to one first connecting buckle 510.

In this embodiment, the first connecting groove 211 is a U-shaped groove penetrating through two end surfaces of the first base 211, and an opening of the U-shaped groove faces an outer periphery of the first base 211. The first connecting buckle 510 includes a circular ring body 511 and a flat connecting body 513 connected to the outer peripheral surface of the circular ring body 511, and the connecting body 513 is provided with a through hole 515. A circle of first annular grooves 213 communicated with the plurality of first connecting grooves 211 are circumferentially formed in the outer circumferential surface of the first base 210, first annular hoops 215 are embedded in the first annular grooves 213, and the first annular hoops 215 are inserted into the insertion holes 515 of each first connecting buckle 510, so that the plurality of first connecting buckles 510 are movably sleeved on the first annular hoops 215, and the connecting bodies 513 of the first connecting buckles 510 are accommodated in the first connecting grooves 211. Two inner wall surfaces opposite to the first connection groove 211 are stopped by two outer wall surfaces opposite to the connection body 513 of the first connection buckle 510, so that the first connection buckle 510 can only rotate up and down around the first annular hoop 215, and the two end surfaces of the first connection groove 211 penetrating through the first base 210 provide a moving space for the up-and-down rotation of the first connection buckle 510. Therefore, each of the supporting rods 220 can be rotatably connected to the first base 210 through one of the first connecting buckles 510, and the plurality of supporting rods 220 can be relatively gathered or diverged with the first base 210 as a node.

The proximal end of the support rod 220 and the first connecting buckle 510 may be fixedly connected by a screw thread connection or a laser welding, which is preferred in this embodiment.

Wherein, a first connecting part 260 is further disposed on the proximal end face of the first base 210, and the first connecting part 260 is used for connecting with the distal end of the delivery catheter 100 so as to deliver the support member 200 through the delivery catheter 100.

A through hole is axially formed in the first base 210, and the through hole is communicated with an inner cavity of the first connection portion 260 so that the adjustment rod 240 can pass through the through hole.

Further, referring to fig. 10 and 11, one end of each connecting rod 230 is correspondingly and rotatably connected to a second connecting buckle 520, and each second connecting buckle 520 is correspondingly sleeved on one supporting rod 520, so as to rotatably connect one supporting rod 220 with one connecting rod 230.

Specifically, in this embodiment, the second connecting fastener 520 is located between the proximal end and the distal end of the supporting rod 220, and the second connecting fastener 520 is fixedly fastened to the supporting rod 220 by laser welding or crimping.

It should be noted that the second connecting link 520 has a similar structure to the first connecting link 510, except that a pair of spaced connecting bodies are fixedly connected to a ring body of the second connecting link 520, a connecting slot is formed between the pair of connecting bodies, and an end of one end of the connecting rod 230 is accommodated in the connecting slot and rotatably connected to the second connecting link 520 through a pin. In this embodiment, the connecting rod 230 is a flat rod, and has two ends both provided with connecting holes 231 and smooth ends.

Further, referring to fig. 8 and 12, the other end of each connecting rod 230 opposite to the end of the supporting rod 220 corresponding to the rotational connection is rotatably connected to the second base 250.

As shown in fig. 12, in the present embodiment, the second base 250 has a structure similar to that of the first base 210. Specifically, the second base 250 is substantially in a round cake shape, a plurality of U-shaped second connecting grooves 252 penetrating through two end faces of the second base 250 are formed in the outer circumferential surface of the second base 250 at intervals in the circumferential direction, a circle of second annular grooves 254 communicated with the plurality of second connecting grooves 252 are formed in the outer circumferential surface of the second base 250 in the circumferential direction, a second annular hoop 256 is embedded in the second annular grooves 254, and the second annular hoops 256 are penetrated into the connecting holes 231 of each connecting rod 230, so that the other end of each connecting rod 230 is movably sleeved on the second annular hoops 256, and therefore, the other end of each connecting rod 230 is rotatably connected with 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.

Wherein, a connecting hole is axially opened on the proximal end surface of the second base 250, and the distal end of the adjusting rod 240 is fixedly connected in the connecting hole by a method including, but not limited to, threaded connection and laser welding, preferably laser welding.

In the present invention, the first annular hoop 215 and the second annular hoop 256 may be respectively formed by fixing two ends of a metal wire by welding, crimping or sleeving in a connecting sleeve after the first connecting buckles 510 or the connecting rods 230 are threaded through the metal wire, so as to form an integral annular hoop, wherein the metal wire includes but is not limited to biocompatible metal wires such as stainless steel wire, nitinol metal wire, and the like. Of course, the first annular hoop 215 and the second annular hoop 256 may also be made of a polymer material.

As described above, the first base 210, the plurality of support rods 220, the plurality of connecting rods 230 correspondingly and rotatably connected to the plurality of support rods 220, the second base 250 and the adjustment rod 240 form a link structure, when the adjustment rod 240 is driven to move axially, the plurality of support rods 220 are driven to present an opening and closing movement relative to the adjustment rod 240, and when the position of the adjustment rod 240 is fixed (controlled by the driving control member), the opening and closing angles of the plurality of support rods 220 are also fixed to form a lock, so that a rigid support function corresponding to the anchor 300 disposed at the distal end of each support rod 220 can be achieved, and each anchor 300 can be accurately, completely and reliably anchored in a corresponding position of the annulus tissue.

Further, in the present invention, the supporting member 200 further includes a plurality of telescopic structures corresponding to the plurality of supporting rods 220, and one of the telescopic structures is used for correspondingly adjusting an axial distance between the proximal end of the anchor 300 and the first base 210 (i.e., a distance along the axial direction of the adjusting rod 240).

Specifically, referring to fig. 3, 13-15, in the present embodiment, the supporting rod 220 is a hollow rod body, and the cross-sectional shape of the hollow rod body includes, but is not limited to, a circle, an oblate circle, a rectangle, a polygon, and the like, and preferably adopts a circle. An anchor control rod 310 is movably arranged in the inner cavity of the supporting rod 220 in a penetrating mode, and an anchor joint 330 is fixedly connected to the distal end of the anchor control rod 310, and the anchor joint 330 is detachably connected with the anchor 300; the anchor control rod 310 and the anchor joint 330 constitute the telescopic structure, the anchor 300 follows the movement of the anchor control rod 310 along the axial direction thereof to change the axial distance between the proximal end of the anchor 300 and the first base 210, and the anchor 300 follows the rotation of the anchor control rod 310 to rotate to anchor the annulus tissue.

Wherein the distal end diameter of the anchor joint 310 is greater than the inner diameter of the support rod 220 such that the anchor 300 is located outside the distal end of the support rod 220.

The anchor control rod 310 may extend out of the patient through the lumen of the delivery catheter 100 and is connected to a corresponding control mechanism (not shown) on the actuating handle, so that the control mechanism can control the anchor control rod 310 to move axially to extend or retract the anchor 300 from the distal end of the supporting rod 220. When the support member 200 is in the expanded state, the control mechanism can control each of the anchor bolts 300 to extend out different distances relative to the distal end of the support rod 220, so that the concave-convex condition of different regions of the annular tissue can be adapted when the plurality of anchor bolts 300 are anchored in the annular tissue, and after the plurality of anchor bolts 300 are anchored in different regions of the annular tissue, the flexible ring-reducing members 400 arranged on the proximal ends of the plurality of anchor bolts 300 are not in a plane, but are adapted to the real 3D physiological structure of the annular tissue similar to a saddle shape, so as to achieve a better ring-reducing effect.

Referring again to fig. 1 to 3, in the annuloplasty device 1000 according to the present invention, the support member 200 is connected to the distal end of the delivery catheter 100, so that the support member 200 is pushed through the delivery catheter 100 when the support member 200 is in the collapsed state, and as mentioned above, the adjustment rod 240 of the support member 200 and the anchor control rod 310 extend out of the body through the lumen of the delivery catheter 100. Specifically, in this embodiment, the delivery catheter 100 is a multi-lumen catheter, and the delivery catheter 100 includes a main sub-lumen extending along an axial direction and a plurality of sub-lumens spaced apart from each other around a circumference of the main sub-lumen. Wherein the primary subchambers are used for the adjustment rod 240 to pass through, and each secondary subchamber is used for the anchor control rod to pass through.

As shown in fig. 3, the flexible loop reducing member 400 is simultaneously threaded through the proximal ends of the plurality of anchors 300 at the distal end of the support member 200, and after the plurality of anchors 300 are anchored into the annular tissue, the annulus is contracted to an appropriate extent by tightening the flexible loop reducing member 400.

The flexible ring-contracting member 400 can be in a closed-loop structure or an open-loop structure, preferably, the flexible ring-contracting member 400 is in the closed-loop structure, the flexible ring-contracting member 400 in the closed-loop structure is tightened to form a closed ring for contracting the ring, the force is more uniform when the ring is contracted, and the shape fixing effect on the orifice is better.

Wherein, the flexible collar member 400 includes but is not limited to a flexible wire, a flexible strip or a flexible band, and the cross-sectional shape of the flexible strip or the flexible band includes but is not limited to an oblate, a rectangle, etc.

Referring to fig. 16 and 17, the annuloplasty device 2000 of the present embodiment is used as follows: first, in an initial state where the supporting rods 220 of the supporting member 200 are relatively gathered and the flexible loop-contracting member 400 is gathered, the delivery catheter 100 pushes the supporting member 100 to pass through a passage (shown by way of example, a sheath passing through a femoral vein, an inferior vena cava, a right atrium, an interatrial septum, and a left atrium) established by the sheath 1000 until the supporting member 200 passes through the sheath 1000, so that the plurality of anchors 300 disposed at the distal end of the supporting member 200 approach the mitral valve annulus; then, the adjusting rod 240 is driven to move axially by the driving control member of the control handle to drive the supporting rods 220 to expand and assume an umbrella shape, and then the control mechanism of the control handle rotates the anchor control rod 310 penetrating through each supporting rod 220 one by one or simultaneously to rotate so as to drive each anchor 300 to rotate, so that each anchor 300 is anchored in the annulus tissue; finally, the flexible loop reducing member 400 arranged on the plurality of anchor bolts 300 is tightened to complete the loop reduction.

During the process of anchoring each anchor 300, each anchor control rod 310 can be driven to move axially by the control mechanism of the operating handle, so as to change the axial distance between the proximal end of each anchor 300 and the first base 210, so that after the plurality of anchors 300 are anchored, the proximal ends of the anchors are located on different horizontal planes, and further, the flexible loop-retracting members 400 arranged on the proximal ends of the plurality of anchors 300 are not located on one plane, which is beneficial to adapting to the real 3D physiological structure of the annular tissue similar to a saddle shape, and achieving a better loop-retracting effect.

The annuloplasty device 1000 of the present embodiment has the following advantages in the process of ring shrinkage: 1. the support 200 can provide a secure rigid support for the plurality of anchors 300 such that the plurality of anchors 300 can be stably anchored to the annulus tissue; 2. the anchors 300 are simultaneously delivered to the mitral valve annulus, so that the operation is more convenient; 3. the degree of the support rods 220 which are spread can be adjusted by controlling the axial movement distance of the adjusting rod 240, so that the radii of circular rings formed by the anchors 300 arranged at the far ends of the support rods 220 are different, and the physiological anatomy conditions of valve rings of different individuals can be adapted; 4. the flexible ring-contracting part 300 adopting a closed-loop structure forms a closed ring for contracting the ring after being tightened, and has more uniform stress and better shape fixing effect on a valve orifice compared with an open ring when contracting the valve ring; 5. the arrangement of the telescopic structure can enable the flexible ring-contracting members 400 arranged on the proximal ends of the anchors 300 to adapt to the real 3D physiological structure of the valve ring tissue similar to the saddle shape after the anchors are anchored, so as to achieve a better ring-contracting effect.

Referring to fig. 18 to 21, the structure of the annuloplasty device according to the second embodiment of the present invention is similar to the annuloplasty device 1000 of the first embodiment, except that: in the second embodiment, a plurality of receiving cavities 212 penetrating through the proximal end surface and the distal end surface of the first base 210b are formed on the first base 210b at intervals around the circumferential direction, the proximal end of each supporting rod 220 movably penetrates through a corresponding receiving cavity 212, the receiving cavity 212 includes a proximal end limiting section, and the axis of the proximal end limiting section gradually gets away from the axis of the first base 210b from the proximal end to the distal end.

Specifically, in the present embodiment, the distal end portion of the receiving cavity 212 penetrates both 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 large movement space at the distal end. When the adjusting rods 240 (not shown) move axially to drive each connecting rod 230 (not shown) to open the corresponding supporting rod 220, the supporting rods 220 have a tendency to move radially outward along the first base 210b, and the proximal ends of the supporting rods 220 abut against the inner wall of the proximal limiting section, at this time, if the connecting rods 230 further open the supporting rods 220, the proximal ends of the supporting rods 220 do not move radially under the stop of the proximal limiting section, but the portions of the supporting rods 220 far away from the proximal ends continue to move outward under the pushing of the connecting rods 230, so that the supporting rods 220 open relative to the adjusting rods 240 with the proximal ends thereof serving as the base points of rotation, the distal end portions of the receiving cavities 212 provide enough space for the opening and closing movement of the supporting rods 220, and finally the supporting rods 220 open to a certain angle relative to the adjusting rods 240, the plurality of struts 220 are expanded into an umbrella shape to provide support for the plurality of anchors 300 at the distal end of the plurality of struts 220.

The first base 210b is axially provided with a through hole 214 for the adjustment rod 240 to pass through.

It can be understood that each of the support rods 220 is constrained by the connecting rod and the second connecting buckle, and the support rod 220 is not separated from the receiving cavity 212.

In this embodiment, the proximal end of each of the support rods 220 is movably disposed through 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 annuloplasty device is simpler and the installation is facilitated.

Referring to fig. 22 to 24, a third embodiment of an annuloplasty device 1000c according to the present invention is similar to the annuloplasty device of the second embodiment, except that: in the third embodiment, the anchor control rod and the anchor joint are not provided, the anchor 300 is directly detachably connected to the distal end of the support rod 220c, the support rod 220c is provided with an external thread extending along the axial direction thereof, the second connection button 520c is provided with an internal thread, each second connection button 520c is correspondingly screwed and sleeved on one support rod 220c, and the second connection button 520c and the external thread on the support rod 220c form the telescopic structure. When the support rod 220c is rotated after the expansion of the support rod 220c relative to the adjustment rod is stopped, since the second connecting buckle 520c does not move axially, the anchor bolt 300 rotates synchronously with the rotation of the support rod 220c and moves axially along the support rod 220c, so as to change the axial distance between the proximal end of the anchor bolt 300 and the first base 210c (i.e., the distance along the axial direction of the first base 210 c).

Specifically, in this embodiment, the supporting rod 220c is a solid rod, the distal end of the supporting rod is provided with a slot 350, and the proximal end of the anchor 300 is inserted into the slot 350, so that the rotation of the supporting rod 220c can drive the anchor 300 to rotate.

The second connection buckle 520c is threadedly sleeved on the support rod 220c, and the second connection buckle 520c is further rotatably connected with a corresponding connection rod 230, when the support rod 220c rotates, because the second connection buckle 520c is limited by the connection rod 230, the support rod 220c can move along its own axial direction relative to the second connection buckle 520c, and further drives the anchor 300 at the far end to move along the axial direction of the support rod 220 c.

It should be noted that the proximal end of the supporting rod 220c is movably disposed in the receiving cavity 212 of the first base 210c, and the proximal end of the supporting rod 220c can be connected to a corresponding control mechanism (such as a snake bone tube) through the sub-cavity of the delivery catheter 100, by which the supporting rod 220c can be rotated, and the proximal end of the supporting rod 220c can not be separated from the receiving cavity 212 when the control mechanism is pulled.

It can be understood that, in this embodiment, when each of the supporting rods 220c is expanded to be umbrella-shaped, the control mechanism controls different supporting rods 220c to rotate for different numbers of turns relative to the corresponding screwed second connecting link 520c, so as to drive the plurality of anchors 300 to axially extend and retract to different degrees, so that when the plurality of anchors 300 are anchored into the annular tissue, the concave-convex conditions of different regions of the annular tissue can be adapted, and after the plurality of anchors 300 are anchored into different regions of the annular tissue, the flexible ring-retracting members 400 penetrating through the proximal ends of the plurality of anchors 300 are not located on a plane, but can be adapted to the actual 3D physiological structure of the annular tissue similar to a saddle shape, so as to achieve a better ring-retracting effect.

In other embodiments, referring to fig. 22, 23 and 8 in combination, when the first base 210c is provided with a plurality of first connecting slots 211 at intervals around the circumferential direction, and the proximal end of each supporting rod 220c is rotatably connected to the first base 210c through a first connecting buckle, in order to prevent the first connecting buckle from obstructing the rotation of the supporting rod 220c, the first connecting buckle is correspondingly provided with internal threads, and the proximal end of each supporting rod 220c is correspondingly screwed with the first connecting buckle 510c, so that when the supporting rod 220c is driven to rotate by the control mechanism, the supporting rod 220c simultaneously moves along its own axial direction relative to the first connecting buckle and the second connecting buckle 520c, and further drives the anchor 300 at the distal end of the supporting rod 220c to move along the axial direction of the supporting rod 220c, and the axial distance between the proximal end of each anchor 300 and the first base 210c can also be changed, so that after the plurality of anchoring bolts 300 are anchored into the annular tissue, the flexible ring-reducing member 400 disposed on the proximal end of the plurality of anchoring bolts 300 is not in a plane, but can adapt to the real 3D physiological structure of the annular tissue similar to a saddle shape, so as to achieve a better ring-reducing effect.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. A support for providing support for a plurality of anchors anchored into body tissue, comprising:

a first base;

the supporting rods are arranged around the first base at intervals in the circumferential direction, the near end of each supporting rod is relatively gathered at the first base, and one anchor is correspondingly arranged at the far end of one supporting rod;

the connecting rods are arranged corresponding to the supporting rods, and one end of one connecting rod is correspondingly and rotatably connected with one supporting rod; and

the adjusting rod movably penetrates through the first base and is rotatably connected with the other end, opposite to each connecting rod, of each connecting rod;

the adjusting rods move axially to drive each connecting rod to prop open the corresponding supporting rod, and the supporting rods are opened into an umbrella shape relative to the adjusting rods.

2. The support of claim 1, further comprising a plurality of telescoping structures disposed in correspondence with the plurality of support rods, a telescoping structure for adjusting an axial distance between a proximal end of the anchor and the first base in correspondence therewith.

3. The support member as claimed in claim 2, wherein the distal end of the adjustment rod is fixedly connected to a second base, and the opposite end of each of the connecting rods is rotatably connected to the second base.

4. The support of claim 3 wherein the axial distance between the second base and the first base is less than the axial distance between the end of the connecting rod connected to the corresponding support rod and the first base when the support rods are collapsed relative to the adjustment rod.

5. The support of claim 3 wherein 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 respective support rod and the first base when the support rods are collapsed relative to the adjustment rod.

6. The support of claim 3, wherein the proximal end of the support rod is pivotally connected to the first base.

7. The supporting member as claimed in claim 6, wherein the first base has a plurality of first connecting grooves formed on an outer peripheral surface thereof at intervals in a circumferential direction, a first connecting buckle is correspondingly received in one of the first connecting grooves, the first connecting buckle is rotatably connected to the first base, and a proximal end of one of the supporting rods is correspondingly connected to one of the first connecting buckles.

8. The support member as claimed in claim 7, wherein a circle of first annular grooves are circumferentially formed on the outer circumferential surface of the first base and are communicated with the plurality of first connecting grooves, a first annular hoop is embedded in the first annular grooves, and the plurality of first connecting buckles are movably sleeved on the first annular hoop.

9. The support member according to claim 3, wherein the first base is provided with a plurality of receiving cavities at intervals along the circumferential direction, the receiving cavities penetrating through the proximal end surface and the distal end surface of the first base, and the proximal end of the support rod movably penetrates through a corresponding receiving cavity; the accommodating cavity comprises a near-end limiting section, and the axis of the near-end limiting section gradually keeps away from the axis of the first base from the near end to the far end.

10. The supporting member as claimed in claim 3, wherein a plurality of second connecting slots are formed on the outer circumferential surface of the second base at intervals along the circumferential direction, one end of one of the connecting rods is correspondingly and rotatably connected with a second connecting buckle, one of the second connecting buckles is correspondingly sleeved on one of the supporting rods, and the other end of each connecting rod opposite to the connecting rod is rotatably connected with the second base.

11. The support according to claim 10, wherein a second annular groove is circumferentially formed on an outer circumferential surface of the second base and is communicated with the plurality of second connecting grooves, a second annular hoop is embedded in the second annular groove, and the opposite end of each connecting rod is movably sleeved on the second annular hoop.

12. The brace of claim 10, wherein the second connector link is positioned between the proximal end and the distal end of the brace, the second connector link being fixedly disposed on the brace.

13. The support of any one of claims 2 to 12, wherein the support rod is a hollow rod, an anchor control rod is movably disposed in the inner cavity of the support rod, and an anchor joint is fixedly connected to a distal end of the anchor control rod, and the anchor joint is detachably connected to the anchor; the anchor control rod and the anchor joint constitute the telescopic structure, the anchor follows the movement of the anchor control rod along the axial direction thereof 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.

14. The support member as claimed in claim 10, wherein the support rod is provided with an external thread extending along an axial direction thereof, the first base is provided with a plurality of first connecting grooves at intervals along a circumferential direction on an outer circumferential surface thereof, a first connecting buckle is correspondingly received in one of the first connecting grooves, the first connecting buckle is rotatably connected to the first base, an internal thread is provided in the first connecting buckle, and a proximal end of one of the support rods is correspondingly screwed with one of the first connecting buckles.

15. The brace of claim 10, wherein the brace has external threads extending axially along the brace, the first base has a plurality of receiving cavities formed therein at intervals circumferentially and extending through a proximal end surface and a distal end surface of the first base, and a proximal end of the brace is movably disposed through a corresponding receiving cavity; the accommodating cavity comprises a near-end limiting section, and the axis of the near-end limiting section gradually keeps away from the axis of the first base from the near end to the far end.

16. The support pole of claim 14 or 15 wherein the second connector has internal threads, a corresponding second connector is threadedly received on a corresponding support pole, the second connector and the external threads of the support pole form the telescopic structure, and the anchor rotates synchronously with the rotation of the support pole and moves axially along the support pole to change the axial distance between the proximal end of the anchor and the first base.

17. The support rod of claim 16 wherein the distal end of the support rod is provided with a slot extending axially therealong and the proximal end of the anchor is received in the slot such that rotation of the support rod causes the anchor to rotate.

18. An annuloplasty device comprising the support of any of claims 1 to 17, a plurality of anchors disposed at a distal end of each of the support rods, and a flexible loop member disposed through a proximal end of the plurality of anchors.

19. The annuloplasty device of claim 18, wherein said flexible ring-retracting member is in a closed-loop configuration or an open-loop configuration.

20. The annuloplasty device according to claim 18, further comprising a delivery catheter, said first base fixedly attached to a distal end of said delivery catheter, said adjustment rod movably disposed within said delivery catheter.