CN113796993B

CN113796993B - Mitral valve repair clamp with stable clamping

Info

Publication number: CN113796993B
Application number: CN202111186662.9A
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: 2023-07-07
Anticipated expiration: 2041-10-12
Also published as: CN113796993A

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a mitral valve repair clamp. A clamp-on stabilized mitral valve repair clamp, comprising: the clamping structure is provided with a first clamping body and a second clamping body, the first clamping body comprises at least two first clamping arms, and the second clamping body comprises at least two second clamping arms; the first clamping arm has on its outer side: a plurality of first friction members disposed in a row from a distal end to a proximal end and facing the second clamping arm; the second clamping arm has on its inner side: a plurality of second friction members are disposed in a row from the distal end to the proximal end and face the first clamping arm. According to the mitral valve repair clamp, the first friction piece is arranged on the first clamping arm, the second friction piece is arranged on the second clamping arm, and the valve leaflet is clamped through the mutual matching of the first friction piece and the second friction piece, so that the valve is prevented from falling off due to heart contraction in the later use process of the mitral valve repair clamp.

Description

Mitral valve repair clamp with stable clamping

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.

In performing an annuloplasty procedure, it is necessary to use a prosthetic clip, typically using first and second clamping arms to cooperatively clamp the leaflet. It is generally recognized in the industry that the first clamping arm serves to capture the leaflet and to drive the captured leaflet into clamping engagement with the second clamping arm. Thus, the first clamping arm is typically provided with barbs, which are designed to be very sharp and thin in order to be able to penetrate the leaflet. However, according to a plurality of clinical experiments, the second clamping arm is generally placed near the valve leaflet, namely, the function of lifting the valve leaflet is achieved, the first clamping arm is pushed to the distal end continuously, and when the valve leaflet is located at the proper position of the second clamping arm, the first clamping arm is pulled back to be matched with the second clamping arm, namely, the barbs on the first clamping arm only play a friction role, namely, the valve is prevented from falling off due to the shrinkage of the heart in the later use process of the repair clamp.

Disclosure of Invention

The invention aims at solving the technical problem that the existing mitral valve repair clamp cannot be suitable for actual use scenes, and aims to provide a clamping stable mitral valve repair clamp.

A clamp-on stabilized mitral valve repair clamp, 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, the first clamping body comprises at least two first clamping arms, and the second clamping body comprises at least two second clamping arms matched with the first clamping arms;

the first clamping arm has on its outer side:

a plurality of first friction members disposed in a row from a distal end to a proximal end and directed toward the second clamping arm;

the second clamping arm has on its inner side:

a plurality of second friction members are disposed in a row from the distal end to the proximal end and toward the first clamping arm.

According to the invention, the first friction piece is arranged on the first clamping arm, and the second friction piece is arranged on the second clamping arm, so that in the actual use process, the second clamping arm is placed near the valve leaflet through the conveying structure, the second clamping arm plays a role of lifting the valve leaflet, the first clamping arm is pushed to the far end continuously, when the valve leaflet is positioned at the proper position of the second clamping arm, the first clamping arm and the second clamping arm are pulled back, and the valve leaflet is clamped by the first friction piece and the second friction piece 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 and the second friction piece are of zigzag structures, and the zigzag structures of the first friction piece and the zigzag structures of the second friction piece are meshed with each other to clamp the valve leaflet.

The first friction piece adopts the triangular prism structure, a quadrilateral bottom surface in the first friction piece set up in on the first clamping arm, two sides of first friction piece are triangle-shaped structure, in the triangle-shaped structure with in the two contained angles of first clamping arm junction, the contained angle that is located the near-end is first contained angle, and the contained angle that is located the distal end is the second contained angle, the angle of first contained angle is greater than the angle of second contained angle, another contained angle that keeps away from first clamping arm in the triangle-shaped structure is towards the second clamping arm.

The first included angle ranges from 80 degrees to 110 degrees.

The angle of the other included angle ranges from 45 degrees to 75 degrees.

Bottom spacing of two adjacent first friction pieces: the height of the first friction piece is 1:0.5-1.5.

The heights of the plurality of first friction members gradually decrease along the proximal direction from the distal ends of the first clamping arms.

The second friction piece adopts the triangular prism structure, one quadrilateral bottom surface in the second friction piece set up in on the second clamping arm, two sides of second friction piece are isosceles triangle, the apex angle of second friction piece is towards the first clamping arm.

The distal ends of the first clamping arms and the distal ends of the second clamping arms are respectively coated with a clamping arm coating film.

The sandwich arm coating film 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 invention has the positive progress effects that: the invention adopts the mitral valve repair clamp with stable clamping, and the valve is prevented from falling off due to heart contraction in the later use process by arranging the first friction piece on the first clamping arm and arranging the second friction piece on the second clamping arm and clamping the valve leaflet through the mutual matching of the first friction piece and the second friction piece.

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 clip stabilized mitral valve repair clip includes a clip structure 100, the clip structure 100 having a first clip body 110 and a second clip body 120 that cooperate to clip a native leaflet.

The first clamping body 110 includes at least two first clamping arms 111, and a plurality of first friction members 112 are disposed on an outer side surface of the first clamping arms 111, and the plurality of first friction members 112 are disposed 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.

The mitral valve repair clip of the present invention can further include a sleeve 200 and a delivery structure 300. The sleeve 200 serves to constrict the first and

second jaws

110 and 120. The delivery structure 300 is used to push and release the clip structure 100 distally.

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 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.

The delivery structure 300 has an inner core rod 310 for use with a nip structure. 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 conveying structure 300 and the clamping structure of the invention are matched to use the mode of clamping connection of the conveying elastic piece, and the concrete structure is as follows:

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. As shown in fig. 4, 5 and 9, the connecting rod 116 has a cylindrical or oval cylindrical structure as a whole, the upper portion of the connecting rod 116 is a first connecting section 1161, and two sides of the connecting rod 116 are respectively cut from the bottom surface to the distal end to form a second connecting section 1162. 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.

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 clamp-on stabilized mitral valve repair clamp, 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, the first clamping body comprises at least two first clamping arms, and the second clamping body comprises at least two second clamping arms matched with the first clamping arms;

the first clamping arm is characterized in that the outer side surface of the first clamping arm is provided with:

the second clamping arm has on its inner side:

a plurality of second friction members disposed in a row from a distal end to a proximal end and facing the first clamping arm;

the first friction piece adopts a triangular prism structure, one quadrilateral bottom surface in the first friction piece is arranged on the first clamping arm, two side surfaces of the first friction piece are triangular structures, one included angle positioned at the near end of two included angles in the triangular structures at the joint of the triangular structures and the first clamping arm is a first included angle, the other included angle positioned at the far end of the triangular structures is a second included angle, the angle of the first included angle is larger than that of the second included angle, and the other included angle far away from the first clamping arm in the triangular structures faces the second clamping arm;

the angle range of the other included angle is 45-75 degrees;

bottom spacing of two adjacent first friction pieces: the height of the first friction piece is 1:0.5-1.5;

the second friction pieces are of triangular prism structures, and a bottom interval is reserved between two adjacent second friction pieces.

2. The pinch-stable mitral valve repair clip of claim 1, wherein the first friction member and the second friction member each have a zigzag structure, and the zigzag structures on the first friction member and the second friction member are engaged with each other to grip the leaflet.

3. The pinch-stabilized mitral valve repair clip of claim 1, wherein the first included angle ranges from 80 ° to 110 °.

4. The pinch-stabilized mitral valve repair clip of claim 1, wherein a plurality of the first friction members decrease in height in a proximal direction from the distal end of the first pinch arm.

5. The pinch-stabilized mitral valve repair clip of claim 1, wherein one quadrilateral bottom surface of the second friction member is disposed on the second pinch-off arm, two sides of the second friction member are isosceles triangles, and a vertex angle of the second friction member faces the first pinch-off arm.

6. The pinch-stabilized mitral valve repair clip of claim 1, wherein the distal ends of the first and second pinch arms are each covered with a pinch arm coating.

7. The pinch-stabilized mitral valve repair clip of claim 6, wherein the material of the pinch-arm coating is a polymeric material or a natural pericardial material, the polymeric material being at least one of expanded polytetrafluoroethylene, polyester, polyurethane, polypropylene, or silicone rubber.