WO2020207332A1 - 一种支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣 - Google Patents

一种支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣 Download PDF

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Publication number
WO2020207332A1
WO2020207332A1 PCT/CN2020/083088 CN2020083088W WO2020207332A1 WO 2020207332 A1 WO2020207332 A1 WO 2020207332A1 CN 2020083088 W CN2020083088 W CN 2020083088W WO 2020207332 A1 WO2020207332 A1 WO 2020207332A1
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WIPO (PCT)
Prior art keywords
valve
stent
interventional
struts
row
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Ceased
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PCT/CN2020/083088
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English (en)
French (fr)
Inventor
金磊
慕宏
范志豪
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Beijing Balance Medical Technology Co Ltd
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Beijing Balance Medical Technology Co Ltd
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Publication date
Application filed by Beijing Balance Medical Technology Co Ltd filed Critical Beijing Balance Medical Technology Co Ltd
Priority to JP2021558007A priority Critical patent/JP2022528091A/ja
Priority to EP20788292.9A priority patent/EP3954331A4/en
Priority to US17/602,711 priority patent/US20220160503A1/en
Priority to SG11202111140QA priority patent/SG11202111140QA/en
Publication of WO2020207332A1 publication Critical patent/WO2020207332A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2/2463—Implants forming part of the valve leaflets
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a connection structure of a stent and leaflet used for an interventional valve or interventional aortic valve, and an interventional valve and an interventional aortic valve using the connection structure.
  • Interventional valve-in-valve is specially used for re-interventional treatment of patients who cannot undergo surgical valve replacement after the previously implanted (inserted) biological artificial heart valve has suffered valve failure due to various reasons. That is, the valve of the interventional valve is inserted into the failed artificial bioprosthesis through the catheter to replace the failed bioprosthesis to achieve the purpose of treatment.
  • the technical problem to be solved by the present invention is to provide a connecting structure for the stent and leaflets of the interventional valve or the interventional aortic valve, and the interventional valve and the interventional aortic valve using the connecting structure, which is in a metal stent There is a buffer part on the inner side to prevent direct contact between the leaflets and the stent, which improves the durability of the valve product.
  • the technical solution adopted by the present invention is to provide a structure for connecting a stent and leaflets of an interventional valve or an interventional aortic valve.
  • the stent is a metal mesh tube, and the three valve leaflets are arranged on the stent.
  • each of the three fan-shaped leaflets has a free edge, an arc-shaped bottom edge, and a leaflet junction connecting portion extending on both sides, and three connecting posts are evenly distributed on the metal mesh tube, and each The connecting column has at least one rectangular slit, the boundary connecting part of the fan-shaped leaflet includes a radially inverted connecting part and an axially inverted connecting part, and the radially inverted connecting part of each fan-shaped leaflet passes through the connecting column
  • the rectangular slits are folded from the inner side to the outer side, and the axially inverted connecting portion is folded on the inner side of the connecting column to form a buffering portion and then connected by sutures and fixed to the connecting column.
  • the radially inverted connecting parts of the two adjacent leaflet junction connecting parts are also connected by sewing a flexible tab, then pass through the rectangular slit of the connecting column, and are fastened inside the flexible tab A rigid gasket is then fixed to the connecting post by sutures.
  • each connecting column is provided with holes or rectangular frames symmetrically on both sides of the rectangular slit, the number of the holes is four to eight, and the number of the rectangular frames is two or four.
  • the material of the stent is an implantable alloy material
  • the implantable alloy material is a cobalt-based alloy, a nickel-titanium alloy or a stainless steel material
  • the material of the valve leaflet is an animal-derived tissue material or a medical polymer material .
  • the present invention also provides an interventional valve or interventional aortic valve using the above-mentioned connection structure, including a radially compressible and balloon-expanded stent that is slightly flared, and three sector-shaped stents arranged inside the stent Valve leaflets, each of the three fan-shaped leaflets has a free edge, an arc-shaped bottom edge and a leaflet junction connecting portion extending on both sides, the bracket is a metal mesh tube, and three connecting posts are evenly distributed on the metal mesh tube, Each of the connecting posts has at least one rectangular slit, the boundary connecting part of the fan-shaped leaflet includes a radially inverted connecting part and an axially inverted connecting part, and the radially inverted connecting part of each fan-shaped leaf passes through The rectangular slit of the connecting column penetrates from the inner side to the outer side and then is folded, the axially inverted connecting portion is folded on the inner side of the connecting column to form a buffer portion and then connected by sutures and fixed to the connecting column.
  • the radially inverted connecting parts of the two adjacent leaflet junction connecting parts are also connected by sewing a flexible tab, then pass through the rectangular slit of the connecting column, and are fastened inside the flexible tab A rigid gasket is then fixed to the connecting post by sutures.
  • each of the connecting posts is provided with holes or rectangular frames symmetrically on both sides of the rectangular slit, the number of the holes is four to eight, and the number of the rectangular frames is two or four.
  • the material of the stent is an implantable alloy material
  • the implantable alloy material is a cobalt-based alloy, a nickel-titanium alloy or a stainless steel material
  • the material of the valve leaflet is an animal-derived tissue material or a medical polymer material .
  • the bracket has a plurality of rows of axial struts arranged between the connecting columns, and three rows of circumferential struts extending transversely are arranged between the connecting columns and the axial struts.
  • the struts define the inflow end of the stent
  • the second row of circumferential struts and the third row of circumferential struts spaced apart from the first row define the outflow end of the stent
  • each row of circumferential struts is composed of multiple angular struts
  • Each group of support rods is in a deformable V shape, and the deformation angle is between 0-90 degrees.
  • Each group of circumferential support rods in the first row and the second row are arranged in parallel with the third row.
  • the directions of each group of circumferential struts are opposite, and the covering film on the body wall of the stent is sewn between the first row of circumferential struts and the second row of circumferential strut
  • the stent has four rows of circumferential struts extending transversely and multiple rows of axial struts arranged between the circumferential struts, wherein the first and second rows of circumferential struts on the lower side define the At the inflow end, the third and fourth rows of circumferential struts define the outflow end of the stent.
  • Each row of circumferential struts is connected by struts with multiple angles.
  • Each group of struts is in a deformable V shape.
  • the angle is between 0-90 degrees, the rows of axial struts and the groups of circumferential struts are connected to each other to form a honeycomb-shaped space, and the covering film on the body wall of the stent is sewn to the first row of circumferential struts Between the rod and the third row of circumferential support rods.
  • the outer side of the body wall of the stent is sewn with a film between the first row of circumferential struts and the second row of circumferential struts.
  • the angle between the outer edge of the stent after balloon expansion and its axis is between 0° and 30°.
  • the beneficial effects that can be achieved by the present invention are: the intervening valve-in-valve or intervening aortic valve stent and leaflet connection structure provided by the present invention and the intervening valve-in-valve and interventional aortic valve using the connection structure , Because it is made of animal-derived tissue materials folded on the inside of the connecting tissue of the valve leaflets to form a buffer, and then connected by sutures and fixed on the connecting column of the stent, it can avoid the valve leaflets during the opening and closing process It is rubbed or scratched by the metal bracket; and because the connecting posts in the connecting structure are double-row holes or rectangular frame routing, the stitches at the joints of the valve leaflets and the holes or rectangular frame are fully fixed.
  • the interventional valve center valve of the present invention draws on the accumulation of more than 50 years of research and clinical application of artificial biological heart valves. Under the same conditions of chemical modification of biological valves, the structure design of the interventional valve, the intervening tissues between the leaflets and the valve The connection and fixation of the leaf tissue and the stent setting structure meet the requirements of fluid mechanics and valve firmness for valve opening and closing.
  • Figure 1 is a schematic diagram of the artificial heart surgical valve structure
  • FIG. 2 is a schematic diagram of an interventional valve-in-valve structure for re-intervention of an artificial biological heart valve according to an embodiment of the present invention
  • Fig. 3 is an expanded plan view of a valve leaflet of an interventional valve for re-intervention of an artificial biological heart valve according to an embodiment of the present invention
  • 4A-C are side views and perspective views of the three leaflet junction connecting parts of an interventional valve in an interventional valve for re-intervention of an artificial biological heart valve according to an embodiment of the present invention
  • FIG. 5 is an expanded plan view of the arc-shaped bottom edge of the valve leaflet of the interventional valve for the re-intervention of the artificial biological heart valve according to an embodiment of the present invention, which is coated with a polyester edge for reinforcement;
  • Fig. 6 is a perspective view of a metal stent for an interventional valve-in-valve used for re-intervention of an artificial biological heart valve according to an embodiment of the present invention
  • Fig. 7 is a perspective view of an interventional valve for re-intervention of a biological artificial heart valve according to an embodiment of the present invention after being expanded by a balloon;
  • Figure 8 is a top plan view of an interventional valve used for re-intervention of an artificial biological heart valve according to an embodiment of the present invention when it is closed;
  • Fig. 9 is a top plan view of an interventional valve for re-intervention of an artificial biological heart valve according to an embodiment of the present invention when the valve is opened.
  • Fig. 10 is a perspective view of a metal stent for interventional aortic valve for re-intervention of artificial biological heart valve according to another embodiment of the present invention.
  • Fig. 11 is a schematic diagram showing the structure of an interventional aortic valve for re-intervention of an artificial biological heart valve according to another embodiment of the present invention.
  • Figures 12A-B are schematic diagrams of the connection between the connecting post and the valve leaflets according to an embodiment of the present invention.
  • the present invention provides a connection structure for an interventional valve-in-valve or interventional aortic valve stent and leaflet, and an interventional valve-in-valve and interventional aortic valve using the connection structure.
  • the central valve of the interventional valve has a "lower” end and an "upper” end.
  • the terms “lower” and “upper” and the terms “inflow” and “outflow” are used interchangeably, respectively.
  • the lower end of the valve in the interventional valve is its inflow end
  • the upper end of the valve in the interventional valve is its outflow end.
  • FIG. 2 is a schematic diagram of an interventional valve-in-valve structure for re-intervention of an artificial biological heart valve according to an implementation of the present invention, including a radially compressible and balloon-expanded stent 10 (see Figure 7)
  • the bracket is a metal mesh tube, and three connecting columns 11 are evenly distributed on the metal mesh tube. A total of 6 rows of axial struts 12 are evenly distributed among the three connecting columns 11.
  • Each row of circumferential struts 13, 14, 15 is connected by struts EE with multiple angles.
  • Each group of struts FF is in a deformable V shape, and the deformation angle is between 0-90 degrees.
  • the first row of circumferential struts 13 and Each group of circumferential struts of the second row of circumferential struts 14 are arranged in parallel and opposite to each group of circumferential struts of the third row of circumferential struts 15 to form multiple grids that can be deformed simultaneously.
  • the stent composed of such a metal mesh tube can be adapted to the use mode in which the valve of the interventional valve is compressed longitudinally and then expanded during interventional treatment.
  • a rectangular slit 18 is provided on the connecting post 11, and two rows of six holes 16 are symmetrically provided on both sides of the rectangular slit 18, which are used to fix the fan-shaped leaflets through sutures.
  • a covering film 17 is sewn between the first row of circumferential struts 13 and the second row of circumferential struts 14.
  • the covering film on the body wall of the stent is sewn between the first row of circumferential struts and the third row of circumferential struts.
  • a layer of outer covering film (not shown in the figure) is further sewn on the outside of the same position as required.
  • the material of the film may be animal-derived tissues or medical polymer materials that those skilled in the art can think of.
  • the junction 23 of the fan-shaped leaflet 20 includes two parts: a radially inverted connecting portion 231 and an axially inverted connecting portion 232.
  • the radially inverted connecting portion 231 Align them in pairs, then pass through the rectangular slit 18 from the inside of the connecting column 11, then open it and fold it outwards, and fix it to the connecting column with sutures. Then turn the connecting part 232 axially on the inside of the connecting column and fold it down in the opposite direction.
  • the fan-shaped leaflets 20 are aligned and connected by sutures, so that a buffer portion 24 is formed at the root of the free edge of the fan leaflet, and the buffer portion 24 is further fixedly connected to the hole 16 of the connecting post 11 of the stent by sutures.
  • the radially inverted connecting portion can be turned over to the extent that it covers the connecting column 11 and then fixed.
  • the arc-shaped bottom edge of the fan-shaped leaflet can also be covered with a layer of reinforced membrane 25, which is further sewn to the body wall of the stent through the membrane 25. In this way, an interventional valve center valve of the embodiment of the present invention is formed.
  • the leaflets of the interventional valve when the leaflets of the interventional valve are opened, due to the presence of the buffer portion 24, the leaflets can be prevented from being rubbed or scratched by the metal bracket during the opening and closing process; and due to the connection structure
  • the connecting column is a double-row hole routing, so that the suture at the junction of the valve leaflet and the hole or rectangular frame are fully fixed, which can avoid the stress concentration of the valve leaflet during the opening and closing process, so as to increase the intervention valve
  • the durability of the valve or interventional aortic valve achieves the same durability effect as the surgical valve.
  • the interventional valve valve of the present invention can be used for the re-intervention treatment of the interventional valve in addition to the re-intervention treatment of the surgical valve in this embodiment.
  • Example 2 Intervention of aortic valve
  • the structure of the present invention can not only be used for the re-intervention treatment in the first embodiment, but also can be directly used for the interventional treatment of the aortic valve.
  • the interventional aortic valve in this embodiment has a stent structure different from that in the first embodiment, and other structures are substantially the same as those in the first embodiment. In some cases, a larger outflow end and a larger bracket height are required.
  • the bracket 50 is a metal mesh tube, and three connecting posts 51 are evenly distributed on the metal mesh tube.
  • the stent has four rows of circumferential struts 52, 53, 54 and 55 extending transversely and a plurality of axial struts 56 arranged between the circumferential struts.
  • the first and second rows of circumferential struts on the lower side The rods 52 and 53 define the inflow end of the stent.
  • the third and fourth rows of circumferential struts 54 and 55 define the outflow end of the stent.
  • Each row of circumferential struts is composed of struts FF with multiple angles.
  • the group of support rods are in a deformable V shape, and the deformation angle is between 0 and 90 degrees.
  • the multiple rows of axial support rods 56 and the multiple groups of circumferential support rods are connected to each other to form a deformable honeycomb grid.
  • the honeycomb grid that defines the outflow end is larger.
  • the upper part of the connecting column 11 is provided with a rectangular slit 59, and two rows of rectangular frames 57 are provided symmetrically on both sides of the slit.
  • the axially inverted connecting parts of adjacent fan-shaped leaflets first pass through the rectangular shape after being aligned.
  • the slit 59 is then opened, passes through the two rectangular frames 57, and is turned over again to cover the outer side of the connecting column, and then fixed to the connecting column by sutures to improve the connection strength between the valve leaflet and the stent.
  • a covering film 58 is sewn between the first row of circumferential struts 52 and the third row of circumferential struts 54.
  • an outer covering film (not shown in the figure) is sewn on the outside of the covering film between the first row of circumferential struts 52 and the second row of circumferential struts 53.
  • the material of the film may be animal-derived tissues or medical polymer materials that those skilled in the art can think of.
  • FIG. 12A-B in some cases, such a way of fixing the leaflets 80 to the stent 70 can also be used.
  • the connecting post 71 of the stent 70 has only one slit 72, and the two adjacent petals A flexible connecting piece 90 is sewn between the axially inverted connecting parts 81 at the leaf junction, and then a rectangular slit 72 is passed through the reinforcing pad 91, and then the connecting post is fully fixed and connected by the suture to form a whole body.
  • the radially inverted connecting portion of the leaflets can be in the same manner as the previous embodiment.
  • valve leaflets are animal-derived tissue materials or medical
  • the polymer material for example, can be any one of porcine pericardium, bovine pericardium or sheep pericardium tissue materials, or any medical polymer material, which is not specifically limited herein.
  • the suture is any of medical polymer materials.

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

Abstract

一种支架（10）和瓣叶（20）的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣。其中的支架（10）为金属网管，瓣叶（20）为三个设置于该支架内侧的扇形瓣叶（20），三个扇形瓣叶（20）均具有游离缘（21）、弧形底边（22）以及延伸于两侧的瓣叶交界连接部（23）。金属网管上均布有三个连接柱（11），扇形瓣叶（20）的交界连接部（23）包括径向翻转连接部（231）和轴向翻转连接部（232）。每一扇形瓣叶（20）的径向翻转连接部（231）穿过连接柱（11）从内侧穿向外侧后翻折、轴向翻转连接部（232）在连接柱（11）内侧翻折后再由缝线连接并固定于该连接柱（11）。该支架（10）和瓣叶（20）的连接结构可避免瓣叶（20）开启与关闭时的应力集中和与支架（10）之间产生摩擦，实现了与生物瓣相近的血流动力学效果和类似的耐久性功能。

Description

一种支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣 技术领域
本发明涉及医疗器械技术领域，具体涉及一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣。
背景技术
介入瓣中瓣是专门用于先前植(介)入的人工生物心脏瓣膜由各种原因发生瓣膜毁损失功后，无法再行手术换瓣的患者的再介入治疗。即经导管把介入瓣中瓣放入已经失功的人工生物瓣内，以替代失功的生物瓣达到治疗的目的。
严重主动脉瓣病变患者左心功能严重受损，患者生活质量下降且生存时间明显缩短，必须进行有效的治疗。65岁以上老年人中，由于主动脉瓣退行性变所致的主动脉瓣病变发生率达10％，随着社会的老龄化主动脉瓣病变比例越来越高，按美国3500万65岁老人有8.5万需要换瓣计算，国内每年应有20余万老年人等待治疗。按着2017年AHC/ACC发布的指南，把外科植入生物瓣的患者年龄降至50岁，以及对任何年龄的患者，抗凝治疗禁忌、不能合适抗凝或不希望抗凝治疗，均推荐使用生物瓣膜。由此未来老年主动脉瓣换人工生物瓣将逐年增加，对于那些高龄、重症无法再行手术换瓣的患者，通过瓣中瓣再介入治疗将成为最后被救治的希望。能有一款介入瓣中瓣，且与外科生物瓣一样的耐久性，将成为这些患者获得再次治疗的利器。
发明内容
本发明所要解决的技术问题在于提供一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣，其在金属支架内侧设有缓冲部，可以防止瓣叶与支架直接接触，提高了瓣膜产品的使用耐久性。
本发明所采取的技术方案是提供一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构，所述支架为金属网管，所述瓣叶为三个设置于所述支架内侧的扇形瓣叶，三个所述扇形瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述金属网管上均布有三个连接柱，所述每一连接柱至少具有一矩形狭缝，所述扇形瓣叶的交界连接部包括径向翻转连接部和轴向翻转连接部，所述每一扇形瓣叶的径向翻转连接部穿过所述连接柱的矩形狭缝从内侧穿向外侧后翻折、轴向翻转连接部在连接柱内侧翻折后形成缓冲部再由缝线连接并固定于所述连接柱。
进一步，所述两相邻瓣叶交界连接部的径向翻转连接部还通过缝接一柔性接片而相连后穿出所述连接柱的矩形狭缝，并于所述柔性接片内侧卡固一刚性垫片后通过缝线与连接柱固定。
进一步，所述每个连接柱上于所述矩形狭缝两侧对称设有孔或矩形框，所述孔的数量为四至八 个，所述矩形框数量为两个或四个。
进一步，所述支架的材料为可植入合金材料，所述可植入合金材料为钴基合金、镍钛合金或不锈钢材料，所述瓣叶的材料为动物源性组织材料或医用高分子材料。
本发明还提供了应用上述连接结构的介入瓣中瓣或介入主动脉瓣，包括径向可压缩并可被球囊扩张后略呈扩口状的支架，三个设置于所述支架内侧的扇形瓣叶，三个所述扇形瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，所述支架为金属网管，所述金属网管上均布有三个连接柱，所述每一连接柱至少具有一矩形狭缝，所述扇形瓣叶的交界连接部包括径向翻转连接部和轴向翻转连接部，所述每一扇形瓣叶的径向翻转连接部穿过所述连接柱的矩形狭缝从内侧穿向外侧后翻折、轴向翻转连接部在连接柱内侧翻折后形成缓冲部再由缝线连接并固定于所述连接柱，所述支架的体壁上设置有覆膜。
进一步，所述两相邻瓣叶交界连接部的径向翻转连接部还通过缝接一柔性接片而相连后穿出所述连接柱的矩形狭缝，并于所述柔性接片内侧卡固一刚性垫片后通过缝线与连接柱固定。
进一步，所述每个连接柱上于所述矩形狭缝两侧对称设有孔或矩形框，所述孔的数量为四至八个，所述矩形框数量为两个或四个。进一步，所述支架的材料为可植入合金材料，所述可植入合金材料为钴基合金、镍钛合金或不锈钢材料，所述瓣叶的材料为动物源性组织材料或医用高分子材料。
进一步，所述支架具有设于所述连接柱之间的多列轴向支杆，所述连接柱与轴向支杆之间设有横向延伸的三行圆周支杆，下侧第一行圆周支杆限定所述支架的流入端，与第一行间隔开的第二行圆周支杆和第三行圆周支杆限定所述支架的流出端，每行圆周支杆由多组成角度的支杆连接组成，所述每组支杆呈可变形的V字形，变形的角度介于0-90度，所述第一行和第二行的每组圆周支杆为平行排列且与第三行的每组圆周支杆方向相反，所述支架的体壁上的覆膜缝接于所述第一行圆周支杆和第二行圆周支杆之间。
进一步，所述支架具有设有横向延伸的四行圆周支杆和设于所述圆周支杆之间的多列轴向支杆，其中下侧第一、二行圆周支杆限定所述支架的流入端，第三、四行圆周支杆限定所述支架的流出端，每行圆周支杆由多组成角度的支杆连接组成，所述每组支杆呈可变形的V字形，所述变形的角度介于0-90度，所述多列轴向支杆与多组圆周支杆相互连接形成蜂窝形空间，所述支架的体壁上的覆膜缝接于所述第一行圆周支杆和第三行圆周支杆之间。
进一步，所述支架的体壁外侧于所述第一行圆周支杆和第二行圆周支杆之间还缝接有覆膜。
进一步，球囊扩张后的支架外缘与其轴线的夹角在0°到30°之间。
本发明所能达到的有益效果是：本发明提供的一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣，由于其是由动物源性组织材料在其 瓣叶交界联结组织内侧翻折形成缓冲部，再由缝线连接并固定在所述支架的连接柱上，可避免瓣叶在开启与关闭过程中被金属支架摩擦或划伤；而且由于该连接结构中的连接柱为双排孔或矩形框走线，使瓣叶的交界连接部的接缝处的缝线与孔或矩形框充分固定，可避免瓣叶在开启与关闭过程中应力集中，以增加该介入瓣中瓣或介入主动脉瓣的使用耐久性，实现了与外科瓣膜等同的耐久效果。本发明的介入瓣中瓣借鉴人工生物心脏瓣膜50余年的研究与临床应用的积累，在同样生物瓣化学改性上技术的条件下，使介入瓣的结构设计、瓣叶交界组织之间以及瓣叶组织和支架设定结构的联结和固定，满足瓣膜启闭的流体力学和瓣膜牢固性要求。
附图说明
图1为人工心脏外科瓣膜结构示意图；
图2为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣结构示意图；
图3为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣的瓣叶展开平面图；
图4A-C为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣的三个瓣叶交界连接部翻折缝合侧视图和透视图；
图5为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣的瓣叶弧形底边处包被有用于加固的聚酯边缘展开平面图；
图6为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣的金属支架透视图；
图7为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣在被球囊扩张后的透视图；
图8为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣关闭时顶视平面图；
图9为根据本发明一实施例的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣打开时顶视平面图。
图10为根据本发明又一实施例的用于人工生物心脏瓣膜再介入治疗的介入主动脉瓣的金属支架透视图；
图11为根据本发明又一实施例的用于人工生物心脏瓣膜再介入治疗的介入主动脉瓣结构示意图。
图12A-B为根据本发明实施例的连接柱和瓣叶的连接方式示意图。
具体实施方式
本发明提供了一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣，下面以具体实施例来说明具体实施方式，应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
实施例一：介入瓣中瓣
介入瓣中瓣具有“下”端和“上”端。在本申请的上下文中，术语“下”和“上”与术语“流 入”和“流出”可分别互换使用。因此，例如，介入瓣中瓣的下端是其流入端，介入瓣中瓣的上端是其流出端。
参阅图2，为根据本发明一实施的用于人工生物心脏瓣膜再介入治疗的介入瓣中瓣结构示意图，包括径向可压缩并可被球囊扩张后略呈喇叭状的支架10(参阅图7)，三个设置于所述支架10内侧的扇形瓣叶20，三个所述扇形瓣叶20均具有游离缘21、弧形底边22以及延伸于两侧的瓣叶交界连接部23(参阅图3)。进一步参阅图6，所述支架为金属网管，所述金属网管上均布有三个连接柱11，三个连接柱11之间均布共设置有6列轴向支杆12，所述连接柱11与6列轴向支杆12之间设有横向贯穿延伸的三行圆周支杆13、14、15，下侧第一行圆周支杆13限定所述支架10的流入端，与第一行圆周支杆13间隔开的第二行圆周支杆14和第三行圆周支杆15限定所述支架的流出端。每行圆周支杆由多组成角度的支杆EE连接组成，所述每组支杆FF呈可变形的V字形，变形的角度介于0-90度，所述第一行圆周支杆13和第二行圆周支杆14的每组圆周支杆为平行排列且与第三行圆周支杆15的每组圆周支杆方向相反，以形成可以同步变形的多个网格。这样的金属网管构成的支架可以适应介入治疗时介入瓣中瓣先被纵向压缩后再膨胀的使用方式。进一步，连接柱11上设有一矩形狭缝18，矩形狭缝18两侧对称设有两排共六个孔16，用于通过缝线固定连接扇形瓣叶。支架11的多个网格中，于所述第一行圆周支杆13和第二行圆周支杆14之间缝接有覆膜17。所述支架的体壁上的覆膜缝接于所述第一行圆周支杆和第三行圆周支杆之间。在某些情况下，根据需要，在同样的位置外侧，进一步缝制有一层外侧覆膜(图中未示出)。所述覆膜的材料，本领域的技术人员能够想到的动物源性组织或医用高分子材料都可以。
再参阅图2和图4A-C、图5，所述扇形瓣叶20的交界连接部23包括两部分：径向翻转连接部231和轴向翻转连接部232，首先将径向翻转连接部231两两对齐，然后从连接柱11内侧穿过矩形狭缝18后向外打开翻折后用缝线固定于连接柱，然后轴向翻转连接部232于连接柱内侧以相反的方向翻折下来与扇形瓣叶20贴合对齐用缝线连接，这样就在扇叶瓣叶游离缘的根部形成了一段缓冲部24，缓冲部24再进一步通过缝线固定连接于支架的连接柱11的孔16。径向翻转连接部可以根据需要翻转到包覆连接柱11的程度再固定。而扇形瓣叶的弧形底边还可包被有一层加固的覆膜25，通过覆膜25进一步缝接于支架的体壁上的覆膜。这样，就形成了本发明实施例的一种介入瓣中瓣。
参阅图8和图9，介入瓣中瓣的瓣叶在打开时，由于缓冲部24的存在，可避免瓣叶在开启与关闭过程中被金属支架摩擦或划伤；而且由于该连接结构中的连接柱为双排孔走线，使瓣叶的交界连接部的接缝处的缝线与孔或矩形框充分固定，可避免瓣叶在开启与关闭过程中应力集中，以增加该介入瓣中瓣或介入主动脉瓣的使用耐久性，实现了与外科瓣膜等同的耐久效果。
本发明的介入瓣中瓣除了可以用于本实施例中的外科瓣的再介入治疗还可以用于介入瓣的再介入治疗。
实施例二：介入主动脉瓣
本发明的结构除了可以用于实施例一中的再介入治疗，还可以直接用于主动脉瓣的介入治疗。本实施例中的介入主动脉瓣具有与实施例一中不同的支架结构，其他结构与实施例一大致相同。在某些情况下，需要更大的流出端和更大的支架高度，参阅图10、图11所示，本实施例中，支架50为金属网管，金属网管上均布有三个连接柱51，所述支架具有设有横向延伸的四行圆周支杆52、53、54、55和设于所述圆周支杆之间的多根轴向支杆56，其中下侧第一、二行圆周支杆52、53限定所述支架的流入端，第三、四行圆周支杆54、55限定所述支架的流出端，每行圆周支杆由多组成角度的支杆FF连接组成，所述每组支杆呈可变形的V字形，所述变形的角度介于0-90度，所述多列轴向支杆56与多组圆周支杆相互连接形成可以变形的蜂窝形网格。其中限定流出端的蜂窝性网格更大。进一步，连接柱11上部设置有矩形狭缝59，对称于狭缝两侧设置两排矩形框57，在本实施例中，相邻的扇形瓣叶的轴向翻转连接部对齐后首先穿过矩形狭缝59，然后再打开分别穿过两矩形框57后再次翻转包覆连接柱外侧后，通过缝线固定于连接柱，以提高瓣叶与支架的连接强度。支架51的多个网格中，于所述第一行圆周支杆52和第三行圆周支杆54之间缝接有覆膜58。在某些情况下，根据需要，在第一行圆周支杆52和第二行圆周支杆53之间覆膜的外侧还缝接有外侧覆膜(图中未示出)。所述覆膜的材料，本领域的技术人员能够想到的动物源性组织或医用高分子材料都可以。
如图12A-B所示，在某些情况下，还可以使用这样的瓣叶80与支架70的固接方式，支架70的连接柱71仅具有一条狭缝72，所述两相邻的瓣叶交界的轴向翻转连接部81之间缝接一个柔性接片90后穿出矩形狭缝72再放入加固垫片91，再通过缝线与连接柱充分固定连接围成一体。瓣叶的径向翻转连接部可以采取与前述实施例相同的方式。
在所有实施例中的支架，可以实施为但不限于钴基合金或镍钛合金或不锈钢材料或其它可植入合金材料支架等，在此不作具体限定；瓣叶为动物源性组织材料或医用高分子材料，例如可以为猪心包、牛心包或羊心包组织材料中的任一种或医用高分子材质任一种，在此不作具体限定。缝线为医用高分子材质中的任一种。
最后应说明的是：以上所述的各实施例仅用于说明本发明的技术方案，而非对其限制；尽管参照前述实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述实施例所记载的技术方案进行修改，或者对其中部分或全部技术特征进行等同替换；而这些修改或替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。

Claims (9)

  1. 一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构，所述支架为金属网管，所述瓣叶为三个设置于所述支架内侧的扇形瓣叶，三个所述瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，其特征在于，所述金属网管上均布有三个连接柱，所述每一连接柱至少具有一矩形狭缝，所述扇形瓣叶的交界连接部包括径向翻转连接部和轴向翻转连接部，所述每一扇形瓣叶的径向翻转连接部穿过所述连接柱的矩形狭缝从内侧穿向外侧后翻折、轴向翻转连接部在连接柱内侧翻折后形成缓冲部再由缝线连接并固定于所述连接柱。
  2. 根据权利要求1所述的一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构，其特征在于，所述两相邻瓣叶交界连接部的径向翻转连接部还通过缝接一柔性接片而相连后穿出所述连接柱的矩形狭缝，并于所述柔性接片内侧卡固一刚性垫片后通过缝线与连接柱固定。
  3. 如权利要求1所述的一种用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构，其特征在于，所述每个连接柱上于所述矩形狭缝两侧对称设有孔或矩形框，所述孔的数量为四至八个，所述矩形框数量为两个或四个。
  4. 如权利要求1所述的用于介入瓣中瓣或介入主动脉瓣的支架和瓣叶的连接结构，其特征在于，所述支架的材料为可植入合金材料，所述可植入合金材料为钴基合金、镍钛合金或不锈钢材料，所述瓣叶的材料为动物源性组织材料或医用高分子材料。
  5. 应用如权利要求1-4中任一所述的支架和瓣叶的连接结构的介入瓣中瓣或介入主动脉瓣，包括径向可压缩并可被球囊扩张后略呈扩口状的支架，三个设置于所述支架内侧的扇形瓣叶，三个所述扇形瓣叶均具有游离缘、弧形底边以及延伸于两侧的瓣叶交界连接部，其特征在于，所述支架为金属网管，所述金属网管上均布有三个连接柱，所述每一连接柱至少具有一矩形狭缝，所述扇形瓣叶的交界连接部包括径向翻转连接部和轴向翻转连接部，所述每一扇形瓣叶的径向翻转连接部穿过所述连接柱的矩形狭缝从内侧穿向外侧后翻折、轴向翻转连接部在连接柱内侧翻折后形成缓冲部再由缝线连接并固定于所述连接柱，所述支架的体壁上设置有覆膜。
  6. 如权利要求5所述的介入瓣中瓣或介入主动脉瓣，其特征在于，所述支架具有设于所述连接柱之间的多列轴向支杆，所述连接柱与轴向支杆之间设有横向延伸的三行圆周支杆，下侧第一行圆周支杆限定所述支架的流入端，与第一行圆周支杆间隔开的第二行圆周支杆和第三行圆周支杆限定所述支架的流出端，每行圆周支杆由多组成角度的支杆连接组成，所述每组支杆呈可变形的V字形，变形的角度介于0-90度，所述第一行和第二行的每组圆周支杆为平行排列且与第三行的每组圆周支杆方向相反，所述支架的体壁上的覆膜缝接于所述第一行圆周支杆和第二行圆周支杆之间。
  7. 如权利要求5所述的介入瓣中瓣或介入主动脉瓣，其特征在于，所述支架具有设有横向延伸的 四行圆周支杆和设于所述圆周支杆之间的多列轴向支杆，其中下侧第一、二行圆周支杆限定所述支架的流入端，第三、四行圆周支杆限定所述支架的流出端，每行圆周支杆由多组成角度的支杆连接组成，所述每组支杆呈可变形的V字形，所述变形的角度介于0-90度，所述多列轴向支杆与多组圆周支杆相互连接形成蜂窝形空间，所述支架的体壁上的覆膜缝接于所述第一行圆周支杆和第三行圆周支杆之间。
  8. 如权利要求5所述的介入瓣中瓣或介入主动脉瓣，其特征在于，所述支架的体壁外侧于所述第一行圆周支杆和第二行圆周支杆之间还缝接有覆膜。
  9. 如权利要求5所述的介入瓣中瓣或介入主动脉瓣，其特征在于，球囊扩张后的支架外缘与其轴线的夹角在0°到30°之间。
PCT/CN2020/083088 2019-04-08 2020-04-03 一种支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣 Ceased WO2020207332A1 (zh)

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