WO2018192197A1 - 主动脉瓣膜装置 - Google Patents

主动脉瓣膜装置 Download PDF

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Publication number
WO2018192197A1
WO2018192197A1 PCT/CN2017/106281 CN2017106281W WO2018192197A1 WO 2018192197 A1 WO2018192197 A1 WO 2018192197A1 CN 2017106281 W CN2017106281 W CN 2017106281W WO 2018192197 A1 WO2018192197 A1 WO 2018192197A1
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Prior art keywords
valve
valve device
aortic
aortic valve
stent
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PCT/CN2017/106281
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English (en)
French (fr)
Inventor
邱克劲
赵轩铖
昌仁操
鲁炳呈
王川
刘小建
张昱昕
Original Assignee
乐普（北京）医疗器械股份有限公司
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Publication of WO2018192197A1 publication Critical patent/WO2018192197A1/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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • 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
    • A61F2/2415—Manufacturing methods
    • 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

Definitions

  • the present disclosure relates to the field of medical devices, for example, to a transcatheter-mounted aortic valve device for use in a mammalian heart.
  • Aortic valve disease is the most common type of valvular heart disease. Especially in the elderly population, the incidence of aortic stenosis is increasing. In some areas, the incidence rate of the population over 65 years old is 2% to 7%, and gradually increases with age, some areas It is 4.6% to 13% in people over 75 years old.
  • Initial aortic valve disease can only be treated conservatively with drugs, but the prognosis of conservative medical treatment is poor, and the 5-year mortality rate can be as high as 52% to 82%.
  • SAVR surgical aortic valve replacement
  • the prosthetic valve was implanted by surgical thoracotomy.
  • Surgical implanted prosthetic valves are classified into mechanical valves and bioprostheses.
  • Mechanical valves require long-term anticoagulation and poor bioprosthetic durability. Therefore, there is considerable controversy about the choice of prosthetic valves, along with companies such as Edwards Lifesciences.
  • a breakthrough in valve management technology has begun to switch from mechanical valves to bioprostheses for the selection of prosthetic valves.
  • the risk of surgery is too high for high-risk patients, and the aortic valve disease increases rocket rate with age, and the mortality rate exceeds 50% after two years. Old and high-risk patients can still only receive conservative treatment.
  • TAVR Transcatheter Aortic Valve Replacement
  • aortic valve devices mainly include the Sapien valve family of Edwards Lifesciences and the Core Valve valve family of Medtronic, but they have more or less deficiencies in use, or can not be recycled, or poorly positioned, or Can not balance the adaptation of the aortic valve Patients with stenosis and aortic valvular insufficiency.
  • the present disclosure provides a transcatheter-delivered aortic valve device with automatic and accurate positioning for implantation into an in situ aortic valve due to aortic stenosis or aortic regurgitation.
  • An aortic valve device comprising:
  • the positioning structure of the valve holder is for limiting the position of the valve stent at the aortic annulus ;as well as
  • the outflow end of the valve stent presents a second bell structure composed of a plurality of diamond-shaped mesh structures, and the diamond mesh structure is evenly distributed to ensure that the valve stent is stably fixed in the ascending aorta and the blood vessel Coaxial.
  • valve support is at least one of a superelastic alloy and a shape memory alloy material, and is laser cut.
  • the middle portion of the valve support is a plurality of perforated straight rod connection structures, and the diamond mesh structure of the second bell structure has a mesh size larger than a diamond mesh structure of the first bell structure Mesh size.
  • the hole of the perforated straight rod connection structure has an elliptical hole, a square hole or a circular hole.
  • the positioning structure is outwardly offset from the axis of the valve support by an angle of 0 to 90 degrees.
  • the tip of the positioning structure of the valve stent is a grooved rod structure or a solid structure.
  • the material of the leaflet comprises an animal pericardium or a polymer material.
  • the material of the inner skirt comprises an animal pericardium or a polymer material.
  • the outer skirt material comprises an animal pericardium or a polymer material.
  • the animal pericardium comprises a bovine pericardium or a pig pericardium.
  • the polymer material comprises a polytetrafluoroethylene, a fiber cloth or a fiber membrane.
  • the connecting claw is a T-shaped structure, and the T-shaped structure may be solid or hollow.
  • the number of the connecting claws is three.
  • the embodiment realizes the loading and releasing of the aortic valve device; realizes the precise positioning of the aortic valve device during the operation; reduces the paravalvular leakage, and improves the safety and reliability of the operation.
  • Figure 1 is a schematic view of an aortic valve device of the present embodiment
  • FIG. 2 is a schematic exploded view of a valve stent of an aortic valve device of the present embodiment
  • FIG. 3 is a schematic structural view of a positioning structure of an aortic valve device of the embodiment.
  • Figure 4 is a schematic view of the aortic valve device of the present embodiment implanted into the in situ aortic valve.
  • Figure 5 is a schematic illustration of the loading of an aortic valve device in a delivery system of the present embodiment.
  • the aortic valve device of the present embodiment is used for implantation into an in situ aortic valve due to aortic valve stenosis or aortic regurgitation/shutdown, with active positioning and adaptive aortic annulus Features.
  • the technical solutions of the present disclosure are further described below in conjunction with the drawings and specific embodiments.
  • FIG. 1 is a schematic view showing the structure of an aortic valve device 100 of the present embodiment.
  • the aortic valve device 100 of this embodiment may be a transcatheter implant, the aortic valve device 100 comprising: a valve support, a leaflet 106 secured to the inside of the intermediate portion of the valve support, secured to the inside of the inflow end 110 of the valve support An inner skirt 103 coupled to the leaflet is secured to the outer skirt 104 on the outer side of the upper portion of the valve stent inflow end 110.
  • the inner skirt 103 and the outer skirt 104 are formed in a circle around the four sides of the valve support, and are fixed on the valve support by suturing, pressing or bonding; the leaflet 106 may be composed of a three-petal structure through the suture The inner portion of the valve stent is sewn and fixedly sutured with the inner skirt 103.
  • the valve stent includes: the valve stent inflow end 110 presents a first flare structure 102 of a plurality of diamond-shaped mesh structures; and a plurality of connecting claws required for loading the valve stent at the end of the lower horn structure 101;
  • the connecting claws 101 may be three; the middle of the valve support is located outside the inflow end 110 a plurality of positioning structures 105 that are expanded upwardly and outwardly; the valve holder is in the middle of the perforated end of the valve holder 120; the valve holder outflow end 120 presents a plurality of rhombic grid structures.
  • Structure 108 The size of the diamond mesh structure of the second bell mouth structure 108 is greater than the size of the diamond mesh structure of the first bell mouth structure 102.
  • the middle portion of the valve support is a plurality of perforated straight rod connecting structures 107, and the number of the perforated straight rod connecting structures 107 may be three to six.
  • the hole of the perforated straight rod connection structure is a suture hole, and the shape of the suture hole may be an elliptical hole, a square hole or a circular hole or the like.
  • the number of the suture holes is 3 to 5.
  • the perforated straight rod connection structure 107 functions to secure the leaflets 106, connect the first bell mouth structure 102 and the second bell mouth structure 108.
  • the length of the perforated straight rod connecting structure 107 is 5 mm to 10 mm
  • the width of the perforated straight rod connecting structure 107 is 1 mm to 2 mm.
  • the perforated straight rod connecting structure 107 The length and width can be adjusted and selected based on factors such as the size and support of the valve support.
  • the perforated straight rod connection structure 107 of the valve stent connects the first flare structure 102 of the valve stent inflow end 110 and the second flare structure 108 of the valve stent outflow end 120.
  • the diameter of the circumscribed circle of the second bell mouth structure 108 of the outflow end 120 is 3 mm to 12 mm larger than the diameter of the circumscribed circle of the first bell mouth structure 102 of the inflow end 110.
  • the first bell mouth structure 102 of the valve stent inflow end 110 has a rhombic grid structure in the circumferential direction of six to fifteen, and the second bell mouth structure 108 of the valve stent outflow end 120 is circumferentially
  • the number of diamond mesh structures is 3 to 9.
  • the end of the first bell mouth structure 102 of the valve stent inflow end 110 may be a flat structure that expands outwardly.
  • the angle of expansion is less than or equal to 10 degrees.
  • the straight section has a length of 3 mm to 9 mm.
  • the end of the first flare structure at the inflow end 110 of the valve stent is a structure with an eyelet 1021 that facilitates suturing with the inner skirt 103.
  • the plurality of connecting claws 101 required for loading the valve holder at the end of the lower horn structure has a T-shaped structure, that is, the end of the connecting claw 101 protrudes to both sides, and the T-shaped structure is hollow or solid. For example, it is solid.
  • the positioning structure root portion 51 of the positioning structure 105 of the valve stent originates from the first bell mouth structure 102 of the inflow end 110 of the valve stent 100, and expands outward toward the outflow end 120 to form a positioning. Structure end 52.
  • the positioning structure is evenly distributed along the circumferential direction of the central portion of the valve stent.
  • the number of valve positioning structures is from 3 to 9.
  • the positioning structure end 52 is a solid or grooved rod structure, such as a grooved rod structure.
  • the rod structure has a length of 2 mm to 5 mm and the rod structure has a width of 0.5 mm to 2 mm. As shown in FIG.
  • the positioning structure 105 is outwardly offset from the axis of the valve support by an angle of 0 to 90 degrees, such as 0 to 45 degrees.
  • the positioning knot The diameter of the circumscribed circle of the positioning structure end 52 of the structure 105 is 1 mm to 9 mm larger than the diameter of the circumcircle corresponding to the positioning structure root 51.
  • FIG. 4 is a schematic view of the aortic valve device of the present embodiment implanted into the in situ aortic valve.
  • the valve stent positioning structure 105 and the first bell mouth structure 102 of the valve stent inflow end 110 are used to limit the valve stent 100 in the aortic valve
  • the positioning structure 105 features active positioning and adaptive aortic annulus 201 and native leaflets 202.
  • the uniform distribution of the diamond-shaped mesh structure of the second bell mouth structure of the valve stent outflow end 120 ensures that the valve stent is coaxial and stable with the blood vessel in the ascending aorta 204.
  • the outer skirt 104 fits between the first flare structure 102 and the aortic annulus 201 of the valve stent inflow end 110 to reduce paravalvular leakage.
  • another feature of the valve stent 100 after implantation into the in situ aortic valve is that the large mesh gap in the middle of the valve stent 100 does not affect the irrigation of the coronary 203 blood flow at all.
  • the material of the valve stent in the embodiment may be at least one of a superelastic alloy and a shape memory alloy, such as a nickel titanium alloy material.
  • the material of the leaflets, the material of the inner skirt and the material of the outer skirt may be animal pericardial materials or polymer materials, such as bovine pericardium, pig pericard, polytetrafluoroethylene, fiber cloth. Or fiber membrane materials, etc. Wherein, the fiber cloth is a fiber fabric.
  • the aortic valve device 100 is contracted in an ice water bath by a loading device and loaded into the loading sheath front portion 303 and the loading sheath rear portion 304 of the delivery system 300 (refer to FIG. 5).
  • the loading sheath front portion 303 of the delivery system 300 is moved forward by the handle 305, releasing the valve stent positioning structure 105 of the aortic valve 100, at which point the material of the valve stent 100 is superelastic. And shape memory characteristics, the positioning structure 105 automatically opens at body temperature (37 ⁇ 1 ° C).
  • the delivery system 300 is then slowly advanced forward such that the positioning structure 105 contacts the human natural leaflet tissue 202 and then stops pushing the delivery system 300, at which time the first flare structure of the aortic valve stent inflow end 110 is still loading.
  • the aortic valve device 100 is then positioned at the position of the aortic annulus 201, and the loading sheath posterior portion 304 of the delivery system is moved rearwardly by the handle 305 such that the valve stent outflow end 120 of the aortic valve device 100
  • the second flare structure 108 is released from the loading sheath rear portion 304 of the delivery system 300.
  • the valve stent outflow end 120 has a second flare structure 108 at body temperature due to the superelastic and shape memory properties of the valve stent 100 material.
  • the lower opening automatically and supports the ascending aorta 204.
  • the loading sheath front 303 of the delivery system is pushed forward through the handle 305, and the aortic valve is placed.
  • the first flare structure 102 and the connecting jaws 101 of the membrane 100 valve stent inflow end 110 are detached from the loading sheath front portion 303 of the delivery system and the loading card slot 302 of the delivery system head end 301 to complete the aortic valve device 100.
  • Accurate implantation The loading sheath front portion 303 and the loading sheath back portion 304 are combined by adjusting the delivery system handle 305 to integrally withdraw the delivery system 300 to reduce damage to the blood vessel when the delivery system 300 is withdrawn.
  • the aortic valve device of the embodiment realizes the loading and releasing of the aortic valve device; the precise positioning of the aortic valve device during the operation is realized; the paravalvular leakage is reduced, and the safety and reliability of the operation are improved.

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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)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)

Abstract

一种主动脉瓣膜装置（100），包括：瓣膜支架；固定在该瓣膜支架内侧的瓣叶（106）；沿该瓣膜支架内侧周边固定、并与该瓣叶（106）连接固定的内裙边（103）；以及沿该瓣膜支架中间靠流入端（110）外侧固定的外裙边（104）；设置在第一喇叭口结构末端的用于该瓣膜支架装载的连接爪；设置在该瓣膜支架的中间靠流入端（110）外侧且向上向外扩张的多个定位结构（105）；该瓣膜支架的定位结构（105）用于限制该瓣膜支架在主动脉瓣环处植入的位置；以及设置在该瓣膜支架的中间靠流出端（120）的多个带孔直杆连接结构（107）。

Description

主动脉瓣膜装置 技术领域
本公开涉及医疗器械领域，例如涉及用于哺乳动物心脏的一种经导管植入的主动脉瓣膜装置。
背景技术
随着人均寿命的延长和人口老龄化的进程，主动脉瓣膜疾病包括主动脉瓣狭窄(aortic stenosis，AS)和主动脉瓣返流/关闭不全(aortic regurgitation，AR)患者的数量将会进一步増长。主动脉瓣膜疾病是瓣膜性心脏病中最为常见的类型。特别是在老年人群中，主动脉瓣狭窄的发病率呈增高趋势，某些地区在65岁以上人口中的发病率达2％～7％，并且随着年龄的增长而逐渐增加，某些地区大于等于75岁人群中达4.6％～13％。最初主动脉瓣膜疾病只能通过药物保守治疗，但是内科保守治疗预后不佳，5年病死率可高达52％～82％。20世纪后期出现了人工心脏瓣膜置换术(surgical aortic valve replacement，SAVR)，通过外科开胸将人工瓣膜植入。通过外科方式植入的人工瓣膜分为机械瓣膜和生物瓣膜两种类型，机械瓣膜需要长期抗凝，生物瓣膜耐久性差，因此关于人工瓣膜的选择也存在较大争议，随着Edwards Lifesciences等公司生物瓣膜处理技术的突破，对于人工瓣膜的选择偏好开始从机械瓣膜向生物瓣膜转换。但是，通过外科开胸手术进行换瓣治疗，对于高龄高危患者，外科手术风险太大，主动脉瓣膜疾病随着年龄増长发病率呈火箭式上升，两年后死亡率超过50％，因此大多高龄高危患者依然只能接受保守治疗。
到了21世纪，随着经导管植入技术的日趋成熟以及心脏瓣膜疾病新器械的涌现，2002年法国Cribier医生首次通过经导管主动脉瓣膜植入术(Transcatheter Aortic Valve Replacement，TAVR)成功治疗了一名57岁的外科手术高危险重度钙化性主动脉瓣狭窄的男性患者。TAVR的发展是基于PCI(Percutaneous Coronary Intervention)的基础之上，将介入技术应用到了一个全新领域，且取得了良好的效果。TAVR经过十几年的发展，已经有超过30万人接受此技术的治疗。
相关技术中主动脉瓣膜装置主要包括Edwards Lifesciences公司的Sapien瓣膜家族和Medtronic公司的Core Valve瓣膜家族等，但他们在使用过程中或多或少存在一些不足，或者不能回收，或者不好定位，或者不能兼顾适应主动脉瓣膜 狭窄患者和主动脉瓣膜关闭不全患者。
发明内容
本公开提供一种经导管输送的主动脉瓣膜装置，具有自动准确定位的特点，以便用于植入到因主动脉瓣狭窄或者主动脉瓣膜关闭不全而导致病变的原位主动脉瓣中，解决多种主动脉瓣膜病症。
一种主动脉瓣膜装置，包括：
瓣膜支架；
固定在所述瓣膜支架内侧的瓣叶；
沿所述瓣膜支架内侧周边固定、并与所述瓣叶连接固定的内裙边；以及
沿所述瓣膜支架中间靠流入端外侧固定的外裙边；其中，所述瓣膜支架的流入端呈现多个菱形网格结构组成的第一喇叭口结构；
设置在所述的第一喇叭口结构末端的用于所述瓣膜支架装载的连接爪；
设置在所述瓣膜支架的中间靠近第一喇叭口结构的外侧有向外扩张的多个定位结构；所述瓣膜支架的定位结构用于限制所述瓣膜支架在主动脉瓣环处植入的位置；以及
设置在所述瓣膜支架的中间靠近流出端一侧的多个带孔直杆连接结构；
其中，所述瓣膜支架的流出端呈现多个菱形网格结构组成的第二喇叭口结构，所述菱形网格结构均匀分布以保证所述瓣膜支架稳定地固定在升主动脉中，且与血管同轴。
可选的，所述瓣膜支架为超弹性合金和形状记忆合金材料中的至少一种，激光切割而成。
可选的，所述瓣膜支架的中间部分为多个带孔直杆连接结构，所述第二喇叭口结构的菱形网格结构的网孔尺寸大于所述第一喇叭口结构的菱形网格结构的网孔尺寸。
可选的，所述带孔直杆连接结构的孔的形状为椭圆形孔、方形孔或圆形孔。
可选的，所述定位结构向外偏离瓣膜支架轴线的角度为0度到90度。
可选的，所述瓣膜支架的定位结构的尖端为带沟槽的杆结构，或者实心结构。
可选的，所述瓣叶的材料包括动物心包膜或高分子材料。
可选的，所述内裙边的材料包括动物心包膜或高分子材料。
可选的，所述外裙边的材料包括动物心包膜或高分子材料。
可选的，所述动物心包膜包括牛心包或猪心包。
可选的，所述高分子材料包括聚四氟乙烯、纤维布或纤维膜。
可选的，所述连接爪为T型结构，所述T型结构可为实心或者空心。
可选的，所述连接爪的个数为三个。
本实施例实现了主动脉瓣瓣膜装置的装载与释放；实现了主动脉瓣瓣膜装置在手术过程中的精确定位；减少了瓣周漏，提高了手术的安全可靠性。
附图概述
图1是本实施例的一种主动脉瓣膜装置的示意图；
图2是本实施例的一种主动脉瓣膜装置瓣膜支架的展开示意图；
图3是本实施例的主动脉瓣膜装置定位结构的结构示意图；
图4是本实施例的一种主动脉瓣膜装置植入到原位主动脉瓣处的示意图；和
图5是本实施例的一种主动脉瓣膜装置在输送系统内的装载示意图。
具体实施方式
本实施例的主动脉瓣膜装置用于植入到因主动脉瓣膜狭窄或者主动脉瓣反流/关闭不全而导致发生病变的原位主动脉瓣膜中，具有主动定位和自适应主动脉瓣环的特点。以下结合说明书附图及具体实施例进一步说明本公开的技术方案。
如图1所示是本实施例的一种主动脉瓣膜装置100的结构示意图。该实施例主动脉瓣膜装置100可以是经导管植入，该主动脉瓣膜装置100包括：瓣膜支架，固定在所述瓣膜支架中间部分内侧的瓣叶106，固定在所述瓣膜支架流入端110内侧并与所述瓣叶连接的内裙边103，固定在所述瓣膜支架流入端110中上部外侧的外裙边104。可选的，内裙边103和外裙边104沿瓣膜支架四周围成一圈，并用缝合、压合或者粘接等方式固定在瓣膜支架上；瓣叶106可以为3瓣结构组成，通过缝线缝于瓣膜支架的中间部分，并与内裙边103固定缝合。
图2所示是本实施例的一种主动脉瓣膜装置的瓣膜支架的展开示意图。所述瓣膜支架包括：所述瓣膜支架流入端110呈现多个菱形网格结构组成的第一喇叭口结构102；在所述下喇叭结构末端用于所述瓣膜支架装载所需的多个连接爪101；可选的，所述连接爪101可以是三个；所述瓣膜支架的中间靠流入端110外侧有 向上且向外扩张的多个定位结构105；所述瓣膜支架中间靠流出端120的带孔直杆连接结构107；所述瓣膜支架流出端120呈现多个菱形网格结构组成的第二喇叭口结构108。第二喇叭口结构108的菱形网格结构的尺寸大于第一喇叭口结构102的菱形网格结构的尺寸。
所述瓣膜支架中间部分为多个带孔直杆连接结构107，带孔直杆连接结构107的数量可以为3个到6个。可选择地，所述带孔直杆连接结构的孔为缝合孔，缝合孔的形状可为椭圆形孔、方形孔或圆形孔等。所述缝合孔的数量为3个到5个。带孔直杆连接结构107的作用为固定瓣叶106、连接第一喇叭口结构102和第二喇叭口结构108。可选择地，所述带孔直杆连接结构107的长度为5mm到10mm，所述带孔直杆连接结构107的宽度为1mm到2mm，在具体实施过程中，带孔直杆连接结构107的长度和宽度可以根据瓣膜支架的规格和支撑力等因素来调整和选择。
所述瓣膜支架的带孔直杆连接结构107连接瓣膜支架流入端110的第一喇叭口结构102和瓣膜支架流出端120的第二喇叭口结构108。所述流出端120第二喇叭口结构108外接圆的直径比所述流入端110第一喇叭口结构102外接圆的直径大3mm到12mm。所述瓣膜支架流入端110的第一喇叭口结构102圆周方向上呈菱形的网格结构的数量为6个到15个，所述瓣膜支架流出端120的第二喇叭口结构108圆周方向上呈菱形的网格结构的数量为3个至9个。
所述瓣膜支架流入端110的第一喇叭口结构102的末端可以为呈向外扩张的平直结构，可选的，扩张角度小于等于10度。可选择地，所述平直段的长度为3mm到9mm。如图2所示，在所述瓣膜支架流入端110的第一喇叭口结构末端为带孔眼1021的结构，这些孔眼的作用为方便其与内裙边103的缝合。在所述下喇叭结构末端用于所述瓣膜支架的装载所需的多个连接爪101的形状为T型结构，即连接爪101的末端向两侧凸出，T型结构为空心或者实心，例如为实心。
如图1和图3所示，所述瓣膜支架的定位结构105的定位结构根部51起源于瓣膜支架100的流入端110第一喇叭口结构102，并朝流出端120方向向外扩张，形成定位结构末端52。所述定位结构沿瓣膜支架中间部分圆周方向均匀分布。可选地，所述瓣膜定位结构的数量为3个到9个。如图3所示，所述定位结构末端52为实心或者带沟槽的杆结构，例如为带沟槽的杆结构。所述杆结构的长度为2mm到5mm，杆结构的宽度为0.5mm到2mm。如图1所示，所述定位结构105向外偏离瓣膜支架轴线的角度为0度到90度，例如为0度到45度。如图1所示，所述定位结 构105的定位结构末端52外接圆的直径比所述定位结构根部51对应的外接圆直径大1mm到9mm。
图4是本实施例的一种主动脉瓣膜装置植入到原位主动脉瓣处的示意图。当所述瓣膜支架100植入到原位主动脉瓣位置时，所述瓣膜支架的定位结构105和瓣膜支架流入端110的第一喇叭口结构102用于限制所述瓣膜支架100在主动脉瓣环处植入的位置，所述定位结构105具有主动定位和自适应主动脉瓣环201和自然瓣叶202的特点。所述瓣膜支架流出端120第二喇叭口结构的菱形网格结构均匀分布保证所述瓣膜支架在升主动脉204中与血管同轴、稳定。所述外裙边104贴合在瓣膜支架流入端110第一喇叭口结构102和主动脉瓣环201的中间以减少瓣周漏。如图4所示，瓣膜支架100植入到原位主动脉瓣膜后的另外一个特点是瓣膜支架100中间的大网格空隙完全不影响冠脉203血流的灌溉。
本实施例中所述瓣膜支架的材料可以为超弹性合金和形状记忆合金中的至少一种，例如为镍钛合金材料。所述瓣叶的材料、所述的内裙边的材料和所述外裙边的材料可以分别为动物心包膜材料或者高分子材料，例如牛心包、猪心包、聚四氟乙烯、纤维布或者纤维膜材料等。其中，所述纤维布为纤维织物。
本实施例所述的一种主动脉瓣膜装置的工作过程如下：
将所述主动脉瓣膜装置100通过装载装置在冰水浴中收缩并装入输送系统300的装载鞘前部303和装载鞘后部304中(参考图5)。在释放过程中，通过手柄305将输送系统300的装载鞘前部303向前移动，将所述主动脉瓣膜100的瓣膜支架定位结构105释放出来，此时由于所述瓣膜支架100材料具有超弹性和形状记忆特性，所述定位结构105在体温(37±1℃)下自动张开。然后慢慢向前推动输送系统300，使得所述定位结构105接触到人体自然瓣叶组织202，然后停止推动输送系统300，此时主动脉瓣膜支架流入端110的第一喇叭口结构依然在装载鞘前部303中。然后确定所述主动脉瓣膜装置100在主动脉瓣环201的位置后，再通过手柄305将输送系统的装载鞘后部304向后移动，使得所述主动脉瓣膜装置100的瓣膜支架流出端120第二喇叭口结构108从输送系统300的装载鞘后部304中释放出来，由于所述瓣膜支架100材料具有超弹性和形状记忆特性，所述瓣膜支架流出端120第二喇叭口结构108在体温下自动张开，并撑住升主动脉204。然后在确定所述主动脉瓣膜装置100在升主动脉稳定释放后，继续通过手柄305向前推动输送系统挂的装载鞘前部303，将所述主动脉瓣 膜100瓣膜支架流入端110的第一喇叭口结构102和连接爪101从输送系统的装载鞘前部303和输送系统头端301的装载卡槽302中脱离出来，完成所述主动脉瓣膜装置100的准确植入。通过调整输送系统手柄305将装载鞘前部303和装载鞘后部304结合起来，整体撤出输送系统300，以减少输送系统300回撤时对血管的损伤。
工业实用性
本实施例的主动脉瓣膜装置实现了主动脉瓣瓣膜装置的装载与释放；实现了主动脉瓣瓣膜装置在手术过程中的精确定位；减少了瓣周漏，提高了手术的安全可靠性。

Claims (13)

  1. 一种主动脉瓣膜装置，包括：
    瓣膜支架；
    固定在所述瓣膜支架内侧的瓣叶；
    沿所述瓣膜支架内侧周边固定、并与所述瓣叶连接固定的内裙边；以及
    沿所述瓣膜支架中间靠流入端外侧固定的外裙边；其中，所述瓣膜支架的流入端呈现多个菱形网格结构组成的第一喇叭口结构；
    设置在所述的第一喇叭口结构末端的用于所述瓣膜支架装载的连接爪；
    设置在所述瓣膜支架的中间靠近第一喇叭口结构的外侧有向外扩张的多个定位结构；所述瓣膜支架的定位结构用于限制所述瓣膜支架在主动脉瓣环处植入的位置；以及
    设置在所述瓣膜支架的中间靠近流出端一侧的多个带孔直杆连接结构；
    其中，所述瓣膜支架的流出端呈现多个菱形网格结构组成的第二喇叭口结构，所述菱形网格结构均匀分布以保证所述瓣膜支架稳定地固定在升主动脉中，且与血管同轴。
  2. 根据权利要求1所述的主动脉瓣膜装置，其中，所述瓣膜支架为超弹性合金和形状记忆合金材料中的至少一种，激光切割而成。
  3. 根据权利要求1所述的主动脉瓣膜装置，其中，所述瓣膜支架的中间部分为多个带孔直杆连接结构，所述第二喇叭口结构的菱形网格结构的网孔尺寸大于所述第一喇叭口结构的菱形网格结构的网孔尺寸。
  4. 根据权利要求3所述的主动脉瓣膜装置，其中，所述带孔直杆连接结构的孔的形状为椭圆形孔、方形孔或圆形孔。
  5. 根据权利要求1所述的主动脉瓣膜装置，其中，所述定位结构向外偏离瓣膜支架轴线的角度为0度到90度。
  6. 根据权利要求5所述的主动脉瓣膜装置，其中，所述瓣膜支架的定位结构的尖端为带沟槽的杆结构，或者实心结构。
  7. 根据权利要求1所述的主动脉瓣膜装置，其中，所述瓣叶的材料包括动物心包膜或高分子材料。
  8. 根据权利要求1所述的主动脉瓣膜装置，其中，所述内裙边的材料包括动物心包膜或高分子材料。
  9. 根据权利要求1所述的主动脉瓣膜装置，其中，所述外裙边的材料包括动物心包膜或高分子材料。
  10. 根据权利要求7-9任一所述的主动脉瓣膜装置，其中，所述动物心包膜包括牛心包或猪心包。
  11. 根据权利要求7-9任一所述的主动脉瓣膜装置，其中，所述高分子材料包括聚四氟乙烯、纤维布或纤维膜。
  12. 根据权利要求1所述的主动脉瓣膜装置，其中，所述连接爪为T型结构，所述T型结构可为实心或者空心。
  13. 根据权利要求1所述的主动脉瓣膜装置，其中，所述连接爪的个数为三个。
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