CN113749823B

CN113749823B - Mitral valve repair clamp connected with conveying structure in clamping mode

Info

Publication number: CN113749823B
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: 2023-06-27
Anticipated expiration: 2041-10-12
Also published as: CN113749823A

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a mitral valve repair clamp. A mitral valve repair clip in snap connection with a delivery structure, comprising: the clamping structure is provided with a first clamping body and a second clamping body; a sleeve for converging the first clamp body and the second clamp body; the conveying structure is provided with an inner core rod matched with the clamping structure for use; the proximal end of the first clamp body is provided with a connecting rod, and the connecting rod comprises: a first connecting section, the distal end of which is connected with the first clamp body; the distal end of the second connecting section is connected with the proximal end of the first connecting section, and the outer side wall of the second connecting section is provided with at least one clamp connecting part; the inner core rod is provided with: at least one conveying elastic piece is connected with the clamp body connecting part in a clamping way. According to the invention, the connection mode of the inner core rod and the connecting rod is changed from threaded connection to clamping connection of the conveying elastic piece, so that incomplete matching is avoided, and the installation and the release are convenient.

Description

Mitral valve repair clamp connected with conveying structure in clamping mode

Technical Field

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

Background

For heart valve insufficiency, particularly atrioventricular valve insufficiency or regurgitation, current treatments mainly include annuloplasty, prosthetic mechanical valve replacement, and biological valve replacement. With the development of cardiac surgical techniques, annuloplasty has become one of the primary means of treating heart valve disease. Compared with the replacement of a prosthetic mechanical valve, the annuloplasty has the advantages that anticoagulation is not needed, complications caused by taking anticoagulants such as warfarin and the like are avoided, and good shaping effect is beneficial to heart function recovery. Although the anticoagulation time is short after the biological valve replacement operation, the short service life is a main obstacle limiting the wide application of the biological valve replacement operation.

Application number 201920111620.0, the invention name is: the patent of a valve repair clamp discloses a mitral valve repair clamp through the apex of the heart, which has simple structure and convenient operation, but in practical application, the following problems can occur:

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

2. The material of the first clamp body and the outer clamp is usually self-expansion material, such as memory alloy, and is not suitable for making internal threads on the connecting rod due to small size, and the current practice is that the connecting rod is made of stainless steel material, and the connecting rod is fixedly connected with the first clamp body after making the internal threads, so that the process operation is very complicated, and in long-term use in vivo, the risk of separating the first clamp body from the connecting rod exists.

Disclosure of Invention

The invention aims at solving the technical problems that the prior mitral valve repair clamp has complex process, uncomfortable matching and the like in a threaded connection mode of a first clamp body and a connecting rod of a conveying structure, and is difficult to convey and separate, and provides a mitral valve repair clamp which is connected with the conveying structure in a clamping mode.

A mitral valve repair clip in snap connection with a delivery structure, comprising: the clamping structure is provided with a first clamping body and a second clamping body which are matched to clamp the native valve leaflet; a sleeve converging the first and second clamps; a conveying structure provided with an inner core rod matched with the clamping structure for use;

the inner core rod is provided with:

at least one conveying elastic piece which is in clamping connection with the clamping structure;

after the conveying elastic piece is clamped and connected with the clamping structure, the conveying structure pushes the first clamping body and the second clamping body to a far-end preset position from 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 proximal end of the first clamp body is provided with a connecting rod, and the connecting rod comprises:

a first connecting section, the distal end of which is connected with the first clamp body;

the distal end of the second connecting section is connected with the proximal end of the first connecting section, and the outer side wall of the second connecting section is provided with at least one clamp connecting part;

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

The width of at least one side of the cross section of the second connecting section is smaller than the width 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 the outer side wall of the first connecting section or concave 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;

the conveying elastic piece is correspondingly provided with a second connecting groove or a second connecting protrusion.

The first connecting section and the second connecting section are of an integrated structure formed by integral molding;

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

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

The proximal end of the second clamp body is provided with a connecting ring, and the connecting ring is 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 integrated structure which is made of memory alloy materials through integrated molding.

The conveying elastic piece is an elastic clamping piece, the proximal end of the elastic clamping piece is fixed with the inner core rod, and the distal end of the elastic clamping piece is in clamping connection with the clamping body connecting part;

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 connecting part of the clamping body.

The elastic clamping piece is axially provided with a stay wire guide groove, and the second stay wire is clamped in the stay wire guide groove and extends to the proximal end of the conveying structure through the guide of the stay wire guide groove.

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

The invention has the positive progress effects that: the mitral valve repair clamp is connected with the conveying structure in a clamping way, the connecting mode of the inner core rod and the connecting rod is changed from threaded connection to clamping connection of the conveying elastic piece, threads do not need to be arranged in the connecting rod, incomplete matching is avoided, and the device is convenient to install and release. Under the condition that the axial directions of the conveying elastic piece and the inner core rod are kept consistent, the second stay wire is arranged on the conveying elastic piece, and when the clamping structure needs to be released, the second stay wire is tensioned, 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 a schematic view of the other side structure of FIG. 1;

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

FIG. 4 is a disassembled view of FIG. 3;

FIG. 5 is a schematic view of the other side structure of FIG. 4;

FIG. 6 is a schematic 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 schematic 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 schematic view of the clip arm spring 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 conveying structure according to the present invention;

fig. 13 is a schematic view of another side structure of fig. 12.

Detailed Description

In order that the manner in which the invention is practiced, as well as the features and objects and functions thereof, will be readily understood and appreciated, the invention will be further described in connection with the accompanying drawings.

Referring to fig. 1-11, a mitral valve repair clip for snap-connection with a delivery structure includes a clip structure 100, a sleeve 200, and a delivery structure 300. The clamping structure 100 has a first clamp 110 and a second clamp 120 that cooperate to clamp the native leaflet. The sleeve 200 serves to constrict the first and

second jaws

110 and 120. The delivery structure 300 has an inner core rod 310 for use with the clip structure, and the delivery structure 300 pushes and releases the clip structure 100 distally through the inner core rod 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 a memory alloy material through integral molding.

The connecting rod 116 comprises a first connecting section 1161 and a second connecting section 1162, wherein the distal end of the first connecting section 1161 is connected with the first clamp 110, the distal end of the second connecting section 1162 is connected with the proximal end of the first connecting section 1161, and at least one clamp connecting part 1163 is arranged on the outer side wall of the second connecting section 1162. The width of at least one side of the cross-section of the second connecting segment 1162 is smaller than the width of the corresponding side of the cross-section of the first connecting segment 1161. So that the clip body connection 1163 on the second connection segment 1162 does not interfere with the fit between the first clip body 110 and the second clip body 120. Specifically, a portion of the second connecting segment 1162 may be cut to form a cutout, and the clip body connecting portion 1163 is disposed in the cutout. Preferably, the outer side wall of the clip body connection 1163 is flush with the outer side wall of the first connection section 1161 or recessed within the outer side wall of the first connection section 1161. The clip body connecting portion 1163 is a first connecting protrusion or is provided with a first connecting groove. The first and

second connection segments

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

Referring to fig. 4, 5 and 9, the connection rod 116 has a cylindrical or oval cylindrical structure as a whole, a first connection section 1161 is formed at an upper portion of the connection rod 116, and a second connection section 1162 is formed by cutting a slit from a bottom surface to a distal end at both sides of the connection rod 116. Two clamp connecting parts 1163 are symmetrically arranged on the second connecting section 1162, and the clamp 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 sleeved outside the connecting rod 116, and preferably the connecting ring 124 is sleeved outside the first connecting section 1161. The second connecting segment 1162 of the connecting rod 116 extends out of the proximal end of the connecting ring 124, so that the clip connection 1163 on the second connecting segment 1162 can be conveniently connected with the inner core rod 310 in a mating manner without affecting the mating between the first clip body 110 and the second clip body 120. The second clamping body 120 and the connecting ring 124 are preferably integrally formed with a memory alloy material.

Referring to fig. 3 to 5 and 12 to 13, at least one conveying elastic member 320 is disposed on the inner core rod 310, the number of conveying elastic members 320 is the same as the number of clip body connecting portions 1163, and one conveying elastic member 320 is in snap-fit connection with a corresponding clip body connecting portion 1163. After the conveying elastic member 320 is engaged with the clip connecting portion 1163, the conveying structure 300 pushes the first clip 110 and the second clip 120 from the inside of the sleeve 200 to a distal preset position via 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 connecting portion 1163, and the conveying structure 300 is separated from the clipped structure. The conveying elastic member 320 is correspondingly provided with a second connection groove or a second connection protrusion. As shown in fig. 12 and 13, the conveying elastic member 320 is correspondingly provided with a second connection groove, which is a through groove or a through hole.

The conveying elastic piece 320 is an elastic clamping piece, the proximal end of the elastic clamping piece is fixed with the inner core rod 310, and the distal end of the elastic clamping piece is connected with the clamp body connecting part 1163 in a clamping way. The elastic clamping piece is provided with a second stay wire 330, and the second stay wire 330 is used as a driving end to drive the elastic clamping piece to be clamped or far away from the clamp body connecting part 1163. The elastic clamping piece is axially provided with a wire pulling guide groove, and the second wire pulling 330 is clamped in the wire pulling guide groove and extends to the proximal end of the conveying structure 300 through the guide of the wire pulling guide groove. The elastic clip is made of memory alloy, and is attached to the outer sidewall of the inner core rod 310 and extends along the axial direction of the inner core rod 310 when no external force is applied.

The present invention may further improve the specific structures of the first clip body 110 and the second clip body 120:

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

The second clamping body 120 includes at least two second clamping arms 121 that mate with the first clamping arms 111. The second clamping arm 121 has a plurality of second friction members 122 on an inner side thereof, the plurality of second friction members 122 being disposed in a row from a distal end to a proximal end. As shown in fig. 1, the number of the second clamping arms 121 is the same as the number 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 in lifting the valve leaflet, the first clamping arm 111 is pushed distally continuously until the valve leaflet is positioned at the proper position of the second clamping arm 121, the first clamping arm 111 and the second clamping arm 121 are pulled back, and the valve leaflet is clamped by the first friction piece 112 and the second friction piece 122 in a mutually matched manner, so that 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 piece 112 and the second friction piece 122 are of zigzag structures, and the zigzag structures on the first friction piece 112 and the zigzag structures on the second friction piece 122 are meshed with each other to clamp the valve leaflet.

Referring to fig. 8, the first friction member 112 adopts a triangular prism structure, wherein a quadrilateral bottom surface of the first friction member 112 is disposed on the first clamping arm 111, two sides of the first friction member 112 are triangular structures, an included angle at a proximal end is a first included angle a, an included angle at a distal end is a second included angle b, an angle of the first included angle a is larger than an angle of the second included angle b, and another included angle c, far away from the first clamping arm 111, of the triangular structures faces the second clamping arm 121. The first included angle a is in the range of 80 deg. -110 deg.. The other included angle c is in the range of 45 deg. -75 deg.. Bottom spacing 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 refers to the distance from the other included angle c of the triangular structure to the first clamping arm 111. Preferably, the height H of the plurality of first friction members 112 gradually decreases in the proximal direction from the distal end of the first clamping arm 111.

Referring to fig. 8, the second friction members 122 have a triangular prism structure, one quadrangular bottom surface of the second friction members 122 is disposed on the second clamping arm 121, two sides of the second friction members 122 are isosceles triangles, and a vertex angle of the second friction members 122 faces the first clamping arm 111.

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

Referring to fig. 1 to 11, the angle between the two first clamping arms 111 is greater than the angle between the two second clamping arms 121. The first clamping arm 111 is provided with a clamping arm elastic member 113, and the second clamping 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 provided 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 piece, a distal end of the clamping arm elastic piece 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 piece. The bending part 114 can lift the slidable member 123 on the second clamping arm 121. The clamping arm spring plate is provided with a spring plate through hole, the spring plate through hole is detachably connected with a first pull wire 115, and the first pull wire 115 drives the clamping arm spring plate to lift or be far away from the slidable piece 123. Preferably, the spring through hole is provided on the bending portion 114. The inner core rod 310 is axially provided with a wire guiding groove 311, and the first wire 115 is clamped in the wire guiding groove 311 and extends to the proximal end of the conveying structure 300 through the guiding of the wire guiding groove 311.

The slidable member 123 is provided on the outer side surface of the second clamping arm 121, and the slidable member 123 is slidably connected to the inner wall of the sleeve 200. The inner side of the slidable member 123 preferably extends beyond the inner side of the second clamping arm 121 so as to be lifted by the bending portion 114. At least a portion of the slidable member 123 contacting the bending portion 114 is a cambered surface. At least a portion of the slidable member 123 contacting the sleeve 200 is a cambered 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 an flaring portion 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 in the axial direction. The sleeve 200 is preferably covered with a sleeve film, which is sewn to the sleeve 200 through the sleeve through hole 220. The sleeve coating is made of 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 silicone 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 along the axial direction of the sleeve 200 on the inner wall of the sleeve 200, so as to drive the second clamping arm 121 to push and pull the sleeve 200 distally. When the distal end of the sleeve 200 is provided with the expanding portion 210, the first clamping arm 111 drives the slidable member 123 to move from the proximal end to the distal end along the axial direction of the sleeve 200 to the expanding portion 210 on the inner wall of the sleeve 200, and then the slidable member 123 moves along the radial direction of the sleeve 200 and is far away from the clamping arm elastic member 113, so that separation between the first clamping arm 111 and the second clamping arm 121 is achieved, 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 invention is specifically used, the conveying elastic element 320 is clamped with the second connecting section 1162 of the first clamp body 110, and the inner core rod 310 drives the second clamp body 120 to push out the sleeve 200 together in the process of pushing the first clamp body 110 from the proximal end to the distal end, so that the second clamping arm 121 of the second clamp body 120 lifts the valve leaflet to the vicinity of the valve leaflet. When the first pull wire 115 is pulled back to ensure that the first clamping body 110 and the second clamping body 120 are separated, the inner core rod 310 pushes the first clamping arm 111 of the first clamping body 110 to continue pushing to the distal end to the preset position, and then the inner core rod 310 pulls back the first clamping body 110, so that the first friction piece 112 of the first clamping arm 111 and the second friction piece 122 of the second clamping arm 121 cooperate with each other to clamp the valve leaflet.

The second pull wire 330 is pulled back, the delivery elastic member 320 is separated from the second connecting segment 1162, the delivery structure 300 is retrieved, and the clamping structure 100 and the sleeve 200 are left at the preset position to clamp the valve leaflet for repairing the heart valve.

The foregoing has shown and described the basic principles, principal 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, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

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

characterized in that the assembly further comprises:

a sleeve converging the first and second clamps;

a conveying structure provided with an inner core rod matched with the clamping structure for use;

the inner core rod is provided with:

after the conveying elastic piece is in clamping connection with the clamping structure, the conveying structure pushes the first clamping body and the second clamping body to a preset position at a far end from the inside 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 proximal end of the conveying elastic piece is fixed with the conveying inner core rod, and the distal end of the conveying elastic piece can be connected with the clamping structure in a clamping mode.

2. The assembly of claim 1, wherein the proximal end of the first clip body is provided with a connecting rod comprising:

3. The assembly of claim 2, wherein the width of at least one side of the cross section of the second connecting section is less than the width of the corresponding side of the cross section of the first connecting section;

4. The assembly of claim 2, wherein the clip body connection is a first connection protrusion or is provided with a first connection groove;

5. The assembly of claim 2, wherein the first connection section and the second connection section are integrally formed as a unitary structure;

6. The assembly of claim 5, wherein the first clamp and the connecting rod are integrally formed as a unitary structure from a memory alloy material.

7. The assembly of any one of claims 2 to 6, wherein a proximal end of the second clamp body is provided with a connecting ring, the connecting ring being sleeved outside the connecting rod;

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

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

8. The assembly of any one of claims 2 to 6, wherein the delivery spring is a spring clip, a proximal end of the spring clip being secured to the inner core rod, a distal end of the spring clip being snap-fittingly connectable to the clip body connection; 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 connecting part of the clamping body.

9. The assembly of claim 8, wherein the resilient clip is provided with a pull wire guide slot axially, and the second pull wire is captured in the pull wire guide slot and extends to the proximal end of the delivery structure via the guide of the pull wire guide slot.

10. The assembly of claim 8, wherein the resilient clip is a memory alloy that engages the outer sidewall of the core rod and extends axially of the core rod when not subjected to an external force.