CN109953778B - Clamping device and system for fixing tissue - Google Patents

Abstract

Translated fromChinese

本发明公开了一种夹合装置及固定组织的系统，所述夹合装置包括两个夹合单元，所述夹合单元包括用于捕获组织的夹合机构，所述夹合机构包括第一夹合部及转动连接在所述第一夹合部上的第二夹合部，两个所述第一夹合部滑动连接。本发明的有益效果：由于两个夹合机构可错位滑动，可以先调节两个夹合机构的相对位置，再使夹合机构闭合，以确保两片瓣叶都可以被完全夹住。

The invention discloses a clamping device and a system for fixing tissue. The clamping device includes two clamping units, the clamping units include a clamping mechanism for capturing tissue, and the clamping mechanism includes a first clamping mechanism. The clamping part and the second clamping part rotatably connected to the first clamping part, and the two first clamping parts are slidably connected. The beneficial effects of the present invention are as follows: since the two clamping mechanisms can slide in dislocation, the relative positions of the two clamping mechanisms can be adjusted first, and then the clamping mechanisms are closed to ensure that both 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 clampingdevice 10 includes two clampingunits 20, each clampingunit 20 includes aclamping mechanism 100 for capturing tissue, and apull rod mechanism 200 connected to theclamping mechanism 100. The clampingmechanisms 100 of the two clamping units are connected in a sliding manner, so that the two clampingmechanisms 100 can slide in a staggered manner, and thepull rod mechanism 200 is used for closing the clampingmechanisms 100 to clamp tissues. Because the two clampingmechanisms 100 can slide relatively, in actual operation, the relative positions of the two clampingmechanisms 100 can be adjusted, so that the two clampingmechanisms 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, aguide mechanism 140 for sliding the two clampingmechanisms 100 in a staggered manner is disposed between the two clampingmechanisms 100, theguide mechanism 140 includes aguide rail 141 disposed on oneclamping mechanism 100 and aguide member 142 disposed on theother clamping mechanism 100, theguide rail 141 is distributed along the axial direction of theclamping mechanism 100, i.e., extends from the distal end of theclamping mechanism 100 to the proximal end of theclamping mechanism 100, and theguide member 142 is slidably inserted in theguide rail 141. In this embodiment, theguide rail 141 is a dovetail groove, theguide 142 is a dovetail boss matched with the dovetail groove, theguide rail 141 and theguide 142 are in interference fit, and the size range of the interference fit is 0.1mm to 1mm, so that theguide 142 can only move along the rail direction of theguide rail 141, and the two clampingmechanisms 100 are prevented from shaking when sliding relatively, thereby improving the accuracy of the staggered sliding of the two clampingmechanisms 100.

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

It is understood that in other embodiments, theguiding mechanism 140 may have other structures, as shown in fig. 5, theguiding mechanism 140 includes a slidingmember 143 between the two clampingmechanisms 100, two guidingmembers 142 respectively disposed at two sides of the slidingmember 143, and a guidingrail 141 disposed on the clampingmechanisms 100, the guidingrail 141 of eachclamping mechanism 100 is slidably connected to the corresponding guidingmember 142 on the slidingmember 143, and theclamping mechanism 100 slides in a staggered manner relative to the slidingmember 143. Alternatively, in other embodiments, theguide 142 is disposed on theclamping mechanism 100, theguide rail 141 is disposed on the slidingmember 143, and theguide 142 of eachclamping mechanism 100 is slidably connected with thecorresponding guide rail 141 on the slidingmember 143.

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

Further, a blocking structure is further disposed between the two clampingmechanisms 100, and the blocking structure is used for limiting the maximum distance for the two clampingmechanisms 100 to slide in a staggered manner, so as to prevent theguide 142 from being separated from the end of theguide rail 141 when the two clampingmechanisms 100 slide. For example, the blocking structure may be a stopper respectively disposed at both ends of theguide rail 141, and when theguide 142 abuts against one stopper of theguide rail 141, the two clampingmechanisms 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 theguide rail 141, a positioning groove disposed on the side wall of theguide rail 141, a positioning groove disposed on the wall of theguide rail 141 opposite to theother clamping mechanism 100, etc.) disposed on oneclamping mechanism 100 and a blocking member disposed on theother 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 clampingmechanisms 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 clampingmechanisms 100 do not continue to slide relative to each other.

Referring to fig. 6, each of the clampingmechanisms 100 includes afirst clamping portion 110, and asecond clamping portion 120 rotatably connected to a distal end of thefirst clamping portion 110, and the leaflet is grasped between thefirst clamping portion 110 and thesecond clamping portion 120. Theguide mechanism 140 is disposed between the twofirst clamping portions 110, and slidably connects the twofirst clamping portions 110.

Thefirst clamping portion 110 includes afirst end portion 111 and asecond end portion 112 connected to a distal end of thefirst end portion 111. Thesecond end 112 is rotatably connected to thesecond clamping portion 120, a surface of thefirst end 111 opposite to thesecond clamping portion 120 is afirst engagement surface 113 for capturing the valve leaflet, thefirst end 111 is provided with at least one slidingslot 114 slidably connected to therod mechanism 200, and the slidingslot 114 is axially distributed along thefirst clamping portion 110 and extends to a proximal end of thefirst end 111.

Thesecond clamping portion 120 includes arotating portion 121, and an engagingportion 122 connected to therotating portion 121. The rotatingportion 121 and thesecond end portion 112 are connected in a matched and rotating manner through a shaft hole, thejoint portion 122 is provided with aninstallation hole 124 connected with thepull rod mechanism 200 in a rotating manner, and a surface of thejoint portion 122 opposite to thefirst clamping portion 110 is a secondjoint surface 123 for capturing the valve leaflet.

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

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

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

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

In this embodiment, the rotatingportion 121 has two connectingplates 1211 disposed opposite to each other, and thesecond end portion 112 is inserted between the two connectingplates 1211 and is rotatably connected to the two connectingplates 1211 through the shaft hole. The width of thesecond end portion 112 is adapted to the distance between the two connectingplates 1211 and is smaller than the width of thefirst end portion 111. The first position-limitingportion 131 is an end surface of the distal end of thefirst end portion 111, and the second position-limitingportion 132 is a protrusion disposed on the connectingplate 1211, which is integrally formed with therotating portion 121 and connected to form a cam structure. When theclamping mechanism 100 is closed, the protrusions on the connectingplate 1211 are in interference fit with the end surface of the distal end of thefirst end portion 111, so that thefirst clamping portion 110 and thesecond clamping portion 120 are tightly connected together. Preferably, in order to enhance the connection strength between the protrusion on theconnection plate 1211 and the end surface of the distal end of thefirst end portion 111 and prevent theclamping mechanism 100 from automatically opening, the interference size between the protrusion on theconnection plate 1211 and the end surface of the distal end of thefirst 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-limitingportion 131 and the second position-limitingportion 132, as long as theclamping mechanism 100 is closed, and the first position-limitingportion 131 and the second position-limitingportion 132 can be tightly connected. For example, referring to fig. 7 and 8, in other embodiments, the first position-limitingpart 131 is a position-limiting block disposed on the side of thesecond end part 112, and when theclamping mechanism 100 is closed, the protrusion on the connectingplate 1211 is in interference fit with the position-limiting block, so that thefirst clamping part 110 is fixedly connected with thesecond clamping part 120. Alternatively, in other embodiments, the first position-limitingpart 131 is a position-limiting block disposed on an end surface or a side surface of the distal end of thefirst end 111, and the second position-limitingpart 132 is a protrusion disposed on a top surface or a side surface of therotating part 121. Alternatively, in other embodiments, the first position-limitingportion 131 and the second position-limitingportion 132 are fixedly connected by fastening, for example, the first position-limitingportion 131 is a fastening structure disposed on thefirst clamping portion 110, and the second position-limitingportion 132 is a slot structure disposed on thesecond clamping portion 120, and when theclamping mechanism 100 is closed, the fastening structure and the slot structure are fastened together, so that the first position-limitingportion 131 and the second position-limitingportion 132 are fixedly connected.

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

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

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

Thepull rod mechanism 200 includes aslider 210 and at least onepull rod 220, theslider 210 is slidably connected in the slidingslot 114 of thefirst clamping portion 110, a proximal end of thepull rod 220 is rotatably connected to theslider 210, and a distal end of thepull rod 220 is rotatably connected to thesecond clamping portion 120. In this embodiment, the number of thepull rods 220 is two, and the twopull rods 220 are respectively disposed on two sides of thesecond clamping portion 120.

In practice, referring to fig. 9, the relative positions of the twofirst clamping portions 110 can be adjusted to make the twosecond 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 thesecond clamping portion 120 approaches the corresponding leaflet, the two clampingmechanisms 100 are sequentially closed by therod mechanism 200 to completely clamp the two leaflets.

Further, a limiting mechanism is disposed between the slidingblock 210 and the slidingslot 114, and when theclamping mechanism 100 is closed, the limiting mechanism fixes the slidingblock 210 on thefirst clamping portion 110, so as to prevent the slidingblock 210 from sliding under the action of gravity. Referring to fig. 12, 13 and 14, the stopper mechanism includes a fixingmember 151 fixed to an inner wall of theslide groove 114, and a fixinggroove 152 provided on theslider 210. When theclamping mechanism 100 is closed, the slidingblock 210 continues to move toward the proximal end of thefirst clamping portion 110 until the fixingmember 151 is held in the fixinggroove 152, so as to prevent the slidingblock 210 from sliding downward. Preferably, in this embodiment, the fixingmember 151 is provided with acircular arc structure 153 to facilitate the fixingmember 151 to enter the fixinggroove 152. It is understood that in other embodiments, the fixingmember 151 of the limiting mechanism may be disposed on the slidingblock 210, and the fixinggroove 152 may be disposed on the inner wall of the slidinggroove 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 pullingrod mechanism 200 is different, in this embodiment, after theclamping mechanism 100 is closed, the pullingrod mechanism 200 can be separated from theclamping 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, thepull rod mechanism 200 includes aslider 210 and at least onepull rod 220, theslider 210 is slidably connected in the slidingslot 114 of thefirst clamping portion 110, a proximal end of thepull rod 220 is rotatably connected to theslider 210, and a distal end of thepull rod 220 is rotatably connected to thesecond clamping portion 120. In this embodiment, the number of thepull rods 220 is two, the twopull rods 220 are respectively disposed on two sides of thesecond clamping portion 120, two sides of thesecond clamping portion 120 are respectively disposed with arotating shaft 125, and therotating shaft 125 is located on thejoint portion 122 of thesecond clamping portion 120.

Referring to fig. 16, thedrawbar mechanism 200 further includes ananchoring line 230 fixed to thedrawbar 220, theanchoring line 230 and thedrawbar 220 define aconnection hole 221 matching with theshaft 125, and the size of the hole diameter of theconnection hole 221 is adjustable. Referring to fig. 17, thepull rod 220 is a hollow structure, and a throughhole 222 is formed therein and penetrates through the proximal end and the distal end of thepull rod 220, one end of theanchor wire 230 is fixed to the distal end of thepull rod 220, and the other end of theanchor wire 230 is a free end, and the free end penetrates through the throughhole 222 at the distal end of thepull rod 220 and penetrates through the throughhole 222 at the proximal end of thepull rod 220. In operation, the size of the aperture of theconnection hole 221 can be adjusted by tightening or loosening theanchor line 230. Preferably, the distal end of thepull rod 220 is provided with an arc-shapedgroove 223 matched with therotating shaft 125, and the arc-shapedgroove 223 and theanchoring line 230 jointly enclose a connectinghole 221 matched with therotating shaft 125. Theanchoring 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, theanchor wire 230 is tightened to securely connect theanchor wire 230 to theshaft 125, and when theclamping mechanism 100 is closed, theanchor wire 230 is loosened and theanchor wire 230 is no longer securely connected to theshaft 125. As thepull rod 220 moves towards the proximal end of thefirst clamping portion 110, theanchor wire 230 moves towards the distal end near thefirst clamping portion 110 relative to thepull rod 220 until theanchor wire 230 disengages from the through hole in thepull rod 220, causing the distal end of thepull rod 220 to disengage from therotation shaft 125, thereby disconnecting thepull rod mechanism 200 from thesecond clamping portion 120.

It should be understood that the invention is not limited to the specific manner in which theanchoring wire 230 and thepull rod 220 enclose theconnection hole 221, and in other embodiments, thepull rod 220 may be a non-hollow structure, with one end of theanchoring wire 230 being fixed to the distal end of thepull rod 220 and the other end of theanchoring wire 230 being a free end that is wound directly from the outside of thepull rod 220 to the proximal end of thepull rod 220. Or, a mounting groove is formed on the side wall of thepull rod 220, the mounting groove extends from the distal end of thepull rod 220 to the proximal end of thepull rod 220, one end of theanchor line 230 is fixed to the distal end of thepull rod 220, the other end of theanchor line 230 is a free end, and the free end of theanchor line 230 extends from the distal end of thepull rod 220 to the proximal end of thepull 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 pullingrod mechanism 200 and theclamping mechanism 100 is different.

Referring to fig. 18, thepull rod mechanism 200 includes aslider 210 and at least onepull rod 220, theslider 210 is slidably connected in the slidingslot 114 of thefirst clamping portion 110, a proximal end of thepull rod 220 is rotatably connected to theslider 210 through a shaft hole, anotch 225 and a limitinghole 224 communicated with thenotch 225 are disposed at a distal end of thepull rod 220, therotating shaft 124 is rotatably connected in the limitinghole 224, a width of thenotch 225 is smaller than an inner diameter of the limitinghole 224, and a width of thenotch 225 is smaller than a length of therotating shaft 124 and larger than a width of therotating shaft 124. When the clamping mechanism is closed, theshaft 124 is disengaged from thenotch 225. The width of thenotch 225 refers to the diameter of an inscribed circle of the section of thenotch 225 in the direction perpendicular to the depth direction of the limitinghole 224, the length of therotating shaft 124 refers to the length of the smallest circumscribed rectangle of the cross section of the rotating shaft, and the width of therotating 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 therotating shaft 124 is substantially rectangular, the length of therotating shaft 124 is matched with the inner diameter of the limitinghole 224, and the width of therotating shaft 124 is matched with the width of thenotch 225. Referring to fig. 19, when theclamping mechanism 100 is in the fully open state, the straight line where the length of therotating shaft 124 is parallel to the line connecting two points where the contour line of thenotch 225 on the cross section perpendicular to the depth direction of the position-limitinghole 224 intersects with the contour line of the position-limitinghole 224, and the length of therotating shaft 124 is larger than the width of thenotch 225, so that therotating shaft 124 is positioned in the position-limitinghole 224. Referring to fig. 20, when theclamping mechanism 100 is in the closed state, the line along which the width of therotating shaft 124 is parallel to the line of two points where the contour line of thenotch 225 on the cross section perpendicular to the depth direction of the position-limitinghole 224 intersects with the contour line of the position-limitinghole 224, and since the width of therotating shaft 124 is smaller than the width of thenotch 225, therotating shaft 124 will be separated from the position-limitinghole 224 through thenotch 225, thereby disconnecting the link between thelever mechanism 200 and thesecond clamping part 120.

As shown in fig. 21 and 23, the present invention further provides asystem 30 for fixing tissue, which comprises the above-mentioned clamping device, abrake mechanism 300 for controlling the opening and closing and the dislocation sliding of the clamping device, aconveyer 400 having a conveyingsheath 401, and aguide mechanism 500.

Wherein theguiding 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 thebrake mechanism 300 and thedelivery sheath 401 delivers the clamping device and thebrake mechanism 300 connected to the clamping device to the diseased valve through the passageway or path. When the clamping device includes ananchor line 230, theanchor line 230 also extends outside the body through the passageway or pathway.

The clamping device of the invention comprises two clampingunits 20, wherein each clampingunit 20 comprises aclamping mechanism 100 for capturing tissues and apull rod mechanism 200 connected to theclamping mechanism 100. Thebrake 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 theclamping mechanism 100 and thepull rod mechanism 200.

Referring to fig. 22 and 23, thebraking mechanism 300 includes at least one first connectingrod 301 connected to theclamping mechanism 100, and at least one second connectingrod 302 connected to thedrawbar mechanism 200. When theclamping mechanism 100 is closed and thepull rod mechanism 200 is still connected to theclamping mechanism 100, the first connectingrod 301 is detachably connected to theclamping mechanism 100, and the second connectingrod 302 is also detachably connected to thepull rod mechanism 200, so that thebrake mechanism 300 can be separated from the clamping device after theclamping mechanism 100 is clamped. Referring to fig. 1, at least onefirst screw hole 115 is formed in an end surface of a proximal end of thefirst clamping portion 110, a distal end of the first connectingrod 301 is coupled into thefirst screw hole 115, at least onesecond screw hole 211 is formed in an end surface of a proximal end of theslider 210, and a distal end of the second connectingrod 301 is coupled into thesecond screw hole 211. In actual operation, an external force may be applied to theclamping mechanism 100 through the first connectingrod 301 to slide the two clampingmechanisms 100 in a staggered manner, and an external force may be applied to the pullingrod mechanism 200 through the second connectingrod 302 to move the pullingrod mechanism 200 and theclamping mechanism 100 relative to each other to close theclamping mechanism 100. When the pullingrod mechanism 200 is separated from theclamping mechanism 100 after theclamping mechanism 100 is closed, the second connectingrod 302 is preferably fixedly connected with the pullingrod mechanism 200, and after the pullingrod mechanism 200 is separated from theclamping mechanism 100, the pullingrod mechanism 200 is integrally withdrawn through the second connectingrod 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 anddetent mechanism 300 through the valve and into the left ventricle. Referring to fig. 25, the two clampingmechanisms 100 are in the open state by thebrake mechanism 300. Referring to fig. 26, the clamping device and thebrake mechanism 300 are withdrawn into the atrium until thesecond clamping portion 120 of theclamping mechanism 100 is adjacent to the valve. Referring to fig. 27 and 28, the two clampingmechanisms 100 are slid out of position by thebraking mechanism 300, and the two clampingmechanisms 100 are closed in turn, clamping the valve. Referring to fig. 29, when the valve is clamped, the connection between thestopper mechanism 300 and theclamping mechanism 100 is released, and thepull rod mechanism 200 is withdrawn from the body through thestopper 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 (12)

Translated fromChinese

1.一种夹合装置，包括两个夹合单元，所述夹合单元包括用于捕获组织的夹合机构，所述夹合机构包括第一夹合部及转动连接在所述第一夹合部上的第二夹合部，其特征在于，两个所述第一夹合部滑动连接，两个所述第一夹合部之间还设置有用于限制两个所述夹合单元之间错位滑动的距离的阻挡结构；1. A clipping device comprising two clipping units, the clipping units comprising a clipping mechanism for capturing tissue, the clipping mechanism comprising a first clipping portion and a rotatable connection on the first clip The second clamping part on the clamping part is characterized in that the two first clamping parts are slidably connected, and there is also a space between the two first clamping parts for limiting the distance between the two clamping units. The blocking structure of the distance between the dislocation sliding;所述夹合机构还包括设置在所述第一夹合部上的第一限位部，及设置在所述第二夹合部上的第二限位部，所述第一限位部在所述夹合机构闭合时与所述第二限位部紧固连接。The clamping mechanism further includes a first limiting portion provided on the first clamping portion, and a second limiting portion provided on the second clamping portion, and the first limiting portion is located on the second clamping portion. When the clamping mechanism is closed, it is tightly connected with the second limiting portion.2.根据权利要求1所述的夹合装置，其特征在于，两个所述第一夹合部中的一个所述第一夹合部上设置有至少一个导轨，两个所述第一夹合部中的另一个所述第一夹合部上设置有至少一个导向件，所述导向件可滑动的插设在所述导轨内。2 . The clamping device according to claim 1 , wherein at least one guide rail is provided on one of the two first clamping parts, and the two first clamping parts are At least one guide piece is disposed on the other of the first clamping parts, and the guide piece is slidably inserted into the guide rail.3.根据权利要求1所述的夹合装置，其特征在于，两个所述第一夹合部之间设置有滑动件，所述滑动件上设置有至少两个导轨，每一所述第一夹合部上设置有至少一个与所述导轨相配合的导向件；或者，所述滑动件上设置有至少两个导向件，每一所述第一夹合部上设置有至少一个与所述导向件相配合的导轨。3 . The clamping device according to claim 1 , wherein a sliding member is arranged between the two first clamping parts, and at least two guide rails are arranged on the sliding member, and each of the first clamping parts is provided with a sliding member. 4 . A clamping part is provided with at least one guide piece matched with the guide rail; or, the sliding piece is provided with at least two guide pieces, and each of the first clamping parts is provided with at least one guide piece matched with the guide rail. The guide rails are matched with the guides.4.根据权利要求2或3所述的夹合装置，其特征在于，所述导轨与所述导向件过盈配合。4 . The clamping device according to claim 2 or 3 , wherein the guide rail and the guide member are in an interference fit. 5 .5.根据权利要求1所述的夹合装置，其特征在于，所述夹合单元进一步包括连接在所述夹合机构上的拉杆机构，所述拉杆机构的一端可滑动的连接在所述第一夹合部上，所述拉杆机构的另一端与所述第二夹合部转动连接，所述拉杆机构朝所述第一夹合部的近端移动时带动所述第二夹合部相对所述第一夹合部转动使所述夹合机构闭合。5 . The clamping device according to claim 1 , wherein the clamping unit further comprises a pull rod mechanism connected to the clamping mechanism, and one end of the pull rod mechanism is slidably connected to the first pull rod mechanism. 6 . On a 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 be opposite when the pull rod mechanism moves toward the proximal end of the first clamping portion. The rotation of the first clamping portion closes the clamping mechanism.6.根据权利要求5所述的夹合装置，其特征在于，所述第一夹合部与所述拉杆机构之间设置有限位机构，所述限位机构使所述拉杆机构在所述夹合机构闭合后固定在所述第一夹合部上。6 . The clamping device according to claim 5 , wherein a limiting mechanism is provided between the first clamping portion and the pulling rod mechanism, and the limiting mechanism enables the pulling rod mechanism to be in the clamping position. 7 . After the closing mechanism is closed, it is fixed on the first clamping part.7.根据权利要求5所述的夹合装置，其特征在于，所述第二夹合部包括相连的转动部及接合部，所述转动部与所述第一夹合部转动连接。7 . The clamping device according to claim 5 , wherein the second clamping part comprises a connected rotating part and an engaging part, and the rotating part is rotatably connected with the first clamping part. 8 .8.根据权利要求7所述的夹合装置，其特征在于，所述拉杆机构包括滑块及至少一个连接在所述滑块上的拉杆，所述滑块可滑动的连接在所述第一夹合部上，所述拉杆的一端与所述滑块转动连接，所述拉杆的另一端与所述接合部转动连接。8 . The clamping device according to claim 7 , wherein the pull rod mechanism comprises a slider and at least one pull rod connected to the slider, and the slider is slidably connected to the first slider. 9 . On the clamping part, one end of the pull rod is rotatably connected with the sliding block, and the other end of the pull rod is rotatably connected with the joint part.9.根据权利要求7所述的夹合装置，其特征在于，所述第一限位部为设置在所述第一夹合部上的限位块，所述第二限位部为设置在所述转动部上的凸起，所述第一限位部在所述夹合机构闭合时与所述第二限位部过盈配合。9 . The clamping device according to claim 7 , wherein the first limiting portion is a limiting block provided on the first clamping portion, and the second limiting portion is a limiting block provided on the first clamping portion. 10 . The protrusion on the rotating portion, the first limiting portion is in an interference fit with the second limiting portion when the clamping mechanism is closed.10.根据权利要求5所述的夹合装置，其特征在于，所述第一夹合部上设置有至少一个滑槽，所述滑槽延伸至所述第一夹合部的近端，所述拉杆机构的一端连接至所述滑槽内。10 . The clamping device according to claim 5 , wherein at least one sliding groove is provided on the first clamping portion, and the sliding groove extends to the proximal end of the first clamping portion, so the One end of the pull rod mechanism is connected to the chute.11.根据权利要求1所述的夹合装置，其特征在于，所述第一夹合部与所述第二夹合部相对的面为第一接合面，所述第二夹合部与所述第一夹合部相对的面为第二接合面，所述第一接合面和/或所述第二接合面上设置有若干倒刺或凸起。11 . The clamping device according to claim 1 , wherein a surface opposite to the first clamping portion and the second clamping portion is a first joint surface, and the second clamping portion is connected to the second clamping portion. 12 . The opposite surface of the first clamping part is the second joint surface, and the first joint surface and/or the second joint surface is provided with several barbs or protrusions.12.一种固定组织的系统，其特征在于，包括如权利要求1～11任一所述的夹合装置，及连接至所述夹合装置的制动机构，所述制动机构包括至少一个与所述夹合装置的夹合机构可拆卸的连接的第一连接杆，及至少一个与所述夹合装置的拉杆机构连接的第二连接杆。12. A system for immobilizing tissue, comprising the 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 The first connecting rod is detachably connected with the clamping mechanism of the clamping device, and at least one second connecting rod is connected with the pulling rod mechanism of the clamping device.

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