Heart valve replacement system

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a heart valve replacement system, which comprises: a valve support, the valve support is a single-layer self-expanding structure, the valve support comprises a support body and a skirt structure which are integrally connected from an outflow end to an inflow end; and an anchoring support, the anchoring support is a spherical structure, the anchoring support is located on the inner side of the skirt structure and is detachably abutted on the skirt structure. The valve support of the application is a single-layer self-expanding support, the single-layer structure is conducive to compression and delivery, the valve support and the anchoring support are a detachable structure, so that they can be delivered separately, the compression diameter is small, and the delivery and implantation through the femoral artery and the like are facilitated, the two are delivered separately and are sequentially introduced into the human body, a thinner catheter can be used for delivery and implantation into the human body, and the expansion of the blood vessel is reduced.

Description

Technical Field

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

[0002] The heart is divided into left and right parts, each containing a ventricle and an atrium. The ventricles and atria are separated by the interventricular septum and the atrial septum. There are valves between the atria and ventricles to prevent backflow of blood. Normal valves only allow blood to flow in one direction in the heart.

[0003] Mitral regurgitation is caused by valvular insufficiency. During left ventricular systole, blood flows from the left ventricle into the aorta and the less resistant left atrium. The left atrium receives blood from the pulmonary veins as well as regurgitated blood from the left ventricle. Therefore, increased left atrial pressure leads to increased pressure in the pulmonary veins and pulmonary capillaries, resulting in dilation and congestion. Simultaneously, the diastolic volume load of the left ventricle increases, causing left ventricular enlargement. In acute mitral regurgitation, the sudden increase in regurgitated blood in the left atrium can cause a sharp rise in pressure in the left atrium and pulmonary veins, leading to acute pulmonary edema.

[0004] Currently, mitral valve repair typically involves edge-to-edge repair or mitral valve replacement. Edge-to-edge repair uses a clamp to clamp the edges of the regurgitating leaflets, essentially turning the large blood flow channel formed by the leaflets into two smaller channels by clamping them together in the middle. For cases where repair is not possible, replacement surgery is necessary. In mitral valve replacement surgery, a prosthetic valve is implanted to replace the original mitral valve and treat regurgitation caused by mitral valve disease. Currently, both mitral valve replacement technology and prosthetic valves are in the early exploratory stages, therefore, further research and improvement of prosthetic valves are necessary.

[0005] Mitral valve replacement surgery is divided into traditional surgical surgery and interventional mitral valve replacement surgery. The former has disadvantages such as large trauma, easy wound infection, and long recovery time. The latter is difficult because of the unique physiological structure of the mitral valve annulus, which makes it difficult to anchor the valve prosthesis and seal the paravalvular leakage. Currently disclosed products and patents usually use barbs, apical tethers, etc. for anchoring and sealing. However, the complex structure results in a large valve prosthesis grip size, which makes it difficult to transport, position, anchor and release in the body, and can only be used for a very small number of patients.

[0006] To address the above problems, it is hoped that a novel mitral valve replacement system can be provided to solve the mitral regurgitation problem. Summary of the Invention

[0007] This invention addresses the technical problems of existing mitral valve replacement systems, such as complex structure, large gripping size, and difficulty in delivery, positioning, anchoring, and release within the body. The purpose is to provide an anchoring stent and a heart valve replacement system.

[0008] To address the aforementioned technical problems, a first aspect of the present invention provides an anchoring stent for a heart valve replacement system, wherein the anchoring stent employs a self-expanding spherical structure composed of a plurality of anchoring grids.

[0009] Alternatively, in the anchoring stent for the heart valve replacement system as described above, a single anchoring grid is formed by a plurality of shape memory metal rods.

[0010] Optionally, in the anchoring stent for the heart valve replacement system as described above, the anchoring stent is a cut stent made of shape memory metal.

[0011] Optionally, in the anchoring stent for the heart valve replacement system as described above, the width of the mesh rod is no greater than 2 mm.

[0012] Optionally, in the anchoring stent for the heart valve replacement system as described above, if the area of ​​a single anchoring grid is X, then 10 mm 2 ≤X≤200mm 2 .

[0013] Optionally, in the anchoring stent for the heart valve replacement system as described above, the anchoring stent is a braided stent made of braided wires, which serve as the mesh poles.

[0014] Optionally, in the anchoring stent for the heart valve replacement system as described above, the diameter of the braided wire is 0.1 to 1 mm, preferably 0.1 to 0.13 mm.

[0015] Optionally, in the anchoring stent for the heart valve replacement system as described above, the braided stent has a multi-layer structure, in which the anchoring grids of adjacent layers are staggered.

[0016] Optionally, in the anchoring stent for the heart valve replacement system as described above, the diameter of the braided yarn used in the inner layer of the multilayer structure is larger than the diameter of the braided yarn used in the outer layer, and the braided anchoring mesh density of the inner layer is smaller than the braided anchoring mesh density of the outer layer.

[0017] Optionally, in the anchoring stent for the heart valve replacement system as described above, the diameter of the braided wire used in the inner layer of the multilayer structure is 0.3-1 mm, and the diameter of the braided wire used in the outer layer is 0.1-0.5 mm.

[0018] Optionally, in the anchoring stent for the heart valve replacement system as described above, the mesh rod is provided with a winding thread, which may be one or more of PTFE, PET, TPU and ultra-high molecular weight polyethylene.

[0019] Optionally, in the anchoring stent for the heart valve replacement system as described above, an anchoring membrane is provided in the area where the anchoring stent contacts the valve stent after expansion.

[0020] Optionally, in the anchoring stent for the heart valve replacement system as described above, both the inlet and outlet ends of the anchoring stent are open structures.

[0021] To address the aforementioned technical problems, a second aspect of the present invention provides an anchoring stent for a heart valve replacement system, wherein the anchoring stent employs a spherical expansion-type quasi-spherical structure composed of a plurality of anchoring grids.

[0022] Optionally, in the anchoring stent for the heart valve replacement system as described above, a single anchoring grid is formed by a plurality of poles, wherein the width of the poles containing the anchoring grid in the middle is smaller than the width of the poles containing the anchoring grids at the converging ends.

[0023] Optionally, in the anchoring stent for the heart valve replacement system as described above, the anchoring stent is a non-self-expanding stent, and the anchoring stent is made of one or more materials such as cobalt-chromium alloy and stainless steel.

[0024] Optionally, in the anchoring stent for the heart valve replacement system as described above, the anchoring stent is formed by cutting and heat-setting a metal tube.

[0025] Optionally, in the anchoring stent for the heart valve replacement system as described above, if the area of ​​a single anchoring grid is X, then 10 mm 2 ≤X≤200mm 2 .

[0026] Optionally, in the anchoring stent for the heart valve replacement system as described above, after balloon dilation, the anchoring grid area in the middle is larger than the anchoring grid area at the converging ends.

[0027] Optionally, in the anchoring stent for the heart valve replacement system as described above, the mesh rod is provided with a winding thread, which may be one or more of PTFE, PET, TPU and ultra-high molecular weight polyethylene.

[0028] Optionally, in the anchoring stent for the heart valve replacement system as described above, an anchoring membrane is provided in the area where the anchoring stent contacts the valve stent after balloon dilation.

[0029] Optionally, in the anchoring stent for the heart valve replacement system as described above, the surface of the anchoring stent is coated with a TPU insulating layer.

[0030] Optionally, in the anchoring stent for the heart valve replacement system as described above, both the inlet and outlet ends of the anchoring stent are open structures.

[0031] To address the aforementioned technical problems, a third aspect of the present invention provides a heart valve replacement system, the heart valve replacement system comprising:

[0032] A valve stent, wherein the valve stent is a single-layer self-expanding structure, and the valve stent comprises an integrally connected stent body and skirt structure from the outflow end to the inflow end;

[0033] An anchoring bracket, which is a spherical structure, is located inside the skirt structure and is separately abutted against the skirt structure.

[0034] Optionally, in the heart valve replacement system described above, the stent body is a cylindrical structure.

[0035] Optionally, in the heart valve replacement system described above, the skirt structure is an outward expansion structure that extends from the outflow end to the inflow end.

[0036] Optionally, in the heart valve replacement system as described above, the skirt structure is provided with a skirt covering.

[0037] Optionally, in the heart valve replacement system as described above, the outflow end of the skirt cover is at least connected to the inflow edge of the artificial leaflet.

[0038] Optionally, in the heart valve replacement system as described above, the skirt covering is disposed inside the skirt structure.

[0039] Optionally, in the heart valve replacement system as described above, the skirt cover located inside the skirt structure extends onto the stent body, causing the skirt cover to form a stent valve.

[0040] Optionally, in the heart valve replacement system as described above, a skirt covering is also provided on the outer side of the skirt structure.

[0041] Optionally, in the heart valve replacement system as described above, a TPU membrane is provided on the inner side of the skirt membrane located inside the skirt structure.

[0042] Optionally, in the heart valve replacement system as described above, the skirt structure is provided with a plurality of outwardly flared barb structures at circumferential intervals.

[0043] Optionally, in the heart valve replacement system as described above, the barb structure has a connecting end and a free end, the connecting end of the barb structure being connected to the skirt structure, and the free end of the barb structure extending out of the outer surface of the skirt structure.

[0044] Optionally, in the heart valve replacement system as described above, the free end of the barb structure is everted and points towards the inflow end.

[0045] Optionally, in the heart valve replacement system described above, the skirt structure is formed by a plurality of skirt meshes, and the connecting end of the barbed structure is integrally connected to the connection between two adjacent skirt meshes.

[0046] Optionally, in the heart valve replacement system as described above, the valve stent further includes a plurality of connecting rods for connection to the delivery device.

[0047] Optionally, in the heart valve replacement system as described above, one end of a plurality of the connecting rods is circumferentially spaced on the skirt structure, and the other end of the plurality of the connecting rods converges toward the inflow end and toward the center.

[0048] Optionally, in the heart valve replacement system described above, the skirt structure is formed by a plurality of skirt meshes, and one end of the connecting rod is integrally connected to the connection between two adjacent skirt meshes.

[0049] Optionally, in the heart valve replacement system as described above, when the skirt structure is provided with a barbed structure, the connecting rod is offset from the barbed structure at the connection between two adjacent skirt grids.

[0050] Optionally, in the heart valve replacement system as described above, the inlet end of the connecting rod is provided with a pull wire hole.

[0051] Optionally, in the heart valve replacement system as described above, the anchoring stent is coaxial with the valve stent.

[0052] Optionally, in the heart valve replacement system as described above, the anchoring stent is the anchoring stent provided in the first aspect of the present invention or the anchoring stent provided in the second aspect.

[0053] Optionally, in the heart valve replacement system as described above, when the anchoring stent is the anchoring stent provided in the second aspect of the present invention, a stent cover is provided on the inner side of the valve stent, and a TPU spun membrane is provided on the inner side of the stent cover.

[0054] Optionally, in the heart valve replacement system as described above, when the anchoring stent is the anchoring stent provided in the second aspect of the present invention, at least one surface of the valve stent and the anchoring stent is coated with a TPU insulating layer.

[0055] The positive and progressive effects of this invention are as follows:

[0056] 1. The valve stent of the present invention is a single-layer self-expanding stent. The single-layer structure facilitates compression and delivery. After implantation, the skirt structure fits into the physiological valve annulus (the area where the physiological valve annulus is located on one side of the atrium), rather than relying on the stent body and the original leaflet for sealing. Therefore, it is not necessary to capture the original leaflet, which reduces the difficulty of valve stent implantation.

[0057] 2. The valve stent and the anchoring stent are separate structures, so they can be delivered separately. The small diameter of the clamp makes it easy to deliver and implant via methods such as transfemoral delivery. The separate delivery and step-by-step entry into the human body allows for the use of finer catheters for implantation, reducing the expansion of blood vessels.

[0058] 3. When implanting an anchoring stent after valve stent implantation, the anchoring stent can be expanded using either a self-expanding or balloon-expanding method, depending on its characteristics. The increased stiffness after expansion keeps the skirt structure of the valve stent pressed against the physiological annulus, ensuring the stability of the valve stent. The anchoring stent essentially functions as the primary anchoring structure of the valve stent. By expanding the anchoring stent and pressing down on the skirt structure of the expanded stent, the skirt structure of the valve stent is made to fit more closely to the physiological annulus, increasing the sealing effect.

[0059] 4. Self-expanding anchoring stents consist of several anchoring grids and are usually not covered with a membrane, allowing for arbitrary release of the anchoring stent without obstructing the flow of blood within the atria, such as the pulmonary veins of the left atrium.

[0060] The cutting stent employs a limited mesh width, ensuring that blood flow is not impeded even if the mesh obstructs the blood vessel opening. The density of the anchoring mesh is controlled to guarantee that blood can pass smoothly through the anchoring mesh of the stent.

[0061] The braided stent, constructed using braided yarns, has its yarn diameter limited to ensure support while the relatively fine yarns minimize their impact on blood flow, allowing for smooth blood passage. To increase the stent's stiffness and support, and to provide sufficient clamping force to the skirt of the valve stent, the braided stent can be a double-layer structure, with the outer and inner anchoring meshes staggered. The thicker inner braided yarns can provide greater radial support with a lower braid density, further reducing the impact on blood flow.

[0062] To promote the integration of the anchoring stent with the atrial endothelialization, the anchoring stent's mesh poles are equipped with winding threads.

[0063] When controlling the release direction of the anchoring stent, an anchoring membrane can be added to the area in contact with the valve stent skirt structure to improve sealing performance.

[0064] 5. The ball-expandable anchoring stent consists of several anchoring grids and is usually not covered with a membrane, allowing for arbitrary release of the anchoring stent without obstructing the flow of blood within the atrium, such as the pulmonary veins of the left atrium.

[0065] The width of the anchoring mesh in the middle of the anchoring bracket is smaller than the width of the anchoring mesh at the two ends. This is because the middle anchoring bracket changes from a compressed state to an expanded spherical anchoring bracket, which has a large deformation. The narrower mesh width can effectively reduce the expansion pressure of the balloon, and the narrower middle mesh also increases the elasticity of the expanded spherical anchoring bracket.

[0066] By limiting the area of ​​the anchoring grid, blood can pass smoothly through the anchoring grid of the anchoring stent, while also preventing the anchoring stent from being overstretched and damaged.

[0067] To promote the integration of the anchoring stent with the atrial endothelialization, the anchoring stent's mesh poles are equipped with winding threads.

[0068] When controlling the release direction of the anchoring stent, an anchoring membrane can be added to the area in contact with the valve stent skirt structure to improve sealing performance.

[0069] Because the anchoring stent and the valve stent are made of different materials, in order to prevent electrochemical reactions, a layer of TPU spun film is spun on the surface of the stent coating (usually PET film) inside the valve stent. The TPU spun film has good insulation properties, which effectively blocks the electronic conduction between the anchoring stent and the valve stent, preventing electrochemical corrosion between the two.

[0070] At least one of the anchoring stent and the valve stent is coated with TPU to cover the stent surface, forming an insulating layer that blocks the electrochemical reaction pathway between the stent and the external environment. Attached Figure Description

[0071] The disclosure of this invention will become more apparent from the accompanying drawings. It should be understood that these drawings are for illustrative purposes only and are not intended to limit the scope of protection of this invention. In the drawings:

[0072] Figure 1(a) is a schematic diagram of an anchoring bracket in Embodiment 1 of the present invention;

[0073] Figure 1(b) is a schematic diagram of another structure of the anchoring bracket in Embodiment 1 of the present invention;

[0074] Figure 2(a) is a schematic diagram of an anchoring bracket in Embodiment 2 of the present invention;

[0075] Figure 2(b) is a schematic diagram of another structure of the anchoring bracket in Embodiment 2 of the present invention;

[0076] Figure 2(c) is a magnified view of a portion of Figure 2(b);

[0077] Figure 3(a) is an exploded view of the anchoring stent and the valve stent in Embodiment 3 of the present invention;

[0078] Figure 3(b) is the front view of Figure 3(a);

[0079] Figure 4(a) is another exploded view of the anchoring stent and valve stent in Embodiment 3 of the present invention;

[0080] Figure 4(b) is the front view of Figure 4(a);

[0081] Figure 5(a) is a schematic diagram of a valve stent structure in Embodiment 3 of the present invention;

[0082] Figure 5(b) is a schematic diagram of a structure with an implanted artificial leaflet as shown in Figure 5(a);

[0083] Figure 6(a) is a schematic diagram of another structure of the valve stent in Embodiment 3 of the present invention;

[0084] Figure 6(b) is a magnified view of a portion of Figure 6(a);

[0085] Figure 6(c) is a schematic diagram of the barbs in Figure 6(b) being replaced by another structure;

[0086] Figure 6(d) is a schematic diagram of the skirt structure after film coating in Figure 6(a);

[0087] Figure 7 This is a schematic diagram of an application of Embodiment 3 of the present invention. Detailed Implementation

[0088] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0089] It should be noted that, unless otherwise specified, the following embodiments and features can be combined with each other.

[0090] In the description of this invention, it should be noted that the directional terms such as "outer side", "middle section", "inner", "outer" indicate the orientation and positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. They should not be construed as limiting the specific protection scope of this invention.

[0091] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features. Thus, the use of "first" and "second" to define a feature may explicitly or implicitly include one or more of that feature. In the description of this invention, "several" or "a number" means two or more, unless otherwise explicitly specified.

[0092] In this application, when describing anchoring stents or valve stents, "inflow end" and "outflow end" are used as directional terms, which are common terms in the field of interventional medical devices. "Inflow end" refers to the end from which antegrade blood first flows into the interventional medical device, such as the upper end in Figure 3(b) or Figure 4(b). "Outflow end" refers to the end from which antegrade blood flows out of the interventional medical device, such as the lower end in Figure 3(b) or Figure 4(b).

[0093] Example 1:

[0094] Referring to Figures 1(a) and 1(b), and Figures 3(a) and 3(b), this embodiment provides an anchoring stent 100, which is used in a heart valve replacement system to stabilize the valve stent 300. The stiffness of the anchoring stent 100 after expansion keeps the skirt structure 320 of the valve stent 300 pressed against the area above the physiological valve annulus. The anchoring stent 100 is equivalent to the main anchoring structure of the valve stent 300.

[0095] The anchoring bracket 100 adopts a self-expanding spherical structure composed of several anchoring grids 110.

[0096] The anchoring stent 100 is a self-expanding anchoring stent composed of several anchoring grids 110. It is usually uncovered, allowing the anchoring stent 100 to be released at will without obstructing the flow of blood in the atria, such as the pulmonary veins of the left atrium.

[0097] After the valve stent 300 is implanted, the anchoring stent 100 is then implanted. The expanded anchoring stent 100 presses the skirt structure 320 of the expanded valve stent 300, making the skirt structure 320 of the valve stent 300 fit more closely with the physiological valve annulus and increasing the sealing effect.

[0098] In this embodiment, a single anchoring grid 110 is formed by a number of grid rods 111, and the grid rods 111 are made of shape memory metal material.

[0099] In this embodiment, the anchoring stent 100 has a certain adaptability to the size of the atrium after expansion. However, in order to accommodate more patients, multiple sizes of anchoring stents 100 can be set up. Here, the diameter of the anchoring stent 100 is not limited.

[0100] In this embodiment, the shape memory metal can be a nickel-titanium alloy material or a nickel-titanium alloy wire.

[0101] In this embodiment, referring to FIG1(a), the anchor bracket 100 is a cut bracket made of shape memory metal.

[0102] For example, anchor bracket 100 is cut from nickel-titanium alloy.

[0103] In this embodiment, the width of the mesh rod 111 for the cutting stent is no more than 2mm. This design ensures that even if the mesh rod 111 blocks the opening of the blood vessel, it will not affect blood flow.

[0104] In this embodiment, for the cutting bracket, the area of ​​a single anchoring mesh 110 is X, then 10mm 2 ≤X≤200mm 2 The density of the anchoring grid 110 is controlled to ensure that blood can pass smoothly through the grid 110 of the anchoring stent 100.

[0105] In this embodiment, referring to FIG1(b), the anchoring bracket 100 is a braided bracket made of braided wire, which serves as the net pole 111.

[0106] For example, the anchor bracket 100 is a braided bracket made of nickel-titanium alloy wire.

[0107] In this embodiment, the diameter of the braided filaments for the braided scaffold is 0.1–1 mm, preferably 0.1–0.13 mm. This design ensures that the braided scaffold has supporting force, while the relatively fine braided filaments reduce their impact on blood flow, allowing blood to pass through smoothly.

[0108] In this embodiment, for the braided stent, in order to increase the stiffness / support force of the braided stent and provide sufficient clamping force for the skirt structure of the valve stent, the braided stent can be a multi-layer structure, in which the anchoring grids 110 of adjacent layers are staggered.

[0109] For example, the bracing adopts a double-layer structure, in which the outer anchoring grid 110 and the inner anchoring grid 110 are staggered.

[0110] In this embodiment, for the multi-layer braided scaffold, the diameter of the braided yarns used in the inner layer is larger than that used in the outer layer, and the density of the braided anchoring mesh 110 in the inner layer is smaller than that in the outer layer. The thicker inner layer braided yarns can provide greater radial support with a smaller braiding density, reducing the impact on blood flow.

[0111] In this embodiment, for the multi-layer braided support, the diameter of the braided wire used in the inner layer is 0.3-1mm, and the diameter of the braided wire used in the outer layer is 0.1-0.5mm.

[0112] In this embodiment, in order to promote the anchoring stent 100 to atrial endothelialization, the mesh rod 111 of the anchoring stent 100 is provided with a winding thread, which can be one or more of PTFE, PET, TPU and ultra-high molecular weight polyethylene.

[0113] In this embodiment, when controlling the release direction of the anchoring stent 100, an anchoring membrane can be added in the area where the anchoring stent 100 contacts the skirt structure 320 of the valve stent 300 to improve the sealing performance. The anchoring membrane must not affect the blood entering the valve stent 300, but the anchoring membrane is a non-essential design.

[0114] In this embodiment, the anchoring membrane can be any of the following medical-grade implantable materials that promote endothelialization: PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, and bovine pericardium, with PTFE or ePTFE being more preferred.

[0115] In this embodiment, both the inflow and outflow ends of the anchoring bracket 100 are open structures. That is, the anchoring meshes 110 do not contact or connect at the inflow and outflow ends, and the anchoring meshes 110 are spaced a certain distance apart at both the inflow and outflow ends, so that the inflow and outflow ends of the anchoring bracket 100 form a flow port that facilitates blood flow.

[0116] Example 2:

[0117] Reference Figures 2(a) to 2(c) Figures 4(a) and 4(b) show that this embodiment provides an anchoring stent 200, which is used in a heart valve replacement system to stabilize the valve stent 300. The stiffness of the anchoring stent 200 after expansion keeps the skirt structure 320 of the valve stent 300 pressed against the area above the physiological valve annulus. The anchoring stent 200 is equivalent to the main anchoring structure of the valve stent 300.

[0118] The anchoring bracket 200 adopts a spherical expansion-type spherical structure composed of several anchoring grids 210.

[0119] The anchoring stent 200 is a ball-expanding anchoring stent composed of several anchoring grids 210. It is usually uncovered, allowing the anchoring stent 200 to be released arbitrarily without obstructing the flow of blood in the atria, such as the pulmonary veins of the left atrium.

[0120] After the valve stent 300 is implanted, the anchoring stent 200 is then implanted. The anchoring stent 200 is expanded by balloon. The expanded anchoring stent 200 presses the skirt structure 320 of the expanded valve stent 300, so that the skirt structure 320 of the valve stent 300 fits more closely with the physiological valve annulus, increasing the sealing effect.

[0121] In this embodiment, a single anchoring grid 210 is formed by a number of grid rods 211, as shown in Figures 2(b) and 2(c). The width of the grid rod 211a where the anchoring grid 210 in the middle is located is smaller than the width of the grid rod 211b where the anchoring grid 210 at both ends is located.

[0122] In this embodiment, the width of the anchoring mesh 210 in the middle of the anchoring bracket 200, where the mesh rod 211a is located, is smaller than the width of the anchoring mesh 210 at both ends, where the mesh rod 211b is located. This is because the middle anchoring bracket 200 changes from a compressed state to an expanded spherical anchoring bracket, which has a large deformation. The narrower mesh rod 211a can effectively reduce the expansion pressure of the balloon. Moreover, the narrower middle mesh rod 211a also increases the elasticity of the expanded spherical anchoring bracket 200.

[0123] In this embodiment, the anchoring bracket 200 is a non-self-expanding bracket, and the anchoring bracket 200 is made of one or more materials such as cobalt-chromium alloy and stainless steel. The anchoring bracket 200 is expanded from a compressed state to an expanded state by a balloon.

[0124] In this embodiment, different balloon dilation pressures can be selected based on the preoperative screening of the patient's atrial size to obtain anchoring stents 200 of different sizes after dilation.

[0125] In this embodiment, the anchor bracket 200 is formed by cutting and heat-setting a metal tube.

[0126] In this embodiment, the area of ​​a single anchoring mesh 210 is X, then 10mm 2 ≤X≤200mm 2 By limiting the area of ​​the anchoring grid 210, blood can be ensured to pass smoothly through the anchoring grid 210 of the anchoring stent 200, while also preventing the anchoring stent 200 from being overstretched and damaged.

[0127] In this embodiment, after the anchoring bracket 200 is expanded by the balloon, the area of ​​the anchoring mesh 210 located in the middle is larger than the area of ​​the anchoring mesh 210 located at the two ends.

[0128] In this embodiment, in order to promote the anchoring stent and atrial endothelialization, the anchoring stent 200 has a winding thread on its mesh rod 211. The winding thread can be one or more of PTFE, PET, TPU and ultra-high molecular weight polyethylene.

[0129] In this embodiment, when controlling the release direction of the anchoring stent 200, an anchoring membrane can be added in the area where the anchoring stent 200 contacts the skirt structure 320 of the valve stent 300 to improve the sealing performance. The anchoring membrane must not affect the blood entering the valve stent 300, but the anchoring membrane is a non-essential design.

[0130] In this embodiment, the anchoring membrane can be any of the following medical-grade implantable materials that promote endothelialization: PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, and bovine pericardium, with PTFE or ePTFE being more preferred.

[0131] In this embodiment, the anchoring stent 200 is a ball-expanding stent made of non-self-expanding materials, such as cobalt-chromium alloy or stainless steel. The valve stent 300, on the other hand, is a self-expanding stent made of self-expanding materials, such as nickel-titanium alloy or shape-memory metals. Therefore, the anchoring stent 200 and the valve stent 300 are made of different materials. To prevent electrochemical reactions, the surface of the anchoring stent 200 is coated with TPU, forming a TPU insulating layer that blocks the electrochemical reaction pathway between the anchoring stent 200 and the external environment.

[0132] In this embodiment, both the inflow and outflow ends of the anchoring support 200 are open structures. That is, the anchoring meshes 210 do not contact or connect at the inflow and outflow ends, and the anchoring meshes 210 are spaced a certain distance apart at both the inflow and outflow ends, so that the inflow and outflow ends of the anchoring support 200 form a flow port that facilitates blood flow.

[0133] Example 3:

[0134] Reference Figures 3(a) to 5(b) This embodiment provides a heart valve replacement system for replacing mitral / tricuspid heart valves to treat valvular regurgitation.

[0135] The heart valve replacement system includes a valve anchoring stent and a membrane stent 300. The valve stent 300 is a single-layer self-expanding structure, and from the outflow end to the inflow end, the valve stent 300 includes an integrally connected stent body 310 and a skirt structure 320. The anchoring stent 400 is a spherical structure, located inside the skirt structure 320 and separately abutting against the skirt structure 320.

[0136] The valve stent 300 of this embodiment is a single-layer self-expanding stent. Its single-layer structure facilitates compression and delivery. After implantation, the skirt structure 320 conforms to the physiological annulus, rather than relying on the stent body 310 to seal against the native leaflet. Therefore, it does not require capturing the native leaflet, reducing the difficulty of valve stent 300 implantation. Since the valve stent 300 does not require the physiological annulus to provide radial support, i.e., it does not need to capture or rely on the native leaflet for sealing, a double-layer structure is unnecessary (in a double-layer structure, the outer layer needs to adapt to or capture the native leaflet, and the inner layer needs to connect with the artificial leaflet; therefore, the outer layer inevitably expands the native leaflet and annulus). The valve stent 300 of this embodiment does not restrict the contraction and expansion movement of the native annulus, and does not cause any restriction on annulus movement.

[0137] As shown in Figure 5(b), the inner side of the valve stent 300 in this embodiment is used to accommodate and connect the leaflet mechanism 500. The leaflet mechanism 500 has a plurality of artificial leaflets, which are connected to the inner side of the stent body 310 of the valve stent 300 and are preferably disposed on the main rod near the outflow end of the stent body 310.

[0138] In this embodiment, the valve stent 300 and the anchoring stent 400 are separate structures, allowing for separate delivery. Their small diameter facilitates implantation via transfemoral or other methods. Separate delivery and step-by-step insertion allow for the use of finer catheters, reducing vascular expansion. In this embodiment, the anchoring stent 400 is implanted after the valve stent 300. Depending on the characteristics of the anchoring stent 400, it can be expanded using a self-expanding or balloon-expanding method. Figure 7 As shown, the expanded stiffness keeps the skirt structure 320 of the valve stent 300 pressed against the area above the physiological valve annulus, ensuring the stability of the valve stent 300. The anchoring stent 400 is equivalent to the main anchoring structure of the valve stent 300. By expanding the anchoring stent 400, the skirt structure 320 of the expanded stent 300 is pressed, making the skirt structure 320 of the valve stent 300 fit more closely to the physiological valve annulus, increasing the sealing effect.

[0139] In this embodiment, the support body 310 has a cylindrical structure.

[0140] In this embodiment, the skirt structure 320 is an outward expansion structure that expands outward from the outflow end to the inflow end.

[0141] In this embodiment, referring to FIG6(d), a skirt cover 321 is provided on the skirt structure 320. The skirt cover 321 provides a sealing function.

[0142] In this embodiment, the outflow end of the skirt covering 321 is at least connected to the inflow edge of the artificial leaflet.

[0143] In this embodiment, the skirt covering 321 is disposed on the inner side of the skirt structure 320.

[0144] In this embodiment, the skirt covering 321 located inside the skirt structure 320 extends to the stent body 310, causing the skirt covering 321 to form a stent valve, so that the valve stent 300 can be covered as a whole.

[0145] In this embodiment, a skirt coating is also provided on the outer side of the skirt structure 320.

[0146] In this embodiment, a TPU membrane is provided on the inner side of the skirt cover 321 located inside the skirt structure 320 to prevent blood from seeping through the membrane gaps.

[0147] In this embodiment, the material of the skirt covering 321 can be any one of the medical-grade implantable materials that promote endothelialization, such as PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, and bovine pericardium, with PTFE or ePTFE being more preferred.

[0148] In this embodiment, refer to Figures 6(a) to 6(c) The skirt structure 320 has several outwardly flared barb structures 330 spaced circumferentially along its upper edge. After the valve stent 300 is implanted, the barb structures 330 insert into the valve annulus, increasing the stability of the valve stent 300 after implantation.

[0149] In this embodiment, referring to FIG6(b), the barb structure 330 has a connecting end and a free end. The connecting end of the barb structure 330 is connected to the skirt structure 320, and the free end 330a of the barb structure 330 extends outward from the outer surface of the skirt structure 320. The skirt structure 320 is an outwardly flared structure, while the barb structure 330 is further flared outward relative to the skirt structure 320. This outward flare of the free end 330a extending outward from the outer surface of the skirt structure 320 facilitates the insertion of the barb structure 330 into the valve ring.

[0150] In this embodiment, referring to FIG6(c), the free end 330a of the barb structure 330 is turned outward and points towards the inflow end, which facilitates the direct insertion of the barb structure 330 into the valve ring.

[0151] In this embodiment, the skirt structure 320 is formed by several skirt meshes, and the connecting end of the barbed structure 330 is integrally connected to the connection between two adjacent skirt meshes.

[0152] In this embodiment, the valve stent 300 further includes several connecting rods 340. The connecting rods 340 are used to connect with the delivery device to increase the stability of the valve stent 300 during the release process.

[0153] Without the connecting rod 340, several pull wires can be directly connected to the skirt structure 320 to increase the stability of the valve stent 300 release process and prevent the valve stent 300 from jumping out of the delivery catheter in the final stage of release, which would cause the valve stent 300 to be misaligned during implantation.

[0154] When the skirt structure 320 is formed by several skirt meshes, the guy wire can be directly threaded through the skirt meshes on the inflow end side.

[0155] In this embodiment, one end of a plurality of connecting rods 340 is spaced circumferentially on the skirt structure 320, and the other end of the plurality of connecting rods 340 is directed toward the inflow end and converges toward the center.

[0156] In this embodiment, when the skirt structure 320 is formed by several skirt meshes, one end of the connecting rod 340 is integrally connected to the connection between two adjacent skirt meshes.

[0157] In this embodiment, when the skirt structure 320 is provided with a barb structure 330, the connecting rod 340 is staggered from the barb structure 330 at the connection point between two adjacent skirt grids. That is, only one of the barb structure 330 and the connecting rod 340 is connected at the connection point between two adjacent skirt grids.

[0158] As shown in Figure 6(a), the skirt structure 320 is provided with six barbed structures 330 and three connecting rods 340, which are evenly arranged along the circumference of the skirt structure 320 with two barbed structures 330 every other connecting rod 340.

[0159] In this embodiment, referring to Figures 6(b) and 6(c), the inflow end of the connecting rod 340 is provided with a pull wire hole 341 for the pull wire to pass through.

[0160] In this embodiment, the anchoring stent 400 and the valve stent 300 are coaxial.

[0161] In this embodiment, referring to Figures 3(a) and 3(b), the anchoring bracket 400 adopts the anchoring bracket 100 provided in each embodiment of Embodiment 1 of the present invention.

[0162] In this embodiment, referring to Figures 4(a) and 4(b), the anchoring bracket 400 adopts the anchoring bracket 200 provided in each embodiment of Embodiment 2 of the present invention.

[0163] In this embodiment, when the anchoring stent 400 adopts the anchoring stent 200 provided in each embodiment of Embodiment 2 of the present invention, the inner side of the valve stent 300 is provided with a stent cover film, and the inner side of the stent cover film is provided with a TPU spun film.

[0164] The method of setting a TPU spun film on the inside of the support film, such as spinning a layer of TPU spun film on the surface of a PET film, is existing technology and will not be described in detail here.

[0165] TPU is thermoplastic polyurethane elastomer, also known as thermoplastic polyurethane rubber, which has good insulation properties. By setting a TPU spinning film on the inside of the stent coating, the electronic conduction between the valve stent 300 and the anchoring stent 400 is effectively blocked, preventing electrochemical corrosion between the two.

[0166] In this embodiment, when the anchoring stent 400 adopts the anchoring stent 200 provided in each embodiment of Embodiment 2 of the present invention, at least one surface of the valve stent 300 and the anchoring stent 400 is coated with a TPU insulating layer, so that the surface of the valve stent 300 and / or the anchoring stent 400 is covered by TPU to form an insulating layer, blocking the electrochemical reaction path between any stent and the outside world.

[0167] The present invention has been described in detail above with reference to the accompanying drawings and embodiments. Those skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention, and the scope of protection of the present invention shall be defined by the appended claims.

Claims

1. A heart valve replacement system, characterized in that, The heart valve replacement system includes: A valve stent, wherein the valve stent is a single-layer self-expanding structure, and the valve stent comprises an integrally connected stent body and skirt structure from the outflow end to the inflow end; An anchoring bracket, which is a spherical structure, is located inside the skirt structure and is separately pressed against the skirt structure. The skirt structure is provided with a number of outwardly expanding barbs at intervals along the circumference.

2. The heart valve replacement system as described in claim 1, characterized in that, The main body of the support is a cylindrical structure; And / or, the skirt structure is an outward expansion structure that expands outward from the outflow end to the inflow end; And / or, the skirt structure is provided with a skirt coating.

3. The heart valve replacement system as described in claim 2, characterized in that, The outflow end of the skirt-shaped membrane is at least connected to the edge of the inflow end of the artificial leaflet; And / or, the skirt sheath film is disposed on the inner side of the skirt sheath structure; And / or, the skirt cover located inside the skirt structure extends to the support body, causing the skirt cover to form a support valve; And / or, the outer side of the skirt structure is provided with a skirt coating; And / or, a TPU coating is provided on the inner side of the skirt coating located inside the skirt structure.

4. The heart valve replacement system as described in claim 1, characterized in that, The barb structure has a connecting end and a free end. The connecting end of the barb structure is connected to the skirt structure, and the free end of the barb structure extends out of the outer surface of the skirt structure. And / or, the barb structure has a connecting end and a free end, the connecting end of the barb structure is connected to the skirt structure, and the free end of the barb structure is turned outward and points towards the inflow end; And / or, the skirt structure is formed by a plurality of skirt meshes, and the connecting end of the barbed structure is integrally connected to the connection between two adjacent skirt meshes.

5. The heart valve replacement system as described in claim 1, characterized in that, The valve stent also includes several connecting rods for connection to the delivery device.

6. The heart valve replacement system as described in claim 5, characterized in that, One end of several connecting rods is circumferentially spaced on the skirt structure, and the other end of several connecting rods is directed toward the inflow end and converges toward the center; And / or, the skirt structure is formed by a plurality of skirt meshes, and one end of the connecting rod is integrally connected to the connection between two adjacent skirt meshes; And / or, when the skirt structure is provided with a barb structure, the connecting rod is staggered from the barb structure at the connection between two adjacent skirt meshes; And / or, the inflow end of the connecting rod is provided with a pull wire hole.

7. The heart valve replacement system according to any one of claims 1 to 6, characterized in that, The anchoring stent is coaxial with the valve stent.

8. The heart valve replacement system according to any one of claims 1 to 6, characterized in that, The anchoring support adopts a self-expanding spherical structure composed of several anchoring grids.

9. The heart valve replacement system as described in claim 8, characterized in that, The anchoring bracket is a cut bracket made of shape memory metal.

10. The heart valve replacement system as described in claim 9, characterized in that, Each anchoring grid is formed by a number of poles, the width of which is no more than 2mm; And / or, if the area of ​​a single anchoring grid is X, then 10 mm² ≤ X ≤ 200 mm².

11. The heart valve replacement system as described in claim 10, characterized in that, The anchoring bracket is a braided bracket made of braided yarn.

12. The heart valve replacement system as described in claim 11, characterized in that, The diameter of the braided yarn is 0.1~1mm; And / or, the braided support is a multi-layer structure, in which the anchoring grids of adjacent layers are staggered; And / or, the braided support is a multi-layer structure, wherein the diameter of the braided yarn used in the inner layer of the multi-layer structure is greater than the diameter of the braided yarn used in the outer layer, and the braided anchoring mesh density of the inner layer is less than the braided anchoring mesh density of the outer layer. And / or, the braided support has a multi-layer structure, wherein the diameter of the braided yarn used in the inner layer of the multi-layer structure is 0.3-1mm, and the diameter of the braided yarn used in the outer layer is 0.1-0.5mm.

13. The heart valve replacement system as described in claim 12, characterized in that, The diameter of the braided yarn is 0.1-0.13 mm.

14. The heart valve replacement system as described in claim 8, characterized in that, Each anchoring grid is formed by a number of poles, and the poles are provided with winding wire, which is one or more of PTFE, PET, TPU and ultra-high molecular weight polyethylene; And / or, the area where the anchoring stent contacts the valve stent after expansion is provided with an anchoring coating; And / or, both the inflow and outflow ends of the anchoring bracket are open structures.

15. The heart valve replacement system according to any one of claims 1 to 6, characterized in that, The anchoring support adopts a spherical expansion-type spherical structure composed of several anchoring grids.

16. The heart valve replacement system as described in claim 15, characterized in that, Each anchoring grid is formed by several poles, and the width of the poles containing the anchoring grid in the middle is smaller than the width of the poles containing the anchoring grids at the two ends. And / or, the anchoring bracket is a non-self-expanding bracket, and the anchoring bracket is made of one or more materials such as cobalt-chromium alloy and stainless steel. And / or, the anchoring bracket is formed by cutting and heat-setting a metal tube; And / or, if the area of ​​a single anchoring grid is X, then 10 mm² ≤ X ≤ 200 mm²; And / or, a single anchoring grid is formed by a plurality of poles, the poles being provided with winding wire, the winding wire being one or more of PTFE, PET, TPU and ultra-high molecular weight polyethylene; And / or, the area where the anchoring stent contacts the valve stent after balloon dilation is provided with an anchoring membrane; And / or, both the inflow and outflow ends of the anchoring bracket are open structures; And / or, at least one surface of the valve stent and the anchoring stent is coated with a TPU insulating layer; And / or, the inner side of the valve stent is provided with a stent cover, and the inner side of the stent cover is provided with a TPU spun film.

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