WO2017121194A1 - Dispositif de valvule aortique transcathéter équipé d'une bague de positionnement - Google Patents

Dispositif de valvule aortique transcathéter équipé d'une bague de positionnement Download PDF

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Publication number
WO2017121194A1
WO2017121194A1 PCT/CN2016/107224 CN2016107224W WO2017121194A1 WO 2017121194 A1 WO2017121194 A1 WO 2017121194A1 CN 2016107224 W CN2016107224 W CN 2016107224W WO 2017121194 A1 WO2017121194 A1 WO 2017121194A1
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WO
WIPO (PCT)
Prior art keywords
valve device
aortic valve
positioning
circular
main bracket
Prior art date
Application number
PCT/CN2016/107224
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English (en)
Chinese (zh)
Inventor
代高旭
周庆亮
孟坚
可大年
史欢欢
李阳
黄韬
杨宇霆
Original Assignee
北京迈迪顶峰医疗科技有限公司
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Publication of WO2017121194A1 publication Critical patent/WO2017121194A1/fr

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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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a transcatheter delivery aortic valve device having a positioning ring.
  • Surgical treatment such as prosthetic heart valve replacement or valvuloplasty, is the cure for valvular heart disease.
  • the mortality rate of surgical thoracotomy is very high. high.
  • the epoch-making technique of transcatheter prosthetic valves has pushed interventional surgery to the peak of technology and tried to solve all the deficiencies of surgical valve replacement.
  • the success of the first transcatheter prosthetic valve replacement surgery marked the beginning of this revolutionary interventional medical technology into a feasible stage. After 10 years of development, more than 100,000 people have rebuilt heart function through this technology. Get a new life.
  • the existing aortic valve device may be released for recovery; or the positioning may be accurate but not recyclable; or the release may be released and the positioning is accurate, but the indication is limited.
  • the present invention provides a transcatheter delivery aortic valve device having a positioning ring, the aorta
  • the valve device includes: a main bracket; a leaflet fixed inside the middle portion of the main bracket; and a skirt fixed along the inner periphery of the main bracket and fixed to the leaflet; wherein the upper end of the main bracket Forming an upper bell mouth structure in the form of a three-lobed; at the upper end of the upper bell mouth structure, there are three upper end circular connecting claws for loading the main bracket; the bottom end of the main bracket is used for reducing the leakage of the valve a downwardly flared lower bell mouth structure; the lower bellows structure has three lower end circular connecting claws at a lower end thereof; the aortic valve device further includes a positioning ring for positioning on a lower side of the main bracket
  • the positioning ring includes three V-shaped or U-shaped circular arc segments, and ends of each of the V-shaped or U-shaped circular arc segments are connected to each other to form an annul
  • the main bracket and/or the positioning ring is a Nitinol material; the middle portion is a vertical section, and the lower bell mouth structure has a degree of opening smaller than a degree of opening of the upper bell mouth structure.
  • the lower bell mouth structure is a flat flare structure that is slightly expanded outward.
  • the lower bell mouth structure height is 3mm to 8mm.
  • the main bracket is a grid structure formed by a diamond-shaped grid unit; and an inclination of an end of the upper bell mouth structure and the lower bell mouth structure from the central axis of the main bracket is 1° to 15°.
  • the center of the upper end circular connecting claw is a circular or square through hole or a non-porous shape, and the upper end circular connecting claw and the upper bell mouth structure are connected by a short connecting rod.
  • the intermediate portion of the main bracket and the upper bell structure of the main bracket are connected to each other by a short link.
  • the short link has a length of 1.5 mm to 4 mm and a width of 0.25 mm to 1 mm.
  • a short connecting rod is used between the adjacent grid units of the main bracket connection.
  • the minimum width of the left and right concave short links is 0.25 mm to 0.5 mm.
  • the left and right concave short links are a concave structure formed by two left and right circular arcs or a concave structure formed by a short straight line segment and left and right circular arcs.
  • the middle of the lower end connecting claw is a circular hole or a square hole, and the bottom end of the lower end connecting claw is a concave arc structure; the lower end connecting claw is evenly distributed at the bottom end of the main bracket. .
  • the middle of the positioning circular connecting claw is a circular hole or a square hole, and the top end of the positioning circular connecting claw is a concave circular arc structure.
  • the concave arc of the bottom end of the lower end circular connecting claw has a radius of 0.3 mm to a radius of 1 mm.
  • the circular arc of the concave end of the positioning circular connecting claw has a radius of 0.3 mm to a radius of 1 mm.
  • the material of the leaflet is pig pericardium, bovine pericardium, horse pericardium or polymer material polytetrafluoroethylene;
  • the material of the skirt is pig pericardium, bovine pericardium, horse pericardium, polymer material polytetrafluoroethylene Ethylene or polyester cloth.
  • the positioning line is a filament material such as a polymer material thread or a nickel-titanium wire such as a general medical suture or a degradable medical suture.
  • the positioning ring is composed of 3 to 12 V-shaped or U-shaped structural units having a rod width of 0.3 mm to 1 mm, and the positioning ring has a height of 7 mm to 15 mm.
  • the length of the positioning line is increased by 5 mm to 12 mm than the height of the positioning ring.
  • the invention has the advantages that the loading and recovery of the aortic valve device is achieved by three circular connecting claws arranged at the upper end of the main stent of the aortic valve as a flared structure; the straight horn passing through the bottom end of the main stent The shape of the mouth reduces the leakage of the valve; the positioning of the aortic valve device is achieved by the positioning line and the positioning ring at the lower end of the main stent, so that the surgical procedure is safer and more reliable.
  • Figure 1 is a schematic view showing the unfolded state of an aortic valve device of the present invention
  • FIG. 2 is a schematic view showing the positioning of an aortic valve device of the present invention
  • Figure 3 is a schematic view showing the structure of a positioning ring of an aortic valve device of the present invention
  • Figure 4 is a schematic illustration of the loading of the aortic valve device of the present invention into a delivery system
  • Figure 5 is a schematic illustration of the semi-release of the positioning ring of the aortic valve device of the present invention.
  • Figure 6 is a schematic view showing the complete release of the positioning ring of the aortic valve device of the present invention.
  • Figure 7 is a schematic view showing the position of the aortic valve device of the present invention delivered to the heart;
  • Figure 8 is a schematic view showing the semi-release of the aortic valve device of the present invention in a cardiac position positioning ring;
  • Figure 9 is a schematic view showing the complete release of the aortic valve device of the present invention at the cardiac position positioning ring;
  • Figure 10 is a schematic view showing the positioning of the main stent of the aortic valve device of the present invention at the heart position;
  • Figure 11 is a schematic illustration of the complete release of the aortic valve device of the present invention at the heart position.
  • the present invention provides a transcatheter delivery aortic valve device having a positioning ring for implantation into an in situ aortic valve resulting from aortic stenosis or regurgitation or regurgitation To solve the problem of accurate positioning of the aortic valve device; further, to solve problems that adapt to a variety of conditions, such as aortic stenosis or regurgitation or reflux or two-valve.
  • An aortic valve device 100 for implantation into an orthotopic aortic valve resulting from a lesion of the aortic stenosis or regurgitation, the aortic valve device comprising a main bracket; a leaflet 104 fixed inside the intermediate portion of the main bracket; and a skirt 102 fixed along the inner periphery of the main bracket and fixed to the leaflet 104; further, the skirt 102 is along the main bracket surrounding In a circle, and sutured with sutures; the leaflets 104 are three pieces, which are sewn in the middle part of the main frame and fixedly stitched with the skirt 102.
  • the upper end of the main bracket forms an upper bell mouth structure 105 in the form of three lobes; at the upper end of the upper bell mouth structure 105, there are three upper end circular connecting claws 106 for loading the main bracket, It may be hollow or solid; the bottom end of the main bracket has an outwardly flared lower bell structure 101 for reducing the leakage of the valve; the lower end of the lower bell structure 101 has three lower end circular connecting claws 110;
  • the aortic valve device further includes a positioning ring 103 for positioning on a lower side of the main bracket, the positioning ring 103 including three V-shaped or U-shaped arc segments, each of the V-shaped or U-shaped arcs The ends of the segments are connected to each other to form an annular shape, and three positioning circular connecting claws 111 are formed on the end portions; the lower circular connecting claws 110 and the corresponding positioning circular connecting claws 111 respectively pass through flexible positioning lines 107 connections.
  • the main bracket and the positioning ring 103 may be a Nitinol material; the middle portion is a vertical section, and the opening of the lower bell mouth structure 101 is smaller than the opening degree of the upper bell mouth structure 105. Further, the lower bell mouth structure 101 is an outwardly slightly expanded flat bell structure. The lower bell mouth structure 101 has a height of 3 mm to 8 mm.
  • the main bracket may be a grid structure formed by a diamond-shaped grid unit; and the inclinations of the ends of the upper bell mouth structure 105 and the lower bell mouth structure 101 deviating from the central axis of the main bracket are respectively 1° to 15 °.
  • the middle portion of the main bracket smoothly transitions with the lower bell mouth structure 101 and the upper bell mouth structure 105.
  • the center of the upper end circular connecting claw 106 is a circular or square through hole or a non-porous shape, and the upper end circular connecting claw 106 and the upper bell mouth structure 105 are connected by a short link.
  • the middle portion of the main bracket and the upper bell mouth structure 105 of the main bracket pass The short links 108 are connected to each other.
  • the short link has a length of 1.5 mm to 4 mm and a width of 0.25 mm to 1 mm.
  • a short link connection 109 that is concave in the left and right may be used between adjacent grid cells of the main bracket.
  • the minimum width of the left and right concave short links is 0.25 mm to 0.5 mm.
  • the left and right concave short links may be a concave structure formed by two left and right circular arcs or a concave structure formed by adding a small straight line segment and a left and right circular arc.
  • the middle of the lower end connecting claw 110 may be a circular hole or a square hole, and the bottom end of the lower end circular connecting claw 110 is a concave arc structure; the lower end circular connecting claw 110 is evenly distributed at the bottom end of the main bracket. .
  • the middle of the positioning circular connecting claw 111 is a circular hole or a square hole, and the top end of the positioning circular connecting claw 111 has a concave circular arc structure 112 (see FIG. 3).
  • the circular arc of the bottom end of the lower end circular connecting claw 110 has a radius of 0.3 mm to a radius of 1 mm.
  • the circular arc of the top end of the positioning circular connecting claw 111 has a radius of 0.3 mm to a radius of 1 mm.
  • the material of the leaflet may be a pig pericardium, a bovine pericardium, a horse pericardium or a polymer material polytetrafluoroethylene; the material of the skirt is pig pericard, bovine pericardium, horse pericard, polymer material polytetrafluoroethylene or polyester cloth.
  • the positioning line 107 may be a filament of a polymer material such as a general medical suture or a degradable medical suture or a nickel wire.
  • the positioning ring 103 may also be composed of 3 to 12 V-shaped or U-shaped structural units having a rod width of 0.3 mm to 1 mm, and the positioning ring 103 has a height of 7 mm to 15 mm.
  • the length of the positioning line 107 may be increased by 5 mm to 12 mm than the height of the positioning ring 103.
  • the middle portion of the upper bell mouth structure 105 may be expanded in a diamond shape, and the upper bell mouth structure 105 is evenly distributed around the main bracket.
  • Transcatheter delivery aortic valve device with positioning ring according to an embodiment of the invention The process is as follows:
  • the aortic valve device 100 (including the main stent and the positioning ring 103) is first loaded into the loading sheath 202 of the delivery system 200 by a certain device (refer to FIG. 4), and the delivery system 200 includes a head end 201, loading The sheath 202 and the handle 203 and the like.
  • the delivery system 200 is delivered to the human lesion site by intervention (see Figure 7).
  • the loading sheath 202 of the delivery system 200 is then moved back to the fixed position by the handle 203, and the positioning ring 103 of the aortic valve device 100 is released halfway (please refer to Figures 5 and 8), at this time
  • the shape and memory characteristics of the aortic valve device 100, the positioning ring 103 automatically expands to form a bell mouth shape (please refer to FIG. 5 and FIG. 8), and then slowly pushes the delivery system 200 toward the ventricle, so that the positioning ring 103 contacts the human body naturally.
  • the push delivery system 200 is stopped.
  • the loading sheath 202 of the delivery system 200 is again moved back to the fixed position by the handle 203, so that the positioning ring 103 is completely released from the loading sheath 202, at which time the positioning ring 103 is fully automatically expanded to the maximum size due to the material shape memory property. (Please refer to Figures 6 and 9).
  • the human natural leaflet tissue 300 is between the lower bell structure 101 and the positioning ring 103 of the aortic valve device 100 (refer to the figure).
  • the aortic valve device 100 performs precise positioning.
  • the loading sheath 202 is again moved rearwardly by the handle 203 of the delivery system 200, releasing the upper flare structure 105 and the upper circular connecting jaw 106 of the aortic valve device 100 from the loading sheath 202, as described Aortic valve device 100
  • the shape memory characteristic of the material, the upper bell mouth structure 105 automatically expands to the maximum, and is fixed to the blood vessel wall (refer to FIG. 11), the conveying system 200 and the upper end circular connecting claw 106, and finally the delivery system 200 is withdrawn, the main The anastomotic valve device 100 is implanted.

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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)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un dispositif de valvule aortique transcathéter (100), comprenant : un support principal ; des feuillets valvulaires (104) fixés à l'intérieur de la partie médiane du support principal ; et une jupe (102) qui est fixée le long de la périphérie interne du support principal, ainsi qu'aux feuillets valvulaires (104). Une structure évasée supérieure (105) à motif trilobé est présente sur l'extrémité supérieure du support principal. Trois mâchoires (106) circulaires supérieures de connexion utilisées pour le chargement du support principal sont disposées au sommet de la structure évasée supérieure (105). Une structure évasée inférieure extensible vers l'extérieur (101), utilisée pour réduire les fuites paravalvulaires, est située sur l'extrémité inférieure du support principal. Trois mâchoires inférieures circulaires de connexion (110) sont situées au fond de la structure évasée inférieure (101). Le dispositif de valvule aortique comprend en outre une bague de positionnement (103), située sur la face inférieure du support principal et qui est utilisée pour le positionnement. La bague de positionnement (103) comprend trois sections d'arc en V ou en U. Les parties terminales des sections d'arc en V ou en U sont reliées les unes aux autres pour former une bague, et trois mâchoires circulaires de connexion et de positionnement (111) sont présentes sur les parties terminales. Les mâchoires inférieures circulaires de connexion (110) sont respectivement reliées aux mâchoires circulaires de positionnement et de connexion (111) correspondantes au moyen de lignes de positionnement flexibles (107).
PCT/CN2016/107224 2016-01-11 2016-11-25 Dispositif de valvule aortique transcathéter équipé d'une bague de positionnement WO2017121194A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201610029112.9A CN105496607A (zh) 2016-01-11 2016-01-11 一种经导管输送主动脉瓣瓣膜装置
CN201610029112.9 2016-01-11

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CN109498215A (zh) * 2018-12-14 2019-03-22 宁波健世生物科技有限公司 一种分离式释放的主动脉瓣膜支架
WO2019136292A1 (fr) * 2018-01-07 2019-07-11 Suzhou Jiecheng Medical Technology Co., Ltd. Prothèse de valvule cardiaque et pose
US10595994B1 (en) 2018-09-20 2020-03-24 Vdyne, Llc Side-delivered transcatheter heart valve replacement
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
US11071627B2 (en) 2018-10-18 2021-07-27 Vdyne, Inc. Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis
US11076956B2 (en) 2019-03-14 2021-08-03 Vdyne, Inc. Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis
US11109969B2 (en) 2018-10-22 2021-09-07 Vdyne, Inc. Guidewire delivery of transcatheter heart valve
US11166814B2 (en) 2019-08-20 2021-11-09 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11173027B2 (en) 2019-03-14 2021-11-16 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11185409B2 (en) 2019-01-26 2021-11-30 Vdyne, Inc. Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis
US11202706B2 (en) 2019-05-04 2021-12-21 Vdyne, Inc. Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus
US11234813B2 (en) 2020-01-17 2022-02-01 Vdyne, Inc. Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery
US11253359B2 (en) 2018-12-20 2022-02-22 Vdyne, Inc. Proximal tab for side-delivered transcatheter heart valves and methods of delivery
US11273032B2 (en) 2019-01-26 2022-03-15 Vdyne, Inc. Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis
US11273033B2 (en) 2018-09-20 2022-03-15 Vdyne, Inc. Side-delivered transcatheter heart valve replacement
US11278437B2 (en) 2018-12-08 2022-03-22 Vdyne, Inc. Compression capable annular frames for side delivery of transcatheter heart valve replacement
US11298227B2 (en) 2019-03-05 2022-04-12 Vdyne, Inc. Tricuspid regurgitation control devices for orthogonal transcatheter heart valve prosthesis
US11331186B2 (en) 2019-08-26 2022-05-17 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11344413B2 (en) 2018-09-20 2022-05-31 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
US11786366B2 (en) 2018-04-04 2023-10-17 Vdyne, Inc. Devices and methods for anchoring transcatheter heart valve

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CN105496607A (zh) * 2016-01-11 2016-04-20 北京迈迪顶峰医疗科技有限公司 一种经导管输送主动脉瓣瓣膜装置
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CN109350311B (zh) * 2018-12-14 2022-07-01 宁波健世科技股份有限公司 一种可控释放的瓣膜支架
CN110314017A (zh) * 2019-07-11 2019-10-11 陈绍良 经导管植入的主动脉瓣支架
CN110507451A (zh) * 2019-08-29 2019-11-29 上海翰凌医疗器械有限公司 瓣膜支架及具有其的人工瓣膜
CN111110400B (zh) * 2019-12-09 2022-02-22 先健科技(深圳)有限公司 心脏瓣膜系绳及具有其的心脏瓣膜组件
CN212996889U (zh) * 2020-07-17 2021-04-20 宁波健世生物科技有限公司 一种带定位件的瓣膜假体及其输送系统
CN113456299B (zh) * 2021-07-30 2024-01-30 上海纽脉医疗科技股份有限公司 一种可拆分的人工瓣膜
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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