Cardiac tissue closure device

Abstract

The invention provides a heart tissue closing device, and relates to the field of medical instruments. The device comprises a first clamping arm, a second clamping arm and an elastic piece, one end of the first clamping arm is rotationally connected with one end of the second clamping arm, and the elastic piece provides clamping force for the first clamping arm and the second clamping arm. According to the heart tissue closing device, clamping force is provided through the elastic piece and applied to the outer sides of the first clamping arm and the second clamping arm, so that the clamping arms are driven to flatten the auricles on the inner sides, the auricles are closed, and the central auricles can be prevented from being folded in the ligation process; the device can continuously apply stable clamping force through the elastic piece, so that the atrial appendage can still be completely closed when the atrophy thickness is reduced. According to the device, through multi-layer wrapping, the contact area is increased, and the tearing risk of heart tissue in the clamping process is prevented.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a cardiac tissue closure device. Background Art

[0002] Atrial fibrillation is one of the most common arrhythmias in clinical practice. The consequences of stroke caused by atrial fibrillation are very serious, with a mortality rate and disability rate of 70%. For patients with valvular atrial fibrillation, 57% of atrial thrombi originate from the left atrial appendage, and for patients with non-valvular atrial fibrillation, 90% of left atrial thrombi originate from the left atrial appendage. Even after the sinus rhythm is restored, the contraction of the left atrial appendage is suppressed, and thrombus formation may still occur again. The atrial appendage is located above the atrium, on the left side of the pulmonary artery and ascending aorta, between the left superior pulmonary vein and the mitral valve ring, and is a narrow, curved tubular blind-end cavity structure.

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

[0004] Among them, drug treatment, such as warfarin, but the use of warfarin has a higher risk of bleeding, and its clinical application is more difficult; in addition, warfarin may also cause osteoporosis and soft tissue necrosis.

[0005] Another method is to intervene in the atrial appendage during cardiac surgery. The surgical treatment of the atrial appendage is divided into surgical operation treatment of the atrial appendage and surgical instrument treatment of the atrial appendage. Among them, the common methods of surgical intervention are direct resection, suturing, and ligation of the atrial appendage. The main disadvantage of this method is the low surgical success rate and high surgical risk. The resection or suturing point has a high risk of bleeding, and the ligation has the risk of tearing and recanalization of the ligature line loosening. Previous studies have shown that the success rate of surgical operation treatment of the atrial appendage is as high as about 80%, and there are more adverse events after surgery. Surgical instrument treatment, such as the Lariat system, consists of an outer sheath, an inner sheath, a push rod, a lasso and a ligature. The head of the sheath is extended into the chest cavity through the intercostal incision, and the lasso and ligature are passed through the sheath into the body. After entering the body segment, the lasso and ligature are released in a ring shape, unfolded on the outside of the atrial appendage, inserted through the top of the atrial appendage, and ligated at the root of the atrial appendage through the ligature. After completion, the system is withdrawn, and finally the blood flow between the atrial appendage and the atrium is blocked by ligation.

[0006] Since the noose of the system is annular, during the operation, the noose is inserted from the top of the auricle and moves along the outer wall of the auricle to the root of the auricle. Since the auricle tissue is a soft tissue, the auricle is folded disorderly during the ligation operation, and the folds are piled up together, resulting in many gaps, which are prone to the risk of residual blood flow. The inner surface of the wrinkled auricle also has a high probability of blood congestion and eventually thrombosis. At the same time, after the auricle tissue shrinks, the suture line will become loose, which will cause the risk of blood recirculation. In addition, the ligature has the risk of cutting the tissue, which is easy to cause tissue tearing. Summary of the invention

[0007] 1. Technical issues to be solved

[0008] In view of the deficiencies of the prior art, the present invention provides a cardiac tissue closure device, which solves the technical problem that disordered folding, residual blood flow and thrombus formation may occur during the processing of the prior art surgical instruments.

[0009] (II) Technical solution

[0010] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0011] A cardiac tissue closure device, comprising:

[0012] A first clamping arm;

[0013] a second clamping arm, wherein one end of the first clamping arm is rotatably connected to one end of the second clamping arm;

[0014] An elastic member provides clamping force for the first clamping arm and the second clamping arm.

[0015] Preferably, the elastic member comprises:

[0016] a first clamping portion, the first clamping portion being connected to the first clamping arm;

[0017] a second clamping portion, the second clamping portion being connected to the second clamping arm;

[0018] an elastic bending portion, the elastic bending portion connecting the first clamping portion and the second clamping portion;

[0019] The elastic bending portion provides clamping force for the first clamping arm and the second clamping arm through the first clamping portion and the second clamping portion.

[0020] Preferably, the clamping portion 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 portion comprises:

[0022] Long gripping arm;

[0023] A short clamping arm, a first end of the long clamping arm and a first end of the first short clamping arm are connected to the first end of the elastic bending portion.

[0024] Preferably, the connection point between the second end of the long clamping arm and the outer wall of the first clamping arm is the first clamping point;

[0025] The connection between the second end of the short clamping arm and the outer wall of the first clamping arm is a second clamping point; and,

[0026] The first clamping point and the second clamping point are distributed along the length direction of the outer wall of the first clamping arm.

[0027] Preferably, the first clamping arm and the second clamping arm are in a wave-shaped structure with at least one protrusion.

[0028] Preferably, a protective cover is provided outside the first clamp arm and the second clamp arm.

[0029] (III) Beneficial effects

[0030] The present invention provides a cardiac tissue closure device. Compared with the prior art, it has the following beneficial effects:

[0031] The cardiac tissue closure device of the present invention provides clamping force through elastic parts, and the clamping force is applied to the outside of the first clamp arm and the second clamp arm, thereby driving the clamp arm to clamp the inner atrial appendage flat, thereby closing the atrial appendage, preventing the folding gap caused by ligating the atrial appendage, and avoiding the risk of residual blood flow and thrombosis. By increasing the contact area between the device and the atrial appendage tissue, the tearing of the atrial appendage tissue caused by the small contact surface of the ligature line is avoided. The device can continuously provide a stable clamping force through the elastic parts to ensure that the atrial appendage can still be completely closed when the thickness of the atrial appendage is reduced due to shrinkage; the V-shaped opening structure at the head end of the device breaks through the limitations of the ligation method, and there is no need to insert from the top of the atrial appendage. The clamp arm is opened and inserted along the root of the atrial appendage for closure. It is more convenient to implement the closure operation at the root of the atrial appendage from all angles, avoiding the complicated operation of ligation, and improving the accuracy of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0033] Figure 1 This is a schematic diagram of the overall structure of the first embodiment of the present invention;

[0034] Figure 2 It is an overall exploded view from a first perspective of the first structure of an embodiment of the present invention;

[0035] Figure 3 It is an overall exploded view from a second perspective of the first structure of an embodiment of the present invention;

[0036] Figure 4 This is a schematic diagram of an elastic member according to an embodiment of the present invention;

[0037] Figure 5This is a top view of the first structure of an embodiment of the present invention;

[0038] Figure 6 for Figure 5 AA section view;

[0039] Figure 7 It is an overall schematic diagram of the second structure of an embodiment of the present invention from a first viewing angle;

[0040] Figure 8 It is a second viewing angle overall schematic diagram of the second structure of an embodiment of the present invention;

[0041] Fig. 9 It is an overall schematic diagram of the second structure of the embodiment of the present invention from a third viewing angle;

[0042] Fig.10 It is a fourth viewing angle overall schematic diagram of the second structure of an embodiment of the present invention;

[0043] Fig.11 It is an overall schematic diagram of the second structure of the embodiment of the present invention from a fifth viewing angle;

[0044] Fig.12 It is a schematic diagram of the first structure and auricle clamping according to an embodiment of the present invention. DETAILED DESCRIPTION

[0045] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are clearly and completely described. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0046] The embodiment of the present application provides a cardiac tissue closure device to solve the technical problems of disordered folding, residual blood flow and thrombus formation during the processing of existing surgical instruments.

[0047] The technical solution in the embodiment of the present application is to solve the above problems, and the overall idea is as follows:

[0048] The atrial appendage is a long and narrow cavity. The cardiac tissue closure device of this embodiment can prevent the folding gap caused by ligating the atrial appendage by clamping the atrial appendage with the first clamp arm and the second clamp arm, thereby avoiding residual blood flow and the risk of thrombosis. By increasing the contact area between the device and the atrial appendage tissue, the tearing of the atrial appendage tissue caused by the small contact surface of the ligature line is avoided. The device can continuously provide a stable clamping force through the elastic member to ensure that the atrial appendage can still be completely closed when the thickness of the atrial appendage is reduced.

[0049] In addition, most existing surgical instruments use a circular closed lasso ligation method, which requires the ligature to be inserted from the top of the auricle to the base of the auricle, and the operation is relatively complicated. The device adopts an open design and does not need to be inserted from the top of the auricle. It can directly act on the base of the auricle, which is simple and convenient.

[0050] In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0051] An embodiment of the present invention provides a cardiac tissue closure device, such as Figures 1 to 11 As shown, it comprises: a first clamping arm 1, a second clamping arm 2 and an elastic member 3;

[0052] One end of the first clamp arm 1 is rotatably connected to one end of the second clamp arm 2, and specifically can be connected by hinge connection, pivot connection, etc. Figure 2 and 3 As shown, the connecting member 4 is used to realize the rotation connection by pivoting; its main purpose is to enable the first clamp arm 1 and the second clamp arm 2 to rotate around their connection to realize the opening and closing of the first clamp arm 1 and the second clamp arm 2, that is, the open state is a V-shaped structure; at the same time, the connecting member 4 can also limit the maximum opening angle of the first clamp arm 1 and the second clamp arm 2 to prevent the opening angle from being too large and the elastic member 3 from getting out of control.

[0053] like Fig.12 As shown, the blood flow between the atrial appendage 6 and the atrium 5 is blocked by clamping with the first clamp arm 1 and the second clamp arm 2, and the elastic member 3 provides clamping force for the first clamp arm 1 and the second clamp arm 2 to close the atrial appendage.

[0054] Specifically, the material of the first clamp arm 1 and the second clamp arm 2 can be implantable metal, such as stainless steel, cobalt-based alloy, platinum-iridium alloy, nickel-titanium alloy, magnesium-based alloy, iron-based alloy, etc., or it can be a polymer material, such as polytetrafluoroethylene, nylon, polyester, polyamide, polylactic acid, PGA, PDO, etc.

[0055] In the above embodiment, the first clamping arm 1 and the second clamping arm 2 are used to clamp the atrial appendage 4 under the clamping force of the elastic member 3 to achieve the closure of the atrial appendage. The clamping arm structure can flatten the atrial appendage, which can prevent residual blood flow and the risk of thrombosis caused by the folding of the atrial appendage during the ligation process. The open structure breaks through the limitations of the ligation method, and there is no need to insert from the top of the atrial appendage to the root of the atrial appendage. Through the V-shaped opening structure, the bottom of the atrial appendage can be more conveniently and directly closed from all angles. In addition, the elastic member 3 can continuously provide a stable clamping force to ensure that the atrial appendage can still be completely closed when the thickness of the atrial appendage is reduced.

[0056] In the specific implementation process of the above embodiment, Figure 2 , Figure 3 , Figure 4 As shown, the elastic member 3 includes a first clamping portion 302, a second clamping portion 303 and an elastic bending portion 301, wherein the first clamping portion 302 is connected to the outer wall of the first clamping arm 1; the second clamping portion 303 is connected to the outer wall of the second clamping arm 2; the elastic bending portion 301 connects the first clamping portion 302 and the second clamping portion 303, wherein the elastic bending portion 301 provides a clamping force for the first clamping portion 302 and the second clamping portion 303, so that the two generate a clamping force with a closing tendency, and the elastic bending portion 301 provides a clamping force for the first clamping arm 1 and the second clamping arm 2 through the first clamping portion 302 and the second clamping portion 303.

[0057] Specifically, the elastic member 3 is made of implantable metal, such as stainless steel, nickel-titanium alloy, etc., or polymer material, such as PLLA, PLGA, etc. The elastic bending portion 301 can be bent or curved by the above material, and the curved structure is driven by the first clamping portion 302 or the second clamping portion 303 to deform into an arc shape, thereby providing a clamping force.

[0058] The first clamping portion 302 and the second clamping portion 303 may be selected to be sheet-like structures to increase the force-bearing area and improve the clamping effect.

[0059] In a specific implementation process, the first clamping portion 302 and the outer wall of the first clamping arm 1 are provided with a plurality of connection points, and the connection points are distributed along the length direction of the first clamping arm 1. In the implementation process, the connection points between the first clamping portion 302 and the outer wall of the first clamping arm 1 are clamping points, and a plurality of connection points are provided to provide a plurality of clamping points, and the connection points are distributed along the length direction of the first clamping arm 1, that is, a plurality of clamping points are distributed along the length direction of the first clamping arm 1 to ensure uniform distribution of the clamping force.

[0060] At the same time, the second clamping portion 303 and the outer wall of the second clamping arm 2 may also be provided with multiple connection points.

[0061] During the specific implementation process, the first clamping part 302 includes a first long clamping part arm 3022 and a first short clamping part arm 3021, and the first end of the first long clamping part arm 3022 and the first end of the first short clamping part arm 3021 are connected to the first end of the elastic bending part 301. The specific first clamping part 302 is composed of the first long clamping part arm 3022 and the first short clamping part arm 3021, and is distributed along the width direction of the first clamping arm 1, and the ends of the first long clamping part arm 3022 and the first short clamping part arm 3021 are integrated 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 part arm 3022 and the first short clamping part arm 3021, that is, the lengths of the two parts are different. Technical personnel in the field can also choose to divide it into more than two parts according to needs.

[0062] In a specific implementation process, the connection between the second end of the first long clamping arm 3022 and the outer wall of the first clamping arm 1 is the first clamping point 304;

[0063] The connection between the second end of the first short clamping arm 3021 and the outer wall of the first clamping arm 1 is a second clamping point 305;

[0064] 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, in the above embodiment, the first clamping portion 302 is split into clamping points of different lengths along the width direction of the clamping arm, namely, the first long clamping arm 3022 and the first short clamping arm 3021, and the second end of the first long clamping arm 3022 and the second end of the first short clamping arm 3021 are connected to the outer wall of the first clamping arm 1, and the connection point is the clamping point. By splitting the first clamping portion 302 into clamping arms of different lengths along the width direction, the plurality of clamping points are distributed along the length direction of the first clamping arm 1.

[0065] At the same time, the second clamping portion 303 can also achieve the distribution of multiple clamping points through the above solution.

[0066] In the specific implementation process, the embodiment of the present invention provides two clamp arm structures, wherein the first clamp arm structure, such as Figures 1 to 6 As shown, the first clamping arm 1 and the second clamping arm 2 are in a straight plate structure, a straight cylinder structure, a straight trapezoidal structure, etc., that is, a linear structure.

[0067] When the first clamp arm structure is adopted, in order to facilitate the connection between the clamp arm and the elastic member 3, a groove 101 is provided on the outer side of the clamp arm along its length direction, and the clamping portion of the elastic member 3 cooperates with the groove 101 and is fixedly connected by welding, bolts or rivets, etc. Figure 2As shown, the groove 101 cooperates with the first long clamping arm 3022, and the first long clamping arm 3022 is embedded in the groove 101 and then fixed.

[0068] The second clamp arm structure, such as Figures 7 to 11 As shown, the first clamp arm 1 and the second clamp arm 2 have a convex wave-shaped structure, and the clamped tissue can be blocked in different areas by the clamp arms with the wave-shaped structure, thereby improving the clamping effect by the regional blocking.

[0069] When the second clamping arm structure is adopted, the first clamping portion 302 or the second clamping portion 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.

[0070] During the specific implementation, the first clamping arm 1 and the second clamping arm 2 are covered with a protective sleeve, so as to increase the force-bearing area and prevent the auricle from being torn.

[0071] Specifically, the protective cover can be composed of a single material or a multi-layer composite polymer material. The polymer material can be selected, such as polyester, silicone, polyurethane, etc., and the metal wire mesh can also be selected, such as nickel-titanium alloy, stainless steel.

[0072] The embodiment of the present invention provides a cardiac tissue closure device. Compared with the prior art, it has the following features:

[0073] Beneficial effects:

[0074] The cardiac tissue closure device of the present invention provides clamping force through elastic parts, and the clamping force is applied to the outside of the first clamp arm and the second clamp arm, thereby driving the clamp arm to clamp the inner atrial appendage flat, thereby closing the atrial appendage, preventing the folding gap caused by ligating the atrial appendage, and avoiding the risk of residual blood flow and thrombosis. By increasing the contact area between the device and the atrial appendage tissue, the tearing of the atrial appendage tissue caused by the small contact surface of the ligature line is avoided. The device can continuously provide a stable clamping force through the elastic parts to ensure that the atrial appendage can still be completely closed when the thickness of the atrial appendage is reduced due to shrinkage; the V-shaped opening structure at the head end of the device breaks through the limitations of the ligation method, and there is no need to insert from the top of the atrial appendage. The clamp arm is opened and inserted along the root of the atrial appendage for closure. It is more convenient to implement the closure operation at the root of the atrial appendage from all angles, avoiding the complicated operation of ligation, and improving the accuracy of the operation.

[0075] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0076] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A cardiac tissue closure device, comprising: A first clamping arm; a second clamping arm, wherein one end of the first clamping arm is rotatably connected to one end of the second clamping arm; An elastic member provides clamping force for the first clamping arm and the second clamping arm.

2. The cardiac tissue closure device of claim 1, wherein the elastic member comprises: a first clamping portion, the first clamping portion being connected to the first clamping arm; a second clamping portion, the second clamping portion being connected to the second clamping arm; an elastic bending portion, the elastic bending portion connecting the first clamping portion and the second clamping portion; The elastic bending portion provides clamping force for the first clamping arm and the second clamping arm through the first clamping portion and the second clamping portion.

3. The cardiac tissue closing device as claimed in claim 2, wherein the clamping portion 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.

4. The cardiac tissue closure device of claim 2, wherein the clamping portion comprises: Long gripping arm; A short clamping arm, a first end of the long clamping arm and a first end of the first short clamping arm are connected to the first end of the elastic bending portion.

5. The cardiac tissue closure device according to claim 4, wherein: The connection between the second end of the long clamping arm and the outer wall of the first clamping arm is a first clamping point; The connection between the second end of the first short clamping arm and the outer wall of the first clamping arm is a second clamping point; and, The first clamping point and the second clamping point are distributed along the length direction of the outer wall of the first clamping arm.

6. The cardiac tissue closure device according to any one of claims 1 to 5, characterized in that: The first clamping arm and the second clamping arm are in a wave-shaped structure with at least one protrusion.

7. The cardiac tissue closure device according to claim 6, wherein: The first clamping portion or the second clamping portion is connected to the protruding position of the clamping arm.

8. The cardiac tissue closure device according to claim 7, wherein: The raised position of the clamping arm is the clamping point.

9. The cardiac tissue closure device according to any one of claims 1 to 5, wherein: One end of the first clamp arm is rotatably connected to one end of the second clamp arm, including a hinge connection and a pivot connection.

10. The cardiac tissue closure device according to any one of claims 1 to 5, wherein: The first clamp arm and the second clamp arm are covered with a protective cover.

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