A heart valve replacement device and method of delivery and release thereof

Abstract

The application discloses a heart valve replacement device, which comprises a support base and a replacement valve, wherein the support base comprises a support framework, the support framework has a hollow structure, and along the central axis direction of the hollow structure, the two ends of the support framework are respectively provided with a myocardial fixing end and a valve leaflet and chordae tendineae fixing end; the myocardial fixing end is used for fixing the support base to the myocardium and / or the native valve annulus of the heart; and the valve leaflet and chordae tendineae fixing end is used for fixing the support base to the valve leaflet and chordae tendineae of the heart; the replacement valve comprises a hollow valve framework and a valve arranged on the valve framework, and the valve framework is detachably arranged in the hollow structure. The application can solve the problem of difficult valve fixation, does not affect the diastole and systole of the myocardium at the valve annulus part, and reduces the heart work efficiency reduction caused by the implanted valve. The application also provides a method for conveying and releasing the heart valve replacement device.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a heart valve replacement device and its delivery and release method. Background Technology

[0002] The human heart has four chambers and four valves: the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. The mitral valve, located between the left atrium and left ventricle, consists of five parts: leaflets, annulus, papillary muscles, chordae tendineae, and the ventricular myocardium to which the papillary muscles attach. The tricuspid valve includes: leaflets, chordae tendineae, papillary muscles, annulus, the right atrium to which the annulus attaches, the right ventricle to which the papillary muscles attach, and the interventricular septum muscle.

[0003] The tricuspid valve is located at the right atrioventricular orifice. A common complication is tricuspid regurgitation, where systolic blood flows back from the right ventricle into the right atrium, causing significant enlargement of the right atrium, increased pressure, and impaired venous return. Due to the increased workload on the right ventricle, it compensates by becoming hypertrophic, which can easily lead to right heart failure.

[0004] The number of patients with severe tricuspid regurgitation who remain untreated is considerable. While transcatheter treatment for aortic, mitral, and pulmonary valve diseases is relatively common, transcatheter treatment for tricuspid valve disease is still in its early stages. Drug therapy aims to reduce volume overload and improve symptoms of right ventricular dysfunction and pulmonary hypertension, but its effectiveness is not ideal. The long-term survival rate of patients with severe tricuspid regurgitation is even lower than that of some malignant tumors.

[0005] Traditional treatments for mitral and tricuspid valve disease include medication for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. For tricuspid annulus repair, if combined with left-sided valve surgery, cardiopulmonary bypass is necessary, requiring sternotomy or minimally invasive open-chest surgery; isolated tricuspid valve surgery may use a right anterolateral thoracotomy.

[0006] The problem with traditional surgical fixation of the valve annulus:

[0007] 1. Surgical methods require a high level of patient tolerance and carry extremely high surgical risks;

[0008] 2. In interventional replacement of the tricuspid valve, the annular cross-section is greater than or equal to that of the tricuspid valve annulus. By implanting a device to compress the autologous annulus, the posterior leaflet of the tricuspid valve often expands outward due to the weakened right ventricular muscle function in patients with tricuspid regurgitation. This method of implanting an interventional device to support the tricuspid valve annulus will aggravate the outward expansion of the already dilated tricuspid valve annulus, causing the right ventricular muscle to be stretched, which further weakens the systolic and diastolic functions of the right ventricle. Summary of the Invention

[0009] The purpose of this invention is to solve the technical problems of improper installation of valve replacement devices, resulting in decreased right ventricular function and valve annulus enlargement. This invention provides a heart valve replacement device that does not support the valve annulus, does not cause excessive abduction of the right ventricular muscle, and does not damage the valve leaflets.

[0010] To address the aforementioned technical problems, embodiments of the present invention disclose a heart valve replacement device, comprising: a stent base including a supporting frame, the supporting frame having a hollow structure, and at both ends of the supporting frame, a myocardial fixation end and a leaflet and chordae tendineae fixation end, the myocardial fixation end being used to fix the stent base to the myocardium and / or the original valve annulus of the heart, and the leaflet and chordae tendineae fixation end being used to fix the stent base to the leaflets and chordae tendineae of the heart (partial fixation points are on the chordae tendineae, and the chordae tendineae and adjacent leaflets are fixed together during fixation); and a replacement valve including a hollow valve frame and a valve disposed on the valve frame, the valve frame being detachably installed within the hollow structure.

[0011] Using the above technical solution, the myocardial fixation end of the stent base of the heart valve replacement device is fixed to the right atrial myocardium and / or the native valve annulus. Exemplarily, the myocardial fixation end (described later) is a disc, partly fixed to the right atrial myocardium and partly fixed to the valve annulus. This application primarily fixes the myocardial fixation end to the right atrial myocardium, without supporting the valve annulus, without causing excessive abduction of the ventricular muscle, and without damaging the valve leaflets. Therefore, it does not compress the native tricuspid valve annulus, thus avoiding "retention force" and also preventing compression of the conduction bundle. It can buffer the heart's rhythm, and the inner valve layer is not affected by retention force. It can solve the problem of difficult valve fixation, does not affect the relaxation and contraction of the myocardium at the valve annulus site, and reduces the decrease in cardiac work efficiency caused by valve placement.

[0012] According to another specific embodiment of the present invention, the cross-sectional area of ​​the myocardial fixation end is larger than the cross-sectional area of ​​the remaining portion of the supporting skeleton, and the myocardial fixation end includes a skirt extending radially outward, the skirt being used to conform to the myocardium of the heart. This achieves the fixation of the myocardial fixation end to the right atrial myocardium.

[0013] According to another specific embodiment of the present invention, the myocardial fixation end is trumpet-shaped.

[0014] According to another specific embodiment of the present invention, the cross-section of the myocardial fixation end is non-circular.

[0015] According to another specific embodiment of the present invention, the cross-section of the myocardial fixation end is D-shaped or oval-shaped.

[0016] According to another specific embodiment of the present invention, the fixed ends of the leaflets and tendineae are folded ears, barbs, or hooks located on the outside of the supporting skeleton.

[0017] According to another specific embodiment of the present invention, the diameter of the portion of the supporting skeleton corresponding to the native valve annulus is larger than the diameter of the native valve annulus. This portion spans the native valve annulus, thus achieving fixation to the native valve annulus.

[0018] According to another specific embodiment of the present invention, the portion of the supporting frame is provided with a bulge.

[0019] According to another specific embodiment of the present invention, the support base further includes a surface coating disposed on the support frame.

[0020] According to another specific embodiment of the present invention, the supporting frame is a hollow ring structure.

[0021] According to another specific embodiment of the present invention, the valve is a tricuspid valve, the myocardium of the heart is the right atrial myocardium of the heart, and the valve leaflets of the heart include the anterior leaflet and / or posterior leaflet of the tricuspid valve.

[0022] According to another specific embodiment of the present invention, the valve skeleton is provided with an extension protruding from the leaflet and the chordae tendineae fixation end, the extension being used to fix to the inner wall of the ventricle and / or the interventricular septum.

[0023] According to another specific embodiment of the present invention, the extension is disposed on the outer periphery of the valve skeleton.

[0024] According to another specific embodiment of the present invention, the surface of the extension is provided with barbs, hooks, or adhesive materials.

[0025] According to another specific embodiment of the present invention, the outer periphery of the valve skeleton is provided with a first connecting portion, the inner wall of the hollow structure is provided with a second connecting portion, the valve skeleton is placed in the hollow structure along the central axis direction, and the first connecting portion and the second connecting portion are detachably connected and sealed.

[0026] According to another specific embodiment of the present invention, the first connecting part and the second connecting part achieve a sealed connection and a detachable connection by means of an interference fit of elastic materials.

[0027] According to another specific embodiment of the present invention, the first connecting part and the second connecting part achieve a sealed connection and a detachable connection by means of a threaded connection.

[0028] This application also provides a method for delivering and releasing the heart valve replacement device described in any of the above claims, comprising:

[0029] The compressed stent base is placed inside the delivery catheter;

[0030] The delivery catheter is inserted into the right atrium, and the delivery catheter is manipulated to release the stent base. The compressed stent base expands outward and crosses the native tricuspid valve, fixing the leaflet and chordae tendineae to the leaflet and chordae tendineae of the heart.

[0031] The compressed replacement valve is placed inside the delivery catheter;

[0032] The delivery catheter is inserted into the right atrium, and the delivery catheter is manipulated to release the replacement valve within the hollow structure. The compressed replacement valve expands outward, and the valve skeleton is detachably installed within the hollow structure.

[0033] The myocardial fixation end is fixed to the right atrial myocardium and / or the native valve annulus.

[0034] According to another specific embodiment of the present invention, the valve skeleton is provided with an extension protruding from the leaflet and the fixed end of the chordae tendineae, and the extension is fixed to the inner wall of the ventricle and / or the interventricular septum.

[0035] According to another specific embodiment of the present invention, the leaflets of the heart include the anterior leaflet and / or posterior leaflet of the tricuspid valve. Attached Figure Description

[0036] Figure 1 A side view of a heart valve replacement device according to an embodiment of the present invention is shown;

[0037] Figure 2 A three-dimensional exploded view of a heart valve replacement device according to an embodiment of the present invention is shown. Figure 1 ;

[0038] Figure 3 A three-dimensional exploded view of a heart valve replacement device according to an embodiment of the present invention is shown. Figure 2 ;

[0039] Figure 4 A top view of a heart valve replacement device according to an embodiment of the present invention is shown;

[0040] Figure 5 A perspective view of the replacement valve in the heart valve replacement device according to an embodiment of the present invention is shown;

[0041] Figure 6 A top view of the replacement valve in the heart valve replacement device according to an embodiment of the present invention is shown;

[0042] Figure 7 A schematic diagram of the tricuspid valve structure of the heart. Figure 1 ;

[0043] Figure 8 A schematic diagram of the heart's structure is shown.

[0044] Figure 9This diagram illustrates the placement of the heart valve replacement device in the heart according to an embodiment of the present invention. Figure 1 ;

[0045] Figure 10 This diagram illustrates the placement of the heart valve replacement device in the heart according to an embodiment of the present invention. Figure 2 ;

[0046] Figure 11 This diagram illustrates the placement of the heart valve replacement device in the heart according to an embodiment of the present invention. Figure 3 ;

[0047] Figure 12 This diagram illustrates the placement of the heart valve replacement device in the heart according to an embodiment of the present invention. Figure 4 ;

[0048] Figure 13 This diagram illustrates the placement of the heart valve replacement device in the heart according to an embodiment of the present invention. Figure 5 . Detailed Implementation

[0049] The following specific embodiments illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Although the description of the present invention is presented in conjunction with preferred embodiments, this does not mean that the features of the invention are limited to these embodiments. On the contrary, the purpose of describing the invention in conjunction with embodiments is to cover other options or modifications that may be derived based on the claims of the present invention. To provide a deep understanding of the invention, many specific details will be included in the following description. The invention may also be implemented without using these details. Furthermore, to avoid confusion or obscuring the focus of the invention, some specific details will be omitted in the description. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0050] It should be noted that in this specification, similar reference numerals and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0051] The terms “first”, “second”, etc., are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0052] To make the objectives, technical solutions, and advantages of the present invention clearer, the embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0053] refer to Figures 1 to 6This application provides a heart valve replacement device 1, including: a stent base 10 and a replacement valve 20. The stent base 10 includes a support frame 11, which has a hollow structure. Exemplarily, the support frame 11 is a hollow annular structure. Along the central axis of the hollow structure (… Figure 3 As shown in direction A), the supporting skeleton 11 has a myocardial fixation end 111 and a leaflet and chordae tendineae fixation end 112 at both ends. The myocardial fixation end 111 is used to fix the stent base 10 to the myocardium and / or the original valve annulus of the heart, and the leaflet and chordae tendineae fixation end 112 is used to fix the stent base 10 to the leaflets and chordae tendineae of the heart. The replacement valve 20 includes a hollow valve skeleton 21 and a valve 22 disposed in the valve skeleton 21. The valve skeleton 21 is detachably installed in the hollow structure. The valve 22 disposed in the valve skeleton 21 can be an artificial valve or a mechanical valve.

[0054] This application uses the tricuspid valve as an example to illustrate the replacement valve 20. The myocardium of the heart is the right atrial myocardium 2a, and the valve leaflets of the heart include the anterior and / or posterior leaflets of the tricuspid valve. That is, the heart valve replacement device 1 of this application is used to replace the tricuspid valve of the heart. In some possible embodiments, the heart valve replacement device 1 of this application can also be used to replace the mitral valve of the heart.

[0055] refer to Figure 7 Observing from the right atrium towards the right ventricle, Figure 7 This diagram shows the tricuspid annulus 2, the leaflets (anterior, posterior, and septal) within the tricuspid annulus 2, and the right atrial myocardium 2a. (Reference) Figures 8 to 10 This application primarily focuses on fixing the myocardial fixation end 111 of the stent base 10 of the heart valve replacement device 1 to the right atrial myocardium 2a. This eliminates the need to support the valve annulus, avoids excessive abduction of the ventricular muscle, and prevents damage to the valve leaflets. Exemplarily, the myocardial fixation end 111, described later, is a disc, partially fixed to the right atrial muscle and partially fixed at the original valve annulus. Therefore, it avoids compressing the original tricuspid valve annulus 2 to generate a "retention force" and also prevents compression of the conduction bundle. This buffers the heart's rhythm, and the inner valve is unaffected by the retention force. It solves the problem of difficult valve fixation, does not affect the relaxation and contraction of the myocardium at the valve annulus site, and reduces the decrease in cardiac efficiency caused by valve placement.

[0056] In some possible implementations, the cross-sectional area of ​​the myocardial fixation end 111 of the stent base 10 is larger than the cross-sectional area of ​​the rest of the support frame 11, and the myocardial fixation end 111 comprises radially ( Figure 3 The skirt 1111 extends outward in the Z-direction (as shown), and is radially perpendicular to the central axis of the hollow structure. The skirt 1111 of the myocardial fixing end 111 is used to fit against the myocardium of the heart (e.g., ...). Figure 10(As shown). The shape and size of the myocardial fixation end 111 are adapted to the right atrial myocardium 2a. This allows the myocardial fixation end 111 to be fixed to the right atrial myocardium 2a.

[0057] For example, the myocardial fixation end 111 of this application is trumpet-shaped.

[0058] In some possible implementations, the cross-section of the myocardial fixation end 111 is non-circular. Exemplarily, the cross-section of the myocardial fixation end 111 is D-shaped or oval. Figure 4 (As shown).

[0059] Continue to refer to Figure 2 and Figure 3 In this application, the leaflet and tendineae fixing end 112 is a folded ear, barb 231 or hook located on the outside of the supporting skeleton 11. Figure 2 and Figure 3 The diagram shows that the leaflet and chordae tendineae fixation ends 112 are folded ears located on the outer side of the support frame 11. The support frame 11 of this application has at least one folded ear on its outer side. The released folded ear is fixed to the anterior and / or posterior leaflets of the tricuspid valve, with some fixation points on the chordae tendineae. During fixation, the chordae tendineae and adjacent leaflets are fixed together. The folded ear clamps the leaflets (anterior and / or posterior leaflets) during surgery, assisting in adjusting the fixation position of the support base 10.

[0060] In some possible implementations, the diameter of the portion of the supporting frame 11 corresponding to the native valve annulus 2 is larger than the diameter of the native valve annulus 2. This portion spans the native valve annulus 2, thus securing it to the native valve annulus 2. This configuration prevents the stent base 10 from shifting after it is fixed to the right atrial myocardium 2a, buffering cardiac rhythm and achieving non-radial support anchoring.

[0061] In some possible implementations, the ventricular end transvalvular diameter of the stent base 10 is not greater than that of the original valve annulus 2, so as not to compress and generate retention force.

[0062] For example, refer to Figure 2 The portion of the supporting skeleton 11 corresponding to the original valve ring 2 has a bulge 114. The design of the bulge 114 makes the diameter of the portion of the supporting skeleton 11 corresponding to the original valve ring 2 larger than the diameter of the original valve ring 2.

[0063] In some possible embodiments, the aforementioned support base 10 further includes a surface coating 12 disposed on the support frame 11. A portion of the coating 12 forms the aforementioned skirt 1111.

[0064] Continue to refer to Figure 1 , Figure 2 , Figure 5 , Figure 6 and Figure 10The valve skeleton 21 of this application has an extension 23 protruding from the leaflet and the chordae tendineae fixing end 112. The extension 23 is used to fix to the inner wall of the ventricle and / or the interventricular septum 2b. In this application, since the valve skeleton 21 is installed in a hollow structure in a detachable manner, it is equivalent to the heart valve replacement device 1 being a split device. This facilitates the adjustment of the relative positions of the leaflet fixing point and the interventricular septum 2b support point (or the inner wall of the ventricle).

[0065] refer to Figure 5 The extension 23 of this application is located on the outer periphery of the valve skeleton 21. The surface of the extension 23 is provided with barbs 231, hooks, or adhesive materials for fixation to the inner wall of the ventricle and / or the interventricular septum 2b. However, the extension 23 of this application is not limited to these; any form that can achieve fixation to the inner wall of the ventricle and / or the interventricular septum 2b falls within the scope of protection of this application.

[0066] This application does not limit the detachable connection method between the stent base 10 and the replacement valve 20. For example, refer to... Figure 2 and Figure 3 The valve skeleton 21 has a first connecting portion 24 on its outer periphery and a second connecting portion 113 on the inner wall of the hollow structure. The valve skeleton 21 is inserted into the hollow structure along the central axis. The first connecting portion 24 and the second connecting portion 113 are detachably connected and sealed. Exemplarily, the first connecting portion 24 and the second connecting portion 113 are mated by an interference fit of elastic materials to achieve a sealed and detachable connection. Alternatively, in some possible embodiments, the first connecting portion 24 and the second connecting portion 113 are connected by a threaded connection to achieve a sealed and detachable connection. Alternatively, in some possible embodiments, the first connecting portion 24 and the second connecting portion 113 are connected by a silicone sealing ring to achieve a sealed and detachable connection.

[0067] In some possible implementations, the stent base 10 described above has a cushioning effect, while the valve skeleton 21 of the replacement valve 20 provides rigid support. This configuration can prevent the rhythmic contractions caused by cardiac contractions and reduce the decrease in cardiac efficiency caused by valve placement.

[0068] Taking tricuspid valve surgery as an example, tricuspid valve replacement can be performed via surgical implantation or open-heart surgery. First, cardiopulmonary bypass is established. During the procedure, the stent base 10 is placed across the native tricuspid valve. The folded tabs of the stent base 10 are reversed to clamp the anterior and / or posterior leaflets of the tricuspid valve. After adjusting the position of the stent base 10, the replacement valve 20 is placed. The stent base 10 and the replacement valve 20 are then assembled and connected. Finally, the stent base 10 is fixed to the right atrial myocardium 2a, thus completing the tricuspid valve replacement.

[0069] In some possible implementations, this application also provides a method for delivering and releasing the heart valve replacement device 1 described in any of the above embodiments. Specifically, the heart valve replacement device 1 is implanted via a catheter. Unlike surgical implantation, the separate stent base 10 and replacement valve 20 can be placed via an interventional cannula. Exemplarily, the stent base 10 is delivered via the femoral vein, and the replacement valve 20 is delivered via the jugular vein, with the stent base 10 and replacement valve 20 delivered to the right atrium assembly. Catheter-guided intervention is made possible by reducing the volume of the stent base 10 and replacement valve 20.

[0070] The above methods include:

[0071] The compressed stent base 10 is placed inside the delivery catheter, and the compressed replacement valve 20 is placed inside the delivery catheter.

[0072] refer to Figure 11 The stent base 10 and the replacement valve 20 are in the delivery catheters 3 and 4 (compressed, respectively), wherein the delivery catheters 3 and 4 include an inner core, an adjusting pusher, and an outer tubing. The outer tubing is further flexible (not shown) by wire traction. The distal end of the inner core has a tapered tip to reduce pushing resistance. The adjusting pusher of each delivery catheter contacts the proximal end of the stent base 10 or the replacement valve 20, respectively, compressing and retracting the stent base 10 and the replacement valve 20 inside the outer tubing.

[0073] refer to Figure 12 In use, the stent base 10 is delivered via the femoral vein. The delivery system is placed in the right atrium. Under X-ray-assisted imaging, after adjusting the position, the stent base 10 is withdrawn from the outer sheath. The stent base 10 elastically returns to its preset shape and can be rotated to adjust the corresponding fixed position. After confirmation, the outer tube is completely released. That is, the delivery catheter 3 enters the right atrium, and the delivery catheter 3 is operated to release the stent base 10. The compressed stent base 10 expands outward and crosses the native tricuspid valve, fixing the leaflet and chordae tendineae fixing end 112 to the leaflet and chordae tendineae of the heart.

[0074] refer to Figure 13 The replacement valve 20 is delivered via the jugular vein. The delivery system is placed in the right atrium under X-ray-assisted imaging. The replacement valve 20 elastically recovers its preset shape and, after adjusting its relative position to the interventricular septum 2b, is fixed within the stent base 10. Alternatively, the delivery catheter 4 enters the right atrium, and the delivery catheter 4 is manipulated to release the replacement valve 20 within the hollow structure. The compressed replacement valve 20 expands outward, and the valve skeleton 21 is detachably installed within the hollow structure.

[0075] Finally, the myocardial fixation end 111 is fixed to the right atrial myocardium 2a and / or the original valve annulus. Exemplarily, the myocardial fixation end 111 is a disc, partly fixed to the right atrial myocardium and partly fixed to the valve annulus. The main purpose of this application is to fix the myocardial fixation end 111 to the right atrial myocardium, which does not support the valve annulus, does not cause excessive abduction of the right ventricular myocardium, and does not damage the valve leaflets.

[0076] Specifically, taking tricuspid valve surgery as an example, the surgical approach involves interventional treatment. The stent base 10 is placed within a catheter and inserted into the right atrium via the femoral vein. The replacement valve 20 is also placed within a catheter and inserted into the right atrium via the femoral vein. During the procedure, the stent base 10 is first released across the native tricuspid valve. The tabs of the stent base 10 fold back to clamp the anterior and / or posterior leaflets. The position of the stent base 10 is adjusted, and then the replacement valve 20 is immediately placed. The stent base 10 and the replacement valve 20 are then assembled and connected. Finally, the stent base 10 is fixed to the right atrial myocardium 2a. This reduces the time required for blood flow across the valve, accelerating the surgical process.

[0077] In some possible implementations, the aforementioned extension 23 is fixed to the inner wall of the ventricle and / or the interventricular septum 2b.

[0078] In summary, the heart valve replacement device 1 of this application is fixed to the right atrial myocardium 2a and / or the original valve annulus, without supporting the valve annulus, without causing excessive abduction of the right ventricular muscle, without damaging the valve leaflets, and without avoiding the 0.5cm conduction bundle. It can buffer the heart rhythm, and the inner valve is not affected by the fixation force.

[0079] While the present invention has been illustrated and described with reference to certain preferred embodiments, those skilled in the art should understand that the above description is a further detailed explanation of the invention in conjunction with specific embodiments, and should not be construed as limiting the specific implementation of the invention to these descriptions. Various changes in form and detail can be made by those skilled in the art, including several simple deductions or substitutions, without departing from the spirit and scope of the invention.

Claims

1. A heart valve replacement device, characterized in that, include: A stent base includes a supporting frame with a hollow structure. Along the central axis of the hollow structure, the supporting frame has a myocardial fixation end and a leaflet and chordae tendineae fixation end at each end. The myocardial fixation end is used to fix the stent base to the myocardium and / or the original valve annulus of the heart, and the leaflet and chordae tendineae fixation end is used to fix the stent base to the valve leaflets and chordae tendineae of the heart. The myocardial fixation end is a disc, partly fixed to the right atrial myocardium and partly fixed to the original valve annulus. A replacement valve includes a hollow valve skeleton and a valve disposed within the valve skeleton, the valve skeleton being detachably installed within the hollow structure.

2. The heart valve replacement device as described in claim 1, characterized in that, The cross-sectional area of ​​the myocardial fixation end is larger than the cross-sectional area of ​​the rest of the supporting skeleton. The myocardial fixation end includes a skirt that flares out radially outward, the skirt being used to fit against the myocardium of the heart.

3. The heart valve replacement device as described in claim 2, characterized in that, The fixed end of the myocardium is trumpet-shaped.

4. The heart valve replacement device as described in claim 2, characterized in that, The cross-section of the myocardial fixation end is non-circular.

5. The heart valve replacement device as described in claim 4, characterized in that, The cross-section of the fixed end of the myocardium is D-shaped or oval-shaped.

6. The heart valve replacement device as described in claim 1, characterized in that, The fixed ends of the leaflets and tendineae are folded ears, barbs, or hooks located on the outside of the supporting skeleton.

7. The heart valve replacement device as described in claim 1, characterized in that, The diameter of the portion of the supporting skeleton corresponding to the original valve annulus is larger than the diameter of the original valve annulus.

8. The heart valve replacement device as described in claim 7, characterized in that, The portion of the supporting frame is provided with a bulge.

9. The heart valve replacement device as described in claim 1, characterized in that, The support base also includes a surface coating on the supporting frame.

10. The heart valve replacement device as described in claim 1, characterized in that, The supporting frame is a hollow ring structure.

11. The heart valve replacement device as claimed in claim 1, characterized in that, The valve is a tricuspid valve, the myocardium of the heart is the right atrial myocardium, and the valve leaflets of the heart include the anterior and / or posterior leaflets of the tricuspid valve.

12. The heart valve replacement device according to any one of claims 1 to 11, characterized in that, The valve skeleton is provided with an extension protruding from the leaflet and the chordae tendineae fixing end, the extension being used to fix to the inner wall of the ventricle and / or the interventricular septum.

13. The heart valve replacement device as described in claim 12, characterized in that, The extension is located on the outer periphery of the valve skeleton.

14. The heart valve replacement device as described in claim 12, characterized in that, The surface of the extension is provided with barbs, hooks, or adhesive materials.

15. The heart valve replacement device as described in claim 12, characterized in that, The valve skeleton is provided with a first connecting part on its outer periphery and a second connecting part on the inner wall of the hollow structure. The valve skeleton is placed into the hollow structure along the central axis. The first connecting part and the second connecting part are detachably connected and sealed.

16. The heart valve replacement device as described in claim 15, characterized in that, The first connecting part and the second connecting part achieve a sealed connection and a detachable connection through an interference fit of elastic materials.

17. The heart valve replacement device as described in claim 15, characterized in that, The first connecting part and the second connecting part achieve a sealed connection and a detachable connection through a threaded connection.

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