WO2022007384A1 - 用于人工心脏瓣膜的复合型裙边及人工心脏瓣膜 - Google Patents

用于人工心脏瓣膜的复合型裙边及人工心脏瓣膜 Download PDF

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Publication number
WO2022007384A1
WO2022007384A1 PCT/CN2021/072480 CN2021072480W WO2022007384A1 WO 2022007384 A1 WO2022007384 A1 WO 2022007384A1 CN 2021072480 W CN2021072480 W CN 2021072480W WO 2022007384 A1 WO2022007384 A1 WO 2022007384A1
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WIPO (PCT)
Prior art keywords
skirt
composite
heart valve
valve
stent
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PCT/CN2021/072480
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English (en)
French (fr)
Inventor
杨威
赵婧
魏鹂萱
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上海臻亿医疗科技有限公司
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Application filed by 上海臻亿医疗科技有限公司 filed Critical 上海臻亿医疗科技有限公司
Priority to EP21806111.7A priority Critical patent/EP3964178A4/en
Priority to US17/609,809 priority patent/US20220331095A1/en
Publication of WO2022007384A1 publication Critical patent/WO2022007384A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2469—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with resilient valve members, e.g. conical spiral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a skirt used for artificial heart valves.
  • the heart contains four chambers, the left atrium and left ventricle are located on the left side of the heart, and the right atrium and right ventricle are located on the right side of the heart.
  • the ventricular inflow tract is formed between the atrium and the ventricle, 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.
  • the mitral valve is located in the inflow tract of the left ventricle.
  • the main structure is the mitral valve complex, including the mitral valve annulus, valve leaflets, chordae tendineae, and papillary muscles.
  • Some literature also includes the ventricular wall.
  • the mitral valve annulus is the dense connective tissue surrounding the left atrioventricular orifice.
  • the anterior valve annulus is composed of part of the aortic valve annulus, part of the left coronary annulus, and left and right fibrous triangles located in the left ventricular outflow tract.
  • the posterior annulus is the attachment of the posterior leaflet.
  • the anterior leaflet of the mitral valve is a fibrous extension of the aortic valve, forming the left ventricular inflow tract with the posterior leaflet, and forming the left ventricular outflow tract corresponding to the cardiac septum.
  • the chordae tendineae of the mitral valve as a supporting device connecting the mitral valve leaflets and the myocardium, are distributed between the valve leaflets and the myocardium.
  • the subvalvular structure of the mitral valve plays an important role in maintaining the structure and function of the left heart.
  • the tricuspid valve is similar in structure to the mitral valve and also includes leaflets, annulus, chordae tendineae, papillary muscles and myocardium. Therefore, prosthetic heart valve structures that replace the native mitral valve can also be used to replace the native tricuspid valve.
  • the present invention provides a composite skirt for an artificial heart valve, which can solve the above-mentioned defects in the prior art.
  • a composite skirt for an artificial heart valve the valve support includes an inflow section, a transition section and an outflow section, and the composite skirt includes at least two of the following skirts: (1) arranged on the inflow section (2) the second skirt of the transition section, (3) the third skirt of the outflow section; wherein, the composite skirt is different according to the layout area, Configure different skirt parameters to adapt to the native tissue and reduce reflux.
  • the composite skirt can only include one of the first skirt, the second skirt, and the third skirt.
  • the parameters of the skirt should be set according to the layout area, and the parameters include the fracture extension of the skirt. rate, redundancy, penetration or skirt material, etc., to match the structure of the valve stent and improve the function of the heart valve.
  • two kinds of skirts or three kinds of skirts can also be included, and the skirts can be fixed to the valve stent by means of suturing, for example, the specific deployment area and deployment area should be set according to actual clinical needs.
  • the specific layout area should be selected according to the actual clinical needs, and the parameters of the corresponding skirt should be set, so that each skirt not only matches the function of the corresponding area, but also cooperates with each other to achieve synergy to reduce reflux. .
  • the elongation at break of the first skirt material is greater than 10%, or, when the first skirt is fixed, it is set to be greater than 10% of redundancy.
  • the first skirt has better elasticity and tensile properties, so as to cooperate with the flexible stent inflow section, it can better adapt to the tissue.
  • the second skirt is a single-layer structure, and the permeation amount of the second skirt material is less than 500 ml/cm 2 ⁇ min.
  • a single-layer structure requires a relatively low permeation material to reduce regurgitation in the valve transition region.
  • the second skirt is a double-layer structure
  • the penetration amount of the second skirt material is ⁇ 1500 ml/cm 2 ⁇ min.
  • the double-layer structure can reduce the gap between the valve and the tissue, and on the other hand, it can play the role of double-layer anti-reflux.
  • blood can penetrate into the double-layer structure to form microcapsules to reduce reflux.
  • the skirt of the double-layer structure needs to use a material with a relatively large amount of penetration.
  • the penetration amount of the second skirt material is greater than that of the third skirt material, and the penetration amount of the third skirt material is less than 500ml/cm 2 ⁇ min, can effectively reduce reflux.
  • the amount of penetration of the third skirt material is ⁇ 500 ml/cm 2 ⁇ min. Has the ability to reduce blood penetration, thereby reducing reflux.
  • the first skirt covers the atrial end of the stent inflow section in order to avoid injury to human tissue by sharp stent rods during implantation edge.
  • the composite skirt includes at least the third skirt, the third skirt covers the ventricular end edge of the outflow section of the stent. Both the atrial edge and the ventricular edge of the stent are wrapped by skirts to avoid tissue damage caused by the exposed stent.
  • the support when the valve support has an inner and outer double-layer structure, the support forms an annular area, and the composite skirt further includes a fourth skirt arranged in the annular area. It is made of anti-thrombotic material, allowing blood to flow into and out of the annular area, preventing the formation of thrombus in the annular area.
  • the material of the fourth skirt can be selected from: polyurethane-heparin graft copolymer, polyion complex, or a combination thereof.
  • the stent of the heart valve has an inner and outer double-layer structure
  • the stent forms an annular area
  • the annular area has a closed end
  • the composite skirt further includes a first Four skirts
  • the fourth skirt is arranged on the outer surface of the inner bracket, the inner surface of the outer bracket and above the closed end to form a closed skirt area
  • the material of the fourth skirt allows blood to enter The closed skirt area, but prevents the formed thrombus from leaving.
  • the fourth skirt can block and/or slow the flow of blood within the closed skirt region, reduce hemodynamic washout, and increase thrombus formation in the closed skirt region, block outflow of the thrombus, and form a canning seal, Further stabilization of the valve prosthesis.
  • the material of the fourth skirt can be selected from: knitted, woven, woven polyester fabric, PTFE, ePTFE, biological tissue material, or a combination thereof.
  • the present invention also provides an artificial heart valve comprising the composite skirt as described above.
  • the first skirt, the second skirt and the third skirt are set with different parameters according to the area where they are arranged, so as to match the structure of the valve support and improve the function of the heart valve;
  • the first skirt in the inflow area has good elasticity and tensile properties, so that it can better adapt to the tissue with the flexible stent inflow section;
  • the second skirt material and the third skirt material choose the corresponding infiltration amount, It can reduce reflux; when the permeability of the second skirt is greater than that of the third skirt, the reflux can be further reduced; when the valve stent is a double-layered structure, the fourth skirt is arranged to be an anti-thrombotic material. Can effectively reduce thrombus formation, or allow blood inflow but prevent thrombus outflow to form a canning seal.
  • Fig. 1 is the schematic diagram of the artificial heart valve in one embodiment of the present invention
  • Fig. 2 is the schematic diagram of the heart valve of the double-layer stent in one embodiment of the present invention
  • Figure 3 is another schematic view of a double-stent heart valve in one embodiment of the present invention.
  • valve prosthesis 100 stent 110; skirt 120; prosthetic leaflet 130; inflow region 101; transition region 102; outflow region 103; inflow section 111; transition section 112; ; second skirt B; third skirt C; fourth skirt D; prosthetic valve 200; valve support 210; valve skirt 220; valve inflow region 201; valve transition region 202; segment 211; valve transition segment 212; valve outflow segment 213; inner stent 2101; outer stent 2102.
  • the present invention provides a composite skirt for an artificial heart valve. Through the design of skirt materials in different regions of the valve prosthesis, it is used to solve the problem that the overall deformation ability of the inflow region is poor, and the transition region and the outflow region are easily formed. Flow problems, as well as the easy formation of thrombus between the dissections of the double-layer stent, etc., to improve the function of the heart valve.
  • the mitral valve prosthesis 100 is composed of three parts: a stent 110 , a skirt 120 and a prosthetic valve leaflet 130 , and can be longitudinally divided into an inflow area 101 , a transition area 102 and an outflow area 103 .
  • the inflow region 101 is attached to the native mitral valve annulus of the heart to prevent the prosthetic valve from falling into the left ventricle from the left atrium, and the transition region 102 is used to carry the artificial valve leaflets 130, At the same time, it is supported on the tissue by the anchoring force of the stent, and plays the role of anchoring and sealing.
  • the stent 110 is divided into an inflow section 111 , a transition section 112 and an outflow section 113 .
  • the stent can provide several functions for the heart valve prosthesis 100, including serving as a main structure, an anchoring structure (including an anchor structure to grasp the leaflets, or puncture into the leaflets, etc.), a support for carrying the inner prosthetic leaflet 130, It can be used as a sealing element for inhibiting the regurgitation of the mitral valve prosthesis 100, a connecting structure (a hanging ear or a fixed ear) with the delivery system, and the like.
  • the stent 110 can be made of Nitinol, titanium alloy, cobalt chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy, platinum chromium, or other biocompatible metals known to those skilled in the art Biocompatible metal frame or laser cut solid metal tube.
  • shape memory alloys optionally also including elastically or plastically deformable materials, such as balloon-expandable, or may be responsive to temperature changes to deliver between a contracted delivery state and an expanded deployed state inter-transformed shape memory alloys.
  • the stent 110 may also be constructed of braided wire or other suitable materials.
  • Prosthetic valve leaflets 130 are dynamically switched between open and closed states, and when the prosthetic leaflets 130 are in the closed state, the prosthetic leaflets 130 are tightened or converged in a sealed abutment manner.
  • Prosthetic valve leaflets 130 may be formed of any suitable material or combination of materials, and in some embodiments, biological tissue may be selected such as chemically stable tissue from a heart valve of an animal (eg, a pig), or pericardial tissue of an animal such as Bovine (bovine pericardium) or ovine (sheep pericardium) or porcine (porcine pericardium) or equine (horse pericardium), preferably bovine pericardium tissue; can also be made from small intestinal submucosal tissue.
  • prosthetic leaflets 130 may be made of synthetic material.
  • synthetic material for example, expanded polytetrafluoroethylene or polyester.
  • thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylenes are also included.
  • the prosthetic leaflets 130 may also be made of biocompatible polymers.
  • biocompatible polymers optionally include polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicone polyesters , siloxane polymers and/or oligomers, and/or polylactones, and block copolymers using them.
  • the leaflets 130 also have a surface treated with (or reacted with) an anticoagulant, including, but not limited to, heparinized polymers.
  • the bracket 110 is provided with a composite skirt, and the composite skirt can be a single-layer structure, arranged on the inner surface of the bracket 110, or arranged on the outer surface of the bracket 110; the skirt can also be a double-layer structure, and at the same time The skirt is arranged on the inner surface and the outer surface of the bracket 110 , or the skirt of the double-layer structure is directly arranged on the outer surface of the bracket 110 . Since different parts of the valve have different structural features and correspond to different functions, correspondingly, different skirt designs should be adopted to ensure the tightness of each skirt.
  • the first skirt needs to have a certain degree of ductility, which can be achieved through the selection of materials, or through the setting of structures, such as selecting a material with certain elasticity, or setting a certain amount of redundancy (such as folds).
  • the original intention of this design is: 1.
  • the tissue around the valve annulus of the patient is not a regular surface, and the heart valve is not necessarily a regular shape, so it is necessary to make the first skirt have a certain ductility, so that the inflow area of the heart valve can pass through
  • the first skirt fits closely with the tissue around the valve annulus as closely as possible to improve sealing; 2.
  • the structure of the heart valve may be slightly deformed, so the first skirt is required to have A certain ductility can prevent the valve from deforming, affecting the fit with the surrounding irregularly shaped tissue and thus affecting the sealing. 3.
  • the heart valve will be mass-produced and used as a standard part. Considering individual differences, the first skirt needs to have a certain extensibility to be suitable for different individuals;
  • the materials of the second skirt and the third skirt are selected according to the infiltration amount, so that the backflow is less than or equal to 25%; when the infiltration amount of the second skirt is greater than that of the third skirt, the backflow is further reduced.
  • the inflow region 101 of the mitral valve prosthesis 100 needs to conform well to the morphology of the native tissue. Therefore, the inflow area 101 is provided with a first skirt A, and the first skirt A needs to have good elasticity.
  • the first skirt A is located in the stent inflow section 111 and wraps the outer layer of the stent inflow section 111 .
  • the first skirt A is folded from the outer layer of the stent inflow section 111 to the inner layer of the stent inflow section 111 .
  • the skirt material of the first skirt A is the first skirt material.
  • the first skirt material requires better tensile properties.
  • the first skirt A cooperates with the flexible stent inflow section 111 to better adapt to the tissue.
  • the elongation at break of the first skirt material is greater than 10%, and the elongation at break is preferably between 10% and 400%. If the elongation at break is too small, it is difficult for the stent inflow section 111 to form a good fit with the native tissue. , When the elongation at break is too large, the material is easily deformed, resulting in the phenomenon of material accumulation.
  • the first skirt edge A can be designed with a redundancy greater than 10% to achieve an elastic function and better adapt to the tissue, such as using multi-layer folded sutures, etc. At this time, the first skirt edge material itself Elongation at break is not required.
  • the first skirt material can be knitted PET.
  • the transition region 102 of the mitral valve prosthesis 100 is prone to regurgitation.
  • the transition region is provided with a second skirt B, the second skirt B is wrapped around the stent transition section 112, and the second skirt B can effectively reduce regurgitation.
  • the skirt material of the second skirt B is the second skirt material, and the second skirt material can be selected from knitted, woven, woven polyester fabric, PTFE or ePTFE and other materials.
  • the second skirt B When the second skirt B is a single-layer structure, it can be covered on the inner surface or the outer surface of the transition section 112 of the stent, and the permeation amount of the second skirt material is ⁇ 500ml/cm 2 ⁇ min (permeation amount under the pressure of 100-140 mmHg) . This is because the second skirt B is a single-layer structure, so a material with a relatively low permeation amount is required to reduce backflow.
  • the second skirt B When the second skirt B is a double-layer structure, it can cover the inner surface and the outer surface of the bracket transition section 112 respectively, or the skirt of the double-layer structure covers the outer surface of the bracket transition section 112, then the second skirt is required to be
  • the permeation amount of the material is ⁇ 1500 ml/cm 2 ⁇ min (permeation amount under the pressure of 100-140 mmHg). This is because the inner and outer double-layer structure of the second skirt B, on the one hand, can reduce the gap between the valve and the tissue; In between, microcapsules are formed to reduce regurgitation. Therefore, compared with the single-layer skirt, when the other structures and materials of the valve are the same, the skirt of the double-layer structure needs to use a material with a relatively large amount of penetration.
  • the outflow region 103 of the mitral valve prosthesis 100 is prone to regurgitation, and the outflow region 103 is provided with a third skirt C, which can effectively prevent regurgitation.
  • the third skirt C wraps the outer layer of the stent outflow section 113, preferably, the third skirt C is further folded from the outer layer of the stent outflow section 113 to the inner layer of the stent outflow section 113 to form a double-layer structure.
  • the folded structure can prevent human tissue from being damaged by sharp stent rods.
  • the third skirt C can also be folded from the inner layer of the stent outflow section 113 to the outer layer.
  • the skirt material of the third skirt C is a third skirt material
  • the third skirt material requires a permeation amount ⁇ 500ml/cm 2 ⁇ min (permeation amount under a pressure of 100-140 mmHg), preferably, the first
  • the penetration amount of the three skirt materials is less than 300ml/cm 2 ⁇ min (permeation amount under the pressure of 100 ⁇ 140mmHg)
  • the third skirt material can be knitted, woven, woven polyester fabric, PTFE, ePTFE, biological tissue material etc., has the function of reducing blood penetration, thereby reducing reflux.
  • the portion of the support body of the prosthetic valve implanted in the mitral valve to carry the prosthetic leaflets needs to be larger in both circumferential diameter and axial height
  • the size of the prosthetic valve leads to the larger size of the prosthetic structure under the mitral valve after the prosthetic valve is implanted into the mitral valve, and there is a greater risk of damage to the subvalvular structure of the native valve assembly.
  • the prosthesis structure under the valve is too large, which will affect the ejection function of the aorta, resulting in obstruction of the left ventricular outflow tract.
  • the double-layer mitral valve prosthesis can distribute the artificial valve leaflets, anchoring, sealing and other functions to different single-layer valve components, so as not to affect the normal operation of other structures of the heart, but also to better play the role of implantation. the purpose of entering the therapeutic function.
  • the mitral valve prosthetic valve 200 is composed of three parts: a valve support 210, a valve skirt 220 and an artificial valve leaflet 130, wherein the valve support 210 is an inner and outer double-layer structure , including the inner support 2101 and the outer support 2102.
  • the longitudinal direction can be divided into a valve inflow area 201 , a valve transition area 202 and a valve outflow area 203 .
  • the subvalve height of the prosthetic valve in the axial direction is smaller than that of the traditional mitral valve prosthetic valve, and will not adversely affect the subvalve tissue.
  • the valve support 210 is divided into a valve inflow section 211 , a valve transition section 212 and a valve outflow section 213 .
  • the inner and outer double layers of the valve stent 210 can provide different functions for the prosthetic valve 200 .
  • the inner stent 2101 is a support that carries the inner artificial valve leaflet 130, and the outer stent 2102 can be used as an anchoring structure (including an anchor claw structure to grab the valve leaflet, or pierce the valve leaflet, etc.) Backflow seals, as well as the connection structure with the delivery system (hanging lugs or fixed lugs), etc.
  • An annular area 240 is formed between the inner bracket 2101 and the outer bracket 2102 .
  • blood from the atria can flow into and out of the annular region 240 between the inner stent 2101 and the outer stent 2102 .
  • Blood can clot to form thrombus, which can be transported through the flow of blood during the heart's circulatory pumping, causing vascular blockage, and in severe cases, cerebral thrombosis, which can even be life-threatening.
  • the outer surface of the outer bracket 2102 is respectively provided with a first skirt A, a second skirt B and a third skirt C, and the composite skirt also includes a In the fourth skirt edge D of the annular region 240, the fourth skirt edge D is made of antithrombotic skirt edge material.
  • the fourth skirt D is attached to the outer layer of the inner bracket 2101 and the inner layer of the outer bracket 2102.
  • the skirt material of the fourth skirt D has an antithrombotic function, and can be selected from polyurethane-heparin graft copolymer, polyion complex, etc. , preferably, the skirt material of the fourth skirt D is a polyurethane-heparin graft copolymer.
  • annular region 240 of the inner and outer stents are used for different types of bilayer valves.
  • the annular region 240 filled with a large number of thrombi can be used to seal the inner structure of the valve prosthesis (including the inner stent and its skirt, and artificial valve leaflets) to further stabilize the valve prosthesis.
  • FIG. 3 if the annular region 240 is a closed structure, this type of valve uses a skirt to block the outflow of thrombus to control the risk, which is different from the aforementioned anti-thrombotic mechanism.
  • the ventricular end of the valve stent 210 is a closed end 250
  • the annular region 240 is provided with a fourth skirt D
  • the fourth skirt D is attached to the outer layer of the inner stent 2101 , the inner layer of the outer stent 2102 and the closed end 250
  • the annular area 240 is completely closed to form a closed skirt area E.
  • the fourth skirt D adopts a D2 type skirt material.
  • the D2 type skirt material should be able to block and/or slow down the flow of blood in the skirt area E, reduce the hemodynamic washout, and increase the flow rate in the skirt area E. thrombus formed.
  • a D2 type of skirt material allows blood (including red blood cells in particular) to enter the closed skirt region E, but prevents large thrombi from leaving this region.
  • the D2 material is knitted, woven, woven polyester fabric, PTFE, ePTFE, etc.
  • skirt materials of the first skirt edge A, the second skirt edge B, the third skirt edge C and the fourth skirt edge D can be the same raw material and are prepared by different technological means, or they can be Prepared from different raw materials.
  • the above-mentioned composite skirt is also suitable for tricuspid valve, pulmonary valve and aortic valve, and the skirt material can be adjusted adaptively according to the specific structure and implantation position.
  • a range represented by "one numerical value to another numerical value” is a general expression that avoids listing all the numerical values in the range in the specification. Therefore, the recitation of a specific numerical range includes any numerical value within the numerical range and a smaller numerical range defined by any numerical value within the numerical range, as if the arbitrary numerical value and the smaller numerical value were expressly written in the specification. same range.
  • valve In the description of the present invention, it should be noted that “valve”, “valve prosthesis”, “prosthetic valve” and “artificial heart valve” have the same meaning.
  • brackets used in the following embodiments are all single-layer brackets, the second skirt is arranged in the transition section, and the third skirt is arranged in the outflow section.
  • both the second skirt and the third skirt use PET as a raw material, and different penetration amounts are produced by different technological means.
  • This embodiment provides a composite skirt, which includes a second skirt and a third skirt.
  • the penetration amount of the second skirt material is denoted as B'
  • the penetration amount of the third skirt material is denoted as C'.
  • the skirt is connected to the stent for testing.
  • the second skirt and the third skirt are both single-layer structures, which are respectively fixed on the outer surface of the stent.
  • the permeation amount B' of the second skirt material is preferably ⁇ 500 ml/cm 2 ⁇ min.
  • This embodiment provides a composite skirt, which includes a second skirt and a third skirt.
  • the penetration amount of the second skirt material is denoted as B'
  • the penetration amount of the third skirt material is denoted as C'.
  • the skirt is connected to the bracket for testing, wherein the second skirt is a double-layer structure and is fixed on the inner and outer surfaces of the transition section of the bracket, and the third skirt is a single-layer structure and is fixed on the outer surface of the bracket.
  • the method of Example 1 was used to carry out the reflux test, and the results are shown in Table 2.
  • the permeation amount B' of the second skirt material is preferably ⁇ 1500 ml/cm 2 ⁇ min.
  • This embodiment provides a composite skirt, which includes a second skirt and a third skirt.
  • the penetration amount of the second skirt material is denoted as B'
  • the penetration amount of the third skirt material is denoted as C'.
  • the skirt is connected to the bracket for testing.
  • the second skirt and the third skirt are both single-layer structures, which are respectively fixed on the outer surface of the bracket.
  • the method of Example 1 is used for the backflow test. The results are shown in Table 3.
  • the penetration amount C' of the third skirt material is preferably ⁇ 500 ml/cm 2 ⁇ min, and more preferably, C' ⁇ 300 ml/cm 2 ⁇ min.
  • This embodiment provides a composite skirt, which includes a second skirt and a third skirt.
  • the penetration amount of the second skirt material is denoted as B'
  • the penetration amount of the third skirt material is denoted as C'.
  • the skirt is connected to the bracket for testing, the second skirt is a double-layer structure and is fixed on the inner and outer surfaces of the bracket, and the third skirt is a single-layer structure and is fixed on the outer surface of the bracket.
  • the method of Example 1 was used to carry out the reflux test, and the results are shown in Table 4.
  • the penetration amount C' of the third skirt material is preferably ⁇ 500 ml/cm 2 ⁇ min, and more preferably, C' ⁇ 300 ml/cm 2 ⁇ min.
  • This embodiment provides a composite skirt, which includes a second skirt and a third skirt.
  • the penetration amount of the second skirt material is denoted as B'
  • the penetration amount of the third skirt material is denoted as C'.
  • the skirt is connected to the bracket for testing.
  • the second skirt and the third skirt are both single-layer structures and are respectively fixed on the outer surface of the bracket.
  • the method of Example 1 is used to carry out the reverse flow test. The results are shown in Table 5.
  • This embodiment provides a composite skirt, which includes a second skirt and a third skirt.
  • the penetration amount of the second skirt material is denoted as B'
  • the penetration amount of the third skirt material is denoted as C'.
  • the skirt is connected to the bracket for testing, the second skirt is a double-layer structure and is fixed on the inner and outer surfaces of the bracket, and the third skirt is a single-layer structure and is fixed on the outer surface of the bracket.
  • the method of Example 1 was used to carry out the reflux test, and the results are shown in Table 6.
  • Step1 Fix the test material between the upper and lower hollow cylinders
  • Step2 Apply a certain fluid pressure to one end of the hollow cylinder, and record the penetration of the other end of the test material within a certain period of time.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种用于人工心脏瓣膜（100，200）的复合型裙边，瓣膜支架（110，210）包括流入段（111，211）、过渡段（112，212）和流出段（113，213），复合型裙边包括以下裙边中的至少两种：（1）布设于流入段（111，211）的第一裙边（A），（2）布设于过渡段（112，212）的第二裙边（B），（3）布设于流出段（113，213）的第三裙边（C）；其中，复合型裙边根据布设的区域不同，配置不同的裙边参量，以适应原生组织、减少反流。复合型裙边，针对瓣膜（100，200）不同区域的功能不同，设置不同区域的裙边参量，以配合瓣膜支架（110，210）的结构，从而提升人工心脏瓣膜（100，200）的功能。

Description

用于人工心脏瓣膜的复合型裙边及人工心脏瓣膜 技术领域
本发明涉及医疗器械技术领域，尤其涉及到用于人工心脏瓣膜的裙边。
背景技术
心脏含有四个心腔，左心房与左心室位于心脏左侧，右心房与右心室位于心脏右侧。心房与心室间形成心室流入道，左心室与主动脉形成左室流出道，右心室与肺动脉形成右室流出道。在室流入道和室流出道处存在具有“单向阀”功能的瓣膜，保证心腔内血液的正常流动。当该瓣膜出现问题时，心脏血液动力学改变，心脏功能异常，称为瓣膜性心脏病。
随着社会经济的发展和人口的老龄化，瓣膜性心脏病的发病率明显增加，研究表明75岁以上的老年人群瓣膜性心脏病发病率高达13.3％。目前，采用传统外科手术治疗仍是重度瓣膜病变患者的首选治疗手段，但是对于高龄、合并多器官疾病、有开胸手术史以及心功能较差的患者来说，传统外科手术的风险大、死亡率高，部分患者甚至没有手术的机会。经导管二尖瓣的置换/修复术具有无需开胸、创伤小、患者恢复快等优点，受到了专家学者的广泛关注。
二尖瓣位于左心室流入道，主要结构为二尖瓣复合体，包括二尖瓣瓣环、瓣叶、腱索和***肌，部分文献中也包含心室壁。二尖瓣瓣环是左心房室口周围的致密***，其前瓣环是由位于左室流出道的主动脉瓣的部分无冠瓣环、部分左冠瓣环以及左、右纤维三角组成，后瓣环是后叶附着部。二尖瓣前瓣叶是主动脉瓣的纤维延伸，与后瓣叶形成左室流入道，与心间隔对应形成左室流出道。二尖瓣的腱索作为连接二尖瓣瓣叶与心肌的支撑装置，分布在瓣叶与心肌之间，二尖瓣的瓣下结构对维持左心结构及功能起着重要作用。三尖瓣作为右心脏的房室瓣，其结构与二尖瓣类似，也包含瓣叶、瓣环、腱索、***肌及心肌。因此替换原生二尖瓣的心脏瓣膜假体结构也可以应用 于代替原生三尖瓣。
近些年，二尖瓣/三尖瓣瓣膜领域发展迅速，但是依然存在一些亟待解决的难题，比如，流入区域整体形变能力较差，不能很好地适应原生组织的形态；过渡区域和流出区域上容易形成反流；以及双层支架的夹层之间容易形成血栓等等。
发明内容
本发明提供了一种用于人工心脏瓣膜的复合型裙边，可以解决现有技术中的上述缺陷。
本发明的技术方案如下：
一种用于人工心脏瓣膜的复合型裙边，瓣膜支架包括流入段、过渡段和流出段，所述复合型裙边包括以下裙边中的至少两种：(1)布设于所述流入段的第一裙边，(2)布设于所述过渡段的第二裙边，(3)布设于所述流出段的第三裙边；其中，所述复合型裙边根据布设的区域不同，配置不同的裙边参量，以适应原生组织、减少反流。
其中，复合型裙边可以仅包括第一裙边、第二裙边、第三裙边中的一种，此时，应根据布设区域设置裙边的参量，所述参量包括裙边的断裂延伸率、冗余量、渗透量或裙边材料等，以配合瓣膜支架的结构，提升心脏瓣膜的功能。当然，还可以包括两种裙边或三种，裙边可以通过如缝合的方式固定至瓣膜支架，具体的布设区域、布设面积，应根据实际的临床需求进行设置。
应根据实际的临床需求选择具体的布设区域，以及设置相应裙边的参量，使得每一裙边既配合对应区域的功能，同时多个裙边之间相互配合，实现协同作用，以减少反流。
较佳的，当所述复合型裙边至少包括所述第一裙边时，所述第一裙边材料的断裂延伸率＞10％，或，所述第一裙边固定时设置大于10％的冗余量。第一裙边具有较好的弹性和拉伸性能，从而配合柔顺的支架流入段，能够与组织更好的适应。
较佳的，当所述复合型裙边至少包括所述第二裙边时，所述第二裙边为单层结构，所述第二裙边材料的渗透量＜500ml/cm 2·min。单层结构时需要渗透量相对较低的材料，来减少瓣膜过渡区域的反流。
较佳的，当所述复合型裙边至少包括所述第二裙边时，所述第二裙边为双层结构，所述第二裙边材料的渗透量＜1500ml/cm 2·min。双层结构一方面可以减少瓣膜与组织的间隙，另一方面可以起到双层防反流的作用，同时血液可以渗透到双层结构之间，形成微囊体，来减少反流，故相对于单层裙边，在瓣膜其它结构和材料相同的情况下，双层结构的裙边需要选用渗透量相对较大的材料。
较佳的，还包括所述第三裙边，所述第二裙边材料的渗透量大于所述第三裙边材料的渗透量，且所述第三裙边材料的渗透量＜500ml/cm 2·min，能有效减少反流。
较佳的，当所述复合型裙边至少包括所述第三裙边时，所述第三裙边材料的渗透量＜500ml/cm 2·min。具有减少血液渗透的功能，从而减少反流。
当所述复合型裙边至少包括所述第一裙边时，在植入过程中，为了避免人体组织被尖锐的支架杆损伤，所述第一裙边包覆所述支架流入段的心房端边缘。或，当所述复合型裙边至少包括所述第三裙边时，所述第三裙边包覆所述支架流出段的心室端边缘。支架的心房端边缘和心室端边缘均由裙边包裹，避免裸露的支架对组织造成损伤。
较佳的，当所述瓣膜支架为内外双层结构时，所述支架形成一环形区域，所述复合型裙边还包括布设于所述环形区域的第四裙边，所述第四裙边采用抗血栓的材料制成，使血液流入以及流出所述环形区域，防止所述环形区域形成血栓。具体的，第四裙边的材料可以选择：聚氨酯—肝素接枝共聚物、聚离子络合物，或其组合。
较佳的，当心脏瓣膜的支架为内外双层结构时，所述支架形成一环形区域，沿所述心脏瓣膜轴向，所述环形区域具有一封闭端，所述复合型裙边还包括第四裙边，所述第四裙边布设于内支架的外表面、外支架的内表面及所述封闭端的上方，以形成一封闭的裙边区域，所述第四裙边的材料允许血液 进入所述封闭的裙边区域，但阻止形成的血栓离开。第四裙边可以阻拦和/或减慢封闭的裙边区域内的血液的流动，减小血液动力冲刷，并且增加在封闭的裙边区域中形成的血栓，阻挡血栓的流出，形成罐封，进一步稳定瓣膜假体。
具体的，第四裙边的材料可以选择：针织、梭织、编织的聚酯织物，PTFE，ePTFE，生物组织材料，或其组合。
本发明还提供了一种包含如上任一所述复合型裙边的人工心脏瓣膜。
与现有技术相比，本发明的有益效果如下：
本发明的复合型裙边，第一裙边、第二裙边、第三裙边根据所布设的区域，设置不同的参量，以配合瓣膜支架的结构，提升心脏瓣膜的功能；其中，布设在流入区域的第一裙边具有较好的弹性及拉伸性能，从而配合柔顺的支架流入段，能够与组织更好的适应；第二裙边材料、第三裙边材料选择对应的渗透量，能够减少反流；当第二裙边的渗透量大于第三裙边的渗透量时，进一步减少反流；瓣膜支架为内外双层结构时，通过布设第四裙边，设置为抗血栓材料时能够有效减少血栓形成，或允许血液流入但阻止血栓流出以形成罐封。
当然，实施本发明的任一产品并不一定需要同时达到以上所述的所有优点。
附图说明
图1是本发明一个实施方式中人工心脏瓣膜的示意图；
图2是本发明一个实施方式中双层支架的心脏瓣膜的示意图；
图3是本发明一个实施方式中双层支架的心脏瓣膜的另一示意图。
附图标记：瓣膜假体100；支架110；裙边120；人工瓣叶130；流入区域101；过渡区域102；流出区域103；流入段111；过渡段112；流出段113；第一裙边A；第二裙边B；第三裙边C；第四裙边D；假体瓣膜200；瓣膜支架210；瓣膜裙边220；瓣膜流入区域201；瓣膜过渡区域202；瓣膜流出区 域203；瓣膜流入段211；瓣膜过渡段212；瓣膜流出段213；内支架2101；外支架2102。
具体实施方式
本发明提供一种用于人工心脏瓣膜的复合型裙边，通过在瓣膜假体的不同区域裙边材料的设计，用以解决流入区域整体形变能力较差、过渡区域和流出区域上容易形成反流的问题，以及双层支架的夹层之间容易形成血栓等等问题，以提高心脏瓣膜的功能。
以下以二尖瓣瓣膜假体为例，阐述本发明的复合型裙边：
如图1所示，该二尖瓣瓣膜假体100由支架110、裙边120和人工瓣叶130三部分组成，纵向可分为流入区域101、过渡区域102和流出区域103。二尖瓣瓣膜假体100植入人体后，流入区域101贴附在心脏原生二尖瓣瓣环上，防止假体瓣膜从左心房坠入左心室，过渡区域102用于承载人工瓣叶130，同时依靠支架的锚固力支撑在组织上，起到锚固和密封的作用。
与瓣膜假体100相对应地，支架110分为流入段111、过渡段112和流出段113。支架能够为心脏瓣膜假体100提供若干功能，包括用作主体结构、锚固结构(包含锚爪结构抓取瓣叶、或者刺扎入瓣叶等)、承载内部人工瓣叶130的支撑件、用作抑制二尖瓣瓣膜假体100反流的密封件、与输送***的连接结构(挂耳或者固定耳)等等。
其中，支架110可以采用如镍钛诺、钛合金、钴铬合金、MP35n、316不锈钢、L605、Phynox/Elgiloy、铂铬，或如本领域技术人员已知的其它生物相容性金属制成的生物相容性金属框架或激光切割的固体金属管。优选地，采用形状记忆合金制备而成，可选地，也包括可弹性或可塑性变形的材料，如球囊可扩张的，或者可以是响应温度变化以在收缩的递送状态和扩张的展开状态之间转变的形状记忆合金。可选地，支架110也可以由编织线或其它合适的材料构造。
人工瓣叶130在打开和闭合两种状态间动态切换，人工瓣叶130在所述 闭合状态时，人工瓣叶130以密封抵接的方式合紧或会合。人工瓣叶130可以由任意合适的材料或材料的组合形成，在一些实施方式中，可选择生物组织例如来自动物(如猪)的心脏瓣膜的化学性稳定的组织，或者是动物的心包组织例如牛(牛心包)或羊(羊心包)或猪(猪心包)或马(马心包)，优选牛心包组织；也可以由小肠粘膜下组织制成。
在一些实施方式中，人工瓣叶130可以由合成材料制成。例如，膨体聚四氟乙烯或聚酯。可选地，还包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、分段聚醚聚氨酯、有机硅聚醚聚氨酯、有机硅-聚碳酸酯聚氨酯，以及超高分子量聚乙烯。
在一些实施方式中，人工瓣叶130还可以由生物相容的聚合物制成。其中，生物相容的聚合物可选地包括聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯基吡咯烷酮、聚氯乙烯、其它的含氟聚合物、有机硅聚酯、硅氧烷聚合物和/或低聚物、和/或聚内酯、以及使用它们的嵌段共聚物。
在一些实施方式中，瓣叶130还具有经抗凝剂进行处理(或与之反应)的表面，所述抗凝剂包括但不限于肝素化聚合物。
支架110布设有复合型裙边，所述复合型裙边可以为单层结构，布设在支架110的内表面，或者布设在支架110的外表面；所述裙边也可以为双层结构，同时布设在支架110的内表面以及外表面，或者双层结构的裙边直接布设在支架110的外表面。由于瓣膜的不同部位有不同的结构特征，对应不同的功能，因此相对应地，应采用不同的裙边设计，确保各裙边的密封性。
具体的，第一裙边需要具有一定的延展性，可以通过材料的选择实现，或通过结构的设置实现，如选择具有一定弹性的材料，或者设置一定的冗余量(比如褶皱)。这样设计的初衷是：1.患者瓣环周围的组织并不是规则的表面，心脏瓣膜也不一定是规则的形状，因而需要使第一裙边具有一定的延展性，使心脏瓣膜的流入区域通过第一裙边与瓣环周围的组织尽量贴合紧密，提高密封性；2.在心脏的活动(收缩或扩张)过程中，心脏瓣膜的结构可能会产生微形变，因而需要第一裙边具有一定的延展性，防止瓣膜产生形变时，影响与周围不规则形状组织的贴合性进而影响密封性。3.心脏瓣膜会进行批量 生产，作为标准件使用，考虑到个体差异性，需要第一裙边具有一定的延展性，以适用于不同的个体；
第二裙边、第三裙边材料通过渗透量选择，使反流≤25％；当第二裙边的渗透量大于第三裙边的渗透量时，进一步减少反流。
二尖瓣瓣膜假体100的流入区域101需要很好地适应原生组织的形态。所以流入区域101布设有第一裙边A，第一裙边A需要有较好的弹性。第一裙边A位于支架流入段111，包裹支架流入段111的外层，优选地，第一裙边A自支架流入段111的外层翻折到支架流入段111的内层。第一裙边A的裙边材料为第一裙边材料，第一裙边材料要求更好的拉伸性能，第一裙边A配合柔顺的支架流入段111，能够与组织更好的适应。在一个实施方式中，第一裙边材料的断裂延伸率＞10％，优选断裂延伸率在10％～400％，断裂延伸率太小时，支架流入段111难以与原生组织之间形成良好的适应，断裂延伸率太大时，材料容易变形，造成材料堆积的现象。
在一些实施方式中，第一裙边A可设计大于10％的冗余量来实现弹性功能，与组织更好的适应，如采用多层折叠缝合等，此时对第一裙边材料本身的断裂延伸率不做要求。其中第一裙边材料可以选择针织PET。
二尖瓣瓣膜假体100的过渡区域102容易发生反流，过渡区域布设有第二裙边B，第二裙边B包裹在支架过渡段112，第二裙边B能够有效减少反流。第二裙边B的裙边材料为第二裙边材料，第二裙边材料可以选择针织、梭织、编织的聚酯织物、PTFE或ePTFE等材料。
当第二裙边B为单层结构时，可覆盖在支架过渡段112内表面或外表面，第二裙边材料的渗透量＜500ml/cm 2·min(100～140mmHg压力下的渗透量)。这是因为第二裙边B为单层结构，因此需要渗透量相对较低的材料，来减少反流。
当第二裙边B为双层结构时，可分别覆盖在支架过渡段112内表面和外表面，或者双层结构的裙边覆盖在支架过渡段112的外表面，则要求在第二裙边材料的渗透量＜1500ml/cm 2·min(在100～140mmHg压力下的渗透量)。这是因为第二裙边B的内外双层结构，一方面可以减少瓣膜与组织的间隙， 另一方面，双层结构可以起到双层防反流的作用，同时血液可以渗透到双层结构之间，形成微囊体，来减少反流，故相对于单层裙边，在瓣膜其它结构和材料相同的情况下，双层结构的裙边需要选用渗透量相对较大的材料。
二尖瓣瓣膜假体100的流出区域103容易产生反流，流出区域103布设有第三裙边C，可以有效防止反流。第三裙边C包裹在支架流出段113的外层，优选地，第三裙边C进一步从支架流出段113的外层翻折到支架流出段113的内层，形成双层结构。在支架植入过程中，翻折结构可以避免人体组织被尖锐的支架杆损伤。当然，在其他实施方式中，第三裙边C也可以自支架流出段113的内层翻折至外层。
具体地，第三裙边C的裙边材料为第三裙边材料，第三裙边材料要求渗透量＜500ml/cm 2·min(在100～140mmHg压力下的渗透量)，优选地，第三裙边材料渗透量＜300ml/cm 2·min(在100～140mmHg压力下的渗透量)，第三裙边材料可为针织、梭织、编织的聚酯织物、PTFE、ePTFE、生物组织材料等，具有减少血液渗透的功能，从而减少反流。
由于解剖学上二尖瓣的瓣环尺寸较大，植入二尖瓣的假体瓣膜的支撑主体中用以承载人工瓣叶的部分无论在周向直径还是轴向高度上均需要更大的尺寸，导致假体瓣膜植入二尖瓣后其瓣下的假体结构尺寸较大，对原生瓣膜组合体的瓣下结构存在较大的损伤风险。同时瓣下的假体结构过大，会影响主动脉的射血功能，导致左室流出道阻塞。对于部分二尖瓣反流患者，其瓣膜上无钙化部分，无法采用现有的利用假体瓣膜与原生瓣膜间产生的径向支撑力来防止假体瓣膜移位的工作原理，所以双层支架的瓣膜假体治疗效果更佳。双层二尖瓣瓣膜假体可将承载人工瓣叶和承担锚固、密封等作用分配到不同的单层瓣膜构件上，从而达到既不影响心脏其他结构的正常运转，又能较好的发挥植入治疗功能的目的。
参见图2，为另一二尖瓣假体瓣膜，该二尖瓣假体瓣膜200由瓣膜支架210、瓣膜裙边220和人工瓣叶130三部分组成，其中，瓣膜支架210为内外双层结构，包括内支架2101和外支架2102。纵向可分为瓣膜流入区域201、瓣膜过渡区域202和瓣膜流出区域203。该假体瓣膜在轴向上的瓣下高度较传 统二尖瓣假体瓣膜小，不会对瓣下组织产生不良影响。
与假体瓣膜200相对应地，瓣膜支架210分为瓣膜流入段211、瓣膜过渡段212和瓣膜流出段213。瓣膜支架210的内外双层结构能够为假体瓣膜200提供不同功能。内支架2101是承载内部人工瓣叶130的支撑件，外支架2102可以作为锚固结构(包含锚爪结构抓取瓣叶、或者刺扎入瓣叶等)、用作抑制二尖瓣假体瓣膜200反流的密封件，以及与输送***的连接结构(挂耳或者固定耳)等等。内支架2101和外支架2102之间形成一个环形区域240。当假体瓣膜200放置于人体心脏瓣膜的瓣环中时，来自心房的血液能够流入和流出内支架2101和外支架2102之间的环形区域240。血液能够凝结形成血栓，血栓能够在心脏的循环泵送期间通过血液的流动而被输送，造成血管阻塞，严重时会造成脑血栓，甚至危及生命。
因此，在一个实施方式中，自流入区域至流出区域，外支架2102的外表面分别布设有第一裙边A、第二裙边B和第三裙边C，该复合型裙边还包括布设在所述环形区域240的第四裙边D，第四裙边D采用抗血栓类裙边材料。第四裙边D附着在内支架2101外层和外支架2102内层，第四裙边D的裙边材料具有抗血栓的功能，可选聚氨酯—肝素接枝共聚物、聚离子络合物等，优选地，第四裙边D的裙边材料为聚氨酯—肝素接枝共聚物。
对于不同类型的双层瓣膜，内外层支架的环形区域240采用不同的裙边材料。有研究表明，大量血栓填充的环形区域240能够用作对瓣膜假体内层结构(包括内层支架及其裙边、人工瓣叶)的罐封，进一步稳定瓣膜假体。如图3所示，如果环形区域240为封闭结构，此类瓣膜是通过裙边阻挡血栓的流出来控制风险，与前述的抗血栓的机理不同。
如图3所示，瓣膜支架210心室端为一封闭端250，环形区域240布设有第四裙边D，第四裙边D附着在内支架2101外层、外支架2102内层以及封闭端250上方，将环形区域240全部封闭，形成封闭的裙边区域E。第四裙边D采用D2类的裙边材料，D2类的裙边材料应当可以阻拦和/或减慢裙边区域E内的血液的流动，减小血液动力冲刷，并且增加在裙边区域E中形成的血栓。具体地，D2类的裙边材料允许血液(特别地包括红血细胞)进入封闭的裙 边区域E，但是阻止大血栓离开此区域。所述D2材料为针织、梭织、编织的聚酯织物，PTFE，ePTFE等。
如本文所述的，第一裙边A、第二裙边B、第三裙边C和第四裙边D的裙边材料可以为相同的原材料，采用不同的工艺手段制备而成，也可以为不同的原材料制备而成。
如本文所述的，上述的复合型裙边同样适用于三尖瓣膜、肺动脉瓣膜及主动脉瓣膜，可以根据具体的结构以及植入位置，对裙边材料做出适应性的调整。
在本发明的描述中，由「一数值至另一数值」表示的范围，是一种避免在说明书中一一列举该范围中的所有数值的概要性表示方式。因此，某一特定数值范围的记载，涵盖该数值范围内的任意数值以及由该数值范围内的任意数值界定出的较小数值范围，如同在说明书中明文写出该任意数值和该较小数值范围一样。
在本发明的描述中，需要说明的是，“瓣膜”、“瓣膜假体”、“假体瓣膜”以及“人工心脏瓣膜”具有相同的含义。
在本发明的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本发明的描述中，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
下面结合具体实施例，进一步阐述本发明。
需要说明的是，以下实施例中所采用的支架均为单层支架，第二裙边布设在过渡段，第三裙边布设在流出段。以下实施例中，第二裙边和第三裙边 均采用PET作为原材料，不同的渗透量由不同的工艺手段而产生。
实施例1
本实施例提供一种复合型裙边，包括第二裙边和第三裙边，第二裙边材料的渗透量记为B’，第三裙边材料的渗透量记为C’。
裙边连接在支架上进行测试，第二裙边和第三裙边均为单层结构，分别固定在支架的外表面，利用MPD-1000体外测试仪器(苏州心瓣测试设备有限公司)，按照YY1449.3-2016方法，在心率＝70次/min，模拟心输出量＝5.0L/min，平均主动脉压力＝100mmHg，心脏收缩百分比＝35％，进行反流测试，测试结果按照YY1449.3-2016标准(反流≤25％)接受；结果如表1所示。
表1第二裙边、第三裙边的裙边材料对瓣膜反流的影响
Figure PCTCN2021072480-appb-000001
从表1可知，第三裙边材料的渗透量C’保持不变时，第二裙边材料的渗透量B’增大至520ml/cm 2·min时，瓣膜反流超过25％，不满足标准。因此，当第二裙边为单层结构时，第二裙边材料的渗透量B’优选<500ml/cm 2·min。
实施例2
本实施例提供一种复合型裙边，包括第二裙边和第三裙边，第二裙边材料的渗透量记为B’，第三裙边材料的渗透量记为C’。
裙边连接在支架上进行测试，其中，第二裙边为双层结构，固定在支架过渡段的内表面和外表面，第三裙边为单层结构固定在支架外表面。采用实施例1的方法进行反流测试，结果如表2所示。
表2第二裙边、第三裙边的裙边材料对瓣膜反流的影响
Figure PCTCN2021072480-appb-000002
从表2可知，当C’保持不变时，逐渐增大B’至1550时，瓣膜反流超过25％，不满足标准。因此，当第二裙边为双层结构，第二裙边材料的渗透量B’优选<1500ml/cm 2·min。
实施例3
本实施例提供一种复合型裙边，包括第二裙边和第三裙边，第二裙边材料的渗透量记为B’，第三裙边材料的渗透量记为C’。
裙边连接在支架上进行测试，第二裙边、第三裙边均为单层结构，分别固定在支架外表面，采用实施例1的方法进行反流测试，结果如表3所示。
表3第二裙边的裙边材料不变下，第三裙边对瓣膜反流的影响
Figure PCTCN2021072480-appb-000003
从表3可知，第二裙边材料的渗透量B’保持不变，逐渐增大C’至520 时，瓣膜反流超过25％，不满足标准。因此，第三裙边材料的渗透量C’优选<500ml/cm 2·min，进一步优选的，C’<300ml/cm 2·min。
实施例4
本实施例提供一种复合型裙边，包括第二裙边和第三裙边，第二裙边材料的渗透量记为B’，第三裙边材料的渗透量记为C’。
裙边连接在支架上进行测试，第二裙边为双层结构，固定在支架内表面和外表面，第三裙边为单层结构，固定在支架外表面。采用实施例1的方法进行反流测试，结果如表4所示。
表4第二裙边的裙边材料不变下，第三裙边对瓣膜反流的影响
Figure PCTCN2021072480-appb-000004
从表4可知，第二裙边材料的渗透量B’保持不变，逐渐增大C’至520时，瓣膜反流超过25％，不满足标准。因此，第三裙边材料的渗透量C’优选<500ml/cm 2·min，进一步优选的，C’<300ml/cm 2·min。
实施例5
本实施例提供一种复合型裙边，包括第二裙边和第三裙边，第二裙边材料的渗透量记为B’，第三裙边材料的渗透量记为C’。
裙边连接在支架上进行测试，第二裙边、第三裙边均为单层结构，分别固定在支架外表面，采用实施例1的方法进行反流测试，结果如表5所示。
表5第二裙边、第三裙边的裙边材料对瓣膜反流的影响
Figure PCTCN2021072480-appb-000005
从表5可知，当第二裙边材料渗透量B’>第三裙边材料渗透量C’时，能够有效降低反流。
实施例6
本实施例提供一种复合型裙边，包括第二裙边和第三裙边，第二裙边材料的渗透量记为B’，第三裙边材料的渗透量记为C’。
裙边连接在支架上进行测试，第二裙边为双层结构，固定在支架内表面和外表面，第三裙边为单层结构，固定在支架外表面。采用实施例1的方法进行反流测试，结果如表6所示。
表6第二裙边、第三裙边的裙边材料对瓣膜反流的影响
Figure PCTCN2021072480-appb-000006
从表6可知，当第二裙边材料渗透量B’>第三裙边材料渗透量C’时，能够有效降低反流。
渗透量的测试方法：
Step1：将测试材料固定在上下两空心圆柱之间；
Step2：对向空心圆柱一端施加一定流体压力，记录通过一定时间内测试材料另一端的渗透量。
以上公开的仅为本发明优选实施例。优选实施例并没有详尽叙述所有的细节，也不限制该发明仅为所述的具体实施方式。显然，根据本说明书的内容，可作很多的修改和变化。本说明书选取并具体描述这些实施例，是为了更好地解释本发明的原理和实际应用，从而使所属领域技术人员能很好地利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。

Claims (12)

  1. 用于人工心脏瓣膜的复合型裙边，其特征在于，瓣膜支架包括流入段、过渡段和流出段，所述复合型裙边包括以下裙边中的至少两种：(1)布设于所述流入段的第一裙边，(2)布设于所述过渡段的第二裙边，(3)布设于所述流出段的第三裙边；其中，所述复合型裙边根据布设的区域不同，配置不同的裙边参量，以适应原生组织、减少反流。
  2. 根据权利要求1所述的用于人工心脏瓣膜的复合型裙边，其特征在于，当所述复合型裙边至少包括所述第一裙边时，所述第一裙边材料的断裂延伸率＞10％，或，所述第一裙边固定时设置大于10％的冗余量。
  3. 根据权利要求1所述的用于人工心脏瓣膜的复合型裙边，其特征在于，当所述复合型裙边至少包括所述第二裙边时，所述第二裙边为单层结构，所述第二裙边材料的渗透量＜500ml/cm 2·min。
  4. 根据权利要求1所述的用于人工心脏瓣膜的复合型裙边，其特征在于，当所述复合型裙边至少包括所述第二裙边时，所述第二裙边为双层结构，所述第二裙边材料的渗透量为＜1500ml/cm 2·min。
  5. 根据权利要求3或4所述的用于人工心脏瓣膜的复合型裙边，其特征在于，还包括所述第三裙边，所述第二裙边材料的渗透量大于所述第三裙边材料的渗透量，且所述第三裙边材料的渗透量＜500ml/cm 2·min。
  6. 根据权利要求1所述的用于人工心脏瓣膜的复合型裙边，其特征在于，当所述复合型裙边至少包括所述第三裙边时，所述第三裙边材料的渗透量＜500ml/cm 2·min。
  7. 根据权利要求1所述的用于人工心脏瓣膜的复合型裙边，其特征在于，当所述复合型裙边至少包括所述第一裙边时，所述第一裙边包覆所述支架流入段的心房端边缘；或，当所述复合型裙边至少包括所述第三裙边时，所述第三裙边包覆所述支架流出段的心室端边缘。
  8. 根据权利要求1所述的用于人工心脏瓣膜的复合型裙边，其特征在于，当所述瓣膜支架为内外双层结构时，所述瓣膜支架形成一环形区域，所述 复合型裙边还包括布设于所述环形区域的第四裙边，所述第四裙边采用抗血栓的材料制成，防止所述环形区域形成血栓。
  9. 根据权利要求8所述的用于人工心脏瓣膜的复合型裙边，其特征在于，所述第四裙边的材料为：聚氨酯—肝素接枝共聚物、聚离子络合物，或其组合。
  10. 根据权利要求1所述的用于人工心脏瓣膜的复合型裙边，其特征在于，当心脏瓣膜的支架为内外双层结构时，所述支架形成一环形区域，沿所述心脏瓣膜轴向，所述环形区域具有一封闭端，所述复合型裙边还包括第四裙边，所述第四裙边布设于内支架的外表面、外支架的内表面及所述封闭端的上方，以形成一封闭的裙边区域，所述第四裙边的材料允许血液进入所述封闭的裙边区域，但阻止形成的血栓离开。
  11. 根据权利要求10所述的用于人工心脏瓣膜的复合型裙边，其特征在于，所述第四裙边的材料为：针织、梭织、编织的聚酯织物，PTFE，ePTFE，生物组织材料，或其组合。
  12. 一种包含如权利要求1-11任一所述复合型裙边的人工心脏瓣膜。
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