Aortic valve assist prosthesis for preventing backflow

Abstract

The present application relates to the field of medical devices, and specifically to an aortic valve auxiliary prosthesis for preventing regurgitation, comprising: a main body, which is configured to remain in place in the aorta at the surgical site; and three auxiliary leaflet segments configured to cooperate with the three free segments of the native leaflets of the aortic valve; the three auxiliary leaflet segments are fixed to the main body. The present invention allows the original native leaflets to be retained, and when the native valve is closed, the purpose of improving the prevention of regurgitation is achieved by overlapping and covering the free segments of the native valve, with significant therapeutic effects and stronger targeting. Since the native valve is retained, most of the impact force of blood when flowing is still on the native valve, the reliability requirements for the fixed positioning of the main body are low, and the morphological changes to the native valve are smaller.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an aortic valve assist prosthesis for preventing regurgitation. Background Art

[0002] At present, aortic valve stents mainly include mechanically expandable stents, balloon-expandable stents and self-expanding stents. After the release of mechanically expandable stents and balloon-expandable stents, the open area of the valve is small, precise positioning is impossible, and the transvalvular pressure difference is large. Although the transvalvular pressure difference and conduction block are small after the release of the self-expanding stent, the coaxiality after release is poor, and precise positioning is impossible, which can easily cause problems such as paravalvular leakage and valve slippage. Most aortic valve stents are currently designed for patients with aortic stenosis. For patients with aortic regurgitation, how to improve the prevention of regurgitation while retaining the function of the native valve leaflets, reducing the amount of implants, and at the same time ensuring the reliable anchoring of the implanted prosthesis in the heart to avoid problems such as falling off, are issues that urgently need to be solved in this field.

[0003] US Patent No. 14063705 discloses a stented prosthetic heart valve comprising a stent assembly, a leaflet assembly, and mounting members. The stent assembly includes a stent post frame, a stent post frame cover, and a base frame. The stent post frame comprises a continuous rail forming a closed curved shape defining a longitudinal axis, and a plurality of circumferentially spaced posts projecting from the apex segment along the longitudinal axis. A fabric covering surrounds the rails. The base frame supports the apex segment. The valve leaflet assembly is attached to the stent assembly and includes leaflets clamped between one of the apex segments and the base frame. Each mounting member passes directly through the stent post frame cover, the first leaflet, and the base frame. The rails may have a constant cross-sectional shape with a major axis dimension that is larger than the minor axis dimension. While this technical solution has shown significant effectiveness in improving the treatment of aortic valve regurgitation, the stent's anchoring position within the heart is unstable, making it prone to dislodgement after implantation. Furthermore, the implanted prosthesis completely replaces the native valve leaflets, requiring a large implant volume and causing significant irritation to the human body.

[0004] Patent US17140366 discloses artificial heart valve leaflets with controlled bending shapes. The prosthetic heart valve may include a leaflet frame having a generally tubular shape with an attached membrane. The hinged frame may define a plurality of hinged windows, and the membrane may define at least one hinge extending from each hinged window. Each leaflet connection area on the leaflet frame may have a substantially isosceles trapezoidal shape having two leaflet sides, a leaflet bottom, and a leaflet free edge opposite the leaflet bottom. The two leaflet sides may diverge from the leaflet base, which is substantially flat. The technical solution of this patent has the drawback that, after the prosthesis is implanted, part of the prosthesis is located in the outflow tract of the aortic valve, which may easily cause the stent to hit the conduction bundle position, resulting in conduction block.

[0005] In summary, the problems that urgently need to be solved in this field include: how to reduce the amount of implants as much as possible while ensuring the anti-reflux effect; the anti-reflux valve prosthesis must be accurately positioned and firmly fixed to the area requiring treatment; the anti-reflux valve prosthesis needs to minimize the impact on the movement of the remaining leaflets with normal function; the anti-reflux valve prosthesis needs to adapt to the differences in the physiological structure of the valve annulus. Summary of the Invention

[0006] In view of the above and other concepts, this application is proposed. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0007] In terms of application in cardiac aortic valve surgery, this application aims to provide an aortic valve auxiliary prosthesis for preventing regurgitation in patients with aortic valve leaflet insufficiency who require interventional treatment, thereby solving problems such as difficult positioning of the aortic valve auxiliary prosthesis and severe regurgitation of the native valve.

[0008] According to one aspect of the present application, an aortic valve auxiliary prosthesis for preventing regurgitation is provided, comprising: a main body configured to remain in place within the aorta at a surgical site; and three auxiliary leaflet segments configured to cooperate with three native leaflet free segments of the aortic valve; wherein the three auxiliary leaflet segments are fixed to the main body.

[0009] According to one embodiment, when the aortic valve is closed, the proximal free edges of adjacent auxiliary leaflet segments are deformed to abut against each other, and each auxiliary leaflet segment covers and abuts against the free segment of the corresponding native leaflet.

[0010] According to one embodiment, when the aortic valve is open, the free edges of the proximal ends of adjacent auxiliary leaflet segments are separated from each other.

[0011] According to one embodiment, each auxiliary leaflet segment has a flexible sheet-like shape.

[0012] According to an embodiment, each auxiliary leaflet segment has a generally quadrilateral, eg rectangular, shape.

[0013] According to one embodiment, each auxiliary leaflet segment has a generally rectangular shape, wherein two longitudinal sides of the rectangle are fixed to the main body.

[0014] According to one embodiment, the transverse extension length of the free edge of the proximal end of each auxiliary leaflet segment is equal to or greater than the transverse extension length of the free edge of the corresponding native leaflet.

[0015] According to one embodiment, the body includes three distal seating portions configured and adapted to remain seated within the native valve sinuses of the aorta.

[0016] According to one embodiment, the distal placement portion is formed of a biocompatible curved strip having an outer contour that is arched toward the distal end.

[0017] According to one embodiment, the distal seating portion has a rounded "W" shape.

[0018] According to an embodiment, the distal seating portion has an adaptive portion.

[0019] According to one embodiment, the adaptive portion is a rounded "W" shaped portion with a curved tip in the middle.

[0020] According to an embodiment, the stiffness of the adaptive portion is less than the stiffness of the remaining portion of the distal seating part.

[0021] According to one embodiment, barbs are provided on the distal seating portion.

[0022] According to an embodiment, the middle portion of the distal seating portion is offset, protrudes or extends radially outward relative to the remaining portion.

[0023] According to one embodiment, the body includes an intermediate section connected between a top end of the body and a corresponding distal seating portion.

[0024] According to one embodiment, after the aortic valve assist prosthesis is installed in place within the aorta, the intermediate segment rides or straddles the commissure of adjacent native valve leaflets.

[0025] According to one embodiment, each intermediate section is provided with a support frame.

[0026] According to one embodiment, the support frame includes two curved rods whose ends are fixed to each other and arched radially opposite to each other.

[0027] According to one embodiment, the aortic valve prosthesis may further include a delivery device for delivering the aortic valve assist prosthesis to a surgical site of the aortic valve.

[0028] According to one embodiment, the auxiliary leaflet segment is located between the native leaflet and the heart tissue in a free state; when the aortic valve auxiliary prosthesis is implanted, the aortic valve auxiliary prosthesis will not change the morphology of the original valve, nor will it replace the original leaflet, but will repair the area where the native valve regurgitation occurs, that is, the free segment of the native valve. This treatment method causes little damage to the native valve and significantly improves the effect of preventing regurgitation.

[0029] According to one embodiment, the auxiliary leaflet segment is a sheet-like structure, and the auxiliary leaflet segment is configured as a prosthetic leaflet similar to a native leaflet.

[0030] According to one embodiment, the main body includes a distal placement portion; the distal placement portion is configured to be suitable for positioning in the native valve sinus; the distal placement portion not only plays a positioning role when the prosthesis is implanted, but is also designed to fit the blood vessel wall more closely, avoiding collision with the leaflets when the valve is working, and effectively protecting the leaflets, while also providing a certain degree of stability for the main body.

[0031] According to one embodiment, the distal placement portion is configured to be away from the center of the native valve.

[0032] According to one embodiment, the distal placement portion is configured in an arcuate configuration, and the distal placement portion abuts against the blood vessel wall.

[0033] According to one embodiment, the distal placement portion is configured to be arched outward and abut against the blood vessel wall; the advantage of such a design is that it can effectively prevent the leaflets from colliding with the distal placement portion and damaging the leaflets.

[0034] According to one embodiment, the distal seating portion comprises an adaptive portion, which enables the distal seating portion to adapt to different sizes of native valve sinuses.

[0035] According to one embodiment, the auxiliary leaflet segment is connected to the middle segment.

[0036] According to one embodiment, the two curved rods include a rod that is generally arched toward the outside in the radial direction and a rod that is generally arched toward the inside in the radial direction, wherein the longitudinal edge of the auxiliary leaflet segment is fixed to the rod that is generally arched toward the inside in the radial direction.

[0037] According to one embodiment, the expanded transverse extension length (L) of the free edge of the proximal end of each auxiliary leaflet segment is equal to or greater than twice the radius (R) of the circle defined by the expanded main body.

[0038] According to one embodiment, the middle section is in close contact with the blood vessel wall; the purpose of this design is to prevent the native valve leaflets from contacting or colliding with the middle section when the native valve leaflets are opening and closing, thereby effectively protecting the native valve leaflets without affecting the operation of the native valve.

[0039] According to one embodiment, the width of the auxiliary leaflet segment after expansion is greater than the width of the native leaflet after expansion.

[0040] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following:

[0041] 1. Traditional stents with valves all use autologous valve replacement as a treatment method. However, this treatment method will also replace the original functional autologous valve leaflets, and at the same time, it has high requirements for the positioning of the valve prosthesis and the anchoring support force in the heart. Different from the existing technology, one embodiment of the present application can retain the original autologous valve leaflets. When the autologous valve is closed, the free edges of the proximal ends of the auxiliary valve leaflet segments covering the autologous valve are pressed against each other to achieve improved or even complete closure, thereby achieving the purpose of improving and preventing reflux. The treatment effect is significant and more targeted. At the same time, since the autologous valve is retained, most of the impact force of blood when flowing is still on the autologous valve, the anchoring force requirement for the main body is low, and the morphological change of the autologous valve is smaller.

[0042] 2. Different from the existing technology, the distal placement part in one embodiment of the present application can not only play a positioning role when the prosthesis is implanted, but is also designed to fit the blood vessel wall more closely, avoiding collision with the valve leaflets when the valve is working, effectively protecting the valve leaflets, and also providing a certain degree of stability for the main body.

[0043] 3. Different from the prior art, in one embodiment of the present application, the distal placement portion is provided with an adaptive portion, which can not only adapt to the size of the valve sinus between different patients, but also the adaptive portion is set to be relatively flexible (the stiffness of the adaptive portion is less than the stiffness of the rest of the distal placement portion) to facilitate sheath retraction.

[0044] 4. Different from the prior art, in one embodiment of the present application, the middle section straddles the junction of adjacent native leaflets, so that during the closure of the aortic valve, it can resist the impact and deformation of the regurgitant blood flow on the junction of the leaflets, thereby more effectively preventing the regurgitation of blood at the junction of the leaflets.

[0045] 5. Different from the prior art, in one embodiment of the present application, the support frame provides a strong radial support force for the main body, further stabilizing the position of the valve prosthesis in the heart.

[0046] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. These other technical effects may be partially described below and can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent, and the embodiments of the present application may be better understood, by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0048] Figure 1a-1b Schematic diagram of native valve regurgitation.

[0049] Figures 2a-2d Schematic diagram of a three-dimensional aortic valve assist prosthesis for preventing regurgitation according to an embodiment of the present invention.

[0050] Figures 3a-3c for Figures 2a-2d Schematic diagram of the aortic valve assist prosthesis of the embodiment shown in FIG. 1 from an open state to a closed state.

[0051] Figures 4a-4d for Figures 2a-2d The illustrated embodiment is a schematic structural diagram of the aortic valve assist prosthesis assisting the closure of the native valve after implantation.

[0052] Figure 5a-5b for Figures 2a-2d A top view of the aortic valve assist prosthesis of the illustrated embodiment assisting the closure of the native valve after implantation.

[0053] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-top, 11-distal placement part, 111-adaptive part, 112-barb, 12-middle section, 121-support frame, 2-auxiliary leaflet segment. DETAILED DESCRIPTION

[0054] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0055] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or executed in various ways. Each example is provided in an explanation of the disclosed embodiments, not in a limiting manner. In fact, it will be apparent to those skilled in the art that various modifications and variations may 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, a feature illustrated or described as part of one embodiment may be used in conjunction with another embodiment to still produce another embodiment. Therefore, the present application discloses such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0056] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes only and should not be considered restrictive. The use of "include," "comprising," or "having" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents, as well as possible additional items.

[0057] As used herein, “axial” refers to a direction generally along the central axis of the aorta at the surgical site, and “transverse” refers to a direction generally transverse to, preferably perpendicular to, the “axial” direction.

[0058] As used herein, the "free segments" of the native valve leaflets refer to the portion of the native valve leaflets that is free to swing and includes the free edge. In the normally open state of the aortic valve, the "free segments" of the native valve leaflets are generally separated from each other to allow blood to flow through; in the normally closed state of the aortic valve, the "free segments" of the native valve leaflets cooperate with each other (deformed to generally abut each other under the pressure of the regurgitant blood flow) to achieve general closure, thereby preventing regurgitation.

[0059] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0060] In this application, the proximal end refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator.

[0061] In the prior art, aortic valve treatment is usually performed by replacing the entire native valve. This traditional treatment method will change the morphology of the native valve and also replace the original functioning native valve leaflets. Figure 1a-1b As shown, it can be clearly seen that the native valve has incomplete closure during closing, which can lead to blood reflux and may cause various diseases.

[0062] According to one embodiment, Figures 2a-2d and Figures 3a-3c As shown, using the treatment of aortic valve disease as an example, an aortic valve assist prosthesis for preventing regurgitation is provided, comprising: a main body with three apexes 1; and three auxiliary leaflet segments 2 positioned between and fixedly connected to two adjacent apexes 1. When the native valve is open, as shown in the figure, each auxiliary leaflet segment 2 substantially abuts against the free segment of the corresponding native leaflet, with adjacent auxiliary leaflet segments 2 separated from each other.

[0063] According to an example, each auxiliary leaflet segment 2 can be designed as a substantially flexible sheet. According to an example, each auxiliary leaflet segment 2 is configured to have a substantially quadrilateral shape, for example Figure 2a The generally rectangular shape shown, the two longitudinal sides of the quadrilateral - that is, the two sides extending substantially parallel to the axial direction are fixed, for example, on the inner frame of the support frame 121 of the main body, and the other two transverse sides remain not directly fixed to the main body, but only extend between the two longitudinal sides, as shown in FIG. Figure 2a-2bAs shown. In this way, the transverse edge located at the proximal end of each auxiliary leaflet segment 2 becomes the free edge of the auxiliary leaflet segment 2. When the aortic body valve is in a closed state, it will deform together with the free edges of the proximal ends of other auxiliary leaflet segments under the action of the regurgitant blood flow until they are close to each other. In this way, they cooperate with each other to achieve substantial closure, thereby assisting in a better, or even complete, closure of the entire aortic body valve, thereby improving or preventing aortic valve regurgitation.

[0064] Each auxiliary leaflet segment 2 is configured to have a generally quadrilateral shape, such as a generally rectangular shape, which offers advantages in terms of cost, assembly, structural simplicity, and reliability. Of course, each auxiliary leaflet segment 2 can also be designed as a biocompatible leaflet segment prosthesis having an outer contour generally similar to the free segment of the corresponding native leaflet.

[0065] As shown in the figure, the number of the auxiliary leaflet segments 2 is three, corresponding to the three leaflets of the aortic valve.

[0066] More specifically, when the aortic valve closes, e.g. Figure 3c As shown, the auxiliary leaflet segments 2 cover and abut against the free segments of the corresponding native leaflets, and the free edges of the proximal ends of adjacent auxiliary leaflet segments 2 are deformed to abut against each other under the pressure of the regurgitant blood flow, thereby forming a basic closure at the adjacent boundaries and tip portions to prevent aortic valve regurgitation; when the aortic valve opens, the free edges of the adjacent auxiliary leaflet segments 2 are separated from each other by the drive of the blood flow pressure, so that the blood flow passes normally, as shown in FIG. Figure 5a When the aortic valve closes, as shown in Figure 5b As shown, the free edges of the proximal ends of each pair of adjacent auxiliary leaflet segments 2 are deformed to fit together to achieve a tight closure, and each auxiliary leaflet segment 2 covers and fits against the free segment of the corresponding native leaflet, so that both the auxiliary leaflet segment and the free segment of the native leaflet bear and resist the impact of the regurgitant blood flow, thereby greatly improving the effect of resisting the regurgitant impact and greatly improving the auxiliary effect of the auxiliary leaflet segment.

[0067] This application innovatively proposes a solution that retains the original native valve leaflets. When the native valve closes, the aortic valve auxiliary prosthesis partially overlaps and covers the free segment of the native valve, and the free edges of the aortic valve auxiliary prosthesis deform to abut against each other to assist closure, thereby improving and preventing regurgitation. Consequently, the treatment effect is significantly improved and more targeted. Furthermore, because the native valve is retained, the majority of the impact force of blood flow remains on the native valve. This, on the one hand, requires relatively less secure positioning of the aortic valve auxiliary prosthesis body, and on the other hand, causes less morphological change to the native valve.

[0068] The composition and connection of each component in this embodiment will be described in detail below with reference to the accompanying drawings.

[0069] like Figures 4a-4d As shown, after installation, each auxiliary leaflet segment 2 of the aortic valve assist prosthesis is maintained in a free state between the corresponding native leaflets and heart tissue. Once implanted, the aortic valve assist prosthesis does not change the original valve morphology or replace the original leaflets. Instead, it only assists / supports and provides auxiliary closure for the area where regurgitation of the native valve occurs, that is, the free segment of the native valve. Therefore, this treatment method causes little damage to the native valve and significantly improves the effect of preventing regurgitation.

[0070] According to one example, the axial dimension of the auxiliary leaflet segment 2 is at least equal to, and preferably greater than, the axial dimension of the native leaflet.

[0071] According to one example, the lateral extension length L of the auxiliary leaflet segment 2 after expansion (eg Figure 2d The transverse extension length of the auxiliary valve leaflet 2 and the native valve leaflet after deployment is at least equal to, and preferably greater than, the transverse extension length of the native valve leaflet after deployment. Here, the "transverse extension length" refers to the extension length of the auxiliary valve leaflet segment 2 and the native valve leaflet in a cross section perpendicular to the centerline of the aorta at the surgical site.

[0072] In the case where the auxiliary valve leaflet segment 2 is substantially rectangular, the transverse edge at its proximal end will become the free edge of the auxiliary valve leaflet segment 2. In this case, the "transverse extension length" refers to the length of the proximal transverse edge after it is fully expanded. In this case, the "transverse extension length" L can be designed to be equal to or greater than the radius R of the circle defined by the main body of the aortic valve auxiliary prosthesis after expansion (e.g., Figure 3a The circumference of the circle extends through the three vertices of the body, e.g. Figures 3a-3c With this design, especially when the "lateral extension length" L of the lateral edge (i.e., the free edge) of the proximal end of the rectangular auxiliary leaflet segment 2 is greater than twice the radius R of the circle, the proximal lateral edge has sufficient margin for deformation when the aortic valve closes, thereby helping the free edges of each auxiliary leaflet segment 2 to be squeezed and deformed by the regurgitant blood flow until they are tightly attached to each other, achieving better or even complete closure.

[0073] According to one example, the main body may further include a distal placement portion 11, which may be provided with three as shown in the figure, and each of which is preferably an integral biocompatible curved strip structure. Figure 4a As shown, the distal placement portion 11 is configured to maintain a configuration seated in the native valve sinus of the aorta.

[0074] According to an example, Figure 2aAs shown, the distal placement portion 11 is preferably constructed to have a generally smooth outline, such as an arc or other outwardly arched or arched shape, rather than a sharp outer contour, and after being implanted in the aorta, it is attached to or against the vascular wall, for example, the sinus floor of the aortic native valve sinus or its vicinity, such as Figure 4a As shown, in order to assist in maintaining the aortic valve auxiliary prosthesis in a reliable position. The advantage of such a design is that it can effectively prevent the native valve leaflet from colliding with the distal placement part 11 and damaging the valve leaflet.

[0075] According to one example, the distal placement portion 11 may be provided with barbs 112 to further enhance the anchoring force of the valve prosthesis within the heart.

[0076] The distal placement portion 11 may further include an adaptive portion 111, which is designed to adapt the distal placement portion 11 to different sizes of the native valve sinus. For example, the distal placement portion 11 may be configured as a rounded "W" shape, and the adaptive portion 111 may be configured as a curved tip portion in the middle of the rounded "W" shape of the distal placement portion 11, such as Figure 2c shown.

[0077] According to one example, the stiffness of the adaptive portion 111 can be designed to be smaller than that of the rest of the distal placement portion 11 so as to more easily achieve the adaptive function. In other words, the adaptive portion 111 is more easily deformed and adjusted than the rest of the distal placement portion 11.

[0078] like Figure 2c As shown, the middle portion of the distal placement portion 11 with the adaptive portion 111 can be further radially offset, protruding, or extending relative to the remaining portion. This design not only facilitates better positioning of the prosthesis during implantation and more closely adheres to the vessel wall, but also prevents the valve prosthesis from colliding with the native leaflets during operation, effectively protecting the native leaflets and providing a certain degree of stability to the main body.

[0079] According to one example, the main body may further include a middle section 12 connected between each top end 1 and the corresponding distal placement portion 11. After being installed at the aortic surgical site, the middle section 12 is positioned at the junction of adjacent native valve leaflets in a manner of riding, straddling or otherwise.

[0080] According to one example, each auxiliary leaflet segment 2 may be fixedly connected to both the corresponding top 1 and the middle segment 12 .

[0081] According to one example, each intermediate segment 12 is configured to be closely attached to a blood vessel wall, such as the side wall of the aorta's native valve sinus. Figure 4aThe purpose of this design is to prevent the native valve leaflets from contacting or colliding with the middle section 12 when the native valve leaflets are opening and closing, thereby effectively protecting the native valve leaflets while not affecting the operation of the native valve.

[0082] According to one example, the middle section 12 may be provided with a support frame 121. Each support frame 121 is shown to be composed of two rods whose ends are fixed together and arched outward in a generally radial direction relative to each other. On the one hand, the overall radial stiffness and resistance moment of the main body are increased. On the other hand, the rods that are arched outward in a generally radial direction close to the blood vessel wall provide the main body with radial support against the blood vessel wall and maintain a reliable positioning effect. Figure 4a and 4c Another rod of the support frame 121 that is generally arched radially inwards can provide a position for the longitudinal edge of the rectangular auxiliary leaflet segment 2 to be fixed thereon, as shown in FIG. Figures 2a-2c As shown in the figure, such radially inwardly arched rods may be provided with a row of perforations to facilitate fixing the longitudinal edges of the rectangular auxiliary leaflet segments 2 thereon by, for example, sewing, anchoring, etc.

[0083] According to one example, the aortic valve prosthesis may further include a delivery device (not shown) designed to help deliver the aortic valve assist prosthesis to the aortic valve lesion site after loading, and release it after reaching the aortic valve lesion site.

[0084] The foregoing description of exemplary embodiments of the present application has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the present application to the precise configurations and / or constructions disclosed, and it is apparent that numerous modifications and variations may be made by those skilled in the art in light of the above teachings without departing from the present invention. It is intended that the scope and full range of equivalents of the present invention be defined by the claims appended hereto.

Claims

1. An aortic valve assist prosthesis for preventing regurgitation, comprising: A main body, which is configured to remain in place in the aorta at the surgical site; and three auxiliary leaflet segments configured to cooperate with the free segments of the three native leaflets of the aortic valve; wherein the three auxiliary leaflet segments are fixed to the main body; the main body includes three distal placement parts, the distal placement parts are configured to be suitable for remaining in place in the native valve sinus of the aorta, the distal placement parts have adaptive parts, and the stiffness of the adaptive parts is less than the stiffness of the remaining parts of the distal placement parts; the main body includes an intermediate section connected between the top of the main body and the corresponding distal placement parts, each of the intermediate sections is provided with a support frame, the support frame includes two curved rods fixed to each other at both ends and arched radially opposite to each other, the two curved rods include a rod arched generally radially outward and a rod arched generally radially inward, wherein the longitudinal edges of the auxiliary leaflet segments are fixed to the rods arched generally radially inward.

2. The aortic valve assist prosthesis according to claim 1, characterized in that: When the aortic valve is closed, the free edges of the proximal ends of the adjacent auxiliary leaflet segments are deformed to be close to each other, and each auxiliary leaflet segment covers and is close to the free segment of the corresponding native leaflet.

3. The aortic valve assist prosthesis according to claim 1, characterized in that: When the aortic valve opens, the free edges of the proximal ends of adjacent auxiliary leaflet segments are separated from each other.

4. The aortic valve assist prosthesis according to claim 1, characterized in that: Each of the auxiliary leaflet segments has a flexible sheet-like shape.

5. The aortic valve assist prosthesis according to claim 1, characterized in that: Each of the auxiliary leaflet segments has a generally quadrilateral shape.

6. The aortic valve assist prosthesis according to claim 1, characterized in that: Each of the auxiliary leaflet segments has a generally rectangular shape, wherein two longitudinal sides of the rectangle are fixed to the main body.

7. The aortic valve assist prosthesis according to claim 1, characterized in that: The transverse extension length of the free edge of the proximal end of each auxiliary leaflet segment is equal to or greater than the transverse extension length of the free edge of the corresponding native leaflet.

8. The aortic valve assist prosthesis according to claim 1, characterized in that: The distal placement portion is composed of a biocompatible curved strip and has an outer contour that is arched toward the distal end.

9. The aortic valve assist prosthesis according to claim 1, characterized in that: The distal seating portion has a rounded "W" shape.

10. The aortic valve assist prosthesis according to claim 1, characterized in that: The adaptive portion is a rounded "W" shaped portion with a curved tip in the middle.

11. The aortic valve assist prosthesis according to claim 1, characterized in that: The middle portion of the distal placement portion extends radially outward relative to the remaining portion.

12. The aortic valve assist prosthesis according to claim 1, characterized in that: After the aortic valve assist prosthesis is installed in the aorta, the intermediate section straddles the junction of adjacent native valve leaflets.

13. The aortic valve assist prosthesis according to claim 1, characterized in that: The transverse extension length of the free edge of the proximal end of each auxiliary leaflet segment after expansion is equal to or greater than twice the radius of the circle defined by the main body after expansion.

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