Tricuspid valve replacement system

Abstract

The invention provides a tricuspid valve replacement system, in which a docking device is pressed against a tricuspid valve annulus to be positioned by an anchoring device, and a valve prosthesis is positioned by the docking device. The butt joint device comprises a cavity section and a disc surface section, the cavity section comprises a cavity framework and a cavity covering film, and the disc surface section comprises a disc surface framework and a disc surface covering film. The cavity framework is generally of a cylindrical structure extending in the axial direction. The disc face framework is connected with the cavity framework and extends outwards in the radial direction relative to the cavity framework. And a development enhancement area is arranged on the disc surface section. The disc surface section is configured to be positioned above a tricuspid valve annulus, and the cavity section is configured to be free of expansion of the tricuspid valve annulus; the development enhancement region is configured to be located over a tricuspid annulus region corresponding to the septal leaflet and span a radial gap between the lumen section and the tricuspid annulus. According to the tricuspid valve replacement system, pace-making wires are easy to arrange, and the influence of the pace-making wires on opening and closing of artificial valve leaflets is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a tricuspid valve replacement system. Background Art

[0002] The human heart valves include the aortic valve, pulmonary valve, and atrioventricular valve, among which the atrioventricular valve includes the mitral valve and tricuspid valve. These valves act as one-way valves that work synchronously with the heart, allowing blood to flow downstream but preventing blood from flowing upstream. For example, the mitral valve allows blood to flow from the left atrium to the left ventricle, but prevents blood from flowing from the left ventricle to the left atrium; the tricuspid valve allows blood to flow from the right atrium to the right ventricle, but prevents blood from flowing from the right ventricle to the right atrium; the aortic valve allows blood to flow from the left ventricle to the aorta, but prevents blood from flowing from the aorta to the left ventricle; the pulmonary valve allows blood to flow from the right ventricle to the pulmonary artery, but prevents blood from flowing from the pulmonary artery to the right ventricle.

[0003] Diseased heart valves often exhibit stenosis or regurgitation, which inhibits the valve's ability to control blood flow, reduces the heart's efficiency in pumping blood, and can lead to life-threatening conditions such as heart failure. For severe valvular disease, heart valve prostheses can be used to replace the diseased native heart valve.

[0004] Among them, the physiological anatomical structure of the tricuspid valve is relatively complex and fragile. Implanting a valve prosthesis to replace the diseased native tricuspid valve is prone to cause conduction block. For this reason or other subsequent heart disease inducers, a pacemaker is often required to be implanted. Existing tricuspid valve prostheses, such as the Edwards Evoque valve and the Medtronic Intrepid valve, usually require radial expansion of the native tricuspid valve ring and / or positioning by clamping, piercing the native valve leaflets, etc., so the subsequent pacemaker electrode wire (referred to as: pacing wire) can only pass between the artificial valve leaflets to enter the right ventricle, which will affect the coaptation movement of the artificial valve leaflets, causing blood reflux between the artificial valve leaflets, and even valve prosthesis failure. Summary of the invention

[0005] In view of this, the present invention aims to provide a tricuspid valve replacement system that can solve the above problems.

[0006] The tricuspid valve replacement system provided by the present invention includes a docking device, an anchoring device and a valve prosthesis. The docking device is configured to be pressed against the tricuspid valve ring through the anchoring device for positioning; the docking device includes a cavity section and a disc section, the cavity section includes a cavity frame and a cavity coating covering it, and the disc section includes a disc frame and a disc coating covering it; wherein the cavity frame is generally a cylindrical structure extending along the axial direction to enclose a containing cavity; the disc frame is connected to the cavity frame and extends radially outward relative to the cavity frame; a development enhancement area is provided on the disc section;

[0007] In the deployed state, the disk section is configured to be located above the tricuspid valve annulus, and the cavity section is configured to avoid dilation of the tricuspid valve annulus; the imaging enhancement area is configured to be located above the tricuspid valve annulus area corresponding to the septal leaflet and span the radial gap between the cavity section and the tricuspid valve annulus; the imaging enhancement area is used for pacing wire to be passed through;

[0008] The valve prosthesis is inserted into the accommodating cavity and is positioned by the docking device.

[0009] Optionally, the disk surface skeleton includes a plurality of unit grids that are interconnected and arranged circumferentially; the contour shape of the unit grid where the development enhancement area is located is different from the contour shapes of other unit grids.

[0010] Optionally, the disk skeleton includes a plurality of unit grids that are interconnected and arranged circumferentially; and development threads are additionally wound around the unit grids where the development enhancement area is located or development materials are plated thereon.

[0011] Optionally, the disk surface skeleton includes a plurality of unit grids that are interconnected and arranged circumferentially; the disk surface coating additionally uses a film with development properties or sewn development threads in the area of ​​the unit grid corresponding to the development enhancement area.

[0012] Optionally, the area of ​​the disk surface coating corresponding to the unit grid where the development enhancement area is located is easier to penetrate than other areas.

[0013] Optionally, the area of ​​the disk surface coating corresponding to the unit grid where the development enhancement area is located is a single-layer film body, and the other areas are double-layer film bodies.

[0014] Optionally, the disk surface coating has a smaller thickness and / or a smaller density in an area of ​​the unit grid where the development enhancement area is located than in other areas.

[0015] In some embodiments, the anchoring device includes a plurality of anchoring members, a plurality of locking members having the same number as the plurality of anchoring members, and a plurality of flexible linear members having the same number as the plurality of anchoring members;

[0016] In the deployed state: one end of the linear member is fixedly connected to one of the anchoring members, and the other end is fixedly connected to one of the locking members after penetrating the disc segment; at least one of the anchoring members is anchored into the right ventricular tissue, and at least another of the anchoring members is anchored into the tricuspid valve ring tissue or the right atrial tissue; the linear member is tensioned by the corresponding anchoring members and the locking members located on opposite sides of the disc segment, so that the docking device is pressed against the tricuspid valve ring to be positioned.

[0017] Preferably, at least one of the anchors is anchored in the ventricular septum tissue, at least another of the anchors is anchored in the tricuspid valve annulus tissue corresponding to the anterior leaflet of the tricuspid valve or the right atrial tissue adjacent to the anterior leaflet of the tricuspid valve, and at least another of the anchors is anchored in the tricuspid valve annulus tissue corresponding to the posterior leaflet of the tricuspid valve or the right atrial tissue adjacent to the posterior leaflet of the tricuspid valve.

[0018] Preferably, the disk surface section is provided with threading holes for the threading of the linear member.

[0019] The tricuspid valve replacement system provided by the present invention positions the valve prosthesis through a docking device, and the docking device is pressed against the tricuspid valve ring through an anchoring device for positioning. Among them, the cavity section of the docking device does not expand the tricuspid valve ring, and the disk section of the docking device is located above the tricuspid valve ring. The disk section is provided with a development enhancement area located on the tricuspid valve ring area corresponding to the septal leaflet, and the development enhancement area spans the radial gap between the cavity section and the tricuspid valve ring. When a pacemaker needs to be implanted, due to the significant development performance of the development enhancement area, it can clearly and unambiguously indicate the position where the pacing wire should be inserted. On the one hand, it helps the pacing wire to pass through the radial gap between the cavity section and the tricuspid valve ring, thereby avoiding the influence of the pacing wire on the opening and closing movement of the artificial valve leaflet and preventing blood from flowing back between the artificial valve leaflets. On the other hand, it also reduces the difficulty of laying the pacing wire. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic diagram of the tricuspid valve replacement system of the present invention in a deployed state from one viewing angle;

[0021] Figure 2 A schematic diagram of laying out a pacing wire after the tricuspid valve replacement system of the present invention is deployed from another perspective;

[0022] Figure 3 It is a three-dimensional schematic diagram of a first embodiment of a docking device in the present invention;

[0023] Figure 4for Figure 3 A three-dimensional exploded schematic diagram of the skeleton of the docking device;

[0024] Figure 5 for Figure 4 A top view of the middle disk skeleton;

[0025] Figure 6 for Figure 5 The enlarged schematic diagram of point B in the middle;

[0026] Figure 7 is a top view schematic diagram of another embodiment of the disk frame;

[0027] Figure 8 is a top view schematic diagram of another embodiment of a disk segment;

[0028] Fig. 9 is a top view schematically showing another embodiment of a disk section;

[0029] Fig.10 is a three-dimensional schematic diagram of a second embodiment of a docking device in the present invention;

[0030] Fig.11 for Fig.10 The enlarged schematic diagram of F in the middle;

[0031] Fig.12 A schematic top view of another embodiment of a disk coating;

[0032] Fig.13 It is a schematic diagram of the anchor lock device in the present invention in the state of being deployed;

[0033] Fig.14 for Fig.13 Schematic diagram of the middle anchor member and the linear member;

[0034] Fig.15 , Fig.16 Schematic diagrams of the locking member not locking the linear member and locking the linear member respectively;

[0035] Fig.17 is a three-dimensional schematic diagram of an embodiment of a valve prosthesis in the present invention;

[0036] Figures 18 to 24 The deployment process of the tricuspid valve replacement system of the present invention is shown;

[0037] in, Fig.18 , Fig.19 The implantation of the anchor is shown from different perspectives;

[0038] Fig. 20 , Fig.21 The docking device is shown in different perspectives being delivered along the linear member to the tricuspid valve;

[0039] Fig. 22 , Fig.23 The implantation and locking of the locking member are shown respectively;

[0040] Fig.24 The valve prosthesis is shown deployed, positioned in a docking device. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. In addition, the embodiments described below can be combined with each other as long as there is no contradiction or conflict, and the same or similar concepts or processes may not be repeated in some embodiments.

[0042] First of all, it should be noted that in this article, "proximal end" refers to the end of the device or component close to the operator, and "distal end" refers to the end of the device or component away from the operator; "inflow end" refers to the end located upstream of the blood, and "outflow end" refers to the end located downstream of the blood; "axial" refers to the direction that coincides with or is parallel to the central axis of the device or component. "Radial" refers to the direction that is perpendicular or approximately perpendicular to the axial direction and along the radius or diameter of the device or component. "Circumferential" refers to the direction surrounding the axial direction. For components used for tricuspid valve replacement, the upper and lower parts are distinguished in the axial direction according to the actual placement orientation or the illustrated orientation.

[0043] It is worth noting that the above-mentioned terms indicating orientation or positional relationship 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, be constructed and operate in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0044] It is also worth noting that some components in the present invention (such as the docking device, valve prosthesis, etc.) have a contracted state suitable for the delivery or deployment process, and also have an expanded state in a free state or after deployment. Unless otherwise specified, the structural descriptions below are all made in the expanded state of each component.

[0045] See also Figure 1 and Figure 2One embodiment of the present invention provides a tricuspid valve replacement system for replacing a diseased native tricuspid valve. The tricuspid valve replacement system includes a docking device 10, an anchoring device 30, and a valve prosthesis 60. The docking device 10 is configured to be positioned by the anchoring device 30 and provide a receiving cavity 11; the anchoring device 30 includes a plurality of anchoring members 31, a plurality of locking members 33 having the same number as the plurality of anchoring members 31, and a plurality of flexible linear members 35 having the same number as the plurality of anchoring members 31.

[0046] exist Figure 1 and Figure 2 In the shown deployed state: one end of a linear member 35 is fixedly connected to an anchoring member 31, and the other end is fixedly connected to a locking member 33 after penetrating the docking device 10; at least one anchoring member 31 is anchored into the right ventricular tissue for fixation, and at least another anchoring member 31 is anchored into the tricuspid valve ring tissue or the right atrial tissue for fixation; the linear member 35 is tensioned by the corresponding anchoring members 31 and the locking member 33 located on the opposite sides of the docking device 10, so that the docking device 10 is pressed against the native tricuspid valve ring for positioning; the valve prosthesis 60 is passed through the accommodating cavity 11 of the docking device 10 and is positioned by the docking device 10, and the positioning methods include but are not limited to interference fit, snap-on, etc.

[0047] Although the tricuspid valve has a special physiological and anatomical structure, the tricuspid valve replacement system of the present invention does not rely on anchors, barbs, claws, etc. provided on the valve prosthesis to act on the native leaflets and / or the native valve ring to implement positioning, but instead uses the docking device 10 to position the valve prosthesis 60, and the docking device 10 is positioned by the anchor locking device 30. At least one anchor 31 in the anchor locking device 30 is anchored into the right ventricular tissue, and at least another anchor 31 is anchored into the tricuspid valve ring tissue or the right atrial tissue. The linear member 35 is tensioned by the corresponding anchors 31 and locking members 33 located on the opposite sides of the docking device 10. The physical means of pulling the locking member 33 with the tensioned linear member 35 enables the docking device 10 to be firmly pressed against the native tricuspid valve ring to be positioned, and then the valve prosthesis 60 can also be reliably fixed by the docking device.

[0048] The docking device, anchoring device, and valve prosthesis in some embodiments of the present invention will be described in sequence below in conjunction with the corresponding drawings. It is understandable that different embodiments of the docking device, anchoring device, and valve prosthesis can be combined in different ways.

[0049] Docking device

[0050] See also Figures 3 to 6 , combined Figure 1 and Figure 2In one embodiment, the docking device 10 includes a frame 13 and a membrane 15 covering the frame 13. The docking device 10 can be divided into a cavity section 12 and a disk section 14. The frame 13 includes a cavity frame 132 and a disk frame 134. The membrane 15 includes a cavity coating 152 covering the cavity frame 132 and a disk coating 154 covering the disk frame 134. The cavity frame 132 is generally a cylindrical structure extending in the axial direction to enclose the accommodating cavity 11; the disk frame 134 is connected to the cavity frame 132 and extends radially outward relative to the cavity frame 132.

[0051] In this embodiment, the cavity skeleton 132 includes an inner frame 1321 and an outer frame 1323. The inner frame 1321 and the outer frame 1323 are respectively formed and fixedly connected together, and the fixed connection methods include but are not limited to welding, binding, etc. The outer frame 1323 is abutted against the radial outer side of the inner frame 1321, and the upper end of the outer frame 1323 extends the disc skeleton 134 in an integral manner, and the inner frame 1321 surrounds the accommodating cavity 11. In order to ensure that the accommodating cavity 11 has sufficient axial length to accommodate the valve prosthesis 60, the axial length of the inner frame 1321 is greater than the axial length of the outer frame 1323. It can be understood that the docking device 10 is placed at the native tricuspid valve as part of the tricuspid valve replacement system, and the above-mentioned "upper end" corresponds to the inflow end, and the "lower end" corresponds to the outflow end.

[0052] In this embodiment, the inner frame 1321 can be formed by a metal wire with biocompatibility and shape memory function, such as a nickel-titanium alloy wire, which is braided and heat-set, and the two ends of the nickel-titanium alloy wire are fixedly connected by a steel sleeve. Further, the inner frame 1321 includes a plurality of roughly U-shaped units A1 that are integrally connected to each other to allow the inner frame 1321 to be radially compressed for easy delivery. The axial height of the inner frame 1321 can be greater than or equal to 3mm, the diameter of the accommodating cavity 11 surrounded by the inner frame 1321 can be in the range of 18mm-40mm, and the wire diameter of the nickel-titanium alloy wire can be in the range of 0.1mm-1mm. It can be understood that the inner frame can also be formed by cutting and heat-setting a nickel-titanium alloy tube with biocompatibility and shape memory function.

[0053] Combination Figure 3 and Figure 4In this embodiment, the outer frame 1323 and the disk skeleton 134 integrally connected thereto are made of metal wires with shape memory function, such as nickel-titanium alloy wires, which are woven and heat-set. Among them, the outer frame 1323 includes a plurality of U-shaped units (not marked), and the disk skeleton 134 includes a plurality of unit grids A2 that are interconnected and arranged circumferentially, and the unit grids A2 are formed by a plurality of metal wire struts. Each unit grid A2 extends radially outward relative to the outer frame 1323. The axial height of the outer frame 1323 is greater than or equal to 1 mm, and the maximum diameter of the disk skeleton 134 is in the range of 40 mm-80 mm.

[0054] Preferably, the radial contour of the unit grid A2 is generally a horizontal S-shape. When the unit grid A2 of the disk segment 14 abuts against the tricuspid valve annulus tissue and the right atrial tissue, it can press against the tricuspid valve annulus tissue more tightly to enhance the effect of preventing paravalvular leakage.

[0055] Please refer again Figure 3 The cavity coating 152 can be closely attached to the cavity frame 132 and covered on the inner surface and / or outer surface of the cavity frame 132 by suture sewing, so that the cavity coating 152 and the cavity frame 132 together form the cavity section 12; the disk surface coating 154 can be closely attached to the disk frame 134 and covered on the inner surface and / or outer surface of the disk frame 134 by suture sewing, so that the disk surface coating 154 and the disk frame 134 together form the disk surface section 14. The cavity coating 152 and the disk surface coating 154 can be made of cloth or film made of synthetic or natural materials such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyurethane (TPU), and expanded polytetrafluoroethylene (ePTFE). It can be understood that the cavity coating 152 and the disk surface coating 154 can be integrated or split and connected together by suture.

[0056] Combination Figure 1 , Figure 2 and Figure 3 The disk section 14 is provided with a plurality of threading holes 141, the number of which is the same as the number of the linear members 35, and each threading hole 141 is provided for a corresponding linear member 35 to pass through. The threading holes 141 are provided at positions closer to the cavity 11 in the radial direction, so that the locking member 33 has a more stable force point after locking the linear member 35.

[0057] The docking device 10 suitable for being arranged at the native tricuspid valve should have at least its disk section 14 arranged to be located above the native tricuspid valve ring, and a portion of the cavity section 12 may be located in the native tricuspid valve ring, but the cavity section 12 is arranged to avoid expanding the native tricuspid valve ring, that is, the outer diameter of the cavity section 12 is set to be smaller than the inner diameter of the native tricuspid valve ring. This arrangement can ensure that the docking device 10 will not compress or expand the native tricuspid valve ring in the radial direction.

[0058] Please refer again Figure 1 , Figure 2 If the patient develops symptoms such as abnormal heart rhythm after the tricuspid valve replacement system is deployed (immediately or after a period of time), and the atrioventricular block reaches type II or III degree (the cause may be the implantation of the tricuspid valve replacement system or other heart diseases), a pacemaker needs to be implanted, and the pacing wire 80 needs to pass through the tricuspid valve replacement system into the right ventricle, so that the distal end of the pacing wire 80 can be screwed into or pierced into the target site in the right ventricle. Figure 5 and Figure 6 In order to facilitate the deployment of the pacing wire 80 and prevent the pacing wire 80 from passing through the artificial leaflets 65 of the valve prosthesis 60 and affecting the normal apposition of the artificial leaflets, the disc section 14 is provided with a development enhancement area 146 for the pacing wire 80 to pass through or deploy. The development enhancement area 146 is configured to be located above the tricuspid valve ring area corresponding to the septal leaflets and span the radial gap between the cavity section 12 and the tricuspid valve ring. Further, the development enhancement area 146 includes the corresponding unit grid A2 of the disc skeleton 134 located in the area and the corresponding disc coating 154 thereon.

[0059] exist Figure 5 and Figure 6 In the illustrated embodiment, the developing wire 70 is wound around the unit grid A2 where the developing enhancement area 146 is located, while no developing wire is set on all unit grids A2 outside the developing enhancement area 146. Specifically, the developing wire 70 can be wound around the support rod of the unit grid A2 where the developing enhancement area 146 is located by winding, sewing, etc. The material of the developing wire 70 includes but is not limited to at least one of platinum, iridium, gold, silver, tantalum, tungsten, etc. The developing wire 70 is wound around the corresponding unit grid A2 to form a closed area, and the boundary of the closed area is the boundary of the developing enhancement area 146. The area of ​​the closed area is equal to the area of ​​a complete unit grid A2. Preferably, the area is not less than 1mm 2 .

[0060] In other embodiments, the unit grid A2 where the development enhancement area 146 is located may be plated with development materials such as platinum, iridium, gold, silver, tantalum, tungsten, etc. instead of the wound development wire.

[0061] It can be understood that, since the unit grid A2 where the development enhancement area 146 is located is additionally wound with a development thread 70 or coated with a development material, the development enhancement area 146 has a significant development performance and can be clearly developed under imaging equipment, especially under radiation. When a pacemaker needs to be implanted, the development enhancement area 146 can clearly indicate the position where the pacing wire should be inserted, thereby helping to reduce the difficulty of laying the pacing wire; and, since the development enhancement area 146 spans the radial gap between the cavity segment 12 and the tricuspid valve ring, the pacing wire is inserted near the inner boundary of the development enhancement area 146 (i.e., close to the boundary of the cavity segment), so that the pacing wire can pass through the radial gap between the cavity segment and the tricuspid valve ring to enter the right ventricle, thereby avoiding the influence of the pacing wire on the opening and closing movement of the artificial valve leaflets, ensuring the normal movement of the artificial valve leaflets and the normal function of the valve prosthesis, and preventing blood from flowing back between the artificial valve leaflets.

[0062] Specifically, the pacing lead deployment process includes: under the development indication of the development enhancement area 146, the disk coating 154 on the unit grid A2 where the development enhancement area 146 is located is punctured; the distal end of the sheath for accommodating and delivering the pacing lead passes through the puncture of the disk coating 154, and then passes through the unit grid A2 where the development enhancement area 146 is located to enter the right ventricle, and then the pacing lead is pushed out from the distal end of the sheath, and finally the pacing lead is controlled to rotate into or pierce the target site in the right ventricle to complete the deployment of the pacing lead.

[0063] See also Figure 7 In another embodiment, with Figure 5 , Figure 6 The main difference between the embodiments shown is that the disk skeleton 2134 includes a plurality of unit grids connected to each other and arranged circumferentially, but the contour shape of the unit grid A23 where the development enhancement area 2146 is located is different from the contour shapes of other unit grids A2. Figure 7 For example, the outline shape of the unit grid A23 where the development enhancement area 2146 is located is roughly circular, and the outline shapes of all unit grids A2 outside the development enhancement area 2146 are roughly rhombus. It can be understood that the outline shape of the unit grid A23 where the development enhancement area 2146 is located can also be a hexagon, a triangle, etc., as long as it is different from the shape of other unit grids A2.

[0064] The contour shape of the unit grid A2 where the development enhancement area 2146 is located is different from the contour shapes of other unit grids A22, and has obvious differences. Therefore, the development enhancement area 2146 is easier to be identified and clearly developed by ultrasound, X-ray and other images.

[0065] Other structures, functions, etc. in this embodiment are similar to Figure 5 , Figure 6 The embodiments shown are the same and will not be described again here.

[0066] See also Figure 8 In another embodiment, with Figure 5 , Figure 6 The main difference between the illustrated embodiments is that the disk skeleton 134 of the disk segment 24 includes a plurality of unit grids A2 that are interconnected and arranged circumferentially, and the area 2155 of the disk coating 2154 corresponding to the unit grid A2 where the development enhancement area 3146 is located is made of a film having development performance, and the areas of the disk coating 2154 corresponding to other unit grids A2 are conventional coating films. The unit grid A2 where the development enhancement area 3146 is located may be the same as other unit grids A2, or may be additionally wound with a development thread or plated with a development material. Specifically, the film having development performance may be formed by weaving together a development thread (the material of the development thread includes but is not limited to platinum, iridium, gold, silver, tantalum, tungsten, etc.) and a general film-making material (such as the aforementioned PET, PTFE, TPU, ePTFE, etc.).

[0067] Since the area 2155 of the disk surface coating 2154 corresponding to the unit grid A2 where the development enhancement area 3146 is located adopts a film with development performance, the development enhancement area 3146 has significant development performance and can be clearly developed under imaging equipment, especially under radiation.

[0068] Other structures, functions, etc. in this embodiment are similar to Figure 5 , Figure 6 The embodiments shown are the same and will not be described again here.

[0069] Fig. 9 Shows Figure 8 A variation of the illustrated embodiment, in which a developing thread 270 is additionally sewn on the disk surface coating 154 of the disk surface segment 34 corresponding to the area of ​​the unit grid A2 where the developing enhancement area 4146 is located, and a closed boundary (such as a circular boundary) is constructed by the developing thread 270, and the area within the boundary is used for laying a pacing lead.

[0070] Since the disc surface coating 154 is additionally sewn with developing threads 270 on the area of ​​the unit grid A2 corresponding to the developing enhancement area 4146, the developing enhancement area 4146 has significant developing performance and can be clearly developed under imaging equipment, especially under radiation.

[0071] As mentioned above, the disc film on the cell grid where the development enhancement area is located needs to be punctured, see Fig.10 and Fig.11 On the basis of any of the above-mentioned embodiments / implementations, the present invention further provides that the disk coating 4154 of the docking device 210 corresponds to the area of ​​the unit grid A2 where the development enhancement area 146 is located, which is easier to penetrate than other areas, so as to make the deployment of the pacing wire easier and more labor-saving.

[0072] In order to make the area of ​​the disk coating 4154 corresponding to the unit grid A2 where the development enhancement area 146 is located easier to penetrate than other areas:

[0073] like Fig.11 As shown, the disk surface coating 4154 corresponding to the area of ​​the unit grid A2 where the development enhancement area 146 is located is a single-layer film (i.e., the film only covers the inner surface or outer surface of the corresponding unit grid A2), and the other areas are double-layer film (i.e., the film covers both the inner and outer surfaces of the unit grids in other areas).

[0074] like Fig.12 As shown, the area of ​​the unit grid where the disk surface coating 5154 corresponds to the development enhancement area 146 is less dense than other areas or is woven more sparsely, for example, the area of ​​the unit grid where the disk surface coating 5154 corresponds to the development enhancement area 146 is made of a knitted membrane, while other areas are made of a woven membrane.

[0075] It can be understood that in other embodiments, the thickness of the unit grid of the disk surface coating corresponding to the development enhancement area can be set to be smaller than that of other areas. For example, the thickness of the unit grid of the disk surface coating corresponding to the development enhancement area can be 0.03mm, while the thickness of other areas is 0.05mm.

[0076] Anchor lock device

[0077] See also Figures 13 to 16 In one embodiment, the anchoring device 30 for positioning the docking device 10 includes a plurality of anchoring members 31, a plurality of locking members 33 having the same number as the anchoring members 31, and a plurality of flexible linear members 35 having the same number as the anchoring members 31.

[0078] In one example, the anchor 31 includes a nail seat 311 and a spiral nail body 313 connected to the nail seat 311, wherein the nail seat 311 is fixedly connected to one end of the linear member 35. The nail seat 311 can be configured as a cylindrical or cylindrical shape, and one end of the linear member 35 can be fixedly connected to the nail seat 311 by crimping. One end of the spiral nail body 313 is fixedly connected to the nail seat 311, and the other end is a sharp tip to facilitate anchoring into the tissue. The material of the nail seat 311 and the spiral nail body 313 can be, but is not limited to, cobalt-chromium alloy, stainless steel, etc.

[0079] The locking member 33 includes a mandrel 331, a first end cap 333 fixedly disposed at the distal end of the mandrel 331, a second end cap 335 selectively and movably disposed on the mandrel 331 and axially spaced from the first end cap 333, and a spring 337 sleeved on the mandrel 331 between the first end cap 333 and the second end cap 335. The mandrel 331, the first end cap 333 and the second end cap 335 may be made of, but not limited to, cobalt-chromium alloy, stainless steel, etc., and the spring 337 is made of a biocompatible, corrosion-resistant material suitable for making a spring. The second end cover 335 may be selectively and movably arranged on the core shaft 331 in ways including but not limited to threaded connection (e.g., the core shaft 331 is provided with an external thread, and the second end cover 335 is provided with a matching internal thread), card connection (e.g., the core shaft 331 is provided with an elastic block, and the second end cover 335 is provided with a slot, and when the elastic block enters the slot, the second end cover 335 can no longer move axially), etc. When the second end cover 335 moves (rotates or moves axially) toward the first end cover 333 to a predetermined position, it can be positioned at the predetermined position.

[0080] The linear member 35 is arranged on each coil of the spring 337 in a wave-like manner, and adjacent wave crests and wave troughs are respectively located radially inward and radially outward of adjacent coils. When the second end cover 335 moves toward the first end cover 333 and is positioned at a predetermined position, the spring 337 can be compressed to clamp the linear member 35 between adjacent coils.

[0081] The linear member 35 can be made of PET, PTFE, ePTFE, ultra-high molecular weight polyethylene (UHMWPE) and other medical sutures that can be implanted in the body for a long time.

[0082] Combination Figures 18 to 24 , the anchoring member 31 in the anchoring device 30 is deployed before the docking device 10. Before the docking device 10 is deployed, one end of the linear member 35 is fixedly connected to an anchoring member 31 anchored in the right ventricular tissue, the tricuspid valve ring tissue or the right atrial tissue, and the other end extends outside the body. During the deployment of the docking device 10, the end of each linear member 35 extending outside the body passes through the threading hole 141, and the linear member 35 guides the docking device 10 to be delivered to the native tricuspid valve. Afterwards, each locking member 33 is passed on the corresponding linear member 35, and the linear member 35 guides the locking member 35 to be delivered to the vicinity of the disc segment 14 of the docking device 10. Next, by controlling the tension of the locking member 33 on the linear member 35, the disc segment 14 can be closely attached to the native tricuspid valve ring tissue and / or the right atrial tissue, and then the locking member 33 is operated to lock the linear member 35. Finally, the portion of the linear member 35 located proximal to the locking member 33 is cut off.

[0083] When the docking device 10 and the anchoring device 30 are deployed, one end of the linear member 35 is fixedly connected to an anchor member 31 , and the other end penetrates the threading hole 141 of the disk section 14 and is fixedly connected to a locking member 33 .

[0084] Combination Figure 1 and Figure 2 , the disk segment 14 is configured to be located above the native tricuspid valve annulus, at least one anchor 31 is anchored into the right ventricular tissue, including but not limited to the right ventricular wall, tricuspid valve papillary muscle, ventricular septum, etc., and at least another anchor 31 is anchored into the tricuspid valve annulus tissue or right atrial tissue. Preferably, at least one anchor 31 is anchored into the ventricular septum, at least another anchor 31 is anchored into the annular tissue corresponding to the native anterior leaflet or the atrial tissue adjacent to the native anterior leaflet, and at least one more anchor 31 is anchored into the annular tissue corresponding to the native posterior leaflet or the atrial tissue adjacent to the native posterior leaflet. The linear member 35 is tensioned by the corresponding anchors 33 and locking members 33 located on opposite sides of the disk segment 14, so that the docking device 10 is pressed against the tricuspid valve annulus for positioning. Such a configuration helps to make the anchoring device 30 position the docking device 10 more symmetrical and balanced without damaging the atrioventricular node.

[0085] Valve prosthesis

[0086] See also Fig.17 The valve prosthesis 60 of the present invention includes a valve frame 61, a membrane 63 covering the valve frame 61, and at least two artificial valve leaflets 65 that can open and close relative to each other. The artificial valve leaflets 65 are fixedly connected to the valve frame 61 and / or the membrane 63.

[0087] The valve frame 61 includes a valve frame body 62 and a loading component 64 connected to the valve frame body 62. The loading component 64 can be loaded by a valve delivery device (not shown).

[0088] The valve frame body 62 is an expandable frame member that supports the artificial valve leaflets 65. The valve prosthesis 60 can be radially compressed to a compressed state to be delivered to a preset deployment site, such as the deployed docking device 10 described above, and together with the docking device 10 and the anchoring device 30, it forms a tricuspid valve replacement system. The valve prosthesis 60 can also expand or swell at the deployment site. In a specific embodiment, the valve prosthesis 60 is self-expanding, and its valve frame body 62 is made of a metal with shape memory function, such as nickel-titanium alloy; in other embodiments, the valve prosthesis 60 can also be expanded by a balloon, and its valve frame body 62 can be made of cobalt-chromium alloy.

[0089] The prosthetic valve leaflet 65 may be made of any suitable biological material (eg, pericardial tissue, such as bovine or porcine pericardium), a biocompatible synthetic material, or other such material.

[0090] The membrane 63 may include a flexible, compressible material having biocompatibility, such as PET fabric, pericardial tissue, or the like.

[0091] Deployment Process of the Tricuspid Valve Replacement System

[0092] The deployment process of the tricuspid valve replacement system of the present invention is described below in the order of operations.

[0093] Step 1:

[0094] See also Fig.18 and Fig.19 , through the superior vena cava, use the first delivery device 91 to deliver and deploy several anchors 31 one by one, at least one, such as two, anchors 31 are anchored into the ventricular septum tissue, at least another anchor 31 is anchored into the annular tissue corresponding to the native anterior leaflet or the atrial tissue adjacent to the native anterior leaflet, at least another anchor 31 is anchored into the annular tissue corresponding to the native posterior leaflet or the atrial tissue adjacent to the native posterior leaflet, and the free ends of the linear members 35 fixedly connected to the corresponding anchors 31 extend outside the body.

[0095] Step 2:

[0096] See also Fig. 20 and Fig.21 After the free ends of each linear member 35 extending outside the body pass through the threading holes 141 of the docking device 10, the docking device 10 is compressed and loaded into the second delivery device 93. The second delivery device 93 is used to deliver and deploy the docking device 10 at the native tricuspid valve along the guidance of the linear member 35.

[0097] Step 3:

[0098] See also Fig. 22 and Fig.23 The free ends of the linear members 35 extending outside the body are correspondingly inserted into the locking members 33, and the third delivery device 95 is used to deliver and lock the locking members 33 one by one. In this process, the degree of tightness of the disc segment 14 and the native tricuspid valve ring tissue and / or the tricuspid valve atrial tissue can be adjusted by controlling the tension of the locking member 33 on the linear member 35, so as to seek a better anti-valvular leakage effect. After the adjustment is completed, the locking member 33 is locked with the linear member 35, so that the docking device 10 is pressed against the native tricuspid valve ring to be positioned.

[0099] Thereafter, a shearing device (not shown) is used to cut off the portion of the linear member 35 located proximal to the locking member 33 .

[0100] Step 4:

[0101] See also Fig.24The valve prosthesis 60 is delivered and deployed in the receiving cavity 11 of the docking device 10 via the superior vena cava using a valve delivery device (not shown) via a catheter.

[0102] At this point, the deployment of the entire tricuspid valve replacement system is completed.

[0103] It is understandable that the tricuspid valve replacement system may also select other suitable intervention pathways.

[0104] For further information, please refer again to Figure 2 After the tricuspid valve replacement system is deployed (which may be immediately or after a period of time), if the patient has symptoms such as abnormal heart rhythm and the atrioventricular block reaches type II or III degree (the reason may be the implantation of the tricuspid valve replacement system or other heart diseases), a pacemaker needs to be implanted. The pacing wire 80 is arranged in the enhanced area 146 of the disk segment 14. The pacing wire 80 passes through the radial gap between the cavity segment of the docking device 10 and the tricuspid valve ring area corresponding to the septal leaflet, and enters the right ventricle to avoid the pacing wire 80 from affecting the opening and closing movement of the artificial valve leaflet 65.

[0105] The above description is only a preferred specific implementation manner of the present invention, and the protection scope of the present invention is not limited to the embodiments listed above. Any simple change or equivalent replacement of the technical solution that can be obviously obtained by any technician familiar with the technical field within the technical scope disclosed in the present invention falls within the protection scope of the present invention.

Claims

1. A tricuspid valve replacement system, characterized in that: It includes a docking device, an anchoring device and a valve prosthesis; The docking device is configured to be pressed against the tricuspid valve annulus and positioned by the anchoring device; The docking device comprises a cavity section and a disk section, wherein the cavity section comprises a cavity frame and a cavity coating thereon, and the disk section comprises a disk frame and a disk coating thereon; wherein the cavity frame is generally in a cylindrical structure extending along the axial direction to enclose a containing cavity; the disk frame is connected to the cavity frame and extends radially outward relative to the cavity frame; and a development enhancement area is provided on the disk section; In the deployed state, the disk section is configured to be located above the tricuspid valve annulus, and the cavity section is configured to avoid dilation of the tricuspid valve annulus; the imaging enhancement area is configured to be located above the tricuspid valve annulus area corresponding to the septal leaflet and span the radial gap between the cavity section and the tricuspid valve annulus; the imaging enhancement area is used to lay a pacing wire; The valve prosthesis is inserted into the accommodating cavity and is positioned by the docking device.

2. The tricuspid valve replacement system according to claim 1, characterized in that: The disk surface skeleton includes a plurality of unit grids which are interconnected and arranged along the circumferential direction; the contour shape of the unit grid where the development enhancement area is located is different from the contour shapes of other unit grids.

3. The tricuspid valve replacement system according to claim 1, wherein: The disk surface skeleton includes a plurality of unit grids which are interconnected and arranged along the circumferential direction; and the unit grids where the development enhancement area is located are additionally wound with development threads or plated with development materials.

4. The tricuspid valve replacement system according to claim 1, wherein: The disk surface skeleton includes a plurality of unit grids which are interconnected and arranged along the circumferential direction; the disk surface coating additionally adopts a film body with development performance or a sewn development thread in the area of ​​the unit grid corresponding to the development enhancement area.

5. The tricuspid valve replacement system according to any one of claims 2 to 4, characterized in that: The area of ​​the disk surface covering corresponding to the unit grid where the development enhancement area is located is easier to penetrate than other areas.

6. The tricuspid valve replacement system according to claim 5, characterized in that: The area of ​​the disk surface coating corresponding to the unit grid where the development enhancement area is located is a single-layer film body, and the other areas are double-layer film bodies.

7. The tricuspid valve replacement system according to claim 5, characterized in that: The area of ​​the disk surface coating corresponding to the unit grid where the development enhancement area is located is thinner in thickness and / or smaller in density than other areas.

8. The tricuspid valve replacement system according to claim 1, wherein: The anchoring device comprises a plurality of anchoring members, a plurality of locking members having the same number as the plurality of anchoring members, and a plurality of flexible linear members having the same number as the plurality of anchoring members; In the deployed state: one end of the linear member is fixedly connected to one of the anchoring members, and the other end is fixedly connected to one of the locking members after penetrating the disc segment; at least one of the anchoring members is anchored into the right ventricular tissue, and at least another of the anchoring members is anchored into the tricuspid valve ring tissue or the right atrial tissue; the linear member is tensioned by the corresponding anchoring members and the locking members located on opposite sides of the disc segment, so that the docking device is pressed against the tricuspid valve ring to be positioned.

9. The tricuspid valve replacement system according to claim 8, wherein: At least one of the anchors is anchored in the ventricular septum tissue, at least another of the anchors is anchored in the tricuspid valve annulus tissue corresponding to the anterior leaflet of the tricuspid valve or the right atrial tissue adjacent to the anterior leaflet of the tricuspid valve, and at least another of the anchors is anchored in the tricuspid valve annulus tissue corresponding to the posterior leaflet of the tricuspid valve or the right atrial tissue adjacent to the posterior leaflet of the tricuspid valve.

10. The tricuspid valve replacement system according to claim 8, wherein: The disk surface section is provided with threading holes for the threading of the linear member.

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