WO2022218445A1 - 人工心脏瓣膜 - Google Patents

人工心脏瓣膜 Download PDF

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Publication number
WO2022218445A1
WO2022218445A1 PCT/CN2022/097352 CN2022097352W WO2022218445A1 WO 2022218445 A1 WO2022218445 A1 WO 2022218445A1 CN 2022097352 W CN2022097352 W CN 2022097352W WO 2022218445 A1 WO2022218445 A1 WO 2022218445A1
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WO
WIPO (PCT)
Prior art keywords
section
heart valve
stent
artificial heart
artificial
Prior art date
Application number
PCT/CN2022/097352
Other languages
English (en)
French (fr)
Inventor
刘浩
葛晨耀
龚霄雁
Original Assignee
苏州茵络医疗器械有限公司
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Publication of WO2022218445A1 publication Critical patent/WO2022218445A1/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
    • A61F2/2403—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 pivoting rigid closure members
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition

Definitions

  • the present application relates to the technical field of medical devices, for example, to an artificial heart valve.
  • the heart has four valves, the mitral valve between the left atrium and the left ventricle, the tricuspid valve between the right atrium and the right ventricle, the aortic valve between the aorta and the left ventricle, and the aortic valve between the pulmonary artery and the right ventricle
  • the valve is the pulmonary valve.
  • a normal valve maintains a unidirectional flow of blood by opening and closing depending on the pressure difference on each side, ensuring that blood is pumped out of the chamber without backflow.
  • the mitral valve when the left ventricle contracts, the mitral valve acts as a check valve to tightly close the atrioventricular orifice and prevent the reverse flow of blood from the left ventricle into the left atrium.
  • the mitral valve when the mitral valve is diseased, it may be difficult to completely close when the left ventricle contracts, causing the left atrium to receive a large amount of backflow blood, which may lead to a sharp increase in left atrial and pulmonary venous pressure, and the left ventricular diastolic volume.
  • the load increases, and further leads to a series of pathological changes such as left ventricular enlargement and pulmonary hypertension, which eventually lead to clinical manifestations such as heart failure and arrhythmia, which can be life-threatening in severe cases.
  • transcatheter (or transapical) mitral valve repair and transcatheter (or transapical) mitral valve replacement have been rapidly developed and applied in clinical practice, and satisfactory results have been achieved.
  • a prosthetic heart valve is implanted into the orthotopic mitral valve through minimally invasive interventional procedures to replace or repair a damaged native valve.
  • the artificial heart valve mainly includes a stent and artificial valve leaflets located inside the stent.
  • the artificial heart valve in the related art has the technical problem that the stent structure design is unreasonable, which causes the artificial valve leaflet to not work in an optimal state.
  • the present application provides an artificial heart valve, which can solve the technical problem in the related art that the stent structure design is unreasonable, which causes the artificial valve leaflet to not work in an optimal state.
  • An embodiment provides an artificial heart valve, comprising: an outer stent, including an upper lip segment, a transition segment and a lower lip segment, the upper part of the upper lip segment has a circular or D-shaped cross-section, and the lower part of the upper lip segment is directed toward
  • the inner frame is bent and arranged, the lower lip section is in the shape of a bell mouth, and the transition section is connected between the upper lip section and the lower lip section; the inner bracket is arranged inside the outer bracket, including the inflow section and the lower lip section.
  • the outflow section is in the shape of a hat, the outflow section is in the shape of a cylinder, the upper end of the inflow section is connected with the upper lip section, the lower end of the inflow section is connected with the upper end of the outflow section, and the outflow section is connected with the upper end of the outflow section.
  • the lower end of the segment extends downward beyond the lower lip segment; the artificial valve leaflet is arranged inside the outflow segment of the inner stent; and the covering film includes an inner covering film and an outer covering film, the inner covering film Coated on the inner wall of the inflow section of the inner stent, and the outer covering film is coated on the inner wall of the transition section of the outer stent.
  • Fig. 1 is the three-dimensional structure schematic diagram of the artificial heart valve provided in the first embodiment of the present application
  • FIG. 2 is a front cross-sectional view of the artificial heart valve provided in Embodiment 1 of the present application;
  • FIG. 3 is a front cross-sectional view of the inner support and the outer support provided in Embodiment 1 of the present application;
  • FIG. 4 is a schematic diagram of the molding of the inner support and the outer support provided in Embodiment 1 of the present application;
  • FIG. 5 is a schematic structural diagram of the outer covering film provided in Embodiment 1 of the present application.
  • FIG. 6 is a schematic structural diagram of the inner coating provided in the first embodiment of the present application.
  • FIG. 7 is a schematic structural diagram of an artificial valve leaflet provided in Embodiment 1 of the present application.
  • FIG. 8 is a schematic structural diagram of an artificial heart valve implanted in a ventricle provided in Embodiment 1 of the present application;
  • FIG. 9 is a schematic three-dimensional structure diagram of the artificial heart valve provided in Embodiment 2 of the present application.
  • FIG. 10 is a front cross-sectional view of the artificial heart valve provided in the second embodiment of the present application.
  • connection should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between the two elements.
  • connection may be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between the two elements.
  • a first feature "on” or “under” a second feature may include direct contact between the first and second features, or may include the first and second features Not directly but through additional features between them.
  • the first feature being “above”, “over” and “above” the second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature is “below”, “below” and “below” the second feature includes the first feature being directly below and diagonally below the second feature, or simply means that the first feature has a lower level than the second feature.
  • the terms “upper”, “lower”, “left”, “right”, etc. are based on the orientation or positional relationship shown in the drawings, and are only for convenience of description and simplified operation , rather than indicating or implying that the referred device or element must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as a limitation on the present application.
  • the terms “first” and “second” are only used for distinction in description, and have no special meaning.
  • the present application provides an artificial heart valve for implantation in the inflow tract of the left ventricle to replace the native mitral valve valve, and can also be implanted in the inflow tract of the right ventricle to replace the native tricuspid valve valve,
  • the artificial heart valve includes an outer stent 1 , an inner stent 2 , a membrane and artificial valve leaflets 3 .
  • the outer bracket 1 includes an upper lip segment 11 , a transition segment 12 and a lower lip segment 13 , the upper part of the upper lip segment 11 has a circular or D-shaped cross section, and the lower part of the upper lip segment 11
  • the lower lip section 13 is in the shape of a bell mouth, and the transition section 12 is connected between the upper lip section 11 and the lower lip section 13 .
  • the upper lip segment 11 is placed on the native valve annulus, the upper part of the upper lip segment 11 protrudes from the native valve annulus, the lower part of the upper lip segment 11 is bent inwardly and is gently connected with the transition segment 12, the transition segment 12 fits the native valve leaflet 61, and the lower lip
  • the segment 13 is placed below the free end of the native valve leaflet 61 , and the outer stent 1 presents a clip-like structure as a whole, which is clamped at the native valve annulus and the native valve leaflet 61 to provide positioning and anchoring for the inner stent 2 .
  • the outer stent 1 exhibits radial reciprocating motion.
  • the transition section 12 is in the shape of a curved section, so that the transition section 12 can adapt to the shape of the native valve leaflet 61 and reduce the compression on the native valve leaflet 61 .
  • the inner support 2 is arranged inside the outer support 1, the inner support 2 includes an inflow section 21 and an outflow section 22, the inflow section 21 is in the shape of a hat, the outflow section 22 is in the shape of a cylinder, and the upper end of the inflow section 21 is in the shape of a hat. Connected to the upper lip section 11 , the lower end of the inflow section 21 is connected to the upper end of the outflow section 22 , and the lower end of the outflow section 22 extends downward to the outside of the lower lip section 13 .
  • the inner support 2 is suspended inside the outer support 1 to provide positioning and anchoring for the artificial valve leaflet 3.
  • the artificial valve leaflet 3 is arranged inside the outflow section 22 of the inner support 2, and is set to replace the native valve leaflet 61 by setting the inflow section 21 as
  • the hat shape can play a role of shock absorption in the heartbeat cycle, thereby reducing the load stress on the artificial valve leaflet 3, and at the same time reducing the load of the outer stent 1 during anchoring; by setting the outflow section 22 into a cylindrical shape, it can act as a
  • the inner stent 2 and the outer stent 1 are integrally formed.
  • a shape memory elastic material nickel-titanium alloy
  • nickel-titanium alloy can be woven into an integrated stent, which is partially folded 180 degrees and heat-set. It has an integrated structure of the inner and outer brackets.
  • the membrane includes an inner membrane 41 and an outer membrane 42.
  • the inner membrane 41 covers the inner wall of the inflow section 21 of the inner stent 2, so that when the blood flows from the atrium to the ventricle, only It can pass through the artificial valve leaflet 3, effectively improving the sealing performance of the inflow section 21 and reducing paravalvular leakage;
  • the outer covering 42 covers the inner wall of the transition section 12 of the outer stent 1, and the outer covering 42 is in contact with the native valve leaflet 61 again. , to increase the endothelialized area, which is more conducive to the native tissue crawling and reduces paravalvular leakage.
  • the inner covering 41 and the inner stent 2 and the outer covering 42 and the outer stent 1 are connected by sutures.
  • the material of the inner covering film 41 and the outer covering film 42 is one or a combination of TPU, PET, e-PTFE, and PTFE, and the thickness of the inner covering film 41 and the outer covering film 42 is 0.01 -1mm.
  • the artificial valve leaflet 3 includes a sutured edge 31 and a free edge 32 , and the artificial valve leaflet 3 is sutured on the inner membrane 41 through the sutured edge 31 .
  • the artificial valve leaflet 3 includes at least two valve leaflets. In one embodiment, the artificial valve leaflet 3 has three valve leaflets. The number of the artificial valve leaflet 3 can be the same as or different from the original valve leaflet 61, and the material can be processed.
  • Flexible polymer or material of treated biological tissue flexible polymer can be polyolefin, elastomer, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, fluoropolymer, organic Silicon polyesters, siloxane polymers and/or oligomers, and/or polylactones, and block copolymers using them; biological tissues are preferably bovine pericardium, porcine pericardium tissue, and also small intestinal submucosal tissue.
  • the method of using the artificial heart valve is: placing the artificial heart valve in the lumen of the conveyor, and entering the ventricle through the guide wire, when the conveyor reaches the designated position, the artificial heart valve is released to make
  • the upper lip segment 11 of the outer stent 1 is placed on the native valve annulus, and the upper part of the upper lip segment 11 protrudes from the native valve annulus.
  • the lower part of the upper lip segment 11 is bent inward and contacts with the surrounding native tissue, and the transition segment 12 fits the native valve annulus.
  • the valve leaflet 61, the lower lip segment 13 is located below the free end of the native valve leaflet 61, the outer stent 1 presents a clip-like structure as a whole, and is clamped at the native valve annulus and the native valve leaflet 61, the inner stent 2 is placed inside the outer stent 1, The artificial valve leaflet 3 is placed inside the inner stent 2 to replace the original heart valve.
  • the conveyor is withdrawn from the centrifugal chamber.
  • This embodiment provides an artificial heart valve.
  • This embodiment is basically the same as the first embodiment. For the sake of simplicity, only the differences from the first embodiment are described.
  • the inner bracket 2 and the outer bracket 1 are spliced together, the inner bracket 2 and the outer bracket 1 can be made of a metal mesh structure, and the splicing method of the two can be suturing, welding
  • a combination of one or more of anchoring in one embodiment, the inner bracket 2 and the outer bracket 1 are laser welded, a plurality of first welding terminals can be arranged on the inner bracket 2, and a plurality of first welding terminals can be arranged on the outer bracket 1 a second welding terminal corresponding to the first welding terminal, the number of the first welding terminal and the second welding terminal can be 2-8, and the first welding terminal and the second welding terminal are fixedly connected together by laser welding,
  • a connecting tube 5 can be sleeved on the outside of the first welding terminal and the second welding terminal, and the material of the connecting
  • the artificial heart valve made by splicing the inner and outer stents compared with the artificial heart valve integrally formed in the first embodiment, has no folding phenomenon, so the artificial heart valve in this embodiment It is easier to put into the organ cavity of the delivery device. On the contrary, the inner diameter of the cavity of the delivery organ in this embodiment can be made smaller.

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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

一种人工心脏瓣膜，包括：外支架(1)，包括上唇段(11)、过渡段(12)和下唇段(13)，上唇段(11)的上部的横截面呈圆形或D形，上唇段(11)的下部向内弯折设置，下唇段(13)呈喇叭口状，过渡段(12)连接于上唇段(11)和下唇段(13)之间；内支架(2)，设置于外支架(1)的内部，包括流入段(21)和流出段(22)，流入段(21)呈斗笠状，流出段(22)呈圆柱状；人工瓣叶(3)，设置于流出段(22)的内部；及覆膜，包括内覆膜(41)和外覆膜(42)。

Description

人工心脏瓣膜
本申请要求申请日为2021年4月12日、申请号为202110389627.0的中国专利申请的优先权，该申请的全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，例如涉及一种人工心脏瓣膜。
背景技术
心脏有四个瓣膜，左心房与左心室间的瓣膜为二尖瓣，右心房与右心室间的瓣膜为三尖瓣，主动脉与左心室间的瓣膜为主动脉瓣，肺动脉与右心室间的瓣膜为肺动脉瓣。正常的瓣膜能根据每一侧上的压力差异而通过开启和闭合来维持血液的单向流动，保证将腔室的血液泵出而不回流。
以二尖瓣为例，在左心室收缩时，二尖瓣起到止回阀的作用，以严密关闭房室口，防止血液从左心室逆流入左心房。但是当二尖瓣发生病变时可能会出现在左心室收缩时难以完全闭合的情况，导致左心房接收了大量返流血液，这样可能导致左心房和肺部静脉压力急剧上升，左心室舒张期容量负荷增加，并进一步导致左心室扩大、肺动脉高压等一系列病理改变，最终导致心力衰竭、心律失常等临床表现，严重时会危及生命。
随着介入治疗技术的进步，经导管(或经心尖)二尖瓣修复术和经导管(或经心尖)二尖瓣置换术得到了快速发展并应用于临床，取得了较为满意的效果。通过微创介入手术将人工心脏瓣膜植入到原位二尖瓣中，以置换或修复损坏的天然瓣膜进行相关工作。人工心脏瓣膜主要包括支架以及位于支架内部的人工瓣叶，相关技术中的人工心脏瓣膜存在支架结构设计不合理，导致人工瓣叶不能以最优的状态工作的技术问题。
发明内容
本申请提供了一种人工心脏瓣膜，能够解决相关技术中存在的支架结构设计不合理，导致人工瓣叶不能以最优的状态工作的技术问题。
一实施例提供了一种人工心脏瓣膜，包括：外支架，包括上唇段、过渡段和下唇段，所述上唇段的上部的横截面呈圆形或D形，所述上唇段的下部向内弯 折设置，所述下唇段呈喇叭口状，所述过渡段连接于所述上唇段和所述下唇段之间；内支架，设置于所述外支架的内部，包括流入段和流出段，所述流入段呈斗笠状，所述流出段呈圆柱状，所述流入段的上端与所述上唇段连接，所述流入段的下端与所述流出段的上端连接，所述流出段的下端向下延伸至所述下唇段以外；人工瓣叶，设置于所述内支架的所述流出段的内部；及覆膜，包括内覆膜和外覆膜，所述内覆膜包覆在所述内支架的所述流入段的内壁，所述外覆膜包覆在所述外支架的所述过渡段的内壁。
附图说明
图1是本申请实施例一提供的人工心脏瓣膜的立体结构示意图；
图2是本申请实施例一提供的人工心脏瓣膜的主视剖视图；
图3是本申请实施例一提供的内支架和外支架的主视剖视图；
图4是本申请实施例一提供的内支架和外支架的成型示意图；
图5是本申请实施例一提供的外覆膜的结构示意图；
图6是本申请实施例一提供的内覆膜的结构示意图；
图7是本申请实施例一提供的人工瓣叶的结构示意图；
图8是本申请实施例一提供的人工心脏瓣膜植入心室内的结构示意图；
图9是本申请实施例二提供的人工心脏瓣膜的立体结构示意图；
图10是本申请实施例二提供的人工心脏瓣膜的主视剖视图。
图中：
1、外支架；11、上唇段；12、过渡段；13、下唇段；2、内支架；21、流入段；22、流出段；3、人工瓣叶；31、缝合边；32、自由边；41、内覆膜；42、外覆膜；5、连接管；6、心脏；61、原生瓣叶。
具体实施方式
在本申请的描述中，除非另有明确的规定和限定，术语“相连”、“连接”、“固定”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。
在本实施例的描述中，术语“上”、“下”、“左”、“右”、等方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述和简化操作，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申请的限制。此外，术语“第一”、“第二”仅仅用于在描述上加以区分，并没有特殊的含义。
实施例一
如图1至图7所示，本申请提供一种人工心脏瓣膜，用于植入左心室流入道内，替代原生二尖瓣瓣膜，也可植入右心室流入道内，替代原生三尖瓣瓣膜，该人工心脏瓣膜包括外支架1、内支架2、覆膜和人工瓣叶3。
在一实施例中，参见图2和图3，外支架1包括上唇段11、过渡段12和下唇段13，上唇段11的上部的横截面呈圆形或D形，上唇段11的下部向内弯折设置，下唇段13呈喇叭口状，过渡段12连接于上唇段11和下唇段13之间。上唇段11置于原生瓣环上，上唇段11的上部凸出于原生瓣环，上唇段11的下部向内弯折与过渡段12平缓连接，过渡段12贴合原生瓣叶61，下唇段13置于原生瓣叶61的自由端的下方，外支架1整体呈现夹子状结构，夹合在原生瓣环和原生瓣叶61处，为内支架2提供定位和锚固。在心跳循环中，外支架1呈现径向往复运动，通过将外支架1设置成上述结构形式，能够减小甚至消除外支架1径向反复运动对内支架2的影响，防止在心跳循环时内支架2形变量过大，从而可以使人工瓣叶3更好的开合，也有利于提高人工瓣叶3的寿命。在一实施例中，过渡段12呈曲线段轮廓，使得过渡段12能自适应原生瓣叶61的形状，减小对原生瓣叶61的压迫。
继续参见图2和图3，内支架2设置于外支架1的内部，内支架2包括流入段21和流出段22，流入段21呈斗笠状，流出段22呈圆柱状，流入段21的上端与上唇段11连接，流入段21的下端与流出段22的上端连接，流出段22的下端向下延伸至下唇段13以外。内支架2悬挂在外支架1内部，为人工瓣叶3提供定位和锚固， 人工瓣叶3设置于内支架2的流出段22的内部，设置为替换原生瓣叶61，通过将流入段21设置为斗笠状，能够在心跳循环中起到减震的作用，从而降低人工瓣叶3上的负载应力，同时减少了外支架1在锚固时的载荷；通过将流出段22设置为圆柱状，能够充当人工瓣叶3的锚固载体，在人工瓣叶3损坏的情况下，流出段22还可以使用球囊做适当的扩张，用于替换人工瓣叶3(瓣中瓣结构)，由于内支架2悬挂在外支架1内，内支架2扩张换瓣后对外支架1的结构定位和锚固影响不大。
在本实施例中，内支架2和外支架1为一体成型，参见图4，可采用形状记忆弹性材料(镍钛合金)编织成一个一体式支架后，经局部翻折180度并热定型处理成内外支架一体式结构。
参见图2、图5和图6，覆膜包括内覆膜41和外覆膜42，内覆膜41包覆在内支架2的流入段21的内壁，使得血流从心房流向心室的时候只能从人工瓣叶3处通过，有效提高流入段21的密封性，减少瓣周漏；外覆膜42包覆在外支架1的过渡段12的内壁，外覆膜42与原生瓣叶61再次接触，增大内皮化面积，更利于原生组织爬皮，减少瓣周漏。在一实施例中，内覆膜41与内支架2之间以及外覆膜42与外支架1之间通过缝合线缝合连接。在一实施例中，内覆膜41和外覆膜42的材质为TPU、PET、e-PTFE、PTFE中的一种或多种的组合，内覆膜41和外覆膜42的厚度为0.01-1mm。
参见图7，人工瓣叶3包括缝合边31和自由边32，人工瓣叶3通过缝合边31缝合在内覆膜41上。人工瓣叶3包括至少两片瓣叶，在一实施例中，人工瓣叶3的瓣叶为三片，人工瓣叶3的数量可以与原生瓣叶61相同或不同，材质可以是经处理的柔性聚合物或经处理的生物组织的材料，柔性聚合物可以是聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯基吡咯烷酮、聚氯乙烯、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；生物组织优选牛心包、猪心包组织，也可以是小肠粘膜下组织。
参见图8，本申请提供的人工心脏瓣膜的使用方法为：将人工心脏瓣膜放置于输送器的管腔内，并经导丝进入心室，当输送器到达指定位置后，释放人工心脏瓣膜，使外支架1的上唇段11置于原生瓣环上，并使上唇段11的上部凸出原生瓣环，此时上唇段11的下部向内弯折与周围原生组织接触，过渡段12贴合原生瓣叶61，下唇段13位于原生瓣叶61的自由端的下方，外支架1整体呈现夹子状结构，夹合在原生瓣环和原生瓣叶61处，内支架2置于外支架1内部，人工瓣叶3 置于内支架2内部，代替原心脏瓣膜，当人工心脏瓣膜完全贴合心脏6后将输送器撤离心室。
实施例二
本实施例提供一种人工心脏瓣膜，本实施例与实施例一基本相同，为简便起见，仅描述与实施例一的不同之处。在本实施例中，参见图9和图10，内支架2和外支架1是拼接而成，内支架2和外支架1可由金属网状结构制成，两者的拼接方式可以为缝合、焊接、锚定中的一种或多种的组合，在一实施例中，内支架2和外支架1采用激光焊接，可在内支架2上设置多个第一焊接端子，在外支架1上设置多个与第一焊接端子一一对应的第二焊接端子，第一焊接端子和第二焊接端子的数量可以为2-8个，第一焊接端子和第二焊接端子通过激光焊接固连在一起，在一实施例中，可以在第一焊接端子和第二焊接端子的外部套设连接管5，连接管5的材质可以为具备显影特性的金属(如铂金、金、钽金属、医用不锈钢等)。
在本实施例中，通过内外支架拼接的方式制成的人工心脏瓣膜，相对于实施例一中一体成型的人工心脏瓣膜而言，由于不存在翻折现象，故本实施例中的人工心脏瓣膜更易放入输送器的官腔内。相对的，本实施例中的输送器官腔内径可以做到更小。

Claims (10)

  1. 一种人工心脏瓣膜，包括：
    外支架(1)，包括上唇段(11)、过渡段(12)和下唇段(13)，所述上唇段(11)的上部的横截面呈圆形或D形，所述上唇段(11)的下部向内弯折设置，所述下唇段(13)呈喇叭口状，所述过渡段(12)连接于所述上唇段(11)和所述下唇段(13)之间；
    内支架(2)，设置于所述外支架(1)的内部，包括流入段(21)和流出段(22)，所述流入段(21)呈斗笠状，所述流出段(22)呈圆柱状，所述流入段(21)的上端与所述上唇段(11)连接，所述流入段(21)的下端与所述流出段(22)的上端连接，所述流出段(22)的下端向下延伸至所述下唇段(13)以外；
    人工瓣叶(3)，设置于所述内支架(2)的所述流出段(22)的内部；及
    覆膜，包括内覆膜(41)和外覆膜(42)，所述内覆膜(41)包覆在所述内支架(2)的所述流入段(21)的内壁，所述外覆膜(42)包覆在所述外支架(1)的所述过渡段(12)的内壁。
  2. 根据权利要求1所述的人工心脏瓣膜，其中，所述过渡段(12)呈曲线段轮廓。
  3. 根据权利要求1所述的人工心脏瓣膜，其中，所述内覆膜(41)和所述外覆膜(42)的材质为TPU、PET、e-PTFE、PTFE中的一种或多种的组合。
  4. 根据权利要求1所述的人工心脏瓣膜，其中，所述内覆膜(41)和所述外覆膜(42)的厚度为0.01-1mm。
  5. 根据权利要求1所述的人工心脏瓣膜，其中，所述人工瓣叶(3)与所述内覆膜(41)缝合连接。
  6. 根据权利要求1所述的人工心脏瓣膜，其中，所述人工瓣叶(3)的材质为柔性聚合物或生物组织。
  7. 根据权利要求1-6任一项所述的人工心脏瓣膜，其中，所述内支架(2)和所述外支架(1)由形状记忆弹性材料一体编织而成。
  8. 根据权利要求1-6任一项所述的人工心脏瓣膜，其中，所述内支架(2)与所述外支架(1)由金属网状结构制成，且所述内支架(2)和所述外支架(1)通过焊接连接。
  9. 根据权利要求8所述的人工心脏瓣膜，其中，所述内支架(2)上设置多个第一焊接端子，所述外支架(1)上设置多个与所述第一焊接端子一一对应的第二焊接端子，所述第一焊接端子和所述第二焊接端子通过焊接固连。
  10. 根据权利要求9所述的人工心脏瓣膜，其中，所述第一焊接端子和所述第二焊接端子的外部套设连接管(5)，所述连接管(5)的材质为金属。
PCT/CN2022/097352 2021-04-12 2022-06-07 人工心脏瓣膜 WO2022218445A1 (zh)

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