WO2024066785A1 - 一种在心脏隔离装置辅助下的瓣膜植入装置 - Google Patents

一种在心脏隔离装置辅助下的瓣膜植入装置 Download PDF

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Publication number
WO2024066785A1
WO2024066785A1 PCT/CN2023/113540 CN2023113540W WO2024066785A1 WO 2024066785 A1 WO2024066785 A1 WO 2024066785A1 CN 2023113540 W CN2023113540 W CN 2023113540W WO 2024066785 A1 WO2024066785 A1 WO 2024066785A1
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WO
WIPO (PCT)
Prior art keywords
valve
isolation device
device body
heart
connecting portion
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PCT/CN2023/113540
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English (en)
French (fr)
Inventor
马琛明
钦湘
李加贤
沈麒麟
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南京圣德医疗科技有限公司
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Application filed by 南京圣德医疗科技有限公司 filed Critical 南京圣德医疗科技有限公司
Priority to EP23809943.6A priority Critical patent/EP4371530A1/en
Publication of WO2024066785A1 publication Critical patent/WO2024066785A1/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
    • 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
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • 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
    • 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
    • A61F2/2466—Delivery devices therefor

Definitions

  • the present invention belongs to the technical field of medical devices, and in particular relates to a valve implantation device assisted by a heart isolation device.
  • Valvular regurgitation is a common heart valve disease, which is mainly divided into two categories: degenerative and functional.
  • Degenerative diseases are mostly pathological changes in the subvalvular structure, mainly chordae tendineae rupture and/or valve leaflet abnormalities.
  • Functional diseases are mostly secondary to ventricular dilatation caused by other diseases, as well as papillary muscle abnormalities.
  • interventional surgical treatment for atrioventricular valve regurgitation is less invasive than surgical surgery, and thus has received a lot of attention.
  • clinical results show that there is no ideal product for interventional atrioventricular valve replacement, and the main reasons are as follows: First, because the structure and etiology of the atrioventricular valve are caused by a variety of reasons, the insufficiency of most patients may have multiple causes or multiple structures involved. Only the implantation of the new valve can be solved, and other structures cannot be improved. For example, the solution disclosed in patent document CN102639179B only replaces the valve leaflets, which is not effective for patients with other causes of impaired ventricular function.
  • the atrioventricular valve is generally large and needs to be replaced by a stent formed by a large number of metal objects.
  • the stent is too large, which makes the operation difficult and the heart structure damaged.
  • the valve anchoring of the prior art mostly relies on the supporting force of the metal stent.
  • a valve implantation device assisted by a heart isolation device comprises a valve, a heart isolation device and a valve connecting device;
  • the heart isolation device comprises an isolation device body;
  • a positioning portion is provided on the isolation device body, and the isolation device body is fixed on the heart tissue through the positioning portion;
  • the valve connecting device comprises a first connecting portion, one side of the first connecting portion is connected to the valve, and a second connecting portion is provided on the isolation device body, and when the valve is implanted, the first connecting portion and the second connecting portion are connected in the ventricle.
  • the positioning portion on the isolation device body is a thorn-like structure, which is located at the position where the isolation device body contacts the heart tissue and can penetrate into the heart tissue to achieve fixation.
  • the thorn-like structure can face any direction, preferably upward, downward, or a combination of upward and downward.
  • the isolation device body also includes a fixing structure, which is arranged below the isolation device body and connected to the ventricular tissue to ensure that the isolation device body is stably positioned.
  • the fixing structure on the cardiac isolation device is connected to the isolation device body by a tether or suture, the fixing structure is located at the apex, the fixing structure includes a structure that can penetrate into the cardiac tissue, including a hook-shaped or thorn-shaped structure, the fixing structure is fixed to the inner wall of the apex, and the cardiac isolation device body is tightened by a tether or suture to provide reliable anchoring for it.
  • first connection portion connected to the valve is fixedly connected to the second connection portion on the isolation device body by means of mechanical connection, preferably by means of threaded connection, snap connection, buckle connection, rotating clip connection or by knotting and bundling.
  • the second connection part on the isolation device body includes a protruding structure
  • the first connection part connected to the valve has a concave structure and a buckle and/or a slot.
  • the protruding structure extends into the first connection part, and the edge of the protruding structure cooperates with the buckle and/or the slot to achieve a fixed connection and prevent the connection from falling off; preferably, the first connection part is connected to the valve by sutures. are connected.
  • the second connecting portion includes a protruding structure
  • the first connecting portion is a rope or a suture.
  • the rope or suture is put on the protruding structure and knotted by a knotting mechanism, thereby achieving a fixed connection between the two.
  • the valve implantation device further comprises a delivery system, which comprises a first delivery system and a second delivery system.
  • the first delivery system is used for delivering the cardiac isolation device into the ventricle, and the second delivery system is used for delivering the valve.
  • the cardiac isolation device in the technical solution of the present invention can improve cardiac function before or simultaneously with valve implantation. It not only treats lesions in the valve ring plane, but also treats lesions outside the valve ring plane. It increases the effectiveness of the surgery and expands the target group of patients to be treated.
  • the present invention fixes the valve by a hook-type structure, and can reduce the metal objects required for replacement of the huge atrioventricular valve.
  • the reduced metal objects can avoid potential damage to the heart valve structure and improve the safety of the operation.
  • the size of the delivery system required to load the metal objects is reduced, thereby improving the safety of the operation.
  • the connecting device for connecting a valve and a cardiac isolation device provided by the present invention can stably position the valve and accurately release the valve height while permanently connecting the subsequently implanted valve thereto, thereby preventing paravalvular leakage and damage to the annular plane.
  • FIG1 is a schematic structural diagram of a valve implantation device of the present invention.
  • FIGS. 2a and 2b are schematic diagrams of structures of various embodiments of the fixing structure
  • 3a to 3c are schematic structural diagrams of various embodiments of the isolation device body
  • 4a to 4e show a first embodiment of valve installation using the implant device of the present invention
  • 5a to 5c are schematic structural diagrams of a first embodiment of a first connecting portion and a second connecting portion
  • 6a and 6b are schematic structural diagrams of a second embodiment of the first connecting portion and the second connecting portion;
  • FIG. 7a to 7c are schematic structural diagrams of a third embodiment of the first connecting portion and the second connecting portion;
  • FIG. 8a to 8d show a process of delivering a cardiac isolation device into a ventricle by a first delivery system
  • 9a to 9e show a second embodiment of valve installation using the implantation device of the present invention.
  • the valve implant device of the present invention includes a valve 1, a heart isolation device 2, and a valve connecting device 3.
  • the heart isolation device 2 includes an isolation device body 21 and an optionally arranged fixing structure 22.
  • a positioning portion 23 is provided on the isolation device body, and the isolation device body 21 is fixed to the heart tissue through the positioning portion 23. More specifically, the isolation device body 21 is attached to the inner wall of the ventricle through the positioning portion 23.
  • the positioning portion is a thorn-like structure that can penetrate into the heart tissue to achieve fixation, and a variety of implementations can be adopted by changing the direction of the hook, as shown in FIGS. 3a to 3c .
  • the fixing structure 22 is disposed below the isolation device body 21.
  • the fixing structure 22 is connected to the isolation device body 21 by a tether or suture.
  • the fixing structure 22 is located at the apex of the heart.
  • the fixing structure 22 includes a structure that can penetrate the heart tissue, including a hook-shaped or thorn-shaped structure, as shown in Figures 2a and 2b.
  • the fixing structure 22 is fixed to the inner wall of the apex of the heart by penetrating the heart tissue, and on the other hand, the tether or suture is used to tighten the heart isolation device body 21 to provide a reliable anchoring for it.
  • the valve connection device 3 includes a first connection portion 31, one side of which is connected to the valve 1 through a flexible structure such as sutures, and a second connection portion 32 is provided on the isolation device body 21.
  • the second connection portion 32 includes a convex structure, which can be a "T" shape as shown in Figure 5a.
  • the first connection portion 31 has an inner concave structure and a buckle structure, as shown in Figures 5a to 5c.
  • the second connection portion 32 is The protruding structure extends into the first connecting portion 31 and is connected with the snap fit, and is clamped and limited by the snap fit to achieve a fixed connection between the first connecting portion 31 and the second connecting portion 32 and effectively prevent disconnection.
  • the first connection part 31 and the second connection part 32 may also adopt other embodiments, such as those shown in Figures 6a and 6b.
  • a slot is provided in the first connection part 31, and the protrusion on the second connection part 32 is in a tower shape, and its edge is in a hook shape.
  • the hook-shaped edge on the second connection part 32 will be stuck in the slot of the first connection part 31 to achieve a fixed connection between the two.
  • the first connection part 31 is a suture, as shown in Figures 7a to 7c.
  • the suture 31 is put on the protruding structure of the second connection part 32 by the knotting mechanism 33 to tie a knot, thereby achieving a fixed connection between the two.
  • the valve implantation device further comprises a delivery system, which comprises a first delivery system and a second delivery system.
  • the first delivery system is used for delivering the cardiac isolation device into the ventricle, and the second delivery system is used for delivering the valve.
  • the heart isolation device 2 is loaded at the distal end of the first delivery system; the heart isolation device 2 is released from the distal end and delivered to the ventricle; the heart isolation device 2 is opened to form; when the heart isolation device 2 is fully opened, the first delivery system is withdrawn, and the thorn-like structure on the heart isolation device 2 pierces into the heart tissue to play a role in positioning and fixing.
  • valve 1 is delivered to the ventricle by the second delivery system, and the valve 1 is installed at the valve ring, and the process is shown in Figures 4a to 4e.
  • the process specifically includes the following steps:
  • S4 Adjust the position and anchoring tightness of the valve 1 by "wire control”.
  • the above operation can be performed by the manipulator at the proximal end of the delivery system to adjust the position and anchoring tightness of the valve 1. After the degree is reached, tie the suture on valve 1 to fix it;
  • FIG. 9a to 9e show another embodiment of the present invention, which relates to another method for installing a valve, comprising the following steps:
  • a second delivery system is used to connect the suture to the second connecting portion 32 on the heart isolation device 2, preferably by tying a knot;

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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

一种在心脏隔离装置辅助下的瓣膜植入装置，包括瓣膜、心脏隔离装置以及瓣膜连接装置；心脏隔离装置包括隔离装置本体；隔离装置本体上设有定位部，隔离装置本体通过所述定位部固定在心脏组织上；所述瓣膜连接装置包括第一连接部，所述第一连接部的一侧与所述瓣膜相连接，所述隔离装置本体上设有第二连接部，使用时，将所述第一连接部与所述第二连接部相连接。本发明的装置能够在瓣膜植入之前/之时改善心脏功能，增加了手术的有效性，依靠挂钩式结构来固定瓣膜，可以减少置换需要的金属物，避免对心脏瓣膜结构的潜在损伤；连接瓣膜的连接器结构使瓣膜稳定定位，精准释放瓣膜高度，能够预防瓣周漏和对瓣环平面的损伤。

Description

一种在心脏隔离装置辅助下的瓣膜植入装置
本申请要求2022年9月26日向中国国家知识产权局提交的，专利申请号为202211177406.8，发明名称为“一种在心脏隔离装置辅助下的瓣膜植入装置”在先申请的优先权。该申请的全文通过引用的方式结合于本申请中。
技术领域
本发明属于医疗器械技术领域，具体涉及一种在心脏隔离装置辅助下的瓣膜植入装置。
背景技术
瓣膜关闭不全是常见的心脏瓣膜疾病，主要分为退行性和功能性两大类别。退行性疾病多为瓣膜下结构病理性改变，主要是腱索断裂和或者瓣叶异常。功能性疾病多位继发于其他疾病导致的心室扩张，以及乳头肌异常。
目前针对房室瓣关闭不全的介入手术治疗，相比于外科手术创伤更小，从而得到了大量的关注。但是临床结果表明，尚未有一款理想的用于介入房室瓣瓣膜置换的产品，其主要原因有以下几点：首先，因为房室瓣的结构和病因由多种原因导致，绝大部分患者的关闭不全可能存在多种病因或者多种结构受累，只解决新瓣膜的植入，不能改善其他结构，比如专利文献CN102639179B公开的方案中只替换了瓣叶，对于带有心室功能受损的其他病因的患者效果不佳。其次，房室瓣普遍偏大，需要通过由大量的金属物形成的支架来做置换。支架过大导致手术操作难度大、心脏结构受损。再次，现有技术的瓣膜锚定多依赖金属支架的支撑力，部分患者出现植入后瓣膜移位，存在锚定不稳定的问题，不可以精准的控制瓣膜的释放高度。
综上所述，亟需一种能够同步改善心室功能，不依赖金属物锚定，可精准释放瓣膜高度的心脏瓣膜植入装置。
发明内容
一种在心脏隔离装置辅助下的瓣膜植入装置，包括瓣膜、心脏隔离装置以及瓣膜连接装置；所述心脏隔离装置包括隔离装置本体；所述隔离装置本体上设有定位部，所述隔离装置本体通过所述定位部固定在心脏组织上；所述瓣膜连接装置包括第一连接部，所述第一连接部的一侧与所述瓣膜相连接，所述隔离装置本体上设有第二连接部，在植入所述瓣膜时，将所述第一连接部与所述第二连接部在心室内进行连接。
进一步地，所述隔离装置本体上的定位部为刺状结构，位于隔离装置本体与心脏组织接触的位置，能够刺入心脏组织内而实现固定，所述刺状结构可以朝向任意方向，优选向上、向下或向上和向下相结合。
进一步地，所述隔离装置本体还包括固定结构，所述固定结构设置在所述隔离装置本体下方，与心室组织连接，以使所述隔离装置本体得到稳定定位。
进一步地，心脏隔离装置上的固定结构与所述隔离装置本体通过系绳或缝线相连接，所述固定结构位于心尖处，所述固定结构上包括可刺入心脏组织的结构，包括钩状或刺状结构，所述固定结构固定在心尖内壁上，并通过系绳或缝线拉紧所述心脏隔离装置本体为其提供可靠的锚定。
进一步地，连接至瓣膜的所述第一连接部与隔离装置本体上的所述第二连接部通过机械连接的方式进行固定连接，优选螺纹连接、卡接、搭扣连接、旋转卡夹连接或通过打结捆绑的方式进行连接。
进一步地，所述隔离装置本体上的第二连接部包括凸起结构，与所述瓣膜相连接的第一连接部具有内凹式结构及卡扣和/或卡槽，连接时，所述凸起结构伸入所述第一连接部内，所述凸起结构的边缘与卡扣和/或卡槽配合连接，从而实现固定连接并防止连接脱落；优选的，所述第一连接部通过缝线与所述瓣膜 相连接。
作为本发明的另一种方案，所述第二连接部包括凸起结构，所述第一连接部为绳索或缝线，连接时，通过打结机构将绳索或缝线套在所述凸起结构上进行打结，从而实现两者固定连接。
根据本发明所述的瓣膜植入装置还包括输送系统，所述输送系统包括第一输送系统和第二输送系统，所述第一输送系统用于将心脏隔离装置送入心室内，所述第二输送系统用于输送瓣膜。
本发明的有益效果：
本发明技术方案中的心脏隔离装置，可以在瓣膜植入之前或者同步改善心脏功能。不但治疗了瓣环平面的病变，也治疗了瓣环平面以外的病变。增加了手术的有效性，扩大了治疗患者的受众群体。
本发明通过挂钩式结构来固定瓣膜，对于结构巨大的房室瓣，可以减少置换需要的金属物。减少的金属物，可以避免对心脏瓣膜结构的潜在损伤，提高手术安全性。同时缩小装载金属物所需的输送系统尺寸，提高手术的安全性。
本发明提供的用于连接瓣膜和心脏隔离装置的连接装置，在使后续植入的瓣膜与其永久连接的同时，可使瓣膜稳定定位，精准释放瓣膜高度，起到预防瓣周漏，以及防止瓣环平面受到损伤的作用。
附图说明
图1为本发明的瓣膜植入装置的结构示意图；
图2a、2b为固定结构的多种实施方式的结构示意图；
图3a至3c为隔离装置本体上的多种实施方式的结构示意图；
图4a至4e示出了采用本发明的植入装置进行瓣膜安装的第一种实施方式；
图5a至5c为第一连接部和第二连接部的第一种实施方式的结构示意图；
图6a、6b为第一连接部和第二连接部的第二种实施方式的结构示意图；
图7a至7c为第一连接部和第二连接部的第三种实施方式的结构示意图；
图8a至8d示出了通过第一输送系统将心脏隔离装置送入心室内的过程；
图9a至图9e示出了采用本发明的植入装置进行瓣膜安装的第二种实施方式。
具体实施方式
下面结合具体实施例，进一步阐述本发明。应理解，实施例仅用于说明本发明而不用于限制本发明的保护范围。此外，应理解，在阅读了本发明所公开的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本发明所限定的保护范围之内。
如图1所示，本发明的瓣膜植入装置包括瓣膜1、心脏隔离装置2以及瓣膜连接装置3。其中，如图2a、2b所示，心脏隔离装置2包括隔离装置本体21以及可地选择设置的固定结构22。隔离装置本体上设有定位部23，隔离装置本体21通过定位部23固定在心脏组织上，更具体地，隔离装置本体21通过定位部23贴合在心室内壁上。在本实施例中，该定位部为刺状结构，能够刺入心脏组织内而实现固定，可以通过改变钩刺的方向而采用多种实施方式，如图3a至3c所示。
固定结构22设置在隔离装置本体21的下方，固定结构22与隔离装置本体21通过系绳或缝线相连接，固定结构22位于心尖处，固定结构22上包括可刺入心脏组织的结构，包括钩状或刺状结构，如图2a、2b所示。固定结构22一方面通过刺入心脏组织而固定在心尖内壁上，另一方面通过系绳或缝线拉紧心脏隔离装置本体21为其提供可靠的锚定。
瓣膜连接装置3包括第一连接部31，其一侧与瓣膜1通过例如缝线等柔性结构相连接，隔离装置本体21上设有第二连接部32。在本实施例中，第二连接部32包括凸起结构，可以为如图5a所示的“T”字形。第一连接部31具有内凹式结构及卡扣结构，具体如图5a至5c所示。连接时，第二连接部32的 凸起结构伸入第一连接部31内，并与卡扣配合连接，被卡扣卡紧限位从而实现第一连接部31和第二连接部32之间的固定连接并有效防止连接断开。
第一连接部31和第二连接部32还可以采用其他实施方式，例如图6a和6b所示。在该实施方式中，第一连接部31内设置有卡槽，第二连接部32上的凸起为塔形，其边缘为回钩状，当两个连接部相连接时，第二连接部32上的回钩形的边缘将卡在第一连接部31的卡槽内而实现两者的固定连接。
作为本发明的另一种实施方式，第一连接部31为缝线，如图7a至7c所示。连接时，通过打结机构33将缝线31套在第二连接部32的凸起结构上进行打结，从而实现两者固定连接。
根据本发明所述的瓣膜植入装置还包括输送系统，输送系统包括第一输送系统和第二输送系统，第一输送系统用于将心脏隔离装置送入心室内，第二输送系统用于输送瓣膜。
图8a至8d示出了通过第一输送系统将心脏隔离装置2送入心室内的过程。在第一输送系统的远端装载心脏隔离装置2；将心脏隔离装置2从远端释放出来，送至心室内；将心脏隔离装置2打开成形；当心脏隔离装置2完全打开后，撤出第一输送系统，心脏隔离装置2上的刺状结构刺入心脏组织内，起到定位固定作用。
当心脏隔离装置2固定后，通过第二输送系统将瓣膜1输送至心室内，并将瓣膜1安装在瓣环处，其过程如图4a至4e所示。其具体包括如下步骤：
S1:在第二输送系统的远端装载瓣膜1，瓣膜上1连接有第一连接部31；
S2：通过在第二输送系统中设置推杆来推送第一连接部31至隔离装置2处，使得第一连接部31与第二连接部32相连接；
S3：回收第二输送系统，使得瓣膜1到达瓣环位置，在该位置将第二输送系统与瓣膜1分离；
S4：通过“线控”的方式，调节瓣膜1的位置及锚定松紧程度，可选择地，通过输送系统近端的操纵装置实施上述操作，调整好瓣膜1的位置及锚定松紧 程度后，将瓣膜1上的缝线打结固定；
S5:在完成瓣膜1的全部植入操作后，撤出第二输送系统。
图9a至图9e示出了本发明的另一种实施方案，涉及另外一种安装瓣膜的方法，包括以下步骤：
S1：当心脏隔离装置2固定后，使用第二输送系统将缝线与心脏隔离装置2上的第二连接部32相连接，优选通过打结的方式连接；
S2：通过线控的方式将瓣膜1输送到第二输送系统的远端；
S3：通过线控的方式将瓣膜1释放到瓣环处的适当位置；
S4:继续通过线控方式将第一连接部31释放到第二连接部32的位置处并连接固定，从而完成了瓣膜1的定位和永久固定；
S5：撤出输送系统和多余缝线，完成整个操作过程。
以上，对本发明的实施方式进行了说明。但是，本发明不限定于上述实施方式。凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (8)

  1. 一种在心脏隔离装置辅助下的瓣膜植入装置，其特征在于，包括瓣膜、心脏隔离装置以及瓣膜连接装置；所述心脏隔离装置包括隔离装置本体；所述隔离装置本体上设有定位部，所述隔离装置本体通过所述定位部固定在心脏组织上；所述瓣膜连接装置包括第一连接部，所述第一连接部的一侧与所述瓣膜相连接，所述隔离装置本体上设有第二连接部，在植入所述瓣膜时，将所述第一连接部与所述第二连接部在心室内进行连接。
  2. 如权利要求1所述的瓣膜植入装置，其特征在于，所述隔离装置本体上的定位部为刺状结构，位于隔离装置本体与心脏组织接触的位置，能够刺入心脏组织内而实现固定，所述刺状结构可以朝向任意方向，优选向上、向下或向上和向下相结合。
  3. 如权利要求2所述的瓣膜植入装置，其特征在于，所述隔离装置本体还包括固定结构，所述固定结构设置在所述隔离装置本体下方，与心室组织连接，以使所述隔离装置本体得到稳定定位。
  4. 如权利要求3所述的瓣膜植入装置，其特征在于，心脏隔离装置上的固定结构与所述隔离装置本体通过系绳或缝线相连接，所述固定结构位于心尖处，所述固定结构上包括可刺入心脏组织的结构，包括钩状或刺状结构，所述固定结构固定在心尖内壁上，并通过系绳或缝线拉紧所述心脏隔离装置本体为其提供可靠的锚定。
  5. 如权利要求4所述的瓣膜植入装置，其特征在于，连接至瓣膜的所述第一连接部与隔离装置本体上的所述第二连接部通过机械连接的方式进行固定连 接，优选螺纹连接、卡接、搭扣连接、旋转卡夹连接或通过打结捆绑的方式进行连接。
  6. 如权利要求5所述的瓣膜植入装置，其特征在于，所述隔离装置本体上的第二连接部包括凸起结构，与所述瓣膜相连接的第一连接部具有内凹式结构及卡扣和/或卡槽，连接时，所述凸起结构伸入所述第一连接部内，所述凸起结构的边缘与卡扣和/或卡槽配合连接，从而实现固定连接并防止连接脱落；优选的，所述第一连接部通过缝线与所述瓣膜相连接。
  7. 如权利要求5所述的瓣膜植入装置，其特征在于，所述第二连接部包括凸起结构，所述第一连接部为绳索或缝线，连接时，通过打结机构将绳索或缝线套在所述凸起结构上进行打结，从而实现两者固定连接。
  8. 如权利要求1-7中任一项所述的瓣膜植入装置，其特征在于，还包括输送系统，所述输送系统包括第一输送系统和第二输送系统，所述第一输送系统用于将心脏隔离装置送入心室内，所述第二输送系统用于输送瓣膜。
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