WO2023103428A1 - Tissue clamping device, tissue clamping system, and valve repair method - Google Patents

Abstract

A tissue clamping device, a tissue clamping system, and a valve repair method. The tissue clamping device (1) comprises a clamping mechanism (11) and a control mechanism. The clamping mechanism (11) comprises at least two clamping arms (111) capable of being opened and closed relative to each other, and at least two gripping members (112) provided between the two clamping arms (111). The control mechanism comprises at least two control wires (121), each control wire (121) being connected to a corresponding gripping member (112) so as to control, by means of the control wire (121), the gripping member (112) to be relatively close to and distant from a corresponding clamping arm (111). Each gripping member (112) comprises a gripping body (1121) and an additional layer provided on the gripping body (1121), at least part of the additional layer being located between the clamping arms (111) and between the clamping arm (111) and the gripping body (1121). Each control wire (121) passes through the gripping body (1121), passes between the gripping body (1121) and the corresponding portion of the additional layer located between the clamping arm (111) and the gripping body (1121) or passes in the corresponding portion of the additional layer located between the clamping arm (111) and the gripping body (1121), and penetrates out of the gripping member (112).

Description

Tissue clamping device, tissue clamping system and valve repair method

References to related applications

This disclosure claims all the rights and interests of the invention patent application with the application number 202111509611.5 and the invention name "tissue clamping device and tissue clamping system" submitted to the State Intellectual Property Office of the People's Republic of China on December 10, 2021, and by reference manner incorporated into this disclosure in its entirety.

field

The present disclosure relates to the field of medical devices, and more particularly relates to a tissue clamping device, a tissue clamping system and a valve repair method.

background

The mitral valve is a one-way valve between the heart's left atrium and left ventricle. A normal, healthy mitral valve controls blood flow from the left atrium to the left ventricle while preventing blood from flowing from the left ventricle to the left atrium. The mitral valve consists of a pair of leaflets called the anterior and posterior leaflets. When the edges of the anterior and posterior leaflets meet, the mitral valve should close completely to prevent blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo organic or functional changes, the anterior and posterior leaflets of the mitral valve do not coapt, so that when the left ventricle of the heart contracts, the mitral valve cannot fully Closed, causing blood to flow back from the left ventricle to the left atrium, causing a series of pathophysiological changes called "mitral regurgitation".

There is a minimally invasive treatment device, which is based on the principle of valve edge-to-edge repair surgery. The valve clip is delivered to the mitral valve through the interventional catheter, and the anterior and posterior leaflets of the mitral valve are clamped, so as to reduce the mitral valve. Purpose of valve regurgitation.

As shown in Figure 1, an existing valve clamping device 00 includes a valve clamp 01 and a control wire 02. The valve clamp 01 includes a gripping body 011 and a gripping arm 012. The anchor thorn 014 of the arm 012, the grasping body 011 is controlled by the control wire 02 to open and close. When in use, the clamping arm 012 is first driven to open, and after the leaflet enters between the grasping body 011 and the clamping arm 012, it passes through The control wire 02 releases the grasping main body 011, so that the leaflet is captured between the grasping main body 011 and the clamping arm 012, and then controls the closing of the clamping arm 012, thereby clamping the valve leaflet; then the control wire is pulled away 02; Finally, the valve clip 01 is released and left on the valve.

The grasping body 011 of the existing valve clamping device 00 shown in FIG. 2 and FIG. 3 is provided with a threading hole 013 , and the control wire 02 moves through the threading hole 013 .

overview

In one aspect, the tissue clamping device provided in the present disclosure includes a clamping mechanism and a control mechanism;

The clamping mechanism includes at least two clamping arms that can be relatively expanded and closed, and at least two grippers arranged between the two clamping arms; the control mechanism includes at least two control wires, each of which is connected to a corresponding A gripper connected to the gripper to control the gripper relatively close to and away from the corresponding gripper arm through the control wire;

Wherein, the gripping member includes a gripping body and an additional layer arranged on the gripping body, at least part of the additional layer is located between the clamping arm and the gripping body; the control wire passes through the gripping body, between the gripping body and the additional layer The layer passes between the location corresponding to the clamping arm and the gripping body or the location of the additional layer correspondingly located between the clamping arm and the gripping body, and out of the gripper.

In certain embodiments, the additional layer includes a first additional layer disposed on a first surface of the grip body, and a second additional layer disposed on a second surface of the grip body, the second additional layer being located on the grip Between the arm and the grasping main body; the control wire passes through the first additional layer and the grasping main body, between the grasping main body and the second additional layer or in the second additional layer, and passes through the grasping member.

In certain embodiments, the first additional layer and the second additional layer combine to entirely cover the grip body.

In some embodiments, both the first additional layer and the second additional layer are film bodies or network structures.

In some embodiments, the material of the first additional layer and the second additional layer is biocompatible polymer or metal fiber.

In some embodiments, the position where the first additional layer and/or the second additional layer is in contact with the control wire is provided with a lubricating channel or coated with a lubricating layer; or the control wire is coated with a lubricating layer .

In certain embodiments, the control wire runs between the gripping body and the second additional layer or within the second additional layer with a length of 1 mm to 6 mm.

In some embodiments, the grasping body is provided with at least one through hole configured to allow the control wire to pass through.

In some embodiments, the gripper further includes at least one anchor thorn disposed on the second surface, the anchor thorn penetrating the second additional layer.

In certain embodiments, the control wire exits the edge of the gripper.

In certain embodiments, the control wire exits the edge of the free-hanging end of the grip.

In some embodiments, the control wire passes through a portion of the second additional layer correspondingly covering the free-hanging end of the gripping body, and the free-hanging end of the gripping body is in contact with the The control wires are isolated by the second additional layer.

In certain embodiments, the control wire passes through the first additional layer and the gripping body sequentially, between the gripping body and the second additional layer or within the second additional layer passing through, back through the grip body, and out of the grip from the first additional layer.

In some embodiments, the control wire passes through the first additional layer and the gripping body sequentially, passes through the second additional layer, and passes back to the gripping body and the second additional layer. between the layers or within the second additional layer, and out of the gripping member.

In some embodiments, the additional layer further includes a third additional layer disposed between the gripping body and the second additional layer, after the control wire passes through the gripping body, passing between the second additional layer and the third additional layer.

In some embodiments, the additional layer further includes a fourth additional layer disposed between the grip body and the first additional layer, the third additional layer and the fourth additional layer are combined to Entirely covering the grasping main body.

In some embodiments, the tissue grasping device further comprises:

A supporting mechanism, the supporting mechanism includes a connecting end and a free end arranged axially opposite; the clamping mechanism is arranged on the outside of the supporting mechanism, and the clamping arm of the clamping mechanism is connected to the connecting end;

A driving mechanism, the driving mechanism is connected with the clamping arm of the clamping mechanism, so as to drive the clamping arm to expand or close with the connecting end as the center.

In some embodiments, the tissue clamping device further includes an elastic mesh adjustment mechanism, and at least a part of the support mechanism is passed through the adjustment mechanism.

In some embodiments, one end of the adjustment mechanism is sheathed outside the connection end and connected to the support mechanism, and the other end of the adjustment mechanism is freely suspended.

In another aspect, the tissue clamping system of the present disclosure includes the above tissue clamping device and a delivery device, the clamping mechanism is detachably connected to the distal end of the delivery device, and the control wire is detachably passed through the delivery device.

In yet another aspect, the valve repair method of the present disclosure includes:

The tissue holding device is inserted through a catheter approach, and the tissue holding device is adjusted to approach the leaflets of the patient's valve;

Tighten the control wire, control the driving mechanism to open the clamping arm, so that the grasping member is away from the clamping arm, and the leaflet enters between the grasping member and the clamping arm space, the clamping arm supports the leaflet;

The control wire is released, and the grasping member expands to both sides and approaches the clamping arm under the elastic action of the grasping body itself, so as to capture the leaflet between the grasping member and the clamping arm. between the clamping arms;

controlling the driving mechanism so that the clamping arm is closed to clamp the leaflet;

After achieving the desired clamping effect, withdrawing the control wire; and

The tissue gripping device is released and the delivery device is withdrawn from the body.

In certain embodiments, the valve is selected from mitral and tricuspid valves.

In some embodiments, the above-mentioned tissue clamping device, tissue clamping system and valve repair method provided by the embodiments of the present disclosure are provided with an additional layer on the grasping body, and at least part of the additional layer is located between the clamping arm and the grasping arm. Between the main bodies, the control wire passes through the holding main body, between the holding main body and the additional layer correspondingly located between the clamping arm and the holding main body or between the additional layer correspondingly located between the clamping arm and the holding main body Pass through the part and pass out from the gripper, so that the control wire located between the gripper body and the clamping arm is constrained by an additional layer, thereby avoiding lengthy control wires between the gripper body and the gripper arm, preventing control The wire hooks other parts and cannot be pulled out, and prevents the control wire from being entangled with other parts to cause wire breakage, so as to ensure that the control wire can be successfully pulled out of the clamping mechanism, so that the tissue clamping device can run smoothly without being hindered by the control wire. release to ensure the safety and reliability of the operation.

Description of drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the disclosure and together with the description serve to explain the principles of the disclosure.

In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, In other words, other drawings can also be obtained from these drawings without paying creative labor.

1 to 3 are schematic structural views of an example valve clamping device in the prior art;

4 to 6 are schematic structural views of the tissue clamping device provided by the first embodiment of the present disclosure;

Fig. 7 is a structural schematic diagram of the cooperation between the gripper and the control wire in Fig. 4 to Fig. 6;

Fig. 8 is a schematic diagram of the wrapping structure of an example through hole in Fig. 4 to Fig. 6;

Fig. 9 is a schematic diagram of the control wire passing between the grasping body and the second additional layer in Fig. 4 to Fig. 6;

Fig. 10 is a schematic diagram of the control wire passing through the second additional layer in Fig. 4 to Fig. 6;

11 to 15 are schematic diagrams of the process of the tissue clamping device in FIGS. 4 to 6 clamping the leaflets of the valve;

Fig. 16 is a schematic diagram of the partial structure of the cooperation between the grasping part and the control wire of the tissue clamping device provided by the second embodiment of the present disclosure;

17 to 19 are schematic diagrams of the connection process of the gripper and the control wire in FIG. 16;

FIG. 20 and FIG. 21 are schematic structural views of the tissue clamping device provided by the third embodiment of the present disclosure;

Fig. 22 is a partial structural schematic diagram of the cooperation between the gripper and the control wire in Fig. 20 and Fig. 21;

Fig. 23 is a schematic diagram of the partial structure of the cooperation between the grasping part and the control wire of the tissue clamping device provided by the fourth embodiment of the present disclosure;

Fig. 24 is a schematic structural view of the tissue clamping device provided by the fifth embodiment of the present disclosure;

25 to 28 are schematic structural diagrams of tissue clamping devices according to other embodiments of the present disclosure.

detail

In order to make the purpose, technical solutions and advantages of the embodiments of the present disclosure clearer, the technical solutions in the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings in the embodiments of the present disclosure. Obviously, the described embodiments It is a part of embodiments of the present disclosure, but not all embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present disclosure.

In the description of the present disclosure, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the end parallel to the medical device. The direction of the connecting line between the center of the distal end and the center of the proximal end of the instrument; the radial direction refers to the direction perpendicular or approximately perpendicular to the axial direction; the circumferential direction refers to the direction around the axial direction. It is worth noting that regardless of "near end", "distal end", "one end", "another end", "first end", "second end", "initial end", "end end", "both ends" , "free end", "upper end", "lower end" and other words, "end" is not limited to the end, end point or end face, but also includes The portion of the element to which the end face belongs extends an axial distance and/or a radial distance. The above definitions are just for convenience of expression, and should not be construed as limiting the present disclosure.

Referring to FIG. 4 to FIG. 7 , the tissue clamping device 1 according to the first embodiment of the present disclosure includes a clamping mechanism 11 and a control mechanism. The clamping mechanism 11 includes at least two clamping arms 111 that can be relatively expanded and closed, and at least two grasping pieces 112 disposed between the two clamping arms 111 . The control mechanism includes at least two control wires 121 , and each control wire 121 is connected to a corresponding gripper 112 , so as to control the gripper 112 to approach and move away from the corresponding clamping arm 111 through the control wires 121 . The grip 112 includes a grip body 1121 and an additional layer disposed on the grip body 1121. In the first embodiment, the additional layer includes a first additional layer 1123 disposed on the first surface 1122 of the grip body 1121, And the second additional layer 1125 disposed on the second surface 1124 of the gripping body 1121 , the second additional layer 1125 is located between the clamping arm 111 and the gripping body 1121 . The control wire 121 passes through the first additional layer 1123 and the holding body 1121 sequentially, passes between the holding body 1121 and the second additional layer 1125 or inside the second additional layer 1125 , and passes through the holding member 112 .

In some embodiments, with reference to FIGS. 4 to 7 and FIGS. 11 to 14 , the gripper 112 is generally a strip-shaped structure, including a connection end 1121a and a dangling end 1121b, and the connection end 1121a is relatively close to the valve clamping device 1 In the supporting mechanism 13, the free end 1121b is the end opposite to the connecting end 1121a. The grasping body 1121 is elastic and usually made of metal materials, such as stainless steel or nickel-titanium alloy. The first surface 1122 and the second surface 1124 are located on opposite sides of the gripping body 1121 , the second surface 1124 is relatively close to the clamping arm 111 , and the first surface 1122 is located on an opposite side of the second surface 1124 . When the control wire 121 pulls the gripper 112, the dangling end 1121b of the gripper 112 is relatively far away from the corresponding clamping arm 111, that is, the gripper 112 is unfolded relative to the clamping arm 111, and a large gap is formed between the two space, so that it is easy to accommodate the valve 3 in the gap space; then, the control wire 121 releases the gripper 112, and under the action of the self-elasticity of the gripper body 1121, the free end 1121b of the gripper 112 is relatively close to the corresponding gripper arm 111 , so that the valve 3 is captured between the grasping member 112 and the clamping arm 111 , and the capture of the valve 3 by the tissue clamping device 1 is completed. In this disclosure, valve 3 is used to illustrate the clamping of tissue by tissue clamping device 1, but this disclosure is not only applicable to clamping valves, but also applicable to clamping other tissues, such as interventricular septum and blood vessels with defects. List them one by one.

The first additional layer 1123 can be separated from the second additional layer 1125 independently, covering part or all of the corresponding first surface 1122 and second surface 1124 respectively; the first additional layer 1123 and the second additional layer 1125 can also be combined as a whole The grasping body 1121 is wrapped so as to wrap the metal sharp edge of the grasping body 1121 to prevent the metal sharp edge of the grasping body 1121 from damaging the valve tissue.

The first additional layer 1123 and the second additional layer 1125 can be both membrane bodies, wherein the membrane body can be a solid membrane body without pores, or a porous membrane body with many tiny pores; the first additional layer 1123 Both the layer and the second additional layer 1125 may also be woven or non-woven mesh structures. When the second additional layer 1125 is a solid membrane body, such as a silicone membrane body, the control wire 121 can pass between the second surface 1124 of the grasping body 1121 and the membrane body of the second additional layer 1125, or can pass between the second additional layer 1125. The film body of the layer 1125 passes through; when the second additional layer 1125 is a porous film body or a mesh structure, the control wire 121 can pass between the second surface 1124 of the gripping body 1121 and the second additional layer 1125, or between the second additional layer 1125 The pores of the porous membrane body or the meshes of the network structure are interspersed and passed through.

The material of the first additional layer 1123 and the second additional layer 1125 is a biocompatible high molecular polymer or a metal fiber that can form a network structure, and has both anti-oxidation and anti-dissolution properties. Wherein, the polymer can be selected from polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), polyester, polytetrafluoroethylene (PTFE), silicone resin, urethane, Silicone etc. In some implementations of this embodiment, a PET porous membrane is used as the first additional layer 1123 and/or the second additional layer 1125 . The surface of the first additional layer 1123 and/or the second additional layer 1125 can also be coated with a drug coating by dipping, spraying, etc., and the drug coating contains at least one of anticoagulant drugs or anti-proliferation drugs, so that Reduce thrombus generation and other tissue proliferation. A PET porous film body or mesh structure with multiple pores is used as the first additional layer 1123 and/or the second additional layer 1125, and the valve 3 is clamped between the second additional layer 1125 and the clamping arm 111, more Facilitate tissue cell crawling.

During the preparation of the tissue clamping device 1 , the first additional layer 1123 and the second additional layer 1125 can be disposed on the grasping body 1121 by coating, hot-melting, suturing, ironing, bonding, or binding. In an exemplary implementation of this embodiment, the first additional layer 1123 and the second additional layer 1125 are prepared by using a PET porous film. The section of the main body 1121 for catching and clamping the valve) is coated with one or more layers; then the edge part is processed by ironing process, so that the first additional layer 1123 and the second additional layer 1125 are integrally covered and gripped The main body 1121; after that, the control wire 121 is sequentially passed through the first additional layer 1123 and the grasping main body 1121, between the grasping main body 1121 and the second additional layer 1125 or in the second additional layer 1125 through a tool such as a lead needle, and Pass out from the gripper 112 . The above process method is to form the first additional layer 1123 and the second additional layer 1125 first and then thread the control wire 121, or firstly pass the control wire 121 through the gripping main body 1121 in turn, and on the second surface 1124 of the gripping main body 1121. and pass through the gripper 112 , and then coat or wrap a film on the gripper body 1121 to form a first additional layer 1123 and a second additional layer 1125 . The above preparation process is only used as an example, and is not a limitation to the present disclosure. Those skilled in the art can adopt a suitable process preparation method based on the teachings of the present disclosure, and the prepared tissue clamping device 1 is within the protection scope of the present disclosure. Inside.

FIG. 7 shows that the gripper 112 further includes at least one anchor 1127 disposed on the second surface 1124 , and the anchor 1127 penetrates the second additional layer 1125 . Usually the anchoring thorns 1127 point to the clamping arm 111 from the second surface 1124, and are used to press the valve to the clamping arm 111 when capturing the valve leaflet, and to enhance the anchoring of the valve by the grasping member 112, so that the valve is stably captured in between the gripper 112 and the clamping arm 111 . In this embodiment, the second additional layer 1125 covers at least the portion of the second surface 1124 where the anchors 1127 are provided, and each anchor 1127 penetrates the second additional layer 1125 . Since the control wire 121 passes between the grasping body 1121 and the second additional layer 1125 or in the second additional layer 1125 when passing through the second surface 1124 side provided with the anchor thorns 1127, the control wire 121 is subjected to the second additional layer 1125. The constraint of the layer 1125, compared with the prior art, can prevent the control wire 121 from being lengthy between the grasping body 1121 and the clamping arm 111, prevent the control wire 121 from hooking on the anchor barb 1127 and cannot be pulled out, and prevent the control wire 121 from 121 winds around the anchor thorn 1127 and breaks the wire, ensuring that the control wire 121 can be successfully withdrawn from the clamping mechanism 11, so that the tissue clamping device 1 can be released smoothly without being hindered by the control wire 121, ensuring the safety and security of the operation. reliability. At the same time, compared to the smooth metal surface of the grasping body 1121 itself, the relatively rough second additional layer 1125 can increase the friction force of the grasping member 112 on the valve, help prevent the valve from slipping, and improve the success rate of valve capture. In addition, since the metal sharp edge on the grasping body 1121 is covered by the first additional layer 1123 and the second additional layer 1125, only the anchor thorns 1127 are exposed, which can not only ensure the anchoring force of the grasping member 112 to the valve but also There is no serious damage to the valve.

4 to 7, the grasping body 1121 is provided with at least one through hole 1126 for the control wire 121 to pass through, and the number of through holes 1126 can be one or more, such as three or six, etc., In this embodiment, four through-holes 1126 are provided on one gripping body 1121, and the through-holes 1126 are arranged at intervals from the free end 1121b of the gripping member 112 toward the connecting end 1121a, and in some embodiments, they are arranged at equal intervals. .

The first additional layer 1123 and the second additional layer 1125 can be provided with corresponding openings at the through hole 1126, that is, the first additional layer 1123 and the second additional layer 1125 do not fill or incompletely fill the through hole 1126, so that the control wire 121 can pass through. Pass. In some embodiments, by adjusting the relative size of the opening and the through hole 1126, the edge of the through hole 1126 can be exposed, in this case the control wire 121 will be in contact with the edge of the through hole 1126 during operation; The edge of the through hole 1126 is covered by the first additional layer 1123 and the second additional layer 1125 with which the control wire 121 will be in contact during operation. In some embodiments, the first additional layer 1123 and the second additional layer 1125 can completely fill the through hole 1126, and the control wire 121 passes through the first additional layer 1123 and the second additional layer 1125 through a tool such as a wire guide needle, and passes through the first additional layer 1123 and the second additional layer 1125. In this case, the control wire 121 does not need to be in contact with the edge of the through hole 1126, but only in contact with the first additional layer 1123 and the second additional layer 1125, which can avoid direct contact and friction between the control wire 121 and the edge of the through hole 1126, preventing The control wire 121 is scratched by the sharp edge of the through hole 1126 .

When the control wire 121 is only in contact with the first additional layer 1123 and the second additional layer 1125, the position where the first additional layer 1123 and/or the second additional layer 1125 contacts the control wire 121 can be provided with a lubricating channel or coated with a lubricating layer or the control wire 121 is coated with a lubricating layer; or the first additional layer 1123 and/or the second additional layer 1125, and the control wire 121 can be coated with a lubricating layer at the parts in contact with each other. The lubricating material can be a hydrophilic coating or a PTFE coating, or silicone oil. By improving the lubricating effect between the two, the control wire 121 can be reduced in the first time when it is tightened for control or released and pulled away. The additional layer 1123 and/or the second additional layer 1125 can improve the operational effect of the wire 121 by controlling the frictional resistance during passage or passing.

As shown in Figure 8, the edge of the through hole 1126 can be provided with a wrapping 1126a, and the wrapping 1126a includes an arc chamfer, through which the wrapping 1126a can effectively reduce the stress on the control wire 121 in the process of tightening control or pulling away. frictional force, so as to improve the operation effect of the control wire 121, and at the same time prevent the control wire 121 from being scratched by the through hole 1126, ensuring reliable and safe operation. The material of the wrapping 1126a can be metal, such as stainless steel, pure titanium or nickel-titanium, etc.), and can also be a polymer material, such as PTFE, TPU (thermoplastic polyurethane elastomer rubber), PET, etc. PTFE is selected in this embodiment. The fixing method of the smooth wrapping 1126a and the through hole 1126 may be bonding, crimping, anchoring, welding and the like.

The material of the control wire 121 can be a polymer material, such as ultra-high molecular polyethylene material; it can also be stainless steel wire or nickel-titanium wire, such as nickel-titanium wire. In this embodiment, nickel-titanium wire is selected as the control wire 121, and its wire diameter ranges from about 0.07 mm to 0.20 mm, and in some embodiments, it is about 0.10 mm to 0.13 mm. If the diameter of the control wire 121 is too small, the strength requirement of the control wire 121 may not be met, and if the diameter of the control wire 121 is too large, the drawing resistance will increase.

Referring to FIG. 9 , in an implementation of this embodiment, after the control wire 121 passes through the first additional layer 1123 and the grasping body 1121, it passes between the grasping body 1121 and the second additional layer 1125, and the length of the passage is L It can be about 1 mm to 6 mm, and in some embodiments, it is about 2 mm to 4 mm. If the length is too long, the resistance to drawing wires will be relatively high, and if the length is too short, the fatigue resistance of the control wire 121 cannot be guaranteed, and it is easy to cause the control wire 121 to be damaged. 121 concentrated force. The length of the control wire 121 associated with the gripping body 1121 is wrapped by the second additional layer 1125 , which can limit the length of the control wire 121 under the gripping body 1121 , so as not to be caught or entangled with the anchor barb 1127 . In addition, due to the restraint of the second additional layer 1125 on the control wire 121, the control wire 121 maintains line contact with the grasping body 1121 during the stress process, which effectively reduces the pulling stress on the control wire 121 and prevents the control wire 121 from 121 fractured due to excessive force at the local point.

Referring to FIG. 10 , in another implementation of this embodiment, after the control wire 121 passes through the first additional layer 1123 and the grasping body 1121, it passes through the second additional layer 1125, and the length L of the passage can be from about 1 mm to 6 mm, and in some embodiments, it is about 2 mm to 4 mm. If the length is too long, the drawing resistance will be greater, and if the length is too short, the fatigue resistance of the control wire 121 cannot be ensured, and the control wire 121 will easily be stressed. Since the length of the control wire 121 associated with the gripping body 1121 is wrapped by the second additional layer 1125 , it can limit the length of the control wire 121 under the gripping body 1121 , so that there will be no problem of hooking or entanglement with the anchor barb 1127 . In addition, due to the restraint of the second additional layer 1125 on the control wire 121, the control wire 121 maintains line contact with the inside of the second additional layer 1125 during the stress process, which effectively reduces the pulling stress on the control wire 121 and prevents The control wire 121 breaks due to excessive force at a local point. Moreover, the second additional layer 1125 can isolate the control wire 121 from the grasping body 1121 , that is, the control wire 121 will not directly contact the grasping body 1121 , and can prevent the control wire 121 from rubbing against the grasping body 1121 in the process of pulling out. In order to further reduce the resistance to pulling out the control wire 121 , the part of the control wire 121 constrained by the second additional layer 1125 basically extends along the central axis of the clamping section of the grasping body 1121 .

After the control wire 121 passes between the gripping main body 1121 and the second additional layer 1125 or inside the second additional layer 1125, it passes through the gripper 112. In this embodiment, the control wire 121 passes through the edge of the gripper 112. For example, in the above-mentioned implementation of this embodiment, the control wire 121 passes through the edge of the free hanging end 1121b of the gripper 112, and in some embodiments, the control wire 121 is correspondingly covered by the second additional layer 1125 The portion of the free hanging end 1121b of the grasping body 1121 passes through, and the free hanging end 1121b of the grasping body 1121 is isolated from the control wire 121 by the second additional layer 1125 . The control wire 121 passes through the free hanging end 1121b of the gripper 112, which can reduce the bending points of the control wire 121 and help to reduce wire drawing resistance. It is worth mentioning that the thickness of the part of the second additional layer 1125 corresponding to the free floating end 1121b of the gripping body 1121 is increased compared to other parts, so as to improve the strength of this part of the second additional layer 1125 and prevent the In this process, this part is ruptured due to the shearing action of the control wire 121. In order to further reduce the resistance to pulling out the control wire 121 , the part of the control wire 121 constrained by the second additional layer 1125 basically extends along the central axis of the clamping section of the grasping body 1121 .

In other embodiments, the additional layer may only include the second additional layer 1125, and the control wire 121 sequentially passes through the gripping body 1121, between the gripping body 1121 and the second additional layer 1125, or between the second additional layer 1125. The second additional layer 1125 passes through the part corresponding to the free hanging end 1121b of the gripping main body 1121 .

Not limited to the embodiments described above, the tissue clamping device 1 of the present disclosure only needs to provide an additional layer on the grasping body 1121, at least part of the additional layer is located between the clamping arm 111 and the grasping body 1121, and the control wire 121 passes through the grasping body 1121. Holding body 1121, walking between the holding body 1121 and the additional layer correspondingly located between the clamping arm 111 and the holding body 1121 or in the additional layer correspondingly located between the holding arm 111 and the holding body 1121 , and pass through the gripper 112, the additional layer can constrain the control wire 121 located between the gripping body 1121 and the clamping arm 111, which can prevent the control wire 121 from appearing between the gripping body 1121 and the clamping arm 111 Lengthy, prevent the control wire 121 from being hooked on the anchor thorn 1127 and cannot be pulled out, and prevent the control wire 121 from being wound around the anchor 1127 to cause wire breakage, so as to ensure that the control wire 121 can be successfully pulled out from the clamping mechanism 11, thereby tissue clamping The device 1 can be released smoothly without being hindered by the control wire 121, ensuring the safety and reliability of the operation.

Referring to FIG. 4 to FIG. 6 and FIG. 11 to FIG. 15 , the tissue clamping device 1 according to this embodiment further includes a supporting mechanism 13 and a driving mechanism 14 . Wherein, the supporting mechanism 13 includes a connecting end 13a and a free end 13b which are axially oppositely arranged. The clamping mechanism 11 is disposed outside the supporting mechanism 13 , and the clamping arm 111 of the clamping mechanism 11 is rotatably connected to the connecting end 13 a of the supporting mechanism 13 . The driving mechanism 14 is connected to the clamping arm 111 of the clamping mechanism 11, and is used to drive the clamping arm 111 to expand or close with the connecting end 13a as the center; in some embodiments, the driving mechanism 14 includes a drive shaft (not shown) And two connecting rods (not marked), one end of the connecting rod is rotatably connected to the drive shaft, and the other end is rotatably connected to the clamping arm 111, and the axial movement of the drive shaft can control the relative opening and closing of the two clamping arms 111.

In some embodiments, the clamping arm 111 and the supporting mechanism 13 may be covered with a film, and the coating can wrap at least part of the metal surface and/or metal sharp edge of the clamping arm 111 and the supporting mechanism 13 prevent the at least part of the metal surface and/or metal sharp edge from directly contacting the clamped valve tissue, reduce or avoid tissue allergies and inflammatory reactions, and reduce damage to the valve.

With reference to FIGS. 4 to 6 and FIGS. 11 to 15 , the present disclosure also relates to a tissue clamping system, including the aforementioned tissue clamping device 1 and a delivery device 2 , the clamping mechanism 11 is detachably connected to the distal end of the delivery device 2 , The control wire 121 is detachably threaded through the delivery device 2 . In some embodiments, the delivery device 2 also includes a push shaft with a certain axial length and a mandrel movably mounted in the push shaft, the push shaft is detachably connected to the support mechanism 13, and the mandrel and the drive mechanism The driving shaft in 14 is detachably connected, and is used to drive the two clamping arms 111 of the clamping mechanism 11 to expand and close relative to each other.

With reference to Fig. 4 to Fig. 6 and Fig. 11 to Fig. 15, the operation process of the tissue gripping device 1 will be described by taking the clipping of the mitral valve by the tissue gripping device 1 as an example:

The tissue clamping device 1 is inserted through the catheter approach, and approaches the mitral valve through the femoral vein-inferior vena cava-right atrium-atrial septum-left atrium; then continue to advance the tissue clamping device 1 to reach the left Ventricular; adjust tissue holding device 1 to approach the anterior and posterior leaflets of the mitral valve.

Referring to Fig. 11, the control wire 121 is tightened so that the gripper 112 is close to the support mechanism 13; the driving mechanism 14 is controlled to open the clamping arm 111, the gripper 112 is away from the clamping arm 111, and the leaflets enter the gripper 112 and the gripper. The space between the holding arms 111, the holding arms 111 support the leaflet 3.

Referring to FIG. 12 , the control wire 121 is released, and the grasping member 112 expands to both sides and approaches the clamping arm 111 under the elastic action of the grasping body 1121 itself, so as to capture the leaflet between the grasping member 112 and the clamping arm 111 between.

Referring to FIG. 13 , the driving mechanism 14 is controlled to close the clamping arm 111 to clamp the anterior leaflet and the posterior leaflet of the mitral valve.

Referring to FIG. 14 , after the ideal clamping effect is achieved, the control wire 121 is pulled out.

Referring to FIG. 15 , the tissue clamping device 1 is released, and the delivery device 2 is withdrawn from the body.

During the above operation, the control wire 121 passing between the gripping body 1121 and the clamping arm 111 is constrained by the second additional layer 1125 when the control wire 121 is tightening the gripping member 112 and releasing the gripping member 112 , so it will not be hooked or entangled with the anchor thorn 1127, ensuring smooth and safe operation.

Referring to FIG. 16 to FIG. 19 , compared with Embodiment 1, in the tissue clamping device 1 according to the second embodiment of the present disclosure, the control wire 121 passes through the first additional layer 1123 and the grasping main body 1121 sequentially, and passes through the second The additional layer 1125 passes back between the holding body 1121 and the second additional layer 1125 or passes through the second additional layer 1125 , and passes out from the holding member 112 . In certain embodiments, referring to FIG. 17 , the control wire 121 passes through the second additional layer 1125 completely through a through hole 1126 of the grasping body 1121 ; referring to FIG. 18 , the control wire 121 passes back into the second additional layer 1125 or Between the second surface 1124 and the second accessory layer 1125 ; referring to FIG. 19 , the control wire 121 passes through there, and finally passes through the part of the second accessory layer 1125 corresponding to the free hanging end 1121 b of the grasping main body 1121 . In this embodiment, a section of control wire 121 is exposed below the through hole 1126, as shown by arrow 121a, which can play a role in enhancing buffering, that is, when the control wire 121 exerts force on the grasping body 1121, the through hole 1126 The thickness and rupture strength of the second additional layer 1125 between the lower portion and the portion of the control wire 121 shown in 121a are increased, which can better prevent the control wire 121 from rubbing against the edge of the through hole 1126, thereby further improving the stability of the control wire 121. stability. On the other hand, the operation of threading the control wire 121 by tools such as thread needles will be more convenient and simple.

Referring to FIG. 20 to FIG. 22 , compared with Embodiment 1, in the tissue clamping device 1 according to the third embodiment of the present disclosure, the control wire 121 passes through the first additional layer 1123 and the grasping main body 1121 in sequence, and in the grasping main body Between 1121 and the second additional layer 1125 or in the second additional layer 1125 , back through the gripping body 1121 , and out of the gripper 112 from the first additional layer 1123 . In some embodiments, the grasping body 1121 is provided with at least two through holes 1126b and 1126c, the control wire 121 passes through one through hole 1126b, and passes through the other through hole 1126c after passing through. The through holes 1126b and 1126c may be two adjacent through holes 1126, or there may be other through holes spaced between the two through holes 1126b and 1126c. In this embodiment, the two through holes 1126b and 1126c are respectively used for the control wire 121 to pass through or pass through, which can ensure that the control wire 121 is basically on the central axis of the clamping section, and the gripper 112 is pulled by the control wire 121 When acting, the force is relatively centered and even. At the same time, the two through holes 1126 can also better limit the control wire 121 and prevent the control wire 121 from shifting during the process of being stressed, thereby affecting the feel of the instrument operation. If the first additional layer 1123 and/or the second additional layer 1125 cover the entire through hole or at least cover the edge of the through hole, the control wire 121 can pass through the center of the through hole so that the control wire only touches the first through hole during pulling. The additional layer 1123 and/or the second additional layer 1125 do not need to be in contact with the edge of the through hole 1126 , so as to avoid abrasion due to friction with the edge of the metal through hole 1126 during the pulling process.

Referring to FIG. 23 , compared with Embodiment 1, in the tissue clamping device 1 according to the fourth embodiment of the present disclosure, the grasping member 112 further includes a third additional layer 1125 disposed between the grasping body 1121 and the second additional layer 1125 Layer 1128 , after the control wire 121 passes through the grasping body 1121 , passes between the second additional layer 1125 and the third additional layer 1128 . In some embodiments, the gripper 112 further includes a fourth additional layer 1129 disposed between the gripping body 1121 and the first additional layer 1123, and the third additional layer 1128 and the fourth additional layer 1129 are combined to integrally cover the Grip the main body 1121 . In some embodiments, if the four additional layers cover the through hole 1126 on the gripping body 1121, the control wire 121 passes through the first additional layer 1123, the fourth additional layer 1129, the through hole 1126, the third additional layer layer 1128 , and pass through between the third additional layer 1128 and the second additional layer 1125 and pass through the suspended end 1121b of the grasping main body 1121 . Of course, in this embodiment, the control wire 121 can also pass in and out from the two through holes 1126 of the grasping body 1121 respectively.

In this embodiment, a third additional layer 1128 is added between the second surface 1124 of the grasping body 1121 and the second additional layer 1125, and the control wire 121 runs between the third additional layer 1128 and the second additional layer 1125, In this way, the control wire 121 neither contacts the edge of the through hole 1126 of the gripping body 1121 nor the second surface 1124 of the gripping body 1121 .

Referring to FIG. 24 , compared with Embodiment 1, in the tissue clamping device 1 according to the fifth embodiment of the present disclosure, the tissue clamping device 1 further includes an elastic mesh adjustment mechanism 15, at least a part of the support mechanism 13 is passed through the adjustment In the mechanism 15; in the present embodiment, one end of the adjustment mechanism 15 is sleeved on the outside of the connection end 13a of the support mechanism 13 and is fixedly connected with the support mechanism 13, and the other end of the adjustment mechanism 15 is freely suspended; two clamping arms 111 clamp the flap Behind the leaves, the two grasping parts 112 are all pressed against the adjustment mechanism 15, because the adjustment mechanism 15 is an elastic mesh structure, so the distance between the leaflets can be adapted by the deformation of the adjustment mechanism 15, thereby adjusting the clamping arm 111 to the leaflets. degree of pulling. In addition, the adjustment part can also play a blocking role to reduce central regurgitation after the valve leaflets are clamped. In other embodiments, both ends of the adjustment mechanism 15 can be fixedly connected to the support mechanism 13; The other end is fixedly connected to the supporting mechanism 13 .

Referring to Fig. 25, on the basis of the above-mentioned embodiments, the tissue clamping device 1 of the present disclosure can change the structural form of the driving mechanism 14, and use a connecting rod to connect the slider 141 to drive the clamping arm 111 to open and close, so as to provide a stable clamping work together.

Referring to FIG. 26 , on the basis of the above-mentioned embodiments, the tissue clamping device 1 of the present disclosure can change the intervention route, such as clamping the leaflets through the transapical route.

Referring to FIG. 27 , on the basis of the above-mentioned embodiments, in the tissue clamping device 1 of the present disclosure, the two clamping arms 111 are provided with oblique slide grooves 111a, and the pivot shafts 131 provided at the connecting ends of the support mechanism 13 pass through at the same time. Through the inclined chute 111a of the two clamping arms 111, the drive shaft drives the pivot 131 to move in the axial direction, so that the inclined chute 111a can slide relative to the pivot 131 to drive the opening and closing of the clamping arm 111. This arrangement can The weight of the whole tissue clamping device 1 is reduced, and the size is reduced, so that the apparatus is miniaturized and lightened.

Referring to FIG. 28 , on the basis of the above embodiments, the driving mechanism 14 of the tissue clamping device 1 of the present disclosure includes: a base (not shown) fixedly connected to the clamping arm 111 , a push rod 142 and a locking member 143 One end of the clamping arm 111 is fixedly connected to the base, and one end of the grasping member 112 is fixedly connected to the push rod 142, and the push rod 142 can move axially relative to the base to drive the grasping member 112 and the clamping arm 111 to be relatively far away from or close to ; The locking member 143 is located outside the base and can move axially relative to the base to drive the clamping arm 111 and the gripping member 112 to draw inward.

In various embodiments, an elastic mesh adjustment mechanism may also be provided between the two gripping parts 112 .

In summary, in the tissue clamping device 1 and the tissue clamping system of the present disclosure, an additional layer is provided on the grasping body 1121, and at least part of the additional layer is located between the clamping arm 111 and the grasping body 1121, the control wire 121 passes through the gripping body 1121, between the gripping body 1121 and the additional layer correspondingly between the gripping arm 111 and the gripping body 1121 or between the gripping arm 111 and the gripping body 1121 at the additional layer and pass through the gripping member 112, so that the control wire 121 between the gripping body 1121 and the clamping arm 111 is constrained by an additional layer, thereby preventing the control wire 121 from being caught between the gripping body 1121 and the gripping arm. 111 is redundant, prevent the control wire 121 from being hooked on the anchor thorn 1127 and cannot be pulled out, and prevent the control wire 121 from being wound around the anchor thorn 1127 to cause wire breakage, so as to ensure that the control wire 121 can be successfully pulled out from the clamping mechanism 11, Therefore, the tissue clamping device 1 can be released smoothly without being hindered by the control wire 121, ensuring the safety and reliability of the operation.

It should be noted that in this article, relative terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply these No such actual relationship or order exists between entities or operations. Furthermore, the term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus comprising a set of elements includes not only those elements, but also includes elements not expressly listed. other elements of or also include elements inherent in such a process, method, article, or device. Without further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article or apparatus comprising said element.

In the description of this specification, descriptions referring to the terms "one embodiment", "certain embodiments", "examples", "specific examples", or "some examples" mean that specific examples described in conjunction with the embodiments or examples A feature, structure, material, or characteristic is included in at least one embodiment or example of the present disclosure. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

The above descriptions are only detailed descriptions of the present disclosure, so as to enable those skilled in the art to understand or implement the present disclosure. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present disclosure. Therefore, the present disclosure will not be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (22)

1. A tissue clamping device, including a clamping mechanism and a control mechanism;

   The clamping mechanism includes at least two clamping arms that can be relatively expanded and closed, and at least two grippers arranged between the two clamping arms; the control mechanism includes at least two control wires, Each of the control wires is connected to a corresponding one of the grippers, so that the grippers are controlled by the control wires to be relatively close to and away from the corresponding clamping arm;

   Wherein, the gripper includes a gripping body and an additional layer arranged on the gripping body, at least part of the additional layer is located between the clamping arm and the gripping body; the control wire Through the gripping body, between the gripping body and the additional layer correspondingly located between the clamping arm and the gripping body or between the additional layer correspondingly located in the clamping body The arm passes through a region between the gripping body and out of the gripping member.
2. The tissue clamping device of claim 1, wherein said additional layer comprises a first additional layer disposed on a first surface of said gripping body, and a first additional layer disposed on a second surface of said gripping body a second additional layer of the second additional layer located between the clamping arm and the gripping body;

   The control wire passes sequentially through the first additional layer and the gripping body, between the gripping body and the second additional layer or in the second additional layer, and from the Gripper threaded out.
3. The tissue clamping device according to claim 2, wherein the first additional layer and the second additional layer combine to completely cover the grasping body.
4. The tissue clamping device according to claim 2 or 3, wherein both the first additional layer and the second additional layer are membrane bodies or mesh structures.
5. The tissue clamping device according to any one of claims 2 to 4, wherein the material of the first additional layer and the second additional layer is biocompatible polymer or metal fiber.
6. The tissue clamping device according to any one of claims 2 to 5, wherein, the part where the first additional layer and/or the second additional layer is in contact with the control wire is provided with a lubricating channel or coated coated with a lubricating layer; or coated with a lubricating layer on the control wire.
7. The tissue clamping device according to any one of claims 2 to 6, wherein the control wire passes between the grasping body and the second additional layer or within the second additional layer The length is 1mm to 6mm.
8. The tissue clamping device according to any one of claims 1 to 7, wherein at least one through hole configured for passing the control wire is provided on the grasping body.
9. The tissue clamping device according to any one of claims 2 to 7, wherein the grasping member further comprises at least one anchor stab disposed on the second surface, the anchor stab penetrates the Second additional layer.
10. The tissue clamping device according to any one of claims 2 to 9, wherein the control wire passes through the edge of the gripping member.
11. The tissue grasping device of claim 10, wherein said control wire protrudes from the edge of the free-hanging end of said gripping member.
12. The tissue clamping device according to claim 11, wherein the control wire passes through a portion of the second additional layer correspondingly covering the free hanging end of the gripping body, and the gripping body The free hanging end is isolated from the control wire by the second additional layer.
13. The tissue clamping device according to any one of claims 2 to 9, wherein the control wire passes through the first additional layer and the gripping body in sequence, and passes between the gripping body and the gripping body. Passes between or within the second additional layer, back through the grip body, and out of the grip from the first additional layer.
14. The tissue clamping device according to any one of claims 2 to 9, wherein the control wire passes through the first additional layer and the grasping body in sequence, passes through the second additional layer, and passing back between the holding body and the second additional layer or inside the second additional layer, and passing out from the holding member.
15. The tissue clamping device according to any one of claims 2 to 9, wherein the additional layer further comprises a third additional layer disposed between the grasping body and the second additional layer, so After passing through the grasping body, the control wire travels between the second additional layer and the third additional layer.
16. The tissue clamping device according to claim 15, wherein the additional layer further comprises a fourth additional layer disposed between the grasping body and the first additional layer, the third additional layer and the The fourth additional layer is combined to completely cover the gripping body.
17. The tissue clamping device according to any one of claims 1 to 16, further comprising:

    A supporting mechanism, the supporting mechanism includes a connecting end and a free end arranged axially opposite; the clamping mechanism is arranged on the outside of the supporting mechanism, and the clamping arm of the clamping mechanism is connected to the connecting end;

    A driving mechanism, the driving mechanism is connected with the clamping arm of the clamping mechanism, so as to drive the clamping arm to expand or close with the connecting end as the center.
18. The tissue clamping device according to claim 17, further comprising an elastic mesh adjustment mechanism, at least a part of the support mechanism is passed through the adjustment mechanism.
19. The tissue clamping device according to claim 18, wherein one end of the adjustment mechanism is sheathed outside the connection end and connected to the support mechanism, and the other end of the adjustment mechanism is freely suspended.
20. A tissue clamping system, comprising the tissue clamping device according to any one of claims 1 to 19, and a delivery device, the clamping mechanism is detachably connected to the distal end of the delivery device, and the control wire can be Disengaged through the delivery device.
21. A method of valve repair comprising:

    The tissue holding device of any one of claims 1 to 19 is accessed through a catheter, and the tissue holding device is adjusted to approach the leaflets of the patient's valve;

    Tighten the control wire, control the driving mechanism to open the clamping arm, so that the grasping member is away from the clamping arm, and the leaflet enters between the grasping member and the clamping arm space, the clamping arm supports the leaflet;

    The control wire is released, and the grasping member expands to both sides and approaches the clamping arm under the elastic action of the grasping body itself, so as to capture the leaflet between the grasping member and the clamping arm. between the clamping arms;

    controlling the driving mechanism so that the clamping arm is closed to clamp the leaflet;

    After achieving the desired clamping effect, withdrawing the control wire; and

    The tissue gripping device is released and the delivery device is withdrawn from the body.
22. The method of repairing a valve according to claim 21, wherein said valve is selected from mitral valve and tricuspid valve.

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