A repair clip system for treating aortic regurgitation

Abstract

The application discloses a repair clamp system for treating aortic regurgitation and belongs to the field of medical devices, comprising a delivery device and a repair device; the repair device comprises a positioning support, at least three leaflet fixing clamps, a delivery guide tube and a delivery catheter; the positioning support is implanted into a native aortic valve ring; the delivery guide tube loaded with the leaflet fixing clamps is guided to the junction of the leaflets through a guide wire; the leaflet fixing clamp is V-shaped and comprises first and second clamp arms and a locking line; the locking line is wound to form a self-locking fisherman knot; after being released, the clamp arms are automatically opened to capture the leaflets; the fisherman knot is tightened by pulling a control wire to make the clamp arms close to clamp the leaflets; a distal anti-falling barb and an anti-skid structure on the inner side of the clamp arms improve the anchoring effect. The system is minimally invasive, retains the function of the autologous leaflets, closes the junction of the leaflets to improve aortic regurgitation, reduces the amount of the implanted device and reduces the risk of complications such as paravalvular leakage.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a repair clip system for treating aortic reflux. Background Technology

[0002] Common valvular insufficiency includes mitral, tricuspid, aortic, and pulmonary valve diseases. Taking the mitral valve as an example, during cardiac systole, some blood in the left ventricle flows back into the left atrium through the incompletely closed mitral valve orifice. The left atrium simultaneously receives blood from the regurgitated blood in the left ventricle and blood from the pulmonary veins, resulting in a significant increase in left atrial blood volume and pressure, leading to left atrial hypertrophy.

[0003] During diastole, more blood flows from the left atrium to the left ventricle, causing the left ventricle to enlarge due to increased contraction. As the condition progresses from the compensated stage to the decompensated stage, both the left atrium and left ventricle develop heart failure, which in turn leads to pulmonary congestion, pulmonary hypertension, right ventricular hypertrophy, right atrial hypertrophy, right heart failure, and systemic circulatory congestion.

[0004] Traditional treatments include aggressive surgical procedures or palliative medication to combat inevitable heart failure. Surgical procedures include valve replacement and valvuloplasty. Among these, typical open-heart surgery is highly invasive, requires cardiopulmonary bypass, and carries a high rate of complications and infection risks. Consequently, many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0005] Currently, aortic valve stents mainly include mechanically expandable stents, balloon-expandable stents, and self-expanding stents. Mechanically expandable and balloon-expandable stents result in a small open area of ​​the valve after deployment, making precise positioning impossible and leading to a large transvalvular pressure gradient. While self-expanding stents have a small transvalvular pressure gradient and minimal conduction block after deployment, their poor coaxiality makes precise positioning impossible, easily causing problems such as paravalvular leakage and valve slippage. Most current aortic valve stent designs are for patients with aortic stenosis. However, for patients with aortic regurgitation, how to improve regurgitation control while preserving the function of the patient's own valve leaflets and reducing the amount of implantable material is an urgent issue that needs to be addressed in this field.

[0006] For example, patent application CN202111564487.2 discloses a stent-type artificial heart valve, including a stent assembly, a leaflet assembly, and mounting members. The stent assembly includes a stent column frame, a stent column frame cover, and a base frame. The stent column frame includes a continuous track forming a closed, curved shape defining a longitudinal axis, and a plurality of circumferentially spaced columns projecting from a tip segment along the longitudinal axis. A cloth covers the area around the rails. The base frame supports the tip segment. The leaflet assembly is attached to the stent assembly and includes a leaflet held between one of the tip segments and the base frame. Each mounting member passes directly through the stent column frame cover, the first leaflet, and the base frame. The track can have a constant cross-sectional shape with a major axis dimension greater than the minor axis dimension. While this technical solution has significant effects in improving the treatment of aortic valve regurgitation, the stent's anchoring position in the heart is unstable, making it prone to dislodgement after implantation. Furthermore, this implant completely replaces the autologous leaflet, resulting in a large implantation volume and significant irritation to the human body.

[0007] In summary, the urgent problem to be solved in this field is how to minimize the amount of implantation while ensuring the anti-reflux effect, so as to reduce the stimulation of cardiac tissue. Summary of the Invention

[0008] This application is made in view of the above and other ideas.

[0009] One of the purposes of this application is to overcome the shortcomings of the prior art and provide an innovative repair clip system for treating aortic regurgitation, addressing issues such as excessive implantation volume or complex structure in existing treatment devices.

[0010] The technical solution adopted to solve the technical problem of the present invention is to provide a repair clip system for treating aortic regurgitation, including a delivery device and a repair device. The repair device includes: a positioning stent, which is releasably installed on the delivery device and configured to match the morphology of the native aortic valve annulus and positioned at the native aortic valve annulus; at least three leaflet fixation clips for capturing and fixing adjacent native aortic leaflets; and a delivery system, which includes a delivery catheter and a guide tube. The guide tube is used to load the leaflet fixation clips and is sleeved on the outside of the delivery catheter. At least one guide wire is detachably connected to the positioning stent, and the distal end of the guide wire is connected to the guide tube for guiding the guide tube through the guide wire to the target leaflet junction after the positioning stent is implanted. The leaflet fixation clips are released from the guide tube and capture adjacent leaflet tissue to close the junction of adjacent leaflets.

[0011] As a further improvement of the present invention, each leaflet fixing clip includes a first clamping arm and a second clamping arm arranged opposite to each other, and at least two locking wires. The at least two locking wires pass through the first clamping arm and the second clamping arm, and their ends are intertwined to form a fisherman's knot. When the leaflet fixing clip is released from the guide tube and captures adjacent leaflet tissue, the fisherman's knot can be tightened and locked by pulling the tail end of the locking wire, thereby driving the first clamping arm and the second clamping arm to come closer to each other and clamp and fix them on the leaflet tissue to close the junction of adjacent leaflets.

[0012] As a further improvement of the present invention, the leaflet retainer has a V-shaped structure, the leaflet retainer has a proximal end and a distal end, and the distal opening of the leaflet retainer is configured to capture adjacent leaflet tissue from the outer side of the leaflet (as further explained in the specification: i.e. the side facing the aortic vessel wall) after the guide tube reaches the target leaflet junction along the guide line.

[0013] As a further improvement of the present invention, the locking line passes through the inner side of the leaflet retaining clamp and connects the first clamping arm and the second clamping arm. The leaflet retaining clamp has an open natural state in which the distal ends of the first clamping arm and the second clamping arm are separated from each other. The leaflet retaining clamp is configured to capture adjacent leaflet tissue located at the leaflet junction in the open natural state after being released from the guide tube. Furthermore, in response to the operation of pulling the tail end of the locking line, the first clamping arm and the second clamping arm move closer to each other until the captured leaflet tissue is locked and anchored.

[0014] As a further improvement of the present invention, the distal end of the leaflet fixing clip is provided with anti-detachment barbs; the anti-detachment barbs are configured such that when the leaflet fixing clip retracts and locks in response to pulling the locking line, the anti-detachment barbs penetrate into the clamped leaflet tissue to increase the anchoring force between the leaflet fixing clip and the leaflet tissue and prevent detachment.

[0015] As a further improvement of the present invention, a control wire is slidably threaded through the delivery catheter, the distal end of the control wire forming a detachable connection with the fisherman's knot; and the radial dimension of the fisherman's knot is larger than the diameter of the distal port of the delivery catheter; wherein, pulling the control wire causes the fisherman's knot to be tightened, and drives the locking line to close the leaflet fixing clamp.

[0016] As a further improvement of the present invention, the positioning stent is made of metal elastic wire and has a circular ring structure; the diameter of the circular ring structure is configured to be 16mm~35mm to match the original aortic valve annulus size of different patients.

[0017] As a further improvement of the present invention, the inner surfaces of the first clamping arm and the second clamping arm are provided with an anti-slip structure; the anti-slip structure is selected from one or more of the following: micro-protrusions, grid-like embossing, serrated protrusions or roughened surfaces; when the leaflet fixing clamp is closed, the anti-slip structure contacts the leaflet tissue surface to enhance clamping stability.

[0018] As a further improvement of the present invention, the leaflet fixing clip is made of an elastic metal material or a polymer material; the first clamping arm and the second clamping arm are in a natural state with an opening angle α, the opening angle α being in the range of 15° to 45°; the opening angle α is configured such that when the leaflet fixing clip is released from the guide tube, it can automatically spring open to the opening angle α to fully expose the capture space.

[0019] As a further improvement of the present invention, the number of guide wires is three, corresponding to the three leaflet junctions respectively; the distal end of each guide wire is detachably connected to the guide tube, and the proximal end is detachably connected to different circumferential positions of the positioning bracket.

[0020] Compared with the prior art, the advantages of the technical solution of this application include at least the following: According to a concept of this application, the positioning stent is preferentially released and positioned on the aortic valve annulus. The leaflet fixation clip is quickly and accurately delivered to the leaflet commissure via a preset guide path, and captures and anchors to the leaflet tissue at the commissure, causing the leaflet commissure to close. Even when the diseased aortic valve closes, its leaflet commissure will not close properly, resulting in regurgitation. Therefore, this solution achieves precise capture and anchoring at the leaflet commissure, which can effectively repair valvular regurgitation. Moreover, it eliminates the need for artificial valve replacement, preserves the patient's original leaflet function, and avoids complications such as paravalvular leak and atrioventricular block. At the same time, the minimally invasive operation reduces surgical trauma, lowers surgical risks, and improves the patient's postoperative quality of life.

[0021] According to one concept of this application, the leaflet retainer is released from the outer side of the leaflet and captures the leaflet, which allows the leaflet retainer to effectively clamp adjacent leaflet tissue and achieve effective fixation.

[0022] According to a concept of this application, the leaflet fixing clip adopts a V-shaped structure, which, together with the fisherman's knot formed by the locking line, allows the clip arm to be retracted and locked by pulling the locking line. It is convenient to operate and has a simple and stable structure. At the same time, the anti-detachment barbs and anti-slip structure further enhance the stability of the clamping, effectively preventing the leaflet fixing clip from falling off and ensuring the durability of the repair effect.

[0023] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0024] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 This is a schematic diagram of the repair clip system of the present invention.

[0025] Figure 2 This is a schematic diagram showing the positional relationship between the positioning bracket and the conveying system of the present invention.

[0026] Figure 3 This is a schematic diagram of the pre-installed state of the leaflet fixing clip and the setup of the guide wires according to the present invention.

[0027] Figure 4 This is a schematic diagram of the leaflet fixing clip of the present invention in its natural state.

[0028] Figure 5 This is a schematic diagram of the leaflet fixing clamp of the present invention closing after being subjected to force.

[0029] Figure 6 In the scenario addressed by this invention, aortic regurgitation occurs, preventing the valve leaflets from closing tightly.

[0030] Figure 7 This is a diagram showing the effect of implanting the repair clip system of the present invention.

[0031] The features represented by the numbers in the attached diagram are as follows: 1-Delivery device, 11-Delivery catheter, 12-Guide tube, 13-Guide wire, 14-Control wire, 2-Repair device, 21-Positioning bracket, 22-Leaf leaflet fixing clip, 221-First clamping arm, 222-Second clamping arm, 223-Locking line, 224-Fisherman's knot, 225-Anti-detachment barb. Detailed Implementation

[0032] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0033] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0034] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0035] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0036] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0037] Example 1: In this example, aortic regurgitation is repaired using annulus angioplasty. A repair clip system for treating aortic regurgitation includes a delivery device 1 and a repair device 2; the repair device 2 includes a positioning stent 21 and at least three leaflet fixing clips 22, such as... Figure 1 and 2 As shown, the delivery system includes a delivery catheter 11 and a guide tube 12; wherein, a positioning stent 21 is releasably mounted on the delivery device 1 and configured to match the morphology of the native aortic valve annulus and be positioned at the native aortic valve annulus; leaflet retaining clips 22 are used to capture and retain adjacent native aortic valve leaflets, such as Figure 6 and Figure 7 As shown; the guide tube 12 is used to load the leaflet fixation clip 22, and the guide tube 12 is sleeved on the outside of the delivery catheter 11. At least one guide wire 13 is detachably connected to the positioning bracket 21, and the distal end of the guide wire 13 is connected to the guide tube 12. This guide wire 13 is used to guide the guide tube 12 to the target leaflet junction after the positioning bracket 21 is implanted. Figure 3 As shown, the leaflet retainer 22 is released from the guide tube 12 and captures adjacent leaflet tissue to close the junction of adjacent leaflets, thereby reducing or blocking aortic regurgitation.

[0038] In this embodiment, each leaflet fixing clip 22 includes a first clamping arm 221 and a second clamping arm 222 disposed opposite to each other, and at least two locking wires 223. The at least two locking wires 223 pass through the first clamping arm 221 and the second clamping arm 222, and their ends are intertwined to form a fisherman's knot 224. Figure 4 As shown; after the leaflet fixing clamp 22 is released from the guide tube 12 and captures the adjacent leaflet tissue, the fisherman's knot 224 can be tightened and locked by pulling the tail end of the locking line 223, thereby driving the first clamping arm 221 and the second clamping arm 222 to come closer to each other and clamp and fix them on the leaflet tissue, so as to close the junction of the adjacent leaflets and realize the backflow repair.

[0039] In this embodiment, the leaflet retainer 22 has a V-shaped structure with a proximal end and a distal end. The distal opening of the leaflet retainer 22 is configured to capture adjacent leaflet tissue from the outer side of the leaflet (i.e., the side facing the aortic vessel wall) after the guide tube 12 reaches the target leaflet junction along the guide line 13. This ensures the accuracy of capture, avoids damage to the functional surface of the inner side of the leaflet, and prevents the leaflet retainer 22 from being impacted by the blood flow when the aortic valve opens and closes. On the one hand, this can avoid hemolysis caused by the blood flow impacting the leaflet retainer 22, and on the other hand, it can effectively prevent the leaflet retainer 22 from falling off due to excessive impact force.

[0040] In this embodiment, the locking line 223 passes through the inner side of the leaflet retaining clip 22 and connects the first clamping arm 221 and the second clamping arm 222. The leaflet retaining clip 22 has an open, natural state in which the distal ends of the first clamping arm 221 and the second clamping arm 222 are separated from each other. The leaflet retaining clip 22 is configured to capture adjacent leaflet tissue located at the leaflet junction in the open, natural state after being released from the guide tube 12. Furthermore, in response to the operation of pulling the tail end of the locking line 223, the first clamping arm 221 and the second clamping arm 222 move closer to each other until the captured leaflet tissue is locked and anchored, ensuring the stability of the clamping.

[0041] In this embodiment, the distal end of the leaflet fixing clip 22 is provided with anti-dislodgement barbs 225; the anti-dislodgement barbs 225 are configured such that when the leaflet fixing clip 22 closes and locks in response to pulling the locking line 223, the anti-dislodgement barbs 225 penetrate into the clamped leaflet tissue to increase the anchoring force between the leaflet fixing clip 22 and the leaflet tissue and prevent dislodgement, thereby further improving the fixation reliability.

[0042] In this embodiment, a control wire 14 is slidably threaded through the delivery catheter 11, and the distal end of the control wire 14 is detachably connected to a fisherman's knot 224; furthermore, the radial dimension of the fisherman's knot 224 is larger than the diameter of the distal end of the delivery catheter 11, such as... Figure 3As shown; where pulling the control wire 14 tightens the fisherman's knot 224, and drives the locking line 223 to close the leaf clamp 22, as shown. Figure 5 As shown, the operation is convenient and allows for precise control of the leaflet fixation clip 22. It is particularly noteworthy that the fisherman's knot 224 has a self-locking characteristic: when the leaflet fixation clip 22 is subjected to an outward expansion force from the leaflet tissue (i.e., a force attempting to reopen the clip arms), this expansion force is transmitted to the fisherman's knot 224 through the locking wires 223, making the entanglement between the two locking wires 223 tighter, thereby further tightening the fisherman's knot 224. In other words, the outward expansion force acting on the clip arms not only does not cause the fisherman's knot 224 to loosen, but also enhances its locking effect, ensuring that the leaflet fixation clip 22 maintains a reliable anchoring state throughout long-term implantation, effectively preventing the risk of postoperative leaflet incomplete closure or clip dislodgement.

[0043] In this embodiment, the positioning stent 21 is made of metal elastic wire and has a ring-shaped structure; the diameter of the ring-shaped structure is configured to be 28 mm to match the original aortic valve annulus size of different patients.

[0044] In this embodiment, the inner surfaces of the first clamping arm 221 and the second clamping arm 222 are provided with an anti-slip structure; the anti-slip structure is a roughened surface; when the leaflet fixing clip 22 is closed, the anti-slip structure contacts the leaflet tissue surface, increases the friction, enhances the clamping stability, and prevents the leaflet fixing clip 22 from sliding during heartbeat.

[0045] In this embodiment, the leaflet fixing clip 22 is made of an elastic metal material or a polymer material; the first clamping arm 221 and the second clamping arm 222 are in a natural state with an opening angle α, which is 45°; the opening angle α is configured such that when the leaflet fixing clip 22 is released from the guide tube 12, it can automatically spring open to the opening angle α to fully expose the capture space and facilitate accurate capture of the leaflet tissue.

[0046] In this embodiment, there are three guide wires 13, which correspond to the three leaflet junctions respectively. The distal end of each guide wire 13 is detachably connected to the guide tube 12, and the proximal end is detachably connected to different circumferential positions of the positioning bracket 21, so as to ensure that the guide tube 12 can accurately correspond to each leaflet junction, realize the synchronous or separate repair of the three leaflet junctions, and further improve the repair effect.

[0047] The procedure for implanting a repair clip system for treating aortic regurgitation into the heart according to the present invention is as follows: 1. Preoperative preparation: Based on the patient's aortic valve annulus size, a positioning stent 21 with an appropriate diameter is selected (since patients with aortic regurgitation have larger annular dilation, the size of the positioning stent 21 selected in this embodiment is 28mm). The positioning stent 21 is installed at the distal end of the delivery device 1. The proximal ends of the three guide wires 13 are connected to the three circumferential connection points of the positioning stent 21, and the distal ends are connected to the guide tube 12. The three leaflet clamps 22 are loaded into the guide tube 12. The distal end of the control wire 14 is connected to the fisherman's knot 224 of each leaflet clamp 22; 2. Positioning stent 21 implantation: Through interventional means, the delivery device 1 is guided to the aortic valve annulus, and the positioning stent 21 is released. The positioning stent 21 adheres to the original aortic valve annulus due to its own elasticity, achieving precise positioning; 3. Guide tube 12 guidance: Guide tube 12 along guide line 13 to the target leaflet junction (three guide lines 13 correspond to three leaflet junctions respectively, and can be guided simultaneously or separately), ensuring that the distal opening of leaflet fixing clip 22 is aligned with the junction of adjacent leaflets; 4. Release and clamping of leaflet fixing clip 22: Retract guide tube 12 to release leaflet fixing clip 22 inside guide tube 12. Leaflet fixing clip 22 automatically springs open to an opening angle of 45°, capturing adjacent leaflet tissue from the outer side of the leaflet; pull the proximal end of control wire 14, control wire 14 drives fisherman's knot 224 to tighten. After fisherman's knot 224 is locked, it drives the first clamping arm 221 and the second clamping arm 222 to move closer to each other until the leaflet tissue is firmly clamped; at this time, anti-detachment barbs 225 pierce into the leaflet tissue, and the anti-slip structure is in close contact with the leaflet tissue, further enhancing the fixation effect; 5. Postoperative management: After clamping is completed, disconnect the control wire 14 from the fisherman's knot 224, disconnect the guide wire 13 from the positioning bracket 21 and the guide tube 12, and withdraw the delivery catheter 11, the guide tube 12 and the delivery device 1 to complete the operation.

[0048] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A repair clip system for treating aortic regurgitation, characterized in that: Includes conveying devices; The repair device includes: a positioning stent releasably mounted on the delivery device and configured to match the morphology of the native aortic valve annulus and be positioned at the native aortic valve annulus, the positioning stent having a circular structure; at least three leaflet retaining clips for capturing and retaining adjacent native aortic valve leaflets; and a delivery system including a delivery catheter and a guide tube, the guide tube for loading the leaflet retaining clips and being sleeved outside the delivery catheter; wherein at least one guide wire is detachably connected to the positioning stent, the distal end of the guide wire being connected to the guide tube for guiding the guide tube through the delivery device after the positioning stent is implanted. The guide wire is guided to the target leaflet junction. The leaflet retaining clamp is released from the guide tube and captures adjacent leaflet tissue to close the junction of adjacent leaflets. Each leaflet retaining clamp includes a first clamping arm and a second clamping arm arranged opposite each other, and at least two locking wires. The at least two locking wires pass through the first clamping arm and the second clamping arm, and their ends are intertwined to form a fisherman's knot. After the leaflet retaining clamp is released from the guide tube and captures adjacent leaflet tissue, pulling the tail end of the locking wire can tighten and lock the fisherman's knot, thereby driving the first clamping arm and the second clamping arm to come closer together and clamp and fix to the leaflet tissue to close the junction of adjacent leaflets. The leaflet retaining clamp is V-shaped. The valve retainer has a structure with a proximal and distal end, the distal opening of which is configured to capture adjacent leaflet tissue from the outer surface of the leaflet after the guide tube reaches the target leaflet junction along the guide line; a control wire is slidably threaded through the delivery catheter, the distal end of which is detachably connected to the fisherman's knot; and the radial dimension of the fisherman's knot is larger than the diameter of the distal port of the delivery catheter; wherein pulling the control wire tightens the fisherman's knot and actuates the locking line to close the valve retainer.

2. The repair clip system for treating aortic regurgitation according to claim 1, characterized in that: The locking line passes through the inner side of the leaflet retaining clamp and connects the first clamping arm and the second clamping arm. The leaflet retaining clamp has an open, natural state in which the distal ends of the first clamping arm and the second clamping arm are separated from each other. The leaflet retaining clamp is configured to capture adjacent leaflet tissue located at the leaflet junction in the open, natural state after being released from the guide tube. In response to pulling the tail end of the locking line, the first clamping arm and the second clamping arm move closer together until the captured leaflet tissue is locked and anchored.

3. The repair clip system for treating aortic regurgitation according to claim 1, characterized in that: The distal end of the leaflet fixing clip is provided with anti-detachment barbs; the anti-detachment barbs are configured such that when the leaflet fixing clip retracts and locks in response to pulling the locking line, the anti-detachment barbs penetrate into the clamped leaflet tissue to increase the anchoring force between the leaflet fixing clip and the leaflet tissue and prevent detachment.

4. The repair clip system for treating aortic regurgitation according to claim 1, characterized in that: The positioning stent is made of elastic metal wire; the diameter of the annular structure is configured to be 16mm to 35mm to match the original aortic valve annulus size of different patients.

5. The repair clip system for treating aortic regurgitation according to claim 1, characterized in that: The inner surfaces of the first clamping arm and the second clamping arm are provided with anti-slip structures; the anti-slip structures are selected from one or more of the following: micro-protrusions, grid-like embossing, serrated protrusions, or roughened surfaces; when the leaflet fixing clamp is closed, the anti-slip structures contact the leaflet tissue surface to enhance clamping stability.

6. The repair clip system for treating aortic regurgitation according to claim 1, characterized in that: The leaflet fixing clip is made of elastic metal or polymer material; the first clamp arm and the second clamp arm are in a natural state with an opening angle α, the opening angle α being in the range of 15° to 45°; the opening angle α is configured such that when the leaflet fixing clip is released from the guide tube, it can automatically spring open to the opening angle α to fully expose the capture space.

7. The repair clip system for treating aortic regurgitation according to claim 1, characterized in that: The number of guide wires is three, corresponding to the three leaflet junctions respectively; the distal end of each guide wire is detachably connected to the guide tube, and the proximal end is detachably connected to different circumferential positions of the positioning bracket.

Images