A minimally invasive transcatheter leaflet coaption repair device

Abstract

This invention relates to a minimally invasive transcatheter valve leaflet folding repair device, belonging to the field of medical device technology. It includes a capture clip, a folding clip, a traction mechanism, and a stop mechanism. One end of the capture clip has a movable, openable and closable clamping arm, and the other end has a traction mechanism for pulling the clamping arm. The folding clip includes two foldable wings, each located on either side of the clamping arm, and each wing has a detachable stop mechanism to restrict the folding movement of the wings. The V-shaped capture clip provided by this invention has a large opening and closing angle, easily capturing prolapsed valve leaflets. The clamping device uses a shape memory alloy design, and after clamping the valve leaflet, it has a self-folding function, enabling rapid leaflet folding; it also has a locking mechanism to further prevent the clamping device from falling off or shifting.

Description

Technical Field

[0001] This invention relates to a minimally invasive transcatheter valve leaflet folding repair device, belonging to the field of medical device technology. Background Technology

[0002] Valvular regurgitation caused by valvular prolapse is one of the most common diseases in cardiac valve surgery. Taking the mitral valve as an example, in developed countries, the incidence of mitral regurgitation exceeds 10% in people over 75 years of age. In China, there are approximately 10 million patients with mitral regurgitation, and about 2 million of them have severe mitral regurgitation requiring surgery. Of these, about 40% are unable to tolerate surgery due to advanced age, heart failure, or multiple organ dysfunction, resulting in extremely high surgical risks and thus not receiving effective treatment. In other words, approximately 800,000 patients with severe mitral regurgitation in China do not receive effective treatment because they cannot tolerate surgery. In addition, tricuspid valve prolapse also accounts for a significant portion of the regurgitation population.

[0003] Currently, for patients with severe mitral regurgitation whose condition cannot be relieved by medication and who cannot tolerate surgery, transcatheter mitral valve intervention is their only treatment option. Similar to open surgery, mitral valve interventional procedures include transcatheter mitral valve repair and transcatheter mitral valve replacement. Mitral valve repair can be further divided into leaflet repair, annular retraction, and artificial chordae tendineae implantation. Leaflet repair, based on the surgical principle of "edge-to-edge" repair, utilizes the Mitralclip technique, which is currently the simplest and most mature mitral valve repair technique, exhibiting the best clinical performance and being the most widely used in clinical practice. Annular retraction and artificial chordae tendineae implantation both have their limitations. Regarding transcatheter mitral valve replacement, more than 20 different types of interventional mitral valve systems are currently under development globally. However, existing interventional mitral valve systems all have certain design flaws and still present many problems.

[0004] In clinical practice, mitral valve prolapse can occur anywhere in the anterior and posterior leaflets or the commissure. The most commonly used techniques in surgical repair of simple mitral valve prolapse are leaflet folding and suturing combined with annulusoplasty. Edge-to-edge suturing is primarily a last resort, as it results in significant loss of the valve orifice area and alters the mitral valve orifice from a single opening to a double-orifice state—a non-physiological condition. However, due to its minimally invasive nature, transcatheter edge-to-edge suturing has its advantages. Furthermore, edge-to-edge suturing is mainly effective for lesions in the A2 and P2 regions, and has limitations in treating lesions in the commissure and A1, A3, P1, and P3 regions. Therefore, this invention addresses the limitations of existing transcatheter leaflet repair techniques by simulating the leaflet folding technique used in surgical repair of mitral valve prolapse, designing a transcatheter leaflet folding device for the simple treatment of valve prolapse. Summary of the Invention

[0005] The purpose of this invention is to address the limitations of existing transcatheter treatments for lesions in the junctional region and A1, A3, P1, and P3 areas. Furthermore, given the current lack of a transcatheter valve prolapse folding repair device, this invention proposes to design a transcatheter valve leaflet folding repair device for valve prolapse lesions, thereby solving the technical problems associated with valve prolapse lesions.

[0006] To address the aforementioned problems, the present invention provides a minimally invasive transcatheter valve leaflet folding repair device, comprising a capture clip, a folding clip, a traction mechanism, and a stop mechanism; one end of the capture clip is provided with a movable, openable and closable clamping arm, and the other end of the capture clip is provided with a traction mechanism for pulling the clamping arm; the folding clip includes two side wings that can be folded together, the two side wings being respectively located on both sides of the clamping arm, and the two side wings are provided with a detachable stop mechanism to restrict the folding movement of the side wings.

[0007] Preferably, the capture clamp includes a clamping arm and a base, one end of the clamping arm is separate from the base, and the other end of the clamping arm is connected to the base through a hinge structure.

[0008] Preferably, one end of the traction mechanism is connected to one end of the clamping arm via a hinge structure, and the other end of the traction mechanism is provided with a traction guide post that opens and closes the clamping arm by pushing and pulling.

[0009] Preferably, one end of the clamping arm, which is separate from the base, has a V-shaped opening with the base.

[0010] Preferably, the two wings move towards each other and fold into the plane where the clamping arm opens and closes.

[0011] Preferably, the two wings are made of shape memory material; the two wings are located on both sides of the base.

[0012] Preferably, the two wings are provided with naturally curled bends, and the bends are provided with detachable stop mechanisms to restrict the folding movement of the wings.

[0013] Preferably, the stopping mechanism is a U-shaped clamp; the U-shaped clamp has a U-shaped groove, the width of which corresponds to the thickness of the side wing; the bends on both sides of the wing are engaged in the U-shaped groove to restrict the folding movement of the side wing.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] Currently, there are no transcatheter leaflet folding devices for valvular prolapse and regurgitation in clinical practice, and there are no similar products internationally.

[0016] 1) The V-clip provided by this invention has a large opening angle, making it easy to capture the petals.

[0017] 2) The clamping device provided by the present invention adopts a shape memory alloy design, which has a self-folding function after clamping the leaflets, and can quickly realize the leaflet folding function.

[0018] 3) The clamping device provided by the present invention has a locking mechanism, which can further prevent the clamping device from falling off or shifting. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of the minimally invasive transcatheter valve leaflet folding repair device of the present invention when the clamping arm is opened.

[0020] Figure 2 This is a schematic diagram of the structure of the clamp arm of the minimally invasive transcatheter valve leaflet folding repair device of the present invention during closure.

[0021] Figure 3 This is a schematic diagram of the structure of the minimally invasive transcatheter valve leaflet folding repair device of the present invention when the side wings are folded and closed.

[0022] Reference numerals: 1. Snap-on clamp; 2. Folding clamp; 3. Pulling mechanism; 4. Stopping mechanism; 5. Clamping arm; 6. Side wing; 7. Base; 8. Hinge structure; 9. Pulling guide post; 10. Clamp. Detailed Implementation

[0023] To make the present invention more apparent and understandable, preferred embodiments are described in detail below:

[0024] The technical solution adopted by the present invention is to provide a minimally invasive transcatheter valve leaflet folding repair device, including a capture clip 1, a folding clip 2, a traction mechanism 3, and a stop mechanism 4; one end of the capture clip 1 is provided with a movable, openable and closable clamping arm 5, and the other end of the capture clip 1 is provided with a traction mechanism 3 for pulling the clamping arm 5; the folding clip 2 includes two side wings 6 that can be folded together, the two side wings 6 are respectively provided on both sides of the clamping arm 5, and the two side wings 6 are provided with a detachable stop mechanism 4 to restrict the folding movement of the side wings 6.

[0025] The capture clamp 1 includes a clamping arm 5 and a base 7. One end of the clamping arm 5 is separate from the base 7, and the other end of the clamping arm 5 is connected to the base 7 via a hinge structure 8. One end of the pulling mechanism 3 is connected to one end of the clamping arm 5 via the hinge structure 8, and the other end of the pulling mechanism 3 is provided with a pulling guide post 9 that opens and closes the clamping arm 5 by pushing and pulling. The clamping arm 5 separated from the base 7 has a V-shaped opening with the base 7. The pulling guide post 9 can move the hinge structure 8 back and forth by pushing and pulling, and the back and forth movement of the hinge structure 8 can open or close the clamping arm 5.

[0026] The two wings 6 move towards each other, and when they open and close towards the clamping arm 5, the plane containing the clamping arm 5 closes and folds. The two wings 6 are made of shape memory material; the two wings 6 are located on both sides of the base 7. The two wings 6 are provided with bending points for the natural curling of the wings 6, that is, the shape memory alloy wing 6 can bend naturally at these bending points; if bending is not required, the upward bending of the two sides of the bending point can be prevented by pressing the bending point.

[0027] The bend is equipped with a detachable stop mechanism 4 to restrict the folding movement of the side wings 6. The stop mechanism 4 is a U-shaped clamp 10; the U-shaped clamp 10 is provided with a U-shaped groove, the width of which corresponds to the thickness of the side wings 6; the bends on both sides of the wings 6 are engaged in the U-shaped groove, and the folding movement of the side wings 6 is restricted by pressing the bends.

[0028] Currently, there is no transcatheter valve prolapse folding repair device. This invention aims to design a transcatheter valve leaflet folding repair device for valve prolapse lesions, thereby solving the technical problems associated with valve prolapse. The product of this invention has the function of clamping the prolapsed valve leaflet; after being deloaded from the delivery system, the device can self-fold and roll up the prolapsed valve leaflet.

[0029] The device of this invention can achieve the following functions:

[0030] 1) Capturing prolapsed leaflets: The V-shaped clamp has a large opening and closing angle, making it easy to capture leaflets; the device is designed to open and close in a V-shape, which can achieve a large opening and closing angle, making it easier to capture prolapsed leaflets.

[0031] 2) Folding: The side wings 6 on both sides of the V-clip have a self-folding function. After the V-clip captures the petals, it is gradually pushed out of the clip 10, and the side wings 6 with the folding function can realize the petal folding effect. The height of the side wings 6 with the folding function determines the depth of the folded petals.

[0032] 3) Locking: The rivet needle can be pushed along the clamp arm 5 to pierce the flap and rivet onto the side wing 6, which can prevent the risk of the V-shaped clamp falling off.

[0033] 4) Deloading: The V-Clip device is deloaded from the conveying system to complete the repair of the drooping leaflets.

[0034] Limitations of existing transcatheter valve repair techniques: While the transcatheter edge-to-edge technique is currently the most mature valve repair technique, it primarily targets lesions in the A2 and P2 regions. It has limitations in treating lesions in the commissural region and the A1, A3, P1, and P3 regions. Furthermore, it addresses the non-physiological state of the mitral valve orifice changing from a single opening to a double opening. Leaflet folding techniques are the most commonly used surgical techniques for managing valve prolapse: For example, in the A3 region, triangular incision sutures or direct folding sutures can be used for valve prolapse.

[0035] This invention completely simulates the surgical leaflet folding technique. By using the V-clip device, leaflet repair is achieved through leaflet capture, leaflet folding, leaflet fixation, and device deloading.

[0036] The principle of the method for repairing prolapsed leaflets by folding in this invention is as follows:

[0037] Step 1: The step involves capturing and securing the prolapsed leaflets. The V-shaped clamp, with arm 5 open, forms a V-shape, allowing for the capture of the prolapsed leaflets. The V-shaped design of the device enables a large opening angle, making it easier to capture the prolapsed leaflets.

[0038] Step 2: Folding the petals. The side wings 6 on both sides of the V-clip have a self-curling function. After the V-clip captures the petals, it gradually pushes the clip 10, which originally restricted the self-curling of the side wings 6. After the clip 10 disengages from the side wings 6, the side wings 6 with the curling function can achieve the petal folding effect. The height of the side wings 6 with the curling function determines the depth of the folded petals.

[0039] Step 3: Locking the clamping device. The rivet needle can be pushed along the clamping arm 5. The rivet needle pierces the leaflet rivet and is attached to the side wing 6, which can prevent the V-shaped clamp from falling off.

[0040] Finally: The deloading device, the V-Clip device as a whole, is deloaded from the conveying system, completing the repair of the drooping leaflets.

[0041] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A minimally invasive transcatheter valve leaflet folding repair device, characterized in that, It includes a capture clamp, a folding clamp, a pulling mechanism, and a stop mechanism; one end of the capture clamp is provided with a movable, openable and closable clamping arm, and the other end of the capture clamp is provided with a pulling mechanism for pulling the clamping arm; the folding clamp includes two side wings that can be folded together, the two side wings are respectively provided on both sides of the clamping arm, and the two side wings are provided with a detachable stop mechanism to restrict the folding movement of the side wings. The two wings move towards each other and fold into the plane where the clamping arm opens and closes. The two wings are made of shape memory material and have naturally curled bends. The bends are equipped with detachable stop mechanisms to restrict the folding movement of the wings. The stop mechanism is a U-shaped clamp. The U-shaped clamp has a U-shaped groove, the width of which corresponds to the thickness of the wing. The bends on the two wings are engaged in the U-shaped groove to restrict the folding movement of the wings.

2. The minimally invasive transcatheter valve leaflet folding repair device according to claim 1, characterized in that, The capture clamp includes a clamping arm and a base. One end of the clamping arm is separate from the base, and the other end of the clamping arm is connected to the base through a hinge structure.

3. The minimally invasive transcatheter valve leaflet folding repair device according to claim 2, characterized in that, One end of the traction mechanism is connected to one end of the clamping arm via a hinge structure, and the other end of the traction mechanism is provided with a traction guide post that opens and closes the clamping arm by pushing and pulling.

4. The minimally invasive transcatheter valve leaflet folding repair device according to claim 2, characterized in that, One end of the clamping arm, which is separate from the base, has a V-shaped opening with the base.

5. The minimally invasive transcatheter valve leaflet folding repair device according to claim 2, characterized in that, The two wings are located on both sides of the base.

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