An interventional annuloplasty device and interventional valve device

Abstract

This invention discloses an interventional valve annulus device and an interventional valve device, which can be used for mitral and tricuspid valve diseases. The interventional valve annulus device mainly consists of a valve annulus, a valve annulus delivery system, a fixation pin, and a fixation pin delivery system. The interventional valve mainly consists of a fixation stent, a support stent, a support stent lining, and valve leaflets. The interventional valve annulus and interventional valve are entered into the heart through the interventional delivery system, which can be via the apex, femoral vein, jugular vein or subclavian vein, right atrium, or left atrium. The interventional valve is fixed in the interventional valve annulus, providing patients with a minimally invasive, safe, and effective treatment method.

Description

Technical Field

[0001] This invention relates to the field of interventional treatment of cardiac membrane diseases, and more particularly to an interventional cardiac valve annulus and an interventional cardiac valve. Background Technology

[0002] Over the past two decades, interventional treatment techniques for heart valve diseases have developed rapidly. While significant success has been achieved in aortic valve interventional treatment, progress in the mitral and tricuspid valve fields remains challenging.

[0003] A key reason for the rapid development and maturation of aortic valve interventional therapy is that the aortic valve has a relatively robust aortic annulus, providing a reliable fixation structure for the insertion of the interventional aortic valve. In contrast, the mitral and tricuspid valves often lack a relatively robust annulus. To secure the interventional valve, some products (interventional mitral valve) fix it at the apex of the heart, some at the chordae tendineae-valve, some at the human valve itself, some at the human valve annulus, some at the left atrium, and some at the right ventricular wall. These methods are not entirely reliable and are relatively complex to perform.

[0004] In the annular-in-valve technique of interventional heart valve treatment, it has been proven that the mitral valve annuloplasty ring implanted during cardiac surgery can provide a very robust fixation structure for the implantation of the interventional valve.

[0005] Existing interventional mitral and tricuspid valve annulus implantation products are very complex to operate, take a long time to operate, have high surgical risks, and have many complications. Therefore, even if they are successfully registered with the State Drug Administration, their clinical use is very limited.

[0006] Common complications of interventional mitral valve surgery include left ventricular outflow tract obstruction, paravalvular leak, and unreliable valve fixation.

[0007] Therefore, we are developing an interventional valve annulus and an interventional valve. The interventional valve annulus placement procedure is simple, safe, and reliable. The interventional valve is prepared to be placed into the interventional valve annulus, and the two fit well together, securing the interventional valve firmly and minimizing the occurrence of left ventricular outflow tract obstruction. Summary of the Invention

[0008] The present invention provides an interventional valve annulus device and an interventional valve device, which can provide patients with minimally invasive, safe, effective and simple treatment methods.

[0009] To achieve the above objectives, the present invention adopts the following technical solution: An interventional valve annulus device mainly comprises an interventional valve annulus, a valve annulus delivery system, a fixation pin, and a fixation pin delivery system. The valve annulus delivery system includes a temporary fixation device, to which the valve annulus is connected. The valve annulus delivery system delivers the interventional valve annulus to a position above the human valve annulus. During pinning, the valve annulus delivery system assists in positioning the interventional valve annulus and exerts counterforce with the front end of the fixation pin delivery system. The fixation pin delivery system can insert the fixation pin into the interventional valve annulus and the human valve annulus or human valve.

[0010] Preferably, the valve annulus height can be 3-30 mm. A higher valve annulus height facilitates the fixation of the interventional valve annulus into the implanted interventional valve.

[0011] Preferably, the valve ring is made of a polymer material.

[0012] Preferably, the valve ring is made of a polymer material and a metal material, wherein the metal material has a mesh structure.

[0013] Preferably, the valve ring is made of a polymer material and a metal material, wherein the metal material has a ring structure.

[0014] Preferably, the width of the interventional valve annulus can be 3-30 mm. A wider valve annulus facilitates the fixation pins passing through the interventional valve annulus for fixation during the interventional procedure.

[0015] Preferably, the width of the interventional valve annulus can be 3-30 mm. A wider valve annulus facilitates the fixation pins to pass through and be fixed during interventional procedures; the wide ring (wing-shaped) of the valve annulus is confined to the posterior valve annulus, which can help optimize local hemodynamics.

[0016] Preferably, the inner wall of the interventional valve annulus has a raised structure to facilitate the fixation of the interventional valve.

[0017] Preferably, the protrusion structure on the inner wall of the interventional valve annulus can be a dotted protrusion.

[0018] Preferably, the protrusion structure on the inner wall of the interventional valve annulus can be an annular protrusion.

[0019] Preferably, the protrusion structure on the inner wall of the interventional valve annulus can be an irregular protrusion.

[0020] Preferably, the inner diameter of the interventional valve annulus is cylindrical, narrow at the top and wide at the bottom.

[0021] Preferably, the fixing nail is formed into an I-shape.

[0022] Preferably, the fixing nail is shaped like a "コ" after being formed.

[0023] Preferably, the fixing nail is shaped like a "Z" after being formed.

[0024] Preferably, the valve annulus has a cylindrical interventional valve fixing portion, which can wrap and fix one-third to three-quarters of the interventional valve.

[0025] Preferably, the valve ring and the temporary fixing device are fixed together by a screw and nut structure.

[0026] Preferably, the petal ring and the temporary fixing device are fixed together by a snap-fit ​​structure.

[0027] Preferably, the petal ring and the temporary fixing device are fixed together by a wire.

[0028] A method for using an interventional valve annulus device is as follows: After the valve annulus and the temporary fixation device are fixed together, they are introduced into the heart chamber via an interventional method through a valve annulus delivery system and then released; the fixation pin reaches the ventricular surface of the valve leaflet via a pin delivery system; after the valve annulus is subjected to force by the temporary fixation device and is tightly attached to the human valve annulus, it exerts mutual force with the front end of the pin delivery system, and the fixation pin (in two cases, the pin moves forward alone, or the pin moves forward together with the pin delivery system) pierces into the human valve annulus tissue through the ventricular surface space of the valve leaflet, and then pierces into the formed valve annulus. After the fixation pin forms a T or ┒ shape on the valve annulus, the pin delivery system is pulled back to make the valve annulus tightly attached to the human valve annulus, and then the fixation pin is released from the pin delivery system. At this time, the fixation pin forms an I-shape, a U-shape, or a Z-shape, fixing the valve annulus to the human valve annulus.

[0029] An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve is mainly composed of a support stent, a support stent cover, and valve leaflets. The support stent is cylindrical in shape, narrow at the top and wide at the bottom.

[0030] An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve is mainly composed of a support stent, a support stent cover, and valve leaflets. The support stent is cylindrical in shape, narrow at the top and wide at the bottom.

[0031] An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve is mainly composed of a support frame, a support frame membrane, and valve leaflets. The support frame is cylindrical.

[0032] An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve is mainly composed of a fixed support, a supporting support, a supporting support membrane, and a leaflet. The fixed support is in the shape of a double claw and fixes the interventional valve on the interventional valve annulus.

[0033] An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve is mainly composed of a fixed support, a supporting support, a supporting support membrane, and a leaflet. The fixed support is single-claw shaped and fixes the interventional valve on the interventional valve annulus.

[0034] An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve is mainly composed of a support frame, a support frame cover, and valve leaflets. The lower part of the support frame is funnel-shaped, which fixes the interventional valve onto the interventional valve annulus.

[0035] An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve mainly consists of a fixed support, a supporting support, a supporting support membrane, and valve leaflets. The lower part of the supporting support is funnel-shaped, and the fixed support is single-claw shaped. The single claw of the fixed support and the funnel-shaped lower part of the supporting support cooperate to fix the interventional valve on the interventional valve annulus.

[0036] An interventional valve device comprises a metal support and leaflets, the leaflets being made of biomaterials or polymers, wherein the interventional valve and the interventional valve annulus can be firmly attached to each other, and the interventional valve has a fixing structure.

[0037] Preferably, the interventional valve has protruding structures to assist in fixing the interventional valve to the valve annulus.

[0038] Preferably, the valve described above is a self-expanding interventional valve or a bulb-expanding interventional valve.

[0039] Preferably, the film covering of the support bracket described above is not necessary.

[0040] A method for using an interventional valve: First, the interventional valve annulus is positioned. After the self-expanding interventional valve is fully pushed into the interventional valve annulus, one-third to two-thirds of the main body of the interventional valve is released. After confirming that the anterior segment of the interventional valve is in the ideal position, the interventional valve is fully released. If the position of the anterior segment of the interventional valve is not ideal after partial release, the valve can be retrieved, its position adjusted, and then released again.

[0041] Compared with existing technologies, the advantages of this invention are as follows: When a patient has mitral and / or tricuspid regurgitation and is scheduled for interventional valve replacement surgery, a valve annulus is placed on the annulus of the diseased valve. The annulus is then stapled from below the valve to attach the interventional annulus to the patient's own valve annulus. The inserted annulus is not required to improve the regurgitation of the diseased valve; it only needs to provide a reliable fixation structure for the subsequently inserted interventional valve. After the interventional annulus is placed, the interventional valve is then inserted. The interventional annulus placement procedure is simple, safe, and reliable. The interventional valve is placed into the interventional annulus, and the two fit well together, securely fixing the interventional valve and minimizing the occurrence of left ventricular outflow tract obstruction.

[0042] The above procedures can be performed via the apex of the heart, the femoral vein, the right atrium, or the left atrium. Attached Figure Description

[0043] Figure 1-1 This is a schematic diagram of an interventional valve annulus (low valve annulus, narrow valve annulus) according to Embodiment 1 of the present invention.

[0044] Figure 1-2 This is a top view (showing the top part) of an interventional valve annulus (low valve annulus, narrow valve annulus) according to Embodiment 1 of the present invention.

[0045] Figure 1-3 This is a bottom view (showing the bottom) of an interventional valve annulus (low valve annulus, narrow valve annulus) according to Embodiment 1 of the present invention.

[0046] Figure 1-4 This is a cross-sectional view of an interventional valve annulus (low valve annulus, narrow valve annulus) according to Embodiment 1 of the present invention.

[0047] Figure 2-1 This is a schematic diagram of an interventional valve annulus (high valve annulus, wide valve annulus) according to Embodiment 2 of the present invention.

[0048] Figure 2-2 This is a top view (showing the top part) of an interventional valve annulus (high valve annulus, wide valve annulus) according to Embodiment 2 of the present invention.

[0049] Figure 2-3 This is a bottom view (showing the bottom) of an interventional valve annulus (high valve annulus, wide valve annulus) according to Embodiment 2 of the present invention.

[0050] Figure 2-4 This is a cross-sectional view of an interventional valve annulus (high valve annulus, wide valve annulus) according to Embodiment 2 of the present invention.

[0051] Figure 3-1 This is a schematic diagram of a regular dot-shaped protrusion structure for an interventional valve annulus (high valve annulus) according to Embodiment 1 of the present invention.

[0052] Figure 3-2Schematic diagram of a ring-shaped protrusion structure of the intervention annulus (high annulus) in Embodiment 3 of the present invention.

[0053] Figure 3-3 Schematic diagram of an irregular dot-shaped protrusion structure of the intervention annulus (high annulus) in Embodiment 1 of the present invention.

[0054] Figure 4-1 Schematic diagram of a semi-C-shaped folding of the intervention annulus in the delivery system in Embodiment 4 of the present invention.

[0055] Figure 4-2 Schematic diagram of a longitudinal O-shaped deformation of the intervention annulus in the delivery system in Embodiment 4 of the present invention.

[0056] Figure 5 Schematic diagram of fixing an intervention valve and a temporary fixing device with a single wire in Embodiment 5 of the present invention.

[0057] Figure 6 Schematic diagram of the intervention annulus installed on the temporary fixing device on the human annulus (transseptal approach, not stapled) in Embodiment 6 of the present invention.

[0058] Figure 7 Schematic diagram of the intervention annulus installed on the temporary fixing device on the human annulus (transseptal approach, stapled) in Embodiment 6 of the present invention.

[0059] Figure 8 Schematic diagram of the intervention annulus installed on the temporary fixing device on the human annulus (apical approach, not stapled) in Embodiment 7 of the present invention.

[0060] Figure 9 Schematic diagram of the intervention annulus installed on the temporary fixing device on the human annulus (apical approach, stapled) in Embodiment 7 of the present invention.

[0061] Figure 10-1 Schematic diagram of the forming effect of the fixing nail (I-shaped or Z-shaped) in Embodiment 8 of the present invention.

[0062] Figure 10-2 Schematic diagram of the forming effect of the fixing nail (C-shaped) in Embodiment 8 of the present invention.

[0063] Figure 11 Schematic diagram of the forming process of the fixing nail in Embodiment 9 of the present invention.

[0064] Figure 12-1 Schematic diagram of an upper-narrow and lower-wide cylindrical support bracket in Embodiment 10 of the present invention.

[0065] Figure 12-2 Schematic diagram of a straight cylindrical valve in Embodiment 11 of the present invention.

[0066] Figure 13 This is a schematic diagram of the stent valve with double claws in Embodiment 12 of the present invention.

[0067] Figure 14-1 This is a schematic diagram of the fixed support valve in Embodiment 13 of the present invention, which has a single claw shape at the bottom.

[0068] Figure 14-2 This is a schematic diagram of the stent valve in Embodiment 14 of the present invention, which has a lower single claw shape (and a single claw has a fixing bar).

[0069] Figure 15 This is a schematic diagram of the stent valve with a funnel-shaped lower part of the support bracket in Embodiment 15 of the present invention.

[0070] Figure 16 This is a schematic diagram of the fixed bracket with an upper single claw and a support bracket with a trumpet-shaped lower part in Embodiment 16 of the present invention.

[0071] Figure 17 This is a schematic diagram of transapical placement and pre-placement of the valve annulus in Embodiment 17 of the present invention.

[0072] Figure 18 This is a schematic diagram of transapical placement of the valve in the interventional valve annulus, as shown in Embodiment 18 of the present invention. Detailed Implementation

[0073] The present invention will be further described below with reference to specific embodiments. The accompanying drawings are for illustrative purposes only, representing schematic diagrams rather than actual physical objects, and should not be construed as limiting the scope of this patent. To better illustrate the embodiments of the present invention, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual dimensions of the product. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0074] In the accompanying drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar components. In the description of the present invention, it should be understood that if terms such as "upper," "lower," "left," "right," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the drawings are only for illustrative purposes and should not be construed as limiting the present patent. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0075] Example 1, an interventional valve annulus 10 (such as...) Figure 1-1The annulus is a low-profile, narrow-profile annulus. The design of the low-profile and narrow-profile annulus helps to reduce the volume of the interventional annulus after contraction, thereby reducing the volume of the interventional annulus delivery device used in conjunction with it. Figure 1-3 There are 3 fixing holes 26 for fixing to the temporary fixing device (e.g.) Figure 1-3 There can be two fixing holes, or the fixing holes can be nut holes.

[0076] Example 2, an interventional valve annulus 11 (such as...) Figure 2-1 The interventional valve annulus is either high or wide. The purpose of the high annulus is to better secure the subsequently implanted interventional valve to the annulus 11; due to its height, it reduces the likelihood of the interventional valve protruding into the left ventricular outflow tract, thus reducing the risk of left ventricular outflow tract obstruction. The purpose of the wide annulus is to facilitate the attachment of fixation pins during interventional procedures and also to help reduce the occurrence of paravalvular leakage. The interventional valve annulus has two or three fixation holes 26 (e.g., ...). Figure 2-3 The fixing hole can also be a nut hole.

[0077] Example 3: The protruding structure within the interventional valve annulus can be a regular dotted protrusion 95 (e.g., Figure 3-1 ), ring-shaped protrusion 97 (such as Figure 3-2 ), or irregular dotted protrusions 99 (such as Figure 3-3 ).

[0078] In Example 4, the interventional valve annulus 11 is folded in half in a C-shape and inserted into the delivery system 333. The interventional valve annulus connecting structure 28 is connected to the temporary fixation device 21. The connecting structure can be a screw and nut hole structure (e.g., Figure 4-1 The interventional valve annulus undergoes longitudinal deformation into an O-shape within the delivery system 333, and the interventional valve annulus connection structure 28 is connected to the temporary fixation device 21. The connection structure can be a screw and nut hole structure (e.g.,...). Figure 4-2 The valve ring 11 and the temporary fixing device 21 can also be fixed together by a snap-fit ​​structure.

[0079] In Example 5, the valve annulus 11 and the temporary fixing device 21 are fixed together by a loop wire 1. Cutting the loop wire allows the valve annulus 11 to be separated from the temporary fixing device 21 (e.g., Figure 5 (As shown).

[0080] In Example 6, the interventional valve annulus delivery system 333 can be inserted via a transvascular route and then through the interatrial septum. The interventional mitral valve 11 is pushed onto the human mitral valve via the temporary fixation device 21. Then, the staple delivery system 31 is introduced under the human valve leaflet and stapled to the adjacent area of ​​the interventional mitral valve 11. The valve annulus 11 is connected to the temporary fixation device 21, which assists in positioning the valve annulus 11 and exerts counterforce with the front end of the staple delivery system 31 during stapled insertion; the staple delivery system 31 can insert the staple 41 into the human valve annulus and the interventional valve annulus 11 (e.g., Figure 6 and Figure 7 (As shown).

[0081] In Example 7, the interventional valve annulus delivery system 333 can be inserted via a transapical approach. The interventional mitral valve 11 is pushed onto the human mitral valve via the temporary fixation device 21. Then, the pin delivery system 31 is introduced under the human valve leaflet and pinned to the adjacent area of ​​the interventional mitral valve 11. The valve annulus 11 is connected to the temporary fixation device 21, which assists in positioning the valve annulus 11 and exerts counterforce with the front end of the pin delivery system 31 during pinning; the pin delivery system 31 can insert the pins 41 into the human valve annulus and the interventional valve annulus 11 (e.g., ...). Figure 8 and Figure 9 (As shown).

[0082] Example 8: The fixation pin can be formed in an I-shape or a Z-shape on the interventional valve annulus (e.g., ...). Figure 10-1 ), can form a コ shape (such as Figure 10-2 ).

[0083] Example 9 illustrates the forming process of three types of fixing pins (e.g., Figure 11 ).

[0084] Example 10: An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve mainly consists of a support stent 84, a support stent cover 85, and leaflets 88. The support stent is cylindrical, narrower at the top and wider at the bottom. The support stent cover 85 may also be partially missing (e.g., Figure 12-1 ).

[0085] Example 11: An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve mainly consists of a support stent 84, a support stent membrane 85, and leaflets 88. The support stent is cylindrical (e.g., ...). Figure 12-2 ).

[0086] Example 12: An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve mainly consists of a fixing bracket 81, a supporting bracket 84, a supporting bracket covering 85, and a leaflet 88. The fixing bracket is in the form of a double claw 811, which fixes the interventional valve onto the interventional valve annulus (e.g., ...). Figure 13 ).

[0087] Example 13: An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve mainly consists of a fixing bracket 81, a supporting bracket 84, a supporting bracket covering 85, and a leaflet 88. The fixing bracket 84 is in the shape of a single claw 813, which fixes the interventional valve on the interventional valve annulus. The valve surface has a raised structure 91 that can have dot-like protrusions to increase friction and reduce the possibility of valve movement (e.g., ...). Figure 14-1 ).

[0088] Example 14: An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve is mainly composed of 85. The fixing bracket 84 has a single claw-shaped 813, and the single claw has fixing spikes 93. The single claw-shaped 813 and the fixing spikes 93 fix the interventional valve on the interventional valve annulus (e.g., Figure 14-2 ).

[0089] Example 10: An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve mainly consists of a fixing bracket 81, a supporting bracket 84, a supporting bracket covering 85, and a leaflet 88. The lower part of the supporting bracket is funnel-shaped 841, which fixes the interventional valve onto the interventional valve annulus (e.g., Figure 15 ).

[0090] Example 11: An interventional valve device includes an interventional valve and an interventional valve delivery system. The interventional valve mainly consists of a fixed support 81, a supporting support 84, a supporting support membrane 85, and leaflets 88. The lower part of the supporting support is funnel-shaped, and the fixed support is single-claw 815. The single claw 815 of the fixed support and the funnel-shaped lower part 841 of the supporting support cooperate to fix the interventional valve on the interventional valve annulus (e.g., Figure 16 ).

[0091] In Example 12, the interventional valve 51 is a self-expanding interventional valve, which can be placed into the interventional annulus using conventional mitral valve annulus-to-valve technique. After pushing the self-expanding interventional valve 51 into the interventional annulus 11, one-third to two-thirds of the main body of the interventional valve 51 is released first. After confirming that the anterior segment of the interventional valve 51 is in the ideal position, the interventional valve 51 is then completely released. If the position of the anterior segment of the interventional valve 51 is not ideal after partial release, the valve can be retrieved, its position adjusted, and then released again. At this time, the interventional annulus is a high-ring, wide-ring. The annulus 11 has a cylindrical interventional valve fixing portion, which can wrap and fix one-third to three-quarters of the interventional valve 51. This can prevent the stent valve 51 from protruding into the left ventricular outflow tract, causing left ventricular outflow tract obstruction. The width of the interventional valve annulus 11 can be 3mm-3cm, facilitating the passage and fixation of the fixation pins during interventional procedures; the interventional valve annulus 11 has wide wings to optimize local blood flow (e.g., Figure 17 , 18 (As shown).

[0092] At this time, the interventional valve 51 may also have protruding structures to assist in fixing the interventional valve 51 to the valve annulus 11. The protruding structure may be a spiky structure, and may be a forward or backward spiky structure (e.g.,...). Figure 14-2 (As shown).

[0093] Example 13, an interventional valve annulus device, mainly composed of a valve annulus, a temporary fixation device, fixation pins, and a fixation pin delivery system. The valve annulus described in this example is a low-height, narrow-width valve annulus, i.e., a low-ring, narrow-ring (as shown in Figure 2). The valve annulus may contain filler or may not contain filler. The valve annulus is made of a polymer material; or a combination of polymer and metal materials, with the metal material in a mesh or ring shape. The valve annulus 11 is connected to the temporary fixation device 21, which assists in positioning the valve annulus 11 and exerts counterforce with the front end of the fixation pin delivery system 31 during pinning; the fixation pin delivery system 31 inserts the fixation pins 41 into the valve annulus and the patient's valve annulus. The valve annulus is made of a polymer material; or a combination of polymer and metal materials, with the metal material in a mesh 15 or ring shape 18. After the valve annulus 11 and the temporary fixation device 21 are fixed together, they are introduced into the heart chamber by an interventional method and then released; the fixation pin 41 reaches the ventricular surface of the valve leaflet via the pin delivery system 31; after the valve annulus 11 is subjected to force by the temporary fixation device 21 and is tightly attached to the human valve annulus, it exerts force against the front end of the pin delivery system 31, and then the fixation pin 41 (in two cases, the pin moves forward alone, or the pin moves forward together with the pin delivery system) pierces into the human valve annulus tissue through the ventricular surface space of the valve leaflet, and then pierces into the formed valve annulus 11. The fixation pin 41 forms a T-shape 43, a ┒42 shape, or a 7-shape 47 on the valve annulus 11. Figure 11 The nail delivery system 31 is pulled back to make the valve ring 11 fit tightly against the human valve ring, and then the fixing nail 41 is released from the nail delivery system 31. At this time, the fixing nail 41 is in the shape of an I-shaped 46, a U-shaped 45, or a Z-shaped 44 (e.g., Figure 5 , Figure 6 (As shown). The shaped valve annulus is fixed to the human valve annulus. The fixing pin 41 can also be shaped and fixed within the interventional valve annulus 11, especially when there is no filler inside the interventional valve annulus 11. In this case, only a thin layer of the interventional valve annulus 11 near the human valve annulus is fixed. It is very important that the valve annulus 11 can be fixed to the temporary fixation device 21 and can exert force with the fixing pin delivery system 31 to fix the interventional valve annulus and the human valve annulus together. At this time, it is acceptable for a small part of the fixation part to be slightly biased towards the valve side near the valve annulus, because at this time the interventional valve annulus 11 mainly serves to fix the interventional valve. The fixing pin 41 can also be inserted from the valve annulus 11, penetrate the human valve annulus, and protrude under the mitral valve leaflet. Such operation requires precise positioning to avoid damage to the cardiac blood vessels (coronary system) and conduction system (as shown).

Claims

1. An interventional valve annulus device, mainly composed of an interventional valve annulus, a valve annulus delivery system, a fixation pin, and a fixation pin delivery system, wherein the valve annulus delivery system includes a temporary fixation device, characterized in that: The valve annulus delivery system delivers the interventional valve annulus to a position above the human valve annulus; the valve annulus delivery system assists in positioning the interventional valve annulus during stapling and exerts opposing forces with the front end of the fixation pin delivery system; the fixation pin delivery system can insert the fixation pin into the interventional valve annulus and the human valve annulus or human valve.

2. The interventional valve annulus device according to claim 1, characterized in that: The height of the valve annulus can be 3-30mm.

3. The interventional valve annulus device according to claim 1, characterized in that: The width of the interventional valve annulus can be 3-30mm, which facilitates the fixation pins to pass through the interventional valve annulus for fixation during interventional procedures.

4. The interventional valve annulus device according to claim 1, characterized in that: The inner wall of the interventional valve annulus has a raised structure, which facilitates the fixation of the interventional valve.

5. An interventional valve annulus device according to claim 1, characterized in that: the fixing pin, after being formed, is in the shape of an I-shaped pin, a U-shaped pin, or a Z-shaped pin.

6. An interventional valve device comprising an interventional valve and an interventional valve delivery system, wherein the interventional valve mainly consists of a support stent, a support stent membrane, and valve leaflets, characterized in that: The support bracket is cylindrical in shape, narrower at the top and wider at the bottom.

7. An interventional valve device comprising an interventional valve and an interventional valve delivery system, wherein the interventional valve mainly comprises a fixing bracket, a supporting bracket, a supporting bracket diaphragm, and valve leaflets, characterized in that: The fixation bracket is in the shape of a double claw, which fixes the interventional valve onto the interventional valve annulus.

8. An interventional valve device comprising an interventional valve and an interventional valve delivery system, wherein the interventional valve mainly comprises a fixed support, a supporting support, a supporting support membrane, and valve leaflets, characterized in that: The fixation bracket is shaped like a single claw at the bottom, which fixes the interventional valve onto the interventional valve annulus.

9. An interventional valve device comprising an interventional valve and an interventional valve delivery system, wherein the interventional valve mainly consists of a support stent, a support stent membrane, and valve leaflets, characterized in that: The lower part of the support bracket is funnel-shaped, which fixes the interventional valve to the interventional valve annulus.

10. An interventional valve device comprising an interventional valve and an interventional valve delivery system, wherein the interventional valve mainly comprises a fixed support, a supporting support, a supporting support membrane, and valve leaflets, characterized in that: The lower part of the support bracket is funnel-shaped, and the fixing bracket is single-claw shaped. The upper single claw of the fixing bracket and the lower funnel-shaped part of the support bracket cooperate to fix the interventional valve on the interventional valve annulus.

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