A prosthetic device for preventing valvular regurgitation

Abstract

The present application relates to the field of medical devices, and specifically to a repair device for preventing valve regurgitation, comprising a mounting bracket, a single anti-reflux prosthesis for replacing the function of a single native valve leaflet, and a fixing member, wherein one end of the single anti-reflux prosthesis is fixed on the mounting bracket, and an atrial segment is provided at the distal end of the mounting bracket, and the atrial segment is configured to adapt to the morphology of the native valve ring tissue, and the atrial segment includes a leak-proof portion, and the proximal end portion of the mounting bracket is anchored in the ventricle by the fixing member, wherein, after the mounting bracket is installed in place, the leak-proof portion abuts against or fits the native valve ring tissue, and when the native valve opens and closes so that the morphology of the native valve ring changes, the leak-proof portion follows the morphological change of the native valve ring and produces adaptive deformation, so that the leak-proof portion always abuts against or fits the native valve ring tissue.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a repair device for preventing valve regurgitation. Background Art

[0002] Tricuspid regurgitation is typically caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annular dilatation. Clinically, the underlying cause of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.) is often the most common manifestation. With tricuspid regurgitation, patients may experience fatigue, ascites, edema, pain in the liver, indigestion, and poor appetite, exacerbating symptoms of right heart failure. Mild tricuspid regurgitation may not cause significant clinical symptoms, but severe regurgitation requires surgical treatment.

[0003] Traditional treatments for mitral and tricuspid valve disease include medications for mild to severe regurgitation and surgical procedures with corresponding surgical indications. These procedures also include valve replacement and valve repair. Among surgical procedures, typical open-chest and open-heart surgeries are highly invasive, requiring extracorporeal circulation and carrying a high incidence of complications and infection. Many patients cannot tolerate the significant surgical risks and are left helplessly awaiting death.

[0004] Following the report of the first aortic valve interventional replacement, numerous companies have made significant progress in interventional aortic valve technology, leading to increasing maturity. However, significant gaps remain in the industry's technological capabilities for interventional treatment of the atrioventricular valve. While a few products for atrioventricular valve intervention have been used in transcatheter valvuloplasty and repair procedures, no mature, usable products for transcatheter valve replacement have yet been developed internationally.

[0005] Patent CN201780028476.8 describes a heart valve leaflet replacement system and method thereof, wherein the prosthetic valve includes a crescent-shaped stent, the crescent-shaped stent includes an upper flared portion and a lower ventricular portion, at least one prosthetic leaflet, and at least one fork-shaped structure for connecting the prosthetic leaflet and the crescent-shaped stent. The replacement prosthesis is fixed to the target position by surgical suturing or the upper flared portion of the crescent-shaped stent is anchored to the rear of the natural valve ring through an interventional catheter. In this solution, the rear of the natural ring is adjacent to the coronary artery, and there is a risk of damage when the prosthetic valve is fixed. Especially during transcatheter intervention, the positioning requirements for the anchoring system are very high, but accurate positioning is still difficult to achieve under existing medical conditions, so the risk of damaging the coronary artery is relatively high. The rear of the natural valve ring lacks fiber cords and is weak, and the incompleteness of the valve ring is more obvious. Therefore, the tissue strength of the rear of the valve ring is weak, and the pressure of the mitral valve is high. There is a risk of tearing the valve ring after the valve prosthesis is anchored. The tricuspid valve annulus is weaker and the tissue has little elasticity due to long-term expansion, making the tissue more prone to tearing and the prosthesis more prone to falling off. In order to stably anchor the valve prosthesis at the target position, at least three anchoring points are required, and the position of each anchoring point is different, the span is large, and the operation is complicated. When the heart moves, the posterior valve ring contracts and expands significantly, and the anchoring position is always in an active state. Anchoring is difficult and the distance between the anchoring points is difficult to grasp, resulting in poor anchoring effect. When the prosthetic valve is closed, the upper flared part used for anchoring is located in the downstream part of the blood flow, and the ventricular part of the prosthetic valve has no fulcrum. The prosthetic valve is prone to displacement and instability, resulting in poor apposition of the prosthetic leaflet and the native anterior leaflet, leading to regurgitation.

[0006] Patent CN201610921114.9 describes a heart valve prosthesis, including a valve stent and a fixing device, wherein the valve stent includes a sewing section and an artificial valve, and the fixing device includes a fixed support section and a fixing piece, wherein one end of the fixed support section is connected to the patient's ventricular septum by a fixing piece to support the heart valve prosthesis and limit the axial movement of the heart valve prosthesis, and the cross-sectional area of ​​the valve sewing section is smaller than the cross-sectional area of ​​the patient's native valve annulus; replacing all the still functional leaflets with artificial valves will cause significant changes to the original hemodynamics, and the impact on cardiac function needs further study. The valve annulus of tricuspid regurgitation lesions is significantly dilated, the force-bearing area of ​​the implanted artificial valve is large, the force borne by the fixing piece is large, and it is easy to detach from the ventricular septal tissue. The shape of the diseased tricuspid valve annulus is irregular, and the implanted valve is circular. Without supporting the valve annulus, the effective opening area of ​​the artificial valve is smaller than the effective opening area of ​​the native valve, and the transvalvular pressure difference will increase. During the implantation process, if an unexpected situation such as valve displacement or valve detachment occurs, it will be difficult to remedy. The right heart system where the tricuspid valve is located has low pressure and large capacity, and the artificial valve leaflets have low mobility. It is easy for cellulose to grow and climb, further reducing the mobility of the artificial valve leaflets. It is easy to calcify in the long term, and the incidence of stenosis is high. In the long term, the artificial valve and tissue will fuse and adhere, and the feasibility of re-interventional valve replacement is small. There are many valve implants. On the one hand, the diameter of the interventional catheter is large, and it is difficult to enter the blood vessels. On the other hand, the implant forms a relatively complex structure in the heart, and the blood flow is prone to form vortices locally, and the risk of thrombosis is high. Moreover, the processing technology of closed-loop artificial valves and stents is difficult and the cost is high.

[0007] Patent US20160354076A1 discloses a method for treating tricuspid valve regurgitation. A catheter is positioned near the tricuspid valve annulus, and a guidewire is passed through the valve annulus or leaflet tissue to establish anchor points. The enlarged valve annulus is reduced by adjusting the distance between the anchor points to treat tricuspid valve regurgitation. The treatment principle of this approach is to reduce the enlarged tricuspid annulus and increase the area of ​​coaptation of the native leaflets. However, the tricuspid annulus is a three-dimensional, saddle-shaped structure. Shortening the distance between two or more anchor points significantly alters the original tricuspid annulus morphology, making it more irregular and unstable. Anchor points are established on tissue near the leaflets or annulus, which is weak and prone to tearing. Positioning the anchor points with this approach is difficult, making it difficult to locate them in the ideal position. Furthermore, this method is complex, requiring the target location to be located first, followed by a guidewire puncturing the tissue or leaflets, then capturing or releasing the gasket with the guidewire, tightening the anchor point, and then proceeding to the next anchor point, ultimately reducing the distance between the anchor points. The human tricuspid valve has anterior, posterior, and diaphragmatic leaflets. The anterior valve leaflet, posterior valve leaflet and diaphragmatic valve leaflet are in a closed state when the heart contracts. When the anterior valve leaflet, posterior valve leaflet and diaphragmatic valve leaflet cannot normally coapt in the closed state, valvular regurgitation will occur.

[0008] Patent US20220096236A1 discloses an auxiliary assist device (20, 120A, 120B, 120C, 320A, 320B, 420, 720) for treating a native atrium valve, comprising an annular ventricular anchor (30, 130, 330, 430, 730) including an anchor loop coil (50, 150, 350, 450, 750) that defines at least a portion of the boundary of the annular ventricular anchor and is configured to be positioned in the ventricle, extending between the ventricular apex region and the subthoracic surface of the target native leaflet, and maintaining the anchor position against surrounding anatomy, including the subthoracic surface, the ventricular wall, and the ventricular apex region. A new brochure (32, 132A, 132B, 132C, 332A, 332B, 332A, 332B, 432, 732) is supported by an annular ventricular anchor and at least partially replaces the function of the target native leaflet by providing an auxiliary surface (34, 434, 734) for one or more opposing native leaflets, which oppose the target native leaflet. The patent solution is to implant the repair device into the ventricle and then clamp the native leaflet to achieve the anchoring of the device, but this fixation method is not stable and can easily cause the repair device to flip over, thereby causing the repair device to fail.

[0009] Therefore, there is an urgent need in the art for an implantable device that can achieve reliable fixation, maximize the use of the original valve function, minimize the impact on cardiac movement and hemodynamics, reduce the difficulty of surgical operation, and has a simple structure. Summary of the Invention

[0010] In view of the above and other considerations, the present invention has been proposed.

[0011] One of the technical problems to be solved by the present invention is to provide an innovative repair device for preventing valvular regurgitation, which can not only reliably fix but also retain the function of the main native valve leaflets, while having little effect on cardiac movement and hemodynamics, low surgical difficulty and simple structure.

[0012] The basic inventive concept according to another aspect of the present invention is that the repair device of the present invention is intended to repair rather than replace the entire native heart valve. In other words, the repair device of the present invention is intended to replace one or two native leaflets rather than the entire number of native leaflets. For the mitral valve, the repair device of the present invention is intended to replace one of the native leaflets while keeping the other native leaflet in normal operation. For the tricuspid valve, the repair device of the present invention is intended to replace one of the native leaflets, such as the posterior leaflet, while keeping the other two native leaflets in normal operation; or, two repair devices of the present invention are used to replace two native leaflets in the tricuspid valve while keeping the other native leaflet in normal operation.

[0013] Specifically, according to one aspect of the present invention, a repair device for preventing valve regurgitation is provided, comprising a mounting bracket, a single anti-reflux prosthesis for replacing the function of a single native valve leaflet, and a fixing member, wherein one end of the single anti-reflux prosthesis is fixed on the mounting bracket, and an atrial segment is provided at the distal end of the mounting bracket, and the atrial segment is configured to adapt to the morphology of the native valve ring tissue, and the atrial segment includes a leak-proof portion, and the proximal end portion of the mounting bracket is anchored in the ventricle by the fixing member, wherein after the mounting bracket is installed in place, the leak-proof portion abuts against or fits the native valve ring tissue, and when the native valve opens and closes so that the morphology of the native valve ring changes, the leak-proof portion follows the morphological change of the native valve ring and produces adaptive deformation, so that the leak-proof portion always abuts against or fits the native valve ring tissue.

[0014] According to one embodiment, the leak-proof portion is arc-shaped and has the function of elastic deformation, so that the leak-proof portion can produce adaptive deformation following the morphological changes of the native valve ring.

[0015] According to one embodiment, the leak-proof part includes multiple elastic threads and a flow-blocking membrane, and the two ends of the elastic threads are fixed on the atrial segment, or one end of the elastic thread is fixed on the atrial segment and the other end is free, wherein the flow-blocking membrane can block blood flow.

[0016] According to one embodiment, the leak-proof part includes two filling units. After the mounting bracket is installed in place, the two filling units are located at the junction of the replaced autologous leaflet and the adjacent autologous leaflet; the two filling units bulge to a greater extent than other areas of the leak-proof part, which facilitates the filling units to fill the junction of the replaced autologous leaflet and the adjacent autologous leaflet, effectively preventing regurgitation at the junction of the leaflets.

[0017] According to one embodiment, the leak-proof part is coated with a filling body. After the mounting bracket is installed in place, the filling body can absorb liquid and swell, so that the leak-proof part abuts against or fits the autologous valve ring tissue; the filling body can be a solid dry gel.

[0018] According to one embodiment, the atrial segment extends circumferentially over the portion of the native annulus of the valve, and both ends of the atrial segment extend to the native annulus corresponding to adjacent native leaflets of the replaced native leaflets.

[0019] According to one embodiment, the atrial segment is an arc-shaped flared portion that extends circumferentially over the portion of the native annulus of the valve when installed in place.

[0020] According to one embodiment, the atrial segment includes an adaptive portion, and after the mounting bracket is installed in place, the adaptive portion is arranged at the native valve annulus corresponding to the adjacent native valve leaflet of the replaced native valve leaflet.

[0021] According to one embodiment, the adaptive portion is flexible, and the adaptive portion is attached to the native valve ring corresponding to the adjacent native valve leaflet of the replaced native valve leaflet, or the adaptive portion is attached to the native valve ring corresponding to the adjacent native valve leaflet of the replaced native valve leaflet and the atrial wall.

[0022] According to one embodiment, the atrial segment includes an adaptive portion. After the mounting bracket is installed in place, part of the adaptive portion is arranged at the native valve ring corresponding to the replaced native valve leaflet and at the native valve ring corresponding to the native valve leaflet adjacent to the replaced native valve leaflet.

[0023] According to one embodiment, the repair device includes at least two fixing members, and there is a preset distance between the at least two fixing members in the axial direction.

[0024] According to one embodiment, the proximal end portion of the mounting stent is in contact with the interventricular septum, and the proximal end portion of the mounting stent is anchored to the interventricular septum tissue by the fixing element.

[0025] According to one embodiment, the area of ​​the single anti-reflux prosthesis after expansion is larger than the area of ​​the replaced native valve leaflet after expansion.

[0026] According to one embodiment, when the native valve is in a closed state, the free edge of the single anti-reflux prosthesis cooperates with the free edges of the remaining native leaflets to achieve normal closure of the valve, or at least partially overlaps with the free edges of the remaining native leaflets to prevent valve regurgitation.

[0027] According to one embodiment, filling units are provided on both sides of the mounting bracket. After the mounting bracket is installed in place, the filling units are arranged at the junction of the native valve leaflets.

[0028] According to one embodiment, the mounting bracket includes a resting portion and an auxiliary anchoring portion, the resting portion has a compressed state and a released state, and when the resting portion is converted from the compressed state to the released state, one end of the resting portion flips toward the distal direction and clamps the replaced autologous leaflet, and the resting portion drives the auxiliary anchoring portion to embrace the autologous leaflet and chordae tendineae tissue.

[0029] According to one embodiment, the auxiliary anchoring portion is fixedly connected to both sides of the mounting bracket, the auxiliary anchoring portion is connected to the abutting portion, and the auxiliary anchoring portion is slidable relative to the abutting portion.

[0030] According to one embodiment, the distal portion of the atrial segment is in contact with the atrial wall, and the distal portion of the atrial segment may be anchored to the atrial wall by a fixing element.

[0031] According to another embodiment, the atrial segment is provided with a limiting portion, and in the released state of the repair device, the limiting portion is a flange of a generally arc-shaped segment, and the flange is sized to be suitable for abutting against the atrial tissue at the atrioventricular orifice of the heart and preventing the repair device from moving further toward the ventricle.

[0032] According to one embodiment, the mounting bracket further comprises a middle section provided between the proximal end and the distal end of the mounting bracket, and a leakage prevention membrane is provided in the middle section.

[0033] According to one embodiment, the repair device has a restrained state before installation and a released state after installation.

[0034] According to one embodiment, the single anti-reflux prosthesis is provided with an anti-reflux skirt in the middle section area.

[0035] According to another embodiment, the single anti-reflux prosthesis includes a form-maintaining portion and a moving portion. When the native valve is in an open or closed state, the position of the form-maintaining portion remains unchanged, and when the native valve is in a closed state, the free edge of the moving portion and the free edges of the remaining native leaflets cooperate to achieve normal closure of the valve, or at least partially overlap with the free edges of the remaining native leaflets to prevent valve regurgitation.

[0036] According to another embodiment, the anti-reflux prosthesis is composed of: an integrated membrane made of a flexible material; and a support frame and a biocompatible coating or membrane covering the support frame.

[0037] According to another embodiment, a single anti-regurgitation prosthesis is used to replace one of the anterior leaflet, the posterior leaflet, and the diaphragmatic leaflet of the tricuspid valve.

[0038] According to another embodiment, the rigidity of the shape retaining portion is greater than the rigidity of the moving portion, and the rigidity of the shape retaining portion gradually decreases from an end close to the mounting bracket to an end away from the mounting bracket.

[0039] According to another embodiment, the shape retaining portion is an arched structure, and the shape retaining portion is arched toward the atrium, and the edge of the shape retaining portion cooperates with the free edge of the remaining native leaflets to achieve normal closure of the valve.

[0040] According to another embodiment, the area of ​​the single anti-reflux prosthesis after expansion is larger than the area of ​​the replaced native valve leaflet after expansion.

[0041] According to another embodiment, the axial length and radial width of the single anti-reflux prosthesis are both greater than the axial length and radial width of the native valve leaflet being replaced.

[0042] According to another embodiment, the shape retaining portion is a grid-like structure; or, the shape retaining portion includes a plurality of retaining rods, and the retaining rods are in an arc-shaped structure.

[0043] According to another embodiment, the fixed end of the single anti-reflux prosthesis is fixedly connected to the mounting bracket, and the movable portion is movably connected to the mounting bracket via a pull line;

[0044] In which, after the repair device is installed in place, the moving part can move between an open state of the native leaflets and a closed state of the native leaflets. In the open state of the native leaflets, the moving part opens together with the remaining native leaflets of the valve except a single native leaflet; in the closed state of the leaflets, the moving part closes together with the remaining native leaflets to prevent valve regurgitation.

[0045] Compared with the prior art, the advantages of this application are:

[0046] 1. Different from the prior art, in one embodiment of the present invention, the repair device is fixed to the ventricular tissue by a fixing member. The atrial segment can effectively prevent the repair device from tipping over. The leak-proof part can effectively block the blood in the atrium from entering between the atrial segment and the replaced native valve leaflet, preventing this part of the blood from entering and accumulating at the root of the anti-reflux prosthesis, thereby preventing the formation of thrombus at the root of the anti-reflux prosthesis. In addition, the leak-proof part can adaptively deform in accordance with the morphological changes of the native valve annulus, so that the leak-proof part can always be in close contact with the native valve annulus, dynamically filling the gap between the atrial segment and the native valve annulus. At the same time, the repair device replaces the problematic valve leaflet, thereby preserving the original function of the remaining native valve leaflet, without changing the morphology of the native valve annulus, causing little damage to the intracardiac tissue, and at the same time, the implant volume is small and the irritation is low.

[0047] 2. Unlike existing technologies, the leak-proof portion of the repair device in one embodiment of the present invention includes two filling units. These two filling units are located at the junction of the replaced native valve leaflets and the adjacent native valve leaflets. Since the gaps at the junction of the native valve leaflets are relatively large, the filling units are designed to further fill the gaps at the junction of the leaflets, effectively preventing regurgitation at the junction.

[0048] 3. Unlike existing technologies, one embodiment of the present invention includes an abutment portion and an auxiliary anchoring portion. When the abutment portion transitions from a compressed state to a released state, one end of the abutment portion flips toward the distal end of the mounting stent, thereby driving the auxiliary anchoring portion to move between the replaced native valve leaflets and the ventricular wall. When the abutment portion returns to its preset configuration and clamps the native valve leaflets between the abutment portion and the mounting stent, the auxiliary anchoring portion embraces the native valve leaflets, further stabilizing the prosthetic device.

[0049] 4. Because different native valve leaflets have different transvalvular pressure differentials depending on their position within the native valve, conventional prosthetic valve leaflets are designed to be completely flexible. When the native valve closes, the transvalvular pressure differential is small, preventing the prosthetic leaflets from swinging to their ideal positions. Unlike conventional prostheses, in one embodiment of the present invention, a single anti-reflux prosthesis comprises a shape-maintaining portion and a moving portion. When the native valve is in an open or closed state, the shape-maintaining portion remains in position, while the moving portion follows the movement of the native leaflet and appositions with the remaining native leaflets to prevent reflux. This design has the advantage that the area of ​​the moving portion is much smaller than that of the entire prosthetic leaflet. Therefore, when the native valve closes, the force required to return the moving portion to its closed position is relatively small. This ensures that the moving portion can apposition with the remaining native leaflets when the native valve closes, even when the transvalvular pressure differential is small.

[0050] 5. Unlike existing technologies, in one embodiment of the present invention, the rigidity of the shape-retaining portion gradually decreases from the end closest to the mounting bracket to the end farther from the mounting bracket. This design offers the advantage of a transition between rigidity and flexibility at the interface between the shape-retaining portion and the moving portion, making the anti-reflux prosthesis more hemodynamically compatible and helping the moving portion to better align with the remaining native valve leaflets during opening and closing.

[0051] 6. Unlike the prior art, in one embodiment of the present invention, the shape-retaining portion is an arched structure that arches toward the atrium. This design has the advantage that the arched shape toward the atrium facilitates alignment or overlap with the edges of the remaining native valve leaflets while not affecting the opening and closing of the remaining native valve leaflets. Furthermore, the axial length and radial width of the expanded anti-reflux prosthesis are both greater than those of the replaced native valve leaflets after expansion. This further ensures that the anti-reflux prosthesis can align or overlap with the edges of the remaining native valve leaflets when the native valve closes, effectively preventing reflux.

[0052] 7. Unlike existing technologies, one embodiment of the present invention utilizes a fixing element to secure the prosthesis against one side of the native valve, providing stability without interfering with heart movement. Furthermore, at least two fixing elements are spaced a certain distance apart axially, ensuring that the stent is securely attached to one side of the native valve, preventing a gap between the stent and the native valve that could lead to paravalvular leakage.

[0053] 8. Unlike existing technologies, one embodiment of the present invention provides a secure and risk-free fixation of the repair device. The area available for fixation of the ventricular septum is much larger than that of the valve annulus and atrium, reducing the need for device positioning. Furthermore, the absence of other important branching vessels near the ventricular septum prevents functional damage, resulting in high safety. During cardiac motion, the ventricular septum moves less than the valve annulus, resulting in more stable fixation, a higher success rate, and excellent results.

[0054] 9. Different from the prior art, in one embodiment of the present invention, the atrial segment is provided with an adaptive portion, and the adaptive portion extends to the autologous valve annulus corresponding to the autologous valve leaflet adjacent to the replaced autologous valve leaflet. This not only provides good stability for the repair device and further prevents the repair device from flipping over after implantation, but also enables the repair device to adapt to the valve annulus size of most patients. Manufacturers can reduce product specifications and reduce the stocking pressure on manufacturers.

[0055] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below and can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent, and the embodiments of the present application may be better understood, by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0057] Figure 1a and 1b FIG. 1 is a schematic diagram of an overall repair device according to an embodiment of the present invention.

[0058] Figures 2a-2e The figure shows the structural diagram and principle diagram of the leak-proof part.

[0059] Figures 3a-3c Schematic diagram of the structure of the adaptive part.

[0060] Figure 4a and 4b Schematic diagram of the filling unit and the auxiliary anchoring portion of the present invention.

[0061] Figure 5a and 5b Schematic diagram of the process of clamping the leaflets at the abutting portion of the present invention.

[0062] Figures 6a-6c Another embodiment of the present invention is presented.

[0063] The names indicated by the numbers in the accompanying drawings are as follows:

[0064] 1-mounting bracket, 11-atrial segment, 111-leakage prevention part, 1111-elastic wire, 1112-flow blocking membrane, 1113-filling unit, 12-adaptive part, 13-filling unit, 14-adhering part, 141-valve clamping cavity, 15-auxiliary anchoring part, 2-anti-reflux prosthesis, 21-morphology maintaining part, 22-movement part, 23-pull wire, 3-fixing part. DETAILED DESCRIPTION

[0065] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0066] In this application, “proximal end” refers to the end close to the apex of the heart, and “distal end” refers to the end away from the apex of the heart.

[0067] Example 1

[0068] The human tricuspid valve has anterior, posterior, and diaphragmatic leaflets. These leaflets are closed during heart contraction. Valvular regurgitation occurs when one of these leaflets fails to close properly.

[0069] like Figure 1a and 1bAs shown, a prosthetic device for preventing valvular regurgitation includes a mounting bracket 1, a single anti-reflux prosthesis 2 for replacing the function of a single native valve leaflet, and a fixing member 3. One end of the single anti-reflux prosthesis 2 is fixed to the mounting bracket 1. The distal end of the mounting bracket 1 is provided with an atrial segment 11, which is configured to adapt to the morphology of the native valve annulus tissue. The atrial segment 11 includes a leak-proof portion 111. The proximal end of the mounting bracket 1 is anchored within the ventricle by the fixing member 3. When the mounting bracket 1 is installed in place, the leak-proof portion 111 abuts against or conforms to the native valve annulus tissue. When the native valve opens and closes, causing the morphology of the native valve annulus to change, the leak-proof portion 111 adaptively deforms to follow the morphological changes of the native valve annulus, ensuring that the leak-proof portion 111 always abuts against or conforms to the native valve annulus tissue. The anti-reflux prosthesis 2 is connected to the mounting bracket 1 by various feasible fixing methods, such as fixing, attaching, bonding, sewing, snapping, and wearing. After the procedure is completed, when the native valve, the target of surgery, is in a closed state, the anti-regurgitation prosthesis 2 is positioned in the middle of the native valve. The free edge of the anti-regurgitation prosthesis cooperates with the free edges of the remaining native valve leaflets to achieve normal valve closure, or at least partially overlaps with the free edges of the remaining native valve leaflets to prevent valvular regurgitation. Unlike treatments that directly replace the entire native valve, the repair device according to the present invention is secured to the target surgical site, such as ventricular tissue, via a fixing member 3, such as an anchoring pin or anchoring needle. This replaces only one problematic target leaflet, such as the septal leaflet (in the case of tricuspid valve repair), while preserving the original structure and function of the remaining native leaflets, which remain unreplaced and the morphology of the native valve annulus remains unchanged. Consequently, minimal damage to cardiac tissue occurs, and the implant volume is reduced, resulting in less irritation and damage to the human heart.

[0070] According to one example, one end of the anti-reflux prosthesis 2 is connected to the mounting bracket 1 by various feasible means, such as fixing, attaching, bonding, sewing, snapping, or wearing, for example, fixed at the distal segment 11 of the mounting bracket 1, while the other end is free, simulating the native valve leaflets. The contour of the fixed portion of the anti-reflux prosthesis 2 at the distal segment 11 is generally arc-shaped, which not only conforms to the shape of the native valve annulus but also facilitates full expansion of the anti-reflux prosthesis 2 when the native valve leaflets close.

[0071] According to one example, the leak-proof portion 111 is in an arc shape, and the leak-proof portion 111 has an elastic deformation function, so that the leak-proof portion 111 can produce adaptive deformation following the morphological changes of the native valve ring, such as Figures 2a to 2e shown.

[0072] According to one example, the leak-proof part 111 includes multiple elastic wires 1111 and a flow-blocking membrane 1112, and the two ends of the elastic wire 1111 are fixed on the atrial segment, or one end of the elastic wire 1111 is fixed on the atrial segment and the other end is free, wherein the flow-blocking membrane 1112 can block blood flow.

[0073] According to one example, the leak-proof part 111 includes two filling units 1113. After the mounting bracket 1 is installed in place, the two filling units 1113 are located at the junction of the replaced autologous leaflet and the adjacent autologous leaflet; the two filling units 1113 bulge to a greater extent than other areas of the leak-proof part 111, which facilitates the filling units 1113 to fill the junction of the replaced autologous leaflet and the adjacent autologous leaflet, effectively preventing regurgitation at the junction of the leaflets.

[0074] According to one example, the leak-proof part 111 is coated with a filler. After the mounting bracket is installed in place, the filler can absorb liquid and swell, so that the leak-proof part 111 abuts against or fits the autologous valve ring tissue; the filler can be a solid dry gel.

[0075] According to one example, the atrial segment 11 extends circumferentially in the portion of the native valve annulus of the valve, and both ends of the atrial segment 11 extend to the native valve annulus corresponding to the adjacent native valve leaflets of the replaced native valve leaflets.

[0076] According to one example, the atrial segment 11 is an arc-shaped flared portion that extends circumferentially over the portion of the native annulus of the valve after being installed in place.

[0077] According to one example, the atrial segment 11 includes an adaptive portion 12, such as Figure 3a and 3b As shown, after the mounting bracket 1 is installed in place, the adaptive portion 12 is arranged at the native valve ring corresponding to the native valve leaflet adjacent to the replaced native valve leaflet.

[0078] According to one example, the adaptive portion 12 is flexible, and the adaptive portion 12 is attached to the native valve ring corresponding to the adjacent native valve leaflet of the replaced native valve leaflet, or the adaptive portion 12 is attached to the native valve ring corresponding to the adjacent native valve leaflet of the replaced native valve leaflet and the atrial wall.

[0079] According to one example, the atrial segment 11 includes an adaptive portion 12. After the mounting bracket 1 is installed in place, part of the adaptive portion 12 is arranged at the native valve ring corresponding to the replaced native valve leaflet and at the native valve ring corresponding to the native valve leaflet adjacent to the replaced native valve leaflet.

[0080] According to an example, the repair device includes at least two fixing members 3, and at least two fixing members 3 are preset with a spacing in the axial direction, such as Figure 3c shown.

[0081] More details of the embodiment of the fixing member 3 (also referred to as "anchoring pin", "anchor pin", etc.) in this embodiment are described in detail, for example, in the patent application No. 202120566797.7 of the same applicant, and the content of the patent application is incorporated into this application by reference.

[0082] According to one example, the proximal end portion of the mounting stent 1 is abutted against the interventricular septum, and the proximal end portion of the mounting stent 1 is anchored on the interventricular septum tissue by the fixing member 3 .

[0083] In this embodiment, the mounting bracket 1 does not affect the functions of the remaining native valve leaflets after installation.

[0084] In this embodiment, the repair device may have a restrained state and a released state.

[0085] According to one example, the area of ​​the single anti-reflux prosthesis 2 after expansion is larger than the area of ​​the replaced native valve leaflet after expansion, such as Figure 3b shown.

[0086] According to one example, when the native valve is in a closed state, the free edge of the single anti-reflux prosthesis 2 and the free edges of the remaining native leaflets cooperate to achieve normal closure of the valve, or at least partially overlap with the free edges of the remaining native leaflets to prevent valve regurgitation.

[0087] According to an example, the two sides of the mounting bracket 1 are provided with filling units 13. After the mounting bracket 1 is installed in place, the filling units 13 are arranged at the junction of the autologous valve leaflets, such as Figure 4a shown.

[0088] According to one example, the mounting bracket 1 includes a rest portion 14 and an auxiliary anchoring portion 15, wherein the rest portion 14 has a compressed state and a released state, and when the rest portion 14 is converted from the compressed state to the released state, one end of the rest portion 14 flips toward the distal direction and clamps the replaced native leaflet, and the rest portion 14 drives the auxiliary anchoring portion 15 to embrace the native leaflet and the chordae tendineae group, as shown in FIG. Figure 4b shown.

[0089] According to an example, the auxiliary anchoring portion 15 is fixedly connected to both sides of the mounting bracket 1 , the auxiliary anchoring portion 15 is connected to the abutting portion 14 , and the auxiliary anchoring portion 15 can slide relative to the abutting portion.

[0090] According to one example, the distal end portion of the atrial segment 11 is in contact with the atrial wall, and the distal end portion of the atrial segment 11 can be anchored to the atrial wall via a fixing element 3 .

[0091] According to one example, the atrial segment is provided with a limiting portion, and in the released state of the repair device, the limiting portion is a flange of a generally arc-shaped segment, and the flange is sized to be suitable for abutting against the atrial tissue at the atrioventricular orifice of the heart and preventing the repair device from moving further toward the ventricle.

[0092] According to one example, the mounting bracket further includes a middle section provided between the proximal end and the distal end of the mounting bracket, and a leakage prevention membrane is provided in the middle section.

[0093] An exemplary cardiac atrioventricular tricuspid valve surgical procedure for the repair device for preventing valve regurgitation according to the first embodiment is as follows:

[0094] 1. The repair device adopts a transfemoral approach, entering the atrium through the femoral vein and superior vena cava and then reaching the atrioventricular orifice;

[0095] 2. Position the mounting bracket 1 so that it abuts the septal leaflet, and partially release the proximal end of the repair device so that it abuts the ventricular septum;

[0096] 3. The repair device is gradually released from the distal end to the proximal end, so that the abutment portion 14 is restored from the restricted state to the preset state. At this time, the free end of the abutment portion 14 is folded from the distal end of the mounting bracket 1 to the proximal end (such as Figure 5a and 5b ), and clamping the autologous valve leaflet (septal valve leaflet) as the replacement target in the valve clamping cavity 141;

[0097] 4. Further release the atrial segment 11 so that it lies against the native valve annulus.

[0098] 5. Continue the surgical procedure and fix the mounting bracket 1 to the ventricular septum through the fixing member 3, as shown in the figure. Figure 3c As shown, this basically completes the main surgical procedure of the repair device.

[0099] Example 2

[0100] The second embodiment is substantially the same as the first embodiment, except that the anti-reflux prosthesis 2 has a different structure from the anti-reflux prosthesis 2 in the first embodiment. Figure 6a As shown, the anti-reflux prosthesis 2 includes a shape-maintaining portion 21 and a moving portion 22 . The rigidity of the shape-maintaining portion 21 is greater than that of the moving portion 22 .

[0101] According to one example, the single anti-reflux prosthesis 2 includes a form-maintaining portion 21 and a moving portion 22. When the native valve is in an open or closed state, the position of the form-maintaining portion 21 remains unchanged, and when the native valve is in a closed state, the free edge of the moving portion 22 cooperates with the free edges of the remaining native leaflets to achieve normal closure of the valve, or at least partially overlaps with the free edges of the remaining native leaflets to prevent valve regurgitation.

[0102] According to an example, the rigidity of the shape retaining portion 21 is greater than the rigidity of the moving portion 22 , and the rigidity of the shape retaining portion 21 gradually decreases from an end close to the mounting bracket 1 to an end away from the mounting bracket 1 .

[0103] According to one example, the shape retaining portion 21 is an arched structure, and the shape retaining portion 21 arches toward the atrium, and the edge of the shape retaining portion 21 cooperates with the free edge of the remaining native leaflets to achieve normal closure of the valve.

[0104] According to one example, the area of ​​the single anti-reflux prosthesis 2 after expansion is larger than the area of ​​the replaced native valve leaflet after expansion. Furthermore, the axial length and radial width of the single anti-reflux prosthesis 2 are both larger than the axial length and radial width of the replaced native valve leaflet.

[0105] According to one example, the shape retaining portion 21 is a grid structure; or, the shape retaining portion 21 includes a plurality of retaining rods, such as Figure 6b As shown, the retaining rod is in an arc-shaped structure.

[0106] According to one example, after the repair device is installed in place, the moving portion 22 can move between an open state of the native leaflets and a closed state of the native leaflets. In the open state of the native leaflets, the moving portion 22 opens together with the remaining native leaflets of the valve except for a single native leaflet; in the closed state of the leaflets, the moving portion 22 closes together with the remaining native leaflets to prevent valve regurgitation.

[0107] According to one example, the anti-reflux prosthesis 2 may also be provided with a pull line 23, such as Figure 6c As shown, one end of the pull wire 23 is connected to the anti-reflux prosthesis 2, and the other end is connected to the mounting bracket 1. According to one example, one end of the pull wire 23 is connected to or near the free edge of the anti-reflux prosthesis 2, and the other end is connected to the mounting bracket 1.

[0108] According to one example, a pull wire 23 is provided on the anti-reflux prosthesis 2, one end of the pull wire 23 is connected to the anti-reflux prosthesis 2, and the other end is connected to the distal part of the mounting bracket 1; one end of the pull wire 23 is connected to the edge of the anti-reflux prosthesis 2.

[0109] According to one example, the anti-reflux prosthesis 2 may also be provided with the pull wire 23 in other ways similar to the native valve leaflet structure.

[0110] Similar to the structure of the native valve leaflets, the anti-regurgitation prosthesis 2 may have a curved surface structure similar to that of the native valve leaflets.

[0111] The remaining structure and concept of the second embodiment are similar to those of the first embodiment, and therefore will not be described again here.

[0112] The foregoing description of several embodiments of the present application has been presented for illustrative purposes. It is not intended to be exhaustive or to limit the present application to the precise configurations, constructions, and / or steps disclosed, and it is apparent that many modifications and variations are possible in light of the above teachings. It is intended that the scope and equivalents of the present invention be defined by the appended claims.

Claims

1. A prosthetic device for preventing valvular regurgitation, comprising a mounting bracket, a single anti-reflux prosthesis for replacing the function of a single native valve leaflet, and a fixing member, wherein one end of the single anti-reflux prosthesis is fixed to the mounting bracket, characterized in that: The distal end of the mounting bracket is provided with an atrial segment, which is configured to adapt to the morphology of the native valve annulus tissue. The atrial segment includes a leak-proof portion. The proximal end of the mounting bracket is anchored in the ventricle by the fixing member. When the mounting bracket is installed in place, the leak-proof portion abuts against the native valve annulus tissue. When the native valve opens and closes, causing the morphology of the native valve annulus to change, the leak-proof portion adaptively deforms following the morphological change of the native valve annulus, so that the leak-proof portion always abuts against the native valve annulus tissue. The mounting bracket includes a contact portion and an auxiliary anchoring portion. The contact portion has a compressed state and a released state. When the contact portion is converted from the compressed state to the released state, one end of the contact portion flips toward the distal end and clamps the replaced native valve leaflet, and the contact portion drives the auxiliary anchoring portion to embrace the native valve leaflet and chordae tendineae tissue. The atrial segment is provided with an adaptive portion, and the adaptive portion extends to the native valve annulus corresponding to the adjacent native valve leaflet of the replaced native valve leaflet.

2. The repair device according to claim 1, characterized in that: The leak-proof portion is in an arc shape and has the function of elastic deformation, so that the leak-proof portion can produce adaptive deformation following the shape change of the native valve ring.

3. The repair device according to claim 1, characterized in that: The leak-proof part includes multiple elastic threads and a flow-blocking membrane, wherein the two ends of the elastic threads are fixed on the atrial segment, or one end of the elastic thread is fixed on the atrial segment and the other end is free, wherein the flow-blocking membrane can block blood flow.

4. The repair device according to claim 1, characterized in that: The leak-proof part includes two filling units. After the mounting bracket is installed in place, the two filling units are located at the junction of the replaced native leaflet and the adjacent native leaflet.

5. The repair device according to claim 1, characterized in that: The leak-proof part is coated with a filling body. After the mounting bracket is installed in place, the filling body can absorb liquid and expand, so that the leak-proof part abuts against the autologous valve ring tissue.

6. The repair device according to claim 1, characterized in that: The atrial segment extends circumferentially at the portion of the native valve annulus of the valve, and both ends of the atrial segment extend to the native valve annulus corresponding to the adjacent native valve leaflets of the replaced native valve leaflets.

7. The repair device according to claim 1, characterized in that: The atrial segment is an arc-shaped flared portion that extends circumferentially over the portion of the native annulus of the valve when installed in place.

8. The repair device according to claim 1, characterized in that: The adaptive portion is flexible.

9. The repair device according to claim 1, characterized in that: The repair device comprises at least two fixing members, and a preset distance between the at least two fixing members is provided in the axial direction.

10. The repair device according to claim 9, characterized in that: The proximal end portion of the mounting bracket is against the ventricular septum, and the proximal end portion of the mounting bracket is anchored on the ventricular septum tissue by the fixing element.

11. The repair device according to claim 1, characterized in that: The area of ​​the single anti-reflux prosthesis after expansion is larger than the area of ​​the replaced native valve leaflet after expansion.

12. The repair device according to claim 1, characterized in that: When the native valve is in a closed state, the free edge of the single anti-reflux prosthesis and the free edges of the remaining native leaflets cooperate to achieve normal closure of the valve to prevent valve regurgitation.

13. The repair device according to claim 1, characterized in that: When the native valve is in a closed state, the free edge of the single anti-regurgitation prosthesis at least partially overlaps with the free edges of the remaining native valve leaflets to prevent valve regurgitation.

14. The repair device according to claim 1, characterized in that: Filling units are provided on both sides of the mounting bracket. After the mounting bracket is installed in place, the filling units are arranged at the junction of the autologous valve leaflets.

15. The repair device according to claim 1, characterized in that: The auxiliary anchoring portion is fixedly connected to both sides of the mounting bracket, the auxiliary anchoring portion is connected to the abutting portion, and the auxiliary anchoring portion can slide relative to the abutting portion.

16. The repair device according to claim 1, characterized in that: The distal end portion of the atrial segment is in contact with the atrial wall, and the distal end portion of the atrial segment can be anchored to the atrial wall via a fixing element.

17. The repair device according to claim 1, characterized in that: The mounting bracket further comprises a middle section arranged between the proximal end and the distal end of the mounting bracket, and an anti-circumferential leakage membrane is arranged in the middle section.

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