WO2022205561A1

WO2022205561A1 - Clamping instrument

Info

Publication number: WO2022205561A1
Application number: PCT/CN2021/092413
Authority: WO
Inventors: 阙诗昊; 徐军; 程增兵; 林林
Original assignee: 上海汇禾医疗科技有限公司
Priority date: 2021-04-02
Filing date: 2021-05-08
Publication date: 2022-10-06
Also published as: CN113017929A

Abstract

A clamping instrument (1), comprising a base (2) capable of being positioned at a target center position, and at least two clamping structures (3) surrounding the base (2), wherein each clamping structure (3) may switch between a clamping state and a releasing state, so that different target tissues adjacent to the target center position are clamped, and the spacing distance between the target tissues is thus adjusted. Therefore, the clamping instrument (1) may separately capture or simultaneously capture different target tissues, so that the capture probability is improved, and the capture difficulty is reduced.

Description

Clamping instruments

This application claims the priority of the Chinese patent application with the application number CN202110376339.1 and the invention titled "Clamping Device" filed with the China Patent Office on April 2, 2021, the entire contents of which are incorporated into this application by reference.

technical field

The embodiments of the present application relate to the technical field of medical devices, and in particular, to a clamping device.

Background technique

Regurgitation of heart valves (mitral valve, tricuspid valve) is a common heart disease. Take the tricuspid valve as an example, which is located at the mouth of the right atrioventricular. The common disease is tricuspid regurgitation, that is, systolic blood flow from the right ventricle Backflow into the right atrium, resulting in a height expansion of the right atrium, increased pressure, and obstruction of venous blood return. Due to the increased load on the right ventricle, compensatory hypertrophy, prone to right heart failure.

Tricuspid valve regurgitation is generally caused by pulmonary hypertension, right ventricle enlargement, and tricuspid valve annulus expansion. After valvular regurgitation, the symptoms of right heart failure such as fatigue, ascites, edema, liver pain, indigestion, and anorexia are aggravated. Mild tricuspid regurgitation has no obvious clinical symptoms, but surgery is required when severe regurgitation occurs.

Traditional treatment methods include drug therapy, and surgical methods with corresponding surgical indications. Among them, surgical methods also include valve replacement and valve repair.

In recent years, with the development of science and technology, domestic and foreign device manufacturers have developed a batch of interventional clamping devices for the treatment of mitral or tricuspid regurgitation. Taking the treatment of mitral valve regurgitation as an example, the gripping device can be transcatheter femoral vein puncture through atrial septal puncture, and delivered from the left atrium down to the vicinity of the mitral valve, to target the dissociation of the anterior and posterior leaflets of the mitral valve. The edge is clamped and fixed, and the mitral valve is clamped into a double hole by a clamping device, so that the anterior and posterior valve leaflets can be well aligned at the end of systole, and the phenomenon of regurgitation can be reduced.

Most of the current edge-to-edge repair techniques of the mitral valve have the problem of difficulty in capturing the valve leaflets. The clamping part of the clamping device can only capture both valve leaflets at the same time. For patients with severe mitral regurgitation, Insufficiency of valve closure results in a longer procedure time and difficulty in capturing the valve leaflets.

How to solve the problems that the current valve leaflets are difficult to capture and the capture failure rate is high is the technical problem to be solved in the present application.

SUMMARY OF THE INVENTION

In view of the above problems, the present application provides a clamping device to overcome the above problems or at least partially solve the above problems.

An embodiment of the present application provides a clamping instrument, which includes: a base, which can be positioned at a target center position; and at least two clamping structures, each of which can be disposed on the base and face different directions The direction extends and is switchable relative to the base between a clamped state and a released state to adjust the separation distance between each of the target tissues by clamping different target tissues adjacent to the target center location.

Optionally, the clipping device includes two clipping structures disposed on opposite sides of the base, for clipping the anterior mitral valve and the posterior mitral valve respectively.

Optionally, the clipping device includes two clipping structures arranged on the base for clipping any two valves of the tricuspid valve respectively; or the clipping device includes a surrounding device. The three clamping structures on the base are used for clamping each valve of the tricuspid valve respectively.

Optionally, each of the clamping structures can be switched between the clamping state and the releasing state synchronously; or each of the clamping structures can be independently switched between the clamping state and the releasing state. switch between.

Optionally, the positioning angles of the clamping structures in the clamping state relative to the base may be the same or different.

Optionally, the clamping structure includes an inner clamping arm and an outer clamping arm; wherein, the inner clamping arm and the outer clamping arm each include a fixed end pivotally connected to the base, and the inner clamping arm and the The outer clamping arms can be pivoted relative to the base through the fixed ends respectively, so that the clamping structure can be switched between a clamping state and a releasing state.

Optionally, the inner clamping arm includes an inner arm clamping portion, the outer clamping arm includes an outer arm clamping portion, and the outer arm clamping portion cooperates with the inner arm clamping portion to clamp or release the target organization.

Optionally, the inner clip arm further includes an inner arm anti-detachment portion provided on the inner arm clip portion; and/or the outer clip arm further includes an outer arm clip portion provided on the outer arm clip portion. Arm detachment prevention part; wherein, when the clamping structure is in a clamping state, the inner arm detachment prevention part and/or the outer arm detachment prevention part is used to prevent the target tissue from being clamped from the outer arm part and the inner arm clamping part.

Optionally, the inner arm detachment prevention portion includes a plurality of barbs provided on the inner arm clamping portion and extending toward the direction of the outer arm clamping portion, and the outer arm detachment prevention portion includes a plurality of barbs formed on the inner arm clamping portion. A plurality of anti-separation grooves on the clamping part of the outer arm.

Optionally, the inner arm clamping portion includes an elastic band, and the outer arm clamping portion includes an arc-shaped blade.

Optionally, the inner clip arm further includes a free end relative to the fixed end, and the free end can be forced to drive the fixed end of the inner clip arm to pivot relative to the base to adjust the The pivot angle of the inner clip arm relative to the base.

Optionally, the clamping structure further includes an actuating rod and a linkage rod; wherein, the actuating rod is movably penetrated on the base, and opposite sides of the linkage rod are pivotally connected to the an outer clamp arm and the actuating rod; and wherein the actuating rod is movable relative to the base along its axial direction to drive the outer clamp arm to pivot relative to the base via the linkage rod to adjust the pivot angle of the outer clamp arm relative to the base.

Optionally, the clamping device includes two actuating rods corresponding to the two clamping structures; wherein, the two actuating rods include two actuating rods which are inserted through the base and sleeved with each other. An outer rod and an inner rod; wherein the two linkage rods are pivotally connected to the bottom of the outer rod of the outer rod and the bottom of the inner rod of the inner rod, and the bottom of the inner rod is located between the bottom of the outer rod and the bottom of the inner rod of the inner rod. Between the bases, the distance between the bottom of the outer rod and the base can define the maximum movement range of the bottom of the inner rod relative to the base.

Optionally, the clamping apparatus includes two actuating rods corresponding to the two clamping structures, the two actuating rods are respectively penetrated in the base and can be independently relative to each other. The base slips.

Optionally, the clamping structure further includes a locking structure provided on the base; wherein, the locking structure can be switched between a locking position and an unlocking position relative to the base to restrict or allow The actuating rod moves relative to the base.

To sum up, the clipping apparatus provided in the embodiment of the present application can improve the capture probability of the target tissue and reduce the capture difficulty by allowing each clipping structure enclosed on the base to independently perform the clipping and capturing operation of the target tissue.

Description of drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the accompanying drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments described in the embodiments of the present application. For those of ordinary skill in the art, other drawings can also be obtained according to these drawings.

1 to 2 are side views of different structures of the clamping device of the present application.

3 to 4 are schematic structural diagrams of an embodiment of the actuating rod of the clamping device of the present application.

FIG. 5 is a schematic structural diagram of another embodiment of the actuating rod of the clamping apparatus of the present application.

FIG. 6 is a schematic structural diagram of the locking structure of the clamping device of the present application.

component number

1: clamping instrument; 2: base; 3: clamping structure; 4: inner clamping arm; 402: fixed end; 404: inner arm clamping part; 406: inner arm disengagement prevention part; 408: barb; 410 : Elastic band; 412: Free end; 5: Outer clamp arm; 502: Fixed end; 504: Outer arm clamping part; 506: Outer arm detachment prevention part; 514: linkage lever; 516: outer lever; 518: inner lever; 520: outer lever bottom; 522: inner lever bottom; 6: locking structure.

Detailed ways

In order to make those skilled in the art better understand the technical solutions in the embodiments of the present application, the following will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the accompanying drawings in the embodiments of the present application. The embodiments described above are only a part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments in the embodiments of the present application should fall within the protection scope of the embodiments of the present application.

The current clamping device used for the treatment of mitral valve insufficiency can only capture both valve leaflets, which leads to the problems of difficulty in capturing the valve leaflets and long operation time. In view of this, the embodiments of the present application provide a clamping device that can independently perform the clamping operation of each leaflet, so as to improve the above-mentioned technical problems.

The specific implementation of the embodiments of the present application will be further described below with reference to the accompanying drawings of the embodiments of the present application.

The clipping device 1 of this embodiment can be used as an edge-to-edge repair implant in the field of structural heart disease interventional therapy, which can achieve the repair and treatment of heart leaflets through a minimally invasive transvascular approach or a transatrial appendage to a designated anatomical position .

As shown in FIGS. 1 and 2 , the clamping device 1 of the present application mainly includes a base 2 and at least two clamping structures 3 .

In this embodiment, the base 2 can be positioned at the target center position, and each clamping structure 3 can be enclosed on the base 2, and can be switched between the clamped state and the released state relative to the base 2, so as to pass the The target tissues adjacent to the center of the target are clamped or released, and the separation distance between the target tissues is adjusted.

Optionally, the clipping device 1 may include two clipping structures 3 disposed on opposite sides of the base 2, and the target tissue may include the anterior mitral valve and the posterior mitral valve. The two clamping structures 3 respectively clamp the anterior mitral valve and the posterior mitral valve to treat the problem of mitral insufficiency.

Optionally, the clipping device 1 can also be used for the treatment of tricuspid regurgitation.

In one embodiment, the clipping device 1 may include two clipping structures 3 surrounding the base 2, which can be used to clip any two valves of the tricuspid valve respectively.

In another embodiment, the clamping device 1 may also include three clamping structures 3 surrounding the base 2 to clamp each valve of the tricuspid valve respectively.

Optionally, each clamping structure 3 can be switched between the clamping state and the releasing state synchronously, or, each clamping structure 3 can be independently between the clamping state and the releasing state. switch between.

In this embodiment, the positioning angles of the clamping structures 3 in the clamping state relative to the base 2 may be the same or different.

In this embodiment, the clamping structure 3 may include an inner clamping arm 4 and an outer clamping arm 5 .

Specifically, the inner clip arm 4 and the outer clip arm 5 respectively include fixed ends 402, 502 pivotally connected to the base 2, and the inner clip arm 4 and the outer clip arm 5 can pivot relative to the base 2 through the fixed ends 402, 502, respectively, Thereby, the clamping structure 3 is provided to switch between the clamped state and the released state.

In this embodiment, the inner clamping arm 4 may include an inner arm clamping portion 404 , and correspondingly, the outer clamping arm 5 may include an outer arm clamping portion 504 , wherein the outer arm clamping portion 504 and the inner arm clamping portion 404 Can cooperate to clamp or release target tissue.

Optionally, inner arm gripping portion 404 may include elastic straps 410 . Outer arm gripping portion 504 may include arcuate vanes 510 .

Optionally, the inner arm 4 may further include an inner arm detachment preventing portion 406 provided on the inner arm clamping portion 404 .

Optionally, the outer clamping arm 5 may further include an outer arm detachment preventing portion 506 provided on the outer arm clamping portion 504 .

When the clamping structure 3 is in the clamped state, the inner arm detachment preventing portion 406 and/or the outer arm detaching preventing portion 506 can be used to prevent the target tissue from falling off between the outer arm clamping portion 504 and the inner arm clamping portion 404, so as to Make sure that the target tissue is firmly clamped between the outer arm clamp 504 and the inner arm clamp 404 .

Optionally, the inner arm detachment preventing portion 406 may include a plurality of barbs 408 provided on the inner arm clamping portion 404 and extending toward the direction of the outer arm clamping portion 504 .

Optionally, the outer arm detachment preventing portion 506 includes a plurality of detachment preventing grooves 508 formed on the outer arm clamping portion 504 .

In this embodiment, the inner clamp arm 4 further includes a free end 412 opposite to the fixed end 402 .

The free end 412 of the inner clamp arm 4 can be forced to drive the fixed end 402 of the inner clamp arm 4 to pivot relative to the base 2 to adjust the pivot angle of the inner clamp arm 4 relative to the base 2 .

For example, by connecting the free end 414 of the inner clamp arm 4 with a control wire (not shown), to actuate the inner clamp arm 4 relative to the base 2 by applying a force to the free end 412 of the inner clamp arm 4 by the control wire Pivoting to achieve the purpose of independently controlling the opening and closing angle of the inner clamp arm 4 relative to the base 2 .

In this embodiment, the clamping structure 3 further includes an actuating rod 512 and a linkage rod 514 .

The actuating rod 512 is movably disposed on the base 2 , and opposite sides of the linkage rod 514 are respectively pivotally connected to the outer clamp arm 5 and the actuating rod 512 .

In this embodiment, the actuating rod 512 can move relative to the base 2 along its axial direction, so as to drive the outer clamping arm 5 to pivot relative to the base 2 via the linkage rod 514, and then adjust the outer clamping arm 5 relative to the base. 2 to achieve the purpose of independently controlling the opening and closing angle of the outer clamp arm 5 relative to the base 2 .

Please refer to FIG. 3 and FIG. 4 , in one embodiment, in the case where the clamping device 1 includes two clamping structures 3 , the two actuating rods 512 corresponding to the two clamping structures 3 may include through The outer rod 516 and the inner rod 518 are sleeved with each other in the base 2 .

Specifically, the two linkage rods 514 are pivotally connected to the outer rod bottom 520 of the outer rod 516 and the inner rod bottom 522 of the inner rod 518 respectively, and the inner rod bottom 522 is located between the outer rod bottom 520 and the base 2 (ie, the inner rod bottom 522 is located between the outer rod bottom 520 and the base 2 ). The rod bottom 522 is closer to the base 2 than the outer rod bottom 520 ), so that the maximum movement range of the inner rod bottom 522 relative to the base 2 is defined by the distance between the outer rod bottom 520 and the base 2 .

Referring to FIG. 5 , in another embodiment, when the clamping apparatus 1 includes two clamping structures 3 , the two actuating rods corresponding to the two clamping structures 3 can respectively pass through the base 2 , for example, two actuating rods can be passed side by side in the base 2 so as to slide independently with respect to the base 2 .

Optionally, the clamping structure 3 may further include a locking structure 6 (refer to FIG. 6 ) provided on the base 2 , wherein the locking structure 6 may be in a locking position relative to the base 2 (for example, the position of the dotted line in FIG. 6 ) The locking configuration 6 ) and the unlocking position (eg, the locking configuration 6 in the solid line position in FIG. 6 ) are toggled to limit or allow movement of the actuating rod 512 relative to the base 2 .

To sum up, the clamping device of the present application can independently control each clamping structure to perform the clamping operation of the target tissue, which can effectively improve the capture probability of the target tissue and reduce the capture difficulty of the target tissue.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, but not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It is still possible to modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements to some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit of the technical solutions in the embodiments of the present application. scope.

Claims

A clamping device, characterized in that it comprises:

a pedestal that can be positioned at the center of the target; and

at least two clamping structures, each of which can be enclosed on the base and can be switched between a clamped state and a released state relative to the base to abut the target by clamping Different target tissues at the central position, and adjust the separation distance between the target tissues.
The clipping device according to claim 1, wherein the clipping device comprises two clipping structures respectively disposed on opposite sides of the base, for clipping the anterior mitral valve and the bicuspid valve respectively. posterior cusp valve.
The clamping device of claim 1, wherein:

The clamping device comprises two clamping structures arranged on the base for clamping any two valves of the tricuspid valve respectively; or

The clipping instrument includes three clipping structures surrounding the base and used for clipping each valve of the tricuspid valve respectively.
The clamping device of claim 1, wherein:

each of the clamping structures is synchronously switchable between the clamping state and the releasing state; or

Each of the clamping structures is independently switchable between the clamping state and the releasing state.
The clamping apparatus according to claim 1, wherein the positioning angles of the clamping structures in the clamping state relative to the base can be the same or different.
The clamping device according to claim 5, wherein the clamping structure comprises an inner clamping arm and an outer clamping arm;

Wherein, the inner clamp arm and the outer clamp arm each include a fixed end pivotally connected to the base, and the inner clamp arm and the outer clamp arm can be relative to the base through the fixed end, respectively pivoting for the clamping structure to switch between a clamped state and a released state.
The clamping device of claim 6, wherein:

The inner clamping arm includes an inner arm clamping portion, the outer clamping arm includes an outer arm clamping portion, and the outer arm clamping portion cooperates with the inner arm clamping portion to clamp or release the target tissue .
The clamping device of claim 7, wherein:

The inner clip arm further includes an inner arm detachment prevention part provided on the inner arm clamping part; and/or the outer clip arm further comprises an outer arm detachment prevention part arranged on the outer arm clamping part ;

Wherein, when the clamping structure is in the clamping state, the inner arm detachment prevention part and/or the outer arm detachment prevention part is used to prevent the target tissue from being separated from the outer arm clamping part and the inner arm It comes off between the arm grips.
The clipping device according to claim 8, wherein the inner arm disengagement preventing portion comprises a plurality of barbs provided on the inner arm clamping portion and extending toward the direction of the outer arm clamping portion , the outer arm detachment prevention part includes a plurality of detachment prevention grooves formed on the outer arm clamping part.
The clipping instrument of claim 7, wherein the inner arm gripping portion comprises an elastic band, and the outer arm gripping portion comprises an arcuate blade.
The clipping device according to claim 6, wherein the inner clipping arm further comprises a free end opposite to the fixed end, the free end being capable of driving the fixed end of the inner clipping arm relative to the fixed end. The base is pivoted to adjust the pivoting angle of the inner clip arm relative to the base.
The clamping instrument of claim 6, wherein the clamping structure further comprises an actuating rod and a linkage rod; wherein,

The actuating rod is movably passed through the base, and opposite sides of the linkage rod are pivotally connected to the outer clamp arm and the actuating rod respectively;

And wherein, the actuating rod can move relative to the base along its axial direction, so as to drive the outer clamp arm to pivot relative to the base via the linkage rod, so as to adjust the relative position of the outer clamp arm the pivoting angle of the base.
The clamping apparatus according to claim 12, wherein the clamping apparatus comprises two actuating rods corresponding to the two clamping structures; wherein, the two actuating rods comprise a An outer rod and an inner rod that are nested in the base and set to each other; wherein,

The two linkage rods are pivotally connected to the bottom of the outer rod of the outer rod and the bottom of the inner rod of the inner rod, and the bottom of the inner rod is located between the bottom of the outer rod and the base, and the bottom of the outer rod is located between the bottom of the outer rod and the base. The separation distance between the bottom of the rod and the base may define a maximum movement range of the bottom of the inner rod relative to the base.
The clamping instrument according to claim 12, wherein the clamping instrument comprises two actuating rods corresponding to the two clamping structures, and the two actuating rods respectively pass through the two actuating rods. in the base, and can independently slide relative to the base.
The clamping device according to claim 12, wherein the clamping structure further comprises a locking structure provided on the base;

Wherein, the locking structure is switchable relative to the base between a locked position and an unlocked position to limit or allow movement of the actuating rod relative to the base.