Semi-flexible auricular clip

Abstract

The present disclosure relates to a semi-flexible atrial appendage clip, which includes a rigid clip arm, a semi-flexible clip arm, and a connector connecting the first end of the rigid clip arm to the first end of the semi-flexible clip arm. Wherein, the second end of the semi-flexible clip arm can be detachably connected to the rigid clip arm, so as to clamp tissue between the rigid clip arm and the semi-flexible clip arm. By setting one clip arm of the atrial appendage clip as a semi-flexible clip arm, the spring between the two rigid clip arms can be omitted, thereby reducing the burden on the delivery system and the doctor. In addition, the semi-flexible clip arm can be deformed by applying force, so that the atrial appendage clip can be easily arranged around the tissue to be clamped, and the tissue can be clamped by connecting the second end of the semi-flexible clip arm to the rigid clip arm. Even when the atrial appendage atrophies due to ischemia, the connection position of the semi-flexible clip arm relative to the rigid clip arm can be appropriately adjusted to adjust the clamping tightness.

Description

Technical Field

[0001] The present application relates to auricle clamps, and particularly to an implantable semi-flexible auricle clamp. Background Art

[0002] Arrhythmia is a series of diseases caused by various reasons, resulting in the loss of the inherent rhythm of the heart beat. It has a high incidence rate and great harm to health. For example, a clinically common type of persistent arrhythmia is atrial fibrillation (abbreviated as AF). It is caused by abnormal changes in the electrophysiological properties of atrial muscle cells due to various pathogenic factors, leading to fast and irregular contractions of the atrium and ventricle, thus causing discomfort symptoms such as palpitations, shortness of breath, and fatigue in patients, and increasing the incidence of adverse events such as heart failure, thromboembolism, and death.

[0003] During a normal cardiac systole and diastole process, there is a cyclic process of blood flowing into and out of the auricle. When blood enters the left auricle, this part of the tissue is filled with blood from the atrium. During the interval between two cardiac contractions, blood flows out of the left auricle and returns to the blood circulation system.

[0004] When atrial fibrillation occurs, the speed of blood flowing into and out of the auricle will be very low. Clinically, the entrance of the left auricle of atrial fibrillation patients is significantly widened, the auricle loses effective regular contractions, and the movement of the auricle wall is difficult to cause sufficient emptying of the left auricle, resulting in blood stasis in the left auricle and then coagulation to form thrombus. The thrombus in the auricle enters the atrium and then enters the blood circulation system. These thrombi may block the cerebral blood vessels or other blood vessels in the body, causing stroke or other lesions. Therefore, closing the auricle is a safe and effective method to prevent the formation of auricle thrombus. One of the instruments used for auricle closure is an auricle clamp.

[0005] Traditional auricle clamps include two rigid clamping arms. The two rigid clamping arms provide a continuous squeezing force on the auricle through the elastic deformation of the springs at both ends, thereby preventing blood from flowing into the auricle and the thrombus in the auricle from falling off into the circulating blood system. However, due to the continuous clamping of the auricle by the springs at both ends, when the auricle gradually atrophies due to ischemia, the auricle clamp will still generate a relatively large closing force, and there is a risk that the auricle will be clamped off and fall off at this time. On the other hand, the clamping arms and springs are usually made of metal materials, and a cladding is coated on the outside of the metal materials. These materials are non-degradable and have an impact on the environment. In addition, traditional auricle clamps need to be opened and placed in position through an auricle clamp delivery mechanism. Due to the elastic force of the springs, a relatively large force is required to keep the auricle clamp in the open state, which brings relatively high requirements for the structural strength of the delivery mechanism and the operating strength of doctors. Summary of the Invention

[0006] This application is proposed in view of the problems in the prior art. According to this application, a semi-flexible auricle clip is provided. The semi-flexible auricle clip includes a rigid clip arm, a semi-flexible clip arm, and a connector connecting the first end of the rigid clip arm to the first end of the semi-flexible clip arm. Wherein, the second end of the semi-flexible clip arm can be detachably connected to the rigid clip arm, so as to clamp the auricle tissue between the rigid clip arm and the semi-flexible clip arm.

[0007] By setting one clip arm of the auricle clip as a semi-flexible clip arm, the spring between the two rigid clip arms can be omitted, thus reducing the burden on the delivery system and the doctor. In addition, the semi-flexible clip arm can be deformed by applying force, so that the auricle clip can be easily fitted around the tissue to be clamped, and the tissue can be clamped by connecting the second end of the semi-flexible clip arm to the rigid clip arm.

[0008] In one embodiment, a chuck is provided at the second end of the semi-flexible clip arm, and the chuck can be clamped onto the rigid clip arm. Preferably, a clamping portion is provided at the second end of the rigid clip arm. The clamping portion includes a plurality of clamping flanges arranged at intervals, and a clamping groove is defined between the clamping flanges. The chuck can be selectively clamped in one of the clamping grooves.

[0009] By providing a plurality of clamping grooves in the connecting section of the rigid clip arm, the semi-flexible clip arm can be selectively clamped onto one of the clamping grooves, thereby adjusting the clamping degree between the rigid clip arm and the semi-flexible clip arm.

[0010] In one embodiment, each clamping groove and clamping flange form a clamping element, and a plurality of clamping elements are detachably mounted on the second end of the rigid clip arm, so that the length of the rigid clip arm can be adjusted as needed.

[0011] In one embodiment, the semi-flexible clip arm includes a plurality of links, and two adjacent links among the plurality of links can rotate relative to each other within a predetermined angle range.

[0012] In one embodiment, the predetermined angle range is in the range of -30 degrees to 30 degrees. By using a plurality of links to form the semi-flexible clip arm, the length of the semi-flexible clip arm can be adjusted as needed.

[0013] In one embodiment, the adjacent links are ball-and-socket joints. Wherein, each link includes a base and a ball head extending from the first end of the base. The base further includes a second end opposite to the first end, and a spherical groove is formed at the second end. The ball head of the adjacent link can be fitted into the groove. Preferably, the fit is an interference fit.

[0014] In one embodiment, the base is in the shape of a frustum of a cone; alternatively, the base is cylindrical.

[0015] In one embodiment, the ball head is formed with opposite planar surfaces, and the groove has corresponding opposite planar surfaces such that when the ball head is fitted into the groove, the planar surfaces of the ball head contact the planar surfaces of the groove, thereby restricting the relative rotation of the link members to a plane parallel to the planar surfaces.

[0016] In an embodiment where the base is cylindrical, when two adjacent link members are fitted together, the ball head of one link member is inserted into the groove of the other link member such that when the two link members are aligned, the two bases form a continuous cylindrical surface.

[0017] In one embodiment, the surface of the ball head and / or the groove forms a rough surface; alternatively or additionally, the surface of the ball head and / or the groove is provided with a friction-increasing coating.

[0018] In one embodiment, the outer surfaces of the rigid clamping arms, the semi-flexible clamping arms, and the connecting head are provided with a bioaffinity coating; or the rigid clamping arms, the semi-flexible clamping arms, and the connecting head are covered with a fabric.

[0019] In one embodiment, the chuck includes a base, a chuck jaw, and a connecting portion connecting the base and the chuck jaw. The base is formed with a spherical groove, and the ball head of the link member is detachably fitted into the groove of the base to connect the chuck to the second end of the semi-flexible clamping arm.

[0020] By using the technical solution of the present disclosure, the problem that the two traditional rigid clamping arms must rely on the elastic deformation of a spring, thereby restricting the application of degradable materials, is solved. Since the technical solution of the present disclosure does not adopt a spring structure, the application range of materials, especially the application of degradable materials, is increased.

[0021] The two rigid clamping arms must pass through a spring ear clip. Due to the difference in material or shape between the spring and the clamping arms, a coupling electrode is likely to be formed in human body fluid and corrosion occurs. The technical solution of the present disclosure effectively overcomes this problem.

[0022] Compared with a flexible soft-connected ear clip, which is inoperable and has a high risk of thrombosis, the structure of the clamping arms is safer and more reliable; and

[0023] The technical solution of the present disclosure adopts a semi-flexible structure, which can be adjusted in length to adapt to the requirements of various different ear clip shapes and sizes for different age groups. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings of the embodiments of the present invention will be briefly introduced below. Among them, the drawings are only used to show some embodiments of the present invention, rather than limiting all embodiments of the present invention thereto.

[0025] Figure 1 is a perspective view showing a semi - flexible atrial appendage clip according to an embodiment of the present application;

[0026] Figure 2 shows Figure 1 a perspective view of the rigid clip arms and the connection head of the semi - flexible atrial appendage clip shown, wherein Figure 2A is an enlarged view showing another embodiment of the engaging end of the rigid clip arm;

[0027] Figure 3 is a perspective view showing two links of the semi - flexible clip arm;

[0028] Figure 4 is a perspective view showing the latch of the semi - flexible clip arm;

[0029] Figure 5 is a side view showing a semi - flexible atrial appendage clip according to another embodiment of the present application;

[0030] Figures 6A to 6C shows Figure 5 side views, cross - sectional views and perspective views of the links of the semi - flexible atrial appendage clip shown; and

[0031] Figure 7 shows Figures 6A to 6C a cross - sectional view of the connected state of two links shown. Detailed Description of the Embodiment

[0032] In order to make the objectives, technical solutions and advantages of the technical solutions of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings of the specific embodiments of the present invention. The same reference numerals in the drawings represent the same components. It should be noted that the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the described embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0033] Unless otherwise defined, technical or scientific terms used herein shall have the ordinary meanings as understood by those of ordinary skill in the art to which this invention pertains. The terms "first", "second" and similar terms used in the description and claims of this patent application for invention do not denote any order, quantity or importance, but are merely used to distinguish different components. Similarly, terms such as "a" or "an" do not necessarily denote a quantity limitation. Terms such as "comprising" or "including" mean that the elements or items appearing before this term cover the elements or items listed after this term and equivalents, without excluding other elements or items. Terms such as "connected" or "coupled" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Terms such as "upper", "lower", "left", "right" are only used to indicate relative positional relationships, and when the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0034] In the following description and the appended claims, the term "semi-flexible" is used, which is intended to illustrate the characteristic that the modified feature can change its shape in a specific direction and at a specific angle as needed, and can maintain the changed shape after the shape change, and this characteristic can be achieved, for example, by the constituent material of the feature or the structure of the feature, and this application is not limited thereto.

[0035] Referring to the accompanying drawings below, a semi-flexible atrial appendage clip according to an embodiment of the present application will be described in detail, wherein, Figure 1 is an overall perspective view showing an embodiment of the semi-flexible atrial appendage clip, Figure 2 is showing Figure 1 a perspective view of the rigid clip arms and the connection head of the semi-flexible atrial appendage clip shown,

[0036] As Figure 1 shown, the semi-flexible atrial appendage clip 100 includes rigid clip arms 1, semi-flexible clip arms 2, and a connection head 3 that connects the rigid clip arms 1 and the semi-flexible clip arms 2. The rigid clip arms 1 are, for example, straight rod-shaped and are formed of materials such as degradable or non-degradable metals, alloys, composite materials, polymers, etc., and optionally have a coating (not shown) or are coated with a fabric (not shown) on their outer surfaces. For example, PTFE, PET fabric, both have good biocompatibility, or a degradable poly-L-lactic acid (PLLA) fiber fabric, etc. can also be used. As Figure 2Further shown, the rigid clamping arm 1 includes a body 14 in its longitudinal direction, an engaging end 11 at one end position of the body 14, and a connecting end 15 opposite to the engaging end 11. The engaging end 11 includes a plurality of annular flanges 13 spaced apart along the longitudinal direction of the rigid clamping arm 1 and an engaging groove 12 formed between two adjacent annular flanges 13. The diameter of the annular flange 13 is greater than the diameter of the body 14, thus protruding circumferentially from the body 14, and the diameter of the engaging groove 12 is less than the diameter of the annular flange 13. At the connecting end 15 of the rigid clamping arm 1, a connecting head 3 is fixedly connected.

[0037] As Figure 2 shown, the connecting head 3 includes a body 31, which is integrally formed with the rigid clamping arm 1 by means such as injection molding, machining, 3D printing, forging, powder metallurgy, etc. that can be conceived by those skilled in the art. Alternatively, the body 31 includes a connecting portion fixed to the connecting end of the rigid clamping arm 1, and the connecting portion is, for example, a hole (not labeled), such that the connecting end 15 of the rigid clamping arm 1 is inserted into the hole and fixed together by means such as welding, bonding, interference fit, etc. that can be conceived by those skilled in the art. At the other end of the body 31 of the connecting head 3, a connecting ball head 32 is provided, and the connecting ball head 32 is, for example, integrally provided on the connecting head 3. Alternatively, the body 31 may include a second hole (not labeled), which is on one side of the first hole and parallel to the first hole, and the connecting ball head 32 is fixed to the second hole by any one of the means such as welding, bonding, interference fit, etc. that can be conceived by those skilled in the art, and thus fixed on the connecting head 3. For this purpose, the connecting ball head 32 may include a shaft section 321 and a spherical head 322. The shaft section 321 is inserted into the second hole and fixed therein; the spherical head 322 is generally spherical in shape and has planes 323 formed on two opposite sides. A connecting end 324 is also formed between the shaft section 321 and the spherical head 322, and the connecting end 324 connects the spherical head 322 and the shaft section 321 and has a conical shape.

[0038] As Figure 1 shown, the semi-flexible atrial clip 100 further includes a semi-flexible clamping arm 2, which is connected by a plurality of links 21, and one end of the semi-flexible arm 2 is connected to the above-mentioned spherical head 322, while the other end is provided with a chuck 22, and the chuck 22 can be engaged with the engaging end 11 of the rigid clamping arm 1, and in particular can be engaged with the engaging groove 13 of the engaging end 11.

[0039] Referring to Figure 3 , Figure 3 shows a detailed view of two links 21 connected to each other. As Figure 3As shown, each link 21 includes a base 211 and a ball head 212. The base 211 is in the shape of a frustum of a cone, and a groove 213 is formed on its bottom surface. The ball head 212 is spherical and has flat surfaces 214 formed on both sides. Thus, the shape of the ball head 212 is the same as that of the spherical head 322 of the connector. The groove 213 is in a shape exceeding a hemisphere and corresponds to the shape of the ball head 212, and includes two opposite flat surfaces 215. Thus, during assembly, the ball head 212 of the first link 21 is inserted into the groove 213 of the base 211 of the second link 21', such that the flat surface 214 of the ball head 212 mates with the flat surface 215 of the groove 213. And because the shape of the groove 213 exceeds the maximum radius of the ball head 212, after the ball head 212 is press-fitted into the groove 213, it can prevent the ball head 212 from disengaging from the groove 213. The ball head 212 and the groove 213 adopt an interference fit, and the interference amount is controlled within the range of 0.2% to 5.0%. By the mating of the flat surface 214 of the ball head 212 and the flat surface 215 of the groove 211, the two links can only rotate within a plane parallel to the plane 214 or 215. And the groove 213 of the base 211 is designed such that when the first link 21 rotates a predetermined angle relative to the second link 21', the edge of the base of the second link 21' abuts against the outer peripheral surface of the base of the first link 21, thereby limiting the rotation angle between adjacent links within a predetermined range. This predetermined angle is controlled within the range of -30° to 30°.

[0040] The link 21 can be formed of a degradable or non-degradable metal, composite material, polymer, etc., and its surface can be formed with a relatively large roughness, whereby the semi-flexible arm 2 can maintain its shape through the frictional resistance between the links 21. Additionally, a friction coating or the like can also be applied to achieve the above-mentioned frictional resistance, and the present application is not limited thereto.

[0041] The following refers to Figure 4 Describe the structure of the chuck 22, as Figure 4As shown, the chuck 22 includes a base 221, a jaw 222, and a connecting portion 223 connecting the base 221 and the jaw 222. The base 221 is similar to the base of a link and includes a groove 2211 that is more than hemispherical so that the ball head 212 of the adjacent link 21 can be snapped into the groove 2211. The structure of the groove 2211 is the same as that of the groove in the base of the link 21, including a spherical groove and an opposing planar surface 2212 for mating with the ball head of the adjacent link 21, and thus will not be elaborated here. The connecting portion 223 is generally in the shape of a quarter circle and is connected to the jaw 222. The jaw 222 includes a bottom connected to the connecting portion 223 and an open claw portion 2221. The cross-section of the claw portion 2221 is in the shape of an arc that is more than a semi-circle, and the diameter of the arc is approximately equal to the diameter of the engaging groove 12. The opening of the claw portion 2221 is smaller than the diameter. Thus, when the claw portion 2221 is snapped into the engaging groove 12, the opening of the claw portion is slightly elastically deformed and elastically reset when passing over the diameter of the engaging groove 12, thereby snapping the jaw 222 or this end of the semi-flexible clamping arm 2 onto the rigid clamping arm 1. Thus, by selecting the engaging groove 12 into which the jaw 222 is snapped, the clamping degree of the semi-flexible clamping arm 2 relative to the rigid clamping arm 1 can be adjusted. For the convenience of snapping the claw portion into the engaging groove 12, the edge of the claw portion is preferably provided with a chamfer or a fillet 2222. The entire chuck 22 can be integrally formed or can be assembled from separate parts. Additionally, for the convenience of engagement, the bottom of the jaw 222 can rotate relative to the connecting portion 223 within a predetermined angle about an axis perpendicular to the plane defined by the bottom.

[0042] Additionally, as described above, the engaging end of the rigid clamping arm 1 is provided with a plurality of flanges and engaging grooves 12 provided between the engaging flanges. The engaging flanges and the engaging grooves can respectively form separate elements 10, and these elements can be sequentially connected to the engaging end of the rigid clamping arm 1, as Figure 2A shown. Thus, the rigid clamping arm 1 can be lengthened or shortened by adding or reducing the engaging elements as needed. This connection is preferably detachable, such as a snap connection, a threaded connection, etc., but the present application is not limited thereto. Similarly, the semi-flexible clamping arm 2 is connected by a plurality of links 21. Therefore, the number of links 21 can be increased or reduced as needed, thereby increasing or shortening the length of the semi-flexible clamping arm 2. Thus, different from traditional atrial appendage clamps that cannot change their sizes, the atrial appendage clamp according to the present application can adjust the length of the clamping arm as needed. For example, when the patient is a child, a shorter atrial appendage clamp can be used, and when the patient is an adult, a longer atrial appendage clamp can be assembled, thereby providing the most suitable atrial appendage clamp.

[0043] The rigid clamping arm 1, semi-flexible clamping arm 2, chuck 22, and connecting head 3 can be made of the same material or can use different materials. These materials include, but are not limited to: one or a combination of materials such as magnesium-based alloys, iron-based alloys, polycarbonate polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethylene glycol (PEG), chitosan (CS), polyhydroxybutyrate valerate (PHBV), polyglycolic acid / polylactic acid copolymer (PGLA), or poly-p-dioxanone (PPDO), and can also be obtained from traditional stainless steel, cobalt-chromium alloy, titanium alloy, shape memory alloy, or polymer materials.

[0044] In addition, a coating can be applied to the outer sides of the rigid clamping arm, semi-flexible clamping arm, and connecting head, or they can be covered with a fabric, and the present application is not limited thereto.

[0045] Since the semi-flexible clamping arm 2 is composed of multiple links 21, and each link 21 can maintain a specific shape through the frictional force between them. Thus, when applying this atrial appendage clip, a large force from the delivery system is not required to open the atrial appendage clip. By selecting the engaging groove 12 where the chuck 22 of the semi-flexible clamping arm 2 is combined, the closing degree between the semi-flexible clamping arm 2 and the rigid clamping arm 1 can be adjusted. That is, the claws 222 of the chuck 22 engaging into the engaging groove 12 at the outermost end will cause the semi-flexible clamping arm 2 to be more tightly fastened to the rigid clamping arm 1.

[0046] The following refers to Figures 5 to 7 Describe another embodiment of the semi-flexible clamping arm 2 according to the present application. The difference between this semi-flexible clamping arm 2 and the semi-flexible clamping arm 2 shown as Figures 1 to 4 lies in the structure of the link. In the following description, the same or similar parts use the same reference numerals, and the previous description can also be applied equally.

[0047] Figure 5 A side view of a semi-flexible atrial appendage clip according to another embodiment of the present application is shown. The semi-flexible atrial appendage clip includes a rigid clamping arm 1, a semi-flexible clamping arm 2, and a connecting head 3. Similar to the semi-flexible atrial appendage clip described with reference to Figures 1 to 4 The rigid clamping arm 1 includes an engaging end, the engaging end includes an engaging flange and an engaging groove defined between adjacent engaging flanges. The semi-flexible clamping arm 2 includes multiple links 21, the multiple links 21 form the main body of the clamping arm, and are connected to the connecting head at one end and a chuck 22 is connected at the other end.

[0048] Refer to Figures 6A to 6C where Figure 6A shows a side view of each link 21; Figure 6B shows a cross-sectional view of the link 21, and Figure 6C shows a perspective view of the link 21.

[0049] As shown in Figures 6A to 6CAs shown, the link 21 includes a base 211, a ball head 212, and a transition section 213 connected between the base 211 and the ball head 212. The ball head 212 is similar to Figure 3 the ball head of the link shown, so it will not be described in detail. It includes a spherical body and flat surfaces 2122 on both sides. The base 211 is generally cylindrical, and an annular depression 2131 is provided at one end connected to the ball head 212, and the connecting end 213 extends to the ball head 212 on the bottom surface of the depression. At the other end of the cylindrical base 211, a groove 2111 is provided. The groove 2111 includes a spherical portion 2111-1 and a flared portion 2111-2. The flared portion extends outwardly from the spherical portion, similar to the embodiment of the link shown with reference to Figure 3 . The spherical portion is used to receive the ball head 212 and also includes opposite flat surfaces 2111-3 to limit the rotation of the mating link within a plane parallel to this surface. Additionally, the depth dimension of the groove 2111 is determined such that when the ball head 212 of an adjacent link 21 is inserted into the spherical portion of the groove 2111, for example, by interference fit, and the two adjacent links 21 are aligned with each other (in a straight line), the rear end edge 215 of the base of the previous link 21 is substantially adjacent to the front end edge 214 of the base of the subsequent link 21, thus forming a continuous cylindrical surface.

[0050] Referring to Figure 7 , Figure 7 a cross-sectional view showing the connected state of two links is shown. As Figure 7 shown, when the two links rotate relative to each other, the edge of the base of the first link will abut against the connecting section, thereby restricting the rotation angle between the two links, for example, between -30 degrees and 30 degrees.

[0051] The structure and connection method of the chuck 22 are similar to those described with reference to Figure 4 , so they will not be described in detail.

[0052] The rigid clamping arm 1, semi-flexible clamping arm 2, chuck 22, and connecting head 3 can be made of the same material or can use different materials. These materials include but are not limited to: one or a combination of materials composed of magnesium-based alloys, iron-based alloys, polycarbonate polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethylene glycol (PEG), chitosan (CS), polyhydroxybutyrate valerate (PHBV), polyglycolic acid / polylactic acid copolymer (PGLA), or poly-p-dioxanone (PPDO), and can also be obtained from traditional stainless steel, cobalt-chromium alloy, titanium alloy, shape memory alloy, or polymer materials.

[0053] Referring again to Figure 5, in use, first, the flexible clamping arm 2 is arranged around the tissue to be clamped, and then the chuck 22 is engaged with the engaging groove of the rigid clamping arm 1. At this time, each link 21 of the semi-flexible clamping arm 2 is tightened, so that the cylindrical link bases of the plurality of links are adjacent to each other and parallel to the rigid clamping arm 1, thereby forming a continuous clamping arm suitable for clamping the tissue between the rigid clamping arm 1 and the semi-flexible clamping arm 2.

[0054] In the second embodiment, the connection part of the flexible rod is designed to be smoother. For details, see Figure 6A the middle base 211. Compared with the cylindrical design in Embodiment 1, the base 211 of this embodiment adopts a cylindrical design, so that the whole semi-flexible rod is within a cylindrical surface, ensuring a tighter fit between the semi-flexible rod and the rigid rod, effectively preventing the invention from damaging the atrial appendage clip tissue due to the deformation of the flexible rod during use, and making the clamping force of each part more uniform.

[0055] In one embodiment, the rigid rod is configured to be length-adjustable. This length adjustment can be achieved, for example, by providing a plurality of weakening parts in the rigid rod that can be cut off or easily broken off. The weakening parts are preferably located in front of the annular flange 13 of the card slot section. Thus, after determining the length, the rigid rod can be cut off or broken off at the weakening part, so that according to the needs of the patient, the size of the semi-flexible clamping arm according to the present disclosure can be determined before the operation and adapted.

[0056] Although the structures of the two embodiments are described in detail above, those skilled in the art can understand that the present invention is not limited to the above two embodiments. For example, although the semi-flexible clamping arm adopts a link form, it can be understood that the semi-flexible clamping arm can adopt other forms, such as shape memory alloy or any other structure that can allow the shape to change when a force is applied and can maintain the shape when the force is removed. In addition, in the above embodiments, an engaging groove is provided at the connection end of the rigid clamping arm, but this is not necessary. It is also possible to provide a part with increased local roughness or a shape / configuration suitable for clamping near the connection end of the rigid clamping arm to facilitate the chuck to be clamped onto the rigid clamping arm. Although in the above embodiments, a ball-and-socket joint is adopted between the links, a pin joint, a chain joint, etc. can also be adopted, and the present application is not limited thereto.

[0057] In one embodiment, a prestress can be applied between adjacent links 21 of the semi-flexible clamping arm 2. This prestress can be achieved, for example, by a spring (not shown) provided between adjacent links 21. The spring is provided, for example, between the groove of the base of the first link and the ball head of the second link, thereby applying a prestress to the first and second links to abut against each other. By applying prestress between adjacent links, the frictional resistance between adjacent links can be further increased.

[0058] From the foregoing description, it will be apparent to those of ordinary skill in the art that, while the methods and apparatuses described herein constitute exemplary embodiments of the present disclosure, the present invention is not limited to these specific embodiments and that changes may be made to such embodiments without departing from the scope of the present invention as defined by the claims. Additionally, it is to be understood that the present invention is defined by the claims and that this does not imply any limitation or element described herein in the description of the exemplary embodiments will be incorporated into the interpretation of any claim element unless such limitation or element is expressly stated. Similarly, it is to be understood that it is not necessary to meet all of the advantages or objectives of the invention disclosed herein in order to fall within the scope of any claim, since the present invention is defined by the claims and since there may be inherent and / or unforeseen advantages of the claimed invention that may not have been explicitly discussed herein even if possible.

Claims

1. A semi-flexible atrial appendage clip, the semi-flexible atrial appendage clip comprising a rigid clip arm, a semi-flexible clip arm, and a connector connecting the first end of the rigid clip arm to the first end of the semi-flexible clip arm, wherein, The second end of the semi-flexible clamping arm can be detachably connected to the rigid clamping arm, so as to clamp the tissue between the rigid clamping arm and the semi-flexible clamping arm. Wherein, the semi-flexible clamping arm includes a plurality of links, and two adjacent links among the plurality of links can rotate relative to each other within a predetermined angular range.

2. The semi-flexible auricular appendix clip according to claim 1, wherein, A chuck is provided at the second end of the semi-flexible clamping arm, and the chuck can be clamped onto the rigid clamping arm.

3. The semi-flexible auricular clip according to claim 2, wherein, A clamping portion is provided at the second end of the rigid clamping arm, and the clamping portion includes a plurality of spaced clamping flanges, and a clamping groove is defined between the clamping flanges, and the chuck can be selectively clamped onto one of the clamping grooves.

4. The semi-flexible atrial appendage clip according to claim 3, wherein, Each clamping groove and clamping flange constitute a clamping element, and a plurality of clamping elements are detachably mounted on the second end of the rigid clamping arm, whereby the length of the rigid clamping arm can be adjusted as needed.

5. The semi-flexible atrial appendage clip according to claim 3, wherein, Each of the clamping grooves is provided with a weakened portion, and the rigid clamping arm is configured to be able to be disconnected at the weakened portion.

6. The semi-flexible atrial appendage clip according to claim 1, wherein, The predetermined angular range is in the range of -30 degrees to 30 degrees.

7. The semi-flexible auricular appendix clip according to claim 1 or 6, wherein, The adjacent links are in ball-and-socket fit or link fit.

8. The semi-flexible atrial appendage clip according to claim 7, wherein, Each link includes a base and a ball head extending from the first end of the base, the base further includes a second end opposite to the first end, and a spherical groove is formed at the second end, and the ball head of the adjacent link can be fitted into the groove.

9. The semi-flexible auricle clip according to claim 8, wherein, The fit is an interference fit.

10. The semi-flexible atrial appendage clip according to claim 8, wherein, The base is in the shape of a frustum of a cone.

11. The semi-flexible atrial appendage clip according to claim 8, wherein, The base is cylindrical.

12. The semi-flexible auricle clip according to claim 8, wherein, The ball head is formed with opposite planar surfaces, and the groove has corresponding opposite planar surfaces, so that when the ball head is fitted into the groove, the planar surfaces of the ball head contact the planar surfaces of the groove, thereby restricting the rotation of the links relative to each other in a plane parallel to the planar surfaces.

13. The semi-flexible atrial appendage clip according to claim 11, wherein, When two adjacent links are fitted, the ball head of one link is inserted into the groove of the other link, so that when the two links are aligned, the two bases form a continuous cylindrical surface.

14. The semi-flexible auricular clip according to claim 8, wherein, The surface of the ball head and / or the groove forms a rough surface; or the surface of the ball head and / or the groove is provided with a friction-increasing coating.

15. The semi-flexible atrial appendage clip according to any one of claims 1 to 6, wherein, The outer surfaces of the rigid clamping arm, the semi-flexible clamping arm and the connecting head are provided with a bioaffinity coating; and / or The rigid clamping arm, the semi-flexible clamping arm and the connecting head are coated with a fabric.

16. The semi-flexible auricle clip according to any one of claims 3 to 6, wherein, The chuck includes a base, a clamping claw and a connecting portion connecting the base and the clamping claw, the base is formed with a spherical groove, and the ball head of the link is detachably fitted into the groove of the base to connect the chuck to the second end of the semi-flexible clamping arm.

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