WO2022267851A1

WO2022267851A1 - Repair device for preventing valve regurgitation

Info

Publication number: WO2022267851A1
Application number: PCT/CN2022/096670
Authority: WO
Inventors: 吕世文; 陈志�; 徐进
Original assignee: 宁波健世生物科技有限公司
Priority date: 2021-06-25
Filing date: 2022-06-01
Publication date: 2022-12-29
Also published as: CN115517824A; CN113712707A

Abstract

A repair device for preventing valve regurgitation, comprising: a mounting bracket (1); and a single anti-regurgitation valve leaflet prosthesis (2) used for replacing the function of a single autologous valve leaflet, one end of the single anti-regurgitation valve leaflet prosthesis (2) being fixed on the mounting bracket (1). The repair device only replaces a faulty single valve leaflet, thereby retaining the original functions of the remaining autologous valve leaflets, without changing the shape of an autologous valve ring; therefore, the damage to intracardiac tissue is small, and moreover, the number of implants is relatively low, and the irritation is small.

Description

A prosthetic device for preventing valve regurgitation

This application claims the priority of the Chinese invention patent application "a repair device for preventing valve regurgitation" with the application number 202110712907.0 filed at the State Intellectual Property Office of China on June 25, 2021. The Chinese invention patent application The entire contents are incorporated by reference into this application.

technical field

The present application relates to the field of medical devices, in particular to a repair device for preventing valve regurgitation.

Background technique

Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricle enlargement, and tricuspid annulus dilatation. It is often clinically manifested as the cause of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.). After tricuspid regurgitation occurs, patients will experience fatigue, ascites, edema, liver pain, indigestion, anorexia and other symptoms of right heart failure. Mild tricuspid regurgitation has no obvious clinical symptoms, but when severe regurgitation requires surgical treatment.

Traditional treatments for mitral and tricuspid valve disease include medical therapy for mild to severe regurgitation and surgical approaches when indicated for surgery. Among them, surgical methods also include valve replacement and valve repair. Among the surgical methods, typical thoracotomy and open-heart surgery are too invasive and require the establishment of extracorporeal circulation, which has a high complication rate and infection risk. Many patients cannot tolerate the huge surgical risk, but can only wait for death helplessly.

With the report of the first case of aortic valve interventional replacement, many companies have done a lot of work in interventional aortic valve technology, and the technology is becoming more and more mature. However, there is still a large technical gap in the field of interventional treatment of the atrioventricular valve. Although a few products for interventional treatment of atrioventricular valves have been applied in transcatheter valvuloplasty and repair, there are no mature and available products in the world for transcatheter valve replacement.

Patent CN201780028476.8 describes a heart valve leaflet replacement system and its method, 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 , at least one fork-shaped structure for connecting the prosthetic leaflets and the crescent-shaped stent, the replacement prosthesis is fixed to the target position by surgical suturing or the upper flare of the crescent-shaped stent is flared through an interventional catheter Partially anchored to the posterior portion of the native annulus. In this scheme, the back of the natural ring is close to the coronary artery, and there is a risk of damage when the prosthetic valve is fixed, especially when transcatheter intervention requires high positioning of the anchoring system, but it is still difficult to achieve under the existing medical conditions Precise positioning, so the risk of damaging the coronary arteries is relatively high. The posterior portion of the natural annulus lacks fiber cords and is weak, and the annulus is incomplete. Therefore, the tissue strength of the posterior annulus is weak, and the pressure of the mitral valve is high, and there is a tear valve after the valve prosthesis is anchored. ring risk. The annulus of the tricuspid valve is weaker and the tissue is less elastic due to long-term expansion, the tissue is more likely to tear, and the prosthesis is more likely to fall off. In order to stably anchor the valvular prosthesis at the target position, at least three anchor points are required, and the positions of each anchor point are different, the span is large, and the operation is complicated. When the heart moves, the contraction and expansion of the posterior valve ring are obvious, and the anchoring position is always active. The anchoring is difficult and the distance between the anchoring points is difficult to grasp, and the anchoring effect is not good. When the prosthetic valve is closed, the upper flaring part used for anchoring is located in the downstream part of the blood flow, and the ventricle part of the prosthetic valve has no force point, and the prosthetic valve is prone to displacement and instability, resulting in prosthetic leaflets and autologous anterior Leaflets do not coapt well, leading to regurgitation.

Patent CN201610921114.9 describes a heart valve prosthesis, including a valve support and a fixing device, the valve support includes a sewing section and an artificial valve, the fixing device includes a fixed support section and an anchor, and one end of the fixed support section is anchored Parts are connected on the patient's interventricular septum 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 segment is smaller than the cross-sectional area of the patient's own valve ring; The replacement of the still functioning valve leaflets with artificial valves will greatly change the original hemodynamics, and further research is needed on the impact on cardiac function. The annulus of tricuspid regurgitation disease is obviously dilated, and the force-bearing area of the implanted artificial valve is large, and the force of the anchor is relatively large, so it is easy to detach from the interventricular septal tissue. The annulus of the diseased tricuspid valve is irregular in shape, and the implanted valve is circular. Without supporting the annulus, the effective opening area of the artificial valve is smaller than that of the native valve, and the transvalvular pressure difference will be raised. It is difficult to remedy unexpected situations such as valve displacement and valve detachment during the implantation process. The pressure of the right heart system where the tricuspid valve is located is low, the volume is large, the mobility of the artificial valve leaflet is small, and fibrin hyperplasia is prone to crawling, which further reduces the mobility of the artificial valve leaflet, and it is prone to calcification for a long time, 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-intervention for valve replacement is small. There are many valve implants. On the one hand, the diameter of the interventional catheter is large, and the transvascular access is difficult. On the other hand, the implant forms a relatively complex structure in the heart, and the blood flow easily forms a vortex in the local area, and the risk of thrombosis is high. . Moreover, closed-loop artificial valves and stents are difficult to process and costly.

Patent US20160354076A1 discloses a method for treating tricuspid valve regurgitation. The catheter is positioned near the tricuspid valve annulus, and the guide wire passes through the valve annulus or valve leaflet tissue to establish anchor points. By adjusting the distance between the anchor points, the Regurgitation of the tricuspid valve is treated by shrinking the enlarged annulus. The treatment principle of this program is to shrink the enlarged tricuspid annulus and increase the apposition area of the native valve leaflets. After shortening the distance, the annulus shape of the original tricuspid valve changes greatly, and the shape becomes more irregular, and the apposition effect of the native valve leaflets will not be very stable; To establish an anchor point, the strength of the tissue is low and it is easy to tear; it is difficult to locate the anchor point in the modified scheme, and it is difficult to locate the ideal position; and this method is complicated to operate, first locate the target position, then the guide wire punctures the tissue or leaflet, and then inserts the The guide wire captures or releases the spacer, then tightens the anchor point, moves on to the next anchor point, and finally closes the distance between the anchor points. The tricuspid valve of the human heart has an anterior leaflet, a posterior leaflet and a diaphragmatic leaflet. The anterior valve leaflet, posterior valve leaflet and diaphragm leaflet are closed during systole. When the anterior leaflet, posterior valve leaflet and diaphragm valve leaflet cannot fit normally in the closed state, valvular regurgitation will occur.

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 motion and hemodynamics, reduce the difficulty of operation, and have a simple structure.

Contents of the invention

The present application has been made in view of the foregoing and other considerations. One of the technical problems to be solved in this application is to provide an innovative repair device for preventing valvular regurgitation, which can not only be reliably fixed, but also retain the function of the main native valve leaflets, and at the same time have a significant impact on cardiac motion and hemodynamics. The impact on science is small, the difficulty of operation is low, and the structure is simple.

The basic inventive concept according to another aspect of the present application is that the prosthetic device of the present application is intended to repair rather than replace the entire native heart valve. In other words, the prosthetic device of the present application is intended to replace one or two of the native valve leaflets, but not the entire number of native valve leaflets. For the mitral valve, the repair device of the present application is intended to replace one of the native valve leaflets while keeping the other native valve leaflet to work normally. For the tricuspid valve, the repair device of the present application is intended to replace one of the native valve leaflets such as the posterior valve leaflet, while retaining the normal work of the other two native valve leaflets; or, two repair devices of the present application are used to replace the three Two native leaflets in the cusp, leaving the other native leaflet functioning normally.

Specifically, according to one aspect of the present application, a repair device for preventing valve regurgitation is provided, including: a mounting bracket; and a single anti-regurgitation valve leaflet prosthesis for replacing the function of a single native valve leaflet; wherein , one end of a single anti-reflux leaflet prosthesis is fixed on the mounting bracket.

According to another aspect of the present application, there is also provided a repair device for preventing valve regurgitation, including: a mounting bracket; and a single anti-regurgitation valve leaflet prosthesis for replacing the function of a single native valve leaflet; wherein, a single One end of the anti-regurgitation leaflet prosthesis is fixed on the proximal end of the mounting bracket; and the proximal end of the mounting bracket is provided with a generally annular flaring portion, and the flaring portion is in the part of the native valve annulus of the valve after being installed in place. Or extend circumferentially over the entire circumference.

According to one embodiment, in the closed state of the leaflets, the free edge of the single anti-reflux leaflet prosthesis and the free edges of the remaining native valve leaflets cooperate to realize the normal closure of the valve, or cooperate with at least the free edges of the remaining native valve leaflets. Partially overlap to prevent valve regurgitation.

According to another embodiment, the repair device further includes an anchor, and after the installation is completed, the distal end of the installation bracket is fixed at a predetermined position of the heart through the anchor.

According to another embodiment, the proximal end of the mounting bracket is configured on the native valve annulus of the heart, the atrium tissue or the atrioventricular opening, and the distal end of the mounting bracket is fixed on the ventricle tissue by an anchor.

According to another embodiment, the prosthetic device has a constrained state before installation and a released state after installation.

According to another embodiment, the mounting bracket comprises a proximal section adapted to be mounted in place at a predetermined location of the heart in a released state of the prosthetic device.

According to another embodiment, the proximal section is provided with a stopper, and in the released state of the prosthetic device, the stopper is a flange of a substantially arcuate section, and the flange is dimensioned to fit against the atrioventricular chamber of the heart. atrial tissue at the ostium and prevent further movement of the prosthetic device into the ventricle.

According to another embodiment, the mounting bracket includes a distal section configured to be attached to a predetermined position of the heart.

According to another embodiment, the distal end section comprises a distal end section main body and a fixation aid unit, which is anchored on the heart tissue by an anchor.

According to another embodiment, the mounting bracket further includes a middle section disposed between the proximal end section and the distal end section, and an anti-peripheral leakage membrane is provided in the middle section area.

According to another embodiment, a single anti-reflux leaflet prosthesis provides an anti-reflux skirt in the mid-section region.

According to another embodiment, an auxiliary abutting portion is provided at the middle section of the mounting bracket, one end of which is fixedly connected to the middle section, and the other end is a free end; the auxiliary abutting portion has a restricted shape and a preset shape, and the free end is in the In the restricted configuration, it is close to the distal end of the installation bracket, and in the preset configuration, the free end is separated from the proximal end of the installation bracket by a certain distance to form a valve clamp cavity.

According to another embodiment, the number of auxiliary abutting parts is 1-3. According to another embodiment, when the prosthetic device is implanted, the replaced native valve leaflet is confined between the auxiliary abutment and the mounting bracket.

According to another embodiment, the anti-reflux leaflet prosthesis is selected from one of the following: an integral membrane made of a flexible material; Formed by film or diaphragm.

According to another embodiment, the mounting bracket includes a limiter configured to abut against and limit deformation of the single anti-reflux leaflet prosthesis in the leaflet-open state.

According to another embodiment, the fixed end of a single anti-reflux valve leaflet prosthesis is fixedly connected to the mounting bracket, and the free end of the anti-reflux valve leaflet prosthesis is flexibly connected to the mounting bracket through a pulling wire; After being in place, the free end of the single anti-reflux leaflet prosthesis can move between the valve leaflet open state and the valve leaflet closed state. In the valve leaflet open state, the single anti-reflux leaflet prosthesis together with the valve The rest of the native valve leaflets are opened together; in the closed state with the valve leaflets, the single anti-reflux valve leaflet prosthesis is closed together with the rest of the native valve leaflets to prevent valve regurgitation.

According to another embodiment, the number of anchors is 1-3. According to another embodiment, after the repair device is installed in place, the limiting portion of the proximal end section of the mounting bracket extends circumferentially on part or the entire circumference of the native valve annulus.

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

According to another embodiment, the anti-reflux leaflet prosthesis may be a spherical structure, and when the native valve is in a closed state, the anti-reflux leaflet prosthesis is located in the middle of the native valve to avoid blood reflux. According to another embodiment, the anti-reflux valve leaflet prosthesis can be a sheet-like structure. When the native valve is in a closed state, one side of the mounting bracket is in contact with a part of the native valve leaflet, and the anti-reflux valve leaflet prosthesis is free. The margin coincides with the rest of the native valve leaflets.

According to another embodiment, after the prosthetic device is implanted, the middle section abuts against a part of the native valve leaflet, and the distal section abuts against the wall of the ventricle, and the installation bracket does not affect the function of the remaining part of the native valve leaflet.

According to another embodiment, the cross-section of the middle section and the distal section is an open-loop structure; when the repair device is implanted, it still retains part of the function of the native valve leaflet, which can effectively improve regurgitation and reduce the cost of the implant. Implantation amount.

According to another embodiment, the proximal section is configured to fit against the native valve annulus or atrial tissue, so that the repair device can better conform to the physiological structure of the native valve annulus.

According to another embodiment, the proximal section includes a limiting portion and an anti-peripheral leakage membrane, and the limiting portion is a fan-shaped continuous network structure or consists of a single rod.

According to another embodiment, the cross-section of the proximal section is a closed circular arc structure.

According to another embodiment, the limiting portion and the middle section are integrally structured.

According to another embodiment, the proximal segment can also be fixed on native annulus or atrial tissue by anchors.

According to another embodiment, the middle section includes an anti-reflux skirt; when the prosthetic device is implanted, the anti-reflux skirt is located in the commissure area of the native valve leaflets.

According to another embodiment, the auxiliary abutting portion is integrally structured with the middle section.

According to another embodiment, the anchored unit is connected to the ventricular tissue by at least two anchors, and at least two anchors are separated by a certain distance in the axial direction. According to another embodiment, at least one of the anchors is fixed to the interventricular septum.

According to another embodiment, the main body of the distal end section is composed of a grid-like structure or a rod-like structure.

According to another embodiment, the distal section is made of flexible material, such as braided mesh, braided cloth, wire, etc.

According to another embodiment, the fixed outline of the anti-reflux valve leaflet prosthesis and the mounting bracket is arc-shaped, so that the anti-reflux valve leaflet prosthesis can fully expand when the native valve leaflet is closed.

According to another embodiment, the anti-reflux leaflet prosthesis is an arc-shaped sheet structure. According to another embodiment, the anti-reflux leaflet prosthesis is provided with a shaping skeleton inside, and the shaping skeleton is a mesh structure or a rod-shaped structure.

According to another embodiment, when the native valve is closed, the middle part of the anti-reflux leaflet prosthesis arches toward the atrium; when the native valve is opened, the middle part of the anti-reflux leaflet prosthesis approaches the mounting bracket.

Compared with the prior art, the advantages of the present application are:

1. Different from the prior art, in one embodiment of the present application, the repair device is fixed on the ventricular tissue through anchors, and only the valve leaflets in question are replaced, thereby retaining the original functions of the remaining parts of the original valve leaflets, and at the same time It will not change the shape of the native valve ring, and will cause less damage to the heart tissue, and at the same time, the amount of the implant is less, and the irritation is small;

2. Different from the prior art, in one embodiment of the present application, the repair device is fixed by anchors and attached to one side of the native valve, which is stable and does not affect the movement of the heart;

3. Different from the prior art, the fixing position of the repair device in one embodiment of the present application is safe and risk-free; the fixable area of the interventricular septum is much larger than the fixable area of the annulus and atrium, and the positioning requirements for the device are low; and There are no other important branch blood vessels near the interventricular septum, which will not cause functional damage and have high safety; during the heart movement, the movement range of the interventricular septum is relatively small compared to the annulus, so it is relatively stable when fixed, with a high success rate and good effect it is good;

4. Different from the prior art, in one embodiment of the present application, the auxiliary abutment part can not only clamp the native valve leaflet, but also further enhance the anti-reflux effect of the repair device;

5. Different from the prior art, in an embodiment of the present application, the anti-regurgitation skirt is set at the junction area of the native leaflets, which can effectively improve the blood regurgitation at the junction of the leaflets.

Embodiments of the present application can achieve other advantageous technical effects not listed one by one, which may be partially described below, and can be expected and understood by those skilled in the art after reading the present application.

Description of drawings

The above-mentioned and other features and advantages of these embodiments, and the manner in which they are achieved, will become more apparent and a better understanding of embodiments of the present application can be obtained by referring to the following description together with the accompanying drawings in which:

1a-1c are overall schematic top views of a repair device according to an embodiment of the present application.

2a-2e are schematic diagrams illustrating auxiliary abutments, anchors and anti-reflux leaflet prosthesis.

Figures 3a-3c are schematic diagrams of regurgitation caused by failure of the anterior valve leaflet, posterior valve leaflet and diaphragmatic valve leaflet to align normally.

4a-4b are schematic diagrams of normal closure of each valve leaflet after the repair device is fixed according to an embodiment of the present application.

5a-5g are schematic diagrams of the process of releasing and completing the fixation of the prosthetic device according to an embodiment of the present application, wherein 5b is the prosthetic device in a compressed state.

Figures 6a and 6b illustrate another embodiment of the present application.

Figures 7a and 7b illustrate yet another embodiment of the present application.

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

1-installation bracket, 11-proximal section, 12-middle section, 121-anti-reflux skirt, 13-distal section, 131-distal section main body, 132-fixing auxiliary unit, 14-auxiliary abutment part, 141-clamping cavity, 15-restriction, 2-anti-reflux leaflet prosthesis, 21-supporting frame, 22-covering, 23-pull wire, 3-anchor.

detailed description

The details of one or more embodiments of the application are set forth in the following description of the accompanying drawings and the detailed description. Other features, objects and advantages of the present application will be apparent from the description, drawings and claims.

It should be understood that the illustrated and described embodiments are not limited in application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments are capable of other embodiments and of being practiced or carried out in various ways. Each example is provided by way of explanation, not 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 in the various embodiments of the present application without departing from the scope or spirit of the present disclosure. For example, features illustrated or described as part of one embodiment, can be used with another embodiment to still yield a further embodiment. Accordingly, it is intended that the present disclosure covers such modifications and alterations as come within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phrases and terms used herein are for the purpose of description and should not be regarded as limiting. The use of "comprising", "comprising" or "having" and variations thereof herein is intended to openly include the items listed thereafter and equivalents thereof as well as additional items.

The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application. In this application, "proximal end" refers to the end close to the operator, and "distal end" refers to the end away from the operator.

Embodiment one

The tricuspid valve of the human heart has an anterior leaflet, a posterior leaflet, and a diaphragmatic leaflet. The anterior valve leaflet, posterior valve leaflet and diaphragm valve leaflet are closed when the heart contracts, and when one of the front valve leaflet, posterior valve leaflet and diaphragm valve leaflet cannot close normally in the closed state, valve regurgitation occurs, such as Figure 3a-3c shows.

As shown in FIGS. 1 a - 1 c , a repair device for preventing valve regurgitation includes a mounting bracket 1 , an anti-reflux leaflet prosthesis 2 and an anchor 3 . The proximal end of the mounting bracket 1 is attached to the native valve annulus or cardiac tissue such as atrial tissue, and the distal end of the mounting bracket 1 is fixed on the cardiac tissue such as ventricular tissue through the anchor 3 . The anti-reflux leaflet prosthesis 2 is connected to the mounting bracket 1 in various feasible fixing ways such as fixing, attaching, bonding, sewing, buckling, wearing, and the like. After the operation is completed, when the native valve as the surgical target is in a closed state, the anti-reflux valve leaflet prosthesis 2 is located in the middle of the native valve, and the free edge of the anti-reflux valve leaflet prosthesis and the rest of the native valve leaflets The free edges cooperate together to achieve normal closure of the valve, or at least partially overlap with the free edges of the remaining native valve leaflets to prevent regurgitation of the valve. Different from the treatment plan of directly replacing the entire native valve, the repair device according to the present application is fixed at the target surgical site such as ventricular tissue through anchors 3, such as anchor nails, and only replaces one of the problematic target valves. Leaflets, such as septal valve leaflets, while retaining the original structure and function of the rest of the autogenous valve leaflets, keeping them from being replaced and not changing the shape of the autologous valve annulus, so the damage to the heart tissue is small, and the amount of the implanted body Less, less stimulation and damage to the human heart.

According to one example, the anti-reflux leaflet prosthesis 2 may be of a generally sheet-like configuration, for example in the form of a posterior leaflet of a tricuspid valve, for replacement of autologous tissue of a patient's posterior leaflet. After the operation, when the native valve of the surgical target is in a closed state, the middle section of the mounting bracket 1 conforms and abuts against a part of the native valve leaflets, and the anti-reflux valve leaflet prosthesis 2 and the remaining native valve leaflets of the native valve Close normally.

According to another example, the anti-reflux leaflet prosthesis 2 may have a generally spherical structure. When the native valve is in a closed state, the anti-reflux leaflet prosthesis 2 is located between the native valves and forms an effective closure with them, avoiding Blood regurgitation occurs.

In this embodiment, the main body of the mounting bracket 1 generally includes a proximal section 11, a middle section 12, and a distal section 13 that are connected together, for example, as shown as a substantially integral body. The proximal section 11 is arranged at the proximal end of the mounting bracket 1 , the distal section 13 is arranged at the distal end of the main body of the mounting bracket 1 , and the middle section 12 is interposed between the proximal section 11 and the distal section 13 . After the prosthetic device is implanted, the middle section 12 is compliant and suitable for adhering to the target tissue site, such as the native valve leaflet to be replaced, and the distal section 13 is compliant and suitable for adhering to the target tissue site, such as the ventricular wall. The proximal section 11 is configured to be conformable and suitable for abutting against target tissue sites such as native valve annulus, atrioventricular ostium or atrial tissue, allowing the prosthetic device to better conform to the physiological structure of, for example, the native valve annulus. After the mounting bracket 1 is installed, it does not affect the functions of the rest of the native leaflets. A prosthetic device may have a constrained state and a released state.

In this embodiment, the proximal section 11 may further include a preferably integrated limiting portion 111, for example, the limiting portion 111 may be a continuous meandering or mesh structure at the proximal section 11, or may also be single shot. This serpentine or mesh-like configuration can be constrained or compressed in the constrained state of the prosthetic device, and released or expanded to its pre-set configuration in the released state of the prosthetic device.

A limiting member 15 can also be provided on the proximal section 11 , which can be integral with the limiting part 111 , for example. Restriction 15 may be used to limit/constrain excessive or undesired deformation of anti-reflux leaflet prosthesis 2 .

In the constrained state of the prosthetic device (shown in Figures 5b and 5c), the orientations of the proximal section 11 and the middle section 12 are substantially identical or have only minor differences. In the released state of the prosthetic device (shown in FIG. 5e ), the limiting portion 111 of the proximal section 11 will be bent relative to the middle section 12 and generally transverse to the direction of extension of the middle section 12 (shown in FIG. 5e ). Axial) extends in the direction (substantially or close to the radial direction), so that the stopper 111 has the configuration of an expanded substantially circular arc segment, such as a flaring portion, whose size and shape are suitable for being reliably placed on the heart Surgical sites, such as the atrioventricular ostium of the heart. This generally arcuate segment configuration may resemble a flange (flange) as shown in Figure 5e, and may prevent further movement of the prosthetic device into the ventricle. The circumferential dimension of the limiting portion 111 in the released state may be, for example, about one-third to one-half of the circumferential length of the native valve annulus. Those skilled in the art can obviously understand that the above-mentioned flaring part can also be arranged at the proximal end of the repair device in other ways/positions/configurations, including but not limited to flanges or flanges, all of which are within the scope of the present application .

The proximal section 11 can also include an anti-peripheral leakage film 112, which can be set at the position-limiting part 111 by clamping, clamping, sleeve, embedding, etc., preferably partially or completely covering the proximal section 11, for example, wrapping at least The outside of the limiting part 111 is used to prevent leakage around the replacement site.

The region of the middle section 12 also includes an anti-reflux skirt 121 . After the prosthetic device is implanted, the anti-reflux skirt 121 is located at the junction area with the native valve leaflet, as shown in Figs. 4a and 4b. The anti-peripheral leakage membrane 112 may provide the configuration of the anti-reflux skirt 121 in the region of the intermediate section 12 .

In addition, the anti-peripheral leakage membrane 112 can also be arranged in the area of the middle section 12, and the anti-peripheral leakage membrane 112 in this area is in close contact with the local autologous tissues such as autologous valve leaflets or atrial tissue to block the backflow of blood.

The installation bracket 1 can also be provided with an auxiliary abutting portion 14, which can be connected to the main body of the installation bracket 1 such as the middle section 12, as shown in Figs. 2a and 2b. The auxiliary abutment portion 14 can be configured to have a curved strip, meander or net-like structure, one end of which is fixedly connected to the middle section 12 and the other free end can be restored to a preset shape during surgery and away from the mounting bracket. 1 have a certain interval to form a clamping cavity 141, as shown in FIG. 2a for example. In this way, after the implantation of the repair device is completed, the native valve leaflet is clamped and limited between the auxiliary abutment portion 14 and the mounting bracket 1, as shown in FIG. 2c, which further facilitates the reliable fixing of the mounting bracket 1 on the Surgical site and anti-peripheral leakage.

The auxiliary abutting portion 14 may be integrally formed with the middle section 12, for example. Of course, the auxiliary abutting portion 14 can also be a separate piece connected to the middle section 12 .

The auxiliary abutting portion 14 can have a restricted state and a preset shape. When the auxiliary abutting portion 14 is converted from a restricted state to a preset shape, the replaced native valve leaflet can be abutted against the auxiliary abutting portion 14 and can be reversed, so that a part of the native valve leaflet is reliably held in, For example, it is clamped at the position of the valve clamp cavity 141, as shown in Figs. 5c and 5d.

At least one, for example two, auxiliary abutting portions 14 may be provided on the mounting bracket 1 , as shown in FIG. 2 c .

The distal section 13 may include a distal section main body 131 and a fixing auxiliary unit 132 . As shown in FIG. 2 d , the distal section main body 131 is connected to the middle section 12 , and the fixing auxiliary unit 132 is connected to the distal section main body 131 , and the fixing auxiliary unit 132 is connected to the heart surgery site such as ventricular tissue through the anchor 3 .

More details of the embodiment of the anchor member 3 (also called "anchor needle", "anchor needle", etc.) in this embodiment are described in detail in the patent application No. 202120566797.7 of the same applicant However, the content of this patent application is incorporated in this application by reference.

In this embodiment, the fixing auxiliary unit 132 can be connected to cardiac tissue such as interventricular septum through the anchor 3, so as to help fix the mounting bracket in place. In this embodiment, the distal section main body 131 may be, for example, a grid-like or frame-like structure, or a rod-like structure such as a curved rod. The main body 131 of the distal section can be integrally formed with the middle section 12 .

In this embodiment, the fixation auxiliary unit 132 of the distal end section 13 may be made of biocompatible flexible materials, such as woven mesh, braided cloth, wire, membrane, and so on. According to one example, the fixation aid unit 132 may be provided by the anti-reflux leaflet prosthesis 2 .

In this embodiment, the anti-reflux leaflet prosthesis 2 may be a sheet-like structure made of flexible materials. During the normal operation of the postoperative heart valve, when the unoperated native valve leaflet in the heart valve is opened, the free edge of the anti-reflux valve leaflet prosthesis 2 is also opened to be close to the mounting bracket 1; The free edge of the regurgitant leaflet prosthesis 2 is closed away from the mounting bracket 1 together with the remaining native leaflets. One end of the anti-reflux leaflet prosthesis 2 is connected to the mounting bracket 1 in various feasible ways such as fixing, attaching, bonding, sewing, buckling, wearing, etc., for example, it is fixed on the proximal end of the mounting bracket 1 11, while the other end is free, simulating the native valve leaflet. The outline of the fixed part of the anti-reflux valve leaflet prosthesis 2 fixed on the proximal section 11 is generally arc-shaped, which can not only conform to the shape of the native valve annulus, but also facilitate the anti-reflux valve leaflet prosthesis 2 when the native valve leaflets are closed can fully expand.

In this embodiment, the anti-reflux leaflet prosthesis 2 may be generally in the form of a sheet. When the rest of the native valve leaflets are closed, the middle part of the anti-regurgitant valve leaflet prosthesis 2 moves toward the atrium until its free edge and the corresponding parts of the native valve leaflets are generally closed, just like the state when the normal heart valve is closed ; When the native valve leaflet is opened, the anti-reflux valve leaflet prosthesis 2 is also opened like a normal heart valve leaflet and is close to the mounting bracket 1 .

According to one example, the anti-reflux valve leaflet prosthesis 2 may include a supporting frame 21 and a biocompatible membrane or membrane 22 overlaid on the supporting frame 21, as shown in FIG. Native heart valve leaflets that are replaced during surgery. The support frame 21 can have, for example, a net-like structure or a frame structure made of rods. The supporting framework 21 may be configured to be flexible at the free edge of the anti-reflux leaflet prosthesis 2 in order to prevent the free edge from wrinkling. Alternatively, the support frame 21 does not extend to the free edge, so that the anti-reflux valve leaflet prosthesis 2 only retains a flexible membrane structure at the free edge, such a structure is not only beneficial to prevent the free edge from wrinkling, but also beneficial to prevent reflux Leaflet prosthesis 2 forms an ideal closure together with the rest of the native leaflets.

According to another example, similar to the native valve leaflet, the anti-reflux valve leaflet prosthesis 2 may be an integral structure, such as an integral diaphragm. The anti-reflux leaflet prosthesis 2 can also be provided with a puller wire 23 , one end of the puller wire 23 is connected to the anti-reflux leaflet prosthesis 2 , and the other end is connected to the distal part of the mounting bracket 1 . According to one example, one end of the pulling wire 23 is connected to the free edge of the anti-reflux leaflet prosthesis 2 or its vicinity, while the other end is connected to the middle section 12 or the distal section 13 of the mounting bracket 1, preferably near the end of the distal segment 13 .

The anti-reflux valve leaflet prosthesis 2 can also be provided with puller wires 23 in other ways similar to the structure of the native valve leaflet. Similar to the structure of the native valve leaflet, the anti-reflux valve leaflet prosthesis 2 may have a curved surface structure similar to that of the native valve leaflet.

The exemplary heart atrioventricular tricuspid valve surgical operation of the repair device for preventing valvular regurgitation of the first embodiment is as follows:

1. The repair device adopts the transfemoral approach, enters the atrium through the femoral vein and the superior vena cava, and reaches the atrioventricular orifice, as shown in Figure 5a;

2. Position the mounting bracket 1 at a position close to the leaflet of the septal valve, and partially release the distal section 13 of the repair device and close against the interventricular septum;

3. The repair device is gradually released from the distal end to the proximal end, so that the auxiliary abutting part 14 is restored from the restricted form to the preset form. At this time, the free end of the auxiliary abutting part 14 moves from the distal end of the mounting bracket 1 to the proximal end Turn over (as shown by the arrow in Figure 5c), and clamp the autogenous valve leaflet (septal valve leaflet) as the replacement target in the clamping cavity 141, as shown in Figure 5c-5d;

4. Further release the proximal section 11 so that it abuts against the native valve annulus, as shown in Figure 5e;

5. Continue the operation procedure, fix the installation bracket 1 to the interventricular septum through the anchor 3, as shown in Figure 5f and 5g, in this way, the main operation procedure of the repair device is basically completed.

Embodiment two

Embodiment 2 is substantially the same as Embodiment 1. The difference is that in the second embodiment, the repair device is connected to the ventricular tissue through at least two anchors 3, and at least two anchors 3 are separated by a certain distance in the axial direction, as shown in Figures 6a-6b shown. The rest of the structure and idea of the second embodiment are similar to the first embodiment, so no repeated description is given here.

Embodiment three

Embodiment 3 is basically the same as Embodiment 1, except that in Embodiment 3, as shown in Figures 7a-7b, in the released state of the prosthetic device, the flared portion of the installation bracket, such as the limit of the proximal section 11 The position part 111 may have a structure similar to a flange (flange), and extend on the entire circumference of the native valve annulus in the circumferential direction, and the circumferential extension dimension of the limiting part 111 is at least equal to, generally larger than the circumference of the native valve ring Circumference so as to prevent the prosthetic device from moving further into the ventricle on the one hand. On the other hand, it helps the prosthetic device to be stable and easy to install and position on the native valve annulus. Embodiment 3 is obviously different from Embodiment 1 in this aspect. In Embodiment 1, the flaring part, such as the limiting part 111, only extends on a part of the circumference of the native valve annulus rather than the entire circumference, and its circumferential extension dimension is About one-third to one-half of the circumference of the native valve annulus. The rest of the structure and idea of Embodiment 3 are similar to Embodiment 1, so no repeated description is given here.

The foregoing description of several embodiments of the present application have been presented for purposes of illustration. The foregoing description is not intended to be exhaustive, nor to limit the application to the precise configuration, construction and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope and equivalents of the invention be defined by the appended claims.

Claims

A repair device for stopping valve regurgitation comprising:

mounting brackets; and

A single anti-reflux leaflet prosthesis used to replace the function of a single native leaflet;

Wherein, one end of the single anti-reflux leaflet prosthesis is fixed on the mounting bracket.
A repair device for stopping valve regurgitation comprising:

mounting brackets; and

A single anti-reflux leaflet prosthesis used to replace the function of a single native leaflet;

wherein one end of the single anti-reflux leaflet prosthesis is fixed to the proximal end of the mounting bracket; and

Wherein, the proximal end of the mounting bracket is provided with a generally annular flaring portion, and the flaring portion extends circumferentially on part or the entire circumference of the native valve annulus of the valve after being installed in place.
The prosthetic device according to claim 1 or 2, wherein, in the leaflet-closed state of the single anti-reflux leaflet prosthesis, the free edge of the single anti-reflux leaflet prosthesis and the remaining native The free edges of the leaflets cooperate together to achieve normal closure of the valve, or at least partially overlap with the free edges of the remaining native valve leaflets to prevent valve regurgitation.
The repair device according to any one of the preceding claims, wherein the repair device further comprises an anchor, and after the installation is completed, the distal end of the installation bracket is fixed at a predetermined position of the heart by the anchor .
The repair device according to claim 4, wherein the proximal end of the mounting bracket is configured on the native valve annulus of the heart, the atrium tissue or the atrioventricular opening, and the distal end of the mounting bracket is fixed by the anchor on ventricular tissue.
A prosthetic device according to any one of the preceding claims, wherein the prosthetic device has a constrained state before installation and a released state after installation.
The prosthetic device according to any one of the preceding claims, wherein the mounting bracket comprises a proximal section adapted to be mounted in place at a predetermined location of the heart in a released state of the prosthetic device.
The prosthetic device according to claim 7, wherein the proximal section is provided with a limiting portion, and in the released state of the prosthetic device, the limiting portion is a flange of a generally arc-shaped segment, and the protruding The rim is sized to abut against atrial tissue at the atrioventricular ostium of the heart and prevent further movement of the prosthetic device toward the ventricle.
The prosthetic device according to any one of claims 7-8, wherein the mounting bracket comprises a distal section configured to be attached to a predetermined position of the heart.
The prosthetic device according to claim 9, wherein the distal section comprises a distal section main body and a fixation assisting unit, and the fixation assisting unit is anchored to the heart tissue through an anchor.
The repair device according to any one of claims 9-10, wherein, the mounting bracket further comprises an intermediate section arranged between the proximal end section and the distal end section, and a protective device is provided in the area of the intermediate section. Peripheral membrane.
11. The prosthetic device of claim 11, wherein said single anti-reflux leaflet prosthesis provides an anti-reflux skirt in said mid-section region.
The repair device according to any one of claims 11-12, wherein an auxiliary abutting portion is provided at the middle section of the mounting bracket, one end of which is fixedly connected to the middle section, and the other end is a free end;

The auxiliary abutting portion has a restricted shape and a preset shape, the free end is close to the distal end of the mounting bracket in the restricted shape, and the free end is in contact with the mounting bracket in the preset shape The proximal end of the valve is separated by a certain interval to form the valve cavity.
The restoration device according to claim 13, wherein the number of the auxiliary abutting parts is 1-3.
The prosthetic device according to claim 13 or 14, wherein when the prosthetic device is implanted, the replaced native valve leaflet is confined between the auxiliary abutment and the mounting bracket.
The prosthetic device according to any one of the preceding claims, wherein the anti-reflux leaflet prosthesis is selected from one of the following:

an integral diaphragm of flexible material; and

It is composed of a supporting frame and a biocompatible membrane or membrane covering the supporting frame.
The prosthetic device according to any one of the preceding claims, wherein the mounting bracket includes a restraint configured to allow the single anti-reflux leaflet prosthesis to abut against in the leaflet-open state. on it and limit its deformation.
A prosthetic device according to any one of the preceding claims,

Wherein, the fixed end of the single anti-reflux leaflet prosthesis is fixedly connected to the mounting bracket, and the free end of the anti-reflux leaflet prosthesis is flexibly connected to the mounting bracket through a puller wire;

Wherein, after the repair device is installed in place, the free end of the single anti-reflux leaflet prosthesis can move between the valve leaflet open state and the valve leaflet closed state, and in the valve leaflet open state, the The single anti-reflux valve leaflet prosthesis is opened together with the rest of the valve leaflets except the single native valve leaflet; in the closed state of the valve leaflet, the single anti-reflux valve leaflet prosthesis is the same as the rest of the valve leaflets. The native valve leaflets close together to prevent valve regurgitation.
The prosthetic device according to any one of the preceding claims, wherein the number of said anchors is 1-3.
The repair device according to any one of the preceding claims, wherein, after the repair device is installed in place, the limiting part of the proximal section of the installation bracket is along the circumference of part or the entire circumference of the native valve annulus. extend to the ground.