CN117045291A - Annuloplasty device - Google Patents

Abstract

The application relates to the technical field of medical appliances, and particularly provides an annuloplasty device which comprises a main body arm, a first clamping arm and a second clamping arm; the first clamping arm is rotatably connected with the main body arm, and is provided with a first clamping part; the second clamping arm is rotatably connected with the main body arm, and is provided with a second clamping part; when the first clamping arm and the second clamping arm are in a clamping state, the first clamping part and the second clamping part are opposite and can clamp an annulus. The annuloplasty ring shrinking device disclosed by the application has the advantages of simple structure, accurate positioning, convenience in operation, safety in use and the like.

Description

Annuloplasty device

Technical Field

The application belongs to the technical field of medical appliances, and particularly relates to an annuloplasty device.

Background

This section provides merely background information related to the present disclosure and is not necessarily prior art.

Ischemic heart disease or dilated cardiomyopathy can cause the left ventricle or left atrium to become larger, so that the mitral valve annulus is dilated, and when the left ventricle contracts, the anterior leaflet and the posterior leaflet of the mitral valve can not be jointed, thereby causing the problems of mitral regurgitation, leakage and the like. Annuloplasty is an important means of delivering repair to the diseased annulus for therapeutic purposes. Annuloplasty mainly performs annular contraction on the expanded mitral valve annulus through minimally invasive medical instruments, and when the ventricle contracts, the front valve leaflet and the rear valve leaflet can be effectively jointed, so that the problems of mitral regurgitation, leakage and the like are solved.

Currently, treatments are often performed by implanting an annuloplasty ring, which requires open heart surgery to place the annuloplasty ring in a set position in the left atrium and secure it. However, open heart surgery is complex, and is traumatic, the recovery time of the patient is long, and the weak patient is difficult to withstand the injury caused by the surgery. Because the minimally invasive surgery of the annuloplasty starts to be carried out later, the proposed minimally invasive surgery instrument for implementing the annuloplasty has the defects of complex structure, inaccurate positioning, high control difficulty and the like.

Disclosure of Invention

The application aims to solve the problems of inaccurate positioning, high control difficulty, complex structure and the like of the existing annuloplasty device. The aim is achieved by the following technical scheme:

the application provides an annuloplasty device, which comprises a main body arm, a first clamping arm and a second clamping arm; the first clamping arm is rotatably connected with the main body arm and is provided with a first clamping part; the second clamping arm is rotatably connected with the main body arm and is provided with a second clamping part; when the first clamping arm and the second clamping arm are in a clamping state, the first clamping part and the second clamping part are opposite and can clamp the valve annulus.

The application can clamp the appointed position of the annulus by the first clamping arm and the second clamping arm in the process of the annuloplasty by enabling the annuloplasty device to comprise the first clamping arm and the second clamping arm, and can accurately and rapidly clamp the appointed position of the annulus. Because the annuloplasty device captures the appointed position of the annulus in a clamping mode, the capturing mode is convenient for not only external operation, but also the adjustment operation of the capturing position. In addition, as the valve ring is in the clamped state in the operation process, the valve ring position aimed at in the operation process can be effectively prevented from being shifted, the aimed operation is conveniently implemented on the clamping position of the valve ring, the operation difficulty of the operation can be effectively reduced, and the operation efficiency and success rate are improved.

In addition, the annuloplasty device according to the present application may further have the following additional technical features:

as some preferred embodiments of the present application, the annuloplasty device further optionally further comprises a needle for pulling the suture; the first clamping arm is provided with a first puncture channel, the second clamping arm is provided with a second puncture channel, and when the first clamping arm and the second clamping arm are in a clamping state, the puncture end of the puncture needle can pull the suture and puncture out of the first puncture channel through the second puncture channel.

According to the application, the first puncture channel is arranged on the first clamping arm, the second puncture channel is arranged on the second clamping arm, and when the first clamping arm and the second clamping arm are in a clamping state, the puncture end of the puncture needle can pass through the first puncture channel through the second puncture channel, so that the puncture operation on clamped tissues can be conveniently performed by puncturing under the action of the first puncture channel and the second puncture channel. Moreover, under the action of the first clamping arm and the second clamping arm, the puncture wound of the puncture needle to the clamped tissue is smaller, the risk of tearing the valve annulus caused by improper operation can be effectively reduced, and the safety and reliability of the valve annulus contraction operation can be improved.

As some preferred embodiments of the present application, the first puncture channel is further selectively made to be a puncture hole penetrating the first clamping section in the puncture direction of the puncture needle; the first end of the second clamping arm is connected with the main body arm, the second clamping part is positioned at the second end of the second clamping arm, the second puncture channel extends from the first end of the second clamping arm to the second clamping part, and the second puncture channel penetrates through the two ends of the second clamping arm.

As some preferred embodiments of the present application, the puncture hole is further selectively tapered in the puncture direction of the puncture needle. According to the application, the puncture hole is gradually reduced along the puncture direction of the puncture needle, so that the puncture needle can be positioned and guided under the action of the puncture hole, the puncture position of the puncture needle is more accurate, and the puncture end of the puncture needle is conveniently penetrated out of the first puncture channel, so that the puncture difficulty of the puncture needle is reduced.

As some preferred embodiments of the present application, a first abdication area adapted to the first clamping arm is further selectively provided on a side wall of the main body arm, a first connection position is provided at a proximal end of the first abdication area, a first end of the first clamping arm is hinged with the first connection position, the first clamping portion is located at a second end of the first clamping arm, and the first clamping arm has a state located in the first abdication area and a state extending out of the first abdication area after rotation to clamp an annulus; the side wall of the main body arm is provided with a second abdication area matched with the second clamping arm, the proximal end of the second abdication area is provided with a second connecting position, the first end of the second clamping arm is hinged with the second connecting position, the second clamping part is positioned at the second end of the second clamping arm, and the second clamping arm is in a state of being positioned in the second abdication area and a state of extending out of the second abdication area to clamp an annulus after rotating; the first yielding region is arranged between the distal end of the main body arm and the second yielding region.

The side wall of the main body arm is provided with the first abdication area and the second abdication area, the first clamping arm is in a state of being positioned in the first abdication area and a state of extending out of the first abdication area after rotating to clamp the valve ring, and the second clamping arm is in a state of being positioned in the second abdication area and a state of extending out of the second abdication area after rotating to clamp the valve ring; so that the annuloplasty device has a folding function, and is convenient for extending into the heart through minimally invasive surgery.

As some preferred embodiments of the present application, the second end of the first clamping arm is further selectively provided to be bent toward the second clamping arm; and/or bending the second end of the second clamping arm towards the first clamping arm.

According to the application, the second end of the first clamping arm is bent towards the second clamping arm and/or the second end of the second clamping arm is bent towards the first clamping arm, so that a sufficient abdication space is formed between the first clamping arm and the second clamping arm when the first clamping arm and the second clamping arm are in a clamping state, valve tissues are accommodated, and valve squeezing and suture operation influence in the clamping process are avoided.

As some preferred embodiments of the present application, the first clamping portion is further optionally provided with a first clamping surface, and the second clamping portion is provided with a second clamping surface; the first puncture channel passes through the first clamping surface; the second clamping surface is positioned on the end surface of the second end of the second clamping arm, and the second puncture channel passes through the second clamping surface; when the first clamping arm and the second clamping arm are in a clamping state, the first puncture channel and the second puncture channel are opposite.

According to the application, the first puncture channel passes through the first clamping surface, the second puncture channel passes through the second clamping surface, so that the puncture needle can pass through tissues between the first clamping surface and the second clamping surface, and the positions of the clamped annuluses can be better restrained under the action of the first clamping surface and the second clamping surface, so that the puncture position is more accurate, and the damage to the annuluses caused by the puncture process can be effectively reduced.

As some preferred embodiments of the present application, the annuloplasty device further optionally further comprises a suture, the penetrating needle having a coupled state and a decoupled state with the suture, the penetrating end of the penetrating needle being capable of pulling the suture through the second penetrating passageway through the first penetrating passageway.

According to the application, the puncture end of the puncture needle is used for pulling the suture, so that the puncture end of the puncture needle can pass through the first puncture channel, and the suture can also pass through the first puncture channel, thereby effectively reducing the damage of the puncture to the tissue of the annulus.

As some preferred embodiments of the present application, the first end of the suture is further optionally provided with a first stop structure for connecting the first clamping arm, the puncture needle is connectable to the suture via the first stop structure, the first stop structure is capable of being pulled through the puncture needle and passed through the first puncture channel for connection to the first clamping portion, and the second end of the suture is provided with a second stop structure for connecting the annulus.

According to the application, the first end of the suture is provided with the first limiting structure for connecting the first clamping arm, so that the suture can be connected with the puncture needle through the first limiting structure, and the puncture needle can pull the suture in the puncture process; the first end of the suture is provided with the first limit structure, and the suture can be connected with the first clamping arm through the first limit structure, so that the suture can be conveniently pulled by the first clamping arm. In addition, the second end of the suture can be firmly connected with the valve annulus by arranging the second limiting structure, so that the suture is prevented from being pulled off in the traction process of the first clamping arm.

As some preferred embodiments of the present application, the puncture needle is further selectively made to be a hollow needle, and the first limit structure can be adaptively connected with the hollow needle; when the puncture needle is in a connection state with the suture, at least part of the first limit structure is positioned in the puncture end of the puncture needle; the annuloplasty device further comprises a pushing member extending into the proximal end of the hollow needle, and the pushing member is capable of pushing the first limiting structure to enable the suture to be separated from the puncture needle and connected with the first clamping portion.

According to the application, the pushing piece is arranged, so that the connection relation between the puncture needle and the first limiting structure can be released, the first limiting structure is connected with the first clamping part, and the first clamping arm can pull the suture, so that the annuloplasty can be smoothly implemented. Moreover, by adopting the arrangement mode, the puncture needle can be firmly connected with the suture in the puncture process, and the puncture needle is convenient to separate from the suture. Besides, the device has the advantages of simple structure, convenient operation and the like.

As some preferred embodiments of the present application, the annuloplasty device further selectively includes a first control member for controlling rotation of the first gripping arm; the inside of the main body arm is provided with a first channel, the first channel is communicated with the proximal end of the main body arm and the joint of the first clamping arm and the main body arm, and the first control piece passes through the first channel and is connected with the first clamping arm; the annuloplasty device further includes a second control member for controlling rotation of the second gripping arm; the inside second passageway that is equipped with of main part arm, the junction of second centre gripping arm and main part arm of second passageway intercommunication main part arm, second operating piece pass the second passageway and be connected with the second centre gripping arm.

The annular ring contraction device comprises the first control piece, and the first control piece is connected with the first clamping arm, so that the first clamping arm can be controlled by controlling the first control piece, and the annular ring contraction device has the advantages of convenience in control, simple structure and the like. Similarly, the annular ring shrinking device comprises a second control piece, the second control piece is connected with the second clamping arm, and the second clamping arm can be controlled by controlling the second control piece, so that the same technical effect can be achieved.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the application. Also, like reference numerals are used to designate like parts throughout the figures. In the drawings:

FIG. 1 schematically illustrates a schematic structural view of an annuloplasty device according to the present application, in an unused state;

FIG. 2 schematically illustrates a schematic structural view of an annuloplasty device according to the present application, in a gripping position;

FIG. 3 is an enlarged view of a portion of the structure at A in FIG. 1;

FIG. 4 is an enlarged view of a portion of the structure at B in FIG. 2;

FIG. 5 schematically illustrates a partial schematic view of an annuloplasty device according to the present invention, shown in an unused state;

FIG. 6 schematically illustrates a partial schematic view of an annuloplasty device according to the present invention, in a gripping position;

FIG. 7 schematically illustrates a partial structural view of the assembly of the body arm, the first clamping arm and the first operating member of the annuloplasty device according to the present invention, the first clamping arm being located in a first yield zone;

FIG. 8 schematically illustrates a partial structural view of the assembly of the body arm, the first clamping arm and the first control member of the annuloplasty device according to the present invention, the first clamping arm being in a clamped condition;

FIG. 9 schematically illustrates a schematic structural view of an assembly of a first gripping arm and a first control of an annuloplasty device according to the present invention;

FIG. 10 schematically illustrates a schematic view of a body arm of an annuloplasty device in accordance with the present invention;

FIG. 11 schematically illustrates a schematic view of another view of the body arm of an annuloplasty device in accordance with the present invention;

FIG. 12 schematically illustrates a schematic structural view of a first clamping arm of an annuloplasty device in accordance with the present invention;

FIG. 13 is a cross-sectional view of the first clamp arm shown in FIG. 12;

FIG. 14 schematically illustrates a schematic structural view of a second clamping arm of an annuloplasty device in accordance with the present invention;

FIG. 15 is a cross-sectional view of the second clamp arm shown in FIG. 14;

FIG. 16 schematically illustrates a structural view of an assembly of a suture and a first retaining structure in accordance with the present invention;

FIG. 17 schematically illustrates a structural view of an assembly of a suture and a second retaining structure in accordance with the present invention;

FIG. 18 schematically illustrates a schematic view of an annuloplasty device according to the present invention in a state of use, wherein the needle and suture are not threaded into the first puncture channel;

FIG. 19 schematically illustrates a schematic view of the annuloplasty device of the present invention in a state of use, wherein the needle and suture are in a state of being passed out of the first puncture passageway, and the first stop feature is disengaged from the needle;

FIG. 20 schematically illustrates a schematic view of a state of the annuloplasty device according to the present invention in use, wherein the needle is in a retracted state and the first stop feature is in a connected state with the first clamping portion;

FIG. 21 schematically illustrates a schematic view of an annuloplasty device according to the present invention in a first state during use, with the first and second clamping arms in a pre-clamping state;

FIG. 22 schematically illustrates a schematic view of the annuloplasty device according to the present invention in a second state during use, wherein the first and second clamping arms are in a state of clamping the annulus;

FIG. 23 schematically illustrates a schematic view of an annuloplasty device according to the present invention in a third state of use, in which the needle is in a position to pass through the first puncture channel;

FIG. 24 schematically illustrates a fourth state of the annuloplasty device according to the present invention in use, with the first limiting structure coupled to the first gripping arm;

FIG. 25 schematically illustrates a fifth state of the annuloplasty device according to the present invention in use, with the first clamping arm pulling the suture;

FIG. 26 schematically illustrates a schematic view of the suture in a connected state with the annulus during an annuloplasty procedure;

FIG. 27 schematically illustrates a schematic view of the structure of a suture without being locked by a locking unit in some embodiments of the invention;

FIG. 28 schematically illustrates a schematic view of a suture locked by a locking unit in some embodiments of the present invention;

FIG. 29 schematically illustrates a schematic view of an annulus repair device provided by the present invention after repair of the annulus;

fig. 30 schematically illustrates another embodiment of the present invention after repair of an annulus by means of an annuloplasty device.

Reference numerals illustrate:

10. an annuloplasty device;

1. a main body arm; 11. a first yield area; 111. a first connection location; 12. a second yield area; 121. a second connection location; 13. a first channel; 14. a second channel; 15. a puncture needle channel;

2. a first clamping arm; 21. a first clamping part; 22. a first puncture channel; 23. a relief notch; 24. a first clamping surface;

3. a second clamping arm; 31. a second clamping portion; 32. a second puncture channel; 33. a second clamping surface;

4. a puncture needle; 41. a hanging notch;

51. a suture; 52. a first limit structure; 53. a second limit structure; 54. a locking unit;

6. a pushing member;

7. a first control;

8. a connecting pipe;

9. a control handle;

x, an annulus; y, heart.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

In the present application, a numerical value or more includes a present number, for example, eight or more includes eight.

It should be noted that the plurality of the present application includes two.

It should be noted that "distal end" and "proximal end" are used as terms of orientation, which are terms commonly used in the field of interventional medical devices, where "distal end" refers to an end that is away from an operator during a surgical procedure and "proximal end" refers to an end that is near the operator during a surgical procedure. Axial, refers to a direction parallel to the line connecting the distal center and the proximal center of the medical instrument; radial refers to a direction perpendicular to the axial direction.

The present application provides an annuloplasty device 10, as shown in fig. 1 to 17, the annuloplasty device 10 comprising a body arm 1, a first clamping arm 2 and a second clamping arm 3; the first clamping arm 2 is rotatably connected with the main body arm 1, and the first clamping arm 2 is provided with a first clamping part 21; the second clamping arm 3 is rotatably connected with the main body arm 1, and the second clamping arm 3 is provided with a second clamping part 31; when the first clamping arm 2 and the second clamping arm 3 are in a clamping state, the first clamping part 21 and the second clamping part 31 are opposite to each other and can clamp the valve annulus X.

It should be noted that the structure of the first clamping arm 2 in the present application is not particularly limited, and may be any structure form capable of being matched with the second clamping arm 3 to realize clamping of an annulus; in particular, the first clamping arm 2 may be selectively formed in a rod shape, a bar shape, or the like. As shown in fig. 3 to 9, 12 and 13, the first clamping arm 2 is arranged in a strip shape as a whole; and the first end of the first clamping arm 2 is hinged with the main body arm 1, and the second end of the first clamping arm 2 is provided with a first clamping part 21.

It should be noted that the structure of the second clamping arm 3 in the present application is not limited in particular, and may be any structure that can cooperate with the first clamping arm 2 to clamp an annulus; in particular, the second clamping arm 3 may be selectively formed in a rod shape or a bar shape as a whole. As shown in fig. 3 to 6, 14 and 15, the second clamping arm 3 is integrally provided in a strip shape, and a first end of the second clamping arm 3 is hinged with the main body arm 1, and a second end of the second clamping arm 3 is provided with a second clamping portion 31.

It should be noted that the rotation angles of the first clamping arm 2 and the second clamping arm 3 are not particularly limited, and may be any angle that satisfies the need to clamp the valve annulus X. In practice, the rotation angle of the first clamping arm 2 and the second clamping arm 3 is preferably each smaller than 90 °.

In practice, the body arm 1, the first clamp arm 2 and the second clamp arm 3 are made of a medical implant material, but are not particularly limited. In particular embodiments, the body arm 1, the first clamping arm 2, and the second clamping arm 3 may be selectively made of stainless steel, cobalt chrome, or the like.

The application can clamp the appointed position of the valve ring X accurately and quickly by enabling the valve ring shrinking instrument 10 to comprise the first clamping arm 2 and the second clamping arm 3, thereby clamping the appointed position of the valve ring X through the first clamping arm 2 and the second clamping arm 3 in the process of the valve ring shrinking operation. Since the annuloplasty device 10 captures the prescribed position of the annulus X by clamping, this capture facilitates not only extracorporeal manipulation, but also adjustment of the capture position. In addition, because the valve ring X is in a clamped state in the operation process, the position of the valve ring X aimed at in the operation process can be effectively prevented from being shifted, and the aimed operation (such as puncture and other operations on the clamping position of the valve ring) can be conveniently carried out on the clamping position of the valve ring X, so that the operation difficulty of the operation can be effectively reduced, and the operation efficiency and success rate can be improved. In addition, because the valve includes the annulus and the valve leaflet, and the annulus X is located the root of valve, and the valve leaflet has certain length, through setting up first clamp arm 2 and second clamp arm 3, because first clamp arm 2 and second clamp arm 3 all have certain length for first clamp arm 2 and second clamp arm 3 can accurate centre gripping to valve root, annulus department promptly, and part valve She Weiyu is between first clamp arm 2 and the second clamp arm 3 when the centre gripping, can avoid in the operation in-process, the position movement that causes because of the activity of valve leads to the centre gripping position inaccurate.

In order to facilitate extension of the annuloplasty device 10 from the apex of the heart Y to a specific location of the heart Y during surgery, the distal end of the body arm 1 is provided with a tapered structure capable of guiding as shown in fig. 1-8, 10 and 11, when embodied.

As some preferred embodiments of the present application, as shown in FIGS. 1 and 2, the annuloplasty device 10 further comprises a connecting tube 8, a first control member 7, a second control member and a control handle 9, wherein the proximal end of the connecting tube 8 is connected to the control handle 9, and the distal end of the connecting tube 8 is connected to the proximal end of the main body arm 1. The control handle 9 is connected with the first clamping arm 2 through the first control piece 7, and the control handle 9 is connected with the second clamping arm 3 through the second control piece; the control handle 9 can control the first clamping arm 2 to rotate through the first control piece 7, and the control handle 9 can control the second clamping arm 3 to rotate through the second control piece, so that the first clamping arm 2 and the second clamping arm 3 clamp the valve annulus X.

As some preferred embodiments of the present application, as shown in fig. 6 to 9, a first channel 13 is provided inside the main body arm 1, the first channel 13 communicates with the proximal end of the main body arm 1 and the connection point between the first clamping arm 2 and the main body arm 1, the distal end of the first control 7 is connected to the first clamping arm 2 through the first channel 13, and the proximal end of the first control 7 is connected to the control handle 9 through the connecting tube 8. In some embodiments, the distal end of the first control element 7 may be further selectively fixedly or hingedly connected to the first clamping arm 2; in practice, as shown in fig. 9, the distal end of the first control member 7 is preferably connected to the first clamping arm 2 in an articulated manner to relieve control stresses between the first control member 7 and the first clamping arm 2. Preferably, the annuloplasty device 10 comprises two first control members 7, wherein two first channels 13 are arranged in the main body arm 1, and each first control member 7 is connected with the first end of the first clamping arm 2 near the first end through one first channel 13. As an alternative embodiment, the annuloplasty device 10 may also be selectively configured to include a first control member 7, and to allow the first gripping arm 2 to be controlled by the first control member 7 to rotate. In particular, the first clamping arm 2 is rotated when the first control 7 is pulled by the operating handle 9 to move towards the proximal or distal end of the annuloplasty device 10.

In a specific implementation, the main body arm 1 is further provided with a puncture needle channel 15 which communicates the proximal end of the main body arm 1 and the connection part of the second clamping arm 3 and the main body arm 1, and the puncture needle 4 can enter the second puncture channel 32 through the puncture needle channel 15.

As some preferred embodiments of the present application, the main body arm 1 is internally provided with a second channel 14, the second channel 14 is communicated with the proximal end of the main body arm 1 and the connection part of the second clamping arm 3 and the main body arm 1, the distal end of the second control piece passes through the second channel 14 to be connected with the second clamping arm 3, and the proximal end of the second control piece passes through the connecting pipe 8 to be connected with the control handle 9. In some embodiments, the distal end of the second control may be further selectively fixedly connected or hinged to the second clamping arm 3, and in the embodiment, the distal end of the second control is preferably connected to the second clamping arm 3 in a hinged manner, so as to reduce internal stress between the second control and the second clamping arm 3. Preferably, the annuloplasty device 10 comprises two second control members, wherein two second channels 14 are arranged in the main body arm 1, and each second control member is connected to the vicinity of the first end of the second clamping arm 3 through one second channel 14. As an alternative embodiment, the annuloplasty device 10 may also optionally include a second control member, and the second gripping arm 3 may be controlled to rotate by the second control member. In particular, the second gripping arm 3 is rotated when the second control is pulled by the operating handle to move toward the proximal or distal end of the annuloplasty device 10.

In specific implementation, the first control piece 7 and the second control piece can be selectively made of control wires made of implantable metal materials, and specifically, the first control piece 7 and the second control piece can be selectively made of materials such as stainless steel, nickel-titanium alloy and the like.

The annular ring shrinking device 10 comprises the first operating piece 7, and the first operating piece 7 is connected with the first clamping arm 2, so that the first clamping arm 2 can be controlled by controlling the first operating piece 7, and the annular ring shrinking device has the advantages of convenience in operation, simple structure and the like. Similarly, by making the annuloplasty device 10 include the second control member and connecting the second control member with the second clamping arm 3, the second clamping arm 3 can be controlled by controlling the second control member, and the same technical effect can be achieved.

Besides, the first clamping arm 2 is connected with and controlled by the first control piece 7, the second clamping arm 3 is connected with and controlled by the second control piece, and the first clamping arm 2 and the second clamping arm 3 are independently controlled, so that the positions and states of the first clamping arm 2 and the second clamping arm 3 can be adjusted according to the requirements of the operation process, and the annuloplasty ring contraction device 10 has better flexibility and adaptability, and better meets the adjustment requirements during the operation.

As some preferred embodiments of the present application, the annuloplasty device 10 further optionally includes a needle 4, the needle 4 for pulling the suture 51; the first clamping arm 2 is provided with a first puncture channel 22, the second clamping arm 3 is provided with a second puncture channel 32, and when the first clamping arm 2 and the second clamping arm 3 are in a clamping state, the puncture end of the puncture needle 4 can pull the suture 51 and penetrate out of the first puncture channel 22 through the second puncture channel 32.

According to the application, the first puncture channel 22 is arranged on the first clamping arm 2, the second puncture channel 32 is arranged on the second clamping arm 3, when the first clamping arm 2 and the second clamping arm 3 are in a clamping state, the puncture end of the puncture needle 4 can penetrate through the first puncture channel 22 through the second puncture channel 32, and under the guiding action of the first puncture channel 22 and the second puncture channel 32, the puncture needle 4 can conveniently perform puncture operation on clamped tissues. Moreover, under the clamping action of the first clamping arm 2 and the second clamping arm 3, the puncture wound of the puncture needle 4 on the clamped tissue is smaller, so that the risk of tearing the valve ring X caused by improper operation can be effectively reduced, and the safety and reliability of the valve ring contraction operation can be improved.

It should be noted that the arrangement position and the structure of the first puncture channel 22 on the first clamping arm 2 and the arrangement position and the structure of the second puncture channel 32 on the second clamping arm 3 in the present application are not particularly limited, and may be any arrangement form that satisfies that the puncture end of the puncture needle 4 can pass through the first puncture channel 22 via the second puncture channel 32 when the first clamping arm 2 and the second clamping arm 3 are in the clamped state. In a specific implementation, when the first clamping arm 2 and the second clamping arm 3 are in a clamping state, the first puncture channel 22 and the second puncture channel 32 are preferably coaxially arranged, so as to ensure that the puncture end of the puncture needle 4 can pass through the first puncture channel 22 smoothly through the second puncture channel 32.

As some preferred embodiments of the present application, as shown in fig. 9, 12 and 13, the first puncture path 22 is further selectively formed as a puncture hole penetrating the first clamping section 21 in the puncture direction of the puncture needle 4. Preferably, the puncture hole is further tapered in the puncture direction of the puncture needle 4. According to the application, the puncture hole is gradually reduced along the puncture direction of the puncture needle 4, so that the puncture needle 4 can be positioned and guided under the action of the puncture hole, and the puncture position of the puncture needle 4 is more accurate. As a preferred embodiment of the present application, the aperture size of the penetrating end of the puncture hole can be further selectively made larger than the aperture size at the outlet of the second puncture channel 32, and even if a certain dislocation occurs between the first puncture channel 22 and the second puncture channel 32, the puncture needle 4 can still penetrate through the second puncture channel 32 and out through the first puncture channel 22, thereby effectively improving the reliability and adaptability of the use of the annuloplasty ring retraction device 10.

As some preferred embodiments of the present application, as shown in fig. 12 and 13, the first puncture channel 22 is a straight channel penetrating the first clamping section 21; as shown in fig. 15, the second puncture path 32 is a bent path penetrating the second holding arm 3 and bending toward the first holding arm 2, and the bent portion of the second puncture path 32 is formed in a gourd shape as a whole so that the puncture needle 4 can smoothly pass through the bent portion. In particular, the bending portion of the second puncture channel 32 may be optionally configured to allow the puncture needle 4 to pass through smoothly.

As some preferred embodiments of the present application, as shown in fig. 15, the second puncture channel 32 is further selectively extended from the first end of the second clamping arm 3 to the second clamping portion 31, and the second puncture channel 32 penetrates both ends of the second clamping arm 3. In a specific implementation, when the first clamping arm 2 and the second clamping arm 3 are in a clamping state, the first puncture channel 22 corresponds to the second puncture channel 32, and the puncture end of the puncture needle 4 can sequentially pass through the second puncture channel 32 and the first puncture channel 22.

As some preferred embodiments of the present application, the second end of the first clamping arm 2 is further selectively provided to be bent toward the second clamping arm 3. As shown in fig. 4, 12 and 13, the whole first clamping arm 2 is bent in a zigzag shape, the first end of the first clamping arm 2 is hinged with the main body arm 1 through a rotating shaft, and the first clamping arm 2 can rotate towards the direction of the second clamping arm 3; the second end of the first clamping arm 2 is bent towards the second clamping arm 3. As some preferred embodiments of the present application, the second end of the second clamping arm 3 may also be selectively bent toward the first clamping arm 2.

According to the application, the second end of the first clamping arm 2 is bent towards the second clamping arm 3 and/or the second end of the second clamping arm 3 is bent towards the first clamping arm 2, so that when the first clamping arm 2 and the second clamping arm 3 are in a clamping state, a sufficient abdication space is formed between the first clamping arm 2 and the second clamping arm 3 to accommodate valve tissues, and the valve is prevented from being squeezed in the clamping process, and the normal use of the annuloplasty device 10 is prevented from being influenced.

As some preferred embodiments of the present application, the first clamping portion 21 is further optionally provided with a first clamping surface 24, and the second clamping portion 31 is provided with a second clamping surface 33; the first puncture passageway 22 passes through the first clamping surface 24; the second clamping surface 33 is located on the end surface of the second end of the second clamping arm 3, and the second puncture channel 32 passes through the second clamping surface 33; when the first clamping arm 2 and the second clamping arm 3 are in the clamping state, the first puncture channel 22 is opposite to the second puncture channel 32. In particular, as shown in fig. 15, the second puncture channel 32 extends from the first end of the second holding arm 3 to the second end of the second holding arm 3 and penetrates the second holding surface 33. According to the application, the first puncture channel 22 passes through the first clamping surface 24, the second puncture channel 32 passes through the second clamping surface 33, so that the puncture needle 4 can pass through tissues between the first clamping surface 24 and the second clamping surface 33, and the clamped position of the valve annulus X can be better restrained under the action of the first clamping surface 24 and the second clamping surface 33, so that the puncture position is more accurate, and the damage to the valve annulus X in the puncture process can be effectively reduced.

As some preferred embodiments of the present application, as shown in fig. 5 to 8, 10 and 11, the sidewall of the main body arm 1 is further optionally provided with a first abdication area 11 adapted to the first clamping arm 2, a first connection site 111 is provided at a proximal end of the first abdication area 11, a first end of the first clamping arm 2 is hinged to the first connection site 111, the first clamping part 21 is located at a second end of the first clamping arm 2, and the first clamping arm 2 has a state of being located in the first abdication area 11 (as shown in fig. 5 and 7) and a state of extending out of the first abdication area 11 to clamp the valve annulus X after rotation (as shown in fig. 6 and 8). During use of the annuloplasty device 10, when the annulus X is to be clamped, the first clamping arm 2 is rotated to extend out of the first yielding region 11 to clamp the annulus X, and in other cases, the first clamping arm 2 may be selectively located in the first yielding region 11 to adjust the position and state of the first clamping arm 2.

As some preferred embodiments of the present application, as shown in fig. 5, 6, 10 and 11, a second yielding area 12 adapted to the second clamping arm 3 is provided on a side wall of the main body arm 1, a second connection position 121 is provided at a proximal end of the second yielding area 12, a first end of the second clamping arm 3 is hinged to the second connection position 121, the second clamping portion 31 is located at a second end of the second clamping arm 3, and the second clamping arm 3 has a state of being located in the second yielding area 12 (as shown in fig. 5 and 7) and a state of extending out of the second yielding area 12 to clamp the valve annulus X after rotating (as shown in fig. 6 and 8). During use of the annuloplasty device 10, when the annulus X is to be clamped, the second clamping arm 3 is rotated to extend out of the second yielding region 12 to clamp the annulus X, and in other cases, the second clamping arm 3 may be selectively positioned in the second yielding region 12 to adjust the position and state of the second clamping arm 3.

In practice, as shown in fig. 3 to 6, 10 and 11, the first yielding zone 11 is provided between the distal end of the body arm 1 and the second yielding zone 12. Preferably, the first yielding region 11 and the second yielding region 12 are further selectively arranged in a step shape.

In the implementation, as shown in fig. 9 and 12, a first end of the first clamping arm 2 is provided with a yielding gap 23 along the length direction, and when the first clamping arm 2 is located in the first yielding region 11 and the second clamping arm 3 is located in the second yielding region 12, at least part of the structure of the second clamping arm 3 is located in the yielding gap 23; this arrangement allows the annuloplasty device 10 to be more compact in the event that it meets the surgical requirements. Furthermore, the length of the main body arm 1 can be shortened as much as possible, and the defect of great operation difficulty caused by too long main body arm 1 can be overcome. As a preferred embodiment of the present application, the width of the second clamp arm 3 can be further selectively made smaller than the width of the first clamp arm 2.

The side wall of the main body arm 1 is provided with a first abdication area 11 and a second abdication area 12, the first clamping arm 2 is in a state of being positioned in the first abdication area 11 and a state of extending out of the first abdication area 11 after rotating to clamp an annulus, and the second clamping arm 3 is in a state of being positioned in the second abdication area 12 and a state of extending out of the second abdication area 12 after rotating to clamp the annulus; thereby providing the annuloplasty device 10 with a folding function so that the annuloplasty device 10 can extend into the heart Y through minimally invasive surgery; and the structure is more compact.

As some preferred embodiments of the present application, the annuloplasty device 10 further optionally includes a suture 51, the penetrating needle 4 having a coupled state (as shown in FIG. 18) and a decoupled state (as shown in FIGS. 19 and 20) with the suture 51, the penetrating end of the penetrating needle 4 being capable of pulling the suture 51 through the first penetrating channel 22 via the second penetrating channel 32.

In a specific implementation, a first end of the suture 51 is further optionally provided with a first limiting structure 52 for connecting to the first clamping arm 2, the puncture needle 4 can be connected to the suture 51 through the first limiting structure 52, the first limiting structure 52 can be pulled through the puncture needle 4 and pass through the first puncture channel 22 to be connected to the first clamping portion 21, and a second end of the suture 51 is provided with a second limiting structure 53 for connecting to an annulus. In practice, as shown in fig. 16, the middle portion of the first limiting structure 52 is connected to the first end of the suture 51. As shown in fig. 17, the second limiting structure 53 is configured as a spacer that is sleeved on the second end of the suture 51. It should be noted that, the connection manner of the puncture needle 4 and the suture 51 is not particularly limited, and may be any arrangement manner capable of meeting the connection and separation requirements of the puncture needle 4 and the suture 51, specifically, as shown in fig. 18 to 21, the puncture needle 4 is a hollow needle, a hanging notch 41 is provided on a side wall of a puncture end of the puncture needle 4, a first limiting structure 52 is inserted from the puncture end of the puncture needle 4 and is hung with the hanging notch 41 (as shown in fig. 18), and during the puncture process of the puncture needle 4, the puncture needle 4 can pull the suture 51 through the first limiting structure 52.

According to the application, the first end of the suture line 51 is provided with the first limiting structure 52 for connecting the first clamping arm 2, so that the suture line 51 can be connected with the puncture needle 4 through the first limiting structure 52, and the puncture needle 4 can pull the suture line 51 in the puncture process; the first limiting structure 52 is disposed at the first end of the suture thread 51, so that the suture thread 51 can be connected with the first clamping arm 2 through the first limiting structure 52, and the suture thread 51 can be conveniently pulled by the first clamping arm 2. In addition, the second end of the suture thread 51 can be firmly connected with the valve annulus by arranging the second limiting structure 53, so that the suture thread 51 is prevented from being pulled off in the traction process of the first clamping arm 2.

As some preferred embodiments of the present application, the puncture needle 4 is further selectively made to be a hollow needle, and the first limiting structure 52 can be adaptively connected with the hollow needle; when the puncture needle 4 and the suture 51 are in a connected state, at least part of the first limiting structure 52 is positioned in the puncture end of the puncture needle 4; the annuloplasty device 10 further comprises a pusher member 6, the pusher member 6 extending from the proximal end of the hollow needle, and the pusher member 6 being configured to push the first stop structure 52 to enable the suture 51 to be separated from the needle 4 and connected to the first clamping portion 21. In the specific implementation, as shown in fig. 19, the pushing member 6 is configured as a pushing rod capable of penetrating the hollow needle, and when the suture 51 needs to be connected to the first clamping portion 21, the pushing rod pushes the first limiting structure 52 out of the hollow needle, and the connection between the suture 51 and the first clamping arm 2 is realized under the action of the first limiting structure 52. According to the application, the puncture needle 4 is made into a hollow needle, and the pushing piece 6 is arranged, so that the connection relation between the puncture needle 4 and the first limiting structure 52 can be released under the action of the pushing piece, the first limiting structure 52 is connected with the first clamping part 21, and the first clamping arm 2 can pull the suture 51, so that the annuloplasty can be conveniently and smoothly implemented. Moreover, by adopting the arrangement mode, the puncture needle 4 can be firmly connected with the suture 51 in the puncture process, and the puncture needle 4 can be conveniently separated from the suture 51. Besides, the device has the advantages of simple structure, convenient operation and the like.

To facilitate an understanding of the use of the annuloplasty device 10 provided by the present application, a mitral valve annuloplasty procedure will now be described with reference to fig. 21-30, as follows:

extending the distal end of the annuloplasty device 10 from the apex position into the heart Y, controlling the second clamping arm 3 to open the second clamping arm 3 (as shown in fig. 21), and abutting the clamping portion of the second clamping arm 3 against the designated position of the annulus to be clamped; further control of the first clamping arm 2 opens the first clamping arm 2 and causes the first clamping arm 2 and the second clamping arm 3 to clamp the designated position of the annulus (as shown in fig. 22), and when there is a deviation in the clamped position, the clamped position can also be adjusted by controlling the first clamping arm 2 and the second clamping arm 3. When the first clamping arm 2 and the second clamping arm 3 clamp a designated position of an annulus, the puncture end of the puncture needle 4 connected with the suture thread 51 is controlled to be penetrated out of the first puncture channel 22 through the second puncture channel 32 (shown in fig. 23), and the suture thread 51 is connected with the first clamping arm 2 while the puncture needle 4 is penetrated through the first puncture channel 22 (shown in fig. 24); after the suture 51 is determined to be connected to the first clamp arm 2, the first clamp arm 2 is rotated and one end of the suture 51 is pulled through the first clamp arm 2 (as shown in fig. 25) until the other end of the suture 51 is connected to the annulus; the above process is further repeated to attach another suture 51 to the designated location of the annulus (as shown in fig. 26 and 27). The implanted two sutures 51 are pulled to shrink the annulus, and after the adjustment, the sutures 51 are locked by a locking unit 54 (as shown in fig. 28) to achieve the effect of ring shrink. In particular embodiments, the annuloplasty may be selectively performed on multiple locations of the annulus for repair purposes. At the time of a specific operation, the contracted position of the annulus may be selected according to the actual situation, for example, two different annuloplasty schemes are shown in fig. 29 and 30.

The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention are intended to be included in the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims (10)

1. An annuloplasty device, which is characterized in that,

comprises a main body arm, a first clamping arm and a second clamping arm; the first clamping arm is rotatably connected with the main body arm, and is provided with a first clamping part; the second clamping arm is rotatably connected with the main body arm, and is provided with a second clamping part; when the first clamping arm and the second clamping arm are in a clamping state, the first clamping part and the second clamping part are opposite and can clamp an annulus.

2. The annuloplasty device according to claim 1, wherein,

the annuloplasty device further comprises a puncture needle for pulling a suture;

the first clamping arm is provided with a first puncture channel, the second clamping arm is provided with a second puncture channel, and when the first clamping arm and the second clamping arm are in the clamping state, the puncture end of the puncture needle can pull the suture to pass through the second puncture channel to penetrate out of the first puncture channel.

3. The annuloplasty device according to claim 2, wherein,

the first puncture channel is a puncture hole penetrating through the first clamping part along the puncture direction of the puncture needle;

the first end of the second clamping arm is connected with the main body arm, the second clamping part is positioned at the second end of the second clamping arm, the second puncture channel extends from the first end of the second clamping arm to the second clamping part, and the second puncture channel penetrates through the two ends of the second clamping arm.

4. An annuloplasty device according to claim 3 wherein said puncture hole is tapered in the direction of penetration of said puncture needle.

5. The annuloplasty device according to claim 2, wherein,

a first yielding area matched with the first clamping arm is arranged on the side wall of the main body arm, a first connecting position is arranged at the proximal end of the first yielding area, the first end of the first clamping arm is hinged with the first connecting position, the first clamping part is positioned at the second end of the first clamping arm, and the first clamping arm is in a state of being positioned in the first yielding area and a state of extending out of the first yielding area after rotating;

A second yielding area matched with the second clamping arm is arranged on the side wall of the main body arm, a second connecting position is arranged at the proximal end of the second yielding area, the first end of the second clamping arm is hinged with the second connecting position, the second clamping part is positioned at the second end of the second clamping arm, and the second clamping arm is in a state of being positioned in the second yielding area and a state of extending out of the second yielding area after rotating;

the first yielding region is arranged between the distal end of the main body arm and the second yielding region.

6. The annuloplasty device according to claim 5, wherein,

the first clamping part is provided with a first clamping surface, and the second clamping part is provided with a second clamping surface; the first puncture channel passes through the first clamping surface; the second clamping surface is positioned on the end surface of the second end of the second clamping arm, and the second puncture channel passes through the second clamping surface; when the first clamping arm and the second clamping arm are in the clamping state, the first puncture channel and the second puncture channel are opposite.

7. The annuloplasty device according to claim 2, wherein,

The annuloplasty device further comprises the suture, the puncture needle and the suture have a connection state and a separation state, and the puncture end of the puncture needle can pull the suture to pass through the first puncture channel through the second puncture channel.

8. The annuloplasty device according to claim 7, wherein,

the first end of the suture is provided with a first limiting structure used for being connected with the first clamping arm, the puncture end of the puncture needle can be connected with the suture through the first limiting structure, and the first limiting structure can be pulled by the puncture needle and penetrates through the first puncture channel to be connected with the first clamping part; the second end of the suture is provided with a second limit structure for connecting with an annulus.

9. The annuloplasty device according to claim 8, wherein,

the puncture needle is a hollow needle, and the first limit structure can be connected with the hollow needle in an adaptive manner; when the puncture needle is in a connection state with the suture line, at least part of the first limiting structure is positioned in the puncture end of the puncture needle;

the annuloplasty device further comprises a pushing piece, the pushing piece stretches into the hollow needle from the proximal end, and the pushing piece can push the first limiting structure so that the suture can be separated from the puncture needle and connected with the first clamping portion.

10. The annuloplasty device according to any of claims 2 to 9, wherein,

the annuloplasty device further comprises a first control piece, wherein the first control piece is used for controlling the first clamping arm to rotate; the first control part penetrates through the first channel and is connected with the first clamping arm;

the annuloplasty device further comprises a second control member for controlling the second clamping arm to rotate; the inside second passageway that is equipped with of main part arm, the second passageway intercommunication the proximal end of main part arm with the junction of second centre gripping arm with the main part arm, second control piece pass the second passageway with the second centre gripping arm is connected.