CN113749823A

CN113749823A - Mitral valve repair clamp connected with conveying structure in clamping manner

Info

Publication number: CN113749823A
Application number: CN202111188017.0A
Authority: CN
Inventors: 吴明明; 耿肖肖; 丁峰; 石成晓; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2021-10-12
Filing date: 2021-10-12
Publication date: 2021-12-07
Anticipated expiration: 2041-10-12
Also published as: CN113749823B

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a mitral valve repair clamp. A mitral valve repair clamp for snap-fit connection with a delivery structure, comprising: the clamping structure is provided with a first clamping body and a second clamping body; the sleeve is used for bundling the first clamp body and the second clamp body; the conveying structure is provided with an inner core rod matched with the clamping structure; the near-end of first clamp is equipped with the connecting rod, and the connecting rod includes: the far end of the first connecting section is connected with the first clamp body; the far end of the second connecting section is connected with the near end of the first connecting section, and at least one clamp body connecting part is arranged on the outer side wall; the inner core rod is provided with: at least one conveying elastic piece which can be clamped and connected with the connecting part of the clamp body. The invention changes the connection mode of the inner core rod and the connecting rod from threaded connection into clamping connection of the conveying elastic piece, thereby not only avoiding incomplete matching, but also being convenient for installation and release.

Description

Mitral valve repair clamp connected with conveying structure in clamping manner

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a mitral valve repair clamp.

Background

For cardiac valve insufficiency, in particular atrioventricular valve insufficiency or regurgitation, the current treatment methods mainly comprise valvuloplasty, artificial mechanical valve replacement and biological valve replacement. With the development of cardiac surgical techniques, annuloplasty has become one of the major means of treating heart valve disease. Compared with the replacement of artificial mechanical valves, the valvuloplasty does not need anticoagulation, avoids complications caused by taking anticoagulant drugs such as warfarin and the like, and has good forming effect and is beneficial to the recovery of cardiac function. Although the anticoagulation time is short after the replacement of the biological valve, the short service life is a main obstacle limiting the wide application of the biological valve.

The invention has application number 201920111620.0 and the name of the invention is: a patent of a valve repair clip discloses a transapical mitral valve repair clip which is simple in structure and convenient to operate, but in practical application, the following problems occur:

1. the inner core rod of the conveying structure is in threaded connection with the connecting rod of the first clamp body, and when the first clamp body is screwed on the inner core rod, the outer periphery of the connecting rod cannot be well matched with the inner core rod to clamp due to the fact that the inner core rod and the connecting rod are of non-cylindrical structures, and conveying difficulty is caused.

2. The first clamp body and the outer clamp are usually made of self-expanding materials, such as memory alloy, and are not suitable for being internally threaded on the connecting rod due to small size.

Disclosure of Invention

The invention aims to solve the technical problems of difficult conveying and separation caused by the conditions of complex process, uncomfortable matching and the like in the conventional mode that a first clamp body of a mitral valve repair clamp is in threaded connection with a connecting rod of a conveying structure, and aims to provide a mitral valve repair clamp which is connected with the conveying structure in a clamping manner.

A mitral valve repair clamp for snap-fit connection with a delivery structure, comprising: a clamping structure, which is provided with a first clamp body and a second clamp body which are matched to clamp the native valve leaflets; the sleeve is used for bundling the first clamp body and the second clamp body; the conveying structure is provided with an inner core rod matched with the clamping structure;

the inner core rod is provided with:

at least one conveying elastic piece which can be clamped and connected with the clamping structure;

after the conveying elastic piece is connected with the clamping structure in a clamping mode, the conveying structure pushes the first clamp body and the second clamp body to a far-end preset position from the interior of the sleeve through the inner core rod, and after the conveying elastic piece is driven to deform, the conveying elastic piece is separated from the clamping structure, so that the conveying structure is separated from the clamping structure.

The near-end of first clamp is equipped with the connecting rod, the connecting rod includes:

the far end of the first connecting section is connected with the first clamp body;

the far end of the second connecting section is connected with the near end of the first connecting section, and at least one clamp body connecting part is arranged on the outer side wall;

the conveying elastic piece and the clamp body connecting part can be connected in a clamping manner.

The width of at least one side of the cross section of the second connecting section is smaller than that of the corresponding side of the cross section of the first connecting section;

the outer side wall of the clamp body connecting part is flush with or recessed in the outer side wall of the first connecting section.

The clamp body connecting part is a first connecting bulge or is provided with a first connecting groove;

and a second connecting groove or a second connecting bulge is correspondingly arranged on the conveying elastic piece.

The first connecting section and the second connecting section are of an integrated structure which is integrally formed;

the whole connecting rod is of a cylindrical structure or an elliptic cylindrical structure, the upper portion of the connecting rod is the first connecting section, and notches are respectively cut from the bottom surface to the far end of the two sides of the connecting rod to form the second connecting section.

The first clamp body and the connecting rod are of an integral structure which is made of memory alloy materials through integral forming.

A connecting ring is arranged at the near end of the second clamp body and sleeved outside the connecting rod;

the second connecting section of the connecting rod extends out of the proximal end of the connecting ring.

The second clamp body and the connecting ring are of an integral structure which is made of memory alloy materials through integral forming.

The conveying elastic piece is an elastic clamping piece, the near end of the elastic clamping piece is fixed with the inner core rod, and the far end of the elastic clamping piece is connected with the connecting part of the clamp body in a clamping manner;

the elastic clamping piece is provided with a second stay wire, and the second stay wire drives the elastic clamping piece to be clamped or far away from the clamp body connecting part.

The elastic clamping piece is provided with a stay wire guide groove along the axial direction, and the second stay wire is clamped in the stay wire guide groove and extends to the near end of the conveying structure through the guidance of the stay wire guide groove.

The elastic clamping piece is made of memory alloy, and is attached to the outer side wall of the inner core rod and extends along the axial direction of the inner core rod when external force is not applied.

The positive progress effects of the invention are as follows: the mitral valve repair clamp is connected with the conveying structure in a clamping mode, the connection mode of the inner core rod and the connecting rod is changed from threaded connection into clamping connection of the conveying elastic piece, threads do not need to be arranged inside the connecting rod, incomplete matching is avoided, and installation and release are facilitated. Under the condition that the axial directions of the conveying elastic piece and the inner core rod are kept consistent, the second pull wire arranged on the conveying elastic piece is used for tensioning the second pull wire when the clamping structure needs to be released, and the conveying structure is separated from the clamping structure.

Drawings

FIG. 1 is a schematic view of an overall structure of the present invention;

FIG. 2 is another schematic structural view of FIG. 1;

FIG. 3 is a schematic view of a portion of the present invention;

FIG. 4 is an exploded view of FIG. 3;

FIG. 5 is another schematic view of the structure of FIG. 4;

FIG. 6 is a schematic structural view of a clamping structure according to the present invention;

FIG. 7 is a top view of the clamping structure of the present invention;

FIG. 8 is an enlarged view of a portion of FIG. 6;

FIG. 9 is a schematic view of a first clip body according to the present invention;

FIG. 10 is an enlarged view of the resilient member of the clamping arm of the present invention;

FIG. 11 is a schematic view of a second clip body according to the present invention;

FIG. 12 is a schematic view of a delivery structure according to the present invention;

fig. 13 is another schematic structural view of fig. 12.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.

Referring to fig. 1-11, a mitral valve repair clamp that is snap-fit to a delivery structure includes a clamping structure 100, a sleeve 200, and a delivery structure 300. The clamping structure 100 has a first clamp body 110 and a second clamp body 120 that cooperate to clamp the native valve leaflets. The sleeve 200 is used for bundling the first clip body 110 and the second clip body 120. The delivery structure 300 has a core pin 310 that cooperates with the sandwich structure, and the delivery structure 300 pushes and releases the sandwich structure 100 distally through the core pin 310.

The proximal end of the first clip body 110 is provided with a connecting rod 116, and the first clip body 110 and the connecting rod 116 are preferably an integral structure made of memory alloy material through integral molding.

The connecting rod 116 includes a first connecting segment 1161 and a second connecting segment 1162, a distal end of the first connecting segment 1161 is connected to the first clip body 110, a distal end of the second connecting segment 1162 is connected to a proximal end of the first connecting segment 1161, and at least one clip body connecting portion 1163 is disposed on an outer sidewall of the second connecting segment 1162. At least one side of the cross-section of the second connecting section 1162 has a width smaller than that of the corresponding side of the cross-section of the first connecting section 1161. So that the clip connecting portion 1163 on the second connecting section 1162 does not affect the fit between the first clip body 110 and the second clip body 120. Specifically, a cut may be cut out in the second connection section 1162, and the clip connecting portion 1163 may be disposed in the cut. Preferably, an outer sidewall of the clip body connecting portion 1163 is flush with or recessed within an outer sidewall of the first connecting section 1161. The clip connecting portion 1163 is a first connecting protrusion or a first connecting groove. The first and

second connection segments

1161 and 1162 are preferably integrally formed as a unitary structure.

Referring to fig. 4, 5 and 9, the connecting rod 116 has an overall cylindrical structure or an elliptical cylindrical structure, the upper portion of the connecting rod 116 is a first connecting section 1161, and a second connecting section 1162 is formed by cutting from the bottom surface to the distal end of the connecting rod 116 at both sides thereof. Two clamp body connecting parts 1163 are symmetrically arranged on the second connecting section 1162, and the clamp body connecting parts 1163 are first connecting protrusions.

Referring to fig. 11, the proximal end of the second clip body 120 is provided with a connecting ring 124, the connecting ring 124 is disposed around the connecting rod 116, preferably the connecting ring 124 is disposed around the first connecting section 1161. The second connecting section 1162 of the connecting rod 116 extends beyond the proximal end of the connecting ring 124, so that the clip connecting portion 1163 of the second connecting section 1162 can be conveniently fitted and connected with the inner core rod 310 without affecting the fitting between the first clip body 110 and the second clip body 120. The second clip body 120 and the connecting ring 124 are preferably integrally formed by a memory alloy material.

Referring to fig. 3 to 5 and 12 to 13, the core rod 310 is provided with at least one conveying elastic member 320, the number of the conveying elastic members 320 is the same as that of the clip connecting portions 1163, and one conveying elastic member 320 and a corresponding clip connecting portion 1163 can be connected in a clamping manner. After the conveying elastic member 320 is engaged with the clip body connecting portion 1163, the conveying structure 300 pushes the first clip body 110 and the second clip body 120 from the sleeve 200 to the distal preset position through the inner core rod 310, and after the conveying elastic member 320 is driven to deform, the conveying elastic member 320 is separated from the clip body connecting portion 1163, and the conveying structure 300 is separated from the engaged structure. The conveying elastic member 320 is correspondingly provided with a second connecting groove or a second connecting protrusion. As shown in fig. 12 and 13, the conveying elastic member 320 is correspondingly provided with a second connecting groove, which is a through groove or a through hole.

The conveying elastic member 320 is an elastic clip, the proximal end of which is fixed to the inner core rod 310, and the distal end of which is connected to the clip body connecting portion 1163 in a snap-fit manner. The elastic clip is provided with a second pulling wire 330, and the second pulling wire 330 is used as a driving end to drive the elastic clip to be clamped or to be away from the clip body connecting part 1163. The elastic clip is provided with a wire guide groove along the axial direction, and the second wire 330 is clamped in the wire guide groove and extends to the near end of the conveying structure 300 through the guiding of the wire guide groove. The elastic clip is made of memory alloy, and when the elastic clip is not subjected to an external force, the elastic clip is attached to the outer side wall of the inner core rod 310 and extends along the axial direction of the inner core rod 310.

The invention can also improve the specific structure of the first clamp body 110 and the second clamp body 120:

referring to fig. 1 to 11, the first clip body 110 includes at least two first clipping arms 111, the first clipping arms 111 have a plurality of first friction members 112 on the outer side surface, and the plurality of first friction members 112 are arranged in a row from the distal end to the proximal end.

The second clip body 120 comprises at least two second clipping arms 121 cooperating with the first clipping arms 111. The second clamping arm 121 has a plurality of second friction members 122 on its inner side, and the plurality of second friction members 122 are arranged in a row from the distal end to the proximal end. As shown in fig. 1, the number of the second clamping arms 121 is the same as that of the first clamping arms 111, and the plurality of second friction members 122 on the second clamping arms 121 are disposed opposite to the plurality of first friction members 112 on the first clamping arms 111.

According to the invention, the first friction piece 112 is arranged on the first clamping arm 111, and the second friction piece 122 is arranged on the second clamping arm 121, so that in the actual use process, the second clamping arm 121 is placed near the valve leaflet through the conveying structure 300, the second clamping arm 121 plays a role of lifting the valve leaflet, the first clamping arm 111 is continuously pushed towards the far end, when the valve leaflet is located at the proper position of the second clamping arm 121, the first clamping arm 111 and the second clamping arm 121 are pulled back, the valve leaflet is clamped by the mutual matching of the first friction piece 112 and the second friction piece 122, and the valve is prevented from falling off due to heart contraction in the later use process of the mitral valve repair clamp.

The first friction member 112 and the second friction member 122 both adopt a saw-tooth structure, and the saw-tooth structure of the first friction member 112 and the saw-tooth structure of the second friction member 122 are engaged with each other to clamp the valve leaflets.

Referring to fig. 8, the first friction member 112 is a triangular prism structure, a quadrilateral bottom surface of the first friction member 112 is disposed on the first clamping arm 111, two side surfaces of the first friction member 112 are triangular structures, an included angle located at a proximal end of two included angles at a connection with the first clamping arm 111 in the triangular structure is a first included angle a, an included angle located at a distal end of the two included angles is a second included angle b, the angle of the first included angle a is greater than that of the second included angle b, and another included angle c away from the first clamping arm 111 in the triangular structure faces the second clamping arm 121. The first included angle a is in the range of 80-110. The other included angle c is in the range of 45-75. Bottom pitch L of two adjacent first friction members 112: the height H of the first friction member 112 is 1: 0.5-1.5. The height H is the distance between another included angle c in the triangular structure and the first clamping arm 111. Preferably, the height H of the plurality of first friction members 112 is gradually decreased from the distal end of the first clamping arm 111 in the proximal direction.

Referring to fig. 8, the second friction member 122 has a triangular prism structure, a quadrilateral bottom surface of the second friction member 122 is disposed on the second clamping arm 121, two side surfaces of the second friction member 122 are isosceles triangles, and a vertex of the second friction member 122 faces the first clamping arm 111.

The distal ends of the first clamping arm 111 and the second clamping arm 121 are coated with clamping arm coating films 130. The material of the clamping arm covering film 130 is a high polymer material or a natural pericardium material, and the high polymer material is at least one of expanded polytetrafluoroethylene, polyester, polyurethane, polypropylene or silicon rubber.

Referring to fig. 1 to 11, an included angle between the two first clamping arms 111 is greater than an included angle between the two second clamping arms 121. The first clipping arm 111 is provided with a clipping arm elastic member 113, and the second clipping arm 121 is provided with a slidable member 123.

Referring to fig. 6 and 10, one end of the clamping arm elastic member 113 is disposed on the outer side surface of the first clamping arm 111, and the other end of the clamping arm elastic member 113 faces the inner side surface of the second clamping arm 121. The clamping arm elastic member 113 is a clamping arm elastic sheet, a distal end of the clamping arm elastic sheet is fixedly connected with an outer side surface of the first clamping arm 111, and a bending portion 114 is disposed at a proximal end of the clamping arm elastic sheet. The bending portion 114 can lift the slidable member 123 on the second clamping arm 121. The clamping arm elastic piece is provided with an elastic piece through hole, the elastic piece through hole is detachably connected with a first pull wire 115, and the first pull wire 115 drives the clamping arm elastic piece to lift or keep away from the slidable part 123. Preferably, the resilient through-hole is disposed on the bending portion 114. The inner core rod 310 is provided with a wire guide slot 311 along the axial direction, and the first wire 115 is clamped in the wire guide slot 311 and extends to the proximal end of the conveying structure 300 through the guidance of the wire guide slot 311.

The slidable member 123 is disposed on an outer side surface of the second clamping arm 121, and the slidable member 123 is slidably connected to an inner wall of the sleeve 200. The inner side of the slidable member 123 preferably protrudes from the inner side of the second clamping arm 121 so as to be lifted by the bending portion 114. At least the portion of the slidable member 123 contacting the bent portion 114 is a curved surface. At least the portion of the slidable member 123 in contact with the sleeve 200 is a curved surface. The slidable member 123 is preferably a ball.

Referring to fig. 1 and 2, the distal end of the sleeve 200 is provided with a flaring 210. The sleeve 200 is provided with a plurality of sleeve through holes 220 so as to reduce the weight of the sleeve 200 itself. Preferably, a plurality of rows of sleeve through holes 220 are distributed on the outer circumferential surface of the sleeve 200, and each row is provided with a plurality of sleeve through holes 220 along the axial direction. The sleeve 200 is preferably covered with a sleeve coating film, which is sewn to the sleeve 200 through the sleeve through-hole 220. The sleeve covering film is made of high polymer material or natural pericardium material, and the high polymer material is at least one of expanded polytetrafluoroethylene, polyester, polyurethane, polypropylene or silicon rubber.

The conveying structure 300 of the present invention can drive the first clamping arm 111 to move from the proximal end to the distal end, and the first clamping arm 111 drives the slidable member 123 to move from the proximal end to the distal end on the inner wall of the sleeve 200 along the axial direction of the sleeve 200, so as to drive the second clamping arm 121 to push towards the distal end and take out of the sleeve 200. When the distal end of the sleeve 200 is provided with the flaring portion 210, the first clamping arm 111 drives the slidable member 123 to move on the inner wall of the sleeve 200 from the proximal end to the distal end along the axial direction of the sleeve 200 to the flaring portion 210, and then the slidable member 123 moves along the radial direction of the sleeve 200 and is away from the clamping arm elastic member 113, so that the first clamping arm 111 and the second clamping arm 121 are separated from each other, and the conveying structure 300 drives the first clamping arm 111 to continue to push to the distal end to a preset position.

When the present invention is used, the delivery elastic member 320 is engaged with the second connecting section 1162 of the first clip body 110, and the inner core rod 310 pushes the first clip body 110 from the proximal end to the distal end, the first clip body 110 drives the second clip body 120 to push out the sleeve 200 together, and the second clipping arm 121 of the second clip body 120 reaches the vicinity of the valve leaflet to lift the valve leaflet. When the first pulling wire 115 is pulled back to ensure that the first clip body 110 and the second clip body 120 are separated, the inner core rod 310 pulls back the first clip body 110 after the inner core rod 310 pushes the first clipping arm 111 of the first clip body 110 to continue to push the distal end to the preset position, and the first friction member 112 of the first clipping arm 111 and the second friction member 122 of the second clipping arm 121 cooperate with each other to clip the valve leaflet.

The second pulling wire 330 is pulled back, the delivery elastic member 320 is separated from the second connecting section 1162, the delivery structure 300 is withdrawn, and the clamping structure 100 and the sleeve 200 are left at the predetermined position to clamp the valve leaflets for repairing the heart valve.

The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A mitral valve repair clamp for snap-fit connection with a delivery structure, comprising: a clamping structure, which is provided with a first clamp body and a second clamp body which are matched to clamp the native valve leaflets;

characterized in that, the mitral valve repair clamp further comprises:

the sleeve is used for bundling the first clamp body and the second clamp body;

the conveying structure is provided with an inner core rod matched with the clamping structure;

the inner core rod is provided with:

2. The mitral valve repair clamp snap-fit to a delivery structure of claim 1, wherein the proximal end of the first clamp body is provided with a connecting rod, the connecting rod comprising:

3. The mitral valve repair clamp snapped into connection with a delivery structure of claim 2, wherein at least one side of the cross-section of the second connecting segment has a width that is less than a width of a corresponding side of the cross-section of the first connecting segment;

4. The mitral valve repair clamp snap-fit connected with a delivery structure of claim 2, wherein the clamp body connecting part is a first connecting protrusion or is provided with a first connecting groove;

5. The mitral valve repair clamp snapped into connection with a delivery structure of claim 2, wherein the first connection segment and the second connection segment are integrally formed as a unitary structure;

6. The mitral valve repair clamp engaged with the delivery structure of claim 5, wherein the first clamp body and the connecting rod are integrally formed by a memory alloy.

7. The mitral valve repair clamp snapped together with a delivery structure according to any one of claims 1 to 6, wherein a connection ring is provided at a proximal end of the second clamp body, and the connection ring is sleeved outside the connection rod;

the second clamp body and the connecting ring are of an integral structure which is made of memory alloy materials through integral forming;

the second connecting section extends beyond the proximal end of the connecting ring.

8. The mitral valve repair clamp snap-fit to a delivery structure of claim 1, wherein the delivery spring is a spring clip, a proximal end of the spring clip is fixed to the inner core rod, and a distal end of the spring clip is snap-fit to the clamp body connection part;

9. The mitral valve repair clamp snap-fit to a delivery structure of claim 8, wherein the resilient clip has a pull wire guide groove disposed thereon along an axial direction, and the second pull wire is clamped in the pull wire guide groove and extends to a proximal end of the delivery structure through guidance of the pull wire guide groove.

10. The mitral valve repair clamp snap-fit connected to the delivery structure of claim 8, wherein the elastic clip is made of a memory alloy, and the elastic clip is engaged with an outer sidewall of the inner core rod and extends in an axial direction of the inner core rod when no external force is applied.