A repair device for preventing valvular regurgitation

Abstract

This application belongs to the field of medical devices, and specifically relates to a repair device for preventing valve regurgitation, including an installation stent, a single anti-regurgitation leaflet prosthesis, and a fixing member; the proximal end of the installation stent abuts against the autologous valve annulus or atrial tissue, and the distal end of the installation stent is fixed to the ventricular tissue through the fixing member; wherein, the single anti-regurgitation leaflet prosthesis is connected to the installation stent, and when the autologous valve is in the closed state, the single anti-regurgitation leaflet prosthesis is located in the middle of the autologous valve; in an embodiment of the present invention, the repair device is fixed to the ventricular tissue through the fixing member, only replaces the problematic leaflets, thereby retaining the original functions of the remaining part of the autologous leaflets, and at the same time does not change the shape of the autologous valve annulus, causing little damage to the intracardiac tissue, and at the same time, the implantation amount of the implant is less and the irritation is small.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and particularly relates to a repair device for preventing valve regurgitation. Background Art

[0002] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular dilation, and tricuspid annulus dilation. Clinically, the manifestations of the causes of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.) are common. After tricuspid regurgitation occurs, symptoms of right heart failure such as fatigue, ascites, edema, liver area pain, indigestion, and anorexia are aggravated. Mild tricuspid regurgitation has no obvious clinical symptoms, but when the regurgitation is severe, surgical treatment is required.

[0003] Traditional treatment methods for mitral and tricuspid diseases include drug treatment applicable to mild to severe reflux and surgical methods with corresponding surgical indications. Among them, surgical methods also include valve replacement and valve repair. In surgical methods, typical open-chest and open-heart surgeries are overly invasive, require extracorporeal circulation to be established, and have a relatively high incidence of complications and infection risks. Many patients cannot tolerate the huge surgical risks and can only helplessly wait for death.

[0004] With the report of the first case of transcatheter aortic valve replacement, many companies have done a lot of work in the field of transcatheter aortic valve technology, and the technology is becoming increasingly mature. However, there is still a large gap in the field of transcatheter treatment of atrioventricular valves. Although there are a few products for transcatheter treatment of atrioventricular valves that have been applied in transcatheter valve plasty and repair, there are no mature products available internationally in terms of transcatheter valve replacement.

[0005] Patent CN201780028476.8 describes a heart valve leaflet replacement system and method, wherein the prosthetic valve comprises a crescent-shaped stent, the crescent-shaped stent comprises 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, wherein 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 by an interventional catheter; in this scheme, 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, and the positioning requirements for the anchoring system are very high, but accurate positioning is difficult to achieve under existing medical conditions. The posterior part of the natural annulus lacks fibrous cords and is weak, and the incompleteness of the annulus is more obvious. Therefore, the tissue strength of the posterior part of the annulus is weak, and the pressure of the mitral valve is high. There is a risk of tearing the annulus after the valve prosthesis is anchored. The tricuspid annulus is even weaker and the tissue has little elasticity 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 valve prosthesis at the target position, at least 3 anchor points are required, and the position of each anchor point is different, the span is large, and the operation is complicated. When the heart moves, the contraction and expansion of the posterior annulus is obvious, and the anchoring position is always in an active state. The 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. 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] The heart valve prosthesis described in Patent CN201610921114.9 includes a valve stent and a fixing device. The valve stent includes a sewing section and an artificial valve. The fixing device includes a fixing support section and a fixing piece. One end of the fixing support section is connected to the ventricular septum of the patient through the fixing piece to support the heart valve prosthesis and limit the axial movement of the heart valve prosthesis. The cross-sectional area of the valve sewing section is smaller than the cross-sectional area of the patient's own valve annulus. Replacing all the functional leaflets with an artificial valve causes a relatively large change in the original hemodynamics, and the impact on heart function remains to be further studied. The valve annulus dilation of the tricuspid regurgitation lesion is obvious. The force-bearing area of the implanted artificial valve is large, and the force borne by the fixing piece is relatively large, making it easy to disengage from the ventricular septum 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 that of the autologous valve, and the transvalvular pressure gradient will increase. It is difficult to remedy accidental situations such as valve displacement and valve detachment during the implantation process. The right heart system where the tricuspid valve is located has a low pressure and a large volume. The mobility of the artificial valve leaflets is small, making it easy for fibrin hyperplasia to adhere, further reducing the mobility of the artificial valve leaflets, and it is prone to calcification in the long term, with a high incidence of stenosis. In the long term, the artificial valve will fuse and adhere to the tissue, and the feasibility of re-interventional valve replacement is relatively small. There are many valve implants. On the one hand, the diameter of the interventional catheter is large, making it difficult to access through blood vessels. On the other hand, the implants form a relatively complex structure in the heart, and the blood flow is prone to form vortices locally, with a high risk of thrombosis. The processing technology of the closed-loop artificial valve and stent is difficult and costly.

[0007] Patent US20160354076A1 discloses a method for treating tricuspid valve regurgitation. By positioning a catheter near the tricuspid valve annulus, a guide wire passes through the valve annulus or leaflet tissue to establish an anchor point, and the enlarged valve annulus is reduced by adjusting the distance between the anchor points to treat tricuspid regurgitation. The treatment principle of this scheme is to reduce the enlarged tricuspid valve annulus of the lesion and increase the coaptation area of the autologous leaflets. However, the tricuspid valve annulus is a three-dimensional saddle-shaped structure. After being treated by shortening the distance between two or more anchor points, the original shape of the tricuspid valve annulus changes greatly and becomes more irregular, and the coaptation effect of the autologous leaflets will not be very stable. Establishing an anchor point on the tissue near the leaflet or valve annulus, the tissue has low strength and is easy to tear. The positioning of the anchor points in this scheme is difficult, and it is very difficult to locate to an ideal position. Moreover, this method is complex in operation. First, it is positioned to the target position, then the guide wire punctures the tissue or leaflet, then the guide wire captures or releases the gasket, then tightens the anchor point, then operates on the next anchor point, and finally reduces the distance between the anchor points.

[0008] Therefore, those skilled in the art are committed to developing an implant device with reliable fixation, maximizing the use of the original valve function, minimizing the impact on heart movement and hemodynamics, low surgical operation difficulty, and simple structure.

[0009] Application content

[0010] The technical problem to be solved by the present invention is to provide a repair device for preventing valve regurgitation, which can be reliably fixed, retain the functions of the main autologous valve leaflets, have little influence on cardiac movement and hemodynamics, have low surgical operation difficulty, and have a simple structure.

[0011] In order to solve the above technical problems, the present application is solved by the following technical solutions:

[0012] The human heart valve has an anterior leaflet, a posterior leaflet and a septal leaflet. The anterior leaflet, posterior leaflet and septal leaflet are in a closed state during cardiac contraction. When the anterior leaflet, posterior leaflet and septal leaflet cannot be completely opposed in the closed state, valve regurgitation occurs.

[0013] According to another basic inventive concept of the present invention, the repair device of the present invention is designed to repair rather than replace the entire autologous heart valve. In other words, the repair device of the present invention is designed to replace one or two autologous valve leaflets, rather than all autologous valve leaflets. For the mitral valve, the repair device of the present invention is designed to replace one of the autologous valve leaflets while retaining the other autologous valve leaflet to work properly. For the tricuspid valve, the repair device of the present invention is designed to replace one of the autologous valve leaflets, such as the posterior leaflet, while retaining the other two autologous valve leaflets to work properly; or, two repair devices of the present invention are used to replace two autologous valve leaflets in the tricuspid valve while retaining the other autologous valve leaflet to work properly.

[0014] Generally speaking, according to one aspect of the present invention, a repair device for preventing valve regurgitation includes a mounting bracket, a fixing member; and a single anti-regurgitation valve leaflet prosthesis for replacing the function of a single autologous valve leaflet; wherein, the proximal end of the mounting bracket is configured in the atrium, and the distal end of the mounting bracket is fixed on the ventricular tissue through the fixing member; wherein, one end of the single anti-regurgitation valve leaflet prosthesis is fixed on the mounting bracket, and when the autologous valve is in a closed state, the free edge of the single anti-regurgitation valve leaflet prosthesis and the free edges of the remaining autologous valve leaflets cooperate to achieve normal closing of the valve, or at least partially overlap with the free edges of the remaining autologous valve leaflets to prevent valve regurgitation.

[0015] The object of the present invention can also be further achieved by the following technical solutions:

[0016] According to an embodiment, the single anti-regurgitation valve leaflet prosthesis can be a spherical structure. When the autologous valve is in a closed state and the single anti-regurgitation valve leaflet prosthesis is located in the middle of the autologous valve, blood reflux is avoided.

[0017] According to one embodiment, at least one fixing member is fixed to the interventricular septum.

[0018] According to a further embodiment, the single anti-reflux leaflet prosthesis may be a sheet-like structure. When the native valve is in the closed state, one side of the mounting bracket abuts against a part of the native leaflet, and the free edge of the single anti-reflux leaflet prosthesis is aligned with the remaining part of the native leaflet.

[0019] According to one embodiment, a limiting section is provided at the proximal end of the mounting bracket; wherein, the limiting section is configured to be adapted to the shape of the native annulus or atrial tissue.

[0020] According to one embodiment, the limiting section presents a flange in the form of a generally arcuate section, and the flange is sized to be adapted to abut against the atrial tissue at the atrioventricular orifice of the heart and prevent the repair device from further moving towards the ventricular direction.

[0021] According to one embodiment, the mounting bracket includes a connecting section and a fixing section, and the fixing section is disposed at the distal end of the connecting section; after the repair device is implanted, the connecting section abuts against a part of the native leaflet, the fixing section abuts against the ventricular wall, and the mounting bracket does not affect the function of the remaining part of the native leaflet.

[0022] According to one embodiment, an arcuate structure is provided between the limiting section and the connecting section, and the shape of the arcuate structure is configured to adapt to the transition region between the native annulus and ventricular tissue.

[0023] According to one embodiment, the connecting section includes a leak-proof structure; and after the repair device is implanted, the leak-proof structure is located at the junction region of the native leaflets.

[0024] According to one embodiment, an auxiliary abutting portion is provided at the connecting section of the mounting bracket, one end of which is fixedly connected to the connecting section and the other end is a free end; the auxiliary abutting portion has a limiting shape and a preset shape, and the free end is close to the distal end of the mounting bracket in the limiting shape, and the free end is spaced apart from the proximal end of the mounting bracket by a certain interval in the preset shape, forming a leaflet clamping cavity.

[0025] According to one embodiment, one end of the auxiliary abutting member is connected to the mounting bracket and the other end is free; and a leaflet clamping cavity is formed between the auxiliary abutting member and the mounting bracket.

[0026] According to another embodiment, the number of the auxiliary abutting portions is 1-3.

[0027] According to one embodiment, the fixing section includes a fixing framework and a unit to be fixed. The fixing framework is connected to the connecting section, the unit to be fixed is connected to the fixing framework, and the unit to be fixed is connected to the ventricular tissue through the fixing member.

[0028] According to one embodiment, the anchored unit is connected to the ventricular tissue through at least two fixing members, and at least two fixing members are axially spaced apart by a certain distance.

[0029] According to one embodiment, the mounting bracket includes a limiting member that extends towards the center of the native valve.

[0030] According to one embodiment, the single anti-reflux leaflet prosthesis includes a support framework and a membrane. During operation, at least a part of the single anti-reflux leaflet prosthesis straddles between the native leaflets.

[0031] According to one embodiment, a pulling wire is provided on the single anti-reflux leaflet prosthesis. One end of the pulling wire is connected to the single anti-reflux leaflet prosthesis, and the other end is connected to the mounting bracket.

[0032] According to one embodiment, one end of the pulling wire is connected to the edge of the single anti-reflux leaflet prosthesis.

[0033] According to one embodiment, a pulling wire is provided on the single anti-reflux leaflet prosthesis. One end of the pulling wire is connected to the single anti-reflux leaflet prosthesis, and the other end is connected to the distal part of the mounting bracket; one end of the pulling wire is connected to the edge of the single anti-reflux leaflet prosthesis.

[0034] According to one embodiment, the single anti-reflux leaflet prosthesis is preset to an arc-shaped surface structure.

[0035] According to one embodiment, a soft edge framework is provided at the free edge of the single anti-reflux leaflet prosthesis to prevent the free edge from wrinkling.

[0036] According to another embodiment, a shaping framework is provided inside the anti-reflux leaflet prosthesis. The shaping framework is a mesh structure or a rod-shaped structure.

[0037] According to one embodiment, the single anti-reflux leaflet prosthesis is an integral structure.

[0038] Compared with the prior art, the advantages of the present application are as follows:

[0039] 1. Different from the prior art, in one embodiment of the present invention, the repair device is fixed to the ventricular tissue through the fixing member, only replaces the problematic leaflets, thereby retaining the original functions of the remaining native leaflets, and at the same time does not change the shape of the native valve annulus, causing less damage to the intracardiac tissue. At the same time, the implant amount of the implant is less and the irritation is small;

[0040] 2. Different from the prior art, in one embodiment of the present invention, the repair instrument uses a fixing member to fix and abut against one side area of the autologous valve, which is both stable and does not affect the movement of the heart;

[0041] 3. Different from the prior art, in one embodiment of the present invention, the fixing position of the repair instrument is safe and risk-free; the fixable area of the interventricular septum is much larger than the fixable areas of the annulus and the atrium, and the positioning requirements for the instrument are low; moreover, there are no other important branch blood vessels near the interventricular septum, so no functional damage will be caused, and the safety is high; during the movement of the heart, the movement amplitude of the interventricular septum is relatively small compared to the annulus, so it is relatively stable during fixation, with a high success rate and good effect;

[0042] 4. Different from the prior art, in one embodiment of the present invention, the auxiliary abutting member can not only clamp the autologous valve leaf, but also further enhance the anti-reflux effect of the repair instrument;

[0043] 5. Different from the prior art, in one embodiment of the present invention, the anti-leakage structure is arranged in the junction area of the autologous valve leaf, which can effectively improve the blood reflux at the valve leaf junction.

[0044] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. Some of these other technical effects may be described hereinafter, and can be expected and understood by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] By referring to the following description together with the drawings, these features and advantages of the above embodiments and other features and advantages, as well as the manner of achieving them, will become more apparent and the embodiments of the present application can be better understood. In the drawings:

[0046] Figure 1a-1c It is a schematic top view of the overall repair device according to one embodiment of the present invention.

[0047] Figure 2a-2e It is a schematic diagram showing the auxiliary abutting part, the fixing member and the anti-reflux valve leaf prosthesis.

[0048] Figure 3a-3c It is a schematic diagram showing the reflux caused by the inability of the anterior valve leaf, posterior valve leaf and septal valve leaf to be properly opposed.

[0049] Figure 4a and 4b It is a schematic diagram showing the normal closing of each valve leaf after the fixation of the repair device of the present invention.

[0050] Figure 5a-5g It is a schematic diagram showing the process of releasing and fixing the repair device of the present invention, where 5b is the repair device in a compressed state.

[0051] Figure 6a and 6b shows another embodiment of the present invention.

[0052] Figure 7a and 7b shows yet another embodiment of the present invention.

[0053] The names of the parts referred to by the numbers in the drawings are as follows: 1 - mounting bracket, 11 - limiting section, 12 - connecting section, 121 - anti-reflux skirt, 13 - fixing section, 131 - fixing section main body, 132 - fixing auxiliary unit, 14 - auxiliary abutting part, 141 - clip flap cavity, 15 - restricting member, 2 - anti-reflux valve leaf prosthesis, 21 - support skeleton, 22 - film, 23 - pulling wire, 3 - fixing member. Detailed implementation manners

[0054] The present application will be further described in detail below in conjunction with the drawings and embodiments.

[0055] As used in the present application, the proximal end refers to the end close to the surgeon, and the distal end refers to the end far from the surgeon. Specific Embodiment 1:

[0057] In the following descriptions of the drawings and specific implementation manners, details of one or more embodiments of the present application will be set forth. From these descriptions, drawings, and claims, other features, objects, and advantages of the present application will be apparent.

[0058] It should be understood that the embodiments illustrated and described 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 drawings. The illustrated embodiments may be other embodiments and can be implemented or carried out 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 the present application without departing from the scope or essence of the disclosure of the present application. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still produce additional embodiments. Therefore, the disclosure of the present application covers such modifications and variations that fall within the scope of the appended claims and their equivalent elements.

[0059] Similarly, it can be understood that the phrases and terms used herein are for the purpose of description and should not be considered restrictive. The use of "including", "comprising", or "having" and their variants herein is intended to open-endedly include the items listed thereafter and their equivalents as well as additional items.

[0060] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0061] In this application, "proximal end" refers to the end closer to the surgical operator, and "distal end" refers to the end farther from the surgical operator.

[0062] Example 1

[0063] The tricuspid valve of the human heart has an anterior leaflet, a posterior leaflet, and a septal leaflet. The anterior leaflet, posterior leaflet, and septal leaflet are in a closed state during heart contraction. When one of the anterior leaflet, posterior leaflet, and septal leaflet cannot close properly in the closed state, valvular regurgitation occurs, as Figure 3a-3c shown.

[0064] According to one example, the anti-regurgitation leaflet prosthesis 2 can be generally in a sheet-like configuration, for example, in the form of the posterior leaflet of the tricuspid valve, for replacing the autologous tissue of the posterior leaflet of the patient. After the operation, when the autologous valve of the surgical target is in the closed state, the connecting section of the mounting bracket 1 conforms to and abuts against a part of the autologous leaflet, and the anti-regurgitation leaflet prosthesis 2 closes normally with the remaining autologous leaflets of the autologous valve.

[0065] According to another example, the anti-regurgitation leaflet prosthesis 2 can be in a generally spherical configuration. When the autologous valve is in the closed state, the anti-regurgitation leaflet prosthesis 2 is located between the autologous valves and forms an effective closure therewith, avoiding blood regurgitation.

[0066] In this embodiment, the main body of the mounting bracket 1 generally includes a limiting section 11, a connecting section 12, and a fixing section 13 that are connected together, for example, shown as being generally integral in the figure. The limiting section 11 is provided at the proximal end of the mounting bracket 1, the fixing section 13 is configured at the distal end of the main body of the mounting bracket 1, and the connecting section 12 is between the limiting section 11 and the fixing section 13. When the repair device is implanted, the connecting section 12 conforms to and is adapted to abut against the target tissue site, such as a part of the autologous leaflet to be replaced, and the fixing section 13 conforms to and is adapted to abut against the target tissue site, such as the ventricular wall. The limiting section 11 is configured to conform to and be adapted to abut against the target tissue site, such as the autologous valve annulus, atrioventricular orifice, or atrial tissue, enabling the repair device to better conform to the physiological structure of, for example, the autologous valve annulus.

[0067] The mounting bracket 1 does not affect the function of the remaining autologous leaflets after installation.

[0068] The repair device can have a constrained state and a released state.

[0069] In this embodiment, the limiting section 11 may further include a limiting portion 111, preferably integral. The limiting portion 111 can be, for example, a continuous meandering or reticular configuration at the limiting section 11, or it can also be a single rod. This meandering or reticular configuration can be constrained or compressed in the constrained state of the repair device and released or expanded to its preset configuration in the released state of the repair device.

[0070] The limiting section 11 may also be provided with a limiting member 15, which may be, for example, integrated with the limiting portion 111. The limiting member 15 may be used to limit / restrain excessive or undesirable deformation of the anti-regurgitation leaflet prosthesis 2.

[0071] In the constraint state of the repair device ( Figure 5b and 5c In the released state of the repair device ( Figure 5e As shown in FIG. 1 ), the limiting portion 111 of the limiting segment 11 will be bent relative to the connecting segment 12 and substantially transverse to the extending direction of the connecting segment 12 ( Figure 5e The stopper 111 extends in a direction (substantially or close to a radial direction) of the substantially axial direction shown in the figure, so that the stopper 111 has an extended substantially circular arc segment structure, such as a flared portion, and its size and shape are suitable for being reliably placed at a surgical site of the heart, such as the atrioventricular orifice of the heart. The substantially circular arc segment structure is as shown in FIG. Figure 5e As shown, it can be similar to a flange (flange), which can prevent the repair device from moving further toward the ventricle. The circumferential size of the limit portion 111 in the released state can be, for example, about one-third to one-half of the circumference of the native valve ring. It is obvious to those skilled in the art that the above-mentioned flared portion can also be set at the proximal end of the repair device in other ways / positions / structures, including but not limited to the form of a flange or flange, which are all within the scope of the present invention.

[0072] The limiting section 11 may also include an anti-circumferential leakage membrane 112, which can be set at the limiting part 111 by clamping, clamping, sleeve, embedding, etc., and preferably partially or completely covers the limiting section 11, such as at least wrapping the outside of the limiting part 111, to prevent circumferential leakage of the replacement part.

[0073] The connecting section 12 also includes an anti-regurgitation skirt 121. When the repair device is implanted, the anti-regurgitation skirt 121 is located at the junction area with the native valve leaflet, such as Figure 4a and 4b The anti-leakage membrane 112 can provide a structure of an anti-backflow skirt 121 in the connecting section 12 area.

[0074] In addition, the anti-leakage membrane 112 can also be arranged in the area of ​​the connecting section 12. The anti-leakage membrane 112 in this area is close to the autologous tissue of the location, such as autologous valve leaflets or atrial tissue, to prevent the backflow of blood.

[0075] The mounting bracket 1 may also be provided with an auxiliary abutment portion 14, which may be connected to the main body of the mounting bracket 1, such as the connecting section 12. Figure 2a and 2bAs shown. The auxiliary abutting portion 14 can be set to have a curved strip-shaped, meandering or reticular structure, one end of which is fixedly connected to the connecting section 12 and the other free end of which can return to a preset shape during surgery and have a certain interval from the mounting bracket 1, forming a valve clamping cavity 141. For example, Figure 2a As shown. In this way, after the repair device is implanted, the autologous valve leaflet is clamped and restricted between the auxiliary abutting portion 14 and the mounting bracket 1, as Figure 2c shown, which further helps the mounting bracket 1 to be reliably fixed at the surgical site and prevent periprosthetic leakage.

[0076] The auxiliary abutting portion 14 can be integrally formed with the connecting section 12, for example. Of course, the auxiliary abutting portion 14 can also be a separate piece connected to the connecting section 12.

[0077] The auxiliary abutting portion 14 can have a restricted state and a preset shape. When the auxiliary abutting portion 14 is converted from the restricted state to the preset shape, the replaced autologous valve leaflet can abut against the auxiliary abutting portion 14 and can be turned over, so that a part of the autologous valve leaflet is reliably held at, for example, clamped at the position of the valve clamping cavity 141, as Figure 5c and 5d shown.

[0078] At least one, for example, two auxiliary abutting portions 14 can be provided on the mounting bracket 1, as Figure 2c shown.

[0079] The fixing section 13 can include a fixing section main body 131 and a fixing auxiliary unit 132. As Figure 2d shown, the fixing section main body 131 is connected to the connecting section 12, the fixing auxiliary unit 132 is connected to the fixing section main body 131, and the fixing auxiliary unit 132 is connected to a cardiac surgical site such as ventricular tissue through an anchor 3.

[0080] More details of the embodiment of the anchor 3 (which can also be called "anchor needle", "anchor pin", etc.) in this embodiment are described in detail, for example, in Patent Application No. 202120566797.7 of the same applicant, and the content of this patent application is incorporated into this application by reference.

[0081] In this embodiment, the fixing auxiliary unit 132 can be connected to cardiac tissue such as the interventricular septum through the anchor 3, so as to help fix the mounting bracket in place.

[0082] In this embodiment, the fixing section main body 131 can be, for example, a grid-like or frame-like structure, or a rod-like structure such as a curved rod.

[0083] The fixing section main body 131 can be integrally formed with the connecting section 12.

[0084] In this embodiment, the fixing auxiliary unit 132 of the fixing section 13 can be made of a biocompatible flexible material, such as a woven mesh, a woven cloth, a wire, a diaphragm, and so on. According to an example, the fixing auxiliary unit 132 can be provided by the anti-reflux valve leaf prosthesis 2.

[0085] In this embodiment, the anti-reflux valve leaf prosthesis 2 can be a sheet-like structure made of a flexible material. During the normal operation of the heart valve after the operation, when the unoperated native valve leaf in the heart valve opens, the free edge of the anti-reflux valve leaf prosthesis 2 also opens and approaches the mounting bracket 1; when the heart valve closes, the free edge of the anti-reflux valve leaf prosthesis 2 closes together with the remaining native valve leaf and moves away from the mounting bracket 1.

[0086] One end of the anti-reflux valve leaf prosthesis 2 is connected to the mounting bracket 1 in various feasible ways such as fixing, attaching, bonding, sewing, buckling, wearing, etc., for example, fixed at the limiting section 11 of the mounting bracket 1, while the other end is free like a native valve leaf. The contour line of the fixing part where the anti-reflux valve leaf prosthesis 2 is fixed at the limiting section 11 is generally arc-shaped, which can not only conform to the shape of the native valve annulus, but also facilitate the full expansion of the anti-reflux valve leaf prosthesis 2 when the native valve leaf closes.

[0087] In this embodiment, the anti-reflux valve leaf prosthesis 2 can be a generally sheet-like structure. When the remaining native valve leaf closes, the middle part of the anti-reflux valve leaf prosthesis 2 moves towards the atrium until its free edge and the corresponding part of the native valve leaf are substantially closed, just like the state when a normal heart valve closes; when the native valve leaf opens, the anti-reflux valve leaf prosthesis 2 also opens like a normal heart valve leaf and approaches the mounting bracket 1.

[0088] According to an example, the anti-reflux valve leaf prosthesis 2 can include a support framework 21 and a biocompatible coating film or diaphragm 22 covering the support framework 21, such as Figure 2e as shown, which simulates the native heart valve leaf to be replaced during the operation in shape. The support framework 21 can have a reticular structure or a frame structure composed of rods, for example. The support framework 21 can be set to be flexible at the free edge of the anti-reflux valve leaf prosthesis 2 to prevent the free edge from wrinkling. Or, the support framework 21 does not extend to the free edge, so that the anti-reflux valve leaf prosthesis 2 only retains a flexible diaphragm structure at the free edge part. Such a structure not only helps to prevent the free edge from wrinkling, but also helps the anti-reflux valve leaf prosthesis 2 and the remaining native valve leaf to form an ideal closure together.

[0089] According to another example, similar to the native valve leaf, the anti-reflux valve leaf prosthesis 2 can be an integrated structure, such as a one-piece diaphragm.

[0090] The anti-reflux valve leaflet prosthesis 2 may also be provided with a pulling wire 23. One end of the pulling wire 23 is connected to the anti-reflux valve leaflet prosthesis 2, and the other end is connected to the mounting bracket 1. According to one example, one end of the pulling wire 23 is connected to the free edge portion of the anti-reflux valve leaflet prosthesis 2 or near it, and the other end is connected to the connecting section 12 or the fixing section 13 of the mounting bracket 1, preferably near the end of the fixing section 13.

[0091] A pulling wire 23 is provided on the anti-reflux valve leaflet prosthesis 2. One end of the pulling wire 23 is connected to the anti-reflux valve leaflet prosthesis 2, and the other end is connected to the distal part of the mounting bracket 1; one end of the pulling wire 23 is connected to the edge of the anti-reflux valve leaflet prosthesis 2.

[0092] The anti-reflux valve leaflet prosthesis 2 may also be provided with the pulling wire 23 in other ways similar to the structure of the autologous valve leaflet.

[0093] Similar to the structure of the autologous valve leaflet, the anti-reflux valve leaflet prosthesis 2 may have a curved surface structure similar to that of the autologous valve leaflet.

[0094] A demonstration of the surgical operation process of the repair device for preventing valve reflux in the first embodiment is as follows:

[0095] 1. The repair device is inserted through the femoral approach. After entering the atrium through the femoral vein and the superior vena cava, it reaches the atrioventricular orifice, as Figure 5a shown;

[0096] 2. Position the mounting bracket 1 against the septal valve leaflet, and partially release the fixing section 13 of the repair device and position it against the interventricular septum;

[0097] 3. Gradually release the repair device from the distal end to the proximal end, so that the auxiliary abutting portion 14 is restored from the restricted shape to the preset shape. At this time, the free end of the auxiliary abutting portion 14 is folded from the distal end to the proximal end of the mounting bracket 1 (as shown by the arrow in Figure 5c ), and the autologous valve leaflet (septal valve leaflet) to be replaced is clamped in the valve leaflet clamping cavity 141, as Figure 5c-5d shown;

[0098] 4. Further release the limiting section 11 so that it abuts against the autologous valve annulus, as Figure 5e shown.

[0099] 5. Continue the surgical procedure, and fix the mounting bracket 1 to the interventricular septum position through the anchor 3, as Figure 5f and 5g shown. In this way, the main surgical procedure of the repair device is basically completed. Specific Embodiment Two:

[0101] Example 2 is substantially the same as Example 1. The difference is that in this Example 2, the repair device is connected to the ventricular tissue through at least two anchor members 3, and at least two of the anchor members 3 are axially spaced apart by a certain distance, such as Figure 6a-6b shown.

[0102] The remaining structures and concepts of Example 2 are similar to those of Example 1, so they will not be described again here. Specific Example 3:

[0104] Example 3 is substantially the same as Example 1. The difference is that in this Example 3, as Figure 7a-7b shown, in the released state of the repair device, the flared portion of the mounting bracket, for example, the limiting portion 111 of the proximal segment 11, may have a structure similar to a flange (flange), and extends circumferentially over the entire circumference of the autologous valve annulus. The circumferential extension dimension of the limiting portion 111 is at least equal to, and generally greater than, the circumferential perimeter of the autologous valve annulus, so as to, on the one hand, prevent the repair device from further moving into the ventricle. On the other hand, it helps the repair device to be stably, easily installed and positioned at the autologous valve annulus site. This aspect of Example 3 is clearly different from Example 1. In Example 1, the flared portion, for example, the limiting portion 111, only extends over a partial circumference rather than the entire perimeter of the autologous valve annulus, and its circumferential extension dimension is about one-third to one-half of the circumferential perimeter of the autologous valve annulus.

[0105] The remaining structures and concepts of Example 3 are similar to those of Example 1, so they will not be described again here.

[0106] The above content is only the preferred embodiments of the present application. For those of ordinary skill in the art, according to the idea of the present application, there will be changes in the specific implementation manners and application scopes. The content of this specification should not be construed as a limitation to the present application.

Claims

1. A repair device for preventing valvular regurgitation, characterized in that: Comprising an installation bracket, a fixing member; and a single anti-reflux valve leaflet prosthesis for replacing the function of a single autologous valve leaflet; wherein, the proximal end of the installation bracket is configured to be within the atrium, and the distal end of the installation bracket is fixed to the ventricular tissue through the fixing member; wherein, one end of the single anti-reflux valve leaflet prosthesis is fixed to the installation bracket, and when the autologous valve is in the closed state, the free edge of the single anti-reflux valve leaflet prosthesis at least partially overlaps with the free edges of the remaining autologous valve leaflets to prevent valve reflux; the installation bracket includes a connecting section and a fixing section; an auxiliary abutting portion is provided at the connecting section of the installation bracket, one end of which is fixedly connected to the connecting section and the other end of which is a free end; the auxiliary abutting portion has a restricted form and a preset form, the free end is close to the distal end of the installation bracket in the restricted form, and the free end is spaced apart from the proximal end of the installation bracket by a certain interval in the preset form to form a valve clamping cavity; a pulling wire is provided on the single anti-reflux valve leaflet prosthesis, one end of the pulling wire is connected to the edge of the single anti-reflux valve leaflet prosthesis, and the other end is connected to the installation bracket.

2. The repair device for preventing valve regurgitation according to claim 1, characterized in that: A limiting section is provided at the proximal end of the installation bracket; wherein, the limiting section is configured to be adapted to the form of abutting against the autologous valve annulus or atrial tissue.

3. The repair device for preventing valve regurgitation according to claim 2, characterized in that: The limiting section presents as a flange of a generally arc-shaped section, and the flange is sized to be adapted to abut against the atrial tissue at the cardiac atrioventricular orifice and prevent the repair device from further moving towards the ventricular direction.

4. A repair device for preventing valvular regurgitation according to claim 1, characterized in that: The fixing section is configured at the distal end of the connecting section; when the repair device is implanted, the connecting section abuts against a part of the autologous valve leaflet, the fixing section abuts against the ventricular wall, and the installation bracket does not affect the function of the remaining part of the autologous valve leaflet.

5. A repair device for preventing valvular regurgitation according to claim 2, characterized in that: An arc-shaped structure is provided between the limiting section and the connecting section, and the form of the arc-shaped structure is configured to adapt to the transition region between the autologous valve annulus and the ventricular tissue.

6. A repair device for preventing valvular regurgitation according to claim 4, characterized in that: The connecting section includes a leak-proof structure; and when the repair device is implanted, the leak-proof structure is located in the autologous valve leaflet junction region.

7. A repair device for preventing valve regurgitation according to claim 4, characterized in that: One end of the auxiliary abutting portion is connected to the installation bracket and the other end is free; and a valve clamping cavity is formed between the auxiliary abutting portion and the installation bracket.

8. A repair device for preventing valve regurgitation according to claim 5, characterized in that: The fixing section includes a fixing framework and a fixed unit, the fixing framework is connected to the connecting section, the fixed unit is connected to the fixing framework, and the fixed unit is connected to the ventricular tissue through the fixing member.

9. A repair device for preventing valvular regurgitation according to claim 8, characterized in that: The fixed unit is connected to the ventricular tissue through at least two fixing members, and at least two fixing members are axially spaced apart by a certain distance.

10. The repair device for preventing valvular regurgitation according to any one of claims 1-9, characterized in that: The installation bracket includes a limiting member that extends towards the center of the autologous valve.

11. The repair device for preventing valvular regurgitation according to any one of claims 1-9, characterized in that: Wherein, The anti-reflux valve leaflet prosthesis is selected from one of the following: an integrated diaphragm made of a flexible material; or a support framework and a biocompatible covering film covering the support framework.

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