WO2020078349A1 - 一种心脏瓣膜支架及其假体 - Google Patents

一种心脏瓣膜支架及其假体 Download PDF

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Publication number
WO2020078349A1
WO2020078349A1 PCT/CN2019/111230 CN2019111230W WO2020078349A1 WO 2020078349 A1 WO2020078349 A1 WO 2020078349A1 CN 2019111230 W CN2019111230 W CN 2019111230W WO 2020078349 A1 WO2020078349 A1 WO 2020078349A1
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WIPO (PCT)
Prior art keywords
stent
heart valve
inflow
channel
protrusion
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PCT/CN2019/111230
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English (en)
French (fr)
Inventor
刘世红
赵婧
陈国明
李�雨
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上海微创心通医疗科技有限公司
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Publication of WO2020078349A1 publication Critical patent/WO2020078349A1/zh

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Classifications

    • 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
    • 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
    • A61F2/2442—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 invention relates to an interventional medical prosthesis, in particular to a heart valve stent and its prosthesis.
  • aortic valve disease has become one of the common cardiovascular diseases.
  • the incidence rate in China is 2% -5%, and it ranks third in the European and American countries after coronary heart disease and hypertension.
  • Thousands of patients can benefit from surgical aortic valve replacement every year, but even in developed countries, there are still a large number of patients with severe aortic valve disease due to advanced disease, advanced age, and multiple comorbidities.
  • Unable to accept surgical treatment the emergence of percutaneous artificial aortic valve products and the continuous improvement of product performance have undoubtedly brought gospel to this part of patients and provided an effective treatment method.
  • TAVI valve prostheses are released through self-expansion or balloon expansion.
  • the principle is to compress the stent in the sheath, deliver it to the aortic valve through the femoral artery or apex through the conveyor, and release it at the calcified annulus.
  • the expanded stent then expands the calcified annulus and fixes the entire artificial valve
  • the prosthesis starts to work after the leaflets are opened.
  • the valve prosthesis has limited ability to prevent perivalvular leakage
  • the technical problem to be solved by the present invention is to provide a heart valve stent and its prosthesis, which can prevent the risk of the stent moving from the inflow channel toward the outflow channel under the flushing of blood flow, and has a simple structure and is easy to implement.
  • the technical solution adopted by the present invention to solve the above technical problems is to provide a heart valve stent including a stent body, the stent body is composed of interconnected grid structure units, and the stent body is divided into successively connected in the axial direction The inflow channel, the transition section and the outflow channel, wherein the bracket further has a limit structure connected to the bracket body; the limit structure is distributed on the outflow channel or the transition section along the circumferential direction, the The limiting structure has a first protrusion for limiting the movement of the bracket from the inflow channel toward the outflow channel.
  • the limiting structure is manufactured separately from the bracket body and then assembled.
  • the first protrusion is an arc-shaped protrusion, a trapezoidal protrusion, a wave-shaped protrusion, or a zigzag protrusion.
  • the area of the grid structure unit located on the transition section on the bracket is larger than the area of the grid structure unit of the inflow channel or the outflow channel.
  • transition section has a concave structure away from the first protrusion.
  • the distance between the plane of the vertex of the first protrusion and the plane of the outlet port is 0-30 mm.
  • the port of the outflow tract does not extend out of the sinus canal junction.
  • the inflow tract has at least one contact position with the native tissue above the annulus.
  • the inflow tract closely adheres to the native tissue under the annulus.
  • the range of the distance d between the plane of the end of the inflow channel of the stent and the plane of the annulus is 0 ⁇ d ⁇ 15mm.
  • a heart valve prosthesis including a stent and a valve leaflet
  • the stent is the above-mentioned stent
  • the valve leaflet is fixed inside the stent.
  • the heart valve prosthesis also has an inner skirt, and the inner skirt is disposed on the inner side of the stent.
  • the inflow tract has at least one contact position with native tissue above the annulus, and the stent is provided with an outer skirt at the contact position of the inflow tract and native tissue .
  • the inflow tract closely adheres to the native tissue under the annulus, and the stent is provided with an outer skirt at the fitting position of the inflow tract and the native tissue.
  • the heart valve stent and its prosthesis provided by the present invention can prevent the stent from being washed out by blood flow by setting a limit structure at the position of the outflow tract or transition section of the stent The risk of moving from the inflow to the outflow.
  • the inflow channel of the stent is set to a shape matching with the original tissue, and at the same time, an outer skirt is provided at the outer circumferential direction of the inflow channel at the place where it is in contact with the original tissue, which can effectively prevent perivalvular leakage.
  • the size of the inflow channel of the stent extending in the direction of the annulus can be set shorter, which can effectively prevent atrioventricular conduction resistance Stagnation.
  • FIG. 1 is a schematic structural diagram of a heart valve stent in an embodiment of the present invention
  • FIG. 2a is a schematic diagram of a limiting structure on a stent outflow tract of a heart valve prosthesis according to an embodiment of the present invention
  • FIGS. 2b to 2e are schematic structural views of the first convex portion on the limiting structure on the stent outflow tract of the heart valve prosthesis in the embodiment of the present invention
  • FIG. 3 is a schematic diagram of the concave structure on the transitional section of the stent of the heart valve prosthesis in the embodiment of the present invention.
  • FIGS. 4a and 4b are schematic structural diagrams of an inflow tract of a heart valve prosthesis according to an embodiment of the present invention.
  • FIG. 1 is a schematic structural diagram of a heart valve stent in an embodiment of the present invention.
  • the heart valve prosthesis provided by the present invention includes a stent 10, a leaflet and a skirt (not shown in the figure).
  • the stent 10 includes a stent body and a limiting structure 1031 connected to the stent body.
  • the stent body is composed of interconnected grid structural units.
  • the stent body is axially divided into an inflow channel 101, a transition section 102, and an outflow channel 103; according to the direction of blood flow, the transition section 102 is located downstream of the inflow channel 101.
  • the outflow channel 103 is located downstream of the transition section 102.
  • the inflow tract 101 corresponds to the portion of blood flowing into the prosthesis during valve operation
  • the outflow tract 103 corresponds to the portion of blood flowing out of the prosthesis during valve operation.
  • the inflow channel 101 matches the shape of the original tissue.
  • the stent 10 is provided with a limiting structure 1031 along the circumferential direction on the outflow channel 103 or the transition section 102.
  • the limiting structure 1031 has a structure for limiting the inflow of the stent 10 from inflow The first protrusion 1032 of the channel 101 moving toward the outflow channel 103.
  • the limiting structure 1031 is disposed on the outflow channel 103, and the plane of the vertex of the first protrusion 1032 is perpendicular to the plane of the port of the outflow channel 103 The distance is 0-30 mm; in another embodiment, the limit structure 1031 is disposed on the transition section 102, preferably, the limit structure 1031 is disposed on the transition section 102 near the outflow channel 103.
  • the port of the outflow tract 103 does not extend out of the sinus canal junction 40, that is, the plane where the port of the outflow tract 103 lies is flush with the plane of the sinus canal junction 40 or is lower than the sinus canal In the plane where the portion 40 is located, the sinus canal junction 40 is the junction of the aortic sinus and the aorta.
  • the limit structure 1031 may be partially distributed in the circumferential direction, or may be completely distributed in the circumferential direction, and preferably distributed completely in the circumferential direction.
  • the stent 10 is made of a metal material, preferably, it is prepared by cutting a nickel titanium tube.
  • the leaflets and skirts are made of animal-derived materials, such as animal pericardium, or biocompatible polymer materials, such as polyurethane.
  • FIG. 2a is a schematic diagram of a limiting structure on a stent outflow tract of a heart valve prosthesis in an embodiment of the present invention.
  • the limiting structure 1031 has a first convex portion 1032, which has elasticity and can be compressed in the radial direction and the axial direction.
  • the first protrusion 1032 may be made of the same material as the main body of the holder, or may be made of other materials or structures with elasticity.
  • the first protrusion 1032 can be manufactured integrally with the main body of the stand, or can be assembled and connected after being manufactured separately.
  • integrated manufacturing refers to cutting from a metal pipe and then shaping by heat treatment; or one or more Made of metal wire.
  • split manufacturing refers to assembly and connection by welding and other methods after separate manufacturing.
  • the first protrusion 1032 may be an arc-shaped protrusion, a trapezoidal protrusion, a wavy protrusion, or a zigzag protrusion, as shown in FIGS. 2b to 2e.
  • the first protrusion 1032 has at least one protrusion, which is located on the area between the sinus canal junction 40 and the coronary sinus ostium 30 when the stent 10 is released and fixed at a specific position of the heart
  • the portion 40 and the coronary sinus ostium 30 have tissue contact or no contact.
  • the function of the first protrusion 1032 is to restrict the movement of the stent 10 from the inflow tract toward the outflow tract along the blood flow direction.
  • the stent 10 When the stent 10 is subjected to an external force in the blood flow direction, such as blood flow, the stent 10 will tend to shift toward the sinus canal junction 40. Under the action of the external force, the first protrusion 1032 and the native tissue The at least one contact point may restrict the bracket 10 from continuing to move upward.
  • the bracket 10 of the present invention has a grid unit structure, generally a diamond shape, or other suitable shapes, such as pentagons, hexagons, etc., which can form a closed shape unit.
  • the transition section 102 may be designed as a grid structure with a larger size, for example, the mesh structure unit area is larger than the cross-sectional area of the coronary sinus ostium 30, or the grid structure of the transition section 102 The cell area is larger than the grid structure cell area of the inflow channel 101 or the outflow channel 103.
  • the transition section 102 may also have a concave structure 1021 away from the first convex portion 1032, and in particular, the transition section 102 may have a concave structure 1021 at the position of the coronary sinus ostium 30.
  • the concave structure 1021 is recessed in a direction away from the coronary sinus ostium 30 and has a certain distance from the coronary sinus ostium 30.
  • the two convex portions 1022 are provided at both ends of the concave structure 1021, as shown in FIG. 3, the concave structure 1021 can also prevent the coronary sinus ostium 30 from being blocked.
  • the shape of the inflow channel 101 of the stent 10 of the present invention is set to match the shape of the original tissue to prevent paravalvular leakage.
  • the present invention uses "above” and “below” as directional words, the inflow channel 101 is located at "below", and the outflow channel 103 is located at "above”.
  • the inflow channel 101 is close to the annulus 20 and closely adheres to the native tissue.
  • the inflow channel 101 of the stent 10 is sewed with a skirt, which may be a single layer or a double layer.
  • the double-layer skirt means that both the inner and outer layers of the inflow channel 101 are sewn with skirts, the inner layer of the inflow channel 101 is sewn with inner skirts, and the outer layer of the inflow channel 101 is sewn with outer skirts.
  • the single-layer skirt means that the inner skirt of the inflow channel 101 is sewn with an inner skirt.
  • the inner skirt is fixed on the inner side of the inflow channel 101 and fixedly connected with the leaflets.
  • the inner layer of the inflow channel 101 is sewn with an inner skirt, and the outer skirt is sewn at the contact position 104, and the outer skirt is sewn at the fitting position of the inflow channel 101 and the native tissue, which can effectively prevent the valve periphery leak.
  • the size of the inflow tract 101 of the stent 10 extending out of the annulus 20 can be The setting is relatively short, for example, the value range of the vertical distance d from the plane where the annulus 20 is located to the plane where the end of the stent inflow channel 101 is located is 0 ⁇ d ⁇ 15mm.
  • the d in the present invention is smaller than the d 'of the traditional stent, which can effectively prevent atrioventricular conduction block; the traditional stent is longer in this part because it is necessary to prevent paravalvular leakage, and the too short stent is easy to move from the inflow channel Move outflow direction.
  • the outflow tract 103 of the heart valve prosthesis and the stent 10 according to the present invention is provided with a limit structure 1031 near the transition section 102, which can prevent the stent 10 from the inflow tract toward the outflow tract under the scouring of blood flow The risk of moving in directions.
  • the inflow channel 101 of the stent 10 is set to a shape matching the original tissue, and at the same time, an outer skirt is provided in the outer circumferential direction of the inflow channel 101 at the place where it is in contact with the original tissue, which can effectively prevent the paravalvular leakage.
  • the size of the inflow channel 101 of the stent 10 extending in the direction of the annulus 20 can be set shorter, and Effectively prevent atrioventricular block, embolism, etc.
  • the port of the outflow tract 103 may not protrude from the sinus tube junction 40, and the size of the outflow tract may also be set shorter to reduce the compression of the aorta.

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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

一种心脏瓣膜支架（10）及其假体，包括支架主体，支架主体由相互连接的网格结构单元组成，支架主体在轴向上分为依次相连的流入道（101）、过渡段（102）和流出道（103），支架（10）还包括与支架主体相连接的限位结构（1031）；限位结构（1031）沿圆周方向分布在流出道（103）或过渡段（102）上，限位结构（1031）具有用于限制支架（10）由流入道（101）朝向流出道（103）方向移动的第一凸起部（1032）。通过在支架（10）的流出道（103）上设置限位结构（1031），可以防止支架（10）在血流的冲刷下向流出道（103）方向窜动。支架（10）的流入道（101）设置为适应原生组织的形状，在与原生组织贴合处在流入道（101）的外侧周向设置外裙边，可以有效地防止瓣周漏，同时防止瓣膜向流入道（101）方向窜动。此外，支架（10）的流入道（101）尺寸可以较短，有效防止了房室传导阻滞，同时流出道（103）尺寸也可以较短，减少对主动脉的压迫。

Description

一种心脏瓣膜支架及其假体 技术领域
本发明涉及一种介入式医用假体，尤其涉及一种心脏瓣膜支架及其假体。
 背景技术
随着全球老龄化社会的到来，主动脉瓣膜病变已成为常见的心血管疾病之一。在我国国内的发病率为2％-5％，而在欧美国家位于冠心病和高血压病之后，居第三位。每年有成千上万的患者能从外科主动脉瓣膜置换术中获益，但即使在发达国家，仍有大量严重主动脉瓣膜病变的患者因为疾病晚期、高龄以及存在多种合并症等原因而不能接受外科手术治疗，经皮人工主动脉瓣产品的出现和产品性能的不断完善，无疑为这部分病人带来了福音，提供了一种有效的治疗方法。
2002年Cribier等首先报道了第一例人体经导管主动脉瓣膜置换病例，此后，国内外众多学者、医生均开展了经导管主动脉瓣膜置换(TAVR)的基础和临床研究，并取得了较好的临床效果，研究表明：对于无法进行外科换瓣或外科换瓣手术存在高风险的患者，这项新技术是安全有效的。与外科手术相比，经皮主动脉瓣膜置换术无需开胸及体外循环支持，是一种创伤小、并发症少、术后康复快、患者痛苦小、容易接受的治疗方法。尽管进行TAVR手术的多为高风险患者，但术后30天存活率高于90％，术后患者血流动力学指标得到了明显的改善。
 技术问题
现有TAVI瓣膜假体的释放大多是通过自膨胀方式或者球囊扩张的方式。其原理是把支架压缩在鞘管内，通过输送器经股动脉或心尖输送到主动脉瓣膜处，在钙化的瓣环处释放，膨胀后的支架随即撑开钙化的瓣环，同时固定整个人工瓣膜假体，瓣叶打开后开始工作。
国内外主动脉支架从临床表现来看，面临一些问题亟待解决。
1、支架在体内释放后，容易发生移位；
2、瓣膜假体的防瓣周漏能力有限；
3、心脏瓣膜假体的流入道过长容易引起房室传导阻滞。
 技术解决方案
本发明所要解决的技术问题是提供一种心脏瓣膜支架及其假体，能够防止在血流的冲刷下，支架由流入道朝向流出道方向移动的风险，且结构简单，易于实施。
本发明为解决上述技术问题而采用的技术方案是提供一种心脏瓣膜支架，包括支架主体，所述支架主体由相互连接的网格结构单元组成，所述支架主体在轴向上分为依次相连的流入道、过渡段和流出道，其中，所述支架还具有与所述支架主体相连接的限位结构；所述限位结构沿圆周方向分布在所述流出道或过渡段上，所述限位结构具有用于限制所述支架由所述流入道朝向所述流出道方向移动的第一凸起部。
进一步地，所述限位结构与所述支架主体分开制造后再组装而成。
进一步地，所述第一凸起部为弧形凸起、梯形凸起、波浪形凸起或锯齿形凸起。
进一步地，所述支架上位于所述过渡段的网格结构单元面积大于所述流入道或流出道的网格结构单元面积。
进一步地，所述过渡段具有远离第一凸起的内凹结构。
进一步地，所述第一凸起部顶点所在的平面与所述流出道端口所在平面的距离为0-30mm。
进一步地，所述支架释放撑开后，所述流出道的端口不伸出窦管结合部。
进一步地，所述支架释放撑开后，所述流入道在瓣环的上方与原生组织存在至少一个接触位置。
进一步地，所述支架释放撑开后，所述流入道在瓣环的下方与原生组织紧密贴合。
进一步地，所述支架的流入道末端所在平面到瓣环所在平面的距离d的取值范围为0＜d≤15mm。
本发明为解决上述技术问题而采用的另一技术方案是提供一种心脏瓣膜假体，包括支架和瓣叶，所述支架为上述支架，所述瓣叶固定于所述支架的内侧。
进一步地，所述心脏瓣膜假体还具有内裙边，所述内裙边设于所述支架的内侧。
进一步地，所述支架释放撑开后，所述流入道在瓣环的上方与原生组织存在至少一个接触位置，并且所述支架在所述流入道和原生组织的接触位置处设置有外裙边。
进一步地，所述支架释放撑开后，所述流入道在瓣环的下方与原生组织紧密贴合，所述支架在所述流入道和原生组织的贴合位置处设置有外裙边。
 有益效果
本发明对比现有技术有如下的有益效果：本发明提供的心脏瓣膜支架及其假体，通过在支架的流出道或过渡段的位置设置限位结构，可以防止在血流的冲刷下，支架由流入道朝向流出道方向移动的风险。支架的流入道设置成与原生组织相匹配的形状，同时在与原生组织贴合处在流入道的外侧周向上设置外裙边，可以有效地防止瓣周漏。此外，由于设置了第一凸起部以及设置流入道与原生组织形状适应来实现支架的固定，支架的流入道向瓣环方向延伸出的尺寸可以设置的较短，可以有效防止房室传导阻滞。
 附图说明
图1为本发明实施例中心脏瓣膜支架的结构示意图；
图2a为本发明实施例中心脏瓣膜假体的支架流出道上的限位结构的示意图；
图2b～2e为本发明实施例中心脏瓣膜假体的支架流出道上的限位结构上第一凸起部的结构示意图；
图3为本发明实施例中心脏瓣膜假体的支架过渡段上的内凹结构的示意图；
图4a、图4b为本发明实施例中心脏瓣膜假体的流入道的结构示意图。
图中：
10支架               20瓣环            30冠状窦口
101流入道            102过渡段      103流出道
104接触位置          1021内凹结构    1022第二凸起部
1031限位结构       1032第一凸起部  40 窦管结合部。
 本发明的实施方式
下面结合附图和实施例对本发明作进一步的描述。
图1为本发明实施例中心脏瓣膜支架的结构示意图。
本发明提供的心脏瓣膜假体，包括支架10、瓣叶和裙边（图中未示出），请参见图1，支架10包括支架主体和与支架主体相连接的限位结构1031。所述支架主体由相互连接的网格结构单元组成，支架主体在轴向上分为流入道101、过渡段102和流出道103；根据血流的方向，过渡段102位于流入道101的下游，流出道103位于过渡段102的下游。流入道101对应于瓣膜操作时血液流入假体的部分，流出道103对应于瓣膜操作时血液流出假体的部分。支架10释放撑开后，流入道101与原生组织的形状相匹配，支架10在流出道103或过渡段102上沿圆周方向设置有限位结构1031，限位结构1031具有用于限制支架10由流入道101朝向流出道103方向移动的第一凸起部1032，较佳地，限位结构1031设置在流出道103上，第一凸起部1032顶点所在的平面与流出道103端口所在平面的垂直距离为0-30mm；在另一实施例中，限位结构1031设置在过渡段102上，优选地，限位结构1031设置在靠近流出道103的过渡段102上。优选地，支架10释放撑开后，流出道103的端口不伸出窦管结合部40，即流出道103的端口所在的平面与窦管结合部40所在的平面齐平或者低于窦管结合部40所在的平面，窦管结合部40为主动脉窦与主动脉交界处。限位结构1031在周向上可以部分分布，也可以在周向上全部分布，优选在周向上全部分布。
本发明提供的心脏瓣膜假体，支架10采用金属材料制造，优选地，采用镍钛管材切割制备而成。瓣叶和裙边采用动物源性材料，如动物心包膜，或者具有生物相容性的高分子材料，如聚氨酯等制备而成。
图2a为本发明实施例中心脏瓣膜假体的支架流出道上的限位结构的示意图。
参见图1和图2a，该限位结构1031具有第一凸起部1032，该第一凸起部1032具有弹性，可以在径向和轴向上被压缩。第一凸起部1032可以采用与支架主体相同的材料来制备，也可以采用具有弹性的其他材料或结构。该第一凸起部1032可以与支架主体一体制造，也可以分体制造后组装连接，所谓的一体制造是指由一根金属管材切割而成，然后通过热处理定型；或者由一根或多根金属丝编制而成。所谓分体制造是指分开制造后通过焊接等方式组装连接而成。第一凸起部1032可以为弧形凸起、梯形凸起、波浪形凸起或锯齿形凸起等，如图2b～2e所示。该第一凸起部1032具有至少一个凸起，当支架10在心脏特定位置释放并固定时，该凸起位于窦管结合部40与冠状窦口30之间的区域上，与位于窦管结合部40与冠状窦口30之间的组织接触或不接触，第一凸起部1032的作用是限制支架10沿着血流方向由流入道朝向流出道方向移动。当支架10沿血流方向受到外力，如血流冲刷，支架10将会有向窦管结合部40方向移位的倾向，在该外力的作用下，第一凸起部1032与原生组织之间的至少一个接触点可以限制支架10继续上移。
本发明的支架10具有网格单元结构，一般为菱形，也可以为其他合适的形状、如五边形、六边形等可形成封闭形状的单元。为了避免冠状窦口30被阻塞，可以将过渡段102设计成具有较大尺寸的网格结构，例如，网格结构单元面积大于冠状窦口30的横截面积，或者过渡段102的网格结构单元面积大于流入道101或流出道103的网格结构单元面积。也可以在过渡段102具有远离第一凸起部1032的内凹结构1021，特别是过渡段102在冠状窦口30的位置具有内凹结构1021。该内凹结构1021朝向远离冠状窦口30的方向凹陷，与冠状窦口30具有一定距离，内凹结构1021的两端设有第二凸起部1022，如图3所示，该内凹结构1021也可以避免冠状窦口30被阻塞。
本发明的支架10的流入道101的形状设置为与原生组织的形状相适应，以防止瓣周漏。为了更加清楚地描述本发明的结构特征，本发明采用“上方”、“下方”作为方位词，流入道101位于“下方”，流出道103位于“上方”。如图4a所示，可以在瓣环20的上方与原生组织存在至少一个接触位置104，，在瓣环20的下方与原生组织紧密贴合，瓣环20上方与原生组织之间的接触位置104可以进一步防止瓣周漏。或者也可以如图4b所示，流入道101在瓣环20附近，与原生组织紧密贴合。
为了更进一步的防止瓣周漏，支架10的流入道101上缝有裙边，裙边可以是单层的，也可以是双层的。双层裙边指的是流入道101的内外层均缝有裙边，流入道101的内层缝有内裙边，流入道101的外层缝有外裙边。单层裙边指的是流入道101的内层缝有内裙边。内裙边固定在流入道101的内侧，并与瓣叶固定连接。优选地，流入道101的内层缝有内裙边，并在接触位置104处缝制外裙边，在流入道101和原生组织的贴合位置处缝制外裙边，可以有效防止瓣周漏。
由于该支架10已经通过在流出道103区域上设置第一凸起部1032以及设置流入道101与原生组织形状适应来实现支架10的固定，支架10的流入道101延伸出瓣环20的尺寸可以设置的较短，例如，从瓣环20所在平面到支架流入道101末端所在平面的垂直距离d的取值范围是0＜d≤15mm。本发明中的d相较于传统支架的d’小，可以有效防止房室传导阻滞；传统的支架这部分较长，原因在于要防止瓣周漏，且设置过短支架容易由流入道朝流出道方向移动。
综上所述，本发明涉及的心脏瓣膜假体及支架10的流出道103在靠近过渡段102的位置设置限位结构1031，可以防止在血流的冲刷下，支架10由流入道朝向流出道方向移动的风险。支架10的流入道101设置成与原生组织相匹配的形状，同时在与原生组织贴合处在流入道101的外侧周向上设置外裙边，可以有效地防止瓣周漏。此外，由于设置了第一凸起部1032以及设置流入道101与原生组织形状适应来实现支架10的固定，支架10的流入道101向瓣环20方向延伸出的尺寸可以设置的较短，可以有效防止房室传导阻滞、栓塞等。同时流出道103的端口可以不伸出窦管结合部40，流出道尺寸也可以设置的较短，减少对主动脉的压迫。
虽然本发明已以较佳实施例揭示如上，然其并非用以限定本发明，任何本领域技术人员，在不脱离本发明的精神和范围内，当可作些许的修改和完善，因此本发明的保护范围当以权利要求书所界定的为准。

Claims (14)

  1. 一种心脏瓣膜支架，包括支架主体，所述支架主体由相互连接的网格结构单元组成，所述支架主体在轴向上分为依次相连的流入道、过渡段和流出道，其特征在于，所述支架还具有与所述支架主体相连接的限位结构；所述限位结构沿圆周方向分布在所述流出道或过渡段上，所述限位结构具有用于限制所述支架由所述流入道朝向所述流出道方向移动的第一凸起部。
  2. 如权利要求1所述的心脏瓣膜支架，其特征在于，所述限位结构与所述支架主体分开制造后再组装而成。
  3. 如权利要求1所述的心脏瓣膜支架，其特征在于，所述第一凸起部为弧形凸起、梯形凸起、波浪形凸起或锯齿形凸起。
  4. 如权利要求1所述的心脏瓣膜支架，其特征在于，所述支架上位于所述过渡段的网格结构单元面积大于所述流入道或流出道的网格结构单元面积。
  5. 如权利要求1所述的心脏瓣膜支架，其特征在于，所述过渡段具有远离第一凸起的内凹结构。
  6. 如权利要求1所述的心脏瓣膜支架，其特征在于，所述第一凸起部顶点所在的平面与所述流出道端口所在平面的距离为0-30mm。
  7. 如权利要求6所述的心脏瓣膜支架，其特征在于，所述支架释放撑开后，所述流出道的端口不伸出窦管结合部。
  8. 如权利要求1所述的心脏瓣膜支架，其特征在于，所述支架释放撑开后，所述流入道在瓣环的上方与原生组织存在至少一个接触位置。
  9. 如权利要求1或8所述的心脏瓣膜支架，其特征在于，所述支架释放撑开后，所述流入道在瓣环的下方与原生组织紧密贴合。
  10. 如权利要求1所述的心脏瓣膜支架，其特征在于，所述支架的流入道末端所在平面到瓣环所在平面的距离d的取值范围为0＜d≤15mm。
  11. 一种心脏瓣膜假体，包括支架和瓣叶，其特征在于，所述支架为权利要求1-10任一项所述的支架，所述瓣叶固定于所述支架的内侧。
  12. 如权利要求11所述的心脏瓣膜假体，其特征在于，所述心脏瓣膜假体还具有内裙边，所述内裙边设于所述支架的内侧。
  13. 如权利要求12所述的心脏瓣膜假体，其特征在于，所述支架释放撑开后，所述流入道在瓣环的上方与原生组织存在至少一个接触位置，并且所述支架在所述流入道和原生组织的接触位置处设置有外裙边。
  14. 如权利要求11或13所述的心脏瓣膜假体，其特征在于，所述支架释放撑开后，所述流入道在瓣环的下方与原生组织紧密贴合，所述支架在所述流入道和原生组织的贴合位置处设置有外裙边。
     
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