WO2022242093A1 - 三尖瓣瓣架及其瓣膜假体 - Google Patents

三尖瓣瓣架及其瓣膜假体 Download PDF

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Publication number
WO2022242093A1
WO2022242093A1 PCT/CN2021/133518 CN2021133518W WO2022242093A1 WO 2022242093 A1 WO2022242093 A1 WO 2022242093A1 CN 2021133518 W CN2021133518 W CN 2021133518W WO 2022242093 A1 WO2022242093 A1 WO 2022242093A1
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WO
WIPO (PCT)
Prior art keywords
frame part
valve
tricuspid valve
outer frame
inner frame
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PCT/CN2021/133518
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English (en)
French (fr)
Inventor
钟生平
靳永富
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金仕生物科技（常熟）有限公司
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Application filed by 金仕生物科技（常熟）有限公司 filed Critical 金仕生物科技（常熟）有限公司
Priority to EP21940537.0A priority Critical patent/EP4342423A1/en
Publication of WO2022242093A1 publication Critical patent/WO2022242093A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—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
    • A61F2/2427—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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present application relates to the technical field of medical devices, in particular to a tricuspid valve frame and a valve prosthesis thereof.
  • the artificial valve is implanted into the body through interventional means, which is to send the artificial valve to the implantation site through the delivery system, expand the valve through the self-expanding property of the valve or expand the valve by means of balloon, and rivet it to the corresponding valve annulus.
  • the aortic interventional valve which is developing rapidly now, is riveted on the aortic valve annulus by way of radial support force.
  • valves in the human heart namely the aortic valve, mitral valve, pulmonary valve and tricuspid valve.
  • the tricuspid valve is located on the atrioventricular annulus of the right heart. Since the annulus of the tricuspid valve is soft, the valve cannot be riveted by radial support force. At the same time, because the structure around the tricuspid valve ring is very complex and there are a large number of nervous systems, if the force of the valve is transmitted to these tissues, it will lead to a vicious accident in which the heart cannot work. However, since the valve is periodically stressed by blood during operation, there must be a stable riveting method. Therefore, it is very necessary to study a tricuspid valve frame and valve prosthesis that can solve the above problems.
  • the present application relates to a tricuspid valve frame and a valve prosthesis thereof, in order to solve the above-mentioned problem in the prior art that the tricuspid valve ring cannot be riveted to the valve by radial support force.
  • the first aspect of the present application provides a tricuspid valve frame, which includes an inner frame part and an outer frame part, one end of the inner frame part is formed as an inflow end, and one end of the outer frame part is formed as an outflow end , the end of the inner frame part away from the inflow end is fixedly connected to the end of the outer frame part away from the outflow end;
  • the radial dimension of the inflow end is smaller than the radial dimension of the outflow end
  • the inflow end forms a supporting edge that is turned outward to a side away from the axis of the tricuspid valve frame in the expanded state.
  • the outer frame part includes a first frame body and a fixed claw, the fixed claw is fixedly arranged on the first frame body, and a gap is held between the fixed claw and the supporting edge for Fixed annulus spacing.
  • a plurality of the fixing claws are provided in the circumferential direction of the outer frame part, and the plurality of fixing claws are covered and connected by fabric.
  • the inner frame part is formed by interlacing a plurality of first connecting beams
  • the outer frame part is formed by interlacing a plurality of second connecting beams
  • the cross-sectional area of the first connecting beams and the The cross-sectional area ratio of the second connecting beam is 1.2-3.0.
  • the inner frame part and the outer frame part are connected by binding metal or non-metallic wires, or the inner frame part and the outer frame part are connected by welding.
  • the inner frame part includes a second frame body and a connecting claw, one end of the connecting claw is fixed to the second frame body, and the other end of the connecting claw passes through the outer frame part and protrudes from the outflow end.
  • the second frame body and the connecting claw are integrally formed.
  • the outer frame part is fixed to the outer side of the inner frame part.
  • the second aspect of the present application also provides a tricuspid valve prosthesis, which includes the tricuspid valve frame provided in the first aspect of the present application, and the tricuspid valve prosthesis also includes a valve skirt, leaflets and A sealing skirt, the flap skirt is arranged on the inner side of the inner frame part and the outer frame part, the leaflets are fixed on the inner side of the flap skirt, and the sealing skirt is arranged on the inner side of the outer frame part Bottom outside.
  • the tricuspid valve frame and its valve prosthesis provided by this application can reliably support the valve frame on the valve annulus through the design of the supporting edge.
  • the outer frame part and the inner frame part are separately processed and assembled. , which facilitates the forming of the connecting claws.
  • the radial dimension of the inflow end smaller than the radial dimension of the outflow end, it can be ensured that the force transmitted to the valve annulus will not have adverse effects on the valve annulus, and it can also prevent the valve prosthesis fall off.
  • FIG. 1 is a schematic structural view of a tricuspid valve frame provided by an embodiment of the present application
  • Fig. 2 is the structural representation of inner frame part
  • Fig. 3 is the structural representation of outer frame part
  • Fig. 4 is a schematic structural diagram of the tricuspid valve provided by the embodiment of the present application.
  • Fig. 5 is a schematic diagram of the tricuspid valve frame provided by the embodiment of the present application after being implanted into a human body.
  • connection can be a fixed connection, a detachable connection, or an integrated Connected, or electrically connected; either directly or indirectly through an intermediary.
  • the tricuspid valve is an important part of the human heart. It is located on the annulus between the atrioventricular chambers of the right heart, which can ensure blood circulation from the right atrium to the right ventricle and through a certain flow.
  • an artificial valve can be implanted in the body through interventional means to replace the function of the native tricuspid valve.
  • the intervention method is to send the artificial valve to the implantation site through the delivery system, expand the valve through the self-expanding property of the valve or expand the valve, and rivet it to the corresponding annulus.
  • the present embodiment provides a tricuspid valve frame 1 and a tricuspid valve prosthesis comprising the tricuspid valve frame 1, and the tricuspid valve prosthesis also includes It includes a petal skirt 3 and a petal leaflet 2 , the petal skirt 3 is arranged inside the inner frame part 11 and the outer frame part 12 , and the petal leaflet 2 is fixed on the inner side of the petal skirt 3 .
  • the tricuspid valve frame 1 includes an inner frame part 11 and an outer frame part 12, one end of the inner frame part 11 is formed as an inflow end 111, one end of the outer frame part 12 is formed as an outflow end 121, and the inner frame part 11 is far away from the inflow end.
  • One end of 111 is fixedly connected to the end of the outer frame part 12 away from the outflow end 121.
  • the radial dimension of the inflow end 111 is smaller than the radial dimension of the outflow end 121, and the inflow end 111 forms a directional An everted support edge 123 on one side away from the axis of the tricuspid valve frame.
  • the inner frame part 11 and the outer frame part 12 can be prepared from metal tubes, specifically, the metal tubes can be cut by cutting process, and then the cut metal tubes can be stretched out through the stretching process to form the stretched inner frame part 11 and outer frame part 12.
  • the tricuspid valve frame When the tricuspid valve frame is implanted into the human body through the delivery system, the tricuspid valve frame is bundled in the delivery system, and at the implanted position in the human body, the tricuspid valve frame automatically expands after being released. and abut against the side of the valve annulus 5 facing the ventricle 6 through the supporting edge 123, thereby completing the implantation of the tricuspid valve frame.
  • the inflow end 111 with a smaller diameter can extend into the atrium 7, and the outflow end 121 with a larger diameter is located in the ventricle 6, and the outflow end 121 can support the original valve leaflet 4 after the valve prosthesis is implanted into the human body. Open, and riveted on the original leaflet 4 at the same time.
  • the ventricle 6 contracts, the valve prosthesis is closed, and the valve prosthesis is pushed by the blood to act on the original valve leaflet 4, and then act on the valve annulus 5 through the original valve leaflet 4.
  • the force transmitted to the valve annulus 5 The force will not cause adverse effects on the valve ring 5, and the valve prosthesis can work smoothly.
  • the outflow end 121 of the valve prosthesis of the present application is also designed to be relatively soft, so that the valve prosthesis can fully fit the original valve leaflet 4, as shown in Figure 5 , and the original valve leaflet 4 is stretched around the outside of the valve prosthesis to prevent paravalvular leakage, and at the same time, the force on the original valve leaflet 4 can be made more uniform, which is more in line with the stress state of the original valve leaflet 4; at the same time, it can also Prevent the valve prosthesis from damaging the original leaflet 4 .
  • outer frame part 12 and the inner frame part 11 can be processed separately, and then the inner frame part 11 and the outer frame part 12 can be assembled to form a complete valve frame.
  • the inner frame part 11 and the outer frame part 12 can be connected by metal or non-metallic wires, or the inner frame part 11 and the outer frame part 12 are welded.
  • the relatively small diameter of the inner frame part 11 can make the overall structure of the inner frame part 11 have higher stability and deformation resistance, thereby improving the reliability of the inner frame part 11 to fix the leaflet 2 . Since the diameter of the outer frame part 12 is relatively large, the structural flexibility of the outer frame part 12 can be improved, and when the outer frame part 12 is in contact with the annulus 5, damage to the annulus 5 can be avoided.
  • the inner frame part 11 is formed by interlacing a plurality of first connecting beams
  • the outer frame part 12 is formed by interlacing a plurality of second connecting beams, so that the inner frame part 11 and the outer frame part 12 form a network structure
  • the first The ratio of the cross-sectional area of the connecting beam to the cross-sectional area of the second connecting beam is 1.2-3.0.
  • the total number of the first connecting beams can be the same as the total number of the second connecting beams, and the first connecting beams are relatively thinner beams, so that the inner frame part 11 can be more easily fitted to the original leaflet 4 , will not cause damage to the original leaflet 4.
  • the outer frame part 12 includes a first frame body 122 and a fixed claw 13, the outflow end 121 is formed as one end of the first frame body 122, the fixed claw 13 is fixedly arranged in the first frame body 122, and fixed The claws 13 protrude from the outer surface of the first frame body 122 , so that a distance 124 for fixing the annulus 5 is maintained between the fixing claws 13 and the supporting edge 123 . It should be noted that the distance dimension of the distance 124 in the axial direction of the valve frame is greater than the thickness of the valve ring 5.
  • the gap between the other side of the valve ring 5 and the fixing claw There is still a gap, so that when the valve prosthesis is closed by the force of blood flow, the valve ring 5 will not be damaged by frequent contact with the fixed claws, and when the valve prosthesis has a tendency to move toward the ventricle 6 under the action of blood flow , the fixing claw can abut against the side of the annulus 5 facing away from the ventricle 6 , so as to prevent the valve prosthesis from falling into the ventricle 6 .
  • a plurality of fixing claws 13 are evenly arranged in the circumferential direction of the outer frame portion 12, so that when the fixing claws 13 abut against the valve annulus 5, the valve annulus 5 can be evenly stressed and the pressure on the valve annulus 5 can be reduced.
  • multiple fixing claws 13 can be covered and connected by fabric, on the one hand, it can improve the stability of each fixing claw 13, on the other hand, it also prevents the fixing claws 13 from piercing the annulus 5, and at the same time, it is also conducive to the tissue on it. grow.
  • the inner frame part 11 includes a second frame body 112 and a connecting claw 14, one end of the connecting claw 14 is fixed to the second frame body 112, and the other end of the connecting claw 14 passes through the outer frame part 12 and connects from the The outflow end 121 of the outer frame part 12 protrudes.
  • the valve prosthesis in this embodiment is delivered to the human body through a dedicated delivery system.
  • the tricuspid valve holder 1 is compressed into the delivery system as a whole through its own radial contraction, and connected to the delivery system through the connecting claws 14 .
  • the delivery system releases the valve prosthesis.
  • the connecting claw 14 is separated from the delivery system, and the tricuspid valve frame 1 is riveted to the annulus by expanding itself radially.
  • the connecting claws 14 cannot be directly processed, and the connecting claws 14 need to be welded separately, and the process is complicated. And it is difficult to ensure the processing accuracy of the connecting claw 14 .
  • the inner frame part 11 and the outer frame part 12 are respectively processed as independent parts, so that the connecting claws 14 can be formed directly on the inner frame part 11 without the need for connecting The claws 14 are processed separately, so that the process is simpler and the processing accuracy is improved.
  • outer frame part 12 is fixed on the outer side of the inner frame part 11 , so that when the inner frame part 11 and the outer frame part 12 are connected, it is beneficial to place the connecting claws 14 .
  • the tricuspid valve prosthesis provided in the embodiment of the present application further includes a sealing skirt, which is arranged outside the bottom end of the outer frame part 12 .
  • the bottom end is the outflow end 121 of the outer frame portion 12 .
  • the sealing skirt can be sewn to the outer frame portion 12 to prevent lateral leakage.
  • the tricuspid valve frame and its valve prosthesis provided by the embodiment of the present application can reliably support the valve frame on the valve annulus through the design of the supporting edge.
  • the outer frame part and the inner frame part are separately processed and assembled
  • the structural form facilitates the forming of the connecting claws.
  • by making the radial dimension of the inflow end smaller than the radial dimension of the outflow end it can ensure that the force transmitted to the valve annulus will not have adverse effects on the valve annulus, and it can also prevent the valve The prosthesis falls off.

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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

一种三尖瓣瓣架及其瓣膜假体，其中，该三尖瓣瓣架包括内架部分（11）和外架部分（12），内架部分（11）的一端形成为流入端（111），外架部分（12）的一端形成为流出端（121），内架部分（11）远离流入端（111）的一端与外架部分（12）远离流出端（121）的一端固定相连，在膨开状态下，流入端（111）的径向尺寸小于流出端（121）的径向尺寸，流出端（121）在膨开状态下形成有向远离三尖瓣瓣架轴线的一侧外翻的支撑缘（123）。通过设计支撑缘（123），可以使瓣架能够可靠地支撑在瓣环上，同时，采用外架部分（12）和内架部分（11）分别加工后组装的结构形式，方便了连接爪（14）的成型，此外，通过使流入端（111）的径向尺寸小于流出端（121）的径向尺寸，可以保证传递到瓣环上的力将不会对瓣环造成不良影响，同时也可以防止瓣膜假体脱落。

Description

三尖瓣瓣架及其瓣膜假体 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种三尖瓣瓣架及其瓣膜假体。
背景技术
通过介入手段将人工瓣膜植入到体内，是将人工瓣膜通过输送系统送到植入部位，通过瓣膜的自膨胀性质或通过球囊扩张的方式将瓣膜展开，铆固在相应的瓣环上。
现在发展较快的主动脉介入瓣膜是通过径向支撑力的方式铆固在主动脉瓣环上。
人的心脏中共有四个瓣膜，分别为主动脉瓣、二尖瓣、肺动脉瓣及三尖瓣。其中三尖瓣位于右心的房室间的瓣环上。由于三尖瓣瓣环较软，无法通过径向支撑力铆固住瓣膜。同时，由于三尖瓣瓣环周边的结构非常复杂，存在大量的神经系统，如果瓣膜的作用力传递到这些组织，将会导致心脏无法工作的恶性事故。但是，由于瓣膜在工作时周期性地受到血液的压力，必须有一个稳定的铆固方式。因此，研究一种能够解决上述难题的三尖瓣瓣架及瓣膜假体十分必要。
申请内容
本申请涉及一种三尖瓣瓣架及其瓣膜假体，以解决上述现有技术中三尖瓣瓣环无法通过径向支撑力铆固住瓣膜的问题。
本申请的第一方面提供了一种三尖瓣瓣架，其中，包括内架部分和外架部分，所述内架部分的一端形成为流入端，所述外架部分的一端形成为流出端，所述内架部分远离所述流入端的一端与所述外架部分远离所述流出端的一端固定相连；
在膨开状态下，所述流入端的径向尺寸小于所述流出端径向尺寸；
所述流入端在膨开状态下形成有向远离所述三尖瓣瓣架轴线的一侧外翻的支撑缘。
在一种可能的设计中，所述外架部分包括第一架体和固定爪，所述固定爪固定设置于所述第一架体，所述固定爪与所述支撑缘之间保持有用于固定瓣环的间距。
在一种可能的设计中，所述固定爪在所述外架部分的周向上设置有多个，多个所述固定爪通过织物包覆和连接。
在一种可能的设计中，所述内架部分由多个第一连接梁交织构成，所述外架部分由多个第二连接梁交织构成，所述第一连接梁的截面积和所述第二连接梁的截面积之比为1.2～3.0。
在一种可能的设计中，所述内架部分和所述外架部分通过金属或非金属线材绑制相连，或，所述内架部分和所述外架部分焊接相连。
在一种可能的设计中，所述内架部分包括第二架体和连接爪，所述连接爪的一端固定于所述第二架体，所述连接爪的另一端穿过所述外架部分并从所述流出端伸出。
在一种可能的设计中，所述连接爪具有多个，多个所述连接爪收向于所述瓣架的 轴心，且多个所述连接爪之间具有间隔。
在一种可能的设计中，所述第二架体与所述连接爪为一体成型结构。
在一种可能的设计中，所述外架部分固定于所述内架部分的外侧。
本申请的第二方面还提供了一种三尖瓣瓣膜假体，其中，包括本申请第一方面提供的三尖瓣瓣架，所述三尖瓣瓣膜假体还包括瓣裙、瓣叶和密封裙，所述瓣裙围设于所述内架部分和所述外架部分的内侧，所述瓣叶固定于所述瓣裙的内侧，所述密封裙围设于所述外架部分的底端外侧。
本申请提供的技术方案可以达到以下有益效果：
本申请提供的三尖瓣瓣架及其瓣膜假体，通过设计支撑缘，可以使瓣架能够可靠地支撑在瓣环上，同时，采用外架部分和内架部分分别加工后组装的结构形式，方便了连接爪的成型，此外，通过使流入端的径向尺寸小于流出端径向尺寸，可以保证传递到瓣环上的力将不会对瓣环造成不良影响，同时也可以防止瓣膜假体脱落。
应当理解的是，以上的一般描述和后文的细节描述仅是示例性的，并不能限制本申请。
附图说明
图1为本申请实施例提供的三尖瓣瓣架的结构示意图；
图2为内架部分的结构示意图；
图3为外架部分的结构示意图；
图4为本申请实施例提供的三尖瓣瓣膜的结构示意图；
图5为本申请实施例提供的三尖瓣瓣架在植入人体后的示意图。
附图标记：
1-三尖瓣瓣架；
11-内架部分；
111-流入端；
112-第二架体；
12-外架部分；
121-流出端；
122-第一架体
123-支撑缘；
124-间距；
13-固定爪；
14-连接爪；
2-瓣叶；
3-瓣裙；
4-原生瓣叶；
5-瓣环；
6-心室；
7-心房。
此处的附图被并入说明书中并构成本说明书的一部分，示出了符合本申请的实施例，并与说明书一起用于解释本申请的原理。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
在本申请的描述中，除非另有明确的规定和限定，术语“第一”、“第二”仅用于描述的目的，而不能理解为指示或暗示相对重要性；除非另有规定或说明，术语“多个”是指两个或两个以上；术语“连接”、“固定”等均应做广义理解，例如，“连接”可以是固定连接，也可以是可拆卸连接，或一体地连接，或电连接；可以是直接相连，也可以通过中间媒介间接相连。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
本说明书的描述中，需要理解的是，本申请实施例所描述的“上”、“下”等方位词是以附图所示的角度来进行描述的，不应理解为对本申请实施例的限定。此外，在上下文中，还需要理解的是，当提到一个元件连接在另一个元件“上”或者“下”时，其不仅能够直接连接在另一个元件“上”或者“下”，也可以通过中间元件间接连接在另一个元件“上”或者“下”。
三尖瓣是人的心脏的重要组成部分，位于右心的房室间的瓣环上，可保证血液循环由右心房向右心室方向流动并通过一定流量。
当原生三尖瓣出现病变时，可以通过介入手段将人工瓣膜植入到体内，以替代原生三尖瓣的功能。介入手段是将人工瓣膜通过输送系统送到植入部位，通过瓣膜的自膨胀性质或通过球囊扩张的方式将瓣膜展开，铆固在相应的瓣环上。
但是，由于三尖瓣原生瓣环较软，无法通过径向支撑力铆固住人工瓣膜，易造成瓣膜假体脱落、瓣膜假体触碰神经系统的风险。
为此，如图1至图5所示，本实施例提供了一种三尖瓣瓣架1和包括该三尖瓣瓣架1的三尖瓣瓣膜假体，该三尖瓣瓣膜假体还包括瓣裙3和瓣叶2，所述瓣裙3围设于所述内架部分11和所述外架部分12的内侧，所述瓣叶2固定于所述瓣裙3的内侧。
该三尖瓣瓣架1包括内架部分11和外架部分12，内架部分11的一端形成为流入端111，外架部分12的一端形成为流出端121，内架部分11上远离流入端111的一端与外架部分12上远离流出端121的一端固定相连，在膨开状态下，流入端111的径向尺寸小于流出端121径向尺寸，流入端111在膨开状态下形成有向远离该三尖瓣瓣架轴线的一侧外翻的支撑缘123。
其中，内架部分11和外架部分12可以由金属管制备而成，具体可以采用切割工艺切割金属管，再通过撑开工艺将切割后的金属管撑开以形成被撑开后的内架部分11和外架部分12。在通过输送系统向人体内植入该三尖瓣瓣架时，该三尖瓣瓣架收束于输送系统内，在人体内的植入位置处，该三尖瓣瓣架被释放后自动膨开，并通过支撑缘123抵接在瓣环5朝向心室6的一侧面上，从而完成该三尖瓣瓣架的植入。
其中，具有较小直径的流入端111可以伸入至心房7中，具有较大直径的流出端 121位于心室6中，且流出端121可以在瓣膜假体植入人体后将原生瓣叶4撑开，同时铆固在原生瓣叶4上。在心室6收缩时，瓣膜假体关闭，瓣膜假体受到血液的推力可以作用在原生瓣叶4上，再通过原生瓣叶4作用到瓣环5上，此时，传递到瓣环5上的力将不会对瓣环5造成不良影响，瓣膜假体可顺利工作。同时，该瓣架在膨开状态下，由于外架部分12的流出端121直径较大，且支撑缘123能够抵接在瓣环5上朝向心室6的一侧面，因此不会因心室6的收缩压将瓣膜假体推入心房7中而造成瓣膜假体脱落的事故。
需要说明的是，由于人体原生瓣叶4很柔软，本申请的瓣膜假体的流出端121也设计得较柔软，从而可使瓣膜假体与原生瓣叶4充分贴合，如图5所示，且原生瓣叶4被撑开在瓣膜假体外侧周围，防止瓣周漏，同时可以使原生瓣叶4上的受力更均匀，更符合原生瓣叶4的受力状态；同时，也可防止瓣膜假体对原生瓣叶4的损伤。
此外，对外架部分12和内架部分11可以分别加工，再对内架部分11和外架部分12进行组装以形成完整瓣架。
其中，为了保证内架部分11和外架部分12的可靠连接，内架部分11和外架部分12可以采用金属或非金属线材绑制相连，或者内架部分11和外架部分12焊接相连。
需要说明的是，使内架部分11的直径相对较小，可以使内架部分11的整体结构具有较高的稳定性和抗变形能力，从而可以提升内架部分11固定瓣叶2的可靠性。而由于外架部分12的直径相对较大，从而能够提升外架部分12的结构柔性，当外架部分12与瓣环5接触时，能够避免损伤瓣环5。
本实施例中，内架部分11由多个第一连接梁交织构成，外架部分12由多个第二连接梁交织构成，使内架部分11和外架部分12形成网状结构，第一连接梁的截面积和第二连接梁的截面积之比为1.2～3.0。其中，第一连接梁的总数量可以与第二连接梁的总数量可以相同，而第一连接梁为相对较细的梁，使内架部分11能够更容易地与原生瓣叶4充分贴合，不会对原生瓣叶4造成伤害。
作为一种具体的实现方式，外架部分12包括第一架体122和固定爪13，流出端121形成为第一架体122的一端，固定爪13固定设置于第一架体122其中，固定爪13凸出于第一架体122的外侧面，使固定爪13与支撑缘123之间保持有用于固定瓣环5的间距124。需要说明的是，该间距124在瓣架轴向上的距离尺寸大于瓣环5的厚度，在支撑缘123抵接在瓣环5的一面上后，瓣环5的另一面与固定爪之间仍保持有间隙，使得瓣膜假体在受到血流作用力关闭时，瓣环5不会与固定爪频繁接触而受到损伤，而当瓣膜假体受血流的作用具有向心室6运动的趋势时，固定爪可以抵接在瓣环5上背离心室6的一面，从而防止瓣膜假体脱落至心室6中。
其中，固定爪13在外架部分12的周向上均匀设置有多个，从而可以在固定爪13与瓣环5抵接时使瓣环5均匀受力，降低对瓣环5的压迫。此外，多个固定爪13可以通过织物包覆和连接，一方面可以提升各个固定爪13的稳定性，另一方面也防止了固定爪13刺破瓣环5，同时也有利于组织在其上生长。
作为一种具体的实现方式，内架部分11包括第二架体112和连接爪14，连接爪14的一端固定于第二架体112，连接爪14的另一端穿过外架部分12并从外架部分12的流出端121伸出。
本实施例中的瓣膜假体是通过专用的输送系统向人体输送，该三尖瓣瓣架1通过自身的径向收缩使其整体压缩至输送系统中，并通过连接爪14与输送系统连接。在进入至人体内的设定位置后，输送系统释放该瓣膜假体，此时，连接爪14与输送系统分离，该三尖瓣瓣架1通过自身径向扩张使其铆固于瓣环。
其中，连接爪14具有多个，多个连接爪14收向于瓣架的轴心，且多个连接爪14之间具有间隔，从而可以为下一次的介入植入瓣膜假体留有操作空间。
此外，需要说明的是，对于采用激光加工的方式加工瓣架，如果使内架部分11和外架部分12一体加工，则无法直接加工出连接爪14，连接爪14需要单独焊接，工艺复杂，且难以保证连接爪14的加工精度。为此，本实施例中，如图3所示，将内架部分11和外架部分12分别作为独立的部分进行加工，从而可以直接在内架部分11上成型出连接爪14，无需对连接爪14单独加工，从而使工艺更简洁，提升了加工精度。
需要说明的是，外架部分12固定于内架部分11的外侧，从而可以在内架部分11与外架部分12连接时，有利于连接爪14的安放。
作为一种具体的实现方式，本申请实施例提供的三尖瓣瓣膜假体还包括密封裙，该密封裙围设于外架部分12的底端外侧。本实施例中，该底端为外架部分12的流出端121。该密封裙可以缝制在外架部分12，以防止侧周漏。
本申请实施例提供的三尖瓣瓣架及其瓣膜假体，通过设计支撑缘，可以使瓣架能够可靠地支撑在瓣环上，同时，采用外架部分和内架部分分别加工后组装的结构形式，方便了连接爪的成型，此外，通过使流入端的径向尺寸小于流出端径向尺寸，可以保证传递到瓣环上的力将不会对瓣环造成不良影响，同时也可以防止瓣膜假体脱落。
以上所述仅为本申请的优选实施例而已，并不用于限制本申请，对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。

Claims (10)

  1. 一种三尖瓣瓣架，其特征在于，包括内架部分(11)和外架部分(12)，所述内架部分(11)的一端形成为流入端(111)，所述外架部分(12)的一端形成为流出端(121)，所述内架部分(11)远离所述流入端(111)的一端与所述外架部分(12)远离所述流出端(121)的一端固定相连；
    在膨开状态下，所述流入端(111)的径向尺寸小于所述流出端(121)径向尺寸；
    所述流入端(111)在膨开状态下形成有向远离所述三尖瓣瓣架轴线的一侧外翻的支撑缘(123)。
  2. 根据权利要求1所述的三尖瓣瓣架，其特征在于，所述外架部分(12)包括第一架体(122)和固定爪(13)，所述固定爪(13)固定设置于所述第一架体(122)，所述固定爪(13)与所述支撑缘(123)之间保持有用于固定瓣环的间距(124)。
  3. 根据权利要求2所述的三尖瓣瓣架，其特征在于，所述固定爪(13)在所述外架部分(12)的周向上设置有多个，多个所述固定爪(13)通过织物包覆和连接。
  4. 根据权利要求1所述的三尖瓣瓣架，其特征在于，所述内架部分(11)由多个第一连接梁交织构成，所述外架部分(12)由多个第二连接梁交织构成，所述第一连接梁的截面积和所述第二连接梁的截面积之比为1.2～3.0。
  5. 根据权利要求1所述的三尖瓣瓣架，其特征在于，所述内架部分(11)和所述外架部分(12)通过金属或非金属线材绑制相连，或，所述内架部分(11)和所述外架部分(12)焊接相连。
  6. 根据权利要求1所述的三尖瓣瓣架，其特征在于，所述内架部分(11)包括第二架体(112)和连接爪(14)，所述连接爪(14)的一端固定于所述第二架体(112)，所述连接爪(14)的另一端穿过所述外架部分(12)并从所述流出端(121)伸出。
  7. 根据权利要求6所述的三尖瓣瓣架，其特征在于，所述连接爪(14)具有多个，多个所述连接爪(14)收向于所述瓣架的轴心。
  8. 根据权利要求6所述的三尖瓣瓣架，其特征在于，所述第二架体(112)与所述连接爪(14)为一体成型结构。
  9. 根据权利要求6所述的三尖瓣瓣架，其特征在于，所述外架部分(12)固定于所述内架部分(11)的外侧。
  10. 一种三尖瓣瓣膜假体，其特征在于，包括权利要求1-9任一项所述的三尖瓣瓣架(1)，所述三尖瓣瓣膜假体还包括瓣裙(3)、瓣叶(2)和密封裙，所述瓣裙(3)围设于所述内架部分(11)和所述外架部分(12)的内侧，所述瓣叶(2)固定于所述瓣裙(3)的内侧，所述密封裙围设于所述外架部分(12)的底端外侧。
PCT/CN2021/133518 2021-05-17 2021-11-26 三尖瓣瓣架及其瓣膜假体 WO2022242093A1 (zh)

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CN113662716B (zh) * 2021-09-27 2024-10-11 广东脉搏医疗科技有限公司 一种植入三尖瓣膜装置
WO2023133723A1 (zh) * 2022-01-12 2023-07-20 金仕生物科技（常熟）有限公司 带有两侧爪的介入二尖瓣瓣架及介入二尖瓣
CN116570404B (zh) * 2023-07-13 2023-11-03 上海威高医疗技术发展有限公司 一种瓣膜支架及人工心脏瓣膜假体

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