Heart valve replacement system

Abstract

The invention belongs to the technical field of medical apparatus and instruments, and particularly relates to a heart valve replacement system which comprises a valve stent, the valve stent is of a single-layer self-expansion structure, and the valve stent comprises a stent body and a skirt structure which are integrally connected from the outflow end to the inflow end; the anchoring support is of a sphere-like structure, and the anchoring support is located on the inner side of the skirt structure and abuts against the skirt structure in a split mode. The valve stent is a single-layer self-expansion stent, the single-layer structure can facilitate pressing, holding and conveying, and the valve stent and the anchoring stent are of a split structure, so that the valve stent and the anchoring stent can be conveyed in a split mode, the pressing and holding diameter is small, conveying and implanting in a transfemoral mode and the like are facilitated, and the valve stent and the anchoring stent are conveyed in a split mode and enter the human body step by step; and a thinner catheter can be adopted to be conveyed and implanted into the human body, so that the expansion of the blood vessel is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a cardiac valve replacement system. Background Art

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

[0003] Among them, mitral regurgitation is due to incomplete valve closure. During left ventricular contraction, blood flows from the left ventricle into the aorta and the left atrium with less resistance. In addition to receiving the blood returning from the pulmonary veins, the left atrium also receives the blood refluxing from the left ventricle. Therefore, the increase in left atrial pressure will lead to an increase in pulmonary vein and pulmonary capillary pressure, followed by dilation and congestion. At the same time, the volume load of the left ventricle during diastole increases, and the left ventricle expands. In acute mitral insufficiency, a large amount of reflux blood suddenly increases in the left atrium, which can cause a sharp rise in left atrial and pulmonary vein pressure, leading to acute pulmonary edema.

[0004] Generally, at present, mitral valve repair edge-to-edge repair or mitral valve replacement is mostly used. Edge-to-edge repair is to clamp the edges of the regurgitant leaflets with a clamp, for example, changing a large blood passage originally formed by the leaflets into two small blood passages, that is, clamping in the middle of the two leaflets. For cases that cannot be repaired, treatment by replacement surgery is required. In mitral valve replacement surgery, a valve prosthesis is implanted to replace the work of the native mitral valve in the human body to treat the regurgitation problem caused by mitral valve lesions. At present, both mitral valve replacement technology and valve prostheses are in the preliminary exploration stage. Therefore, it is necessary to research and improve the valve prosthesis.

[0005] Mitral valve replacement surgery is divided into traditional surgical procedures and interventional mitral valve replacement surgery. The former has disadvantages such as large trauma, easy wound infection, and long recovery time. The difficulty of the latter lies in the unique physiological structure of the mitral annulus, resulting in difficulties in anchoring the valve prosthesis and sealing paravalvular leaks. Currently, the disclosed products and patents usually use barbs, apical tethers, etc. for anchoring and sealing. However, the complex structure leads to a large crimp size of the valve prosthesis, making it difficult to deliver, position, anchor, and release in the body, and it can only be applicable to a very small number of patients.

[0006] In view of the above problems, it is hoped that a new type of mitral valve replacement system can be provided to solve the problem of mitral regurgitation. Summary of the Invention

[0007] In view of the technical problems of the existing mitral valve replacement system, such as complex structure, large crimping size, and great difficulties in in-vivo delivery, positioning, anchoring, and releasing, the present invention aims to provide an anchoring stent and a heart valve replacement system.

[0008] To solve the foregoing technical problems, a first aspect of the present invention provides an anchoring stent for a heart valve replacement system, and the anchoring stent adopts a self-expanding spherical-like structure composed of a plurality of anchoring meshes.

[0009] Optionally, in the anchoring stent for a heart valve replacement system as described above, a single said anchoring mesh is surrounded by a plurality of wire rods made of a shape memory metal material.

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

[0011] Optionally, in the anchoring stent for a heart valve replacement system as described above, the width of the wire rod is not greater than 2 mm.

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

[0013] Optionally, in the anchoring stent for a heart valve replacement system as described above, the anchoring stent is a braided stent braided by braided wires, and the braided wires serve as the wire rods.

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

[0015] Optionally, in the anchoring stent for a heart valve replacement system as described above, the braided stent is a multi-layer structure, and the anchoring meshes of adjacent two layers in the multi-layer structure are arranged in a staggered manner.

[0016] Optionally, in the anchoring stent for a heart valve replacement system as described above, the diameter of the braided wire used in the inner layer of the multi-layer structure is greater than the diameter of the braided wire used in its outer layer, and the density of the braided anchoring meshes in the inner layer is less than the density of the braided anchoring meshes in the outer layer.

[0017] Optionally, in the anchoring stent for a heart valve replacement system as described above, the diameter of the braided wire used in the inner layer of the multi-layer 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 aforementioned anchoring stent for a heart valve replacement system, a winding wire is provided on the mesh rod, and the winding wire may be one or more of PTFE, PET, TPU, ultra-high molecular weight polyethylene, and the like.

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

[0020] Optionally, in the anchoring stent for a heart valve replacement system as described above, both the inflow end and the outflow end of the anchoring stent are open structures.

[0021] In order to solve 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 adopts a ball-expandable 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 surrounded by a plurality of mesh rods, and the width of the mesh rods where the anchoring grid located in the middle is located is smaller than the width of the mesh rods where the anchoring grids located at the folded positions at both ends are located.

[0023] Optionally, in the aforementioned anchoring stent for a heart valve replacement system, 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 metal.

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

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

[0026] Optionally, in the anchoring stent for a heart valve replacement system as described above, after the anchoring stent is expanded by a balloon, the area of ​​the anchoring grid located in the middle is larger than the area of ​​the anchoring grid located at the folded positions at both ends.

[0027] Optionally, in the aforementioned anchoring stent for a heart valve replacement system, a winding wire is provided on the mesh rod, and the winding wire may be one or more of PTFE, PET, TPU, ultra-high molecular weight polyethylene, and the like.

[0028] Optionally, in the anchoring stent for the heart valve replacement system as described above, an anchoring coating is provided in the area of ​​the anchoring stent that contacts the valve stent after balloon expansion.

[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 inflow end and the outflow end of the anchoring stent are of an open structure.

[0031] To solve the foregoing technical problems, a third aspect of the present invention provides a heart valve replacement system, which includes:

[0032] A valve stent, which is of a single-layer self-expanding structure, and the valve stent includes a stent main body and a skirt structure integrally connected from the outflow end to the inflow end;

[0033] An anchoring stent, which is of a spherical structure, and the anchoring stent is located inside the skirt structure and is detachably pressed against the skirt structure.

[0034] Optionally, in the heart valve replacement system as described above, the stent main body is of a quasi-straight cylindrical structure.

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

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

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

[0038] Optionally, in the heart valve replacement system as described above, the skirt film is provided on the inner side of the skirt structure.

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

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

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

[0042] Optionally, in the heart valve replacement system as described above, a number of outwardly expanding barbs are provided on the skirt structure 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 is connected to the skirt structure, and the free end of the barb structure extends 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 turned outwards and points to the inflow end.

[0045] Optionally, in the heart valve replacement system as described above, the skirt structure is surrounded by a plurality of skirt meshes, and the connecting end of the barb structure is integrally connected to the connection part 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 connecting with the delivery device.

[0047] Optionally, in the heart valve replacement system as described above, one ends of a plurality of the connecting rods are arranged at intervals in the circumferential direction on the skirt structure, and the other ends of a plurality of the connecting rods converge towards the inflow end and towards the middle.

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

[0049] Optionally, in the heart valve replacement system as described above, when the barb structure is provided on the skirt structure, the connecting rod and the barb structure are staggeredly arranged at the connection part between two adjacent skirt meshes.

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

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

[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 of the present invention.

[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 coating film is provided on the inner side of the valve stent, and a TPU spun film is provided on the inner side of the stent coating film.

[0054] Optionally, in the heart valve replacement system as described above, when the anchoring stent is the anchoring stent provided by 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 the present invention are as follows:

[0056] 1. The valve stent of the present invention is a single-layer self-expanding stent. The single-layer structure is beneficial for crimping and delivery. After implantation, the skirt structure fits the position of the physiological valve annulus (the area of the physiological valve annulus on the atrial side), rather than relying on the stent body to seal with the native leaflets. Therefore, it is not necessary to capture the native leaflets, reducing the difficulty of implanting the valve stent.

[0057] 2. The valve stent and the anchoring stent are separate structures, so they can be delivered separately. The crimping diameter is small, facilitating delivery and implantation by means such as trans-femoral. The two are delivered separately and enter the human body in steps, enabling delivery and implantation into the human body using a thinner catheter, reducing the dilation of blood vessels.

[0058] 3. After the valve stent is implanted, when the anchoring stent is implanted, the anchoring stent can be expanded in a self-expanding or balloon-expandable manner according to the characteristics of the anchoring stent. The stiffness after expansion presses the skirt structure of the valve stent against the area above the physiological valve annulus all the time, ensuring the stable posture of the valve stent. The anchoring stent is equivalent to the main anchoring structure of the valve stent. Through the expanded anchoring stent, pressing the skirt structure of the expanded stent makes the skirt structure of the valve stent fit the physiological valve annulus more closely, increasing the sealing effect.

[0059] 4. The self-expanding anchoring stent is composed of several anchoring meshes and is usually not covered with a membrane, enabling the arbitrary release of the anchoring stent without blocking the blood flow in the atrium, such as the pulmonary veins in the left atrium.

[0060] For the cutting stent using cutting, the width of the mesh bars is limited. Even if the mesh bars block the blood vessel opening, it will not affect the blood flow. Controlling the density of the anchoring meshes ensures that blood can pass through the anchoring meshes of the anchoring stent smoothly.

[0061] For the braided stent made of braided wires, the diameter of the braided wires is limited, ensuring that the braided stent has a supporting force, while the relatively thin braided wires reduce their influence on blood flow, allowing blood to pass through smoothly. To increase the stiffness / supporting force of the braided stent and provide sufficient pressing force for the skirt of the valve stent, the braided stent can be a double-layer structure, with the outer anchoring meshes and the inner anchoring meshes arranged in a staggered manner. The thicker inner braided wires can provide a greater radial supporting force with a smaller braiding density, reducing the influence on blood flow.

[0062] In order to promote the anchoring stent and atrial endothelialization, a winding wire is arranged on the mesh rod of the anchoring stent.

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

[0064] 5. The balloon-expandable anchoring stent is composed of a number of anchoring grids and is usually not covered with a membrane, which enables the anchoring stent to be released arbitrarily without blocking the blood flow in the atrium, such as the pulmonary vein in the left atrium.

[0065] The width of the mesh rod where the anchoring grid in the middle of the anchoring stent is located is smaller than the width of the mesh rod where the anchoring grid is located at the two ends of the anchoring stent. This is because the middle anchoring stent changes from a compressed state to an expanded spherical anchoring stent, and its deformation is large. The thinner mesh rod width can effectively reduce the expansion pressure of the balloon, and the thinner middle mesh rod also increases the elasticity of the expanded spherical anchoring stent.

[0066] By limiting the area of ​​the anchoring grid, it is ensured that blood can smoothly pass through the anchoring grid of the anchoring stent, while also preventing the anchoring stent from expanding excessively and causing damage to the anchoring stent.

[0067] In order to promote the anchoring stent and atrial endothelialization, a winding wire is arranged on the mesh rod of the anchoring stent.

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

[0069] Since the anchoring stent and the valve stent are made of different materials, in order to prevent electrochemical reactions, a layer of TPU spun membrane is spun on the surface of the stent coating (usually PET film) on the inner side of the valve stent. The TPU spun membrane has good insulation properties and 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 subjected to stent TPU coating treatment so that the stent surface is covered with TPU to form an insulating layer, thereby blocking the electrochemical reaction path between the stent and the outside world. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0072] FIG. 1( a ) is a schematic structural diagram of an anchoring bracket in Example 1 of the present invention;

[0073] FIG1( b ) is another schematic structural diagram of the anchoring bracket in Example 1 of the present invention;

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

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

[0076] Figure 2(c) is a partial enlarged view of Figure 2(b);

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

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

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

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

[0081] Figure 5(a) is a schematic structural view of a valve bracket in Embodiment 3 of the present invention;

[0082] Figure 5(b) is a schematic structural view when an artificial valve leaf is built in Figure 5(a);

[0083] Figure 6(a) is another schematic structural view of the valve bracket in Embodiment 3 of the present invention;

[0084] Figure 6(b) is a partial enlarged view of Figure 6(a);

[0085] Figure 6(c) is a schematic view when the barbs are equivalently replaced with another structure in Figure 6(b);

[0086] Figure 6(d) is a schematic view of the skirt structure in Figure 6(a) after being coated with a film;

[0087] Figure 7 is a schematic application view of Embodiment 3 of the present invention. Specific Embodiments

[0088] The following uses specific specific examples to illustrate the implementation manners 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 implementation manners. 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, without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0090] In the description of the present invention, it should be noted that for orientation terms, such as the terms "outer side", "middle section", "inner", "outer", etc., which indicate the orientation and positional relationship are based on the orientation or positional relationship shown in the drawings. This is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and should not be construed as limiting the specific protection scope of the present invention.

[0091] In addition, for terms such as "first" and "second", they are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the present invention, the meanings of "several" and "a number of" are two or more, unless otherwise specifically defined.

[0092] In the present application, when describing the anchoring stent or the valve stent, the terms "inflow end" and "outflow end" are orientation terms, which are common terms in the field of interventional medical devices. The "inflow end" represents the end where the antegrade blood first flows into the interventional medical device, such as the upper end in Fig. 3(b) or Fig. 4(b). The "outflow end" represents the end where the antegrade blood flows out of the interventional medical device, such as the lower end in Fig. 3(b) or Fig. 4(b).

[0093] Example 1:

[0094] Referring to Fig. 1(a), Fig. 1(b), Fig. 3(a) and Fig. 3(b), the present 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 always presses the skirt structure 320 of the valve stent 300 above the physiological valve annulus area. The anchoring stent 100 is equivalent to the main anchoring structure of the valve stent 300.

[0095] The anchoring stent 100 adopts a self-expanding spherical-like structure composed of several anchoring meshes 110.

[0096] The anchoring stent 100 is a self-expanding anchoring stent, which is composed of several anchoring meshes 110 and is usually not covered with a film, enabling the arbitrary release of the anchoring stent 100 and not blocking the blood flow in the atrium, such as the pulmonary veins of the left atrium.

[0097] After the valve stent 300 is implanted, the anchoring stent 100 is implanted. Through the expanded anchoring stent 100, the skirt structure 320 of the expanded valve stent 300 is pressed, so that the skirt structure 320 of the valve stent 300 fits better with the physiological valve annulus, increasing the sealing effect.

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

[0099] In this embodiment, after the anchoring bracket 100 expands, it has a certain adaptability to the atrial size by itself. However, in order to adapt to more patients, it can be achieved by setting multiple specifications of the anchoring bracket 100, and the diameter of the anchoring bracket 100 is not limited herein.

[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 Fig. 1(a), the anchoring bracket 100 is a cutting bracket cut from a shape memory metal.

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

[0103] In this embodiment, for the cutting bracket, the width of the grid bar 111 is not greater than 2 mm. With such a design, even if the grid bar 111 blocks the blood vessel opening, it will not affect the blood flow.

[0104] In this embodiment, for the cutting bracket, if the area of a single anchoring grid 110 is X, then 10 mm 2 ≤X≤200 mm 2 . By controlling the density of the anchoring grid 110, it is ensured that blood can pass through the grid 110 of the anchoring bracket 100 smoothly.

[0105] In this embodiment, referring to Fig. 1(b), the anchoring bracket 100 is a braided bracket made by braiding braided wires, and the braided wires serve as the grid bars 111.

[0106] For example, the anchoring bracket 100 is a braided bracket made by braiding nickel-titanium alloy wires.

[0107] In this embodiment, for the braided bracket, the diameter of the braided wire is 0.1 - 1 mm, preferably 0.1 - 0.13 mm. With such a design, it is ensured that the braided bracket has a supporting force, and the relatively thin braided wire reduces its influence on the blood flow, enabling the blood to pass through smoothly.

[0108] In this embodiment, for the braided bracket, in order to increase the stiffness / supporting force of the braided bracket and provide sufficient pressing force for the skirt structure of the valve bracket, the braided bracket can be a multi-layer structure, and the anchoring grids 110 of adjacent two layers in the multi-layer structure are arranged in a staggered manner.

[0109] For example, the braided bracket adopts a double-layer structure, and the anchoring grid 110 of the outer layer in the double-layer structure is arranged in a staggered manner with the anchoring grid 110 of the inner layer.

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

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

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

[0113] In this embodiment, when controlling the release direction of the anchoring stent 100, an anchoring film 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 film shall not affect the blood from entering the valve stent 300, but the anchoring film is a non-essential design.

[0114] In this embodiment, the material of the anchoring film can be any medical-grade implant material that promotes endothelialization, such as PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, and bovine pericardium. More preferably, it is PTFE or ePTFE.

[0115] In this embodiment, both the inflow end and the outflow end of the anchoring stent 100 are open structures. That is, several anchoring grids 110 do not contact or connect at the inflow end and the outflow end, and there is a certain distance between several anchoring grids 110 at the inflow end and the outflow end, so that the inflow end and the outflow end of the anchoring stent 100 form a flow port that helps blood to flow through.

[0116] Embodiment 2:

[0117] Refer to Figures 2(a) to 2(c) FIGS. 4(a) and 4(b), 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 always presses the skirt structure 320 of the valve stent 300 above the physiological valve annulus area. The anchoring stent 200 is equivalent to the main anchoring structure of the valve stent 300.

[0118] The anchoring stent 200 adopts a balloon-expandable spherical structure composed of several anchoring grids 210.

[0119] The anchoring stent 200 is a balloon-expandable anchoring stent, which is composed of a plurality of anchoring grids 210 and is usually not covered with a film, so that the anchoring stent 200 can be released arbitrarily without blocking the blood circulation in the atrium, such as the pulmonary vein of the left atrium.

[0120] After the valve stent 300 is implanted, the anchoring stent 200 is implanted, and the anchoring stent 200 is expanded by a 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 is more closely fitted to the physiological valve ring, thereby increasing the sealing effect.

[0121] In this embodiment, a single anchoring grid 210 is surrounded by a plurality of rods 211, as shown in FIG. 2(b) and FIG. 2(c), the width of the rods 211a where the anchoring grid 210 located in the middle is located is smaller than the width of the rods 211b where the anchoring grids 210 located at the retracted positions at both ends are located.

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

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

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

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

[0126] In this embodiment, the area of ​​a single anchor grid 210 is X, then 10 mm 2 ≤X≤200mm 2 By limiting the area of ​​the anchoring grid 210 , it is ensured that blood can smoothly pass through the anchoring grid 210 of the anchoring stent 200 , and at the same time, it is prevented that the anchoring stent 200 is expanded excessively, causing damage to the anchoring stent 200 .

[0127] In this embodiment, after the anchoring stent 200 is expanded by a balloon, the area of ​​the anchoring grid 210 located in the middle is larger than the area of ​​the anchoring grid 210 located at the folded positions at both ends.

[0128] In this embodiment, in order to promote the endothelialization of the anchoring stent and the atrium, a winding wire is provided on the mesh rod 211 of the anchoring stent 200, and the winding wire can be one or more of PTFE, PET, TPU, ultra-high molecular weight polyethylene, etc.

[0129] In this embodiment, when controlling the release direction of the anchoring stent 200, an anchoring film 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 film shall not affect the blood entering the valve stent 300, but the anchoring film is a non-essential design.

[0130] In this embodiment, the material of the anchoring film can be any medical-grade implant material that promotes endothelialization, such as PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, and bovine pericardium, and more preferably PTFE or ePTFE.

[0131] In this embodiment, since the anchoring stent 200 is a balloon-expandable stent and is made of a non-self-expanding material, such as cobalt-chromium alloy, stainless steel metal, etc. While the valve stent 300 is a self-expanding stent and is made of a self-expanding material, such as a shape memory metal like nickel-titanium alloy metal. Therefore, the materials of the anchoring stent 200 and the valve stent 300 are different. In order to prevent an electrochemical reaction from occurring, the surface of the anchoring stent 200 is treated with TPU coating, so that the surface of the anchoring stent 200 is covered with TPU, forming a TPU insulating layer to block the electrochemical reaction path between the anchoring stent 200 and the outside.

[0132] In this embodiment, both the inflow end and the outflow end of the anchoring stent 200 are open structures. That is, several anchoring meshes 210 do not contact or connect at the inflow end and the outflow end, and there is a certain distance between several anchoring meshes 210 at the inflow end and the outflow end, so that the inflow end and the outflow end of the anchoring stent 200 form a flow port that helps blood to flow through.

[0133] Embodiment 3:

[0134] Referring to Figures 3(a) to 5(b) , this embodiment provides a heart valve replacement system, which is used to replace the mitral / tricuspid heart valve to achieve the treatment of heart valve 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. From the outflow end to the inflow end, the valve stent 300 includes a stent body 310 and a skirt structure 320 that are integrally connected. The anchoring stent 400 is a spherical-like structure, and the anchoring stent 400 is located inside the skirt structure 320 and is detachably pressed against the skirt structure 320.

[0136] The valve stent 300 of this embodiment is a single-layer self-expanding stent. The single-layer structure facilitates crimping and delivery. After implantation, the skirt structure 320 fits the position of the physiological valve annulus, rather than relying on the stent body 310 to seal with the native leaflets. Therefore, it is not necessary to capture the native leaflets, reducing the difficulty of implanting the valve stent 300. Since the valve stent 300 does not need to use the physiological valve annulus to provide radial support force, that is, it does not need to capture the native leaflets or rely on the native leaflets for sealing, a double-layer structure is not required (in a double-layer structure, the outer layer needs to adapt to or capture the native leaflets, and the inner layer needs to be connected to the artificial leaflets, so the outer layer inevitably expands the native leaflets and the valve annulus). The valve stent 300 of this embodiment does not restrict the contraction and expansion movement of the native valve annulus and does not cause limited movement of the valve annulus.

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

[0138] The valve stent 300 and the anchoring stent 400 of this embodiment are separate structures. Therefore, the two can be delivered separately, with a small crimping diameter, facilitating delivery and implantation by means such as trans-femoral. The two are delivered separately and enter the human body in steps, enabling delivery and implantation into the human body using a thinner catheter, reducing the dilation of blood vessels. After the valve stent 300 of this embodiment is implanted, the anchoring stent 400 is implanted. According to the characteristics of the anchoring stent 400, the anchoring stent 400 can be expanded by self-expansion or balloon dilation, as Figure 7 shown in, the stiffness after expansion presses the skirt structure 320 of the valve stent 300 against the area above the physiological valve annulus all the time, ensuring the stable posture of the valve stent 300. The anchoring stent 400 is equivalent to the main anchoring structure of the valve stent 300. Through the expanded anchoring stent 400, the skirt structure 320 of the expansion stent 300 is pressed, making the skirt structure 320 of the valve stent 300 fit the physiological valve annulus more closely and increasing the sealing effect.

[0139] In this embodiment, the stent body 310 is a quasi-straight cylindrical structure.

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

[0141] In this embodiment, referring to FIG. 6(d), a skirt film 321 is provided on the skirt structure 320. The skirt film 321 provides a sealing function.

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

[0143] In this embodiment, the skirt film 321 is disposed inside the skirt structure 320.

[0144] In this embodiment, the skirt film 321 located inside the skirt structure 320 extends onto the stent main body 310, causing the skirt film 321 to form a stent valve, so as to achieve that the valve stent 300 can be integrally covered with a film.

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

[0146] In this embodiment, a TPU film is disposed inside the skirt film 321 located inside the skirt structure 320 to prevent blood from permeating through the film gap.

[0147] In this embodiment, the material of the skirt film 321 can be any medical-grade implant material that promotes endothelialization among PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, and bovine pericardium, and more preferably PTFE or ePTFE.

[0148] In this embodiment, with reference to Figures 6(a) to 6(c) , a plurality of outwardly expanding barbed structures 330 are circumferentially and spacedly disposed on the skirt structure 320. After the valve stent 300 is implanted, the barbed structures 330 penetrate into the annulus position to increase the stability of the valve stent 300 after implantation.

[0149] In this embodiment, with reference to FIG. 6(b), the barbed structure 330 has a connecting end and a free end. The connecting end of the barbed structure 330 is connected to the skirt structure 320, and the free end 330a of the barbed structure 330 extends out of the outer surface of the skirt structure 320. The skirt structure 320 is an outwardly expanding structure, and the barbed structure 330 further expands outward relative to the skirt structure 320. This outward expansion with the free end 330a extending out of the outer surface of the skirt structure 320 facilitates the insertion of the barbed structure 330 into the annulus.

[0150] In this embodiment, with reference to FIG. 6(c), the free end 330a of the barbed structure 330 turns outward and points to the inflow end, which facilitates the direct insertion of the barbed structure 330 into the annulus.

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

[0152] In this embodiment, the valve stent 300 further includes a plurality of 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] When the connecting rod 340 is not provided, several guy wires can be directly connected to the skirt structure 320 to increase the stability of the valve stent 300 during the release process and prevent the valve stent 300 from popping out of the delivery catheter at the final stage of release, resulting in a skewed implantation posture of the valve stent 300.

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

[0155] In this embodiment, one end of several connecting rods 340 is circumferentially and spacedly arranged on the skirt structure 320, and the other ends of several connecting rods 340 converge towards the inflow end and towards the middle.

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

[0157] In this embodiment, when the skirt structure 320 is provided with barbed structures 330, the connecting rod 340 and the barbed structures 330 are staggeredly arranged at the connection part between two adjacent skirt meshes. That is, only one of the barbed structures 330 and the connecting rod 340 is connected at the connection part between two adjacent skirt meshes.

[0158] As shown in FIG. 6(a), six barbed structures 330 and three connecting rods 340 are provided on the skirt structure 320, and they are evenly arranged in a manner that two barbed structures 330 are separated by one connecting rod 340 along the circumference of the skirt structure 320.

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

[0160] In this embodiment, the anchoring stent 400 is coaxial with the valve stent 300.

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

[0162] In this embodiment, referring to FIGS. 4(a) and 4(b), the anchoring stent 400 adopts the anchoring stent 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, a stent coating film is provided inside the valve stent 300, and a TPU spun film is provided inside the stent coating film.

[0164] The method of setting a TPU spun film on the inner side of the stent covering, for example, spinning a layer of TPU spun film on the surface of a PET film, is a prior art and will not be elaborated here.

[0165] TPU is thermoplastic polyurethane elastomer, also known as thermoplastic polyurethane rubber, which has good insulation performance. By setting a TPU spun film on the inner side of the stent covering, the electron 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, a TPU insulating layer is applied to at least one surface of the valve stent 300 and the anchoring stent 400, so that the surfaces of the valve stent 300 and / or the anchoring stent 400 are covered by TPU to form an insulating layer, blocking the electrochemical reaction path between any stent and the outside.

[0167] The present invention has been described in detail with reference to the embodiments accompanied by drawings. Those of ordinary skill in the art can make various variations to the present invention according to the above description. Therefore, some details in the embodiments should not constitute a limitation to the present invention, and the present invention will take the scope defined by the appended claims as the protection scope.

Claims

1. A heart valve replacement system, characterized in that, the heart valve replacement system comprises: a valve stent, the valve stent is a single-layer self-expanding structure, and the valve stent includes a stent body and a skirt structure integrally connected from the outflow end to the inflow end; an anchoring stent, the anchoring stent is a spherical-like structure, and the anchoring stent is located inside the skirt structure and is detachably pressed against the skirt structure.

2. The heart valve replacement system according to claim 1, characterized in that, the stent body is a straight cylinder-like structure; and / or, the skirt structure is an outwardly expanding structure that expands outward from the outflow end to the inflow end; and / or, a skirt film is provided on the skirt structure.

3. The heart valve replacement system according to claim 2, characterized in that, at least the outflow end of the skirt film is connected to the inflow end edge of the artificial valve leaflet; and / or, the skirt film is provided on the inner side of the skirt structure; and / or, the skirt film located inside the skirt structure extends to the stent body, so that the skirt film forms a stent valve; and / or, a skirt film is provided on the outer side of the skirt structure; and / or, a TPU film is provided on the inner side of the skirt film located inside the skirt structure.

4. The heart valve replacement system according to claim 1, characterized in that, a plurality of outwardly expanding barbs are circumferentially spaced on the skirt structure.

5. The heart valve replacement system according to claim 4, characterized in that, the barb has a connecting end and a free end, the connecting end of the barb is connected to the skirt structure, and the free end of the barb extends out of the outer surface of the skirt structure; and / or, the barb has a connecting end and a free end, the connecting end of the barb is connected to the skirt structure, and the free end of the barb is turned outwards and points to the inflow end; and / or, the skirt structure is surrounded by a plurality of skirt grids, and the connecting end of the barb is integrally connected to the connection between two adjacent skirt grids.

6. The heart valve replacement system according to claim 1, characterized in that, the valve stent further includes a plurality of connecting rods for connecting with a delivery device.

7. The heart valve replacement system according to claim 6, characterized in that, one ends of a plurality of the connecting rods are circumferentially spaced on the skirt structure, and the other ends of the plurality of the connecting rods converge towards the inflow end and towards the middle; and / or, the skirt structure is surrounded by a plurality of skirt grids, and one end of the connecting rod is integrally connected to the connection between two adjacent skirt grids; and / or, when barbs are provided on the skirt structure, the connecting rod and the barb are staggeredly arranged at the connection between two adjacent skirt grids; and / or, a wire hole is provided at the inflow end of the connecting rod.

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

9. The heart valve replacement system according to any one of claims 1 to 7, characterized in that, the anchoring stent adopts a self-expanding spherical-like structure composed of a plurality of anchoring grids.

10. The heart valve replacement system according to claim 9, It is characterized in that The anchoring bracket is a cut bracket cut from memory metal.

11. The heart valve replacement system according to claim 10, It is characterized in that A single anchoring grid is surrounded by a plurality of mesh rods, and the width of the mesh rods is no more than 2 mm; And / or, if the area of a single said anchoring grid is X, then 10 mm 2 ≤ X ≤ 200 mm 2 .

12. The heart valve replacement system according to claim 9, It is characterized in that The anchoring stent is a braided stent made by braiding wires.

13. The heart valve replacement system according to claim 12, It is characterized in that The diameter of the braided wire is 0.1-1 mm, preferably 0.1-0.13 mm; And / or, the braided stent is a multi-layer structure, and the anchoring grids of two adjacent layers in the multi-layer structure are staggered; And / or, the braided stent is a multi-layer structure, the diameter of the braided wire used in the inner layer of the multi-layer structure is larger than the diameter of the braided wire used in the outer layer, and the braided anchoring grid density of the inner layer is smaller than the braided anchoring grid density of the outer layer; And / or, the braided stent is a multi-layer structure, in which the diameter of the braided wire used in the inner layer is 0.3-1 mm, and the diameter of the braided wire used in the outer layer is 0.1-0.5 mm.

14. The heart valve replacement system according to claim 9, It is characterized in that A single anchoring grid is surrounded by a plurality of mesh rods, and a winding wire is arranged on the mesh rods, and the winding wire 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, the inflow end and the outflow end of the anchoring bracket are both open structures.

15. The heart valve replacement system according to any one of claims 1 to 7, It is characterized in that The anchoring bracket adopts a ball-expanding spherical structure composed of a plurality of anchoring grids.

16. The heart valve replacement system according to claim 15, It is characterized in that A single anchoring grid is surrounded by a plurality of net rods, and the width of the net rods where the anchoring grid located in the middle is located is smaller than the width of the net rods where the anchoring grids located at the closed positions at both ends are located; And / or, the anchoring stent is a non-self-expanding stent, and the anchoring stent is made of one or more materials of cobalt-chromium alloy and stainless steel metal; And / or, the anchoring stent is formed by cutting a metal tube and heat-setting it; And / or, if the area of a single said anchoring grid is X, then 10 mm 2 ≤ X ≤ 200 mm 2 ; And / or, a single anchoring grid is surrounded by a plurality of mesh rods, and a winding wire is arranged on the mesh rods, and the winding wire is one or more of PTFE, PET, TPU and ultra-high molecular weight polyethylene; And / or, the region where the anchoring stent contacts the valve stent after balloon expansion is provided with an anchoring coating; And / or, the inflow end and the outflow end of the anchoring stent are both 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, a stent coating is provided on the inner side of the valve stent, and a TPU spinning membrane is provided on the inner side of the stent coating.

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