WO2022199172A1 - 一种人工心脏瓣膜 - Google Patents

一种人工心脏瓣膜 Download PDF

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Publication number
WO2022199172A1
WO2022199172A1 PCT/CN2021/141262 CN2021141262W WO2022199172A1 WO 2022199172 A1 WO2022199172 A1 WO 2022199172A1 CN 2021141262 W CN2021141262 W CN 2021141262W WO 2022199172 A1 WO2022199172 A1 WO 2022199172A1
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WO
WIPO (PCT)
Prior art keywords
conical
grid
heart valve
artificial heart
frame
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Application number
PCT/CN2021/141262
Other languages
English (en)
French (fr)
Inventor
王森
周国磊
蒋健健
戴志豪
Original Assignee
上海申淇医疗科技有限公司
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Application filed by 上海申淇医疗科技有限公司 filed Critical 上海申淇医疗科技有限公司
Priority to EP21932779.8A priority Critical patent/EP4316425A1/en
Publication of WO2022199172A1 publication Critical patent/WO2022199172A1/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
    • 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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • 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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to an artificial heart valve.
  • valve-related diseases mainly includes repair (including valve annulus repair, key cable repair, valve leaflet repair, etc.) and replacement.
  • Valve replacement is divided into surgical replacement and transcatheter minimally invasive replacement according to the types of clinical operations.
  • Transcatheter minimally invasive artificial heart valve replacement is a new method of valve replacement treatment in recent years. Compared with traditional surgical replacement, this method does not require thoracotomy, which greatly reduces the pain of patients and the occurrence of complications. It also brings new hope for the treatment of critically ill patients who cannot be treated by traditional surgery.
  • an artificial heart valve is provided.
  • an artificial heart valve in one aspect of the present application, includes a grid tube body, a first tapered tube sleeved to the same end of the grid tube body in sequence along the axial direction of the grid tube body A mesh frame, a second conical mesh frame, and a film respectively arranged on the mesh tube body, the first conical mesh frame and the second conical mesh frame.
  • the conical surface of the first conical mesh frame and the conical surface of the second conical mesh frame are arranged opposite to each other to clamp the conical surface between the first conical mesh frame and the second conical mesh frame.
  • the inner wall of the heart, and the film on the first conical grid frame and the second conical grid frame and the inner wall of the heart respectively form a first sealing surface and a second sealing surface.
  • the angle between the conical surface of the first conical grid frame and the horizontal plane is 0-80 degrees
  • the angle between the conical surface and the horizontal plane of the second conical grid frame is 0-80 degrees
  • the second conical grid frame includes a first grid frame body and a second grid frame body that are connected, the first grid frame body has a first taper, and the second grid frame body is For the second taper, the angle between the conical surface of the first grid body and the horizontal plane is 0-80 degrees, the angle between the conical surface of the second grid body and the horizontal plane is approximately 90 degrees, and the second The central angle ⁇ of the grid body is 50-180 degrees.
  • first conical mesh frame and the second conical mesh frame are integrally formed.
  • barbs are provided on the second conical mesh frame, and an included angle between the barbs and the conical surface of the second conical mesh frame is an acute angle.
  • the grid of the grid tube body is in a rhombus shape, and the apex angle of the rhombus is 37-100 degrees.
  • the total length of the prosthetic heart valve is 10-35 mm.
  • the cross section of the second conical grid is D-shaped.
  • the other end of the grid tube body is provided with a circumferential array of discrete connecting parts.
  • the number of the connecting parts is 2-12.
  • the connecting body between two adjacent meshes on the mesh tube body is provided with a stress release hole.
  • the conical surface of the first conical mesh frame and the conical surface of the second conical mesh frame are arranged opposite to each other, so as to clamp the inner wall of the heart between the first conical mesh frame and the second conical mesh frame, and make the inner wall of the heart located between the first conical mesh frame and the second conical mesh frame
  • the film on the first conical grid frame and the second conical grid frame and the inner wall of the heart form the first sealing surface and the second sealing surface respectively, which can prevent the blood from the left ventricle from being fixed to the heart from the artificial heart valve. Problems such as arrhythmia and heart failure caused by reflux back into the left atrium increase the success rate of the operation.
  • FIG. 1 is a schematic structural diagram of an artificial heart valve provided in an embodiment of the present application.
  • FIG. 2 is a schematic structural diagram of the artificial heart valve provided in the embodiment of the present application after transplantation
  • Fig. 3 is the front view of Fig. 1;
  • Figure 4 is a schematic cross-sectional view taken along line A-A in Figure 3;
  • Fig. 5 is the structural representation of the first conical grid in Fig. 1 and the second conical grid;
  • Fig. 6 is the front view of Fig. 5;
  • Fig. 7 is the top view of Fig. 5;
  • Fig. 8 is the front view of the grid pipe body in Fig. 1;
  • FIG. 9 is a partial enlarged view of R in FIG. 8 .
  • connection should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between the two elements.
  • connection may be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between the two elements.
  • a first feature "on” or “under” a second feature may include direct contact between the first and second features, or may include the first and second features Not directly but through additional features between them.
  • the first feature being “above”, “over” and “above” the second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature is “below”, “below” and “below” the second feature includes the first feature being directly below and diagonally below the second feature, or simply means that the first feature has a lower level than the second feature.
  • An artificial heart valve can be implanted in the heart to replace a diseased heart valve.
  • the mitral valve the left atrioventricular valve, is attached to the annulus fibrosus around the left atrioventricular orifice and has two valves. When the left ventricle contracts, the mitral valve closes the atrioventricular orifice to prevent the backflow of blood from the left ventricle into the left atrium.
  • Transcatheter minimally invasive prosthetic heart valve replacement is a new method of valve replacement therapy in recent years. This method does not require open-heart treatment, but instead compresses the artificial heart valve into a delivery sheath, passes through the blood vessel into the corresponding location in the heart, and then releases the compressed artificial heart valve in the delivery sheath.
  • the existing artificial heart valve is fixed on the annulus fibrosus at the periphery of the left atrioventricular orifice by setting barbs.
  • the artificial heart valve fixed by the barb does not fit the heart ideally, which will cause the blood in the left ventricle to flow from the artificial heart valve.
  • the gap between the fixed position of the heart and the back of the left atrium can cause arrhythmia, heart failure, and in severe cases, sudden death.
  • the present application provides an artificial heart valve, as shown in FIG. 1 and FIG. 3 , the artificial heart valve includes a mesh tube body 1, a first conical mesh frame 21, a second conical mesh frame 22, Membrane and leaflets 4.
  • the first conical mesh frame 21 and the second conical mesh frame 22 are sequentially sleeved to the same end of the mesh tube body 1 along the axial direction of the mesh tube body 1 to fix the artificial heart valve to the peripheral edge of the left atrioventricular orifice. on the fibrous ring.
  • the coating includes a first coating 31 arranged on the first conical grid 21 , a second coating 32 arranged on the second conical grid 22 and a third coating arranged on the grid tube body 1 . 33 , so that the artificial heart valve forms a channel from one end of the grid tube body 1 to the other end of the grid tube body 1 .
  • the valve leaflet 4 is arranged in the channel, and when the left ventricle 52 contracts, the heart squeezes the blood in the left ventricle 52, the blood impinges on the valve leaflet 4, the valve leaflet 4 closes the channel, and the blood does not flow into the left atrium 51.
  • the artificial heart valve After the artificial heart valve is compressed, it is delivered to the heart through a delivery sheath, and the released artificial heart valve undergoes elastic deformation in order to restore the original state.
  • the first conical grid 21 and the second conical grid 22 clamp the peripheral edge of the left atrioventricular orifice.
  • the conical surface of the first conical mesh frame 21 and the horizontal plane are clamped.
  • the angle is 0-80 degrees
  • the included angle between the conical surface of the second conical grid 22 and the horizontal plane is 0-80 degrees.
  • the second conical grid frame 22 includes a first grid frame body 221 and a second grid frame body 222 .
  • the first grid body 221 has a first taper
  • the second grid body 222 has a second taper.
  • the conical surface of the second conical grid 22 with the first taper that is, the angle between the conical surface of the first grid body 221 and the horizontal plane is 0-80 degrees
  • the conical surface, that is, the angle between the conical surface of the second grid body 222 and the horizontal plane is approximately 90 degrees; and, as shown in FIG.
  • the central angle ⁇ of the two grid bodies 222 is 50-180 degrees.
  • the first conical mesh frame 21 and the second conical mesh frame 22 are integrally formed, which can not only improve the artificial heart.
  • the strength of the valve can also be firmly clamped on the annulus fibrosus at the periphery of the left atrioventricular orifice, thereby improving the sealing performance of the artificial heart valve.
  • barbs 223 are provided on the second conical mesh frame 22 .
  • the included angle between the barbs 223 and the conical surface of the second conical mesh frame 22 is an acute angle, so that the first conical mesh frame 21 and the second conical mesh frame 22 clamp the annulus fibrosus at the periphery of the left atrioventricular orifice.
  • the barbs 223 can hook the annulus fibrosus at the periphery of the left atrioventricular orifice clamped by the first conical mesh frame 21 and the second conical mesh frame 22, so as to fix the artificial heart valve more stably.
  • the released artificial heart valve has sufficient supporting force, as shown in FIG. 3 , FIG. 8 and FIG. 9 , the mesh tube body 1
  • the grid is in the shape of a rhombus, and the apex angle of the rhombus is 37-100 degrees, so that the prosthetic heart valve can be compressed to the delivery sheath and at the same time, the prosthetic heart valve after release has sufficient supporting force.
  • the total length of the artificial heart valve in this embodiment is 10-35 mm.
  • the cross-sectional shape of the annulus fibrosus at the periphery of the left atrioventricular orifice is D-shaped, in order to prevent the artificial heart valve from being placed in the in-situ mitral valve of the heart, it will cause compression on the flat sidewall of the accommodation space. As a result, the outflow tract of the heart becomes narrow.
  • the cross section of the second conical grid 22 is D-shaped.
  • the other end of the grid tube body 1 is provided with a circumferential array of discrete connection parts 11,
  • the number of the connecting parts 11 is 2-12, so that the artificial heart valve can be evenly stressed, and it is convenient for the compressed artificial heart valve to enter or exit the delivery sheath.
  • the blood flowing into the aorta 53 from the left ventricle 52 is oxygen-enriched and high-pressure blood, it will cause a certain impact on the grid tube body 1 .
  • the radial direction of the grid tube body 1 can be contracted, so as to reduce the impact of the impact force on the grid tube body 1 .
  • stress relief holes 12 are provided on the connecting body between two adjacent grids on the grid tube body 1 .
  • the stress release hole 12 can disperse the stress in the central part of the connecting body between two adjacent meshes, thereby avoiding the phenomenon of stress concentration in the central part of the connecting body, thereby enhancing the strength of the mesh tube body 1 .
  • the grid tube body 1 , the first conical grid 21 and the second conical grid 22 can be integrally formed or separately made of nickel-titanium alloy with superelasticity and memory. Welded, riveted or glued.
  • the coating can be made of polymer materials such as polytetrafluoroethylene, and the first coating 31 can be fixed on the first conical grid 21 by sewing, gluing or ultrasonic welding, etc.
  • the second coating 32 is fixed on the second conical grid frame 22
  • the third coating 33 is fixed on the grid tube body 1 .
  • the valve leaflet 4 can be made of bovine pericardium, porcine pericardium, or other polymer membranes, and can be sewn into the channel of the mesh tube body 1 by sutures.

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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

一种人工心脏瓣膜，包括网格管体（1）、沿网格管体（1）的轴向依次套设至网格管体（1）同一端的第一锥形网架（21）和第二锥形网架（22），以及分别设置于网格管体（1）、第一锥形网架（21）及第二锥形网架（22）上的覆膜，第一锥形网架（21）的锥面和第二锥形网架（22）的锥面相对设置，以夹持位于第一锥形网架（21）和第二锥形网架（22）之间的心脏的内壁，并使位于第一锥形网架（21）及第二锥形网架（22）上的覆膜与心脏的内壁分别形成第一密封面和第二密封面。

Description

一种人工心脏瓣膜
相关申请的交叉引用
本申请要求于2021年03月26日提交中国专利局、申请号为2021103266789的中国专利申请的优先权，所述专利申请的全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，尤其涉及一种人工心脏瓣膜。
背景技术
随着人口老龄化，瓣膜性心脏病的发病率明显增加。据调查数据显示，在11911名随机选择的成人中有615名成人发现了中度或重度瓣膜病，患病率随着年龄的增长而增加，从18-44岁人群患病率的0.7％增加到75岁及以上年龄组的13.2％。
目前临床上治疗瓣膜相关的疾病主要有修复(包括瓣环修复、键索修复、瓣叶修复等)和置换，瓣膜的置换根据临床手术种类分为外科手术置换和经导管微创置换2种。
传统的外科手术置换需要通过外科手术打开患者的心脏，一方面，此种外科手术方法会给患者带来很大的痛苦，即便是手术顺利，由于是开胸治疗，难免会留下术后后遗症；另一方面，由于瓣膜相关的疾病大多都是中老年患者，而由于大部分中老年患者的身体条件受限，不允许进行传统的外科手术治疗。
经导管微创人工心脏瓣膜置换术是近年来瓣膜置换治疗的新方法，相较于传统的外科置换术，该方法不需要开胸治疗，大大减轻了病人的痛苦及并发后遗症的发生，同时，也给对于无法进行传统外科手术治疗的危重症患者带来了新的治疗希望。
但是，由于人体二尖瓣结构的复杂性，使得经导管的人工心脏瓣膜在植入后，人工心脏瓣膜在固定至心脏的相应位置时，人工心脏瓣膜与心脏贴合效果不理想，会导致左心室的血液从人工心脏瓣膜与心脏固定的位置反流回左心房，这可能引起心律失常以及心力衰竭，严重的还可能导致猝死。
因此，亟于解决上述问题。
发明内容
根据本申请的各种实施例，提供一种人工心脏瓣膜。
在本申请的一方面，提供一种人工心脏瓣膜，该人工心脏瓣膜包括网格管体、沿所述网格管体的轴向依次套设至所述网格管体同一端的第一锥形网架和第二锥形网架，以及分别设置于所述网格管体、所述第一锥形网架及所述第二锥形网架上的覆膜。所述第一锥形网架的锥面和所述第二锥形网架的锥面相对设置，以夹持位于所述第一锥形网架和所述第二锥形网架之间的心脏的内壁，并使位于所述第一锥形网架及所述第二锥形网架上的所述覆膜与所述心脏的内壁分别形成第一密封面和第二密封面。
在其中一个实施例中，所述第一锥形网架的锥面与水平面的夹角为0-80度，所述第二锥形网架的锥面与水平面的夹角为0-80度。
在其中一个实施例中，所述第二锥形网架包括相连的第一网架体和第二网架体，所述第一网架体呈第一锥度，所述第二网架体呈第二锥度，所述第一网架体的锥面与水平面的夹角为0-80度，所述第二网架体的锥面与水平面的夹角大致为90度，并且所述第二网架体的中心角α为50-180度。
在其中一个实施例中，所述第一锥形网架与所述第二锥形网架一体成型。
在其中一个实施例中，所述第二锥形网架上设置有倒刺，所述倒刺与所述第二锥形网架的锥面之间的夹角为锐角。
在其中一个实施例中，所述网格管体的网格呈菱形，所述菱形的顶角为37-100度。
在其中一个实施例中，所述人工心脏瓣膜的总长度为10-35mm。
在其中一个实施例中，所述第二锥形网架的横截面为D型。
在其中一个实施例中，所述网格管体的另一端设置有离散的连接部的周向阵列。
在其中一个实施例中，所述连接部的个数为2-12个。
在其中一个实施例中，所述网格管体上相邻的两个网格之间的连接体上设置有应力释放孔。
通过第一锥形网架的锥面和第二锥形网架的锥面相对设置，以夹持位于第一锥形网架和第二锥形网架之间的心脏的内壁，并使位于第一锥形网架及第二锥形网架上的覆膜与心脏的内壁分别形成第一密封面和第二密封面，可防止出现因左心室的血液从人工心脏瓣膜与心脏固定的位置反流回左心房而引起的心律失常以及心力衰竭等问题，提高了手术的成功率。
附图说明
为了更清楚地说明本申请实施例或传统技术中的技术方案，下面将对实施例或传统技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅是本申请的一些实施例，对于本领域普通技术人员而言，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本申请实施例提供的人工心脏瓣膜的结构示意图；
图2是本申请实施例提供的人工心脏瓣膜移植后的结构示意图；
图3是图1的主视图；
图4是沿图3中的A-A线截取的截面示意图；
图5是图1中的第一锥形网架和第二锥形网架的结构示意图；
图6是图5的主视图；
图7是图5的俯视图；
图8是图1中的网格管体的主视图；
图9是图8中R处的局部放大图。
图中：
1、网格管体；11、连接部；12、应力释放孔；
21、第一锥形网架；22、第二锥形网架；221、第一网架体；222、第二网架体；223、倒刺；
31、第一覆膜；32、第二覆膜；33、第三覆膜；
4、瓣叶；
51、左心房；52、左心室；53、主动脉；541、第一原生瓣叶；542、第二原生瓣叶。
具体实施方式
下面结合附图和实施例对本申请作进一步的详细说明。可以理解的是，此处所描述的具体实施例仅仅用于解释本申请，而非对本申请的限定。另外还需要说明的是，为了便于描述，附图中仅示出了与本申请相关的部分而非全部结构。
在本申请的描述中，除非另有明确的规定和限定，术语“相连”、“连接”、“固定”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申 请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。
在本实施例的描述中，术语“上”、“下”、“右”、等方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述和简化操作，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”仅仅用于在描述上加以区分，并没有特殊的含义。
人工心脏瓣膜能够植入心脏内代替发生病变的心脏瓣膜。二尖瓣，即左房室瓣，附于左房室口周缘的纤维环上，具有两个瓣膜。在左心室收缩时，二尖瓣关闭房室口，以防止左心室内的血液逆流进入左心房。
经导管微创人工心脏瓣膜置换术是近年来瓣膜置换治疗的新方法。该方法不需要开胸治疗，而是将人工心脏瓣膜压缩至输送鞘管中，经过血管进入心脏的相应位置中，然后释放输送鞘管中被压缩的人工心脏瓣膜。
现有的人工心脏瓣膜通过设置倒刺固定在左房室口周缘的纤维环上，然而通过倒刺固定的人工心脏瓣膜与心脏贴合效果不理想，会导致左心室内的血液从人工心脏瓣膜与心脏固定的位置之间的缝隙反流回左心房，这可能引起心律失常以及心力衰竭，严重的还可能导致猝死。
为了解决上述问题，本申请提供一种人工心脏瓣膜，如图1和图3所示，该人工心脏瓣膜包括网格管体1、第一锥形网架21、第二锥形网架22、覆膜及瓣叶4。第一锥形网架21和第二锥形网架22沿网格管体1的轴向依次套设至网格管体1的同一端，以将人工心脏瓣膜固定至左房室口周缘的纤维环上。
覆膜包括设置于第一锥形网架21上的第一覆膜31、设置于第二锥形网架22上的第二覆膜32及设置于网格管体1上的第三覆膜33，以使人工心脏瓣膜形成由网格管体1的一端至网格管体1的另一端的通道。
瓣叶4设置于通道内，并且当左心室52收缩时，心脏挤压左心室52内血液，血液冲击瓣叶4，使瓣叶4关闭通道，从而使血液不流入左心房51中。
人工心脏瓣膜在被压缩后，经输送鞘管输送至心脏，被释放的人工心脏瓣膜为了恢复初始状态发生弹性变形。通过将第一锥形网架21的锥面和第二锥形网架22的锥面相对设置，使第一锥形网架21和第二锥形网架22夹持左房室口周缘的纤维环，并使位于第一锥形网架21及第二锥形网架22上的覆膜与左房室口周缘的纤维环分别形成第一密封面和第二密封面，从而可使左心室52中的血液无法在左心室52收缩时，从人工心脏瓣膜与左房室口周缘的纤维环之间回流至左心房51中，以防止出现因左心室52的血液从人工心脏瓣膜与心脏固定的位置反流回左心房51而引起的心律失常以及心力衰竭等问题，提高了手术的成功率。
进一步地，为了能够使第一锥形网架21和第二锥形网架22稳固地夹持在左房室口周缘的纤维环上，第一锥形网架21的锥面与水平面的夹角为0-80度，第二锥形网架22的锥面与水平面的夹角为0-80度。
由于第一锥形网架21和第二锥形网架22在夹持左房室口周缘的纤维环时，第二锥形网架22会使心脏的第一原生瓣叶541和第二原生瓣叶542贴近于左心室52的周壁，从而可能导致第一原生瓣叶541遮挡由左心室52通至主动脉53的通道，从而可能会阻碍左心室52中的血流进入由左心室52流入主动脉53，从而导致全身供血不足。
为了解决上述问题，进一步地，如图2至图6所示，在本实施例中，第二锥形网架22包括第一网架体221和第二网架体222。第一网架体221呈第一锥度，第二网架体222呈第二锥度。呈第一锥度的第二锥形网架22的锥面，即第一网架体221的锥面与水平面的夹角为0-80度；呈第二锥度的第二锥形网架22的锥面，即第二网架体222的锥面与水平面的夹角大致为90度；并且，如图7所示，呈第二锥度的第二锥形网架22的中心角α，即第二网架体222的中心角α为50-180度。通过如此构造，第一原生瓣叶541远离由左心室52通至主动脉53的通道，从而防止第一原生瓣叶541阻挡血流进入主动脉53。
进一步地，为了提高人工心脏瓣膜的强度以及能够稳固地夹持于左房室口周缘的纤维环，第一锥形网架21与第二锥形网架22一体成型，这不仅能够提高人工心脏瓣膜的强度，而且还能够稳固地夹持在左房室口周缘的纤维环上，提高人工心脏瓣膜的密封性。
进一步地，为了使人工心脏瓣膜能够更加稳固地固定在左房室口周缘的纤维环上，第二锥形网架22上设置有倒刺223。倒刺223与第二锥形网架22的锥面之间的夹角为锐角，以使第一锥形网架21与第二锥形网架22在夹持左房室口周缘的纤维环时，倒刺223能够勾住被第一锥形网架21与第二锥形网架22夹持的左房室口周缘的纤维环，从而更加稳固地固定人工心脏瓣膜。
进一步地，为了使人工心脏瓣膜在能够被压缩至输送鞘管的同时，使释放后的人工心脏瓣膜具有足够的支撑力，如图3、图8和图9所示，网格管体1的网格呈菱形，菱形的顶角为37-100度，从而使得人工心脏瓣膜在能够被压缩至输送鞘管的同时，使释放后的人工心脏瓣膜具有足够的支撑力。
进一步地，为了防止由于人工心脏瓣膜的长度过长从而遮挡或阻碍由左心室52通至主动脉53的通道，本实施例中的人工心脏瓣膜的总长度为10-35mm。
进一步地，由于左房室口周缘的纤维环的横截面形状是D型，为了防止人工心脏瓣膜置入心脏的原位二尖瓣中后，会对容置空间平直的侧壁造成压迫，致使心脏的流出道变得狭窄，在本实施例中，第二锥形网架22的横截面为D型。
进一步地，在人工心脏瓣膜由输送鞘管输送至心脏的过程中，为了便于人工心脏瓣膜进入或退出输送鞘管，网格管体1的另一端设置有离散的连接部11的周向阵列，连接部11的个数为2-12个，以使人工心脏瓣膜受力均匀，并且便于被压缩的人工心脏瓣膜进入或退出输送鞘管。
进一步地，由于从左心室52流入主动脉53的血液为富氧高压血液，会对网格管体1造成一定的冲击力，为了减小对网格管体1的影响，连接部11沿网格管体1的径向可收缩，以而减小冲击力对网格管体1的影响。
进一步地，为了增强网格管体1的强度，网格管体1上相邻的两个网格之间的连接体上设置有应力释放孔12。应力释放孔12能够分散相邻的两个网格之间的连接体中心部分的应力，从而避免了连接体的中心部分出现应力集中的现象，从而增强了网格管体1的强度。
进一步地，在本实施例中，网格管体1、第一锥形网架21和第二锥形网架22可以由具备超弹性和记忆性的镍钛合金一体成型或分体制成后再焊接、铆接或粘接而成。
覆膜可以采用聚四氟乙烯等高分子材料制作而成，并可以采用缝线缝制、粘接或超声波焊接等方式将第一覆膜31固定在第一锥形网架21上、将第二覆膜32固定在第二锥形网架22上，以及将第三覆膜33固定在网格管体1上。
瓣叶4可以采用牛心包、猪心包、或其它高分子膜制成，并可以通过缝线缝制在网格管体1的通道中。
显然，本申请的上述实施例仅仅是为了清楚说明本申请所作的举例，而并非是对本申请的实施方式的限定。对于所属领域的普通技术人员来说，能够进行各种明显的变化、重新调整和替代而不会脱离本申请的保护范围。这里无需也无法对所有的实施方式予以穷举。凡在本申请 的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本申请权利要求的保护范围之内。

Claims (11)

  1. 一种人工心脏瓣膜，其特征在于，包括网格管体(1)、沿所述网格管体(1)的轴向依次套设至所述网格管体(1)同一端的第一锥形网架(21)和第二锥形网架(22)，以及分别设置于所述网格管体(1)、所述第一锥形网架(21)及所述第二锥形网架(22)上的覆膜，
    其中，所述第一锥形网架(21)的锥面和所述第二锥形网架(22)的锥面相对设置，以夹持位于所述第一锥形网架(21)和所述第二锥形网架(22)之间的心脏的内壁，并使位于所述第一锥形网架(21)及所述第二锥形网架(22)上的所述覆膜与所述心脏的内壁分别形成第一密封面和第二密封面。
  2. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述第一锥形网架(21)的锥面与水平面的夹角为0-80度，所述第二锥形网架(22)的锥面与水平面的夹角为0-80度。
  3. 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述第二锥形网架(22)包括相连的第一网架体(221)和第二网架体(222)，所述第一网架体(221)呈第一锥度，所述第二网架体(222)呈第二锥度，所述第一网架体(221)的锥面与水平面的夹角为0-80度，所述第二网架体(222)的锥面与水平面的夹角大致为90度，并且所述第二网架体(222)的中心角α为50-180度。
  4. 根据权利要求3所述的人工心脏瓣膜，其特征在于，所述第一锥形网架(21)与所述第二锥形网架(22)一体成型。
  5. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述第二锥形网架(22)上设置有倒刺(223)，所述倒刺(223)与所述第二锥形网架(22)的锥面之间的夹角为锐角。
  6. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述网格管体(1)的网格呈菱形，所述菱形的顶角为37-100度。
  7. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述人工心脏瓣膜的总长度为10-35mm。
  8. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述第二锥形网架(22)的横截面为D型。
  9. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述网格管体(1)的另一端设置有离散的连接部(11)的周向阵列。
  10. 根据权利要求9所述的人工心脏瓣膜，其特征在于，所述连接部(11)的个数为2-12个。
  11. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述网格管体(1)上相邻的两 个网格之间的连接体上设置有应力释放孔(12)。
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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100023121A1 (en) * 2008-07-23 2010-01-28 "Medeng" Heart valve prosthesis
CN105581858A (zh) * 2015-12-15 2016-05-18 先健科技(深圳)有限公司 人工心脏瓣膜支架及人工心脏瓣膜
CN105726167A (zh) * 2016-02-02 2016-07-06 上海纽脉医疗科技有限公司 一种介入式人工心脏瓣膜
CN105873542A (zh) * 2013-10-24 2016-08-17 美敦力公司 心脏瓣膜假体
CN108135696A (zh) * 2015-10-09 2018-06-08 美敦力瓦斯科尔勒公司 心脏瓣膜假体
CN111329621A (zh) * 2019-07-26 2020-06-26 闫朝武 经导管主动脉人工瓣膜、输送系统及输送方法
CN113057765A (zh) * 2021-03-26 2021-07-02 上海申淇医疗科技股份有限公司 一种人工心脏瓣膜

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9662206B2 (en) * 2011-09-12 2017-05-30 Highlife Sas Transcatheter valve prosthesis
EP4209196A1 (en) * 2017-01-23 2023-07-12 Cephea Valve Technologies, Inc. Replacement mitral valves
CN209790095U (zh) * 2018-09-03 2019-12-17 高洋 一种心外科适用的瓣膜支架
CN212662031U (zh) * 2020-09-15 2021-03-09 杭州德晋医疗科技有限公司 人工心脏瓣膜支架、人工心脏瓣膜及人工心脏瓣膜置换系统

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100023121A1 (en) * 2008-07-23 2010-01-28 "Medeng" Heart valve prosthesis
CN105873542A (zh) * 2013-10-24 2016-08-17 美敦力公司 心脏瓣膜假体
CN108135696A (zh) * 2015-10-09 2018-06-08 美敦力瓦斯科尔勒公司 心脏瓣膜假体
CN105581858A (zh) * 2015-12-15 2016-05-18 先健科技(深圳)有限公司 人工心脏瓣膜支架及人工心脏瓣膜
CN105726167A (zh) * 2016-02-02 2016-07-06 上海纽脉医疗科技有限公司 一种介入式人工心脏瓣膜
CN111329621A (zh) * 2019-07-26 2020-06-26 闫朝武 经导管主动脉人工瓣膜、输送系统及输送方法
CN113057765A (zh) * 2021-03-26 2021-07-02 上海申淇医疗科技股份有限公司 一种人工心脏瓣膜

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