Tricuspid valve replacement system

Abstract

The application provides a tricuspid valve replacement system, wherein a docking device is positioned against a tricuspid annulus by an anchoring device, and a valve prosthesis is positioned by the docking device. The docking device comprises a cavity section and a disc section. The cavity section comprises a cavity skeleton and a cavity covering, and the disc section comprises a disc skeleton and a disc covering. The cavity skeleton is generally in a cylindrical structure extending in an axial direction. The disc skeleton is connected to the cavity skeleton and extends outward in a radial direction relative to the cavity skeleton. The disc section is provided with a development-enhancing area. The disc section is configured to be positioned on the tricuspid annulus, the cavity section is configured to avoid expanding the tricuspid annulus, and the development-enhancing area is configured to be positioned on a region of the tricuspid annulus corresponding to a septal leaflet and to span a radial gap between the cavity section and the tricuspid annulus. The tricuspid valve replacement system is easy to arrange a pacing lead and avoids the influence of the pacing lead on the opening and closing of the artificial valve leaflets.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a tricuspid valve replacement system. Background Technology

[0002] The human heart valves include the aortic valve, pulmonary valve, and atrioventricular valves, with the atrioventricular valves further divided into the mitral and tricuspid valves. These valves act as one-way valves, working in sync 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; and 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 narrowing or regurgitation, which inhibits the valve's ability to control blood flow, reduces the heart's pumping efficiency, and can lead to life-threatening conditions such as heart failure. For severe valvular disease, prosthetic heart valves can be used to replace the diseased native heart valves.

[0004] The tricuspid valve has a complex and fragile physiological anatomy. Replacing a diseased native tricuspid valve with a prosthetic valve can easily cause conduction block. For this reason, or due to other subsequent heart disease triggers, a pacemaker is often required. Existing tricuspid valve prostheses, such as the Edwards Evoque valve and Medtronic Intrepid valve, usually require radial expansion of the native tricuspid valve annulus and / or positioning by clamping or inserting into the native leaflet. In this case, the pacemaker's electrode lead (pacing lead) can only pass between the artificial leaflets to enter the right ventricle, which can affect the occlusal motion of the artificial leaflets, causing blood backflow between the artificial leaflets, or 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-mentioned problems.

[0006] The tricuspid valve replacement system provided by this invention includes a docking device, an anchoring device, and a valve prosthesis. The docking device is configured to be positioned against the tricuspid valve annulus via the anchoring device. The docking device includes a cavity section and a disc section. The cavity section includes a cavity skeleton and a cavity covering membrane thereon. The disc section includes a disc skeleton and a disc covering membrane thereon. The cavity skeleton is generally cylindrical in shape, extending axially, to enclose the cavity. The disc skeleton connects to the cavity skeleton and extends radially outward relative to the cavity skeleton. The disc section has a contrast-enhancing area.

[0007] In the deployed state, the disc section is configured to be located above the tricuspid valve annulus, and the cavity section is configured to avoid dilating the tricuspid valve annulus; the contrast enhancement zone is configured to be located above the tricuspid valve annulus region corresponding to the septal leaflet and spans the radial gap between the cavity section and the tricuspid valve annulus; the contrast enhancement zone is used for pacing lead insertion.

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

[0009] Optionally, the disk skeleton includes several interconnected unit grids arranged circumferentially; the outline shape of the unit grid where the development enhancement area is located is different from the outline shape of the other unit grids.

[0010] Optionally, the disk skeleton includes several interconnected unit grids arranged circumferentially; the unit grid where the development enhancement area is located is additionally wound with development threads or coated with development material.

[0011] Optionally, the disk surface skeleton includes several interconnected unit grids arranged circumferentially; the disk surface coating, corresponding to the area of ​​the unit grid where the development enhancement zone is located, additionally employs a film with development properties or sewn with development threads.

[0012] Optionally, the area of ​​the disk coating corresponding to the cell grid where the development enhancement area is located is more easily penetrated than other areas.

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

[0014] Optionally, the area of ​​the disk coating corresponding to the cell grid where the development enhancement area is located has a smaller thickness and / or lower density than other areas.

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

[0016] In the deployed state: one end of the linear component is fixedly connected to an anchoring component, and the other end penetrates the disc section and is fixedly connected to a locking component; at least one anchoring component is anchored into the right ventricular tissue, and at least another anchoring component is anchored into the tricuspid valve annulus tissue or the right atrial tissue; the linear component is tensioned by the anchoring components and locking components located on opposite sides of the disc section, so that the docking device is pressed against the tricuspid valve annulus for positioning.

[0017] Preferably, at least one of the anchoring elements is anchored into the interventricular septum tissue, at least another anchoring element is anchored into the tricuspid valve annulus tissue corresponding to the anterior tricuspid valve leaflet or into the right atrial tissue adjacent to the anterior tricuspid valve leaflet, and at least a third anchoring element is anchored into the tricuspid valve annulus tissue corresponding to the posterior tricuspid valve leaflet or into the right atrial tissue adjacent to the posterior tricuspid valve leaflet.

[0018] Preferably, the disc section is provided with a threading hole for the linear component to be threaded through.

[0019] The tricuspid valve replacement system provided by this invention uses a docking device to position the valve prosthesis, which is further positioned against the tricuspid valve annulus via an anchoring device. The cavity section of the docking device does not expand the tricuspid valve annulus; the disc section of the docking device is located above the tricuspid valve annulus. This disc section has a contrast-enhancing zone located on the tricuspid valve annulus region corresponding to the septal leaflet, and this contrast-enhancing zone spans the radial gap between the cavity section and the tricuspid valve annulus. When a pacemaker is implanted, the significant contrast-enhancing properties of this zone clearly indicate the placement position of the pacing lead. This helps the pacing lead pass through the radial gap between the cavity section and the tricuspid valve annulus, thus avoiding interference with the opening and closing motion of the prosthetic valve leaflet and preventing blood reflux between the prosthetic leaflets. It also reduces the difficulty of pacing lead placement. Attached Figure Description

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

[0021] Figure 2 This is a schematic diagram of the tricuspid valve replacement system of the present invention after deployment, showing the pacing lead being laid out, from another perspective.

[0022] Figure 3 This is a perspective view of the first embodiment of the docking device in this invention;

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

[0024] Figure 5 for Figure 4 Top view of the mid-plate frame;

[0025] Figure 6 for Figure 5 Enlarged view of point B in the middle;

[0026] Figure 7 A top view schematic diagram of another embodiment of the disk surface skeleton;

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

[0028] Figure 9 A top view schematic diagram of another implementation of the disk section;

[0029] Figure 10 This is a perspective view of the second embodiment of the docking device in this invention;

[0030] Figure 11 for Figure 10 Enlarged view of point F in the middle;

[0031] Figure 12 A top view schematic diagram of another embodiment of the disc surface coating;

[0032] Figure 13 This is a schematic diagram of the anchor lock device in the completed deployment state in this invention;

[0033] Figure 14 for Figure 13 Schematic diagram of the anchoring component and linear component;

[0034] Figure 15 , Figure 16 These are schematic diagrams of a linear component with the locking element not locked and a linear component with the locking element locked, respectively.

[0035] Figure 17 This is a three-dimensional schematic diagram of an embodiment of the valve prosthesis of 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, Figure 18 , Figure 19 The implantation of the anchor is shown from different perspectives;

[0038] Figure 20 , Figure 21 The docking device is shown from different perspectives as it is conveyed along the linear component to the tricuspid.

[0039] Figure 22 , Figure 23 The insertion and locking of the locking element are shown separately;

[0040] Figure 24 The valve prosthesis is shown being deployed and positioned within the docking device. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Furthermore, 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, it should be noted that in this article, "proximal" refers to the end of the device or component closer to the operator, and "distal" refers to the end of the device or component farther from the operator; "inflow end" refers to the end located upstream of the blood flow, and "outflow end" refers to the end located downstream of the blood flow; "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 in tricuspid valve replacement, "upper" and "lower" are distinguished in the axial direction according to the actual placement orientation or the orientation shown in the diagram.

[0043] It is worth noting that the terms indicating orientation or positional relationship mentioned above are only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention.

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

[0045] Please see Figure 1 and Figure 2An 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 via the anchoring device 30 and provides a receiving cavity 11; the anchoring device 30 includes a plurality of anchoring elements 31, a plurality of locking elements 33 equal to the plurality of anchoring elements 31, and a plurality of flexible linear elements 35 equal to the plurality of anchoring elements 31.

[0046] exist Figure 1 and Figure 2 In the completed deployment state shown: one end of the linear component 35 is fixedly connected to an anchor 31, and the other end penetrates the docking device 10 and is fixedly connected to a locking component 33; at least one anchor 31 is anchored into the right ventricular tissue for fixation, and at least another anchor 31 is anchored into the tricuspid valve annulus tissue or the right atrial tissue for fixation; the linear component 35 is tensioned by the corresponding anchor 31 and locking component 33 located on opposite sides of the docking device 10, so that the docking device 10 is pressed against the original tricuspid valve annulus for positioning; the valve prosthesis 60 is inserted into the receiving cavity 11 of the docking device 10 and positioned by the docking device 10, and the positioning method includes, but is not limited to, interference fit, snap-fit, 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, clamps, etc. on the valve prosthesis that act on the original leaflet and / or original annulus for positioning. Instead, the valve prosthesis 60 is positioned by the docking device 10, which is in turn positioned by the anchoring device 30. At least one anchor 31 in the anchoring device 30 is anchored into the right ventricular tissue, and at least another anchor 31 is anchored into the tricuspid valve annulus tissue or right atrial tissue. The linear member 35 is tensioned by the corresponding anchors 31 and locking members 33 located on opposite sides of the docking device 10. By using the physical means of the tensioned linear member 35 pulling the locking member 33, the docking device 10 can be firmly pressed against the original tricuspid valve annulus for positioning, and thus 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 with reference to the accompanying drawings. It is understood that different embodiments of the docking device, the anchoring device, and the valve prosthesis can be combined in different ways.

[0049] docking device

[0050] Please see Figures 3 to 6 Combination 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 correspondingly includes a cavity frame 132 and a disk frame 134. The membrane 15 includes a cavity membrane 152 covering the cavity frame 132 and a disk membrane 154 covering the disk frame 134. The cavity frame 132 is generally cylindrical in shape extending axially to enclose the accommodating cavity 11. The disk frame 134 connects to the cavity frame 132 and extends radially outward relative to the cavity frame 132.

[0051] In this embodiment, the cavity frame 132 includes an inner frame 1321 and an outer frame 1323. The inner frame 1321 and the outer frame 1323 are formed and then fixedly connected together. The fixing connection method includes, but is not limited to, welding and binding. The outer frame 1323 abuts against the radially outer side of the inner frame 1321, and the upper end of the outer frame 1323 integrally extends into a disc frame 134. The inner frame 1321 surrounds the receiving cavity 11. In order to ensure that the receiving 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 original 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 braiding and heat-setting biocompatible and shape-memory ductile metal wire, such as nickel-titanium alloy wire, and then fixing the ends of the nickel-titanium alloy wire with steel sleeves. Furthermore, the inner frame 1321 includes several interconnected, generally U-shaped units A1 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 3 mm, the diameter of the accommodating cavity 11 enclosed by the inner frame 1321 can be in the range of 18 mm to 40 mm, and the wire diameter of the nickel-titanium alloy wire can be in the range of 0.1 mm to 1 mm. It is understood that the inner frame can also be formed by cutting and heat-setting biocompatible and shape-memory ductile metal.

[0053] Combination Figure 3 and Figure 4In this embodiment, the outer frame 1323 and the disk frame 134 integrally connected thereto are made of shape-memory metal wire, such as nickel-titanium alloy wire, through weaving and heat setting. The outer frame 1323 includes multiple U-shaped units (not shown), and the disk frame 134 includes multiple interconnected and circumferentially arranged unit grids A2, each unit grid A2 being formed by several metal wire supports. 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 frame 134 is in the range of 40 mm to 80 mm.

[0054] Preferably, the radial contour of the unit grid A2 is generally a transverse S-shape. When the unit grid A2 of the disc 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, thereby improving the effect of preventing paravalvular leakage.

[0055] Please refer to it again. Figure 3 The cavity covering 152 can be sewn onto the inner and / or outer surfaces of the cavity frame 132, thus forming the cavity segment 12 together with the cavity frame 132. Similarly, the disc covering 154 can be sewn onto the inner and / or outer surfaces of the disc frame 134, thus forming the disc segment 14 together with the disc frame 134. Both the cavity covering 152 and the disc covering 154 can be made of synthetic or natural materials such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyurethane (TPU), or expanded polytetrafluoroethylene (ePTFE). It is understood that the cavity covering 152 and the disc covering 154 can be integral or separate pieces connected by sewing.

[0056] Combination Figure 1 , Figure 2 and Figure 3 The disc section 14 has a number of thread holes 141, the number of which is the same as the number of linear members 35. Each thread hole 141 allows a corresponding linear member 35 to pass through. The thread holes 141 are located radially closer to the cavity 11 so that the locking member 33 has a more stable point of force after locking the linear member 35.

[0057] For a docking device 10 suitable for placement at the native tricuspid valve, at least its disc section 14 should be configured above the native tricuspid valve annulus. A portion of the cavity section 12 may lie within the native tricuspid valve annulus, but the cavity section 12 is configured to avoid dilating the native tricuspid valve annulus; that is, the outer diameter of the cavity section 12 is set smaller than the inner diameter of the native tricuspid valve annulus. This configuration ensures that the docking device 10 does not radially compress or dilate the native tricuspid valve annulus.

[0058] Please refer to it again. Figure 1 , Figure 2 If, after the tricuspid valve replacement system is deployed (either immediately or after some time), the patient experiences symptoms such as arrhythmia, and atrioventricular block reaches grade II, type II, or III (the cause may be the implantation of the tricuspid valve replacement system or other heart diseases), a pacemaker needs to be implanted. The pacing lead 80 must pass through the tricuspid valve replacement system into the right ventricle so that the distal end of the pacing lead 80 can be rotated into or inserted into the target site within the right ventricle. Combined with... Figure 5 and Figure 6 To facilitate the placement of the pacing lead 80 and prevent it from passing through the artificial leaflets 65 of the valve prosthesis 60 and affecting their proper occlusion, the disc section 14 is provided with a contrast-enhancing region 146 for the pacing lead 80 to pass through or be placed. The contrast-enhancing region 146 is configured to be located above the tricuspid valve annulus region corresponding to the septal leaflet and spans the radial gap between the cavity section 12 and the tricuspid valve annulus. Furthermore, the contrast-enhancing region 146 includes a corresponding unit grid A2 of the disc skeleton 134 located within this region and a corresponding disc coating 154 thereon.

[0059] exist Figure 5 and Figure 6 In the illustrated embodiment, developing threads 70 are wound around the unit grid A2 where the developing enhancement zone 146 is located, while no developing threads are provided on any unit grid A2 outside the developing enhancement zone 146. Specifically, the developing threads 70 can be wound around the support rod of the unit grid A2 where the developing enhancement zone 146 is located by means of winding, sewing, etc. The material of the developing threads 70 includes, but is not limited to, at least one of platinum, iridium, gold, silver, tantalum, and tungsten. The developing threads 70 form a closed area on the corresponding unit grid A2, and the boundary of this closed area is the boundary of the developing enhancement zone 146. The area of ​​this closed area is equal to the area of ​​a complete unit grid A2, preferably not less than 1 mm². 2 .

[0060] In other embodiments, the unit grid A2 where the development enhancement area 146 is located can be plated with a developing material such as platinum, iridium, gold, silver, tantalum, or tungsten to replace the wound developing wire.

[0061] Understandably, because the imaging enhancement zone 146 is additionally wound with imaging threads 70 or coated with imaging material on the unit grid A2, the imaging enhancement zone 146 has significant imaging performance and can be clearly visualized under imaging equipment, especially X-rays. When a pacemaker needs to be implanted, the imaging enhancement zone 146 can clearly indicate the position where the pacing lead should be placed, thereby helping to reduce the difficulty of laying the pacing lead; and, since the imaging enhancement zone 146 spans the radial gap between the cavity segment 12 and the tricuspid valve annulus, the pacing lead can be placed near the inner boundary of the imaging enhancement zone 146 (i.e., near the boundary of the cavity segment), allowing the pacing lead to pass through the radial gap between the cavity segment and the tricuspid valve annulus to enter the right ventricle, thereby avoiding the influence of the pacing lead 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 reflux between the artificial valve leaflets.

[0062] Specifically, the pacing lead placement process includes: under the imaging indication of the imaging enhancement zone 146, puncturing the disc coating 154 on the unit grid A2 where the imaging enhancement zone 146 is located; the distal end of the sheath used to accommodate and deliver the pacing lead passes through the puncture of the disc coating 154, then passes through the unit grid A2 where the imaging enhancement zone 146 is located and enters the right ventricle; then the pacing lead is pushed out from the distal end of the sheath; finally, the pacing lead is manipulated to be screwed into or punctured into the target site in the right ventricle to complete the pacing lead placement.

[0063] Please see Figure 7 In another implementation, with Figure 5 , Figure 6 The main difference in the illustrated embodiment is that the disk skeleton 2134 includes several interconnected unit grids arranged circumferentially, but the outline shape of the unit grid A23 where the development enhancement region 2146 is located is different from the outline shape of the other unit grids A2. Specifically, as shown... Figure 7 For example, the outline shape of the cell grid A23 containing the development enhancement area 2146 is generally circular, while the outline shape of all cell grids A2 outside the development enhancement area 2146 is generally rhomboid. Understandably, the outline shape of the cell grid A23 containing the development enhancement area 2146 can also be hexagonal, triangular, etc., as long as it is different from the shape of other cell grids A2.

[0064] The outline shape of the unit grid A2 where the imaging enhancement area 2146 is located is different from the outline shape of other unit grids A22, and has obvious differences. Therefore, the imaging enhancement area 2146 is more easily identified and clearly developed by ultrasound, X-ray and other imaging.

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

[0066] Please see Figure 8 In another implementation, with Figure 5 , Figure 6 The main difference in the illustrated embodiment is that the disk surface skeleton 134 of the disk surface section 24 includes several interconnected unit grids A2 arranged circumferentially. The area 2155 of the disk surface coating 2154 corresponding to the unit grid A2 where the development enhancement area 3146 is located uses a film with development properties, while the area of ​​the disk surface coating 2154 corresponding to other unit grids A2 is a conventional coating film. The unit grid A2 where the development enhancement area 3146 is located can be no different from other unit grids A2, or it can be additionally wound with development threads or coated with development material. Specifically, the film with development properties can be formed by weaving development threads (the material of the development threads includes, but is not limited to, platinum, iridium, gold, silver, tantalum, tungsten, etc.) together with common film-forming materials (such as the aforementioned PET, PTFE, TPU, ePTFE, etc.).

[0067] Since the region 2155 of the cell grid A2 where the development enhancement region 3146 is located is made of a film with development properties, the development performance of the development enhancement region 3146 is significant, and it can be clearly developed in imaging equipment, especially under X-ray.

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

[0069] Figure 9 It shows Figure 8 In one variation of the embodiment shown, additional developing threads 270 are sewn onto the area of ​​the unit grid A2 where the developing enhancement area 4146 is located on the disk surface coating 154 of the disk surface section 34. The developing threads 270 form a closed boundary (such as a circular boundary), and the area within the boundary is used to lay the pacing leads.

[0070] Because the disc coating 154 has additional developing threads 270 sewn on the area of ​​the unit grid A2 where the developing enhancement area 4146 is located, the developing performance of the developing enhancement area 4146 is significantly improved, and it can be clearly developed in imaging equipment, especially under X-ray.

[0071] As mentioned earlier, the disk coating on the cell grid containing the development enhancement zone needs to be punctured. Please refer to [link / reference]. Figure 10 and Figure 11 Based on any of the above embodiments / implementations, the present invention further provides that the area of ​​the disc surface coating 4154 of the docking device 210 corresponding to the unit grid A2 where the imaging enhancement area 146 is located is more easily penetrated than other areas, so as to make the laying of the pacing lead easier and less labor-intensive.

[0072] To achieve the effect that the area of ​​cell grid A2 corresponding to the development enhancement zone 146 of the disk surface coating 4154 is more easily penetrated than other areas:

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

[0074] like Figure 12 As shown, the area of ​​the disc surface coating 5154 corresponding to the unit grid where the development enhancement area 146 is located has a lower density or is sparser than other areas. For example, the area of ​​the disc surface coating 5154 corresponding to the unit grid where the development enhancement area 146 is located is made of knitted film, while other areas are made of woven film.

[0075] Understandably, in other embodiments, the thickness of the disc coating corresponding to the unit grid where the development enhancement area is located may be smaller than that of other areas. For example, the thickness of the disc coating corresponding to the unit grid where the development enhancement area is located may be 0.03 mm, while the thickness of other areas may be 0.05 mm.

[0076] Anchor Locking Device

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

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

[0079] The locking element 33 includes a spindle 331, a first end cap 333 fixedly disposed at the distal end of the spindle 331, a second end cap 335 selectively movably disposed on the spindle 331 and axially spaced from the first end cap 333, and a spring 337 sleeved on the spindle 331 between the first end cap 333 and the second end cap 335. The materials of the spindle 331, the first end cap 333, and the second end cap 335 may be, but are not limited to, cobalt-chromium alloy, stainless steel, etc., while the spring 337 is selected from a biocompatible and corrosion-resistant material suitable for making springs. The second end cap 335 can be selectively and movably mounted on the spindle 331 in ways including but not limited to screw connection (e.g., the spindle 331 has an external thread, and the second end cap 335 has a matching internal thread) and snap connection (e.g., the spindle 331 has an elastic locking block, and the second end cap 335 has a locking groove; when the elastic locking block enters the locking groove, the second end cap 335 can no longer move axially). After the second end cap 335 moves (rotates or moves axially) toward the first end cap 333 to a predetermined position, it can be positioned at that predetermined position.

[0080] The linear element 35 is arranged in an approximately wave-like pattern on each coil of the spring 337, with adjacent crests and troughs located radially inside and radially outside of adjacent coils, respectively. When the second end cap 335 moves toward the first end cap 333 and is positioned at a predetermined position, it can compress the spring 337 to clamp the linear element 35 between adjacent coils.

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

[0082] Combination Figures 18 to 24 In the anchoring device 30, the anchoring element 31 is deployed before the docking device 10. Before the docking device 10 is deployed, one end of the linear element 35 is fixedly connected to an anchoring element 31 that anchors into the right ventricular tissue, tricuspid valve annulus tissue, or right atrial tissue, while the other end extends outside the body. During the deployment of the docking device 10, the extended end of each linear element 35 passes through the threading hole 141, and the linear element 35 guides the docking device 10 to the native tricuspid valve. Then, each locking element 33 is threaded onto the corresponding linear element 35, and the linear element 35 guides the locking element 35 to be delivered near the disc section 14 of the docking device 10. Next, by controlling the tension of the locking element 33 on the linear element 35, so that the disc section 14 can closely adhere to the native tricuspid valve annulus tissue and / or right atrial tissue, the locking element 33 is operated to lock the linear element 35. Finally, the portion of the linear element 35 located proximal to the locking element 33 is cut off.

[0083] With the docking device 10 and the anchoring device 30 deployed: one end of the linear component 35 is fixedly connected to an anchoring component 31, and the other end penetrates the wire hole 141 of the disc section 14 and is fixedly connected to a locking component 33.

[0084] Combination Figure 1 and Figure 2 The disc segment 14 is configured to lie on the native tricuspid valve annulus, with at least one anchor 31 anchored into right ventricular tissue, including but not limited to the right ventricular wall, tricuspid valve papillary muscles, and interventricular septum, and at least another anchor 31 anchored into the tricuspid valve annulus tissue or right atrial tissue. Preferably, at least one anchor 31 is anchored into the interventricular septum, at least another anchor 31 is anchored into the annulus tissue corresponding to the native anterior leaflet or the atrial tissue adjacent to the native anterior leaflet, and at least another anchor 31 is anchored into the annulus 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 disc segment 14, so that the docking device 10 is positioned against the tricuspid valve annulus. This arrangement helps to ensure that the anchoring device 30 is positioned more symmetrically and evenly on the docking device 10 without damaging the atrioventricular node.

[0085] valve prosthesis

[0086] Please see Figure 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 leaflets 65 that can be opened and closed relative to each other, wherein the artificial 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 member 64 connected to the valve frame body 62. The loading member 64 can be loaded by a valve delivery device (not shown).

[0088] The valve frame body 62 is an expandable frame component that supports the artificial valve leaflet 65. The valve prosthesis 60 can be radially compressed to a compressed state for delivery to a predetermined deployment site, such as within the pre-deployed docking device 10 described above, forming a tricuspid valve replacement system together with the docking device 10 and the anchoring device 30. The valve prosthesis 60 can also expand or inflate 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 shape-memory metal, such as a 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 a cobalt-chromium alloy.

[0089] Artificial leaflets 65 can be made from any suitable biological material (e.g., pericardial tissue, such as bovine or porcine pericardium), biocompatible synthetic material, or other such material.

[0090] Membrane 63 may include biocompatible flexible compressible materials, such as PET fabrics, pericardial tissue, etc.

[0091] Deployment process of tricuspid valve replacement system

[0092] The deployment process of the tricuspid valve replacement system of the present invention will be described below in chronological order of operation.

[0093] Step 1:

[0094] Please see Figure 18 and Figure 19 The first delivery device 91 delivers and deploys several anchors 31 one by one via the superior vena cava. At least one or two anchors 31 are anchored into the interventricular septum tissue, at least another anchor 31 is anchored into the valve annulus tissue corresponding to the original anterior leaflet or the atrial tissue adjacent to the original anterior leaflet, and at least another anchor 31 is anchored into the valve annulus tissue corresponding to the original posterior leaflet or the atrial tissue adjacent to the original posterior leaflet. The free ends of the linear members 35 that are fixedly connected to each anchor 31 extend outside the body.

[0095] Step 2:

[0096] Please see Figure 20 and Figure 21 After the free ends of each linear member 35 extending outside the body pass through the corresponding wire 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 along the guide of the linear member 35 at the original tricuspid valve.

[0097] Step 3:

[0098] Please see Figure 22 and Figure 23 The free ends of each linear component 35 extending outside the body are respectively inserted into each locking component 33. The third delivery device 95 delivers and locks the locking components 33 one by one. During this process, the tightness between the disc section 14 and the original tricuspid valve annulus tissue and / or tricuspid valve atrial tissue can be adjusted by controlling the tension of the locking component 33 on the linear component 35, in order to seek a better paravalvular leakage prevention effect. After the adjustment is completed, the locking component 33 is locked to the linear component 35, so that the docking device 10 is pressed against the original tricuspid valve annulus for positioning.

[0099] Then, a cutting device (not shown) is used to cut the portion of the linear member 35 located near the locking member 33.

[0100] Step 4:

[0101] Please see Figure 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] This completes the deployment of the entire tricuspid valve replacement system.

[0103] Understandably, other suitable interventional approaches can also be chosen for tricuspid valve replacement systems.

[0104] For further details, please refer to the following: Figure 2 After the tricuspid valve replacement system is deployed (either immediately or after some time), if the patient experiences symptoms such as arrhythmia and atrioventricular block reaches type II or III (the cause may be the implantation of the tricuspid valve replacement system or other heart diseases), a pacemaker needs to be implanted. A pacing lead 80 is placed in the contrast-enhanced area 146 of the disc segment 14. The pacing lead 80 passes through the radial gap between the cavity segment of the docking device 10 and the tricuspid valve annulus region corresponding to the septal leaflet, and enters the right ventricle, avoiding the influence of the pacing lead 80 on the opening and closing motion of the artificial leaflet 65.

[0105] The above description is only a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the embodiments listed above. Any simple changes or equivalent substitutions of the technical solutions that can be obviously obtained by those skilled in the art within the scope of the technology disclosed in the present invention shall fall within the scope of protection of the present invention.

Claims

1. A tricuspid valve replacement system, characterized in that, Includes docking device, anchoring device and valve prosthesis; The docking device is configured to be positioned by pressing against the tricuspid annulus via the anchoring device; The docking device includes a cavity section and a disk section. The cavity section includes a cavity skeleton and a cavity coating covering it. The disk section includes a disk skeleton and a disk coating covering it. The cavity skeleton is generally cylindrical in shape, extending axially, to enclose the cavity. The disk skeleton connects to the cavity skeleton and extends radially outward relative to the cavity skeleton. The disk section has a development enhancement area. In the deployed state, the disc section is configured to be located above the tricuspid valve annulus, and the cavity section is configured to avoid dilating the tricuspid valve annulus; the contrast enhancement zone is configured to be located above the tricuspid valve annulus region corresponding to the septal leaflet and spans the radial gap between the cavity section and the tricuspid valve annulus; the contrast enhancement zone is used for laying pacing leads. The valve prosthesis is inserted into the receiving cavity and positioned by the docking device; The anchoring device includes several anchoring elements, several locking elements of the same number as the anchoring elements, and several flexible linear elements of the same number as the anchoring elements; In the deployed state: one end of the linear component is fixedly connected to an anchoring component, and the other end penetrates the disc section and is fixedly connected to a locking component; at least one anchoring component is anchored into the right ventricular tissue, and at least another anchoring component is anchored into the tricuspid valve annulus tissue or the right atrial tissue; the linear component is tensioned by the anchoring components and locking components located on opposite sides of the disc section, so that the docking device is pressed against the tricuspid valve annulus for positioning.

2. The tricuspid valve replacement system as described in claim 1, characterized in that, The disk skeleton comprises several interconnected unit grids arranged circumferentially; the outline shape of the unit grid where the development enhancement area is located is different from the outline shape of the other unit grids.

3. The tricuspid valve replacement system as described in claim 1, characterized in that, The disk skeleton includes several interconnected unit grids arranged circumferentially; the unit grid where the development enhancement area is located is additionally wound with development threads or coated with development material.

4. The tricuspid valve replacement system as described in claim 1, characterized in that, The disk surface skeleton includes several interconnected unit grids arranged circumferentially; the disk surface coating, corresponding to the area of ​​the unit grid where the development enhancement zone is located, additionally uses a film with development properties or sewn development threads.

5. The tricuspid valve replacement system as described in any one of claims 2-4, characterized in that, The area of ​​the disk coating corresponding to the cell grid where the development enhancement area is located is more easily penetrated than other areas.

6. The tricuspid valve replacement system as described in claim 5, characterized in that, The area of ​​the disk coating corresponding to the unit grid where the development enhancement area is located is a single-layer film, while other areas are double-layer films.

7. The tricuspid valve replacement system as described in claim 5, characterized in that, The coating on the disk surface corresponds to a region of the cell grid where the development enhancement area is located that has a smaller thickness and / or lower density than other regions.

8. The tricuspid valve replacement system as described in claim 1, characterized in that, At least one of the anchoring elements is anchored into the interventricular septum tissue, at least another anchoring element is anchored into the tricuspid valve annulus tissue corresponding to the anterior tricuspid valve leaflet or into the right atrial tissue adjacent to the anterior tricuspid valve leaflet, and at least a third anchoring element is anchored into the tricuspid valve annulus tissue corresponding to the posterior tricuspid valve leaflet or into the right atrial tissue adjacent to the posterior tricuspid valve leaflet.

9. The tricuspid valve replacement system as described in claim 1, characterized in that, The disc section is provided with threading holes for threading the linear component.

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