WO2022236929A1

WO2022236929A1 - Heart valve prosthesis apparatus

Info

Publication number: WO2022236929A1
Application number: PCT/CN2021/101844
Authority: WO
Inventors: 赵婧; 闻靖
Original assignee: 上海臻亿医疗科技有限公司
Priority date: 2021-05-14
Filing date: 2021-06-23
Publication date: 2022-11-17

Abstract

A heart valve prosthesis apparatus (100), comprising a frame structure (110) for bearing a prosthetic leaflet (130) and a sealing mechanism (120) covering the surface of the frame structure (110), wherein the sealing mechanism (120) comprises at least one layer of a first sealing member (121) having a liquid absorption capability and at least one layer of a second sealing member (122), the second sealing member (122) covering the outer side surface of the frame structure (110), the first sealing member (121) covering the surface of the second sealing member (122), and the first sealing member (121) having an expanded shape after absorbing liquid. The present heart valve prosthesis apparatus (100) is used for replacing a native valve, and the sealing mechanism (120) has a sealing function; if there is seepage on the surface of the first sealing member (121) in contact with the tissue, the first sealing member (121) can absorb liquid and expand, the volume thereof becoming large to help with sealing and prevent further leakage; after absorbing the liquid and expanding, the first sealing member (121) becomes flexible, and the expanded shape can match the irregular shape of the native annulus; the hydrophilic property of the first sealing member (121) also facilitates the adhesion and proliferation of endothelial cells, thereby facilitating endothelialisation.

Description

A kind of heart valve prosthesis device

technical field

The invention relates to the technical field of medical instruments, in particular to a heart valve prosthesis device for replacing a native valve.

Background technique

The heart has four chambers, the left atrium and left ventricle are on the left side of the heart, and the right atrium and right ventricle are on the right side of the heart. The atrium and ventricle form the ventricular inflow tract, the left ventricle and the aorta form the left ventricular outflow tract, and the right ventricle and the pulmonary artery form the right ventricular outflow tract. There are valves with the function of "one-way valve" at the ventricular inflow and ventricular outflow to ensure the normal flow of blood in the heart chamber. When there is a problem with this valve, the hemodynamics of the heart are altered and the heart functions abnormally, which is called valvular heart disease.

With the development of social economy and the aging of the population, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. At present, traditional surgical treatment is still the first choice for patients with severe valvular disease, but for patients who are elderly, complicated with multiple organ diseases, have a history of thoracotomy, and have poor heart function, the risk of traditional surgery is high and death The rate is high, and some patients do not even have the chance of surgery. Transcatheter replacement/repair has the advantages of no need for thoracotomy, less trauma, and faster recovery of patients, and has attracted extensive attention from experts and scholars.

Although the field of transcatheter delivery of prosthetic valves has developed rapidly in recent years, there are still some problems to be solved, such as leakage between the implanted valve prosthesis and the surrounding natural tissue. Minimally invasive percutaneous heart valve replacement generally does not involve the actual physical removal of a diseased or injured heart valve, but rather the delivery of a stented valve prosthesis in a compressed state to the site of the native valve. At the valve site, the prosthetic valve expands to its working state within the diseased valve. Calcified or diseased native valve leaflets are compressed against the sidewall of the native valve by the radial force of the prosthetic valve stent. Since the calcified leaflets do not fit perfectly to the shape of the stent, this can be a source of paravalvular leak (PVL).

In addition, significant pressure gradients across the valve can also cause leakage of blood through the gap between the implanted prosthetic valve and the calcified anatomy.

Contents of the invention

The invention provides a heart valve prosthesis device, which can solve the above-mentioned defects in the prior art.

Technical scheme of the present invention is as follows:

A heart valve prosthesis device, comprising a frame structure for carrying artificial valve leaflets and a sealing mechanism covered on the surface of the frame structure, wherein the sealing mechanism includes at least one layer of first sealing member with liquid absorption capacity and at least one layer of second sealing member, the second sealing member covers the outer surface of the frame structure, the first sealing member covers the outer surface of the second sealing member, and the first sealing member absorbs It has a swollen form after liquid.

The heart valve prosthesis device of the present invention is used to replace a diseased native valve, the inner peripheral side of the frame structure bears artificial valve leaves, and the outer peripheral side of the frame structure is attached to the peripheral side of the original tissue. The sealing mechanism plays a role of sealing. Further, the outermost part of the sealing mechanism is configured as a first sealing member. If liquid seepage occurs on the surface of the first sealing member in contact with the tissue, the first sealing member can absorb liquid and expand, and the volume changes. Large, secondary seal to prevent further leaks. Moreover, after absorbing liquid and expanding, the first sealing member becomes flexible, and the expanded shape can be matched with the irregular shape of the natural valve annulus to fill the gap between the prosthetic device and the tissue. In addition, the hydrophilic nature of the first seal also facilitates adhesion and proliferation of endothelial cells, thereby facilitating endothelialization.

In some embodiments, the frame structure includes a first frame portion attached to the native tissue, the first frame portion includes an inflow end and an outflow end at both ends, and a In the middle section of the first frame part, the sealing mechanism is arranged in the middle section of the first frame part. Among them, the frame structure is a single-layer frame structure, and the artificial valve leaflet is fixed on the middle section of the first frame part, so the structure at this place needs to have a certain rigidity, which makes it difficult for the middle section to fit the tissue. Outflow in an unintended direction, ie, from the center of the prosthetic device through the mid-segment, causes a paravalvular leak. The sealing mechanism arranged in the middle section can play a sealing role, thereby solving the problem of paravalvular leakage.

In some embodiments, the frame structure further includes a second frame part, the second frame part is coaxially arranged inside the first frame part, and between the first frame part and the second frame part An annular gap is configured, and the annular gap is provided with a third sealing member, and the third sealing member closes the annular gap formed by the first frame part and the second frame part, thereby forming an annular space that allows blood to flow in and prevents thrombus from flowing out.

Wherein, the frame structure is a double-layer frame structure, the first frame part is attached to the tissue for anchoring, the artificial valve leaflet is fixed on the inner peripheral side of the second frame part to form an inner-outer composite structure, and the outer peripheral side of the second frame part is connected to the second frame part. An annular gap is formed between inner peripheral sides of a frame portion. The arrangement of the third sealing member may be by sewing, fixed on the inflow end of the first frame part, across the annular gap and fixed on the second frame part. The third sealing member can be a whole piece of material, and can also be spliced by multiple pieces of material. At the outflow end near the first frame part, the third sealing part connects the end of the first frame part and the end of the second frame part. The part is covered to form a closed annular space.

In this double-layer frame structure, the expected flow direction of blood is from one end of the second frame part to the other end, but in actual application, the blood may flow unexpectedly, such as flowing into the annular gap or flowing out from the middle section of the first frame part. The cooperation of the three seals and the sealing mechanism can trap the thrombus in the annular space, and the sealing mechanism arranged in the middle section of the first frame part can prevent the unexpected flow of blood, prevent paravalvular leakage, and further improve the performance of the valve. Device stability, safety and effectiveness.

In some embodiments, the sealing mechanism includes a layer of the second seal, wherein the second seal is made of a non-permeable material. Wherein, the use of the second sealing member of non-permeable material in conjunction with the first sealing member can help the first sealing member immobilize the leaking blood, prevent paravalvular leakage and prevent blood from penetrating into the first frame part, resulting in free thrombus.

In some embodiments, the sealing mechanism includes at least two layers of second sealing elements, and the two layers of second sealing elements are separately provided on the outer surface and the inner surface of the first frame part. The double-layer second sealing member can effectively seal, and cooperate with the first sealing member to further prevent paravalvular leakage.

In some embodiments, the second sealing member is made of permeable material, so that blood can pass through one layer of the second sealing member, coagulate to form a thrombus in the interlayer region of the two layers of second sealing members, and be trapped in the double layer of the second sealing member. layer between the second seal.

In some embodiments, the sealing mechanism includes at least two layers of the first sealing material, wherein at least one layer of the first sealing material is arranged between two adjacent layers of the second sealing material. If blood penetrates between the double-layer second seals, the first seal will absorb liquid and swell, on the one hand, promote the blood to form microcapsules to reduce paravalvular leakage, and on the other hand, the first seal will keep the blood in the second seal. In the interlayer of the seal, it prevents thrombus from flowing out, causing the risk of embolism. Therefore, through the cooperation of at least two layers of the first sealing member and the second sealing member, paravalvular leakage can be effectively prevented while reducing the risk of embolism.

In some embodiments, the surface of the third sealing member is provided with a liquid-absorbing polymer coating, and the polymer coating is located on the side of the annular gap near the outflow end of the first frame part. The setting of the third sealing member reduces the unexpected flow of blood, and when the blood penetrates the third sealing member and flows to the annular gap, it can be absorbed by the polymer coating to promote the formation of microcapsules of blood and be retained in the coating or In the annular space, the thrombus is prevented from flowing out of the annular space. The third seal, the polymer coating after liquid absorption, the sealing mechanism, and the annular space filled with thrombus can be used to seal the inner structure of the valve prosthesis, further stabilizing the valve prosthesis. body.

In some embodiments, the polymer coating is made of a hydrophilic polymer material selected from the group consisting of: polyethylene oxide, polyvinyl alcohol, polyacrylic acid, polypropylene fumaric acid- Coethylene glycol and peptides, agarose, alginate, chitosan, collagen, fibrin, gelatin, hyaluronic acid, polyhydroxyethylmethacrylate, poly-2-hydroxyethylmethacrylate and their copolymers material, polyvinylpyrrolidone, poly-N-vinylpyrrolidone hydrogel, poly-2-hydroxyethyl methacrylate/poly-N-vinylpyrrolidone copolymer, and polyacrylamide.

In some embodiments, the polymer coating is formed by spraying, electrospinning or rolling.

In some embodiments, the first sealing member is made of a hydrophilic polymer material selected from the group consisting of: polyethylene oxide, polyvinyl alcohol, polyacrylic acid, polypropylene fumaric acid- Coethylene glycol and peptides, agarose, alginate, chitosan, collagen, fibrin, gelatin and hyaluronic acid, polyhydroxyethylmethacrylate, poly-2-hydroxyethylmethacrylate (p-HEMA ) and their copolymers, polyvinylpyrrolidone (PVP), poly-N-vinylpyrrolidone (pNVP) hydrogel, poly-2-hydroxyethyl methacrylate (p-HEMA)/poly-N-vinyl At least one of pyrrolidone (pNVP) copolymer and polyacrylamide (pAM).

In some embodiments, the first sealing member is a coating covering the surface of the second sealing member, and the coating is formed by spraying, electrospinning or rolling.

Compared with the prior art, the beneficial effects of the present invention are as follows:

First, the heart valve prosthesis device of the present invention is used to replace the diseased original valve, and the sealing mechanism plays a sealing role. Further, the outermost part of the sealing mechanism is configured as a first sealing member. If the first sealing member is in contact with the When the surface in contact with the tissue leaks, the first seal can absorb the liquid and expand, and its volume becomes larger, which assists in sealing and prevents further leakage. Moreover, after absorbing liquid and expanding, the first sealing member becomes flexible, and the expanded shape can be matched with the irregular shape of the natural valve annulus to fill the gap between the prosthetic device and the tissue. In addition, the hydrophilic nature of the first seal also facilitates adhesion and proliferation of endothelial cells, thereby facilitating endothelialization.

Second, in the heart valve prosthesis device of the present invention, the double-layer frame structure can distribute the functions of carrying artificial valve leaflets, anchoring, sealing, etc. Better play the purpose of implantation treatment function; the setting of the third seal reduces the unexpected flow of blood, when the surface of the third seal near the outflow end is provided with a polymer coating, when the blood penetrates the third seal Parts flow to the annular gap, are absorbed by the polymer coating, promote blood to form microcapsules, and are retained in the coating or in the annular space, the third seal, the polymer coating after liquid absorption, and the annular space filled with thrombus It can be used as an encapsulation of the inner structure of the valve prosthesis to further stabilize the valve prosthesis.

Of course, any product implementing the present invention does not necessarily need to achieve all the above-mentioned advantages at the same time.

Description of drawings

Fig. 1 is the structural representation of the heart valve prosthesis device of embodiment 1 of the present invention;

Fig. 2 is a schematic structural view of the first frame part of Embodiment 1 of the present invention;

Fig. 3 is a schematic structural view of a heart valve prosthesis device according to Embodiment 2 of the present invention.

Detailed ways

The invention provides a heart valve prosthesis device, which solves the problem of paravalvular leakage by setting a sealing mechanism. The following embodiments all take mitral valve prosthesis as an example. It should be noted that the heart valve prosthesis device of the present invention is also applicable to aortic, tricuspid or pulmonary valves.

In the present invention, it should be noted that "inside" refers to the side close to the axis of the valve prosthesis, and "outside" refers to the side away from the axis of the valve prosthesis.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, or in a specific orientation. construction and operation, therefore, should not be construed as limiting the invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and should not be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that unless otherwise specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations.

As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

Below in conjunction with specific embodiment, further illustrate the present invention.

Example 1

This embodiment provides a mitral valve prosthesis 100. As shown in FIG. The sealing mechanism 120, wherein, the sealing mechanism 120 includes at least one layer of first sealing member 121 with liquid absorption capacity and at least one layer of second sealing member 122, and the second sealing member 122 is covered on the frame structure 110, the first sealing member 121 is covered on the surface of the second sealing member 122, and the first sealing member 121 has a swollen shape after absorbing liquid.

The frame structure can provide several functions for the heart valve prosthesis 100, including being used as a main structure, an anchoring structure (including an anchor claw structure grabbing the valve leaflet, or piercing into the valve leaflet, etc.), a support for carrying the internal artificial valve leaflet 130, It is used as a sealing member to suppress the paravalvular leakage between the mitral valve prosthesis 100 and the native valve, a connection structure connected with the delivery system (such as hanging ear or fixed ear), and the like. The frame structure can be made of biophasic materials such as Nitinol, titanium alloys, cobalt chromium alloys, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum chromium, or other biocompatible metals known to those skilled in the art. Capacitive metal frame or laser cut solid metal tube. Preferably fabricated from shape memory alloys, but can optionally also include materials that are elastically or plastically deformable, such as balloons that are expandable, or that respond to changes in temperature to switch between a contracted delivery state and an expanded deployed state Transformation between shape memory alloys. Optionally, the frame structure 110 may also be constructed of braided wires or other suitable materials.

The artificial valve leaflet 130 is dynamically switched between an open state and a closed state. In the closed state, the artificial valve leaflet 130 is tightly closed or converged in a sealing abutting manner. Prosthetic leaflet 130 may be formed from any suitable material or combination of materials. In some embodiments, a biological tissue such as a chemically stable tissue from a heart valve of an animal (such as a pig), or pericardial tissue of an animal such as bovine (bovine pericardium) or sheep (ovine pericardium) or porcine (porcine pericardium) may be selected. ) or horse (equine pericardium), preferably bovine pericardium tissue. The prosthetic valve leaflet 130 can also be made from the submucosal tissue of the small intestine. Additionally, synthetic materials may also be used for the prosthetic valve leaflet 130 . For example, expanded polytetrafluoroethylene or polyester. Optionally, thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylenes are also included. Additional biocompatible polymers can optionally include polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicone poly Esters, silicone polymers and/or oligomers, and/or polylactones, and block copolymers using them. Optionally, leaflet 130 has a surface treated with (or reacted with) an anticoagulant, including but not limited to heparinized polymers.

When the valve prosthesis 100 is deployed within the annulus of a native heart valve, the frame structure 110 expands within the native leaflets of the patient's defective native valve, thereby maintaining the native leaflets in a permanently open state (against the on the side wall). The native valve annulus includes surface irregularities on its inner surface, and thus one or more gaps will exist or can form between the perimeter of the valve prosthesis 100 and the native valve annulus. For example, there may be calcium deposits on the native valve leaflets and/or there may be a difference in shape between the native heart valve annulus and the prosthesis 100 . More specifically, some native valve annulus are not perfectly round, but have depressions corresponding to the commissures of the native valve leaflets (for example, the mitral valve annulus is saddle-shaped or D-shaped or kidney-shaped), both horizontally and vertically Surfaces can move and change shape. Thus, a prosthesis with a generally circular cross-section cannot provide a precise fit to the native valve leaflets. Regardless of the cause, ultimately these surface irregularities can make it difficult for the valve prosthesis to form a blood seal between the inner surfaces of the valve annulus, causing undesired paravalvular leak and/or regurgitation at the implantation site.

In the mitral valve prosthesis of this embodiment, the sealing mechanism 120 plays a sealing role. Further, the outermost part of the sealing mechanism 120 is configured as a first sealing member 121. If the surface of the first sealing member 121 in contact with the tissue In the event of liquid seepage, the first sealing member 121 can absorb liquid and swell to increase in volume, assisting in sealing and preventing further leakage. Moreover, the first sealing member 121 becomes flexible after being absorbed and expanded, and the expanded shape can match the irregular shape of the natural valve annulus, thereby solving the problem of sealing between the valve prosthesis and the inner surface of the valve annulus. In addition, the hydrophilic property of the first sealing member 121 also facilitates the adhesion and proliferation of endothelial cells, thereby facilitating endothelialization.

Continuing to refer to Fig. 1 and Fig. 2, the frame structure 110 of this embodiment is a single-layer frame, including a first frame part 111, the first frame part 111 is configured as a grid hole structure, and the artificial valve leaflet 130 is fixed on the first frame part 111 on the inner peripheral side. The first frame part 111 includes an inflow end 101 and an outflow end 103 at both ends, and an intermediate section 102 between the inflow end 101 and the outflow end 103. The edge of the inflow end 101 expands outwards into a trumpet structure, and the mitral valve pseudo After the body 100 is implanted into the human body, the inflow end 101 is attached to the original mitral valve annulus of the heart to prevent the prosthetic valve from falling into the left ventricle from the left atrium. The anchoring force is supported on the calcified valve leaflet, which plays the role of anchoring and sealing. Blood flows in from the inflow end 101 of the first frame part 111 and flows out from the outflow end 103 .

Specifically, the first frame part 111 can be a cylindrical structure, an elliptical column, etc., and its cross section can be circular, elliptical, D-shaped, saddle-shaped, petal-shaped or a combination thereof, which can be compressed, loaded in the transport Within the device, upon delivery to the target site, it releases and self-expands into the target shape.

The artificial valve leaflet 130 of this embodiment is fixed on the middle section 102 of the first frame part 111, so the structure at this place needs to have a certain rigidity, which makes it difficult for the middle section 102 to fit the tissue. The direction of outflow, that is, outflow from the center of the first frame part 111 through the middle section 102 causes paravalvular leakage. Therefore, the sealing mechanism 120 in this embodiment is arranged at the middle section 102 of the first frame part 111, and the first sealing member 121 plays the role of auxiliary sealing, and is used to fill the first frame part 111 and the flap after absorbing liquid and expanding. The space between the annulus or the native valve leaflets, thereby preventing paravalvular leak.

In some embodiments, the sealing mechanism 120 includes a layer of the second sealing member 122, wherein the second sealing member 122 is made of a non-permeable material. The sealing mechanism 120 of this embodiment consists of a layer of second sealing member 122 and a first sealing member 121 located outside the second sealing member 122, wherein the non-permeable material cooperates with the use of the first sealing member 121, which can help the first sealing The member 121 immobilizes leaking blood, prevents paravalvular leakage and prevents blood from penetrating into the first frame part 111 to form a thrombus that can move freely. Specifically, the non-permeable material has a permeation rate of <300ml/cm ² ·min under a pressure of 100-140mmHg, and polyester fabric, PTFE, ePTFE, etc. can be selected. Of course, in some alternative embodiments, the second sealing member 122 can also be made of permeable material.

In some embodiments, the sealing mechanism 120 includes at least two layers of second sealing elements 122 , and the two layers of second sealing elements 122 are respectively disposed on the outer surface and the inner surface of the first frame part 111 . The sealing mechanism 120 of this embodiment is composed of two layers of second seals 122 and the first seal 121 located on the outside. The double-layer second seals 122 can effectively seal, and at the same time cooperate with the first seals 121 to effectively prevent Perivalvular leak.

Further, when the sealing mechanism 120 includes two layers of second seals 122, the second seals 122 are made of permeable materials, so that blood can penetrate one layer of second seals 122, and the two layers of second seals The interlayer region of member 122 coagulates to form a thrombus, which is trapped between the double-layered second seal members 122 . Specifically, the permeable material has a permeation rate of >500ml/cm ² ·min at 100-140mmHg, and polyester fabric, PTFE, ePTFE, etc. can be selected.

Further, when the sealing mechanism 120 includes at least two layers of second sealing members 122 , at least one layer of the first sealing member 121 is arranged between two adjacent layers of the second sealing members 122 . If blood penetrates between the double-layered second seals 122, the first seal 121 will absorb liquid and swell, on the one hand, promote the blood to form microcapsules to reduce paravalvular leakage; on the other hand, the first seal 121 fixes the blood to keep In the interlayer of the second sealing member 122, thrombus is prevented from flowing out, causing the risk of embolism. Therefore, through the cooperation of at least two layers of the first sealing member 121 and the second sealing member 122 , paravalvular leakage can be effectively prevented while reducing the risk of embolism.

The first sealing member 121 is made of a cross-linked hydrophilic macromolecular material to form a hydrogel polymer coating. The hydrogel polymer has a three-dimensional network structure, which is capable of swelling and contains about 20wt% to about 95wt% of water. Natural hydrogel polymers include fibrin, collagen, elastin, and others. Hydrogel polymers can be solutions, gels, foams, and other materials. In some cases, the hydrogel polymer is capable of absorbing greater than 50%, greater than 75%, greater than 100%, greater than 150%, etc. of water (or bodily fluids such as blood) relative to its dry weight. Hydrogel polymers include polyethylene oxide, polyvinyl alcohol, polyacrylic acid, polypropylene fumarate-coethylene glycol and peptides, agarose, alginate, chitosan, collagen, fibrin, gelatin, and transparent Hyaluronic acid, polyhydroxyethyl methacrylate, poly-2-hydroxyethyl methacrylate (p-HEMA) and their copolymers, polyvinylpyrrolidone (PVP), poly-N-vinylpyrrolidone (pNVP) water Gel, pHEMA/pNVP copolymer, polyacrylamide (pAM) or other similar materials. Appropriate materials can be selected according to actual clinical needs.

Specifically, the first sealing member 121 is a coating covering the surface of the second sealing member 122, and the coating is formed by spraying, electrospinning or rolling.

Further, the inflow end 101 and the outflow end 103 of the first frame part 111 are provided with skirts, the skirts can be single-layer or double-layer, and the skirt material can be knitted, woven, woven polyester fabric, PTFE, ePTFE and other materials, the skirt mainly plays the role of sealing.

Specifically, the second sealing member 122 and the skirt are covered on the surface (inner side and/or outer side) of the first frame part 111 , and can be fixed to the frame structure by sewing.

Example 2

This embodiment provides a mitral valve prosthesis. The mitral valve prosthesis 200 includes a frame structure 210 for carrying artificial valve leaflets 230 and a sealing mechanism 220 covering the surface of the frame structure 210 . The valve prosthesis of this embodiment is similar to that of Embodiment 1, except that the frame structure 210 of this embodiment is a double-layer frame structure.

Due to the large size of the annulus of the mitral valve anatomically, the part of the supporting body of the prosthetic valve implanted in the mitral valve to carry the artificial valve leaflets needs to be larger in both circumferential diameter and axial height. After the prosthetic valve is implanted into the mitral valve, the size of the subvalvular prosthetic structure is larger, and there is a greater risk of damage to the subvalvular structure of the original valve assembly. At the same time, the prosthetic structure under the valve is too large, which will affect the ejection function of the aorta and cause left ventricular outflow tract obstruction. For some patients with mitral valve regurgitation, there is no calcification on the valve, and the existing working principle of using the radial support force generated between the prosthetic valve and the native valve to prevent the displacement of the prosthetic valve cannot be used, so the double-layer stent The valve prosthesis treatment effect is better. The double-layer mitral valve prosthesis can distribute the functions of bearing artificial valve leaflets and undertaking anchoring and sealing to different single-layer valve components, so as to achieve the purpose of not affecting the normal operation of other structures of the heart, but also giving full play to the implant. Into the purpose of therapeutic function.

Specifically, the frame structure 210 of this embodiment includes a first frame portion 211 and a second frame portion 212, the second frame portion 212 is axially arranged inside the first frame portion 211, and the first frame An annular gap is disposed between the portion 211 and the second frame portion 212 . The first frame part 211 includes an inflow end 201 and an outflow end 203 located at both ends, and an intermediate section 202 located between the inflow end 201 and the outflow end 203, and the sealing mechanism 220 is arranged on the first The middle section 202 of the frame part 211 . The annular gap is provided with a third sealing member 240, and the third sealing member 240 closes the annular gap formed by the first frame part 211 and the second frame part 212, thereby forming an annular space allowing blood to flow in and preventing thrombus from flowing out.

Wherein, the third sealing member 240 can be a whole piece of skirt, and can also be spliced by multiple pieces of skirt material. The third sealing member 240 can be a single-layer structure or a double-layer structure. The skirt material and implementation The skirt of Example 1 is similar.

When the valve prosthesis 200 is placed in the annulus of a human heart valve, blood from the atrium will flow into and out of the annular gap between the first frame part 211 and the second frame part 212 . Blood can coagulate to form thrombus, which will be transported through the flow of blood during the circulation of the heart, causing blood vessel blockage, and in severe cases, cerebral thrombosis, even life-threatening. Through the cooperation of the third sealing member 240 and the sealing mechanism 220, when blood flows into the annular space, the formed thrombus is trapped in the annular space, thereby reducing the risk of embolism. At the same time, the function of the sealing mechanism 220 can effectively prevent paravalvular leakage.

The sealing mechanism 220 of this embodiment includes a second sealing member 222 covering the inner and outer surfaces of the first frame part 211, and a first sealing member covering the surface of the second sealing member 222 and located outside the valve prosthesis 200. 221. Certainly, the second sealing member 222 may be provided in only one layer, such as on the inner side or the outer side of the first frame part 211 . Wherein, a layer of first sealing member may also be arranged between the double-layer second sealing members 222 .

In some embodiments, the surface of the third sealing member 240 is provided with a polymer coating 241 with liquid absorption capacity, and the polymer coating 241 is located in the annular gap and close to the outflow end 203 of the first frame part 211 side.

In this embodiment, a polymer coating 241 is added to the inner layer of the third sealing member 240 at the annular gap, and the inner layer here refers to being located in the annular space. If blood penetrates into the annular space 250 and contacts the polymer coating 241, the polymer coating 241 will absorb liquid and swell to fix the blood in the annular space 250, preventing thrombus from flowing out and causing embolism risk. The expanded polymer coating 241 and the thrombus-filled annular space 250 can be used to seal the inner structure of the valve prosthesis 100 (including the inner first frame part 211 and its skirt, and artificial valve leaflets), further stabilizing the valve Prosthesis. In addition, the potting formed by the sealing mechanism 220 and the annular space 250 can further improve the stability.

Wherein, the polymer coating 241 is made of a hydrophilic polymer material, and the hydrophilic polymer material is selected from: polyethylene oxide, polyvinyl alcohol, polyacrylic acid, polypropylene fumaric acid-coethylene glycol and polypeptide, agar Sugar, alginate, chitosan, collagen, fibrin, gelatin and hyaluronic acid, polyhydroxyethylmethacrylate, poly-2-hydroxyethylmethacrylate (p-HEMA) and their copolymers, Polyvinylpyrrolidone (PVP), poly-N-vinylpyrrolidone (pNVP) hydrogel, poly-2-hydroxyethyl methacrylate (p-HEMA)/poly-N-vinylpyrrolidone (pNVP) copolymer, At least one of polyacrylamide (pAM). Polymer coatings are formed by spraying, electrospinning or rolling.

In this embodiment, the shapes, structures, materials, and molding methods of the first frame portion 211 and the second frame portion 212 are similar to those of the first frame portion 111 in Embodiment 1, and will not be repeated here. In this embodiment, the shapes, structures, materials, and molding methods of the first frame part 211 and the second frame part 212 may be the same or different.

In this embodiment, the first frame part 211 and the second frame part 212 abut against the end close to the outflow end 203, specifically, on the side close to the outflow end 203, the outer peripheral side of the second frame part 212 abuts against the first frame part 211, and the two are connected and sealed by skirts, and the skirts cover the bottom ends (near the outflow ends) of the first frame part 211 and the second frame part 212 respectively. The first frame portion 211 expands outward near the inflow end 201 to form a bell mouth shape, and there is a predetermined gap between the side of the second frame portion 212 near the inflow end and the inside of the first frame portion 211, so that the first frame portion 212 The frame portion 211 and the second frame portion 212 form the annular gap on a side close to the inflow end 201 .

Of course, the first frame part 211 and the second frame part 212 may also have a certain gap at the end close to the outflow end 203, and then they are covered and connected by skirts.

In this embodiment, blood can flow into the annular space 250 from the third sealing member 240 above the annular gap, and can flow out from the skirt on the side surface of the second frame part 212, and the thrombus is confined in the annular space to form a potting.

In this embodiment, the annular gap between the first frame part 211 and the second frame part 212 near the inflow end is a continuous annular gap along the circumference. Of course, in some embodiments, the annular gap can also be configured as a A non-continuous gap in the circumferential direction, or an arc-shaped gap in the circumferential direction, this embodiment does not limit the shape and size of the annular gap.

The above disclosures are only preferred embodiments of the present invention, and the preferred embodiments do not describe all details in detail. It should be understood that these embodiments are only used to illustrate the present invention, and are not used to limit the protection scope of the present invention. Limitations on the Requirements and their full scope and equivalents.

This description selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can make good use of the present invention. Improvements and adjustments made by those skilled in the art according to the present invention in practical applications still belong to the protection scope of the present invention. The technical features in the above different embodiments can be combined arbitrarily on the premise of not conflicting with each other.

Claims

A heart valve prosthesis device, characterized in that it includes a frame structure for carrying artificial valve leaflets and a sealing mechanism covering the surface of the frame structure, wherein,

The sealing mechanism includes at least one layer of first seal with liquid absorption capability and at least one layer of second seal, the second seal is covered on the outer surface of the frame structure, and the first seal is covered On the outer surface of the second sealing member, the first sealing member has an expanded form after absorbing liquid.
The heart valve prosthesis device according to claim 1, wherein the frame structure includes a first frame portion attached to the native tissue, the first frame portion includes an inflow end and an outflow end at both ends, and Located in the middle section between the inflow end and the outflow end, the sealing mechanism is arranged in the middle section of the first frame part.
The heart valve prosthesis device according to claim 2, wherein the frame structure further includes a second frame part, the second frame part is coaxially arranged inside the first frame part, and the first frame part An annular gap is arranged between the frame part and the second frame part;

The annular gap is provided with a third sealing member, and the third sealing member closes the annular gap formed by the first frame part and the second frame part, thereby forming an annular space that allows blood to flow in and prevents thrombus from flowing out .
The heart valve prosthesis device according to claim 1, 2 or 3, wherein the sealing mechanism comprises a layer of the second sealing member, wherein the second sealing member is made of non-permeable material.
The heart valve prosthesis device according to claim 1, 2 or 3, characterized in that, the sealing mechanism comprises at least two layers of second sealing elements, and the two layers of second sealing elements are separately arranged on the sides of the first frame part. Outer and inner sides.
The heart valve prosthesis device according to claim 5, wherein the second sealing member is made of permeable material.
The heart valve prosthesis device according to claim 5, wherein at least one layer of the first sealing member is arranged between two adjacent layers of the second sealing member.
The heart valve prosthesis device according to claim 3, characterized in that, the surface of the third sealing member is provided with a polymer coating capable of absorbing liquid, and the polymer coating is provided on the third sealing member The side close to the outflow end of the first frame part.
The heart valve prosthesis device according to claim 8, wherein the polymer coating is made of a hydrophilic polymer material selected from the group consisting of polyethylene oxide, polyethylene Alcohol, polyacrylic acid, polypropylene fumarate-coethylene glycol and peptides, agarose, alginate, chitosan, collagen, fibrin, gelatin, hyaluronic acid, polyhydroxyethylmethacrylate, poly-2 - Hydroxyethyl methacrylate and their copolymers, polyvinylpyrrolidone, poly-N-vinylpyrrolidone hydrogel, poly-2-hydroxyethylmethacrylate/poly-N-vinylpyrrolidone copolymer, polyvinylpyrrolidone at least one of acrylamide.
The heart valve prosthesis device according to claim 9, wherein the polymer coating is formed by spraying, electrospinning or rolling.
The heart valve prosthesis device according to claim 1, 2 or 3, wherein the first sealing member is made of a hydrophilic polymer material selected from: polyethylene oxide Alkane, polyvinyl alcohol, polyacrylic acid, polypropylene fumaric acid-coethylene glycol and peptides, agarose, alginate, chitosan, collagen, fibrin, gelatin, hyaluronic acid, polyhydroxyethylmethacrylate , poly-2-hydroxyethyl methacrylate and their copolymers, polyvinylpyrrolidone, poly-N-vinylpyrrolidone hydrogel, poly-2-hydroxyethyl methacrylate/poly-N-vinylpyrrolidone At least one of copolymer and polyacrylamide.
The heart valve prosthesis device according to claim 11, wherein the first sealing member is a coating covering the surface of the second sealing member, and the coating is sprayed, electrospun or rolled way of shaping.