A tricuspid valve prosthesis

Abstract

The present invention discloses a tricuspid valve prosthesis, comprising: a stent body implanted at the tricuspid valve annulus for supporting artificial valve leaflets; an anchoring structure disposed above the stent body for anchoring the stent body at the native annulus to prevent its displacement; wherein the anchoring structure is configured to be partially attached to the fossa ovalis of the interatrial septum, and a retention force is formed by attaching to the fossa ovalis, thereby realizing the anchoring effect on the valve prosthesis. Inspired by the native structure of the fossa ovalis, the present invention makes full use of the concave structure of the fossa ovalis to partially clamp the anchoring structure in the fossa ovalis, thereby providing a certain retention force to prevent the valve prosthesis from shifting during cardiac compression; the anchoring structure of the present invention changes the traditional anchoring method of clamping or grasping valve leaflets, and will not pull the chordae tendineae or damage the valve leaflets.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a valve prosthesis implanted in the heart for replacing the native tricuspid valve. Background Art

[0002] The heart valve is a membranous structure that can open and close inside the organs of humans or certain animals. There are four valves in each person's heart, namely, the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle. They all act as one-way valves, enabling blood to flow in only one direction and not reverse.

[0003] With the development of social economy and the aging of the population, the incidence of valvular heart disease has increased significantly. Research shows that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. Currently, traditional surgical treatment is still the preferred treatment method for patients with severe valvular lesions. However, for patients who are elderly, have multiple organ diseases, have a history of thoracotomy, and have poor cardiac function, traditional surgical treatment has high risks and high mortality rates, and some patients even have no chance of surgery.

[0004] As the atrioventricular valve of the right heart, the tricuspid valve has a structure similar to that of the mitral valve, including valve leaflets, valve annulus, chordae tendineae, papillary muscles, and myocardium. Transcatheter tricuspid valve replacement / repair has the advantages of no need for thoracotomy, small trauma, and fast patient recovery, and has received extensive attention from experts and scholars.

[0005] Although the tricuspid valve replacement technology has developed rapidly, there are still some recognized problems in the valve design. For example, 1. Anchoring of the valve. The existing tricuspid valve designs basically use clamping the valve leaflets or grasping the valve leaflets for anchoring. These two anchoring methods will both pull the chordae tendineae and cause damage to the native valve leaflets. Some people have proposed using the atrioventricular septum for anchoring, but this anchoring method is not reliable and also requires additional clamping of the valve leaflets, otherwise it is easy to fall off and there are safety hazards. 2. There is a risk of conduction block. When anchoring through the stent body, the stent compresses the conduction tissue and there is a risk of conduction block. Summary of the Invention

[0006] The present invention provides a tricuspid valve prosthesis that can solve the above defects in the prior art.

[0007] The technical solution of the present invention is as follows:

[0008] A tricuspid valve prosthesis, comprising: a stent body implanted at the tricuspid annulus for supporting artificial valve leaflets; an anchoring structure disposed above the stent body for anchoring the stent body at the native annulus to prevent displacement thereof; wherein the anchoring structure is configured to be partially attached to the fossa ovalis of the interatrial septum, and a retaining force is formed by attaching to the fossa ovalis, thereby realizing the anchoring effect on the valve prosthesis. Inspired by the native structure of the fossa ovalis, the present invention makes full use of the concave structure of the fossa ovalis to partially clamp the anchoring structure in the fossa ovalis, thereby providing a certain retaining force to prevent the valve prosthesis from moving during cardiac compression; the anchoring structure of the present invention changes the traditional anchoring method of clamping or grasping the valve leaflets, and will not pull the chordae tendineae or damage the valve leaflets.

[0009] Preferably, the anchoring structure includes a first anchor, and the first anchor is configured to have at least one protruding portion, and the protruding portion is embedded into the fossa ovalis and fits against the inner wall of the fossa ovalis to play an anchoring role and provide an effective anchoring force for the valve prosthesis.

[0010] Wherein, the protruding portion is preferably a circular arc structure formed by a rod-shaped member. At this time, there may be one protruding portion. Preferably, there are at least two protruding portions. Each protruding portion extends axially and the plurality of protruding portions are arranged side by side. Arranged side by side means that the plurality of protruding portions are distributed along the long axis direction of the fossa ovalis. The forming process of the rod-shaped member is simple, and the plurality of protruding portions are simultaneously embedded into the fossa ovalis and fit against the short axis, which can provide a more stable retaining effect.

[0011] Preferably, the anchoring structure further includes a second anchor, and the second anchor is fixed to the atrial wall by a radial acting force to provide further anchoring force. Among them, the second anchor is arranged in the right atrium in an Oversize manner to provide a radial acting force to achieve anchoring.

[0012] Preferably, the second anchor is configured to be provided with a convex portion, and the convex portion is embedded into the fossa ovalis to provide further anchoring force. The convex portion fits against the inner wall of the fossa ovalis, which can prevent the displacement of the second anchor.

[0013] In order to prevent the connection between the first anchor and the second anchor from damaging the relatively thin and soft fossa ovalis, at the upper edge of the protruding portion, the second anchor is connected to the first anchor. The atrial wall at the upper edge of the fossa ovalis is thicker and can withstand greater extrusion, and can also play a role in further stabilizing the anchoring structure.

[0014] Specifically, the second anchor is configured as a circular or arc-shaped rod structure. The extending direction of the second anchor is set at a predetermined angle with respect to the extending direction of the first anchor. The predetermined angle is such that the stressed portion of the second anchor is near the fossa ovalis, avoiding squeezing the Koch triangle and the conduction tissue. Preferably, the anchoring structure further includes at least one connecting portion. The anchoring structure is fixed to the stent body through the connecting portion. At a position near the stent body, the connecting portion is configured to extend in a direction towards the stent body, such that the stressed portion of the anchoring structure of the present invention is near the fossa ovalis, avoiding squeezing the Koch triangle and the conduction tissue, and avoiding blocking the coronary sinus ostium and the inferior vena cava ostium in the bottom region of the right atrium.

[0015] Preferably, a plurality of the connecting portions are provided, and the upper edge of the connecting portion extends in a direction away from the axis of the stent body. That is, the upper edge of the connecting portion is attached to the atrial wall. The plurality of connecting portions can increase the contact area of the anchoring structure, thereby providing enhanced anchoring force. At the same time, the plurality of connecting portions can also be used to stabilize the above-mentioned anchoring structure. Preferably, the connecting portions are evenly distributed along the circumferential direction of the stent body, and the specific number should be set according to the anchoring requirements and the difficulty of crimping.

[0016] Preferably, the anchoring structure further includes a protruding portion. The protruding portion includes an anchor needle that pierces the atrial wall or barbs that grab tissue, so as to play a further anchoring role.

[0017] Preferably, the protruding portion is arranged at an end away from the stent body, avoiding the fossa ovalis to prevent the anchor needle or barbs from piercing the fossa ovalis.

[0018] Preferably, the anchoring structure is made of a material with good biocompatibility. The material with good biocompatibility is beneficial for endothelialization and can help repair the fossa ovalis defect, such as congenital patent foramen ovale, secundum atrial septal defect or the channel hole left on the fossa ovalis after left heart interventional surgery.

[0019] Preferably, a film layer or a skirt is further provided on the surface of the anchoring structure. The film layer can be provided in the form of film coating, woven fabric suture, etc. The material of the film layer can be selected from PET, PTFE or ePTFE, PU and other materials with good biocompatibility and easy endothelialization. It can not only protect the native tissue from being scratched by the stent frame but also increase the area of endothelialization, providing assistance for anchoring. When a skirt is provided on the surface of the anchoring structure, the skirt can be provided on the connecting portion of the anchoring structure, and a part of the mesh should be exposed to avoid squeezing and contacting the Koch triangle, and at the same time avoid blocking the inferior vena cava ostium and the coronary sinus ostium.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0021] First, the anchoring structure of the present invention is partially attached to the fossa ovalis of the interatrial septum, and the retaining force for the anchoring structure is formed through the concave structure of the fossa ovalis, thereby realizing the anchoring effect on the valve prosthesis, changing the traditional anchoring method of clamping or grasping the valve leaflets, and not pulling the chordae tendineae or damaging the valve leaflets.

[0022] Second, the first anchor is anchored by embedding the protruding part into the fossa ovalis. The forming method of the protruding part is simple and easy to implement. When the anchoring structure further includes a second anchor anchored to the atrial wall and the second anchor is configured to be partially embedded in the fossa ovalis, an enhanced anchoring force is further provided; the first anchor and the second anchor act together to provide reliable anchoring.

[0023] Third, the anchoring structure of the present invention plays a fixing role through the connecting part, extends towards the stent body at a position near the stent body to avoid the conduction tissue, and the main stress part of the anchoring structure is near the fossa ovalis, avoiding squeezing the Koch triangle and the conduction tissue and preventing conduction block.

[0024] Of course, it is not necessary for any product implementing the present invention to achieve all the above-mentioned advantages simultaneously. Description of the Drawings

[0025] Figure 1 is a front view structural schematic diagram of the valve prosthesis according to Embodiment 1 of the present invention;

[0026] Figure 2 is a side view structural schematic diagram of the valve prosthesis according to Embodiment 1 of the present invention;

[0027] Figure 3 is a side view structural schematic diagram of the valve prosthesis according to Embodiment 2 of the present invention;

[0028] Figure 4 is a top view structural schematic diagram of the valve prosthesis according to Embodiment 2 of the present invention;

[0029] Figure 5 is a front view structural schematic diagram of the valve prosthesis according to Embodiment 2 of the present invention;

[0030] Figure 6 is a structural schematic diagram of the valve prosthesis according to Embodiment 2 of the present invention implanted at the tricuspid annulus;

[0031] Figure 7 is an anatomical structural schematic diagram of the right atrium.

[0032] Reference numerals: stent body 110; inflow section 111; outflow section 113; transition section 112; anchoring structure 210; second anchor 212; protruding part 213; first anchor 211; protruding portion 2111; first connecting section 2112; outward protruding part 2121; second connecting section 2122. Detailed implementation mode

[0033] The present invention provides an implantable tricuspid valve prosthesis, which makes full use of the original structure of the oval fossa, and provides a certain anchoring force by partially embedding the anchoring structure into the oval fossa, so as to realize the anchoring of the valve prosthesis.

[0034] The so-called tricuspid valve generally refers to the tricuspid valve complex, which is located between the right atrium and the right ventricle and consists of the tricuspid valve annulus, the tricuspid valve, the chordae tendineae and the papillary muscles. It forms an integral whole in terms of function and structure to ensure the blood flow from the atrium to the ventricle. See Figure 7 , which is a schematic diagram of the anatomical structure of the right atrium. The right atrium has three entrances, namely the superior and inferior vena cava orifices and the coronary sinus orifice; and one exit, namely the tricuspid orifice. The superior vena cava orifice is located at the posterior upper part of the atrium, and the inferior vena cava orifice is below it. The left front of the inferior vena cava is the tricuspid orifice, and the coronary sinus orifice is between the inferior vena cava valve and the tricuspid orifice. The medial wall of the right atrium is the interatrial septum, and there is an oval depression in its lower part, called the oval fossa. The oval fossa is in the lower 1 / 3 of the interatrial septum, to the left and above the inferior vena cava orifice, and there is a small groove reaching 3-4 mm deep at the central depression.

[0035] There is an atrioventricular node around the original valve annulus under the endocardium on the right side of the interatrial septum. At the anterior inner edge of the coronary sinus orifice, the attachment edge of the septal leaflet of the tricuspid valve and the Todaro tendon form the Koch triangle. The vertex of the anterior part of the triangle, that is, the junction of the anterior leaflet and the septal leaflet, is near the atrioventricular node. The atrioventricular node is an important part of the cardiac conduction system. In addition to supporting and pulling the inferior vena cava valve and the coronary sinus valve, the Todaro tendon also has a certain supporting and fixing effect on the myocardium of the lower part of the interatrial septum. Therefore, in the design of the valve replacement at the original position of the tricuspid valve, the Koch triangle area should be avoided being squeezed and covered as much as possible.

[0036] The generally said valve prosthesis consists of two parts: a valve stent and artificial valve leaflets fixed thereon. Among them, the valve stent mainly includes a stent body 110 and an anchoring structure 210. The stent body 110 is a hollow columnar structure with openings at both ends, and the artificial valve leaflets are fixed on the inner circumference of the stent body 110. The stent body 110 and the anchoring structure 210 are connected by means such as riveting, welding, buckling, and suturing. The anchoring structure 210 can be made of nitinol or other biocompatible materials with shape memory characteristics, or materials that can be elastically or plastically deformed, such as balloon-expandable materials.

[0037] The valve prosthesis has two forms: a compressed state and an expanded state, that is, both the stent body 110 and the anchoring structure 210 have these two states. In the present invention, unless otherwise emphasized, the descriptions are all the characteristics in the expanded state.

[0038] Among them, see Figure 1, the stent body 110 includes an inflow section 111, an outflow section 113, and a transition section 112 located therebetween. The outflow section 113 is downstream of the inflow path according to the direction of blood flow. Optionally, the stent body 110 further includes lugs (not shown in the figure), and the lugs are connected to the end of the outflow section 113 away from the transition section 112. The lugs are used to connect to the delivery system to ensure that the relative position between the valve prosthesis and the delivery system remains unchanged when the valve is loaded into the delivery system, the valve is released from the delivery system, and the valve is transported in the body in the delivery system.

[0039] The cross-sectional shape of the stent body 110 can be circular, oval, D-shaped, flower-shaped, or other irregular shapes. The stent body 110 can be made of metals such as nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox / Elgiloy, platinum-chromium, etc., or other biocompatible metals known to those skilled in the art. Optionally, the stent body 110 can also be made of materials that can be elastically or plastically deformed, such as balloon-expandable, or can be a shape memory alloy that responds to temperature changes to transition between a contracted delivery state and an expanded deployed state. Preferably, the stent body 110 is manufactured by cutting a nitinol alloy tube, and the outer diameter of the tube is 5 - 15 mm, and the diameter size after sizing is selected according to actual needs.

[0040] The stent body 110 has significant radial and axial stiffness and can withstand the traction of the valve leaflets. The stent body 110 is composed of structural units such as reticular structural units or wavy structural units whose axial morphology can be changed. These structural units are connected to each other circumferentially, and are composed of at least one row of the structural units axially, and multiple rows of units can be directly or indirectly connected to each other axially. The stent body 110 preferably has a reticular structure, and the mesh units are mesh units such as triangles, rhombuses, pentagons, and teardrop shapes that can form closed shapes, and a rhombus structure is preferred.

[0041] The inner surface or outer surface or both sides of the stent body 110 are covered with skirts to achieve a sealing function and ensure that the single blood channel is from the inflow section end of the prosthetic valve leaflet to the outflow section end of the prosthetic valve leaflet. The skirts are made of pericardium (such as porcine pericardium, bovine pericardium, ovine pericardium, etc.) or other biocompatible polymer materials (such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), etc.).

[0042] The valve prosthesis includes at least two artificial valve leaflets. The number of artificial valve leaflets is the same as or different from that of the native valve leaflets. The valve leaflets are made of animal pericardium or other biocompatible polymer materials. One end of the valve leaflet is directly or indirectly stably connected to the stent body 110, and the other end of the valve leaflet is a free end. In the working state, the artificial valve leaflets replace the native valve leaflets to achieve the function of opening and closing the blood channel.

[0043] The valve prosthesis as described above is implanted into the heart through a delivery system. After being compressed and held, the valve prosthesis is loaded into a delivery device such as a sheath, and is released after being implanted at the target position. The released valve prosthesis expands and anchors at the target position.

[0044] The present invention will be further described below in conjunction with specific embodiments.

[0045] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention.

[0046] In the description of the present invention, it should be noted that "valve prosthesis" and "valve" have the same meaning. In the description of the present invention, it should be noted that "axial direction" refers to the axial direction of the stent body, and "above" includes not only directly above but also laterally above.

[0047] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0048] As used in this specification, the singular forms "a", "an", and "the" include plural objects unless the content clearly indicates otherwise. The terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance. The term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0049] Embodiment 1

[0050] This embodiment provides a tricuspid valve prosthesis. The valve prosthesis includes a stent body 110, which is implanted at the tricuspid valve annulus and is used to support the artificial valve leaf; it also includes an anchoring structure 210, which is arranged above the stent body 110 and is used to anchor the stent body 110 at the native valve annulus to prevent it from shifting; wherein, the anchoring structure 210 is configured to be partially attached to the fossa ovalis of the interatrial septum, and forms a retaining force by attaching to the fossa ovalis, so as to realize the anchoring effect on the valve prosthesis.

[0051] Inspired by the native structure of the fossa ovalis, a new anchoring structure is proposed in this embodiment. The anchoring structure 210 is arranged in a manner of partially embedding into the fossa ovalis and fitting the fossa ovalis, and the retention force generated by the concave structure of the fossa ovalis is utilized to prevent the valve prosthesis from shifting during the cardiac compression process.

[0052] See Figure 1 - Figure 2 , Figure 1 which is the front view structural schematic diagram of the valve prosthesis in this embodiment, Figure 2 and which is the side view structural schematic diagram of the valve prosthesis in this embodiment.

[0053] Among them, the anchoring structure 210 includes a first anchor 211, and the first anchor 211 is configured to have at least one protrusion 2111. The protrusion 2111 is embedded into the fossa ovalis to play an anchoring role. In this embodiment, the first anchor 211 is configured to have two protrusions 2111. The protrusion 2111 is an arc-shaped rod structure, extending along the short axis direction of the fossa ovalis, and the two protrusions 2111 are arranged side by side on the left and right. During implantation, the protrusions 2111 are respectively embedded into the fossa ovalis, and the two protrusions 2111 are arranged along the long axis direction of the fossa ovalis. Compared with a single protrusion 2111, a more stable anchoring force can be provided. Of course, in other alternative embodiments, more than two protrusions 2111 can also be selected for configuration, which can be set according to actual needs.

[0054] The anchoring structure 210 further includes a connecting portion, and the connecting portion fixes the anchoring structure 210 above the stent main body 110. The connecting portion can be integrally formed with other parts of the anchoring structure 210 (such as the protrusion 2111 in this embodiment), and then fixed to the stent main body 110 by welding or suturing. Or the connecting portion can also adopt a drawstring and connect other parts of the anchoring structure 210 and the stent main body 110 by suturing and knotting.

[0055] In this embodiment, the first anchor 211 is formed by bending a rod-shaped member. The first anchor 211 is bent in the middle to form a symmetrical structure, which protrudes outward at a predetermined position away from the stent body 110, and two of the above-mentioned protrusions 2111 are formed on the left and right rod-shaped structures respectively; a first connecting section 2112 is formed at one end close to the stent body 110, and the two first connecting sections 2112 are respectively located at the lower edges of the protrusions 2111. The first connecting section 2112 is the connecting part of the anchoring structure 210 in this embodiment. During implantation, the junction of the first connecting section 2112 and the protrusion 2111 fits the lower edge of the oval fossa. The first anchor 211 in this embodiment is integrally formed, which has the advantages of simple structure and easy implementation. Moreover, the formed first anchor 211 has a smooth and round structure as a whole, and will not cause damage to the native tissue. At the same time, compared with a single first connecting section 2112, the protrusions 2111 are respectively connected to the stent body 110 through the first connecting section 2112, which can improve the structural stability of the first anchor 211 and prevent torsional deformation. Of course, in other embodiments, the first connecting section 2112 and the protrusions 2111 can be manufactured separately and then connected together.

[0056] Wherein, in the direction from the protrusion 2111 to the stent body 110, the first connecting section 2112 gradually extends in the direction of the stent body 110. The first connecting section 2112 is located at the lower edge of the first anchor 211. Since the distance between the coronary sinus orifice and the tricuspid orifice is very short and the coronary sinus orifice cannot be blocked, the lower end of the first anchor 211, that is, at the coronary sinus orifice, should be set away from the atrial wall to leave enough space to prevent blocking the coronary sinus orifice.

[0057] In this embodiment, the protrusions 2111 are arranged in such a way that they can be embedded in the oval fossa and fit the short axis of the oval fossa to provide effective anchoring force. The maximum depth d1 of the protrusions 2111 is 2-4 mm, and the height h2 is 6-10 mm. Among them, if the maximum depth or height is too large, the resistance force will be too large, and there is a risk of damaging the native structure of the oval fossa. If the maximum depth or height is too small, it will not be able to embed well in the oval fossa and it is difficult to provide stable anchoring force. Here, the "depth" refers to the vertical distance from the tangent of the outer surface of the protrusion 2111 to the lower edge of the protrusion 2111, and the "height" refers to the dimension in the axial direction of the stent body 110.

[0058] The distance w1 between the lower edges of the two protrusions 2111 is 5 to 15 mm. A suitable distance is set between the protrusions 2111 to be embedded in the fossa ovalis, which can provide a stable anchoring force. The depth (i.e., the vertical distance) d2 between the upper edge and the lower edge of the first connecting segment 2112 is 2 to 9 mm, and the height h1 of the first connecting segment 2112 is 11 - 13 mm. The first connecting segment 2112 presses the protrusions 2111 against the fossa ovalis to generate the above-mentioned anchoring force. The two first connecting segments 2112 are generally distributed along the two sides of a trapezoid, making the structure of the first anchor 211 more stable. The width of the lower edges of the two first connecting segments 2112 is related to the nodes of the stent body 110.

[0059] In some embodiments, the first anchor 211 further includes a protrusion 213, and the protrusion 213 includes an anchor needle that pierces the atrial wall. In this embodiment, the protrusion 213 is constructed on the first anchor 211 during molding. The protrusion 213 is located at the free end of the first anchor 211. During implantation, the protrusion 213 extends out of the upper edge of the fossa ovalis, and the anchor needle pierces the atrial wall to strengthen the anchoring of the valve prosthesis. On the other hand, the upper and lower parts of the protrusion 2111 are simultaneously stressed, further stabilizing the protrusion 2111 in the fossa ovalis. In other embodiments, the protrusion 213 can also be a barb for grasping tissue, which can also play a role in further anchoring.

[0060] Furthermore, a film layer or a skirt is provided on the surface of the anchoring structure 210. In some embodiments, a film layer is provided on the surface of the protrusion 2111. The film layer is made of a polymer material and can be set in the form of film coating, woven fabric stitching, etc. Specific polymer materials can be selected from PET, PTFE or ePTFE, PU and other materials with good biocompatibility and easy endothelialization. It can not only protect the native tissue from being scratched by the stent frame, but also increase the area of endothelialization to provide assistance for anchoring. In some embodiments, the surface of the first connecting segment 2112 is partially covered with a skirt or not covered with a skirt, exposing at least part of the large mesh. At the same time, in cooperation with the large mesh design or notch design of the stent body 110, it can avoid squeezing and contacting the Koch triangle, and at the same time avoid blocking the inferior vena cava orifice and the coronary sinus orifice. In some embodiments, the protrusion 213 is covered with a skirt, and the skirt is an anchor needle, which can also protect the native tissue from being scratched by the stent frame.

[0061] In an alternative embodiment, fixing ears are further provided on the anchoring structure 210, and the fixing ears are provided on the protrusion 213. The fixing ears are used to connect with the delivery system to ensure that the relative position of the valve prosthesis and the delivery system remains unchanged when the valve is loaded into the delivery system, the valve is released from the delivery system, and the valve is transported in the body in the delivery system.

[0062] In this embodiment, the rod-shaped member may have a certain width, and the width of the rod-shaped member determines the contact area with the native tissue, that is, different anchoring strengths may be provided by adjusting the width of the rod-shaped member.

[0063] The position and function of the overall placement of the valve prosthesis in this embodiment:

[0064] In this embodiment, the inflow section of the stent body 110 is placed at the native valve ring, and a small amount of oversize in the outflow section can expand the native valve leaflets to prevent their free movement from affecting the prosthetic valve. The first connecting section 2112 is attached to the right atrium wall, or suspended in the right atrium, and the protrusion 2111 is embedded in the oval fossa. The junction between the first connecting section 2112 and the protrusion 2111 fits the lower edge of the oval fossa, and the protruding portion 213 is placed on the upper edge of the oval fossa, and the depression of the oval fossa is used to prevent the prosthetic valve from shifting after implantation.

[0065] The triangular area between the anterior inner edge of the coronary sinus ostium of the right atrium, the attachment edge of the tricuspid valve septum and the Todaro tendon is called Koch's triangle. Excessive stimulation in this triangle will lead to arrhythmia. The anchoring structure 210 of this embodiment mainly bears force near the oval fossa to avoid squeezing the Koch's triangle and the conductive tissue.

[0066] Example 2

[0067] This embodiment provides a tricuspid valve prosthesis, which is an improvement on the basis of the embodiment 1, wherein the anchoring structure 210 further includes a second anchoring member 212, see Figure 3 - Figure 6 , the second anchor 212 is fixed to the atrial wall by radial force, thereby providing enhanced anchoring effect for the valve prosthesis.

[0068] See also Figure 3 , Figure 4 In this embodiment, the first anchor 211 is a rod-shaped structure, and a protrusion 2111 is arranged along the axial direction. The second anchor 212 is arranged at the upper edge of the protrusion 2111, and the second anchor 212 is constructed to have an outer protrusion 2121. When implanted, the outer protrusion 2121 is embedded into the oval fossa from the upper edge of the protrusion 2111, providing enhanced anchoring effect, and at the same time, the force point at the upper edge of the oval fossa can prevent damage to the original structure of the oval fossa.

[0069] Specifically, the second anchor 212 is a circular or partially arc-shaped rod structure. The second anchor 212 is arranged in a manner that is substantially perpendicular to the extending direction of the first anchor 211, that is, the second anchor 212 is substantially parallel to the upper end face of the stent body 110, so that the stressed part of the second anchor 212 is near the fossa ovalis, avoiding squeezing the Koch triangle and the conduction tissue. Among them, the chord length w2 of the second anchor 212 is 48 - 55 mm, and the overall Oversize method is used to fit the atrial wall to increase the anchoring strength. The convex part 2121 is arc-shaped, and the chord length w3 is 9 - 12 mm. When implanted, the convex part 2121 fits the upper edge of the fossa ovalis. Here, the "chord length" refers to the distance between the two farthest endpoints of the arc.

[0070] See Figure 5 , the second anchor 212 is configured as a partially arc-shaped structure. The connecting part of the anchoring structure 210 further includes second connecting segments 2122 provided at both ends of the second anchor 212. The second connecting segments 2122 fix the second anchor 212 to the stent body 110. The height h7 of the second connecting segment 2122 is 20 - 24 mm, and the width at the connection with the stent body 110 is related to the node of the stent body 110. The second connecting segments 2122 are connected to the second anchor 212 in forms such as suture and welding. The second connecting segments 2122 are divided into upper, middle, and lower parts. The upper part fits the atrial wall, and the range of the height h6 is 3 - 6 mm; the middle part is a transition part, which provides a guarantee for the upper part of the second connecting segment 2122 to fit the atrial wall, and the height h5 is 9 - 13 mm; the lower part is connected to the stent body 110, and the lower part of the second connecting segment 2122 extends in the direction towards the stent body 110, that is, the lower part converges near the stent body 110 to avoid blocking the coronary sinus ostium and the inferior vena cava ostium in the right atrial bottom area. Of course, in other embodiments, the number of the second connecting segments 2122 can be one, two or more, and the design is carried out considering the overall anchoring requirements and the difficulty of crimping. Preferably, the anchoring structure 210 is a symmetric structure, and the second connecting segments 2122 are symmetrically distributed on both sides of the first anchor 211, or the second connecting segments 2122 are evenly distributed along the circumferential direction of the stent body 110. The number and connection positions of the second connecting segments 2122 should be set according to the anchoring requirements and the difficulty of crimping.

[0071] In this embodiment, the second anchor 212 is formed into a partially arc-shaped rod structure. In other alternative embodiments, multiple second anchors 212 can be provided, and the multiple second anchors 212 are connected to each other to form a three-dimensional structure. Through the radial force of the three-dimensional structure, a more stable anchoring force can be provided.

[0072] In this embodiment, the second anchor 212 is disposed on the upper edge of the protrusion 2111. To prevent damage to the relatively thin and soft fossa ovalis at the connection between the first anchor 211 and the second anchor 212, at a predetermined position on the upper edge of the protrusion 2111, the second anchor 212 is further connected to the first anchor 211 by means such as welding, suturing, or coating. The atrial wall at the upper edge of the fossa ovalis is thicker and can withstand greater extrusion, and at the same time, it can further play a role in stabilizing the anchoring structure 210.

[0073] In this embodiment, the upper part of the second connecting section 2122 is an extending part 213, and an anchoring needle can be provided thereon. The valve prosthesis is anchored by piercing the atrial wall with the anchoring needle.

[0074] See Figure 6 , in this embodiment, the second anchor 212 of the present invention is positioned at the fossa ovalis position by using Oversize and the native anatomical structure. During implantation, the upper part of the second connecting section 2122 fits against the atrial wall, and the convex part 2121 is embedded in the fossa ovalis to provide enhanced anchoring and a reliable anchor.

[0075] The above-disclosed are only the preferred embodiments of the present invention. The preferred embodiments do not describe all details in detail, nor limit the invention to the specific embodiments described. It should be understood that these embodiments are only used to illustrate the present invention, rather than to limit the protection scope of the present invention. In actual applications, the improvements and adjustments made by those skilled in the art according to the present invention still fall within the protection scope of the present invention.

[0076] Obviously, according to the content of this specification, many modifications and changes can be made. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the present invention, so that those skilled in the art can make good use of the present invention. The present invention is only limited by the claims and their full scope and equivalents.

Claims

1. A tricuspid valve prosthesis, characterized in that, Comprising: A stent body, implanted at the tricuspid valve annulus, for supporting artificial valve leaflets; An anchoring structure, provided above the stent body, for anchoring the stent body at the native annulus to prevent its displacement; Wherein, the anchoring structure is configured to be partially attached to the fossa ovalis of the interatrial septum, and a retention force is formed by attaching to the fossa ovalis, thereby realizing the anchoring effect on the valve prosthesis; The anchoring structure includes a first anchor, and the first anchor is configured to have at least one protrusion, and the protrusion is embedded into the fossa ovalis to play an anchoring role; The anchoring structure further includes a second anchor, and the second anchor is fixed to the atrial wall by a radial acting force to provide an enhanced anchoring force; The second anchor is configured to be provided with an outward protrusion, and the outward protrusion is embedded into the fossa ovalis to provide a further anchoring force.

2. The tricuspid valve prosthesis according to claim 1, wherein There are at least two of the protrusions, and each of the protrusions extends axially and the plurality of protrusions are arranged side by side.

3. The tricuspid valve prosthesis according to claim 1, wherein, At the upper edge of the protrusion, the second anchor is connected to the first anchor.

4. The tricuspid valve prosthesis according to claim 1, characterized in that, The extending direction of the second anchor is set at a predetermined angle with the extending direction of the first anchor.

5. The tricuspid valve prosthesis according to claim 1, characterized in that, The anchoring structure further includes at least one connecting portion, and the anchoring structure is fixed to the stent body through the connecting portion. At a position near the stent body, the connecting portion is configured to extend in a direction towards the stent body.

6. The tricuspid valve prosthesis according to claim 5, wherein, The number of the connecting portions is set to be plural, and the upper edge of the connecting portion extends in a direction away from the axis of the stent body.

7. The tricuspid valve prosthesis according to claim 1, characterized in that, The anchoring structure further includes a protruding portion, and the protruding portion includes an anchor needle that pierces the atrial wall or barbs that grab tissue.

8. The tricuspid valve prosthesis according to claim 7, wherein, The protruding portion is arranged at an end away from the stent body.

9. The tricuspid valve prosthesis according to any one of claims 1 or 3 - 8, characterized in that, A film layer or a skirt is further provided on the surface of the anchoring structure.

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