Heart tissue closure device

Abstract

The application provides a heart tissue closure device. The device comprises a first clamping arm, a second clamping arm and an elastic member. One end of the first clamping arm is rotatably connected to one end of the second clamping arm, and the elastic member provides clamping force for the first clamping arm and the second clamping arm. The heart tissue closure device of the application provides clamping force through the elastic member, which is applied to the outside of the first clamping arm and the second clamping arm, so as to drive the clamping arms to flatten the inside auricle, realize the closure of the auricle, and prevent the auricle from being folded during ligation. The device can continuously provide stable clamping force through the elastic member, so as to ensure that the auricle can be completely closed when the thickness of the auricle is reduced. The device is wrapped by multiple layers, the contact area is increased, and the risk of tearing the heart tissue during clamping is prevented.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 201910023439.9, filed on January 10, 2019. The original application was entitled "Heart Tissue Closure Device". Technical Field

[0002] This invention relates to the field of medical devices, specifically to a cardiac tissue closure device. Background Technology

[0003] 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.

[0004] 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.

[0005] 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.

[0006] 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.

[0007] Because the system uses a loop-shaped ligature, during the procedure, the ligature is inserted from the top of the atrial appendage and moved along the outer wall to the base. Since the atrial appendage is soft tissue, it is folded randomly during the ligation process, creating numerous gaps and increasing the risk of residual blood flow. Furthermore, the inner surface of the folded atrial appendage has a high probability of blood pooling and eventually thrombosis. Additionally, the sutures may loosen as the atrial appendage shrinks, increasing the risk of blood flow re-entry. Moreover, the ligatures may cut the tissue, potentially causing tearing. Summary of the Invention

[0008] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a cardiac tissue closure device that solves the technical problem of disordered folding, residual blood flow, and thrombus formation that occurs during the processing of existing surgical instruments.

[0009] (II) Technical Solution To achieve the above objectives, the present invention provides the following technical solution: 1. A cardiac tissue closure device, comprising: First clamping arm; The second clamping arm, wherein one end of the first clamping arm is rotatably connected to one end of the second clamping arm; An elastic element, comprising: a first clamping portion, a second clamping portion, and an elastically bent portion connecting the first clamping portion and the second clamping portion; The elastic bending portion provides clamping force to the first clamping arm and the second clamping arm through the first clamping portion and the second clamping portion; The first clamping part and the outer wall of the first clamping arm are provided with multiple connection points, and the multiple connection points are distributed along the length direction of the first clamping arm. The second clamping part and the outer wall of the second clamping arm are provided with a plurality of connection points, and the plurality of connection points are distributed along the length direction of the second clamping arm.

[0010] Preferably, the first clamping part is connected to the outer wall of the first clamping arm through a plurality of spaced connection points, which are discretely distributed along the length direction of the first clamping arm.

[0011] Preferably, the first clamping part is fixedly connected to the outer wall of the first clamping arm at each connection point, and the plurality of connection points include at least two connection points spaced apart along the length direction of the first clamping arm.

[0012] Preferably, the first clamping part includes a first long clamping arm and a first short clamping arm, which are distributed along the width direction of the first clamping arm; the second clamping part includes a second long clamping arm and a second short clamping arm, which are distributed along the width direction of the second clamping arm.

[0013] Preferably, the first end of the first long clamping arm and the first end of the first short clamping arm are connected to the first end of the elastically bent portion, and the first ends of the first long clamping arm and the first short clamping arm are integral and converge at the end of the elastically bent portion.

[0014] Preferably, one end of the first clamping arm and one end of the second clamping arm are pivotally connected to achieve a rotatable connection.

[0015] Preferably, the first clamping arm and the second clamping arm have a wave-shaped structure.

[0016] Preferably, the first clamping arm and the second clamping arm are covered with protective sleeves.

[0017] Preferably, the first clamping arm and the second clamping arm are formed of implantable metal.

[0018] Preferably, the first clamping arm and the second clamping arm are formed of a polymer material. A cardiac tissue closure device, comprising: First clamping arm; The second clamping arm, wherein one end of the first clamping arm is rotatably connected to one end of the second clamping arm; An elastic element provides clamping force for the first clamping arm and the second clamping arm.

[0019] Preferably, the elastic element includes: First clamping part, the connection between the first clamping part and the first clamping arm; The second clamping part is connected to the second clamping arm; An elastically bent portion, wherein the elastically bent portion connects the first clamping portion and the second clamping portion; The elastic bending portion provides clamping force to the first clamping arm and the second clamping arm through the first clamping portion and the second clamping portion.

[0020] Preferably, the clamping part and the outer wall of the clamping arm are provided with a plurality of connection points, and the connection points are distributed along the length direction of the clamping arm.

[0021] Preferably, the clamping part includes: Long clamping arm; The short clamping arm, wherein the first end of the long clamping arm is connected to the first end of the first short clamping arm at the first end of the elastically bent portion.

[0022] Preferably, the first clamping point is the connection between the second end of the long clamping arm and the outer wall of the first clamping arm; The second end of the short clamping arm connects to the outer wall of the first clamping arm at a second clamping point; and... The first clamping point and the second clamping point are distributed along the length of the outer wall of the first clamping arm.

[0023] Preferably, the first clamping arm and the second clamping arm have at least one convex wavy structure.

[0024] Preferably, the first clamping arm and the second clamping arm are covered with protective sleeves.

[0025] (III) Beneficial Effects This invention provides a cardiac tissue closure device. Compared with the prior art, it has the following advantages: The cardiac tissue closure device of this invention provides clamping force through an elastic element. This clamping force is applied to the outer sides of the first and second clamping arms, thereby driving the clamping arms to flatten the inner atrial appendage, achieving closure of the atrial appendage. This prevents folding gaps caused by ligation of the atrial appendage, avoiding residual blood flow and the risk of thrombosis. By increasing the contact area between the device and the atrial appendage tissue, it avoids tearing of the atrial appendage tissue caused by an insufficient contact area of ​​the ligation suture. The device, through the elastic element, can continuously provide a stable clamping force, ensuring that the atrial appendage can still be completely closed even when its thickness decreases due to atrophy. The V-shaped opening structure at the head of the device overcomes the limitations of the ligation method, eliminating the need to slip it from the top of the atrial appendage. Closure is achieved by opening the clamping arms and inserting them along the root of the atrial appendage, allowing for more convenient closure operations from various angles at the root of the atrial appendage, avoiding the complex operation of ligation, and improving operational accuracy. Attached Figure Description

[0026] 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.

[0027] Figure 1 This is a schematic diagram of the overall structure of the first embodiment of the present invention.

[0028] Figure 2 This is a first-view exploded view of the overall structure of the first embodiment of the present invention.

[0029] Figure 3This is a second-view exploded view of the overall structure of the first embodiment of the present invention.

[0030] Figure 4 This is a schematic diagram of the elastic element in an embodiment of the present invention.

[0031] Figure 5 This is a top view of the first structure according to an embodiment of the present invention.

[0032] Figure 6 for Figure 5 AA sectional view.

[0033] Figure 7 This is a first-view overall schematic diagram of the second structure according to an embodiment of the present invention.

[0034] Figure 8 This is a second-view overall schematic diagram of the second structure according to an embodiment of the present invention.

[0035] Figure 9 This is a third-view overall schematic diagram of the second structure according to an embodiment of the present invention.

[0036] Figure 10 This is a fourth-view overall schematic diagram of the second structure according to an embodiment of the present invention.

[0037] Figure 11 This is a fifth-view overall schematic diagram of the second structure in an embodiment of the present invention.

[0038] Figure 12 This is a schematic diagram of the first structure and the auricle clamping method according to an embodiment of the present invention. Detailed Implementation

[0039] 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.

[0040] This application provides a cardiac tissue closure device, which solves the technical problems of disordered folding, residual blood flow, and thrombus formation that occur during the processing of existing surgical instruments.

[0041] The technical solution in this application is to solve the above problems, and the overall approach is as follows: The auricle of the heart is a long and narrow cavity. The cardiac tissue closure device in this embodiment uses a first and second clamping arm to flatten the auricle, preventing folds and gaps caused by ligation, thus avoiding residual blood flow and the risk of thrombosis. By increasing the contact area between the device and the auricle tissue, it avoids tearing of the auricle tissue due to insufficient contact area of ​​the ligation suture. The device uses an elastic element to continuously provide a stable clamping force, ensuring that the auricle can still be completely closed even when it shrinks and its thickness decreases.

[0042] In addition, most existing surgical instruments use a closed loop ligation method, which requires the ligation suture to be inserted from the top of the atrial appendage to the base of the atrial appendage, making the operation relatively complicated. This device uses an open design, which eliminates the need to insert it from the top of the atrial appendage and can be applied directly to the base of the atrial appendage, making it simple and convenient.

[0043] 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.

[0044] This invention provides a cardiac tissue closure device, such as... Figures 1-11 As shown, it includes: a first clamping arm 1, a second clamping arm 2, and an elastic element 3; One end of the first clamping arm 1 and one end of the second clamping arm 2 are rotatably connected, specifically by a hinge connection, pivot connection, etc. Figure 2 and 3 As shown, the connecting piece 4 is used to achieve a rotating connection through a pivoting method; its main purpose is to enable the first clamping arm 1 and the second clamping arm 2 to rotate around their connection point, so as to open and close the first clamping arm 1 and the second clamping arm 2, that is, the open state is a V-shaped structure; at the same time, the connecting piece 4 can also limit the maximum opening angle of the first clamping arm 1 and the second clamping arm 2, and prevent the opening angle from being too large and the elastic element 3 from going out of control.

[0045] like Figure 12 As shown, the blood flow between the auricle 6 and the atrium 5 is blocked by the first clamping arm 1 and the second clamping arm 2, and the elastic member 3 provides clamping force for the first clamping arm 1 and the second clamping arm 2, so that the auricle closes.

[0046] 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.

[0047] In the above embodiment, the atrial appendage 4 is clamped by the first clamping arm 1 and the second clamping arm 2 under the clamping force of the elastic member 3, thereby closing the atrial appendage. The clamping arm structure flattens the atrial appendage, preventing residual blood flow and thrombosis risks caused by the atrial appendage being folded during ligation. The open structure overcomes the limitations of the ligation method, eliminating the need to insert the clamp from the top of the atrial appendage to its base. The V-shaped opening structure allows for more convenient closure of the bottom of the atrial appendage from various angles. Furthermore, the elastic member 3 can continuously provide a stable clamping force, ensuring that the atrial appendage can still be completely closed even when it shrinks and its thickness decreases.

[0048] In the specific implementation process of the above embodiments, such as Figure 2 , Figure 3 , Figure 4 As shown, the elastic member 3 includes a first clamping part 302, a second clamping part 303, and an elastic bending part 301. The first clamping part 302 is connected to the outer wall of the first clamping arm 1; the second clamping part 303 is connected to the outer wall of the second clamping arm 2; the elastic bending part 301 connects the first clamping part 302 and the second clamping part 303, wherein the elastic bending part 301 provides clamping force to the first clamping part 302 and the second clamping part 303, so that the two generate a clamping force with a closing tendency. The elastic bending part 301 provides clamping force to the first clamping arm 1 and the second clamping arm 2 through the first clamping part 302 and the second clamping part 303.

[0049] Specifically, the elastic element 3 is made of implantable metal, such as stainless steel or nickel-titanium alloy, or polymer materials, such as PLLA or PLGA. The elastic bending portion 301 can be bent or folded into an arc-shaped structure by the above-mentioned material, and the arc-shaped deformation is driven by the first clamping portion 302 or the second clamping portion 303 to provide clamping force.

[0050] The first clamping part 302 and the second clamping part 303 can be selected as sheet-like structures to increase the force-bearing area and improve the clamping effect.

[0051] In specific implementation, the first clamping part 302 and the outer wall of the first clamping arm 1 are provided with multiple connection points, and the connection points are distributed along the length direction of the first clamping arm 1. In implementation, the connection points between the first clamping part 302 and the outer wall of the first clamping arm 1 are the clamping points. Multiple connection points provide multiple clamping points, and the connection points are distributed along the length direction of the first clamping arm 1, that is, multiple clamping points are distributed along the length direction of the first clamping arm 1 to ensure the uniform distribution of clamping force.

[0052] Meanwhile, the second clamping part 303 and the outer wall of the second clamping arm 2 may also be provided with multiple connection points.

[0053] In specific implementation, the first clamping part 302 includes a first long clamping arm 3022 and a first short clamping arm 3021. The first end of the first long clamping arm 3022 and the first end of the first short clamping arm 3021 are connected to the first end of the elastic bending part 301. Specifically, the first clamping part 302 is composed of the first long clamping arm 3022 and the first short clamping arm 3021, and is distributed along the width direction of the first clamping arm 1. The ends of the first long clamping arm 3022 and the first short clamping arm 3021 are integral and converge at the first end of the elastic bending part 301. It can also be understood that the first clamping part 302 is divided into two parts along the width direction, namely the first long clamping arm 3022 and the first short clamping arm 3021, that is, the two parts have different lengths. Those skilled in the art can also choose to divide it into more than two parts as needed.

[0054] In the specific implementation process, the second end of the first long clamping arm 3022 is connected to the outer wall of the first clamping arm 1 at the first clamping point 304. The second end of the first short clamping arm 3021 is connected to the outer wall of the first clamping arm 1 at the second clamping point 305. Furthermore, the first clamping point 304 and the second clamping point 305 are distributed along the length direction of the outer wall of the first clamping arm 1. That is, the above embodiment is achieved by splitting the first clamping part 302 along its width direction into clamping points of different lengths, namely a first long clamping arm 3022 and a first short clamping arm 3021, and the connection point between the second end of the first long clamping arm 3022 and the second end of the first short clamping arm 3021 and the outer wall of the first clamping arm 1 is the clamping point. By splitting the first clamping part 302 along its width direction into clamping arms of different lengths, multiple clamping points are distributed along the length direction of the first clamping arm 1.

[0055] Meanwhile, the second clamping part 303 can also achieve the distribution of multiple clamping points through the above scheme.

[0056] In specific implementation, the embodiments of the present invention provide two clamping arm structures, wherein the first clamping arm structure is as follows: Figures 1-6 As shown, the first clamping arm 1 and the second clamping arm 2 have straight plate structure, straight cylinder structure, straight trapezoidal structure, etc., which are linear structures.

[0057] When the first clamping arm structure is adopted, to facilitate the connection between the clamping arm and the elastic element 3, a groove 101 is provided on the outer side of the clamping arm along its length. The clamping part of the elastic element 3 mates with the groove 101 and is fixedly connected by welding, bolts, or rivets, as shown in the figure. Figure 2As shown, the groove 101 cooperates with the first long clamping arm 3022, and the first long clamping arm 3022 is embedded into the groove 101 and then fixed.

[0058] The second type of clamping arm structure, such as Figures 7-11 As shown, the first clamping arm 1 and the second clamping arm 2 have a raised wavy structure. The clamping arms with the wavy structure can block the clamped tissue in sections, thereby improving the clamping effect.

[0059] When the second clamping arm structure is adopted, the first clamping part 302 or the second clamping part 303 can be connected to the protruding position of the clamping arm, that is, the protruding position of the clamping arm is the clamping point.

[0060] In the specific implementation process, the first clamping arm 1 and the second clamping arm 2 are covered with protective sleeves to increase the force-bearing area and prevent tearing of the auricle.

[0061] Specifically, the protective cover 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, as well as metal wire mesh such as nickel-titanium alloy and stainless steel.

[0062] This invention provides a cardiac tissue closure device. Compared with the prior art, it has the following advantages: The cardiac tissue closure device of this invention provides clamping force through an elastic element. This clamping force is applied to the outer sides of the first and second clamping arms, thereby driving the clamping arms to flatten the inner atrial appendage, achieving closure of the atrial appendage. This prevents folding gaps caused by ligation of the atrial appendage, avoiding residual blood flow and the risk of thrombosis. By increasing the contact area between the device and the atrial appendage tissue, it avoids tearing of the atrial appendage tissue caused by an insufficient contact area of ​​the ligation suture. The device, through the elastic element, can continuously provide a stable clamping force, ensuring that the atrial appendage can still be completely closed even when its thickness decreases due to atrophy. The V-shaped opening structure at the head of the device overcomes the limitations of the ligation method, eliminating the need to slip it from the top of the atrial appendage. Closure is achieved by opening the clamping arms and inserting them along the root of the atrial appendage, allowing for more convenient closure operations from various angles at the root of the atrial appendage, avoiding the complex operation of ligation, and improving operational accuracy.

[0063] 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.

[0064] 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: First clamping arm; The second clamping arm, wherein one end of the first clamping arm is rotatably connected to one end of the second clamping arm; An elastic element, comprising: a first clamping portion, a second clamping portion, and an elastically bent portion connecting the first clamping portion and the second clamping portion; The elastic bending portion provides clamping force to the first clamping arm and the second clamping arm through the first clamping portion and the second clamping portion; The first clamping part and the outer wall of the first clamping arm are provided with multiple connection points, and the multiple connection points are distributed along the length direction of the first clamping arm. The second clamping part and the outer wall of the second clamping arm are provided with a plurality of connection points, and the plurality of connection points are distributed along the length direction of the second clamping arm.

2. The cardiac tissue closure device as described in claim 1, characterized in that, The first clamping part is connected to the outer wall of the first clamping arm through a plurality of spaced connection points, which are discretely distributed along the length direction of the first clamping arm.

3. The cardiac tissue closure device as described in claim 2, characterized in that, The first clamping part is fixedly connected to the outer wall of the first clamping arm at each connection point, and the plurality of connection points include at least two connection points that are spaced apart along the length direction of the first clamping arm.

4. The cardiac tissue closure device as described in claim 1, characterized in that, The first clamping part includes a first long clamping arm and a first short clamping arm, which are distributed along the width direction of the first clamping arm; the second clamping part includes a second long clamping arm and a second short clamping arm, which are distributed along the width direction of the second clamping arm.

5. The cardiac tissue closure device as described in claim 4, characterized in that, The first end of the first long clamping arm and the first end of the first short clamping arm are connected to the first end of the elastic bending portion, and the first ends of the first long clamping arm and the first short clamping arm are integral and converge at the end of the elastic bending portion.

6. The cardiac tissue closure device as claimed in claim 1, characterized in that, One end of the first clamping arm and one end of the second clamping arm are pivotally connected to achieve a rotatable connection.

7. The cardiac tissue closure device as claimed in claim 1, characterized in that, The first clamping arm and the second clamping arm have a wave-shaped structure.

8. The cardiac tissue closure device as claimed in claim 1, characterized in that, The first clamping arm and the second clamping arm are covered with protective sleeves.

9. The cardiac tissue closure device as claimed in any one of claims 1 to 8, characterized in that, The first and second clamping arms are formed of implantable metal.

10. The cardiac tissue closure device as claimed in any one of claims 1 to 8, characterized in that, The first clamping arm and the second clamping arm are formed of polymer material.

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