WO2008052422A1 - Endoprothèse valvulaire composée d'une endoprothèse et d'une biovalvule tissées solidaires et procédé de fabrication de ladite endoprothèse - Google Patents

Endoprothèse valvulaire composée d'une endoprothèse et d'une biovalvule tissées solidaires et procédé de fabrication de ladite endoprothèse Download PDF

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Publication number
WO2008052422A1
WO2008052422A1 PCT/CN2007/003017 CN2007003017W WO2008052422A1 WO 2008052422 A1 WO2008052422 A1 WO 2008052422A1 CN 2007003017 W CN2007003017 W CN 2007003017W WO 2008052422 A1 WO2008052422 A1 WO 2008052422A1
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WO
WIPO (PCT)
Prior art keywords
stent
valve
animal
woven
vessel wall
Prior art date
Application number
PCT/CN2007/003017
Other languages
English (en)
Chinese (zh)
Inventor
Ning Wen
Original Assignee
Ning Wen
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ning Wen filed Critical Ning Wen
Publication of WO2008052422A1 publication Critical patent/WO2008052422A1/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
    • 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

  • Stent valve in which stent and biological valve are woven into one body and manufacturing method thereof
  • the invention relates to a substitute for human tissue, in particular to a stent valve in which a stent and a biological valve are woven together and a manufacturing method thereof.
  • the heart is the most important organ of the human body.
  • the heart is divided into two parts, each part including the atria and the ventricle.
  • the left and right atrium and the left and right ventricles are separated by atrial septum and a septal compartment, respectively.
  • There are four cardiac valves in the heart namely the tricuspid valve, the pulmonary valve, the mitral valve, and the aortic valve.
  • four heart valves play a vital role.
  • the hypoxic blood of the systemic circulation enters the right atrium through the vena cava, and then enters the right ventricle through the tricuspid valve.
  • the right ventricle contracts to press the blood into the pulmonary circulation through the pulmonary valve.
  • the aortic valve has a left and right coronary artery opening.
  • the structure of the four heart valves ensures that the valve opens when the blood is in the forward direction and closes in the opposite direction, preventing the heart burden from being aggravated by the reflux of the blood.
  • it may lead to acquired damage or lesions of the heart valve, such as rheumatism, atherosclerosis and the like.
  • congenital heart disease such as tetralogy of Fallot can also produce pulmonary valve disease in the long-term after surgery. After valvular lesions, the valve function is gradually lost. For example, valvular insufficiency leads to blood regurgitation. Valve stenosis leads to poor blood circulation, or the combination of incomplete and stenosis, which increases the burden on the heart and leads to heart failure.
  • the traditional treatment method is to open the chest, after the heart stops, under the support of hypothermia cardiopulmonary bypass, open the heart for surgical repair of the diseased valve or replacement with artificial heart valve.
  • Existing artificial heart valves fall into two broad categories: metal mechanical valves and biological valves.
  • the biological valve is made of animal materials such as bovine pericardium, bovine jugular vein valve and porcine aortic valve.
  • the balloon-expandable prosthetic heart valve is a biological valve
  • the intervention method is to fix the biological valve on a plastically deformable stent respectively, and after diameter is compressed on a balloon, the diameter is reduced, transcutaneously delivered, and then Pressurize the balloon to expand and secure the stent to achieve working condition.
  • the diameter is determined by the diameter of the balloon. If the diameter of the prosthetic valve is not selected at first, or after some physiological changes, such as natural growth, pathological vasodilation, etc. The diameter of the natural valve may increase, and the diameter of the prosthetic valve cannot be adaptively increased. The prosthetic valve may be loose or slipped, and only the secondary balloon may be re-expanded.
  • the prosthetic valve is provided with an elastically deformable stent that expands radially after compression.
  • FIG. 1 Chinese Patent Application No. CN200510110144. 3 and CN200510110145. 8 show a stent valve that is radially compressible and radially expandable.
  • the bracket can be a single wire bracket or a tube cutting bracket.
  • the leaflets and the membrane may be synthetic leaflets and synthetic membranes, or may be biological leaflets and biofilms.
  • the fixation between the synthetic leaflets and the synthetic membrane and the radially deformable stent is achieved by directly shaping the elastic polymer material constituting the leaflets and the membrane on the stent.
  • the above-mentioned stent valve is compared with a conventional non-radial-compressible surgical biological valve (such as US Patent No. 4,084,268, US Pat. No. 4,106,129, US Pat. No. 4,439, 091), and a sheet-like synthetic leaflet or flaky biological valve leaflet or animal valve sputum can be:
  • the problem of suture fixation between the stents is not well solved.
  • the object of the present invention is to overcome the problems of the prior art, and to provide a stent valve in which a stent and a biological valve are woven together and a manufacturing method thereof.
  • a stent valve in which a stent is woven integrally with a biological valve, comprising a self-expanding braided stent woven from an elastic metal wire and a leaflet made of an animal valve and
  • the membrane is characterized in that: the leaflet of the animal valve constitutes a leaflet of the stent valve, and the blood vessel wall of the animal valve constitutes a membrane of the stent valve, and the blood vessel wall of the animal valve that constitutes the stent valve membrane is constituted by the stent
  • the braided wire is woven through the stent to form an integrated stent valve.
  • the bracket comprises a single-layer bracket, a two-layer bracket with an inner layer tongue structure or an outer tongue structure, or a multi-layer bracket with an inner layer tongue structure and an outer layer tongue structure, and a radial protruding structure. Bracket.
  • valve leaflets and the covered animal valve constituting the stent valve are composed of three animal-shaped leaflets combined with a blood vessel wall having a uniform size.
  • the method for manufacturing the above stent valve comprises the following steps:
  • the single elastic metal braided wire is woven into the stent for the first time, and the natural straight passage of the stent is greater than or equal to the straightness of the animal valve;
  • the detached stent braid is reduced to the second weave of the stent and passed through the vessel wall of the animal valve to woven the animal valve into the stent.
  • the first weave of the reduction to the stent described in step d is performed in the order, position, shape, and up-and-down staggered position of the first weaving, or in the different order, the two ends of the braided wire are respectively in the blood vessel of the animal valve.
  • the wall is shuttled to woven.
  • the braided wires woven in the vessel wall of the animal valve are all woven in the vessel wall of the animal valve, or locally exposed on the inside or on the side of the vessel wall of the animal valve.
  • step d a plurality of positioning thin tubes having an inner diameter slightly larger than the outer diameter of the braided wire are inserted into the blood vessel wall of the animal valve according to the direction of the braided wire of the stent.
  • the braided wire is positioned. Pass through the thin tube and remove the positioning tubing after the braided wire has passed through the positioning tubule.
  • the braided wire woven within the vessel wall of the animal valve is sutured with the suture and the vessel wall at the intersection of any length of braided or braided wire.
  • the elastic braided wire, as well as the inner lingual structure and/or the outer lingual structure, located within the vessel wall of the animal valve, are sutured with the suture and the vessel wall at the intersection of any length of braided or braided wire.
  • the knitted sleeve is fully or partially covered on the elastic braided wire.
  • the sheet-like biomaterial is sewn on the upstream section of the stent to form a film on the upstream section of the stent or through a braided wire.
  • the biomaterial constitutes the upstream segment of the stent, and the downstream end of the upstream segment is sutured to the upstream end of the animal valve wall, and the upstream end of the upstream segment is sutured to the upstream end of the stent. together.
  • the axial natural length of the upstream segment coating is slightly longer than the axial natural length of the corresponding upstream section of the stent, forming an upstream segment of the wrinkle that protrudes outward.
  • FIG. 1 is a schematic perspective view showing an embodiment of a stent valve in which a stent and a biological valve are woven together;
  • FIG. 2 is a schematic view showing a process of disassembling in a reverse direction after the first braided stent is memorized by heat treatment in the present invention
  • Figure 3 is a schematic illustration of the procedure for the second weaving of the stent in the present invention and through the vessel wall of the aortic valve of the animal.
  • the stent valve of the present invention is woven with a biological valve, including a tubular mesh stent 1, a leaflet 2 and a membrane 3.
  • the tubular mesh stent 1 is woven from an elastic metal wire 101 and is a stretchable body that can be radially deformed between an expanded state and a compressed state.
  • the mesh stent 1 can be divided into upstream according to the blood flow direction in the blood vessel. Segment 11, middle segment 12 and downstream segment 13.
  • a plurality of deformable units 14 are formed between the mesh lines 101 of the mesh support, and a plurality of curved turns 15 are formed at both ends of the mesh support.
  • the leaflet 2 is disposed in the middle section 12 of the stent 1, and the membrane 3 is disposed in the upstream section 11 of the stent 1.
  • the leaflet 2 and the membrane 3 in the present invention are made of an animal valve, and the leaflets of the valve constitute the leaflets of the stent valve, and the blood vessel wall of the animal valve constitutes a membrane of the stent valve, and the animal constituting the valve leaf covering
  • the valve is woven into the stent body 1 by a braided wire 101 constituting a self-expanding woven stent to form an integrated stent valve.
  • the stent valve of the present invention is prepared as follows: First, the stent is woven for the first time with a single elastic braided wire 101, and the stent is naturally straight through greater than or equal to the animal aortic valve. Straight.
  • the support may be a single-layer support; i may also be a two-layer support with an inner or outer tongue structure, or a multi-layer support with an inner tongue and an outer tongue. Rack.
  • one leaflet longitudinally cuts the vessel wall along the commissure point and retains two commissure points of the same leaflet.
  • the edges of the two longitudinally cut blood vessel walls are suture edges.
  • Three leaflets of the same size and shape are combined to form a group.
  • the suture edges of the adjacent sutures are temporarily sutured. After removing the excess blood vessel wall upstream and downstream, the upstream edge and the lower margin are formed.
  • the three animal leaflets and the vessel wall that fit together to form a group are aligned according to the anatomical position.
  • the stent elastic braiding line 101 may be woven at the median level of the vessel wall, or may be woven on the medial side of the median plane or laterally outside the median layer, or may be locally exposed to the inside of the vessel wall or locally exposed to the outside of the vessel wall as needed.
  • the stent elastic braided wire 101 is shuttled and woven in the blood vessel wall of the animal valve, the size, shape, outer contour, braided wire position, braided wire, and the position of the braided wire are returned to the pre-opening condition, but partially woven.
  • the wire is wrapped by the blood vessel wall of the animal's valve.
  • the blood vessel wall of the animal valve and the stent are fixed to each other.
  • the second braiding should ensure that the elastic braided wire does not deform beyond the elastic deformation limit of Nitinol.
  • a plurality of positioning thin tubes 4 having an inner diameter slightly larger than the outer diameter of the braided wire may be utilized, and the orientation of the elastic braided wire of the stent may be used. Place the upper and lower crosses in the blood vessel wall of the animal valve. After the braided wires are worn from the positioning thin tubes 4, the positioning thin tubes are removed.
  • the single stent elastic braided wire 101 is permanently sewn together using sutures between the suture edges of adjacent different vessel walls after the second re-weaving of the vessel wall through the three animal leaflets.
  • the elastic braided wire worn within the vessel wall of the animal valve can also be sutured and affixed to the vessel wall at any of the braided segments or intersections with sutures.
  • the elastic braided wire within the vessel wall of the animal valve, as well as the inner lingual or outer tongue structure, may also be sutured and affixed to the vessel wall at any of the braided segments or intersections.
  • the elastic braided wire of the stent is shuttled into the blood vessel wall of the animal valve, and the elastic braiding wire of the stent can be fully or partially coaxially sleeved with the knitting sleeve.
  • This kind of knitting sleeve can be made of polyester
  • Textile materials such as (Dacron) are made by knitting or weaving. Both ends of the knitted sleeve are stitched at the intersection of the braided wire of the stent body or the closed eye to prevent it from slipping.
  • a sheet of biological material such as an animal pericardium may be added to form a film of the upstream section of the stent.
  • the upstream section film 3 may be on the inside or outside of the woven support or may be passed through the intermediate layer of the cover wall by the stent elastic braiding line 101.
  • the downstream end of the upstream segment membrane 3 is sutured to the upstream end of the vessel wall of the animal valve 2.
  • the upstream end of the upstream segment of the membrane 3 is fixed to the upstream end of the stent 1.
  • the axially natural length of the upstream section membrane 3 may be the same as or slightly longer than the axially natural length of the corresponding upstream section 11 of the stent which is fully expanded radially.
  • the axial natural length of the above-mentioned film 3 is slightly longer than the axial natural length of the corresponding upper support portion 11 of the bracket, and after the two are stitched together, the wrinkles of the upstream portion protruding toward the outside are formed.
  • the wrinkles of the film of the upstream section 3 disappear when the stent is axially elongated in the direction of compression, and are reproduced when the longitudinal direction of the stent is shortened.
  • the upstream segment of the wrinkle that protrudes outward can fill the gap between the stent valve and the surrounding vessel wall to prevent leakage around the stent valve.
  • the stent valve When the stent valve is compressed in the warp direction or axially pulled, the axial traction of the leaflets is relatively reduced. 3.
  • the stent braided wire When the stent braided wire is located in the wall of the valve vessel or in the membrane, the inside and outside of the stent in the upstream segment of the stent valve are not exposed outward, and the vessel wall can increase the radial elasticity of the stent before the stent is restored to the natural diameter.
  • the wrinkles of the upstream segment protruding to the outside can fill the gap between the stent valve and the surrounding vessel wall to prevent leakage around the stent valve.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (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)
  • Prostheses (AREA)

Abstract

L'invention concerne une endoprothèse valvulaire composée d'une endoprothèse et d'une biovalvule tissées solidaires. Ledit ensemble comprend une endoprothèse tissée auto-expansible (1) tissée par des fils métalliques flexibles, des valves (2) et un film de recouvrement (3) constitué par une valvule d'un animal. Les valves de la valvule de l'animal forment les valves (2) de l'endoprothèse valvulaire, et la paroi vasculaire de la valvule de l'animal forme le film de recouvrement (3) de l'endoprothèse valvulaire. La paroi vasculaire de la valvule de l'animal formant le film de recouvrement (3) de l'endoprothèse valvulaire est traversée par les fils de tissage formant l'endoprothèse (1), et tissée dans le corps de l'endoprothèse, formant ainsi une endoprothèse valvulaire solidaire. Le procédé de fabrication de l'endoprothèse valvulaire comprend les étapes suivantes qui consistent : à tisser l'endoprothèse une première fois; à soumettre l'endoprothèse tissée à un traitement thermique pour lui conférer des propriétés de mémoire de forme; à défaire le tissage de l'endoprothèse traitée thermiquement dans un sens opposé à celui du premier tissage; à restaurer les fils de tissage défaits de l'endoprothèse afin de procéder à un deuxième tissage de l'endoprothèse; et à faire passer les fils à travers la paroi vasculaire de la valvule de l'animal, de façon à tisser la valvule de l'animal et l'endoprothèse afin d'obtenir une structure solidaire, etc.
PCT/CN2007/003017 2006-10-31 2007-10-22 Endoprothèse valvulaire composée d'une endoprothèse et d'une biovalvule tissées solidaires et procédé de fabrication de ladite endoprothèse WO2008052422A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN 200610117807 CN101172058B (zh) 2006-10-31 2006-10-31 支架与生物瓣膜编织成一体的支架瓣膜及其制作方法
CN200610117807.9 2006-10-31

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WO2008052422A1 true WO2008052422A1 (fr) 2008-05-08

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CN (1) CN101172058B (fr)
WO (1) WO2008052422A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110604633A (zh) * 2019-10-18 2019-12-24 江苏百优达生命科技有限公司 一种一体变结构的血管支架覆膜及其制造方法

Families Citing this family (8)

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Publication number Priority date Publication date Assignee Title
CN101601611B (zh) * 2009-04-03 2012-02-01 中国人民解放军第二军医大学 微创手术下反复置换的装配式人造心脏生物瓣膜治疗装置
FR2947716B1 (fr) * 2009-07-10 2011-09-02 Cormove Implant prothetique ameliore
US8945209B2 (en) * 2011-05-20 2015-02-03 Edwards Lifesciences Corporation Encapsulated heart valve
CN109561961B (zh) * 2017-04-07 2021-02-23 上海甲悦医疗器械有限公司 一种人工瓣膜及人工瓣膜植入方法
CN107280806B (zh) * 2017-06-30 2023-06-23 中国人民解放军第二军医大学 一种尿道控尿器
CN109745144B (zh) * 2017-11-06 2020-06-12 先健科技(深圳)有限公司 覆膜支架
CN112826632B (zh) * 2019-11-22 2022-06-21 先健科技(深圳)有限公司 覆膜支架
CN115976730A (zh) * 2023-03-21 2023-04-18 北京爱霖医疗科技有限公司 支架及其编织方法、编织胎具

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WO2001054625A1 (fr) * 2000-01-31 2001-08-02 Cook Biotech Incorporated Valvules sur stents et leur utilisation
WO2003071990A1 (fr) * 2002-02-26 2003-09-04 Forschungszentrum Karlsruhe Gmbh Prothese veineuse
CN1799520A (zh) * 2006-01-16 2006-07-12 孔祥清 经皮主动脉瓣置换装置

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CN1745727A (zh) * 2004-09-08 2006-03-15 王蓉珍 介入式人工心脏瓣膜及其植入和回收装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001054625A1 (fr) * 2000-01-31 2001-08-02 Cook Biotech Incorporated Valvules sur stents et leur utilisation
WO2003071990A1 (fr) * 2002-02-26 2003-09-04 Forschungszentrum Karlsruhe Gmbh Prothese veineuse
CN1799520A (zh) * 2006-01-16 2006-07-12 孔祥清 经皮主动脉瓣置换装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110604633A (zh) * 2019-10-18 2019-12-24 江苏百优达生命科技有限公司 一种一体变结构的血管支架覆膜及其制造方法
CN110604633B (zh) * 2019-10-18 2024-03-05 江苏百优达生命科技有限公司 一种一体变结构的血管支架覆膜及其制造方法

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CN101172058B (zh) 2011-04-06

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