Disclosure of Invention
The present invention provides a tricuspid valve prosthesis that addresses the above-described deficiencies in the prior art.
The technical scheme of the invention is as follows:
A tricuspid valve prosthesis comprises a support body implanted at a tricuspid valve annulus for supporting a prosthetic valve leaflet, an anchoring structure provided above the support body for anchoring the support body at the native valve annulus against displacement, wherein the anchoring structure is configured to be partially attached to an interatrial septum fossa ovalis, and a retention force is created by attachment of the fossa ovalis, thereby effecting an anchoring action on the valve prosthesis. According to the invention, under the teaching of the original structure of the fossa ovalis, the concave structure of the fossa ovalis is fully utilized to clamp and fix the anchoring structure part in the fossa ovalis, so that a certain retention force is provided to prevent the valve prosthesis from moving during heart compression, and the anchoring structure changes the anchoring mode of the traditional clamping valve leaflet or grabbing the valve leaflet, so that the chordae tendineae cannot be pulled or the valve leaflet cannot be damaged.
Preferably, the anchoring structure comprises a first anchor configured with at least one protrusion that is embedded into the fossa ovalis and engages the inner wall of the fossa ovalis to perform an anchoring function providing an effective anchoring force for the valve prosthesis.
The protruding parts are preferably in a circular arc structure formed by rod-shaped pieces, at this time, one protruding part can be arranged, preferably, at least two protruding parts are arranged, each protruding part extends along the axial direction and a plurality of protruding parts are arranged in parallel, and the arrangement refers to that a plurality of protruding parts are distributed along the direction of the long axis of the oval fossa. The rod-shaped piece is simple in molding process, and the plurality of protruding parts are simultaneously embedded into the oval fossa and are attached to the short shaft, so that a more stable retention effect can be provided.
Preferably, the anchoring structure further comprises a second anchor secured to the atrial wall by a radial force to provide a further anchoring force. Wherein the second anchor is deployed in the right atrium using a method of Oversize to provide a radial force to achieve anchoring.
Preferably, the second anchor is configured with an outer flange that is embedded within the fossa ovalis to provide further anchoring force, the outer flange conforming to the fossa ovalis inner wall to prevent displacement of the second anchor.
In order to prevent the connection of the first anchoring member and the second anchoring member from damaging the thinner and softer fossa ovalis, the second anchoring member is connected with the first anchoring member at the upper edge of the protruding portion, the atrial wall at the upper edge of the fossa ovalis is thicker, and the greater extrusion can be borne, and meanwhile, the function of further stabilizing the anchoring structure can be achieved.
Specifically, the second anchoring member is configured in a circular or arc-shaped rod-like structure, and the extending direction of the second anchoring member is arranged at a predetermined angle with the extending direction of the first anchoring member, and the predetermined angle enables the stressed part of the second anchoring member to be near the fossa ovalis so as to avoid extrusion of Koch triangle and conduction tissue. Preferably, the anchoring structure further comprises at least one connecting portion, by means of which the anchoring structure is fixed to the stent body, the connecting portion being configured to extend in a direction towards the stent body at a position proximal to the stent body, such that the stressed portion of the anchoring structure of the invention is in the vicinity of the fossa ovalis, avoiding squeezing Koch triangle and conductive tissue, avoiding shielding the coronary sinus ostium and inferior vena cava of the right atrial bottom region.
Preferably, the number of the connecting portions is plural, and the upper edge of the connecting portion extends in a direction away from the axis of the bracket main body. I.e. the upper edge of the connection is attached to the atrial wall, the plurality of connections may increase the contact area of the anchoring structure, thereby providing an enhanced anchoring force. Simultaneously, a plurality of connecting portions can also be used for stabilizing foretell anchor structure, and preferred connecting portion evenly distributed along the circumference of support main part, specific quantity should set up according to the anchor demand and press the degree of difficulty.
Preferably, the anchoring structure further comprises a protrusion comprising an anchoring needle penetrating the atrial wall or barbs that grasp tissue for further anchoring.
Preferably, the extension is disposed at an end remote from the stent body, avoiding the fossa ovalis, preventing the anchoring needle or barb from puncturing the fossa ovalis.
Preferably, the anchoring structure is made of a biocompatible material that facilitates endothelialization to help repair oval fossa defects, such as congenital patent foramen ovale, secondary foramen atrial septal defects, or left-heart access procedures followed by left-heart intervention.
Preferably, the surface of the anchoring structure is also provided with a film coating layer or a skirt edge, the film coating layer can be arranged in the modes of film coating, woven cloth sewing and the like, the film coating layer is made of PET, PTFE or ePTFE, PU and other materials which are good in biocompatibility and easy to endothelialize, the primary tissue can be protected from being scratched by the bracket frame, the endothelialized area can be increased, and the assistance is provided for anchoring. When the skirt edge is covered on the surface of the anchoring structure, the skirt edge can be arranged on the connecting part of the anchoring structure, and partial grids are exposed, so that extrusion and contact with the Koch triangle are avoided, and shielding of the inferior vena cava and the coronary sinus is avoided.
Compared with the prior art, the invention has the following beneficial effects:
First, the anchoring structure of the present invention is partially attached to the fossa ovalis of the atrial septum, and the anchoring effect on the valve prosthesis is achieved by the retention force of the fossa ovalis's concave structure, changing the anchoring manner of the conventional clip leaflet or the grasping leaflet, without pulling chordae tendineae, or damaging the leaflet.
And secondly, the first anchoring piece is anchored by the convex part in a manner of being embedded in the fossa ovalis, the convex part is formed in a simple and easy manner, when the anchoring structure further comprises a second anchoring piece anchored to the atrial wall, and the second anchoring piece is configured to be partially embedded in the fossa ovalis, the enhanced anchoring force is further provided, and the first anchoring piece and the second anchoring piece act together and are firmly anchored.
Thirdly, the anchoring structure of the invention plays a role in fixation through the connecting part, extends towards the direction of the bracket main body at the position close to the bracket main body so as to avoid conductive tissues, and the main stressed part of the anchoring structure is near the fossa ovalis so as to avoid extrusion of Koch triangle and conductive tissues and prevent conduction block.
Of course, it is not necessary for any one product to practice the invention to achieve all of the advantages set forth above at the same time.
Detailed Description
The invention provides an implantable tricuspid valve prosthesis, which fully utilizes the original structure of an oval fossa, and provides a certain anchoring force in a mode that an anchoring structure is partially embedded into the oval fossa, so that the anchoring of the valve prosthesis is realized.
The tricuspid valve is a tricuspid valve complex, which is positioned between the right atrium and the right ventricle and consists of the tricuspid valve annulus, tricuspid valve, chordae tendineae and papillary muscles, and functionally and structurally forms a whole to ensure blood flow from the atrium to the ventricle. Referring to fig. 7, there is shown a schematic anatomical view of the right atrium with three inlet ports, the superior and inferior vena cava ports and the coronary sinus port, and one outlet port, the tricuspid valve port. The superior vena cava port is positioned at the upper part of the atrium, the inferior vena cava port is arranged below, the tricuspid valve port is arranged at the left front part of the inferior vena cava, and the coronary sinus port is arranged between the inferior vena cava valve and the tricuspid valve port. The right atrium has an atrial septum with an oval shaped depression in its lower portion called the fossa ovalis. The oval fossa is arranged at the lower 1/3 of the septum, the left upper part of the inferior vena cava orifice, and a small groove with the depth of 3-4 mm is arranged in the central depression.
The atrioventricular node is arranged around the native valve annulus and below the endocardium on the right side of the atrial septum, a Koch triangle is formed by the front inner edge of the coronary sinus orifice, the attachment edge of the tricuspid valve and the Todaro tendon, and the vertex of the front part of the triangle, namely the joint of the front valve and the valve, is the atrioventricular node nearby. The atrioventricular node is an important component of the heart conduction system, and the function of the Todaro tendon has certain supporting and fixing functions on the cardiac muscle at the lower part of the atrial septum besides supporting and pulling the inferior vena cava valve and the coronary sinus valve. Extrusion and coverage of Koch triangle areas should therefore be avoided as much as possible in tricuspid valve replacement valve designs.
The valve prosthesis is generally composed of a valve stent and artificial valve leaflets fixed on the valve stent, wherein the valve stent mainly comprises a stent main body 110 and an anchoring structure 210, the stent main body 110 is a hollow columnar structure with two open ends, and the artificial valve leaflets are fixed on the inner periphery of the stent main body 110. The bracket main body 110 and the anchoring structure 210 are connected by riveting, welding, buckling, sewing and the like. The anchoring structures 210 may be made of nitinol or other biocompatible material having shape memory properties, or may be selected from materials that are elastically or plastically deformable, such as balloon-expandable materials.
The valve prosthesis has two modes, namely a press-grip state and an expanded state, namely the stent body 110 and the anchoring structure 210, and the valve prosthesis is characterized in the expanded state unless special emphasis is given in the present invention.
Wherein, referring to fig. 1, the stent body 110 comprises an inflow section 111, an outflow section 113 and a transition section 112 therebetween, and the outflow section 113 is positioned downstream of the inflow channel according to the direction of blood flow. Optionally, the stent body 110 further comprises a tab (not shown) connected to the end of the outflow segment 113 remote from the passage segment 112, the tab being adapted to be connected to a delivery system to ensure that the valve is loaded into the delivery system, released out of the delivery system and the relative position of the valve prosthesis to the delivery system is unchanged during in vivo transport of the valve in the delivery system.
The cross-sectional shape of the holder body 110 may be circular, oval, D-shaped, flower-shaped, or other irregular shape. The stent body 110 may be made of a metal such as nitinol, titanium alloy, cobalt chrome alloy, MP35n, 316 stainless steel, L605, phynox/Elgiloy, platinum chrome, or other biocompatible metals as known to those skilled in the art. Alternatively, the stent body 110 may also be made of an elastically or plastically deformable material, such as a balloon expandable, or may be a shape memory alloy that is responsive to temperature changes to transition between a contracted delivery state and an expanded deployment state. Preferably, the bracket main body 110 is manufactured by cutting nickel-titanium alloy pipes, the outer diameter of the pipes is 5-15 mm, and the diameter size after shaping is selected according to actual needs.
The stent body 110 has significant radial and axial stiffness to withstand leaflet traction. The stent body 110 is composed of structural units, which are changeable in axial morphology, such as mesh-shaped structural units or wave-shaped structural units, which are connected to each other in the circumferential direction, are composed of at least one row of the structural units in the axial direction, and are directly or indirectly connected to each other in the axial direction. The stent body 110 is preferably a mesh structure, and the mesh units are triangular, diamond-shaped, pentagonal, drop-shaped, etc. mesh units which can form a closed shape, preferably a diamond-shaped structure.
The inner or outer surface or both surfaces of the stent body 110 are covered with skirts to achieve a sealing function, ensuring that a single passage of blood flows from the inflow end of the prosthetic leaflet to the outflow end of the prosthetic leaflet. The skirt is made of pericardium (pig pericardium, cattle pericardium, sheep pericardium, etc.) or other biocompatible polymer materials (such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), etc.).
The valve prosthesis comprises at least two artificial valve leaves, the number of the artificial valve leaves is the same as or different from that of the original valve leaves, the valve prosthesis is prepared from animal pericardium or other biocompatible polymer materials, one end of each valve leaf is directly or indirectly and stably connected with the bracket main body 110, and the other end of each valve leaf is a free end. In the working state, the artificial valve leaves replace the original valve leaves to realize the function of opening and closing the blood channel.
The valve prosthesis as described above is implanted in the heart by a delivery system, is loaded into a delivery device, such as a sheath, after crimping, is released after implantation at the target site, and the released valve prosthesis is expanded and anchored at the target site.
The invention will be further illustrated with reference to specific examples.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
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, the term "axial direction" refers to the axial direction of the stent body, and "above" includes not only directly above but also laterally above.
In the description of the present invention, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected via an intervening medium, or in communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. The terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. The term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
Example 1
The embodiment provides a tricuspid valve prosthesis, which comprises a stent body 110, wherein the stent body 110 is implanted at the tricuspid valve annulus and is used for supporting artificial valve leaflets, and an anchoring structure 210 which is arranged above the stent body 110 and is used for anchoring the stent body 110 at the native valve annulus to prevent the displacement of the native valve annulus, wherein the anchoring structure 210 is configured to be partially attached to an oval fossa at an atrial septum, and the anchoring effect of the valve prosthesis is realized by attaching the oval fossa to form a retention force.
In this embodiment, in the light of the original structure of the fossa ovalis, a new anchoring structure is proposed, and the anchoring structure 210 is disposed in a manner of being partially embedded in the fossa ovalis and fitting the fossa ovalis, so that the valve prosthesis is prevented from being displaced during the cardiac compression process by using the retention force generated by the concave structure of the fossa ovalis.
Referring to fig. 1-2, fig. 1 is a schematic front view of the valve prosthesis in this embodiment, and fig. 2 is a schematic side view of the valve prosthesis in this embodiment.
Wherein the anchoring structure 210 comprises a first anchor 211, the first anchor 211 is configured with at least one protrusion 2111, the protrusion 2111 being embedded into the fossa ovalis to serve as an anchoring function. In the present embodiment, the first anchor 211 is configured to have two protrusions 2111, the protrusions 2111 are of an arc-shaped rod-like structure, extend in the short axis direction of the fossa ovalis, and the two protrusions 2111 are of a side-by-side structure. When the implant is performed, the protrusions 2111 are respectively embedded in the fossa ovalis, and the two protrusions 2111 are arranged along the long axis direction of the fossa ovalis, so that a more stable anchoring force can be provided than that of a single protrusion 2111. Of course, in other alternative embodiments, more than two protrusions 2111 may be selected for configuration, and may be configured according to actual needs.
The anchoring structure 210 further includes a connection portion that secures the anchoring structure 210 above the stent body 110. The connecting portion may be integrally formed with other portions of the anchoring structure 210 (e.g., the protrusions 2111 of the present embodiment) and then fixed to the bracket main body 110 by welding or sewing, or the connecting portion may be a pull cord, and the other portions of the anchoring structure 210 and the bracket main body 110 may be connected by sewing or knotting.
In this embodiment, the first anchoring member 211 is formed by bending a rod-shaped member, the first anchoring member 211 is bent in the middle to form a symmetrical structure, two protruding portions 2111 are formed on the left and right rod-shaped structures respectively at predetermined positions far away from the bracket main body 110, a first connecting section 2112 is formed at one end near the bracket main body 110, the two first connecting sections 2112 are respectively located at the lower edges of the protruding portions 2111, and the first connecting section 2112 is the connecting portion of the anchoring structure 210 in this embodiment. When implanted, the junction of the first connection section 2112 and the protrusion 2111 engages the lower edge of the fossa ovalis. The mode of integrally forming the first anchoring member 211 in this embodiment has the advantages of simple structure and easy realization, and the formed first anchoring member 211 is of a smooth and round structure as a whole, and cannot damage the primary tissue. Meanwhile, compared to the single first connection section 2112, the protrusions 2111 are connected to the stent body 110 through the first connection sections 2112, respectively, it is possible to improve stability of the structure of the first anchor 211, preventing torsional deformation. Of course, in other embodiments, the first connection section 2112 and the protrusion 2111 may be manufactured separately and then connected.
Wherein, from the protrusion 2111 to the direction of the bracket main body 110, the first connection section 2112 gradually extends toward the direction of the bracket main body 110. The first connection section 2112 is located at the lower edge of the first anchor 211, and since the distance between the coronary sinus orifice and the tricuspid orifice is short and the coronary sinus orifice cannot be blocked, the lower end of the first anchor 211, i.e., the coronary sinus orifice, should be disposed away from the atrial wall to leave a sufficient space to prevent blocking the coronary sinus orifice.
In this embodiment, the protrusions 2111 are provided in a manner that can be inserted into the fossa ovalis and fit the short axis of the fossa ovalis to provide effective anchoring force. The maximum depth d1 of the protrusion 2111 is 2-4 mm, and the height h2 is 6-10 mm, wherein the interference force is too large if the maximum depth or the height is too large, the risk of damaging the original structure of the oval fossa is provided, and the oval fossa cannot be well embedded if the maximum depth or the height is too small, so that stable anchoring force is difficult to provide. Here, "depth" refers to a vertical distance from a tangent line of an outer surface of the protrusion 2111 to a lower edge of the protrusion 2111, and "height" refers to a dimension along an axial direction of the holder main body 110.
The distance w1 between the lower edges of the two protruding portions 2111 is 5-15 mm, and the protruding portions 2111 are embedded in the oval fossa at a proper distance, so that stable anchoring force can be provided. The depth (i.e., vertical distance) d2 between the upper edge of the first connection section 2112 and the lower edge of the first connection section 2112 is 2 to 9mm, the height h1 of the first connection section 2112 is 11 to 13mm, and the first connection section 2112 pushes the protrusion 2111 against the fossa ovalis to generate the above-mentioned anchoring force. The two first connection sections 2112 are distributed approximately at two sides of the trapezoid, so that the structure of the first anchor 211 is more stable, and the width of the lower edges of the two first connection sections 2112 is related to the node of the bracket main body 110.
In some embodiments, the first anchor 211 further comprises a protrusion 213, the protrusion 213 comprising an anchoring needle penetrating the atrial wall. In this embodiment, the first anchoring member 211 is configured with the protruding portion 213 when formed, the protruding portion 213 is located at a free end of the first anchoring member 211, and the protruding portion 213 protrudes from an upper edge of the fossa ovalis when implanted, and the anchoring of the valve prosthesis is reinforced by the anchoring needle penetrating the atrial wall. On the other hand, the protrusions 2111 are simultaneously forced above and below, further stabilizing the protrusions 2111 in the fossa ovalis. In other embodiments, the protrusions 213 may also be barbs for grasping tissue, as well as further anchoring.
Further, the surface of the anchoring structure 210 is further provided with a coating or skirt. In some embodiments, the surface of the protrusion 2111 is provided with a film coating layer, and the film coating layer is made of a polymer material, and can be optionally arranged in a mode of film coating, braiding, sewing, and the like, and the specific polymer material can be selected from materials with good biocompatibility, such as PET, PTFE, ePTFE, PU, and the like, and can be easily endothelialized, so that not only can the primary tissue be protected from being scratched by a stent frame, but also the endothelialized area can be increased, and assistance is provided for anchoring. In some embodiments, the surface of first connection segment 2112 is partially covered with or uncovered from the skirt, exposing at least a portion of the macro-mesh, while avoiding extrusion, contact with the Koch triangle, and shielding of the inferior vena cava and coronary sinus ostium in cooperation with the macro-mesh design or notch design of stent body 110. In some embodiments, the protrusions 213 cover the skirt, which is an anchoring needle, while protecting native tissue from being scratched by the stent frame.
In an alternative embodiment, the anchoring structure 210 is further provided with a fixing lug, which is provided on the protruding portion 213. The fixed lugs are used for being connected with the conveying system, so that the relative positions of the valve prosthesis and the conveying system are unchanged when the valve is loaded into the conveying system, released and separated from the conveying system and conveyed in the conveying system in vivo.
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, the width of the rod-shaped member may be adjusted to provide different anchoring forces.
The position and function of the overall placement of the valve prosthesis in this embodiment:
The inflow section of the stent main body 110 of the present embodiment is placed at the native valve annulus, a small amount Oversize of the outflow section can prop open the native valve to prevent free movement of the native valve from affecting the prosthetic valve, the first connecting section 2112 is attached to the wall of the right atrium or is suspended in the right atrium, the protruding portion 2111 is embedded in the fossa ovalis, the juncture of the first connecting section 2112 and the protruding portion 2111 is attached to the lower edge of the fossa ovalis, the protruding portion 213 is placed at the upper edge of the fossa ovalis, and the recess of the fossa ovalis used to prevent the prosthetic valve from being displaced after implantation.
The triangle between the anterior and medial coronary sinus ostium, the attachment margin of the tricuspid valve and the tendon of today, known as Koch triangle, where overstimulation can lead to arrhythmia. The anchor structure 210 of the present embodiment has a main stressed portion near the fossa ovalis, avoiding squeezing the Koch triangle and conducting tissue.
Example 2
This embodiment provides a tricuspid valve prosthesis that is an improvement over embodiment 1 in that the anchoring structure 210 further comprises a second anchor 212, see fig. 3-6, the second anchor 212 being secured to the atrial wall by radial forces, thereby providing enhanced anchoring of the valve prosthesis.
Referring to fig. 3 and 4, in the present embodiment, the first anchor 211 has a rod-shaped structure, and one protrusion 2111 is disposed along the axial direction. The second anchor 212 is disposed at the upper edge of the protrusion 2111 and the second anchor 212 is configured with an outer flange 2121, which, when implanted, embeds the outer flange 2121 into the fossa ovalis from the upper edge of the protrusion 2111, providing enhanced anchoring while the point of stress at the upper edge of the fossa ovalis prevents damage to the native structure of the fossa ovalis.
Specifically, the second anchoring member 212 has a circular or partially circular arc rod-shaped structure, and the second anchoring member 212 is disposed in a manner substantially perpendicular to the extending direction of the first anchoring member 211, that is, the second anchoring member 212 is substantially parallel to the upper end surface of the stent main body 110, so that the stressed portion of the second anchoring member 212 is near the oval fossa, thereby avoiding extrusion of Koch triangle and conduction of tissues. Wherein, second anchor piece 212 chord length w2 is 48~55mm, and laminating the atrium wall through whole Oversize's mode increases anchor intensity, and outer convex portion 2121 is the arc, and chord length w3 is 9~12mm, and when implanting, outer convex portion 2121 laminating oval nest's upper edge. Here, "chord length" refers to the distance between the two endpoints of the arc furthest.
Referring to fig. 5, the second anchor 212 is configured in a partial circular arc shape, and the connection portion of the anchoring structure 210 further includes second connection sections 2122 provided at both end portions of the second anchor 212, the second connection sections 2122 fixing the second anchor 212 to the stent body 110. The height h7 of the second connecting section 2122 is 20-24 mm, and the width of the connecting portion with the bracket main body 110 is related to the node of the bracket main body 110. The second connecting section 2122 is connected with the second anchoring member 212 in a sewing, welding or other mode, the second connecting section 2122 is divided into an upper part, a middle part and a lower part, the upper part is attached to the atrial wall, the height h6 ranges from 3mm to 6mm, the middle part is a transition part, the upper part of the second connecting section 2122 can be attached to the atrial wall, the height h5 ranges from 9 mm to 13mm, the lower part of the second connecting section 2122 is connected with the support main body 110, the lower part of the second connecting section 2122 extends towards the direction of the support main body 110, namely the lower part is retracted at the position close to the support main body 110, and the coronary sinus opening and the inferior vena cava opening of the right atrial bottom area are prevented from being blocked. Of course, in other embodiments, the number of second connecting segments 2122 may be one, two or more, with a combination of anchoring requirements and crimping difficulty. Preferably, the anchoring structure 210 is a symmetrical structure, the second connecting sections 2122 are symmetrically distributed on two sides of the first anchoring member 211, or the second connecting sections 2122 are uniformly distributed along the circumferential direction of the bracket main body 110, and the number of the second connecting sections 2122 and the connecting positions are set according to the anchoring requirement and the pressing difficulty.
In this embodiment, the second anchoring member 212 is formed into a partially circular arc rod-shaped structure, and in other alternative embodiments, a plurality of second anchoring members 212 may be provided, and a plurality of second anchoring members 212 are connected to each other to form a three-dimensional structure, so that a more stable anchoring force can be provided by the radial acting force of the three-dimensional structure.
In this embodiment, the second anchor 212 is disposed at the upper edge of the protrusion 2111, and in order to prevent the connection between the first anchor 211 and the second anchor 212 from damaging the thin and soft fossa ovalis, the second anchor 212 is further connected to the first anchor 211 at a predetermined position of the upper edge of the protrusion 2111, such as welding, suturing, and film coating. The superior border of the fossa ovalis has a thicker atrial wall, can withstand greater compression, and can also serve to further stabilize the anchoring structure 210.
In this embodiment, the upper portion of the second connecting section 2122 is a projection 213 and may be provided with an anchoring needle by which anchoring of the valve prosthesis is enhanced by penetration of the anchoring needle into the atrial wall.
Referring to fig. 6, the second anchor 212 of the present embodiment is positioned in the fossa ovalis using Oversize and the native anatomy, and when implanted, the upper portion of the second connecting section 2122 engages the atrial wall, and the outer flange 2121 is embedded into the fossa ovalis to provide enhanced anchoring and secure anchoring.
The foregoing disclosure is only of the preferred embodiments of the invention. The preferred embodiments are not exhaustive or to limit the invention to the precise form disclosed. It should be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. Modifications and adaptations of the invention will occur to those skilled in the art and are intended to be within the scope of the invention in practice.
Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. The invention is limited only by the claims and the full scope and equivalents thereof.