WO2023083387A1 - 一种自膨式生物瓣膜 - Google Patents

一种自膨式生物瓣膜 Download PDF

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Publication number
WO2023083387A1
WO2023083387A1 PCT/CN2022/142335 CN2022142335W WO2023083387A1 WO 2023083387 A1 WO2023083387 A1 WO 2023083387A1 CN 2022142335 W CN2022142335 W CN 2022142335W WO 2023083387 A1 WO2023083387 A1 WO 2023083387A1
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valve
support structure
self
support
outflow end
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PCT/CN2022/142335
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English (en)
French (fr)
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马琛明
虞发新
李加贤
钦湘
潘守翔
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南京圣德医疗科技有限公司
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Publication of WO2023083387A1 publication Critical patent/WO2023083387A1/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

Definitions

  • the invention belongs to the field of medical devices, in particular to a self-expanding biological valve, which is composed of nickel-titanium memory alloy, biological tissue and other materials. Implanted by surgery, it is suitable for the replacement of diseased valves, and it can be applied to the position of aortic valve, pulmonary valve, mitral valve and tricuspid valve.
  • Heart valves are damaged by various pathogenic factors or congenital malformations lead to abnormal anatomical structure and function of one or more valves, manifested as valve orifice stenosis and/or insufficiency. Mainly affects the mitral and aortic valves (less often the tricuspid and pulmonary valves), presenting as mitral stenosis (MS), mitral regurgitation (MR), aortic stenosis (AS), aortic stenosis Pathological types such as regurgitation (AR) and combined valvular disease.
  • MS mitral stenosis
  • MR mitral regurgitation
  • AS aortic stenosis
  • AR aortic stenosis
  • valve replacement by surgery tends to implement minimally invasive, small-incision surgery in order to reduce the damage of the patient and speed up the recovery.
  • the traditional surgical method has the problem that the valve is difficult to suture.
  • the original sutures need to be carefully removed, which not only increases the operation time, but also increases the incidence of complications after re-suture because the annulus has been sutured and knotted. .
  • transcatheter valve implantation has been increasingly used in the treatment of valvular diseases, but it is difficult to position the valve accurately during the implantation process, which can easily lead to inaccurate valve implantation positions; for elderly patients with severe calcification, the original Unresected calcifications make it difficult for the valve to fully fit the annulus, and paravalvular leakage is prone to occur; in addition, stent implantation is also prone to displacement, which will also affect the long-term prognosis of patients.
  • a self-expanding bioprosthesis which can be easily removed without mechanical damage to the valve annulus.
  • the self-expanding bioprosthesis has low requirements for surgical operations, is safe to implant, facilitates the development of minimally invasive surgery, and is also easy for young cardiac surgeons to master.
  • Self-expanding biological valve implantation technology is feasible and safe, it can significantly benefit hemodynamics, and can also significantly improve clinical symptoms, and shorten the time of blood flow occlusion and extracorporeal circulation, so it can effectively reduce death rate and recurrence rate, it has a wide range of indications and application prospects.
  • the object of the present invention is to provide a self-expanding biological valve.
  • valve replacement can be performed without complicated sutures, which reduces the time of extracorporeal circulation, reduces the incidence of complications in important organs such as the heart, brain, liver, and kidneys after surgery, and avoids surgical procedures such as suture knotting.
  • the manipulation entails potential damage to, for example, the aortic root.
  • the present invention realizes through following technical scheme:
  • the present invention provides a self-expanding biological valve, comprising a fixed bracket, an inflow end support structure, an outflow end support structure and a silicone suture ring;
  • the position of the lower edge of the junction of the three leaflets of the fixed bracket; the support structure of the inflow end and the support structure of the outflow end are arranged on the fixed bracket, and in the unfolded state, the support structure of the inflow end and the support structure of the outflow end
  • the support structure at the outflow end protrudes outward relative to the fixing bracket in the radial direction, and is used to support the valve at a predetermined position, continuously apply outward and/or downward force to surrounding tissues, and ensure reliable fixation of the valve
  • the silicone suture ring is arranged at the position of the annulus plane on the fixed support, and the valve is sutured at three points with the surrounding human tissue through the silicone suture ring to ensure that the three leaflets in the valve are in the valve annulus appropriate position in the plane.
  • the support structure at the inflow end and the support structure at the outflow end are support buckles or corollas.
  • the support buckle structure is made of nickel-titanium alloy material, and has a petal-shaped protrusion protruding outward in the unfolded state;
  • the corolla is composed of a uniformly distributed mesh structure, so
  • the net-like structure is made of nickel-titanium alloy material, and its exterior is wrapped with a skirt made of polymer material. In the unfolded state, its diameter is larger than that of the valve annulus to prevent valve displacement.
  • the stretching part has a structure with a cross-sectional area smaller than that of other parts of the fixing bracket. When in use, it is interrupted by radial expansion force applied from the outside, stretched After the part is cut off, the diameter of the fixed stent can be enlarged and expanded outward.
  • the stretching part is in the shape of a "face”, and its expected disconnection position is located at its bending part.
  • the number of the protrusions of the support buckle is 3 or more, preferably a multiple of 3, and is evenly distributed on the circumference of the fixing bracket.
  • the fixing bracket is made of metal or polymer material.
  • the support structure at the inflow end and the support structure at the outflow end are integrally formed.
  • the support structure at the inflow end is a corolla, and the support structure at the outflow end is a support buckle.
  • the support structure at the inflow end is a support buckle, and the support structure at the outflow end is a corolla.
  • the support structure at the inflow end and the support structure at the outflow end are corollas.
  • both the inflow end support structure and the outflow end support structure are support buckles.
  • the advantage of the present invention is that the valve of the present invention can be used for valve replacement without complicated suturing, which reduces the operation time and reduces the risk of post-operative complications. Itsaki design can realize the rapid release of the valve support, In addition, reliable fixation of the valve support can be realized. If the intraoperative inspection finds problems such as paravalvular leakage and needs to be replaced again, the self-expanding bioprosthesis is easy to remove, and there is no mechanical damage to the valve annulus. It requires less surgical operation, which is conducive to minimally invasive surgery and is also convenient for young cardiac surgeons. Doctor master. The position where the stent is interrupted and stretched is located at the junction of the leaflets of the fixed stent, and is completely covered by the polymer skirt. It has been verified by experiments and is very safe and reliable.
  • FIG. 1 is a schematic diagram of an embodiment of the self-expanding biological valve of the present invention used in aortic valve replacement;
  • FIG. 2 is a partial enlarged view of the stretching part of the self-expanding biological valve fixing bracket of the embodiment of the present invention
  • FIG. 3 is a schematic diagram of implanting a self-expandable biological valve into the aorta according to an embodiment of the present invention
  • Fig. 4 is a top view of a self-expanding biological valve according to an embodiment of the present invention.
  • Fig. 5 is a schematic diagram of the structure of a self-expanding biological valve single-layer fixed stent according to an embodiment of the present invention
  • FIG. 6 is a schematic diagram of the structure of a self-expanding biological valve double-layer fixed stent according to an embodiment of the present invention.
  • FIG. 7 is a schematic diagram of the outer stent of the self-expanding biological valve double-layer fixed stent according to the embodiment of the present invention.
  • Fig. 8 is a schematic diagram of the inner stent of the self-expanding biological valve double-layer fixed stent according to the embodiment of the present invention.
  • Fig. 9 shows a schematic diagram of an embodiment of the self-expanding biological valve of the present invention used for pulmonary valve replacement
  • Fig. 10 shows a schematic diagram of an embodiment of the self-expanding biological valve of the present invention used for mitral valve replacement
  • Fig. 11 shows a schematic diagram of an embodiment of the self-expanding biological valve of the present invention used for tricuspid valve replacement.
  • the self-expandable biological valve used for aortic valve replacement is taken as an example, and the self-expandable biological valve of the present invention is specifically described as follows.
  • the self-expanding biological valve includes a fixed support 1 , an outflow end support structure 3 , a silicone suture ring 4 and an inflow end support structure 5 .
  • the fixing bracket 1 is made of metal or polymer materials, such as PETG and ABS materials.
  • the fixed bracket 1 is provided with three stretching parts 2 (see Figure 2), which are respectively located at the lower edge of the junction of the three leaflets (not shown in the figure) of the fixing bracket 1, and the stretching parts 2 are in the shape of " ⁇ ".
  • the cross-sectional area of this part is smaller than that of other parts of the fixed bracket, so the strength is low, and it is easy to break when subjected to radial outward expansion force, especially the bent part is more likely to break.
  • the fixed bracket 1 can adopt various structures, and in this embodiment, two schemes of a single-layer bracket structure and a double-layer bracket structure are respectively adopted.
  • Fig. 5 shows a scheme of a single-layer stent structure
  • Fig. 6 shows a scheme of a double-layer stent structure.
  • the outer stent 11 is a short stent structure (see Figure 7) made of metal material
  • the inner stent 12 is a long stent structure (see Figure 8) and is made of a polymer material, and the two are fixed by suturing to form a fixed stent 1 .
  • Outflow end support structure 3 adopts support buckle structure, and described outflow end support structure 3 (i.e. support buckle) is arranged on the fixed support 1, and it is positioned at the outflow end of valve, and under unfolded state, support buckle is relative to in radial direction.
  • the fixed bracket 1 protrudes outwards (as shown in Figure 1 and Figure 4) and is in the shape of an open petal, which is used to support the valve in the aortic sinus, and continuously exerts outward and downward forces on the surrounding tissues to ensure that the valve reliable fixation.
  • the support buckle includes three petal-shaped protrusions, the number of which can be more than three, preferably in multiples of 3, evenly distributed on the circumference of the fixing bracket 1, all made of nickel-titanium alloy material.
  • the silicone suture ring 4 is arranged at the position of the annulus plane on the fixed bracket, and the artificial valve is sutured at three points with the surrounding tissue through the silicone suture ring, so as to determine the accurate positions of the three valve leaflets in the annulus plane.
  • the support structure 5 at the inflow end adopts a corolla structure, and its exterior is wrapped with a skirt made of polymer material (not shown in the figure). In the expanded state, its diameter is larger than that of the valve annulus, and it exerts an outward force on the surrounding tissue. , to prevent valve displacement (as shown in Figure 3).
  • the corolla 5 and the support buckle 3 are manufactured in an integrated molding and integral cutting manner. When sewing the skirt, connect the corolla 5, the support buckle 3 and the fixed bracket 1 together,
  • the valve tightens the support buckle 3 and the corolla 5 by binding the silk thread to keep it contracted.
  • the binding wire is removed, and the supporting buckle 3 and the corolla 5 are released naturally. Due to the good elasticity of the nickel-titanium alloy material, the supporting buckle 3 and the corolla 5 can be quickly released to the expected shape . As shown in FIG. 3 , the force exerted by the supporting buckle 3 and the corolla 5 on the tissues around the valve makes the valve fixed at the expected position and not easy to slip.
  • an expansion device such as a high-pressure balloon device, is inserted into the valve stent to apply a radial expansion force to it, and the stretching parts 2 on the fixed support 1 are disconnected by the expansion force.
  • the fixed bracket 1 After opening, the fixed bracket 1 expands rapidly in the radial direction, closely cooperates with the surrounding blood vessel tissue, and ensures the reliable fixation of the valve.
  • Fig. 9 shows an embodiment of using the self-expanding biological valve of the present invention for pulmonary valve replacement.
  • the inflow end support structure 5 and the outflow end support Structure 3 is corolla.
  • Fig. 10 shows the embodiment of using the self-expanding biological valve of the present invention for mitral valve replacement.
  • the support structures 3 are all support buckles.
  • Fig. 11 shows an embodiment in which the self-expanding biological valve of the present invention is used for tricuspid valve replacement.
  • the inflow end support structure 5 is The supporting buckle, the supporting structure 3 at the outflow end is a corolla.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic 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

一种自膨胀式生物瓣膜，包括固定支架(1)、流入端支撑结构(5)、流出端支撑结构(3)和硅胶缝合环(4)。固定支架(1)包括拉伸部(2)，其在受到扩张力后会断开，然后，瓣膜在预定位置膨胀。在展开状态下，流入端支撑结构(5)和流出端支撑结构(3)在径向方向上相对于固定支架(1)向外伸出，用于将瓣膜支撑在预定位置，对周围组织持续施加向外和/或向下的力，确保瓣膜的可靠固定。这一瓣膜不需要复杂的缝合便可进行瓣膜置换，减少了手术时间，降低了手术后并发症发生的风险，其设计既能够实现瓣膜支架的快速释放，又能够实现瓣膜支架的可靠固定。

Description

一种自膨式生物瓣膜
本申请要求2021年11月15日向中国国家知识产权局提交的，专利申请号为202111350732.X，发明名称为“一种自膨式生物瓣膜”的在先申请的优先权。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领域，特别是涉及一种自膨式生物瓣膜，由镍钛记忆合金、生物组织等材料组成。经外科手术方式植入、适用于病变瓣膜的置换，其可应用在主动脉瓣、肺动脉瓣、二尖瓣和三尖瓣瓣膜位置。
背景技术
心脏瓣膜受到各种致病因素损伤或先天发育畸形导致一个或多个瓣膜解剖结构和功能异常，表现为瓣膜口狭窄和/或关闭不全。主要累及二尖瓣和主动脉瓣(三尖瓣和肺动脉瓣较少受累)，表现为二尖瓣狭窄(MS)、二尖瓣关闭不全(MR)、主动脉瓣狭窄(AS)、主动脉瓣关闭不全(AR)和联合瓣膜病变等病理类型。
现有技术中，通过外科手术进行瓣膜置换目前多倾向于实施微创的，小切口的外科手术，以减轻患者的损伤和加快恢复的速度。尤其是当无法清除原有瓣膜钙化，解剖位置显露不佳，传统的手术方法存在瓣膜难以缝合的问题。而且，如果在术中检查发现瓣周漏等问题需要再次更换时，需要谨慎拆除原有缝线，不仅增加手术时间，而且由于瓣环已经被缝合打结损伤，再次缝合后并发症发病率增加。
近年来，经导管瓣膜植入术越来越多地应用于瓣膜病治疗中，但瓣膜在植 入过程中难以准确定位，易导致瓣膜植入位置不准确；对于严重钙化的老年患者，原有钙化灶未切除，致使瓣膜与瓣环难以完全贴合，易发生瓣周漏；此外，支架植入也容易出现位移情况，这些也将影响患者远期预后。
因此，期待一种自膨式生物瓣膜，其拆除简单，而且没有对瓣环的机械损伤。同时自膨式生物瓣膜对外科操作要求较低，植入安全，方便微创手术的开展，也便于年轻心外科医生掌握。自膨式生物瓣膜植入技术是可行和安全的，其可以使血流动力学明显获益，也可以使临床症状显著改善，并且缩短血流阻断时间和体外循环时间，因此可以有效减少死亡率和复发率，其有广泛适应症与应用前景。
发明内容
因此本发明的目的在于提供一种自膨式生物瓣膜。它通过特有的设计，不需要复杂的缝合便可进行瓣膜置换，减少了体外循环时间，降低了手术后心、脑、肝、肾等重要器官并发症发生率，也避免了缝合打结等外科操作对例如主动脉根部带来潜在的损伤。
本发明通过如下技术方案实现：
本发明提供一种自膨式生物瓣膜，包括固定支架、流入端支撑结构、流出端支撑结构和硅胶缝合环；所述固定支架包括拉伸部，所述拉伸部设置为三个，分别位于所述固定支架的三个瓣叶交界处的下缘位置；所述流入端支撑结构和所述流出端支撑结构设置在所述固定支架上，在展开状态下，所述流入端支撑结构和所述流出端支撑结构在径向方向上相对于所述固定支架向外伸出，用于将瓣膜支撑在预定位置，对周围组织持续施加向外和/或向下的力，确保瓣膜的可靠固定；所述硅胶缝合环设置在所述固定支架上的瓣环平面位置处，瓣膜通过所述硅胶缝合环与周围的人体组织进行三点定位缝合，以确保瓣膜中的三个瓣叶处于瓣环平面中的适当位置处。
根据本发明所述的瓣膜，所述流入端支撑结构和流出端支撑结构为支撑扣 或花冠。
根据本发明所述的瓣膜，所述支撑扣结构由镍钛合金材料制成，在展开状态下具有向外伸出的花瓣状的突出部；所述花冠由均匀分布的网状结构组成，所述网状结构由镍钛合金材料制成，其外部包裹高分子材料制成的裙边，在展开状态下，其直径大于瓣环的直径，防止瓣膜移位。
根据本发明所述的瓣膜，所述拉伸部具有截面面积小于所述固定支架的其他部分的截面面积的结构，在使用时，借助从外部施加的径向扩张力将其打断，拉伸部断开后能够使得所述固定支架直径变大，向外扩张。
根据本发明所述的瓣膜，所述拉伸部呈“几”字型，其预期断开位置位于其弯折部分。
根据本发明所述的瓣膜，所述支撑扣的突出部的数量为3个或者大于3个，优选为3的倍数，均匀分布在所述固定支架的圆周上。
根据本发明所述的瓣膜，所述固定支架由金属或高分子材料制成。
根据本发明所述的瓣膜，所述流入端支撑结构和所述流出端支撑结构为一体成型。
根据本发明所述的瓣膜，当用于流入端直径偏小，流出端直径偏大的瓣膜，如主动脉瓣膜时，所述流入端支撑结构为花冠，所述流出端支撑结构为支撑扣。
根据本发明所述的瓣膜，当用于流入端直径偏大，流出端直径偏小的瓣膜，如三尖瓣时，所述流入端支撑结构为支撑扣，所述流出端支撑结构为花冠。
根据本发明所述的瓣膜，当用于流入端直径和流出端直径均偏小的瓣膜，如肺动脉瓣时，所述流入端支撑结构和所述流出端支撑结构均为花冠。
根据本发明所述的瓣膜，当用于流入端直径和流出端直径均偏大的瓣膜，如二尖瓣时，所述流入端支撑结构和所述流出端支撑结构均为支撑扣。
本发明的有益效果：
本发明的优点是，使用本发明的瓣膜不需要复杂的缝合便可进行瓣膜置换，减少了手术时间，降低了手术后并发症发生的风险，其精巧的设计既能够实现 瓣膜支架的快速释放，又能够实现瓣膜支架的可靠固定。如术中检查发现瓣周漏等问题需要再次更换时，自膨式生物瓣膜拆除简单，而且没有对瓣环的机械损伤，对外科操作要求较低，利于开展微创手术，也便于年轻心外科医生掌握。支架打断拉伸的位置位于固定支架瓣叶交界的位置，完全由高分子裙边覆盖，经过试验验证，非常安全可靠。
附图说明
图1为本发明的自膨式生物瓣膜用于主动脉瓣置换的实施例示意图；
图2为本发明实施例的自膨式生物瓣膜固定支架的拉伸部的局部放大图；
图3为本发明实施例的自膨式生物瓣膜植入主动脉的示意图；
图4为本发明实施例的自膨式生物瓣膜的俯视图；
图5为本发明实施例的自膨式生物瓣膜单层固定支架结构示意图；
图6为本发明实施例的自膨式生物瓣膜双层固定支架结构示意图；
图7为本发明实施例的自膨式生物瓣膜双层固定支架的外层支架示意图；
图8为本发明实施例的自膨式生物瓣膜双层固定支架的内层支架示意图；
图9示出了本发明的自膨式生物瓣膜用于肺动脉瓣置换的实施例示意图；
图10示出了本发明的自膨式生物瓣膜用于二尖瓣置换的实施例示意图；
图11示出了本发明的自膨式生物瓣膜用于三尖瓣置换的实施例示意图。
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。
本实施例以用于主动脉瓣膜置换的自膨式生物瓣膜为例，对本发明的自膨式生物瓣膜做出如下具体说明。如图1所示，自膨式生物瓣膜包括固定支架1、 流出端支撑结构3、硅胶缝合环4和流入端支撑结构5。固定支架1由金属或高分子材料制成，例如PETG和ABS材料。固定支架1上设有三个拉伸部2(参见图2)，分别位于固定支架1的三个瓣叶(图中未示出)交界处的下缘位置，拉伸部2呈“几”字型，该部分的截面面积比固定支架其他部分的截面面积小，因此强度较低，在受到径向向外的扩张力时易于断裂，特别是其弯折部分更易断裂。
固定支架1可以采用多种结构，本实施例中分别采用单层支架结构和双层支架结构两种方案。图5示出了单层支架结构的方案；图6示出了双层支架结构的方案。外层支架11是短支架结构(参见图7)，由金属材料制成，内层支架12是长支架结构(参见图8)，由高分子材料制成，两者通过缝合固定构成固定支架1。
流出端支撑结构3采用支撑扣结构，所述流出端支撑结构3(即支撑扣)设置在固定支架1上，其位于瓣膜的流出端，在展开状态下，支撑扣在径向方向上相对于固定支架1向外伸出(如图1和图4所示)，呈打开的花瓣状，用于将瓣膜支撑在主动脉窦内，对周围组织持续施加向外和向下的力，确保瓣膜的可靠固定。支撑扣包括三个花瓣状的突出部，该突出部的数量也可以为三个以上，优选为3的倍数，均匀分布在固定支架1的圆周上，均由镍钛合金材料制成。
硅胶缝合环4设置在所述固定支架上的瓣环平面位置处，人工瓣膜通过硅胶缝合环与周围组织进行三点定位缝合，从而确定三个瓣叶在瓣环平面中的准确位置。流入端支撑结构5采用花冠结构，其外部包裹高分子材料制成的裙边(图中未示出)，在展开状态下，其直径大于瓣环的直径，对周围组织实施向外的的力，防止瓣膜移位(如图3所示)。花冠5和支撑扣3采用一体成型、整体切割方式制造。缝合裙边时，一并将花冠5、支撑扣3与固定支架1相连接，
在植入前，瓣膜通过束缚丝线将支撑扣3和花冠5收紧而使其保持收缩状 态。当瓣膜被植入到主动脉预定位置时，移除束缚丝线，支撑扣3和花冠5自然释放，由于金属镍钛合金材料具有很好的弹性，支撑扣3和花冠5能够迅速释放至预期形态。如图3所示，支撑扣3和花冠5对瓣膜周围组织的作用力使得瓣膜固定在预期位置，不易滑动。然后，通过扩张装置，例如高压气囊装置，伸入瓣膜支架内，对其施加径向扩张力，固定支架1上的拉伸部2受到扩张力而断开，随着各拉伸部2的断开，固定支架1在径向上迅速扩张，与周围的血管组织紧密配合，确保了瓣膜的可靠固定。
图9示出了将本发明的自膨式生物瓣膜用于肺动脉瓣置换的实施例，在该实施例中，由于流入端直径和流出端直径均偏小，流入端支撑结构5和流出端支撑结构3均为花冠。
图10示出了将本发明的自膨式生物瓣膜用于二尖瓣置换的实施例，在该实施例中，由于流入端直径和流出端直径均偏大，流入端支撑结构5和流出端支撑结构3均为支撑扣。
图11示出了将本发明的自膨式生物瓣膜用于三尖瓣置换的实施例，在该实施例中，由于其流入端直径偏大而流出端直径偏小，流入端支撑结构5为支撑扣，流出端支撑结构3为花冠。

Claims (12)

  1. 一种自膨式生物瓣膜，其特征在于，包括固定支架、流入端支撑结构、流出端支撑结构和硅胶缝合环；所述固定支架包括拉伸部，所述拉伸部设置为三个，分别位于所述固定支架的三个瓣叶交界处的下缘位置；所述流入端支撑结构和所述流出端支撑结构设置在所述固定支架上，在展开状态下，所述流入端支撑结构和所述流出端支撑结构在径向方向上相对于所述固定支架向外伸出，用于将瓣膜支撑在预定位置，对周围组织持续施加向外和/或向下的力，确保瓣膜的可靠固定；所述硅胶缝合环设置在所述固定支架上的瓣环平面位置处，瓣膜通过所述硅胶缝合环与周围的人体组织进行三点定位缝合，以确保瓣膜中的三个瓣叶处于瓣环平面中的适当位置处。
  2. 根据权利要求1所述的自膨式生物瓣膜，其特征在于，所述流入端支撑结构和流出端支撑结构为支撑扣或花冠。
  3. 根据权利要求2所述的自膨式生物瓣膜，其特征在于，所述支撑扣结构由镍钛合金材料制成，在展开状态下具有向外伸出的花瓣状的突出部；所述花冠由均匀分布的网状结构组成，所述网状结构由镍钛合金材料制成，其外部包裹高分子材料制成的裙边，在展开状态下，其直径大于瓣环的直径，防止瓣膜移位。
  4. 根据权利要求1-3中任一项所述的自膨式生物瓣膜，其特征在于，所述拉伸部具有截面面积小于所述固定支架的其他部分的截面面积的结构，在使用时，借助从外部施加的径向扩张力将其打断，拉伸部断开后能够使得所述固定支架直径变大，向外扩张。
  5. 根据权利要求4所述的自膨式生物瓣膜，其特征在于，所述拉伸部呈“几”字型，其预期断开位置位于其弯折部分。
  6. 根据权利要求3-5中任一项所述的自膨式生物瓣膜，其特征在于，所述支撑扣的突出部的数量为3个或者大于3个，优选为3的倍数，均匀分布在所述固定支架的圆周上。
  7. 根据权利要求1-6中任一项所述的自膨式生物瓣膜，其特征在于，所述固定支架由金属或高分子材料制成。
  8. 根据权利要求1-7中任一项所述的自膨式生物瓣膜，其特征在于，所述流入端支撑结构和所述流出端支撑结构为一体成型。
  9. 根据权利要求2-8中任一项所述的自膨式生物瓣膜，其特征在于，当用于流入端直径偏小，流出端直径偏大的瓣膜时，所述流入端支撑结构为花冠，所述流出端支撑结构为支撑扣。
  10. 根据权利要求2-8中任一项所述的自膨式生物瓣膜，其特征在于，当用于流入端直径偏大，流出端直径偏小的瓣膜时，所述流入端支撑结构为支撑扣，所述流出端支撑结构为花冠。
  11. 根据权利要求2-8中任一项所述的自膨式生物瓣膜，其特征在于，当用于流入端直径和流出端直径均偏小的瓣膜时，所述流入端支撑结构和所述流出端支撑结构均为花冠。
  12. 根据权利要求2-8中任一项所述的自膨式生物瓣膜，其特征在于，当用于流入端直径和流出端直径均偏大的瓣膜时，所述流入端支撑结构和所述流出端支撑结构均为支撑扣。
PCT/CN2022/142335 2021-11-15 2022-12-27 一种自膨式生物瓣膜 WO2023083387A1 (zh)

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CN101011298A (zh) * 2006-01-16 2007-08-08 孔祥清 经皮主动脉瓣膜或肺动脉瓣膜置换装置
CN102458309A (zh) * 2009-06-26 2012-05-16 爱德华兹生命科学公司 整体式快速连接人工心脏瓣膜和展开系统与方法
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