A heart valve repair device and method

Abstract

The application relates to the field of medical devices, in particular to a heart valve repair device which comprises a mounting support, a single anti-reflux prosthesis for replacing the function of a single native leaflet, a leaflet anchoring mechanism and a fixing member, one end of the single anti-reflux prosthesis is fixed on the mounting support, the proximal end of the mounting support is anchored on the ventricular tissue through the fixing member, one end of the leaflet anchoring mechanism is fixed on the mounting support, when the mounting support is installed in place, the replaced native leaflet is located between the mounting support and the leaflet anchoring mechanism, and the other end of the leaflet anchoring mechanism penetrates the replaced native leaflet, the heart valve repair device can be firmly fixed in the heart.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to a heart valve repair device and its operating method. Background Technology

[0002] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annular dilation. Clinically, it often presents as a manifestation of the underlying cause of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.). After tricuspid regurgitation occurs, patients may experience worsening of right heart failure symptoms such as fatigue, ascites, edema, liver pain, indigestion, and loss of appetite. Mild tricuspid regurgitation may not present with obvious clinical symptoms, but severe regurgitation requires surgical treatment.

[0003] Traditional treatments for mitral and tricuspid valve disease include medication for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. Among these, typical open-heart surgery and open-heart surgery are highly invasive, require cardiopulmonary bypass, and have a high complication rate and infection risk. Many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0004] Following the report of the first aortic valve replacement surgery, numerous companies have conducted extensive research in interventional aortic valve technology, which has become increasingly mature. However, significant technological gaps remain in the interventional treatment of atrioventricular valves. Although a few products are currently used in transcatheter valve repair and angioplasty for atrioventricular valves, no mature and usable products have yet been launched internationally for transcatheter valve replacement.

[0005] Patent CN202210730620.5 discloses a repair device for preventing valvular regurgitation, including an implantation bracket and a single anti-regurgitation leaflet prosthesis for replacing the function of a single autologous leaflet; wherein one end of the single anti-regurgitation leaflet prosthesis is fixed to the implantation bracket. The repair device replaces only the problematic single leaflet, thus preserving the original function of the remaining autologous leaflets without altering the morphology of the autologous valve annulus, minimizing damage to intracardiac tissue, and requiring a smaller implantation volume with less irritation. In this design, the implantation bracket is anchored in the ventricle by a fixation element, and its auxiliary abutment holds the autologous leaflet. However, during cardiac pulsation, the distal portion of the implantation bracket cannot be tightly attached to the cardiac tissue, causing the bracket to tilt or sway, resulting in unstable bracket positioning and potentially leading to problems such as paravalvular leakage and thrombosis.

[0006] Therefore, there is an urgent need in this field for an implantable device that can achieve reliable fixation, maximize the use of the original valve function, minimize the impact on cardiac motion and hemodynamics, reduce the difficulty of surgical operation, and has a simple structure. Summary of the Invention

[0007] In view of the foregoing and other concepts, the present invention is proposed.

[0008] One of the technical problems to be solved by the present invention is to provide an innovative heart valve repair device that can reliably fix the valve, preserve the function of the main autologous valve leaflets, have little impact on cardiac motion and hemodynamics, and has a simple structure with low surgical difficulty.

[0009] The basic inventive concept of another aspect of the present invention is that the repair device of the present invention is intended to repair rather than replace the entire autologous heart valve. In other words, the repair device of the present invention is intended to replace one or two autologous leaflets, rather than all of the autologous leaflets. For the mitral valve, the repair device of the present invention is intended to replace one of the autologous leaflets while retaining the other autologous leaflet to function normally. For the tricuspid valve, the repair device of the present invention is intended to replace one of the autologous leaflets, such as the posterior leaflet, while retaining the other two autologous leaflets to function normally; or, two repair devices of the present invention are used to replace two autologous leaflets of the tricuspid valve while retaining the other autologous leaflet to function normally.

[0010] Specifically, according to one aspect of the present invention, a heart valve repair device is provided, comprising a mounting bracket, a single anti-reflux prosthesis for replacing the function of a single autologous leaflet, a leaflet anchoring mechanism, and a fixation member, wherein one end of the single anti-reflux prosthesis is fixed to the mounting bracket, the proximal end of the mounting bracket is anchored to ventricular tissue by the fixation member, one end of the leaflet anchoring mechanism is fixed to the mounting bracket, and when the mounting bracket is installed in place, the replaced autologous leaflet is located between the mounting bracket and the leaflet anchoring mechanism, and the other end of the leaflet anchoring mechanism passes through the replaced autologous leaflet.

[0011] According to one embodiment, the distal end of the mounting bracket is provided with an anchoring area, and the other end of the leaflet anchoring mechanism passes through the replaced autologous leaflet and is fixedly connected to the anchoring area.

[0012] According to one embodiment, the other end of the leaflet anchoring mechanism has a preset shape. When the mounting bracket is installed in place, the other end of the leaflet anchoring mechanism passes through the replaced autologous leaflet and returns to the preset shape to achieve anchoring with the replaced autologous leaflet.

[0013] According to one embodiment, the leaflet anchoring device includes a clamping element and a puncture element, the puncture element being slidable relative to the clamping element, and, when the mounting bracket is installed in place, the replaced autologous leaflet is located between the mounting bracket and the clamping element, the puncture element moving distally relative to the clamping element and passing through the replaced autologous leaflet.

[0014] According to one embodiment, one end of the clamping element is fixed to the mounting bracket. During pre-installation, the other end of the clamping element is close to the proximal end of the mounting bracket. When the mounting bracket is transported to the target position, the other end of the clamping element is folded towards the distal end so that the autologous leaflet is clamped between the clamping element and the mounting bracket.

[0015] According to another embodiment, one end of the clamping element is fixed to the mounting bracket, and the other end is a free end; the clamping element has a restricted form and a preset form, the free end being close to the proximal end of the mounting bracket in the restricted form, and in the preset form, the free end is spaced from the distal end of the mounting bracket to form a clamping cavity.

[0016] According to one embodiment, the clamping element is provided with a connector, and the piercing element is provided with a limiting member. The connector and the limiting member cooperate to constrain the sliding stroke of the piercing element relative to the clamping element.

[0017] According to one embodiment, after the mounting bracket is installed in place, the puncture element moves distally relative to the clamping element and passes through the root region of the autologous leaflet.

[0018] According to one embodiment, the heart valve repair device further includes an actuating element, one end of which is connected to the puncture element. When the mounting bracket is installed in place, pulling the actuating element can cause the puncture element to move distally relative to the clamping element and pass through the autologous valve leaflet.

[0019] According to one embodiment, the distal end of the mounting bracket is provided with an atrial portion, which is configured to adapt to the shape of the autologous valve annulus tissue, and after the mounting bracket is installed in place, the two sides of the atrial portion are located at the junction of the autologous valve leaflets.

[0020] According to one embodiment, when the autologous valve is in a closed state, the free edge of the single anti-reflux prosthesis works together with the free edges of the remaining autologous leaflets to achieve normal valve closure, or at least partially overlaps with the free edges of the remaining autologous leaflets to prevent valve regurgitation.

[0021] According to another embodiment, there are multiple fasteners, and at least two fasteners are spaced a certain distance apart in the axial direction.

[0022] According to another embodiment, the proximal segment of the mounting bracket abuts against the interventricular septum, and the proximal end of the mounting bracket is anchored to the interventricular septum tissue by the fastener.

[0023] According to another embodiment, the anti-reflux prosthesis is selected from the following: an integral membrane made of flexible material; and a support frame and a biocompatible membrane or sheet covering the support frame; and an implantable balloon.

[0024] According to another embodiment, the mounting bracket includes a limiting member configured to allow the single anti-backflow prosthesis to rest against it in the leaflet-open state and to limit its deformation.

[0025] According to another embodiment, the fixed end of the single anti-reflux prosthesis is fixedly connected to the mounting bracket, and the free end of the anti-reflux prosthesis is movably connected to the mounting bracket via a traction wire; wherein, after the repair device is installed in place, the free end of the single anti-reflux prosthesis can move between a leaflet-open state and a leaflet-closed state; in the leaflet-open state, the single anti-reflux prosthesis, together with the remaining autologous leaflets of the valve except for the single autologous leaflet, opens together; in the leaflet-closed state, the single anti-reflux prosthesis, together with the remaining autologous leaflets, closes together to prevent valve regurgitation.

[0026] According to another aspect of this application: the heart valve repair device is operated into the surgical site; the mounting stent is gradually released from the proximal end, and the proximal end of the mounting stent is placed against the interventricular septum tissue; the mounting stent is further released, causing the clamping element to fold towards the distal end of the mounting stent and clamp the replaced autologous leaflet; the actuating element is pulled, causing the puncture element to slide distally relative to the clamping element and pass through the replaced autologous leaflet; the actuating element is further pulled, causing the puncture element to be fixedly connected to the anchoring area; at this time, the actuating element and the puncture element are disassembled (the specific structure and method of disassembly and connection are prior art and will not be described in detail); the heart valve repair device is further operated, causing the proximal end of the mounting stent to be fixed to the interventricular septum tissue by the fixation element; and the valve stent delivery device is withdrawn.

[0027] Compared with the prior art, the advantages of this application are: 1. Unlike the prior art, in one embodiment of the present invention, the proximal end of the mounting bracket is anchored in the ventricle by a fixing member. After the leaflet anchoring device returns to the preset shape, it passes through the replaced autologous leaflet. This makes the mounting bracket and the autologous leaflet form a stable connection, realizes the reliable fixation of the repair device in the heart, and avoids the repair device from tilting or swaying after implantation, which may lead to paravalvular leakage.

[0028] 2. Unlike the prior art, in one embodiment of the present invention, one end of the leaflet anchoring device is fixed on the mounting bracket, and the other end passes through the replaced autologous leaflet and is fixedly connected to the anchoring area, so that the leaflet anchoring device and the mounting bracket form a closed loop connection. Furthermore, the other end of the leaflet anchoring device passes through the autologous leaflet, thereby making the anchoring of the repair device and the autologous leaflet more stable and avoiding tilting or swaying after the repair device is implanted.

[0029] 3. Unlike the prior art, in one embodiment of the present invention, the clamping element has a preset shape. When the clamping element returns from the restricted shape to the preset shape, the other end of the clamping element will be folded and its autologous leaflet will be located between the clamping element and the mounting bracket. Then, the other end of the puncture element passes through the root region of the autologous leaflet. Since the muscle tissue in the root region of the autologous leaflet is thicker, it can withstand greater force. And anchoring at the root position of the autologous leaflet can also make the repair device fit tightly against one side of the heart wall. While replacing the problematic leaflet, it will not affect the movement of other autologous leaflets.

[0030] 4. Unlike existing technologies, in one embodiment of the present invention, the repair device is fixed to the ventricular tissue by a fixator, the leaflet anchoring device is anchored to the replaced autologous leaflet, and the distal end is disposed on the autologous valve annulus. This allows the repair device to be stably attached to one side of the replaced autologous leaflet of the autologous valve, and only the problematic leaflet is replaced, thereby preserving the original function of the remaining autologous leaflet, while not changing the shape of the autologous valve annulus. This results in minimal damage to intracardiac tissue, a smaller implantation volume, and less irritation.

[0031] 5. Unlike existing technologies, in one embodiment of the present invention, the fixation position of the repair device is safe and risk-free; the fixable area of ​​the ventricular septum is much larger than that of the valve annulus and atrium, which reduces the requirements for device positioning; and there are no other important branch vessels near the ventricular septum, so it will not cause functional damage and is highly safe; during cardiac motion, the amplitude of movement of the ventricular septum is relatively small compared to the valve annulus, so it is more stable during fixation, with a high success rate and good effect.

[0032] 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

[0033] 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: Figures 1a-1eThis is a schematic diagram of the overall repair device of the present invention, wherein... Figure 1c This is a schematic diagram of the connector structure of the present invention. Figure 1d This is a schematic diagram of the puncture element structure of the present invention.

[0034] Figures 2a-2c This is a schematic diagram of the repair device of the present invention after implantation.

[0035] Figures 3a-3c This is a schematic diagram illustrating the backflow caused by the inability of the anterior leaflet, posterior leaflet, and diaphragmatic leaflet to properly align.

[0036] Figure 4a and 4b This is a schematic diagram showing the normal closure of each leaflet after the repair device of the present invention has been fixed.

[0037] Figures 5a-5h This is a schematic diagram of the implantation process of the repair device of the present invention.

[0038] The names that the numbers in the attached diagram refer to are as follows: 1-Installation bracket, 2-Anti-reflux prosthesis, 3-Valve leaflet anchoring mechanism, 31-Clamping element, 311-Connector, 32-Puncture element, 321-Limiting element, 4-Fixing element, 5-Anchoring area, 6-Actuating element, 7-Atrial part, 8-Tension wire. Detailed Implementation

[0039] 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.

[0040] 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.

[0041] 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.

[0042] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0043] In this application, "proximal" refers to the end closest to the apex of the heart, and "distal" refers to the end furthest from the apex of the heart.

[0044] Example 1 The tricuspid valve of the human heart has anterior, posterior, and diaphragmatic leaflets. These leaflets are normally closed during cardiac contraction. If any of these leaflets fails to close properly, valvular regurgitation occurs. Figures 3a-3c As shown.

[0045] like Figures 1a-1e As shown, a heart valve repair device includes a mounting bracket 1, a single anti-regurgitation prosthesis 2 for replacing the function of a single autologous leaflet, a leaflet anchoring mechanism 3, and a fixing member 4. One end of the single anti-regurgitation prosthesis 2 is fixed to the mounting bracket 1, and the proximal end of the mounting bracket 1 is anchored to the ventricular tissue by the fixing member 4. One end of the leaflet anchoring mechanism 3 is fixed to the mounting bracket 1. When the mounting bracket 1 is installed in place, the replaced autologous leaflet is located between the mounting bracket 1 and the leaflet anchoring mechanism 3, and the other end of the leaflet anchoring mechanism 3 passes through the replaced autologous leaflet.

[0046] Mounting bracket 1 does not affect the function of the remaining autologous leaflets after installation.

[0047] Heart valve repair devices can have a constrained state and a released state.

[0048] According to another example, in the treatment of tricuspid valve disease, the heart valve repair device replaces the leaflet of the septal valve.

[0049] According to one example, the distal end of the mounting bracket 1 is provided with an anchoring region 5, and the other end of the leaflet anchoring mechanism 3 passes through the replaced autologous leaflet and is fixedly connected to the anchoring region 5. The anchoring region 5 is covered with a membrane to facilitate the other end of the leaflet anchoring mechanism 3 passing through the replaced autologous leaflet and being fixedly connected to the anchoring region 5. Figure 2b and 2c As shown.

[0050] According to another example, the other end of the leaflet anchoring mechanism 3 has a preset shape. When the mounting bracket 1 is installed in place, the other end of the leaflet anchoring mechanism 3 passes through the replaced autologous leaflet and returns to the preset shape to anchor with the replaced autologous leaflet.

[0051] According to one example, the leaflet anchoring mechanism 3 includes a clamping element 31 and a puncture element 32, the puncture element 32 being slidable relative to the clamping element 31, and, when the mounting bracket 1 is installed in place, the replaced autologous leaflet is located between the mounting bracket 1 and the clamping element 31, and the puncture element 32 moves distally relative to the clamping element 31 and passes through the replaced autologous leaflet.

[0052] According to one example, one end of the clamping element 31 is fixed to the mounting bracket 1. During pre-installation, the other end of the clamping element 31 is close to the proximal end of the mounting bracket 1. When the mounting bracket 1 is transported to the target position, the other end of the clamping element 31 is folded distally so that the autologous leaflet is clamped between the clamping element 31 and the mounting bracket 1.

[0053] According to one example, the clamping element 31 is provided with a connector 311, and the piercing element 32 is provided with a limiting member 321, such as... Figures 1b-1d As shown, the connector 311 cooperates with the limiting member 321 to constrain the sliding stroke of the puncture element 32 relative to the clamping element 31. When the mounting bracket 1 is installed in place, the puncture element 32 moves distally relative to the clamping element 31 and passes through the root region of the autologous leaflet.

[0054] According to one example, the heart valve repair device further includes an actuator 6, one end of which is connected to the puncture element 32. When the mounting bracket 1 is in place, pulling the actuator 6 causes the puncture element 32 to move distally relative to the clamping element 31 and pass through the autologous valve leaflet. Figure 5e-5g As shown.

[0055] According to one example, the actuator 6 and the puncture element 32 are detachably connected. After the puncture element 32 completes the puncture of the autologous valve leaflet, the actuator 6 and the puncture element 32 are detached and withdrawn from the body.

[0056] According to one example, the distal end of the mounting bracket 1 is provided with an atrial portion 7, which is configured to adapt to the shape of the autologous valve annulus tissue, and after the mounting bracket 1 is installed in place, the two sides of the atrial portion 7 are positioned at the junction of the autologous valve leaflets, such as... Figure 2a and 2c As shown.

[0057] According to one example, when the autologous valve is in the closed state, the free edge of the single anti-regurgitation prosthesis 2 works together with the free edges of the remaining autologous leaflets to achieve normal valve closure, or at least partially overlaps with the free edges of the remaining autologous leaflets to prevent valve regurgitation, such as... Figure 4a and4b As shown.

[0058] According to another example, there are two fasteners 4, and the two fasteners 4 are spaced a certain distance apart in the axial direction, such as... Figure 2a As shown.

[0059] According to another example, the proximal segment of the mounting bracket 1 rests against the interventricular septum, and the proximal end of the mounting bracket 1 is anchored to the interventricular septal tissue by the fastener 4.

[0060] According to another example, the fixed end of the single anti-backflow prosthesis 2 is fixedly connected to the mounting bracket 1, and the free end of the anti-backflow prosthesis 2 is movably connected to the mounting bracket 1 via a tension wire 8, as shown below. Figure 1a As shown; wherein, after the repair device is installed in place, the free end of the single anti-reflux prosthesis 2 can move between the leaflet open state and the leaflet closed state. In the leaflet open state, the single anti-reflux prosthesis 2, together with the other autologous leaflets of the valve except for the single autologous leaflet, opens together; in the leaflet closed state, the single anti-reflux prosthesis 2, together with the other autologous leaflets, closes together to prevent valve regurgitation, as shown. Figure 4a and 4b As shown.

[0061] The anti-reflux prosthesis 2 can also be configured with traction wires 8 in other ways similar to the autologous valve structure.

[0062] Similar to the structure of a natural valve leaflet, the anti-reflux prosthesis 2 may have a curved surface structure similar to that of a natural valve leaflet.

[0063] An exemplary cardiac atrioventricular tricuspid valve surgery procedure for the valve regurgitation repair device of this embodiment is as follows: Figures 5a-5h As shown: 1. The heart valve repair device is accessed via the femoral approach, entering the atrium through the femoral vein and superior vena cava before reaching the atrioventricular orifice; 2. Position the mounting bracket 11 against the septal leaflet, and release the proximal portion of the heart valve repair device and place it against the interventricular septum; 3. The heart valve repair device is gradually released from the distal end to the proximal end, causing the leaflet anchoring mechanism 3 to return from its restricted state to its preset state. At this time, the free end of the leaflet anchoring mechanism 3 is folded from the distal end of the mounting bracket 1 towards the proximal end, as shown below. Figure 5c As shown by the arrow, the autologous leaflet (septal leaflet) to be replaced is held within the valve clamping cavity, as... Figure 5c and 5d As shown; 4. Further release the atrial portion 7, allowing it to adhere to the autologous valve annulus, such as... Figure 5e As shown.

[0064] 5. Continue the surgical procedure by fixing the mounting bracket 1 to the ventricular septum using the fixation device 4. This completes the main surgical procedure for the repair device.

[0065] The foregoing description of several embodiments of this application has been 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; obviously, many modifications and variations can be made in light of the teachings above. The scope and equivalents of this invention are intended to be defined by the appended claims.

Claims

1. A heart valve repair device, comprising a mounting bracket, a single anti-regurgitation prosthesis for replacing the function of a single autologous valve leaflet, a leaflet anchoring mechanism, and a fixation element, wherein one end of the single anti-regurgitation prosthesis is fixed to the mounting bracket, and the proximal end of the mounting bracket is anchored to ventricular tissue via the fixation element, characterized in that: One end of the leaflet anchoring mechanism is fixed to the mounting bracket. After the mounting bracket is installed in place, the replaced autologous leaflet is located between the mounting bracket and the leaflet anchoring mechanism, and the other end of the leaflet anchoring mechanism passes through the replaced autologous leaflet. The leaflet anchoring mechanism includes a clamping element and a puncture element. The puncture element can slide relative to the clamping element. After the mounting bracket is installed in place, the replaced autologous leaflet is located between the mounting bracket and the clamping element. The puncture element moves distally relative to the clamping element and passes through the replaced autologous leaflet.

2. The heart valve repair device according to claim 1, characterized in that: The mounting bracket has an anchoring area at its distal end, and the other end of the leaflet anchoring mechanism passes through the replaced autologous leaflet and is fixedly connected to the anchoring area.

3. The heart valve repair device according to claim 1, characterized in that: The other end of the leaflet anchoring mechanism has a preset shape. When the mounting bracket is installed in place, the other end of the leaflet anchoring mechanism passes through the replaced autologous leaflet and returns to the preset shape to achieve anchoring with the replaced autologous leaflet.

4. The heart valve repair device according to claim 1, characterized in that: One end of the clamping element is fixed to the mounting bracket. During pre-installation, the other end of the clamping element is close to the proximal end of the mounting bracket. When the mounting bracket is transported to the target position, the other end of the clamping element is folded towards the distal end so that the autologous leaflet is clamped between the clamping element and the mounting bracket.

5. The heart valve repair device according to claim 1, characterized in that: The clamping element is provided with a connector, and the piercing element is provided with a limiting element. The connector and the limiting element cooperate to constrain the sliding stroke of the piercing element relative to the clamping element.

6. The heart valve repair device according to claim 1, characterized in that: Once the mounting bracket is in place, the puncture element moves distally relative to the clamping element and passes through the root region of the autologous valve leaflet.

7. The heart valve repair device according to claim 1, characterized in that: The heart valve repair device also includes an actuating element, one end of which is connected to the puncture element. When the mounting bracket is installed in place, pulling the actuating element can cause the puncture element to move distally relative to the clamping element and pass through the autologous valve leaflet.

8. The heart valve repair device according to claim 1, characterized in that: The distal end of the mounting bracket is provided with an atrial portion, which is configured to adapt to the shape of the autologous valve annulus tissue. After the mounting bracket is installed in place, the two sides of the atrial portion are positioned at the junction of the autologous valve leaflets.

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