CN216221854U

CN216221854U - Prosthetic device for preventing valve regurgitation

Info

Publication number: CN216221854U
Application number: CN202121428904.6U
Authority: CN
Inventors: 吕世文; 陈志�; 王青杰
Original assignee: Jenscare Scientific Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2021-06-25
Filing date: 2021-06-25
Publication date: 2022-04-08
Anticipated expiration: 2031-06-25

Abstract

The present application relates to the field of medical devices, and in particular to a prosthetic device for preventing valve regurgitation comprising a mounting bracket; and a single anti-regurgitation leaflet prosthesis for replacing the function of a single native leaflet; wherein one end of the single anti-regurgitation leaflet prosthesis is fixed on the mounting bracket. The repair device only replaces a single valve leaflet with problems, so that the original functions of the remaining autologous valve leaflet are retained, the shape of the autologous valve annulus cannot be changed, the injury to the endocardial tissue is small, and meanwhile, the implantation amount of the implant is small and the irritation is small.

Description

Prosthetic device for preventing valve regurgitation

Technical Field

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

Background

Tricuspid valve regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement and expansion of tricuspid valve annulus, and is clinically commonly represented by the etiology of tricuspid valve regurgitation (left heart failure, pulmonary hypertension and the like). After the tricuspid valve regurgitation occurs, the patients can have aggravated symptoms of right heart failure such as hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like. Mild regurgitation of the tricuspid valve has no obvious clinical symptoms, but when severe regurgitation occurs, surgical treatment is required.

Traditional treatment approaches for mitral and tricuspid valve disease include drug therapy for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Wherein the surgical method further comprises a valve replacement procedure and a valve repair procedure. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection. Patients are largely intolerant of the enormous surgical risk and can only wait indefinitely for death.

With the first report of aortic valve intervention replacement, many companies have done a lot of work on interventional aortic valve technology, and the technology is mature. However, there remains a significant technical gap in the industry in the interventional treatment of atrioventricular valves. Although a few products are currently used for transcatheter valve formation and repair, there are no mature products available internationally for transcatheter valve replacement.

A heart valve leaflet replacement system and method are described in patent CN201780028476.8, the prosthetic valve comprising a crescent-shaped stent comprising an upper flared portion and a lower ventricular portion, at least one prosthetic leaflet, at least one forked structure for connecting the prosthetic leaflet and the crescent-shaped stent, the replacement prosthesis being secured to a target site by surgical suturing or anchoring the upper flared portion of the crescent-shaped stent to the posterior of the native annulus by means of an interventional catheter. In this solution, the posterior part of the natural ring is in close proximity to the coronary arteries, and the prosthetic valve is fixed with a risk of injury, and in particular when the valve is inserted through a catheter, the positioning requirement for the anchoring system is high, but precise positioning is difficult under the existing medical conditions, so the risk of injury to the coronary arteries is relatively high. The posterior part of the native valve annulus is weak due to the lack of fibrous cords, and the incomplete phenomenon of the valve annulus is obvious, so that the tissue strength of the posterior part of the valve annulus is weak, the pressure of the mitral valve is high, and the risk of tearing the valve annulus after the valve prosthesis is anchored exists. The tricuspid valve annulus is weaker, and the tissue has less elasticity due to long-term expansion, so that the tissue is better and easy to tear, and the prosthesis is better and easy to fall off. In order to stably anchor the valve prosthesis at the target position, at least 3 anchor points are needed, and the position of each anchor point is different, the span is large, and the operation is complex. When the heart moves, the contraction and expansion of the posterior valve ring are obvious, the anchoring position is always in an active state, the anchoring difficulty is high, the distance between anchoring points is difficult to grasp, and the anchoring effect is poor. When the prosthetic valve is closed, the upper flaring portion for anchoring is positioned at the downstream part of blood flow, the ventricular part of the prosthetic valve has no force application point, the prosthetic valve is easy to shift and unstable, the coaptation effect of the prosthetic leaflets and the autologous anterior valve leaflets is poor, and the backflow is caused.

Patent CN201610921114.9 describes a heart valve prosthesis, which comprises a valve stent and a fixing device, wherein the valve stent comprises a sewing section and a prosthetic valve, the fixing device comprises a fixing support section and an anchoring piece, one end of the fixing support section is connected on the ventricular septum of a patient through the anchoring piece to support the heart valve prosthesis and limit the heart valve prosthesis to move axially, and the cross-sectional area of the valve sewing section is smaller than that of the native valve annulus of the patient; the valve leaflets still having functions are completely replaced by the artificial valves, the change of the original hemodynamics is large, and the influence on the heart functions needs to be further researched. The annulus of the tricuspid valve regurgitation lesion is obviously expanded, the stress area of the implanted artificial valve is large, and the anchoring piece bears large force and is easy to separate from the interventricular tissue. The diseased tricuspid valve has irregular valve ring shape, the implanted valve is circular, the effective opening area of the artificial valve is smaller than that of the autologous valve on the premise of not supporting the valve ring, and the trans-valve pressure difference is increased. The repair is difficult in the implantation process due to the occurrence of unexpected situations such as valve displacement, valve falling and the like. The right heart system where the tricuspid valve is located has low pressure and large volume, the mobility of the artificial valve leaflet is small, cellulose hyperplasia easily crawls, the mobility of the artificial valve leaflet is further reduced, calcification is easily caused for a long time, and the incidence rate of stenosis is high. The long-term artificial valve and the tissue are fused and adhered, and the feasibility of inserting the valve replacement is small. The valve implants are multiple, on one hand, the diameter of an interventional catheter is large, and the vascular access is difficult, on the other hand, the implants form a relatively complex structure in the heart, blood flow easily forms vortex in local parts, and the risk of thrombus is high. Moreover, the closed-loop artificial valve and the stent have high processing difficulty and high cost.

A method of treating tricuspid valve regurgitation is disclosed in patent US20160354076a1 by positioning a catheter near the tricuspid annulus, passing a guidewire through the annulus or leaflet tissue to establish anchoring points, and adjusting the distance between the anchoring points to constrict the dilated annulus to treat the tricuspid valve regurgitation. The treatment principle of the scheme is that the tricuspid valve ring with enlarged lesion is reduced, the coaptation area of the autologous valve leaflets is increased, but the tricuspid valve ring is of a three-dimensional saddle-like structure, and after the treatment by the way of shortening the distance between two or more anchoring points, the valve ring shape of the original tricuspid valve is greatly changed, the shape change is more irregular, and the coaptation effect of the autologous valve leaflets is not stable; establishing an anchoring point on the tissue near the valve leaflet or valve annulus, wherein the tissue has low strength and is easy to tear; positioning of the anchor point of the scheme is difficult, and the ideal position is difficult to position; the method is complex in operation, firstly, the target position is located, then the guide wire punctures tissues or valve leaflets, then the guide wire catches or releases the gaskets, then the anchoring points are contracted, then the operation of the next anchoring point is carried out, and finally the distance between the anchoring points is reduced. The human heart tricuspid valve has anterior, posterior and septal leaflets. The anterior valve leaflet, the posterior valve leaflet and the diaphragmatic valve leaflet are in a closed state when the heart contracts, and when the anterior valve leaflet, the posterior valve leaflet and the diaphragmatic valve leaflet cannot be normally aligned in the closed state, valve regurgitation can be generated.

Therefore, there is a strong need in the art for an implantation instrument that can achieve reliable fixation, maximize the use of the original valve function, minimize the impact on cardiac motion and hemodynamics, reduce the difficulty of surgical operation, and have a simple structure.

Disclosure of Invention

The present invention has been made in view of the above and other concepts.

The technical problem to be solved by the present invention is to provide an innovative prosthetic device for preventing valve regurgitation, which can not only reliably fix the valve, but also retain the functions of the main autologous valve leaflets, and has small influence on cardiac motion and hemodynamics, low difficulty in operation, and simple structure.

The basic inventive concept according to a further aspect of the invention is that the prosthetic device of the invention is intended to repair, rather than replace, a whole native heart valve. In other words, the prosthetic device of the present invention is intended to replace one or both of the native leaflets, rather than the entire number of native leaflets. In the case of the mitral valve, the prosthetic device of the present invention is intended to replace one of the native leaflets, while leaving the other native leaflet working properly. For the tricuspid valve, the repair device of the present invention is intended to replace one of the native leaflets, such as the posterior leaflet, while leaving the other two native leaflets working properly; alternatively, two prosthetic devices of the present invention are used to replace two native leaflets in the tricuspid valve, while leaving the other native leaflet working properly.

Specifically, according to one aspect of the present invention, there is provided a prosthetic device for inhibiting valve regurgitation comprising: mounting a bracket; and a single anti-regurgitation leaflet prosthesis for replacing the function of a single native leaflet; wherein one end of the single anti-regurgitation leaflet prosthesis is fixed on the mounting bracket.

According to another aspect of the present invention, there is also provided a prosthetic device for inhibiting valve regurgitation comprising: mounting a bracket; and a single anti-regurgitation leaflet prosthesis for replacing the function of a single native leaflet; wherein one end of the single anti-regurgitation valve leaflet prosthesis is fixed at the proximal end of the mounting bracket; and the proximal end of the mounting bracket is provided with a substantially annular flared portion which, when mounted in place, extends circumferentially over part or the entire circumference of the native annulus of the valve.

According to an embodiment, in the leaflet closed state, the free edge of the single anti-regurgitation leaflet prosthesis cooperates together with the free edges of the remaining native leaflets to effect normal closing of the valve or at least partially overlap with the free edges of the remaining native leaflets to prevent valve regurgitation.

According to another embodiment, the prosthetic device further comprises an anchor by which the distal end of the mounting scaffold is secured to the predetermined site of the heart after installation.

According to another embodiment, the proximal end of the mounting bracket is deployed at the native annulus, atrial tissue or atrioventricular orifice of the heart, and the distal end of the mounting bracket is secured to the ventricular tissue by an anchor.

According to another embodiment, the prosthetic device has a pre-installation constrained state and a post-installation released state.

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

According to another embodiment, the proximal section is provided with a stop portion which, in the released state of the prosthetic device, presents a substantially arc-shaped segment of a flange dimensioned to abut against atrial tissue at the atrioventricular orifice of the heart and to prevent further movement of the prosthetic device in the direction of the ventricles.

According to another embodiment, the mounting bracket includes a distal section configured to be adapted to be placed against a predetermined portion of the heart.

According to another embodiment, the distal segment comprises a distal segment body and a fixation aid unit, the fixation aid unit being anchored to the cardiac tissue by means of an anchor.

According to another embodiment, the mounting bracket further comprises an intermediate section disposed between the proximal section and the distal section, the intermediate section being provided with a perimeter barrier in the region of the intermediate section.

According to another embodiment, the single anti-regurgitation leaflet prosthesis provides an anti-regurgitation skirt in the middle section area.

According to another embodiment, the middle section of the mounting bracket is provided with an auxiliary abutting part, one end of the auxiliary abutting part is fixedly connected with the middle section, and the other end of the auxiliary abutting part is a free end; the auxiliary attaching part is provided with a limiting form and a preset form, the free end is close to the far end of the mounting bracket in the limiting form, and the free end is separated from the near end of the mounting bracket by a certain interval in the preset form to form a clamping valve cavity.

According to another embodiment, the number of auxiliary abutments is 1-3.

According to another embodiment, the replaced native leaflets are trapped between the auxiliary abutments and the mounting bracket when the prosthetic device is implanted.

According to another embodiment, the anti-regurgitation leaflet prosthesis is selected from one of the following: an integrated diaphragm constructed of a flexible material; and consists of a supporting framework and a biocompatible coating or film coated outside the supporting framework.

According to another embodiment, the mounting bracket includes a limiting member configured to allow the single anti-regurgitation leaflet prosthesis to abut thereon and limit its deformation in the leaflet-open condition.

According to another embodiment, the fixed end of the single anti-regurgitation leaflet prosthesis is fixedly connected to the mounting bracket, and the free end of the anti-regurgitation leaflet prosthesis is movably connected to the mounting bracket by the pulling wire; after the prosthetic device is in place, the free end of the single anti-regurgitation leaflet prosthesis is movable between a leaflet-open state, in which the single anti-regurgitation leaflet prosthesis opens along with the remaining native leaflets of the valve other than the single native leaflet, and a leaflet-closed state; in the closed state with the valve leaflets, the single anti-regurgitation leaflet prosthesis closes together with the remaining native valve leaflets to prevent valve regurgitation.

According to another embodiment, the number of anchors is 1-3.

According to another embodiment, the stop portion of the proximal section of the mounting bracket extends circumferentially over part or the entire circumference of the native annulus after the prosthetic device is installed in place.

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

According to another embodiment, the anti-regurgitation leaflet prosthesis may be a spherical structure, and when the native valve is in the closed state, and the anti-regurgitation leaflet prosthesis is located in the middle of the native valve, the occurrence of blood regurgitation is avoided.

According to another embodiment, the anti-regurgitation 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 portion of the native leaflets, and the free edge of the anti-regurgitation leaflet prosthesis is coaptated with the remaining portion of the native leaflets.

According to another embodiment, when the prosthetic device is implanted, the intermediate segment abuts a portion of the native valve leaflets and the distal segment abuts a ventricular wall, and the mounting bracket does not interfere with the function of the remaining portion of the native valve leaflets.

According to another embodiment, the cross-section of the intermediate segment and the distal segment is an open loop structure; when the repair device is implanted, the function of partial autologous valve leaflets is still kept, the backflow can be effectively improved, and the implantation amount of the implant can be reduced.

According to another embodiment, the proximal segment is configured to conform to the shape of the native annulus or atrial tissue, allowing the repair device to better conform to the physiologic configuration of the native annulus.

According to another embodiment, the proximal section comprises a limiting part and a circumferential leakage prevention film, wherein the limiting part is of a fan-shaped continuous net structure or consists of a single rod.

According to another embodiment, the proximal section has a cross-section in the form of a closed circle arc.

According to another embodiment, the limiting portion and the middle section are of an integral structure.

According to another embodiment, the proximal segment may be further secured to the native annulus or atrial tissue by an anchor.

According to another embodiment, the intermediate section comprises a backflow prevention skirt; when the repair device is implanted, the backflow prevention skirt is positioned at the junction area of the autologous valve leaflets.

According to another embodiment, the auxiliary abutment is of unitary construction with the intermediate section.

According to another embodiment, the anchored unit is connected to the ventricular tissue by at least two anchors, at least two of which are axially spaced apart.

According to another embodiment, wherein the at least one anchor is fixed to the ventricular septum.

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

According to another embodiment, the distal section is comprised of a flexible material, such as a woven mesh, a knitted cloth, a wire, or the like.

According to another embodiment, the fixation contour lines of the anti-regurgitation leaflet prosthesis and the mounting bracket are arc-shaped so that the anti-regurgitation leaflet prosthesis can be fully deployed when the native valve leaflet is closed.

According to another embodiment, the anti-regurgitation leaflet prosthesis is a circular arc sheet-like structure; according to another embodiment, the middle portion of the anti-regurgitation leaflet prosthesis arches in the atrial direction when the native valve is closed; when the native valve is open, the middle portion of the anti-regurgitation leaflet prosthesis is approached towards the mounting bracket.

According to another embodiment, the anti-regurgitation leaflet prosthesis is internally provided with a shaping framework, and the shaping framework is a net-shaped structure or a rod-shaped structure.

Compared with the prior art, the application has the advantages that:

1. different from the prior art, the repair device in one embodiment of the invention is fixed on the ventricular tissue through the anchoring piece, and only replaces the problematic valve leaflet, so that the original function of the remaining autologous valve leaflet is retained, the shape of the autologous valve annulus is not changed, the damage to the intracardiac tissue is small, and meanwhile, the implantation amount of the implant is small, and the irritation is small;

2. unlike the prior art, in one embodiment of the present invention, the prosthetic device is secured to and against a side region of the native valve using the anchors, which is stable and does not affect the motion of the heart;

3. different from the prior art, the fixing position of the repairing device in one embodiment of the invention is safe and has no risk; the ventricular septum fixable region is much larger than the annulus and atrium fixable regions, and the positioning requirements for the apparatus are low; besides, other important branch blood vessels do not exist near the ventricular septum, so that functional damage is avoided, and the safety is high; in the heart movement process, the movement amplitude of the ventricular septum is smaller relative to the valve ring, so that the fixation is more stable, the success rate is high, and the effect is good;

4. different from the prior art, the auxiliary attachment part in one embodiment of the invention can clamp the autologous valve leaflet and can further enhance the backflow prevention effect of the repair device;

5. different from the prior art, the backflow-preventing skirt is arranged at the junction area of the autologous valve leaflets in one embodiment of the invention, so that the backflow of blood at the junction of the valve leaflets can be effectively improved.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

fig. 1a-1c are schematic top views of an overall prosthetic device according to an embodiment of the invention.

Figures 2a-2e are schematic views illustrating the auxiliary abutments, the anchors and the anti-regurgitation leaflet prosthesis.

Fig. 3a-3c are schematic views illustrating the abnormal coaptation of the anterior leaflet, the posterior leaflet, and the diaphragmatic leaflet to generate regurgitation.

Fig. 4a and 4b are schematic views showing the normal closing of the leaflets after fixation of the prosthetic device of the invention.

Fig. 5a-5g are schematic views of the release and fixation of the prosthetic device of the present invention, wherein 5b is the prosthetic device in a compressed state.

Fig. 6a and 6b show another embodiment of the invention.

Fig. 7a and 7b show a further embodiment of the invention.

The numbers in the drawings refer to the following names:

1-mounting bracket, 11-proximal section, 12-middle section, 121-backflow prevention skirt, 13-distal section, 131-distal section main body, 132-fixing auxiliary unit, 14-auxiliary abutting part, 141-clamping valve cavity, 15-limiting part, 2-backflow prevention valve leaflet prosthesis, 21-supporting framework, 22-covering film, 23-pulling line and 3-anchoring part.

Detailed Description

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

It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass 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 various embodiments and examples of several aspects of the application.

In this application, "proximal" refers to the end proximal to the operator and "distal" refers to the end distal to the operator.

Example one

The tricuspid valve of the human heart has anterior, posterior and septal leaflets. The anterior, posterior and diaphragmatic leaflets are in a closed state when the heart contracts, and valve regurgitation occurs when one of the anterior, posterior and diaphragmatic leaflets fails to close normally in the closed state, as shown in fig. 3a-3 c.

As shown in fig. 1a-1c, a prosthetic device for preventing valve regurgitation comprises a mounting stent 1, an anti-regurgitation leaflet prosthesis 2 and anchors 3. The proximal end of the mounting bracket 1 abuts against the native annulus or cardiac tissue, such as atrial tissue, and the distal end of the mounting bracket 1 is secured to the cardiac tissue, such as ventricular tissue, by the anchor 3. The anti-regurgitation leaflet prosthesis 2 is attached to the mounting bracket 1 in various possible fixing manners, such as fixing, attaching, adhering, sewing, snapping, wearing, etc. After the operation is completed, when the native valve targeted for the operation is in a closed state, the regurgitation preventing leaflet prosthesis 2 is located in the middle of the native valve, and the free edges of the regurgitation preventing leaflet prosthesis and the free edges of the remaining native leaflets cooperate together to achieve normal closing of the valve or at least partially overlap with the free edges of the remaining native leaflets to prevent regurgitation of the valve. In contrast to the treatment scheme of directly replacing the whole native valve, the repair device according to the present invention is fixed at the target operation site such as ventricular tissue by the anchoring means 3, e.g. anchoring nails, to replace only one problematic target leaflet, e.g. septal leaflet, while retaining the original structure and function of the remaining native leaflets, keeping them un-replaced and not changing the morphology of the native valve annulus, thus causing less damage to the endocardial tissue, and at the same time, less amount of implant, less irritation and damage to the human heart.

According to one example, the anti-regurgitation leaflet prosthesis 2 may be of a generally sheet-like configuration, for example in the form of the posterior leaflet of the tricuspid valve, for replacing the patient's posterior leaflet anatomy. After surgery, when the native valve of the surgical target is in a closed state, the middle section of the mounting stent 1 conforms and abuts on a portion of the native valve leaflets, and the anti-regurgitation leaflet prosthesis 2 is normally closed with the remaining native valve leaflets of the native valve.

According to another example, the anti-regurgitation leaflet prosthesis 2 may assume a substantially spherical configuration, with the anti-regurgitation leaflet prosthesis 2 being located between and forming an effective closure with the native valve when the native valve is in the closed state, avoiding the occurrence of regurgitation of blood.

In this embodiment, the main body of the mounting bracket 1 generally includes a proximal section 11, an intermediate section 12, and a distal section 13 connected together, such as shown as being generally integral. The proximal section 11 is provided at the proximal end of the mounting stent 1, the distal section 13 is arranged at the distal end of the body of the mounting stent 1, and the intermediate section 12 is interposed between the proximal section 11 and the distal section 13. When the prosthetic device is fully implanted, the intermediate section 12 conforms and is adapted to abut a target tissue site, such as a native leaflet portion to be replaced, and the distal section 13 conforms and is adapted to abut a target tissue site, such as a ventricular wall. The proximal segment 11 is configured to conform and adapt to the target tissue site, such as the native annulus, atrioventricular orifice, or atrial tissue, allowing the repair device to better conform to the physiological configuration of, for example, the native annulus.

The function of the rest autologous valve leaflets is not affected by the mounting bracket 1 after mounting.

The prosthetic device can have a constrained state and a released state.

In this embodiment, the proximal section 11 may further comprise a preferably integral stop portion 111, and the stop portion 111 may be, for example, a continuous serpentine or web-like configuration at the proximal section 11, or may be a single rod. Such a serpentine or mesh-like configuration may be constrained or compressed in a constrained state of the repair device and released or expanded to its preset configuration in a released state of the repair device.

A limiting member 15 may also be provided at the proximal section 11, which may for example be integral with the limiting portion 111. The limiting member 15 may serve to limit/restrict excessive or undesired deformation of the anti-regurgitation leaflet prosthesis 2.

In the constrained state of the prosthetic device (shown in fig. 5b and 5 c), the proximal segment 11 and the intermediate segment 12 are oriented substantially the same or with only minor differences. In the released state of the prosthetic device (shown in fig. 5 e), the stop portion 111 of the proximal section 11 will bend relative to the intermediate section 12 to extend in a direction (substantially or close to radial) substantially transverse to the direction of extension of the intermediate section 12 (substantially axial as shown in fig. 5 e), such that the stop portion 111 has an expanded substantially circular-arc-segment configuration, such as a flared portion, sized and shaped for reliable placement at a surgical site of the heart, such as an atrioventricular orifice site of the heart. The substantially circular arc segment configuration, as shown in fig. 5e, may resemble a flange, which may prevent further movement of the prosthetic device toward 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 circumference of the native valve annulus. It will be apparent to those skilled in the art that the flared portion described above may be provided at the proximal end of the prosthetic device in other ways/locations/configurations, including but not limited to in the form of a flange or flange, which are within the scope of the present invention.

The proximal segment 11 may further include a leakage prevention film 112, which may be disposed at the retention portion 111 by clipping, sleeving, embedding, etc., and preferably partially or completely covers the proximal segment 11, such as wrapping at least outside the retention portion 111 to prevent leakage around the replacement site.

The region of the intermediate section 12 also includes an anti-reflux skirt 121. When the prosthetic device is implanted, the anti-regurgitation skirt 121 is located at the interface with the native valve leaflets, as shown in figures 4a and 4 b. The anti-leak membrane 112 can provide a configuration of the anti-reflux skirt 121 in the area of the intermediate section 12.

In addition, the anti-perileakage membrane 112 may also be provided in the region of the middle section 12, where the anti-perileakage membrane 112 abuts against the autologous tissue at the site, such as the autologous valve leaflets or atrial tissue, to prevent the backflow of blood.

The mounting bracket 1 may also be provided with an auxiliary abutment 14 which may, for example, be attached to the body of the mounting bracket 1, such as the intermediate section 12, as shown in fig. 2a and 2 b. The auxiliary abutment 14 can be provided with a curved strip, a serpentine or a net-like configuration, one end of which is fixedly connected to the intermediate section 12 and the other free end of which can be returned to a predetermined configuration at the time of surgery at a distance from the mounting bracket 1, forming a clipping cavity 141, as shown in fig. 2a, for example. Thus, when the prosthetic device is implanted, the native leaflets are clamped and trapped between the auxiliary abutments 14 and the mounting bracket 1, as shown in FIG. 2c, further facilitating secure fixation of the mounting bracket 1 at the surgical site and leakage prevention.

The auxiliary abutments 14 can be, for example, integrally formed with the intermediate section 12. Of course, the auxiliary abutment 14 can also be a separate piece connected to the intermediate section 12.

The auxiliary abutment 14 can have a restrained condition and a preset configuration. When the auxiliary abutment 14 is transformed from the restrained state to the preset configuration, the replaced native valve leaflet can abut against the auxiliary abutment 14 site and can be inverted so that a portion of the native valve leaflet is securely held, e.g., clamped, in the clipping cavity 141 position, as shown in fig. 5c and 5 d.

At least one, for example two, auxiliary abutments 14 can be provided on the mounting bracket 1, as shown in fig. 2 c.

The distal segment 13 may comprise a distal segment body 131 and a fixation assist unit 132. As shown in fig. 2d, the distal segment body 131 is connected to the intermediate segment 12, the fixation assisting unit 132 is connected to the distal segment body 131, and the fixation assisting unit 132 is connected to a cardiac operation site such as ventricular tissue via the anchor 3.

Further details of embodiments of the anchor 3 (which may also be referred to as "anchor needle", etc.) in this embodiment are described in detail, for example, in patent application No.202120566797.7 of the same applicant, the content of which is incorporated by reference in the present application.

In this embodiment, the fixation assist unit 132 can be attached to cardiac tissue, such as the ventricular septum, by the anchor member 3 to help secure the mounting bracket in place.

In this embodiment, the distal section body 131 may be a grid-like or frame-like structure, or a rod-like structure such as a bent rod body, for example.

The distal segment body 131 can be integrally formed with the intermediate segment 12.

In this embodiment, the fixation assisting unit 132 of the distal section 13 may be made of, for example, a biocompatible flexible material, such as a woven mesh, a woven cloth, a wire, a membrane, and the like. According to one example, the fixation assistance unit 132 may be provided by the anti-regurgitation leaflet prosthesis 2.

In this embodiment, the anti-regurgitation leaflet prosthesis 2 may be a sheet-like structure made of a flexible material. During normal operation of the post-operative heart valve, when the non-operative native leaflets in the heart valve open, the free edges of the anti-regurgitation leaflet prosthesis 2 also open close to the mounting bracket 1; when the heart valve is closed, the free edge of the anti-regurgitation leaflet prosthesis 2 closes away from the mounting stent 1 together with the remaining native leaflets.

One end of the anti-regurgitation leaflet prosthesis 2 is attached to the mounting bracket 1 in various possible ways, e.g. fixed, attached, glued, sewn, snapped on, donned, etc., e.g. at the proximal section 11 of the mounting bracket 1, while its other end appears free like a native leaflet. The contour line of the fixing part of the anti-regurgitation valve leaflet prosthesis 2 fixed on the proximal section 11 is generally arc-shaped, which can conform to the shape of the autologous valve annulus and is convenient for the anti-regurgitation valve leaflet prosthesis 2 to be fully unfolded when the autologous valve leaflets are closed.

In this embodiment, the anti-regurgitation leaflet prosthesis 2 may be a substantially sheet-like structure. When the rest of the autologous valve leaflets are closed, the middle part of the anti-regurgitation valve leaflet prosthesis 2 moves towards the atrial direction until the free edges of the middle part are substantially closed with the corresponding parts of the autologous valve leaflets, just like the state when a normal heart valve is closed; when the native valve leaflets are open, the anti-regurgitation leaflet prosthesis 2 also opens like a normal heart valve leaflet to be adjacent to the mounting stent 1.

According to one example, the anti-regurgitation leaflet prosthesis 2 may comprise a support skeleton 21 and a biocompatible covering film or membrane 22 that is coated over the support skeleton 21, as shown in fig. 2e, which mimics in shape the native heart valve leaflets to be replaced in surgery. The support frame 21 may have, for example, a net-like structure or a frame structure composed of rods. The support skeleton 21 may be arranged to be flexible at the free edge of the anti-regurgitation leaflet prosthesis 2 to prevent the free edge from wrinkling. Alternatively, the support frame 21 does not extend to the free edge, so that the anti-regurgitation leaflet prosthesis 2 only retains a flexible membrane configuration at the free edge region, which configuration is not only advantageous for preventing the free edge from wrinkling, but also for the anti-regurgitation leaflet prosthesis 2 to form the desired closure together with the rest of the native leaflets.

According to another example, similar to a native leaflet, the anti-regurgitation leaflet prosthesis 2 may be a unitary construction, such as a unitary membrane.

The anti-backflow valve leaflet prosthesis 2 can also be provided with a pulling line 23, one end of the pulling line 23 is connected with the anti-backflow valve leaflet prosthesis 2, and the other end is connected with the mounting bracket 1. According to one example, the pulling wire 23 is connected at one end at or near the free edge region of the anti-regurgitation leaflet prosthesis 2, while its other end is connected at the intermediate section 12 or the distal section 13 of the mounting stent 1, preferably near the end of the distal section 13.

A traction line 23 is arranged on the anti-backflow valve leaflet prosthesis 2, one end of the traction line 23 is connected with the anti-backflow valve leaflet prosthesis 2, and the other end is connected with the distal end part of the mounting bracket 1; one end of the pulling wire 23 is connected with the edge of the anti-regurgitation valve leaflet prosthesis 2.

The anti-regurgitation leaflet prosthesis 2 may also be provided with the puller wire 23 in other ways similar to the native leaflet construction.

Similar to the native leaflet configuration, the anti-regurgitation leaflet prosthesis 2 may have a curved configuration similar to the native leaflet.

An exemplary procedure for performing a heart atrioventricular tricuspid surgery on a prosthetic device for preventing valve regurgitation in accordance with this embodiment is as follows:

1. the prosthetic device is accessed via the femoral vein by a transfemoral approach, and the superior vena cava enters the atrium and reaches the atrioventricular orifice, as shown in fig. 5 a;

2. positioning the mounting stent 1 in position against the septal leaflet, partially releasing and abutting the distal section 13 of the prosthetic device to a position in the ventricular septum;

3. the prosthetic device is gradually released from the distal end to the proximal end, so that the auxiliary attachment 14 is restored from the constrained configuration to the preset configuration, and the free end of the auxiliary attachment 14 is folded back from the distal end of the mounting bracket 1 to the proximal direction (as shown by the arrow in fig. 5 c), and the native valve leaflet (septal valve leaflet) as the replacement target is clamped in the valve clamping cavity 141, as shown in fig. 5c-5 d;

4. the proximal segment 11 is further released against the native annulus, as shown in fig. 5 e.

5. The surgical procedure is continued with the mounting bracket 1 secured to the interventricular site by the anchor 3 as shown in fig. 5f and 5g, thus substantially completing the primary surgical procedure for the prosthetic device.

Example two

The second embodiment is substantially the same as the first embodiment. The difference is that in the second embodiment, the prosthetic device is attached to the ventricular tissue by at least two anchoring elements 3, and at least two anchoring elements 3 are axially spaced apart, as shown in fig. 6a-6 b.

The remaining configuration and concept of embodiment two is similar to embodiment one and therefore will not be repeated here.

EXAMPLE III

Third embodiment is substantially the same as first embodiment except that in the third embodiment, as shown in fig. 7a-7b, in the released state of the prosthetic device, the flared portion of the mounting stent, e.g., the limiting portion 111 of the proximal section 11, may have a configuration similar to a flange (flange) and extend circumferentially around the entire circumference of the native annulus, the circumferential extension of the limiting portion 111 being at least equal to, and generally greater than, the circumferential perimeter of the native annulus so as to, on the one hand, prevent further movement of the prosthetic device towards the ventricle. On the other hand, the stable and easy installation and positioning of the repair device at the native annulus site are facilitated. This third embodiment is clearly different from the first embodiment, in which the flared portion, such as the limiting portion 111, extends only over a part of the circumference of the native valve annulus, not the entire circumference, and the circumferential extension size is about one third to one half of the circumference of the native valve annulus.

The remaining configuration and concept of embodiment three are similar to embodiment one and therefore will not be repeated here.

The foregoing description of several embodiments of the application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration, configurations 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 following claims.

Claims

1. A prosthetic device for preventing valve regurgitation, comprising: the method comprises the following steps:

mounting a bracket; and

a single anti-regurgitation leaflet prosthesis for replacing the function of a single native leaflet;

wherein one end of the single anti-regurgitation leaflet prosthesis is fixed to the mounting bracket, and the prosthetic device further comprises an anchor by which the distal end of the mounting bracket is fixed to a predetermined portion of the heart after the mounting is completed.

2. A prosthetic device for preventing valve regurgitation, comprising: the method comprises the following steps:

mounting a bracket; and

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

Wherein the proximal end of the mounting bracket is provided with a substantially annular flared portion which, when mounted in place, extends circumferentially over part or the entire circumference of the native annulus of the valve, the prosthetic device further comprising an anchor by which the distal end of the mounting bracket is secured in a predetermined location of the heart after mounting is completed.

3. The repair device of claim 1 or 2, wherein in the leaflet closed state of the single anti-regurgitation leaflet prosthesis, the free edge of the single anti-regurgitation leaflet prosthesis and the free edges of the remaining native leaflets cooperate together to effect normal closing of the valve or at least partially overlap with the free edges of the remaining native leaflets to prevent valve regurgitation.

4. The repair device of claim 3 wherein the proximal end of the mounting bracket is configured to be disposed at a native annulus, atrial tissue, or ostium of the heart, and the distal end of the mounting bracket is secured to the ventricular tissue by the anchor.

5. The prosthetic device of claim 4 having a pre-installation constrained state and a post-installation released state.

6. The repair device of claim 5 wherein the mounting stent includes a proximal section adapted to be mounted in place at a predetermined site of the heart in a released state of the repair device.

7. The prosthetic device of claim 6, wherein the proximal section is provided with a stop portion that, in a released state of the prosthetic device, presents a generally arcuate segment flange sized to fit against atrial tissue at an atrial ostium of the heart and prevent further movement of the prosthetic device in a ventricular direction.

8. The prosthetic device of claim 7 wherein the mounting stent includes a distal section configured to be adapted to abut a predetermined portion of the heart.

9. The repair device of claim 8 wherein the distal segment includes a distal segment body and a fixation assist unit anchored to cardiac tissue by an anchor.

10. The prosthetic device of claim 9 wherein the mounting stent further comprises an intermediate section disposed between the proximal and distal sections, a circumferential leak prevention membrane being disposed in the region of the intermediate section.

11. The prosthetic device of claim 10, wherein the single anti-regurgitation leaflet prosthesis provides an anti-regurgitation skirt in the middle section area.

12. The prosthetic device of claim 10 wherein the intermediate section of the mounting bracket is provided with an auxiliary abutment having one end fixedly attached to the intermediate section and the other end being a free end;

the auxiliary abutting portion has a limiting shape and a preset shape, the free end is close to the far end of the mounting bracket in the limiting shape, and the free end is separated from the near end of the mounting bracket by a certain interval in the preset shape to form a clamping valve cavity.

13. The prosthetic device of claim 12 wherein the number of auxiliary abutments is 1-3.

14. The repair device of claim 13 wherein the replaced native valve leaflet is trapped between the auxiliary abutment and the mounting bracket when the repair device is implanted.

15. The repair device of claim 14, wherein the anti-regurgitation leaflet prosthesis is selected from one of the following:

an integrated diaphragm constructed of a flexible material; and

the device consists of a support framework and a biocompatible coating or film coated outside the support framework.

16. The repair device of claim 15 wherein the mounting bracket includes a restraint configured to receive the single anti-regurgitation leaflet prosthesis thereagainst and to restrain deformation thereof in the leaflet-open condition.

17. The repair device of claim 16, wherein a fixed end of the single anti-regurgitation leaflet prosthesis is fixedly connected to the mounting bracket and a free end of the anti-regurgitation leaflet prosthesis is movably connected to the mounting bracket by a pulling wire;

wherein, after the repair device is in place, a free end of the single anti-regurgitation leaflet prosthesis is movable between a leaflet-open state in which the single anti-regurgitation leaflet prosthesis opens along with the remaining native leaflets of the valve other than the single native leaflet, and a leaflet-closed state; in the leaflet closed state, the single anti-regurgitation leaflet prosthesis closes with the remaining native leaflets to prevent valve regurgitation.

18. The prosthetic device of claim 17 wherein the number of anchors is 1-3.

19. The repair device of claim 18 wherein the stop of the proximal section of the mounting stent extends circumferentially over part or the entire circumference of the native annulus after the repair device is in place.