Cardiac tissue closure device

Abstract

The invention provides a heart tissue closing device, and relates to the field of medical instruments. Comprising a first clamping arm, a second clamping arm and a locking part, and the first clamping arm comprises a first end part and a second end part; the second clamping arm comprises a first end part and a second end part, and the first clamping arm and the second clamping arm can rotate around the first end parts of the first clamping arm and the second clamping arm so as to realize opening and closing of the second end part of the first clamping arm and the second end part of the second clamping arm; the locking part acts on the first clamping arm and the second clamping arm so as to prevent the first clamping arm and the second clamping arm from being opened. According to the heart tissue closing device, the heart tissue is closed through clamping of the first clamping arm and the second clamping arm, the first clamping arm and the second clamping arm which are in a closed state are kept through the locking part, the limitation of a loop ligature mode is broken through through a V-shaped opening structure, sleeving from the top end of an auricle is not needed, and the heart tissue is closed. And the clamping arms are opened to be inserted along the root of the auricle for closing, so that the closing operation can be more conveniently implemented at the root of the auricle from various angles.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a cardiac tissue closure device. Background Technology

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. Stroke caused by AF has extremely serious consequences, with a mortality and disability rate reaching 70%. In patients with valvular AF, 57% of atrial thrombi originate from the left atrial appendage; in patients with non-valvular AF, 90% of left atrial thrombi originate from the left atrial appendage. Even after sinus rhythm is restored, left atrial appendage contraction may cause thrombus formation again. The atrial appendage is located above the atria, to the left of the pulmonary artery and ascending aorta, between the left superior pulmonary vein and the mitral valve annulus, and is a long, narrow, tortuous, tubular, blind-ended cavity structure.

[0003] Currently, there are two main methods for preventing ischemic stroke of cardiogenic origin in clinical practice: drug therapy and surgical intervention of the cardiac appendage.

[0004] Drug treatment, such as warfarin, is an option, but warfarin carries a high risk of bleeding, making its clinical application difficult. In addition, warfarin may cause osteoporosis and soft tissue necrosis.

[0005] Another approach involves surgical intervention of the atrial appendage. Surgical intervention of the atrial appendage is further divided into surgical manipulation and instrumental manipulation. Surgical intervention commonly involves direct resection, suturing, and ligation of the atrial appendage. The main drawbacks of this method are its low success rate and high surgical risk. Resection or suturing carries a high risk of bleeding, while ligation carries the risk of tearing and recanalization due to suture loosening. Previous studies have shown that surgical manipulation of the atrial appendage has a success rate of approximately 80%, but also a high incidence of adverse events postoperatively. Instrumental manipulation, such as the Lariat system, consists of an outer sheath, an inner sheath, a pusher, a lasso, and ligatures. The sheath tip is inserted into the thoracic cavity through an intercostal incision. The lasso and ligature are then passed through the sheath into the body. Once inside the body, the lasso and ligature are released and looped outwards, extending to the lateral side of the atrial appendage. The loop is then inserted through the top of the atrial appendage, and ligated at the base using the ligature. After completion, the system is withdrawn, ultimately blocking blood flow between the atrial appendage and the atrium through ligation.

[0006] Because the system's lasso is a loop, the operation involves slipping the lasso through the top of the auricle and moving it along the outer wall of the auricle to the base of the auricle, making the operation quite complex. Summary of the Invention

[0007] (a) Technical problems to be solved

[0008] To address the shortcomings of existing technologies, this invention provides a cardiac tissue closure device that solves the problem of the complex operation of existing surgical instruments, which involve using a lasso to slip the instrument from the top of the atrial appendage and move it along the outer wall of the atrial appendage to the root of the atrial appendage.

[0009] (II) Technical Solution

[0010] To achieve the above objectives, the present invention provides the following technical solution:

[0011] A cardiac tissue closure device, comprising:

[0012] The first clamping arm includes a first end and a second end;

[0013] The second clamping arm includes a first end and a second end, wherein the first clamping arm and the second clamping arm are rotatable about their first ends to open and close the second ends of the first clamping arm and the second clamping arm.

[0014] A locking part acts on the first clamping arm and the second clamping arm to prevent the first clamping arm and the second clamping arm from opening.

[0015] Preferably, the locking part includes:

[0016] A rope, through which the second end of the first clamping arm and the second end of the first clamping arm are connected, to prevent the first clamping arm and the second clamping arm from opening.

[0017] Preferably, the rope comprises:

[0018] A first rope, the second end of which is fixedly connected to the second end of the first clamping arm, and the first rope extends along the inner wall of the first clamping arm to the first end of the first clamping arm;

[0019] The second rope has a second end fixedly connected to the second end of the second clamping arm, and the second rope extends along the inner wall of the second clamping arm to the first end of the second clamping arm;

[0020] The first end of the first rope is fixedly connected to the first end of the second rope.

[0021] Preferably, the rope comprises:

[0022] A first rope, the second end of which is fixedly connected to the second end of the second clamping arm, and the first end of the first rope extends along the inner wall of the first clamping arm to the first end of the first clamping arm through the second end of the first clamping arm;

[0023] The second rope has a second end fixedly connected to the second end of the first clamping arm, and the first end of the second rope extends along the inner wall of the second clamping arm to the first end of the second clamping arm through the second end of the second clamping arm.

[0024] The first end of the first rope is fixedly connected to the first end of the second rope.

[0025] Preferably, the first end of the first clamping arm and the first end of the second clamping arm rotate.

[0026] Preferably, the locking part includes:

[0027] A retaining ring acts on the first clamping arm and the second clamping arm to prevent the first clamping arm and the second clamping arm from opening.

[0028] Preferably, the retaining ring comprises:

[0029] A first clamping member is slidably connected to the first clamping arm;

[0030] The second clamping member is slidably connected to the second clamping arm;

[0031] The first clamping member and the second clamping member are disposed opposite to each other, and the first clamping arm and the second clamping arm are located between the first clamping member and the second clamping member. The clamping of the first clamping member and the second clamping member prevents the first clamping arm and the second clamping arm from opening.

[0032] Preferably, the inner walls of the first clamping member and the second clamping member are provided with a first barb structure;

[0033] The outer walls of the first clamping arm and the second clamping arm are provided with a second barb structure. The first barb structure and the second barb structure cooperate to prevent the first clamping arm and the second clamping arm from opening.

[0034] Preferably, the first clamping arm and the second clamping arm are covered with protective sleeves.

[0035] (III) Beneficial Effects

[0036] This invention provides a cardiac tissue closure device. Compared with the prior art, it has the following advantages:

[0037] The cardiac tissue closure device of the present invention achieves closure of cardiac tissue through the clamping of a first clamping arm and a second clamping arm. The first and second clamping arms can rotate relative to each other around one end, realizing the opening and closing of the other end. The opened first and second clamping arms clamp the cardiac tissue, and the locking part maintains the closed state of the first and second clamping arms, thereby maintaining the clamping state of the first and second clamping arms on the cardiac tissue. The V-shaped opening structure at the head end of the device overcomes the limitations of the ligation method, eliminating the need to slip it from the top of the atrial appendage. The clamping arms are opened and inserted along the root of the atrial appendage for closure, making it more convenient to perform the closure operation at the root of the atrial appendage from various angles, avoiding the complex operation of ligation, and improving the accuracy of operation. Furthermore, the locking part maintains the closed state of the first and second clamping arms to continuously maintain a stable closed state, ensuring that the cardiac tissue can still be completely closed even when it shrinks and its thickness decreases. Attached Figure Description

[0038] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0039] Figure 1 This is a schematic diagram of the overall structure of the first locking part from a first perspective in an embodiment of the present invention;

[0040] Figure 2 This is a schematic diagram of the overall structure of the first locking part from a second perspective in an embodiment of the present invention;

[0041] Figure 3 This is a schematic diagram of the overall structure of the first locking part from a third perspective in an embodiment of the present invention;

[0042] Figure 4 This is an exploded view of the overall structure of the first locking part from a first perspective, according to an embodiment of the present invention.

[0043] Figure 5 This is an exploded view of the overall structure of the first locking part from a second perspective, according to an embodiment of the present invention.

[0044] Figure 6 This is an exploded view of the overall structure of the first locking part from a third perspective, according to an embodiment of the present invention.

[0045] Figure 7 This is a cross-sectional view of an embodiment of the present invention using the first rope winding method;

[0046] Figure 8This is a cross-sectional view of an embodiment of the present invention using the second rope winding method;

[0047] Figure 9 This is a schematic diagram of the overall structure of the second locking part from a first perspective in an embodiment of the present invention;

[0048] Figure 10 This is a schematic diagram of the overall structure of the second locking part from a second perspective in an embodiment of the present invention;

[0049] Figure 11 This is a schematic diagram of the overall structure of the second locking part from a third perspective in an embodiment of the present invention;

[0050] Figure 12 This is a cross-sectional view of the second locking part used in an embodiment of the present invention;

[0051] Figure 13 This is an exploded view of the overall structure of the second locking part from a third perspective, according to an embodiment of the present invention.

[0052] Figure 14 This is an exploded view of the overall structure of the second locking part from a fourth perspective, according to an embodiment of the present invention. Detailed Implementation

[0053] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are described clearly and completely. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0054] This application provides a cardiac tissue closure device, which solves the problem that existing surgical instruments require inserting ligatures into cardiac tissue, making the operation relatively complicated.

[0055] The technical solution in this application is to solve the above problems, and the overall approach is as follows:

[0056] The heart tissue is closed by clamping the first clamping arm 1 and the second clamping arm 2. The first clamping arm 1 and the second clamping arm 2 can rotate relative to each other around one end, so as to open and close the other end. After opening, the first clamping arm 1 and the second clamping arm 2 clamp the heart tissue, and the locking part restricts the opening of the first clamping arm 1 and the second clamping arm 2, thereby maintaining the closed state of the first clamping arm 1 and the second clamping arm 2 on the heart tissue.

[0057] To better understand the above technical solutions, the following will provide a detailed explanation of the technical solutions in conjunction with the accompanying drawings and specific implementation methods.

[0058] This invention provides a cardiac tissue closure device, such as... Figures 1-14 As shown, it includes:

[0059] For ease of description, the first clamping arm 1, the second clamping arm 2, and the locking part 3 are described as follows: one end of the first clamping arm 1 is named the first end, and the other end is named the second end; one end of the second clamping arm 2 is named the first end, and the other end is named the second end. The first clamping arm 1 and the second clamping arm 2 can rotate around their first ends to open and close the second ends of the first clamping arm 1 and the second clamping arm 2. That is, the first clamping arm 1 and the second clamping arm 2 can open to form a V-shaped opening, wherein the apex of the V-shaped structure is the first end of the first clamping arm 1 and the second clamping arm 2.

[0060] The locking part 3 acts on the first clamping arm 1 and the second clamping arm 2 to prevent the first clamping arm 1 and the second clamping arm 2 from opening.

[0061] Specifically, the materials of the first clamping arm 1 and the second clamping arm 2 can be implantable metals, such as stainless steel, cobalt-based alloys, platinum-iridium alloys, nickel-titanium alloys, magnesium-based alloys, iron-based alloys, etc., or polymer materials, such as polytetrafluoroethylene, nylon, polyester, polyamide, polylactic acid, PGA, PDO, etc.

[0062] In the above embodiment, the heart tissue is sealed by clamping with the first clamping arm 1 and the second clamping arm 2. The first clamping arm 1 and the second clamping arm 2 can rotate relative to each other around one end, allowing the other end to open and close. When opened, the first clamping arm 1 and the second clamping arm 2 clamp the heart tissue, and a locking part restricts the opening of the first clamping arm 1 and the second clamping arm 2, thereby maintaining the clamping force of the first clamping arm 1 and the second clamping arm 2 on the heart tissue. The open structure overcomes the limitations of the ligation method, eliminating the need to insert a loop into the heart tissue. The V-shaped opening structure allows for more convenient sealing operations from various angles at the bottom of the heart tissue. Furthermore, the locking part can continuously provide a stable clamping force, ensuring that the heart tissue can still be completely sealed even when it shrinks and its thickness decreases.

[0063] Furthermore, existing ligation methods using ligatures are prone to tearing of cardiac tissue during the ligation process due to the thinness of the ligatures, posing a high risk of bleeding. Additionally, the heart, being a long and narrow cavity, is severely folded during ligation, increasing the risk of recanalization. This invention, through the clamping of a first clamping arm 1 and a second clamping arm 2, flattens the cardiac tissue, preventing the risk of recanalization caused by folding of the cardiac tissue during ligation.

[0064] This invention provides two locking mechanisms with different structures, which will be described in detail below:

[0065] The first method is to achieve this by winding ropes, which prevents the first clamping arm 1 and the second clamping arm 2 from opening. Specifically, the rope used in this invention refers to a line with a certain length and light strength, such as a rope made of fiber or a rope made of steel wire.

[0066] Based on rope winding, embodiments of the present invention provide two rope winding methods, namely:

[0067] In the specific implementation process, the first method of rope winding, such as Figures 4-7 As shown, the rope includes a first rope 301 and a second rope 302, wherein the second end of the first rope 301 is fixedly connected to the second end of the first clamping arm 1, and the first rope 301 extends along the inner wall of the first clamping arm 1 to the first end of the first clamping arm 1.

[0068] The second end of the second rope 302 is fixedly connected to the second end of the second clamping arm 2, and the second rope 302 extends along the inner wall of the second clamping arm 2 to the first end of the second clamping arm 2;

[0069] The first end of the first rope 301 is fixedly connected to the first end of the second rope 302.

[0070] That is, the first rope 301 and the second rope 302 form a force that closes the first clamping arm 1 and the second clamping arm 2, preventing the first clamping arm 1 and the second clamping arm 2 from opening. The structure is simple and easy to operate.

[0071] In practical implementation, the second method of rope wrapping, such as... Figure 8 As shown, the rope includes a first rope 301 and a second rope 302. The second end of the first rope 301 is fixedly connected to the second end of the second clamping arm 2, and the first end of the first rope 301 extends along the inner wall of the first clamping arm 1 to the first end of the first clamping arm 1 through the second end of the first clamping arm 1.

[0072] The second end of the second rope 302 is fixedly connected to the second end of the first clamping arm 1, and the first end of the second rope 302 extends along the inner wall of the second clamping arm 2 to the first end of the second clamping arm 2 through the second end of the second clamping arm 2.

[0073] The first end of the first rope 301 is fixedly connected to the first end of the second rope 302.

[0074] That is, a closed loop is formed by the first rope 301 and the second rope 302, thereby generating a force that closes the first clamping arm 1 and the second clamping arm 2, preventing the first clamping arm 1 and the second clamping arm 2 from opening. The structure is simple and easy to operate.

[0075] In the specific implementation of the above embodiment, the first end of the first clamping arm 1 and the first end of the second clamping arm 2 rotate, and the first end of the first clamping arm 1 and the first end of the second clamping arm 2 are axially connected by the connecting member 5.

[0076] Meanwhile, to facilitate rope traction, a through hole is provided in the middle part of the connector 5, and a connecting shaft 501 is provided in the through hole. During the rope winding process, the first rope 301 and the second rope 302 are located on both sides of the connecting shaft 501, which facilitates rope traction.

[0077] The second method is achieved through a retaining ring, which acts on the first clamping arm and the second clamping arm to prevent them from opening.

[0078] Specifically, such as Figures 9-14 As shown, the retaining ring includes a first clamping member 401 and a second clamping member 402. The first clamping member 401 is slidably connected to the first clamping arm 1, and the second clamping member 402 is slidably connected to the second clamping arm 2.

[0079] The first clamping member 401 and the second clamping member 402 are disposed opposite to each other, and the first clamping arm 1 and the second clamping arm 2 are located between the first clamping member 401 and the second clamping member 402. The clamping of the first clamping member 401 and the second clamping member 402 prevents the first clamping arm 1 and the second clamping arm 2 from opening, thereby maintaining the clamping force of the first clamping arm 1 and the second clamping arm 2 on the heart tissue.

[0080] Specifically, the slidable connection between the clamping member and the clamping arm can be achieved as follows: sliding grooves 6 are provided on both sides of the first clamping arm 1 and the second clamping arm 2, and sliding members 7 are provided on both sides of the first clamping member 401 and the second clamping member 402. The sliding grooves 6 and sliding members 7 cooperate to achieve sliding between the clamping member and the clamping arm. When the first clamping arm 1 and the second clamping arm 2 are in a closed state, such as... Figure 12 and 13 As shown, the first clamping arm 1 and the second clamping arm 2 are located between the first clamping member 401 and the second clamping member 402.

[0081] Specifically, the clamping component is made of implantable metal, such as stainless steel or nickel-titanium alloy, or polymer materials, such as PLLA or PLGA.

[0082] In the implementation of the above embodiments, the inner walls of the first clamping member 401 and the second clamping member 402 are provided with a first barb structure 403;

[0083] The outer walls of the first clamping arm 1 and the second clamping arm 2 are provided with a second barb structure 8. The first barb structure 403 and the second barb structure 8 cooperate to prevent the first clamping arm 1 and the second clamping arm 2 from opening.

[0084] The aforementioned clamping mechanism is designed to prevent the first clamping arm 1 and the second clamping arm 2 from opening, resulting in better strength and a more stable clamping effect.

[0085] In all the above embodiments, a protective sleeve is provided on the outside of the first clamping arm 1 and the second clamping arm 2 during implementation. The protective sleeve increases the force-bearing area and prevents tearing of heart tissue. Specifically, the protective sleeve can be composed of a single material or multiple layers of composite polymer materials. Polymer materials such as polyester, silicone, and polyurethane can be selected.

[0086] This invention provides a cardiac tissue closure device. Compared with the prior art, it has the following advantages:

[0087] Beneficial effects:

[0088] The cardiac tissue closure device of this invention achieves closure of cardiac tissue through the clamping of a first clamping arm and a second clamping arm. The first and second clamping arms can rotate relative to each other around one end, allowing the other end to open and close. When open, the first and second clamping arms clamp the cardiac tissue, and a locking part restricts the opening of the first and second clamping arms, thereby maintaining the clamping force on the cardiac tissue. It eliminates the need for a ligature, overcoming the limitations of ligation methods with its open structure. It does not require inserting a loop into the cardiac tissue, and the V-shaped opening structure allows for more convenient closure from various angles at the bottom of the cardiac tissue. Furthermore, the locking part provides a continuous and stable clamping force, ensuring complete closure even as the cardiac tissue shrinks and its thickness decreases.

[0089] Furthermore, existing ligation methods using sutures are prone to tearing of cardiac tissue during the ligation process due to the thinness of the sutures, posing a high risk of bleeding. Additionally, the heart, being a long and narrow cavity, is severely folded during ligation, increasing the risk of recanalization. This invention, through the clamping of a first and second clamping arm, flattens the cardiac tissue, preventing the risk of recanalization caused by folding of the cardiac tissue during ligation.

[0090] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0091] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A cardiac tissue closure device, characterized in that, include: The first clamping arm includes a first end and a second end; The second clamping arm includes a first end and a second end, wherein the first clamping arm and the second clamping arm are rotatable about their first ends to open and close the second ends of the first clamping arm and the second clamping arm. A locking part acts on the first clamping arm and the second clamping arm to prevent the first clamping arm and the second clamping arm from opening.

2. The cardiac tissue closure device as described in claim 1, characterized in that, The locking part includes: A rope, through which the second end of the first clamping arm and the second end of the first clamping arm are connected, to prevent the first clamping arm and the second clamping arm from opening.

3. The cardiac tissue closure device as described in claim 2, characterized in that, The rope includes: A first rope, the second end of which is fixedly connected to the second end of the first clamping arm, and the first rope extends along the inner wall of the first clamping arm to the first end of the first clamping arm; The second rope has a second end fixedly connected to the second end of the second clamping arm, and the second rope extends along the inner wall of the second clamping arm to the first end of the second clamping arm; The first end of the first rope is fixedly connected to the first end of the second rope.

4. The cardiac tissue closure device as described in claim 2, characterized in that, The rope includes: A first rope, the second end of which is fixedly connected to the second end of the second clamping arm, and the first end of the first rope extends along the inner wall of the first clamping arm to the first end of the first clamping arm through the second end of the first clamping arm; The second rope has a second end fixedly connected to the second end of the first clamping arm, and the first end of the second rope extends along the inner wall of the second clamping arm to the first end of the second clamping arm through the second end of the second clamping arm. The first end of the first rope is fixedly connected to the first end of the second rope.

5. The cardiac tissue closure device as described in claim 1, characterized in that, The first end of the first clamping arm and the first end of the second clamping arm rotate.

6. The cardiac tissue closure device as claimed in claim 1, characterized in that, The locking part includes: A retaining ring acts on the first clamping arm and the second clamping arm to prevent the first clamping arm and the second clamping arm from opening.

7. The cardiac tissue closure device as described in claim 6, characterized in that, The retaining ring component includes: A first clamping member is slidably connected to the first clamping arm; The second clamping member is slidably connected to the second clamping arm; The first clamping member and the second clamping member are disposed opposite to each other, and the first clamping arm and the second clamping arm are located between the first clamping member and the second clamping member. The clamping of the first clamping member and the second clamping member prevents the first clamping arm and the second clamping arm from opening.

8. The cardiac tissue closure device as claimed in claim 7, characterized in that, The inner walls of the first clamping member and the second clamping member are provided with a first barb structure; The outer walls of the first clamping arm and the second clamping arm are provided with a second barb structure. The first barb structure and the second barb structure cooperate to prevent the first clamping arm and the second clamping arm from opening.

9. The cardiac tissue closure device according to any one of claims 1 to 8, characterized in that, The first clamping arm and the second clamping arm are covered with protective sleeves.

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