CN109953778B

CN109953778B - Clamping device and system for fixing tissue

Info

Publication number: CN109953778B
Application number: CN201711435776.6A
Authority: CN
Inventors: 谢琦宗; 麦锐诚; 王刚; 江巍
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2017-12-26
Filing date: 2017-12-26
Publication date: 2022-02-22
Anticipated expiration: 2037-12-26
Also published as: CN109953778A

Abstract

The invention discloses a clamping device and a system for fixing tissues, wherein the clamping device comprises two clamping units, each clamping unit comprises a clamping mechanism for capturing the tissues, each clamping mechanism comprises a first clamping part and a second clamping part which is rotatably connected to the first clamping part, and the two first clamping parts are connected in a sliding manner. The invention has the beneficial effects that: because the two clamping mechanisms can slide in a staggered manner, the relative positions of the two clamping mechanisms can be adjusted firstly, and then the clamping mechanisms are closed, so that the two valve leaflets can be completely clamped.

Description

Clamping device and system for fixing tissue

Technical Field

The invention relates to the technical field of medical instruments, in particular to a clamping device and a system for fixing tissues.

Background

The mitral valve includes a pair of leaflets that are positioned between the left atrium and the left ventricle and that open and close naturally to control the proper direction of blood flow in the atria and ventricles. Normally, the mitral valve allows blood to flow in one direction from the left atrium to the left ventricle, but if the mitral valve is not completely closed during the opening and closing process, the flowing blood flows backwards in the opposite direction, i.e. mitral regurgitation. The heart, lungs and other organs are heavily loaded by the retrograde flow of blood, and this additional load can lead to heart failure, irregular heartbeat, stroke, and even sudden death. In the case of mitral regurgitation, it is currently possible to deliver an implantable coaptation device to the coaptation of incompetent leaflets by percutaneous intervention, by which the free edges of both leaflets are simultaneously coapted, closing the mitral valve. However, in the case of beating the heart, it is difficult to simultaneously perform clamping of two leaflets, and when the valve has a misaligned flail structure, that is, an asymmetric structure of two leaflets, if the clamping device is used for clamping, there may be a defect that one leaflet is completely clamped, the clamping area of the other leaflet is too small or cannot be clamped, and the clamping area of the leaflets is too small, which may easily cause the clamping device to be separated from the leaflets.

Disclosure of Invention

The present invention is directed to a clamping device and a system for fixing tissue, which overcome the above-mentioned shortcomings in the prior art.

The technical scheme adopted by the invention for solving the technical problems is as follows:

the clamping device comprises two clamping units, each clamping unit comprises a clamping mechanism for capturing tissues, each clamping mechanism comprises a first clamping part and a second clamping part which is rotatably connected to the first clamping part, and the two first clamping parts are connected in a sliding mode.

In the clamping device of the invention, at least one guide rail is arranged on one of the two first clamping parts, and at least one guide piece is arranged on the other one of the two first clamping parts and is slidably inserted in the guide rail.

In the clamping device, a sliding part is arranged between the two first clamping parts, the sliding part is provided with at least two guide rails, and each first clamping part is provided with at least one guide piece matched with the guide rails; or, the sliding part is provided with at least two guide pieces, and each first clamping part is provided with at least one guide rail matched with the guide piece.

In the clamping device of the present invention, the guide rail is in interference fit with the guide.

In the clamping device, a blocking structure used for limiting the staggered sliding distance between the two clamping units is further arranged between the two first clamping parts.

In the clamping device of the present invention, the clamping unit further includes a pull rod mechanism connected to the clamping mechanism, one end of the pull rod mechanism is slidably connected to the first clamping portion, the other end of the pull rod mechanism is rotatably connected to the second clamping portion, and the pull rod mechanism drives the second clamping portion to rotate relative to the first clamping portion when moving toward the proximal end of the first clamping portion, so as to close the clamping mechanism.

In the clamping device, a limiting mechanism is arranged between the first clamping part and the pull rod mechanism, and the limiting mechanism enables the pull rod mechanism to be fixed on the first clamping part after the clamping mechanism is closed.

In the clamping device of the present invention, the second clamping portion includes a rotating portion and a joint portion connected to each other, and the rotating portion is rotatably connected to the first clamping portion.

In the clamping device, the pull rod mechanism comprises a slide block and at least one pull rod connected to the slide block, the slide block is slidably connected to the first clamping part, one end of the pull rod is rotatably connected with the slide block, and the other end of the pull rod is rotatably connected with the joint part.

In the clamping device of the invention, the clamping mechanism further comprises a first limiting part arranged on the first clamping part and a second limiting part arranged on the second clamping part, and the first limiting part is tightly connected with the second limiting part when the clamping mechanism is closed.

In the clamping device of the present invention, the first limiting portion is a limiting block disposed on the first clamping portion, the second limiting portion is a protrusion disposed on the rotating portion, and the first limiting portion is in interference fit with the second limiting portion when the clamping mechanism is closed.

In the clamping device, at least one sliding groove is formed in the first clamping portion, the sliding groove extends to the near end of the first clamping portion, and one end of the pull rod mechanism is connected into the sliding groove.

In the clamping device of the present invention, a surface of the first clamping portion opposite to the second clamping portion is a first engaging surface, a surface of the second clamping portion opposite to the first clamping portion is a second engaging surface, and a plurality of barbs or protrusions are disposed on the first engaging surface and/or the second engaging surface.

The invention also provides a system for fixing tissues, which comprises the clamping device and a braking mechanism connected to the clamping device, wherein the braking mechanism comprises at least one first connecting rod detachably connected with the clamping mechanism of the clamping device and at least one second connecting rod connected with the pull rod mechanism of the clamping device.

In summary, the clamping device and the tissue fixing system of the present invention have the following advantages: the clamping device comprises two clamping units, each clamping unit comprises a clamping mechanism for capturing tissues, the clamping mechanisms of the two clamping units can slide in a staggered mode, in actual operation, the relative positions of the two clamping mechanisms can be adjusted firstly, the two clamping mechanisms are close to corresponding valve leaflets respectively, and then the clamping mechanisms are closed, so that the two valve leaflets can be completely clamped.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

fig. 1 is a schematic structural diagram of a clamping device according to a preferred embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of the guide rail and guide of the guide mechanism of the clamping device of FIG. 1 in a dovetail configuration;

FIG. 3 is a schematic cross-sectional view of the guide rail and guide of the guide mechanism of the clamping device of FIG. 1, which is T-shaped;

FIG. 4 is a schematic cross-sectional view of the guide rail and the guide of the guide mechanism of the clamping device shown in FIG. 1;

FIG. 5 is a schematic view of the guide mechanism of the clamping device of FIG. 1 including a slider;

FIG. 6 is a schematic view of the clamping mechanism of the clamping device of FIG. 1;

FIG. 7 is a schematic view of the clamping mechanism of the clamping device of FIG. 1 shown open;

FIG. 8 is a schematic view of the clamping mechanism of the clamping device of FIG. 1 closed;

FIG. 9 is a schematic view of the clamping device of FIG. 1 showing the two clamping mechanisms sliding in a staggered manner;

FIG. 10 is a schematic view of a closed clamping mechanism of the clamping device of FIG. 9;

FIG. 11 is a schematic view of the closure of the two clamping mechanisms of the clamping device of FIG. 9;

FIG. 12 is a schematic view of the structure of a limiting mechanism of the clamping device shown in FIG. 1;

FIG. 13 is a schematic view of the retainer mechanism of FIG. 12 with the retainer member not engaged in the retaining groove;

FIG. 14 is a schematic view of the securing member of the spacing mechanism of FIG. 12 attached within a securing slot;

FIG. 15 is a schematic structural diagram of a clamping device according to a second preferred embodiment of the present invention;

FIG. 16 is a schematic view of the pull rod mechanism of the clamping device of FIG. 15;

FIG. 17 is a schematic view of the structure of the drawbar mechanism shown in FIG. 16;

FIG. 18 is a schematic structural diagram of a clamping device according to a third preferred embodiment of the present invention;

FIG. 19 is a schematic view of the clamping mechanism of the clamping device of FIG. 18 shown open;

FIG. 20 is a schematic view of the clamping mechanism of the clamping device of FIG. 18 closed;

FIG. 21 is a schematic structural view of a system for tissue fixation according to a preferred embodiment of the present invention;

FIG. 22 is an enlarged view of portion G of the system shown in FIG. 21;

FIG. 23 is a schematic structural view of a braking mechanism of the system shown in FIG. 21;

FIG. 24 is a schematic view of the system of FIG. 21 deployed to the left atrium using interatrial puncture and with the clamping device and detent mechanism pushed through the valve and into the left ventricle;

FIG. 25 is a schematic view of the clamping device of FIG. 24 open;

FIG. 26 is a schematic view of the clipping device and the braking mechanism of FIG. 25 being retrieved to the valve;

figure 27 is a schematic view of one of the clamping mechanisms of the clamping device of figure 26 closed, clamping the respective leaflet;

fig. 28 is a schematic view of another coaptation mechanism of the coaptation device shown in fig. 27 closed, clamping the corresponding leaflet;

fig. 29 is a schematic view of the clamping device shown in fig. 27 after the pull rod mechanism is removed.

Detailed Description

For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

It should be noted that "distal" and "proximal" are used as terms of orientation that are commonly used in the field of interventional medical devices, wherein "distal" refers to the end that is distal from the operator during the procedure, and "proximal" refers to the end that is proximal to the operator during the procedure. Axial, meaning a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; radial, means the distance from the axis in a direction perpendicular to the axial direction, and means the distance to the axis in the radial direction.

As shown in fig. 1, the present invention provides an implantable clipping device that is applicable to procedures including endovascular, minimally invasive and open surgical procedures, and can be used in various anatomical areas, such as the abdomen, thorax, cardiovascular system, heart or other organs, vessels and tissues, etc. Particularly in procedures requiring minimally invasive or intravascular access to remote tissue locations. The clamping device of the present invention is used to fix tissue at a treatment site, applications of which include heart valve repair, septal defect repair, vessel ligation and clamping, laceration repair and wound closure, and is particularly useful in repairing heart valves, particularly mitral valves, as a preferred mode of treatment for regurgitation.

Referring to fig. 1, the clamping device 10 includes two clamping units 20, each clamping unit 20 includes a clamping mechanism 100 for capturing tissue, and a pull rod mechanism 200 connected to the clamping mechanism 100. The clamping mechanisms 100 of the two clamping units are connected in a sliding manner, so that the two clamping mechanisms 100 can slide in a staggered manner, and the pull rod mechanism 200 is used for closing the clamping mechanisms 100 to clamp tissues. Because the two clamping mechanisms 100 can slide relatively, in actual operation, the relative positions of the two clamping mechanisms 100 can be adjusted, so that the two clamping mechanisms 100 are respectively close to the corresponding valve leaflets, the two valve leaflets can be completely clamped, and the defects that one valve leaflet is completely clamped, the clamping area of the other valve leaflet is too small or the other valve leaflet cannot be clamped are avoided.

Referring to fig. 2, a guide mechanism 140 for sliding the two clamping mechanisms 100 in a staggered manner is disposed between the two clamping mechanisms 100, the guide mechanism 140 includes a guide rail 141 disposed on one clamping mechanism 100 and a guide member 142 disposed on the other clamping mechanism 100, the guide rail 141 is distributed along the axial direction of the clamping mechanism 100, i.e., extends from the distal end of the clamping mechanism 100 to the proximal end of the clamping mechanism 100, and the guide member 142 is slidably inserted in the guide rail 141. In this embodiment, the guide rail 141 is a dovetail groove, the guide 142 is a dovetail boss matched with the dovetail groove, the guide rail 141 and the guide 142 are in interference fit, and the size range of the interference fit is 0.1mm to 1mm, so that the guide 142 can only move along the rail direction of the guide rail 141, and the two clamping mechanisms 100 are prevented from shaking when sliding relatively, thereby improving the accuracy of the staggered sliding of the two clamping mechanisms 100.

It is understood that in other embodiments, the cross-sections of the guide rail 141 and the guide member 142 may have other shapes, as shown in fig. 3, the cross-sections of the guide rail 141 and the guide member 142 are both T-shaped, or as shown in fig. 4, the cross-sections of the guide rail 141 and the guide member 142 are both circular arc-shaped. The present invention is not limited to the specific structure of the guide rail 141 and the guide 142, as long as the guide 142 is slidably coupled in the guide rail 141. Preferably, the cross-sectional shape of rail 141 is the same as the cross-sectional shape of guide 142, and rail 141 and guide 142 are in an interference fit.

It is understood that in other embodiments, the guiding mechanism 140 may have other structures, as shown in fig. 5, the guiding mechanism 140 includes a sliding member 143 between the two clamping mechanisms 100, two guiding members 142 respectively disposed at two sides of the sliding member 143, and a guiding rail 141 disposed on the clamping mechanisms 100, the guiding rail 141 of each clamping mechanism 100 is slidably connected to the corresponding guiding member 142 on the sliding member 143, and the clamping mechanism 100 slides in a staggered manner relative to the sliding member 143. Alternatively, in other embodiments, the guide 142 is disposed on the clamping mechanism 100, the guide rail 141 is disposed on the sliding member 143, and the guide 142 of each clamping mechanism 100 is slidably connected with the corresponding guide rail 141 on the sliding member 143.

Preferably, when the two clamping mechanisms 100 are directly connected in a sliding manner, the static friction force between the two clamping mechanisms 100 is greater than the gravity of any one clamping unit 20 of the two clamping units 20, so that the two clamping units 20 can slide relative to each other only under the action of an external force, and the two clamping units 20 are prevented from moving relative to each other under the action of the gravity of the two clamping units 20, thereby improving the accuracy of the staggered sliding between the two clamping units 20. Or, when the two clamping mechanisms 100 are slidably connected through the sliding member 143, the static friction force between the clamping mechanisms 100 and the sliding member 143 is greater than the gravity of the sliding member 143 and the clamping unit 20, which is relatively heavy, so that the clamping unit 20 and the sliding member 143 can slide with each other only under the action of an external force, and the two clamping units 20 are prevented from moving relatively under their own gravity.

Further, a blocking structure is further disposed between the two clamping mechanisms 100, and the blocking structure is used for limiting the maximum distance for the two clamping mechanisms 100 to slide in a staggered manner, so as to prevent the guide 142 from being separated from the end of the guide rail 141 when the two clamping mechanisms 100 slide. For example, the blocking structure may be a stopper respectively disposed at both ends of the guide rail 141, and when the guide 142 abuts against one stopper of the guide rail 141, the two clamping mechanisms 100 do not continue to slide relatively without an external force. Alternatively, in other embodiments, the blocking structure comprises a positioning groove (e.g., a positioning groove disposed at the bottom of the guide rail 141, a positioning groove disposed on the side wall of the guide rail 141, a positioning groove disposed on the wall of the guide rail 141 opposite to the other clamping mechanism 100, etc.) disposed on one clamping mechanism 100 and a blocking member disposed on the other clamping mechanism 100, the blocking member is slidably connected in the positioning groove, and when the blocking member slides to the end of the positioning groove, the two clamping mechanisms 100 do not slide relative to each other. Alternatively, in other embodiments, the blocking structure comprises a first blocking member disposed on one of the first clamping portions and a second blocking member disposed on the other of the first clamping portions, and when the first blocking member abuts against the second blocking member, the two clamping mechanisms 100 do not continue to slide relative to each other.

Referring to fig. 6, each of the clamping mechanisms 100 includes a first clamping portion 110, and a second clamping portion 120 rotatably connected to a distal end of the first clamping portion 110, and the leaflet is grasped between the first clamping portion 110 and the second clamping portion 120. The guide mechanism 140 is disposed between the two first clamping portions 110, and slidably connects the two first clamping portions 110.

The first clamping portion 110 includes a first end portion 111 and a second end portion 112 connected to a distal end of the first end portion 111. The second end 112 is rotatably connected to the second clamping portion 120, a surface of the first end 111 opposite to the second clamping portion 120 is a first engagement surface 113 for capturing the valve leaflet, the first end 111 is provided with at least one sliding slot 114 slidably connected to the rod mechanism 200, and the sliding slot 114 is axially distributed along the first clamping portion 110 and extends to a proximal end of the first end 111.

The second clamping portion 120 includes a rotating portion 121, and an engaging portion 122 connected to the rotating portion 121. The rotating portion 121 and the second end portion 112 are connected in a matched and rotating manner through a shaft hole, the joint portion 122 is provided with an installation hole 124 connected with the pull rod mechanism 200 in a rotating manner, and a surface of the joint portion 122 opposite to the first clamping portion 110 is a second joint surface 123 for capturing the valve leaflet.

Referring to fig. 7, when the clamping mechanism 100 is opened, the first engagement surface 113 and the second engagement surface 123 move away from each other to capture a leaflet therebetween. Referring to fig. 8, when the clamping mechanism 100 is closed, the first engagement surface 113 and the second engagement surface 123 are brought closer together, trapping the leaflet therebetween. In order to improve the stability of the connection between the clipping mechanism 100 and the valve leaflet and to prevent the clipping mechanism 100 from falling off, a plurality of barbs, protrusions or other anti-slip structures may be respectively disposed on the first engaging surface 113 and the second engaging surface 123. Alternatively, at least one concave portion may be provided on the first engaging surface 113, and at least one convex portion may be provided on the second engaging surface 123, wherein the convex portion is inserted into the concave portion after the clamping mechanism 100 is closed, and the convex portion and the concave portion are in interference fit.

In this embodiment, the first engaging surface 113 and the second engaging surface 123 are flat surfaces, and it is understood that in other embodiments, the first engaging surface 113 may be a convex arc surface, and the second engaging surface 123 is a concave arc surface adapted to the convex arc surface; alternatively, the first bonding surface 113 and the second bonding surface 123 may be other curved surfaces such as concave and convex surfaces that are matched with each other.

Further, the clamping mechanism 100 further includes a self-locking mechanism 130, and when the clamping mechanism 100 is closed, the self-locking mechanism 130 enables the first clamping portion 110 and the second clamping portion 120 to be fixedly connected, so as to prevent the clamping mechanism 100 from being automatically opened.

Referring to fig. 6, the self-locking mechanism 130 includes a first position-limiting portion 131 disposed on the first clamping portion 110, and a second position-limiting portion 132 disposed on the second clamping portion 120, and when the clamping mechanism 100 is closed, the first position-limiting portion 131 is tightly connected with the second position-limiting portion 132.

In this embodiment, the rotating portion 121 has two connecting plates 1211 disposed opposite to each other, and the second end portion 112 is inserted between the two connecting plates 1211 and is rotatably connected to the two connecting plates 1211 through the shaft hole. The width of the second end portion 112 is adapted to the distance between the two connecting plates 1211 and is smaller than the width of the first end portion 111. The first position-limiting portion 131 is an end surface of the distal end of the first end portion 111, and the second position-limiting portion 132 is a protrusion disposed on the connecting plate 1211, which is integrally formed with the rotating portion 121 and connected to form a cam structure. When the clamping mechanism 100 is closed, the protrusions on the connecting plate 1211 are in interference fit with the end surface of the distal end of the first end portion 111, so that the first clamping portion 110 and the second clamping portion 120 are tightly connected together. Preferably, in order to enhance the connection strength between the protrusion on the connection plate 1211 and the end surface of the distal end of the first end portion 111 and prevent the clamping mechanism 100 from automatically opening, the interference size between the protrusion on the connection plate 1211 and the end surface of the distal end of the first end portion 111 is 0.2mm to 1 mm.

It should be understood that the present invention is not limited to the specific structure and the installation position of the first position-limiting portion 131 and the second position-limiting portion 132, as long as the clamping mechanism 100 is closed, and the first position-limiting portion 131 and the second position-limiting portion 132 can be tightly connected. For example, referring to fig. 7 and 8, in other embodiments, the first position-limiting part 131 is a position-limiting block disposed on the side of the second end part 112, and when the clamping mechanism 100 is closed, the protrusion on the connecting plate 1211 is in interference fit with the position-limiting block, so that the first clamping part 110 is fixedly connected with the second clamping part 120. Alternatively, in other embodiments, the first position-limiting part 131 is a position-limiting block disposed on an end surface or a side surface of the distal end of the first end 111, and the second position-limiting part 132 is a protrusion disposed on a top surface or a side surface of the rotating part 121. Alternatively, in other embodiments, the first position-limiting portion 131 and the second position-limiting portion 132 are fixedly connected by fastening, for example, the first position-limiting portion 131 is a fastening structure disposed on the first clamping portion 110, and the second position-limiting portion 132 is a slot structure disposed on the second clamping portion 120, and when the clamping mechanism 100 is closed, the fastening structure and the slot structure are fastened together, so that the first position-limiting portion 131 and the second position-limiting portion 132 are fixedly connected.

It is also understood that in other embodiments, the rotating portion 121 may include only one connecting plate 1211, and the connecting plate 1211 is located on one side of the second end portion 112 and is rotatably connected to the second end portion 112. The present invention is not limited to the specific structure of the rotating part 121, as long as the rotating part 121 is rotatably connected to the second end 112.

Further, the clamping mechanism 100 further comprises a positioning mechanism (not shown) for preventing the second clamping part 120 from rotating further to the side far away from the first clamping part 120 when the clamping mechanism 100 is fully opened. For example, the positioning structure includes a first positioning block fixed on the end surface of the distal end of the first end portion 111 and a second positioning block fixed on the rotating portion 121, when the clamping mechanism 100 is completely opened, the first positioning block and the second positioning block abut against each other, so that the second clamping portion 120 cannot rotate towards the side far away from the first clamping portion 120. Preferably, the second nip 120 is distributed substantially in a direction perpendicular to the first nip 110 when the nip mechanism 100 is fully opened.

Referring to fig. 9, one end of the pull rod mechanism 200 is slidably connected to the first clamping portion 110, and the other end of the pull rod mechanism 200 is rotatably connected to the second clamping portion 120. When the pull rod mechanism 200 slides towards the proximal end of the first clamping portion 110, the second clamping portion 120 is driven to rotate relative to the first clamping portion 110, so that the clamping mechanism 100 is closed.

The pull rod mechanism 200 includes a slider 210 and at least one pull rod 220, the slider 210 is slidably connected in the sliding slot 114 of the first clamping portion 110, a proximal end of the pull rod 220 is rotatably connected to the slider 210, and a distal end of the pull rod 220 is rotatably connected to the second clamping portion 120. In this embodiment, the number of the pull rods 220 is two, and the two pull rods 220 are respectively disposed on two sides of the second clamping portion 120.

In practice, referring to fig. 9, the relative positions of the two first clamping portions 110 can be adjusted to make the two second clamping portions 120 close to the corresponding leaflets, respectively, so as to ensure that both leaflets can be completely clamped. Referring to fig. 10 and 11, after the second clamping portion 120 approaches the corresponding leaflet, the two clamping mechanisms 100 are sequentially closed by the rod mechanism 200 to completely clamp the two leaflets.

Further, a limiting mechanism is disposed between the sliding block 210 and the sliding slot 114, and when the clamping mechanism 100 is closed, the limiting mechanism fixes the sliding block 210 on the first clamping portion 110, so as to prevent the sliding block 210 from sliding under the action of gravity. Referring to fig. 12, 13 and 14, the stopper mechanism includes a fixing member 151 fixed to an inner wall of the slide groove 114, and a fixing groove 152 provided on the slider 210. When the clamping mechanism 100 is closed, the sliding block 210 continues to move toward the proximal end of the first clamping portion 110 until the fixing member 151 is held in the fixing groove 152, so as to prevent the sliding block 210 from sliding downward. Preferably, in this embodiment, the fixing member 151 is provided with a circular arc structure 153 to facilitate the fixing member 151 to enter the fixing groove 152. It is understood that in other embodiments, the fixing member 151 of the limiting mechanism may be disposed on the sliding block 210, and the fixing groove 152 may be disposed on the inner wall of the sliding groove 114.

Fig. 15 to 17 illustrate a clamping device according to a second preferred embodiment of the present invention, which is different from the first preferred embodiment in that the structure of the pulling rod mechanism 200 is different, in this embodiment, after the clamping mechanism 100 is closed, the pulling rod mechanism 200 can be separated from the clamping mechanism 100, so as to reduce the weight of the clamping device, reduce the burden on the valve, reduce the probability of the clamping device falling off the valve, and improve the stability of the clamping device.

Referring to fig. 15, the pull rod mechanism 200 includes a slider 210 and at least one pull rod 220, the slider 210 is slidably connected in the sliding slot 114 of the first clamping portion 110, a proximal end of the pull rod 220 is rotatably connected to the slider 210, and a distal end of the pull rod 220 is rotatably connected to the second clamping portion 120. In this embodiment, the number of the pull rods 220 is two, the two pull rods 220 are respectively disposed on two sides of the second clamping portion 120, two sides of the second clamping portion 120 are respectively disposed with a rotating shaft 125, and the rotating shaft 125 is located on the joint portion 122 of the second clamping portion 120.

Referring to fig. 16, the drawbar mechanism 200 further includes an anchoring line 230 fixed to the drawbar 220, the anchoring line 230 and the drawbar 220 define a connection hole 221 matching with the shaft 125, and the size of the hole diameter of the connection hole 221 is adjustable. Referring to fig. 17, the pull rod 220 is a hollow structure, and a through hole 222 is formed therein and penetrates through the proximal end and the distal end of the pull rod 220, one end of the anchor wire 230 is fixed to the distal end of the pull rod 220, and the other end of the anchor wire 230 is a free end, and the free end penetrates through the through hole 222 at the distal end of the pull rod 220 and penetrates through the through hole 222 at the proximal end of the pull rod 220. In operation, the size of the aperture of the connection hole 221 can be adjusted by tightening or loosening the anchor line 230. Preferably, the distal end of the pull rod 220 is provided with an arc-shaped groove 223 matched with the rotating shaft 125, and the arc-shaped groove 223 and the anchoring line 230 jointly enclose a connecting hole 221 matched with the rotating shaft 125. The anchoring line 230 may be made of metal wire, such as stainless steel, nitinol, cobalt-chromium alloy, or the like, or polymer wire, such as nylon, polyurethane, PE, Pebax, or the like.

In operation, the anchor wire 230 is tightened to securely connect the anchor wire 230 to the shaft 125, and when the clamping mechanism 100 is closed, the anchor wire 230 is loosened and the anchor wire 230 is no longer securely connected to the shaft 125. As the pull rod 220 moves towards the proximal end of the first clamping portion 110, the anchor wire 230 moves towards the distal end near the first clamping portion 110 relative to the pull rod 220 until the anchor wire 230 disengages from the through hole in the pull rod 220, causing the distal end of the pull rod 220 to disengage from the rotation shaft 125, thereby disconnecting the pull rod mechanism 200 from the second clamping portion 120.

It should be understood that the invention is not limited to the specific manner in which the anchoring wire 230 and the pull rod 220 enclose the connection hole 221, and in other embodiments, the pull rod 220 may be a non-hollow structure, with one end of the anchoring wire 230 being fixed to the distal end of the pull rod 220 and the other end of the anchoring wire 230 being a free end that is wound directly from the outside of the pull rod 220 to the proximal end of the pull rod 220. Or, a mounting groove is formed on the side wall of the pull rod 220, the mounting groove extends from the distal end of the pull rod 220 to the proximal end of the pull rod 220, one end of the anchor line 230 is fixed to the distal end of the pull rod 220, the other end of the anchor line 230 is a free end, and the free end of the anchor line 230 extends from the distal end of the pull rod 220 to the proximal end of the pull rod 220 through the mounting groove.

Fig. 18 to 20 show a clamping device provided in the third preferred embodiment of the present invention, which is different from the second preferred embodiment in that the structure of the rotational connection between the pulling rod mechanism 200 and the clamping mechanism 100 is different.

Referring to fig. 18, the pull rod mechanism 200 includes a slider 210 and at least one pull rod 220, the slider 210 is slidably connected in the sliding slot 114 of the first clamping portion 110, a proximal end of the pull rod 220 is rotatably connected to the slider 210 through a shaft hole, a notch 225 and a limiting hole 224 communicated with the notch 225 are disposed at a distal end of the pull rod 220, the rotating shaft 124 is rotatably connected in the limiting hole 224, a width of the notch 225 is smaller than an inner diameter of the limiting hole 224, and a width of the notch 225 is smaller than a length of the rotating shaft 124 and larger than a width of the rotating shaft 124. When the clamping mechanism is closed, the shaft 124 is disengaged from the notch 225. The width of the notch 225 refers to the diameter of an inscribed circle of the section of the notch 225 in the direction perpendicular to the depth direction of the limiting hole 224, the length of the rotating shaft 124 refers to the length of the smallest circumscribed rectangle of the cross section of the rotating shaft, and the width of the rotating shaft 124 refers to the width of the smallest circumscribed rectangle of the cross section of the rotating shaft.

In this embodiment, the cross section of the rotating shaft 124 is substantially rectangular, the length of the rotating shaft 124 is matched with the inner diameter of the limiting hole 224, and the width of the rotating shaft 124 is matched with the width of the notch 225. Referring to fig. 19, when the clamping mechanism 100 is in the fully open state, the straight line where the length of the rotating shaft 124 is parallel to the line connecting two points where the contour line of the notch 225 on the cross section perpendicular to the depth direction of the position-limiting hole 224 intersects with the contour line of the position-limiting hole 224, and the length of the rotating shaft 124 is larger than the width of the notch 225, so that the rotating shaft 124 is positioned in the position-limiting hole 224. Referring to fig. 20, when the clamping mechanism 100 is in the closed state, the line along which the width of the rotating shaft 124 is parallel to the line of two points where the contour line of the notch 225 on the cross section perpendicular to the depth direction of the position-limiting hole 224 intersects with the contour line of the position-limiting hole 224, and since the width of the rotating shaft 124 is smaller than the width of the notch 225, the rotating shaft 124 will be separated from the position-limiting hole 224 through the notch 225, thereby disconnecting the link between the lever mechanism 200 and the second clamping part 120.

As shown in fig. 21 and 23, the present invention further provides a system 30 for fixing tissue, which comprises the above-mentioned clamping device, a brake mechanism 300 for controlling the opening and closing and the dislocation sliding of the clamping device, a conveyer 400 having a conveying sheath 401, and a guide mechanism 500.

Wherein the guiding mechanism 500 comprises a plurality of elongated tubes, or consists of a multi-lumen catheter, or comprises a single lumen tube for establishing a passageway or pathway within a blood vessel of the human body. The clamping device is connected to the distal end of the brake mechanism 300 and the delivery sheath 401 delivers the clamping device and the brake mechanism 300 connected to the clamping device to the diseased valve through the passageway or path. When the clamping device includes an anchor line 230, the anchor line 230 also extends outside the body through the passageway or pathway.

The clamping device of the invention comprises two clamping units 20, wherein each clamping unit 20 comprises a clamping mechanism 100 for capturing tissues and a pull rod mechanism 200 connected to the clamping mechanism 100. The brake mechanism 300 is composed of a plurality of connecting rods, such as steel cables, and the distal ends of the connecting rods are respectively connected to the clamping mechanism 100 and the pull rod mechanism 200.

Referring to fig. 22 and 23, the braking mechanism 300 includes at least one first connecting rod 301 connected to the clamping mechanism 100, and at least one second connecting rod 302 connected to the drawbar mechanism 200. When the clamping mechanism 100 is closed and the pull rod mechanism 200 is still connected to the clamping mechanism 100, the first connecting rod 301 is detachably connected to the clamping mechanism 100, and the second connecting rod 302 is also detachably connected to the pull rod mechanism 200, so that the brake mechanism 300 can be separated from the clamping device after the clamping mechanism 100 is clamped. Referring to fig. 1, at least one first screw hole 115 is formed in an end surface of a proximal end of the first clamping portion 110, a distal end of the first connecting rod 301 is coupled into the first screw hole 115, at least one second screw hole 211 is formed in an end surface of a proximal end of the slider 210, and a distal end of the second connecting rod 301 is coupled into the second screw hole 211. In actual operation, an external force may be applied to the clamping mechanism 100 through the first connecting rod 301 to slide the two clamping mechanisms 100 in a staggered manner, and an external force may be applied to the pulling rod mechanism 200 through the second connecting rod 302 to move the pulling rod mechanism 200 and the clamping mechanism 100 relative to each other to close the clamping mechanism 100. When the pulling rod mechanism 200 is separated from the clamping mechanism 100 after the clamping mechanism 100 is closed, the second connecting rod 302 is preferably fixedly connected with the pulling rod mechanism 200, and after the pulling rod mechanism 200 is separated from the clamping mechanism 100, the pulling rod mechanism 200 is integrally withdrawn through the second connecting rod 302.

Referring to fig. 24, the tissue fixation system described above is delivered to the left atrium using a transseptal puncture procedure, first advancing the distal end of the clamping device and detent mechanism 300 through the valve and into the left ventricle. Referring to fig. 25, the two clamping mechanisms 100 are in the open state by the brake mechanism 300. Referring to fig. 26, the clamping device and the brake mechanism 300 are withdrawn into the atrium until the second clamping portion 120 of the clamping mechanism 100 is adjacent to the valve. Referring to fig. 27 and 28, the two clamping mechanisms 100 are slid out of position by the braking mechanism 300, and the two clamping mechanisms 100 are closed in turn, clamping the valve. Referring to fig. 29, when the valve is clamped, the connection between the stopper mechanism 300 and the clamping mechanism 100 is released, and the pull rod mechanism 200 is withdrawn from the body through the stopper mechanism 300. It will be appreciated that the tissue-fixating system described above may also be delivered from the femoral artery against the blood stream to the left ventricle, or from an apical intervention to the left ventricle.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A clamping device comprises two clamping units, wherein each clamping unit comprises a clamping mechanism for capturing tissues, and each clamping mechanism comprises a first clamping part and a second clamping part rotatably connected to the first clamping part;

the clamping mechanism further comprises a first limiting part arranged on the first clamping part and a second limiting part arranged on the second clamping part, and the first limiting part is tightly connected with the second limiting part when the clamping mechanism is closed.

2. The clamping device as claimed in claim 1, wherein at least one guide rail is provided on one of the two first clamping portions, and at least one guide member is provided on the other of the two first clamping portions, the guide member being slidably inserted in the guide rail.

3. The clamping device according to claim 1, wherein a sliding member is disposed between the two first clamping portions, the sliding member is provided with at least two guide rails, and each first clamping portion is provided with at least one guide member which is matched with the guide rail; or, the sliding part is provided with at least two guide pieces, and each first clamping part is provided with at least one guide rail matched with the guide piece.

4. A clamping device according to claim 2 or 3, wherein the guide track is an interference fit with the guide.

5. The clamping device of claim 1, wherein the clamping unit further comprises a pull rod mechanism connected to the clamping mechanism, one end of the pull rod mechanism is slidably connected to the first clamping portion, the other end of the pull rod mechanism is rotatably connected to the second clamping portion, and the pull rod mechanism moves towards the proximal end of the first clamping portion to drive the second clamping portion to rotate relative to the first clamping portion to close the clamping mechanism.

6. The clamping device as claimed in claim 5, wherein a limiting mechanism is arranged between the first clamping part and the pull rod mechanism, and the limiting mechanism enables the pull rod mechanism to be fixed on the first clamping part after the clamping mechanism is closed.

7. The clamping device of claim 5, wherein the second clamping portion comprises a rotating portion and an engaging portion connected together, the rotating portion being rotatably connected to the first clamping portion.

8. The clamping device of claim 7, wherein the pull rod mechanism comprises a slider and at least one pull rod connected to the slider, the slider is slidably connected to the first clamping portion, one end of the pull rod is rotatably connected to the slider, and the other end of the pull rod is rotatably connected to the engaging portion.

9. The clamping device according to claim 7, wherein the first position-limiting portion is a position-limiting block disposed on the first clamping portion, the second position-limiting portion is a protrusion disposed on the rotating portion, and the first position-limiting portion is in interference fit with the second position-limiting portion when the clamping mechanism is closed.

10. The clamping device as claimed in claim 5, wherein the first clamping portion is provided with at least one sliding slot, the sliding slot extends to the proximal end of the first clamping portion, and one end of the pull rod mechanism is connected to the sliding slot.

11. The clamping device according to claim 1, wherein the surface of the first clamping portion opposite to the second clamping portion is a first joint surface, the surface of the second clamping portion opposite to the first clamping portion is a second joint surface, and a plurality of barbs or protrusions are arranged on the first joint surface and/or the second joint surface.

12. A system for fixing tissue, comprising a clamping device according to any one of claims 1 to 11, and a braking mechanism connected to the clamping device, the braking mechanism comprising at least one first connecting rod detachably connected to the clamping mechanism of the clamping device, and at least one second connecting rod connected to the pull rod mechanism of the clamping device.