WO2010058406A1 - External stent - Google Patents

External stent Download PDF

Info

Publication number
WO2010058406A1
WO2010058406A1 PCT/IL2009/001105 IL2009001105W WO2010058406A1 WO 2010058406 A1 WO2010058406 A1 WO 2010058406A1 IL 2009001105 W IL2009001105 W IL 2009001105W WO 2010058406 A1 WO2010058406 A1 WO 2010058406A1
Authority
WO
WIPO (PCT)
Prior art keywords
support
vein
diameter
optionally
vein support
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IL2009/001105
Other languages
English (en)
French (fr)
Inventor
Eyal Orion
Yehuda Bachar
Yanai Ben-Gal
Avraham Rapaport
Gilad Cibulski
Ronny Winshtein
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vascular Graft Solutions Ltd
Medical Research Infrastructure and Health Services Fund of the Tel Aviv Medical Center
Original Assignee
Vascular Graft Solutions Ltd
Medical Research Infrastructure and Health Services Fund of the Tel Aviv Medical Center
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
Priority to US13/130,760 priority Critical patent/US8734503B2/en
Priority to CA2743803A priority patent/CA2743803C/en
Priority to JP2011537010A priority patent/JP5855460B2/ja
Priority to EP09796098.3A priority patent/EP2361059B1/en
Priority to DK09796098.3T priority patent/DK2361059T3/da
Priority to CN200980155497.1A priority patent/CN102307542B/zh
Priority to AU2009318772A priority patent/AU2009318772B2/en
Application filed by Vascular Graft Solutions Ltd, Medical Research Infrastructure and Health Services Fund of the Tel Aviv Medical Center filed Critical Vascular Graft Solutions Ltd
Publication of WO2010058406A1 publication Critical patent/WO2010058406A1/en
Priority to ZA2011/03750A priority patent/ZA201103750B/en
Priority to IL213111A priority patent/IL213111A/en
Anticipated expiration legal-status Critical
Priority to US14/287,030 priority patent/US9265632B2/en
Priority to US15/008,929 priority patent/US9949852B2/en
Ceased legal-status Critical Current

Links

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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure

Definitions

  • a vein support for use with a vein to help provide a desired blood flow between a first point in a vascular system of a patient and a second point in the vascular system by incorporation of the vein into the vascular system
  • the vein support comprising an elongate body having a first end and a second end with a channel therebetween, the elongate body having a relaxed pre-deformation configuration, the channel sized to freely receive the vein when the body is in the pre-deformation configuration so that an axis of the channel extends along an axis of the vein; and the body being manually manipulatable from the pre-deformation configuration to a relaxed post-deformation configuration selected in response to the vascular system, the channel in the post-deformation configuration supporting receiving the vein therein so as to inhibit tissue-response induced occlusion of the desired flow.
  • FIGs. 7 A - 7C schematically illustrate a method of using a vein support in a vein- based bypass operation, in accordance with an embodiment of the present invention
  • FIGs. 1OA - 1OC schematically illustrate exemplary coverings and/or sleeves applied to an end portion of a vein support, in accordance with some embodiments of the present invention
  • FIGs.17A and 17B depict photographs of a portion of an extended support substantially resembling that used in a CABG procedure, and an enlarged view of a section of the support, respectively, in accordance with some embodiments of the present invention.
  • the formable tubular support is provided as a mesh that includes at least one plastically deformable thread.
  • the mesh may be braided, woven, knitted, pressed and/or in any other known construction and/or any combination thereof.
  • the at least one thread may be a wire, a yarn, a filament a fiber, a rod, a stripe or any other longitudinal element having a relatively large length- to-diameter/width ratio; and may be made of any plastically deformable material, including but not limited to metal, polymers, composites, glued bundles, or any combination thereof.
  • specific braid pattern and/or threads parameters are chosen for a tubular blood vessel support to allow at least one of the following end points:
  • the formable support is provided as a tube and can only be pulled over (or under) the tubular bodily vessel or graft having at least one free end (i.e., prior to anastomosing).
  • the formable support is opened along its length and can be closed over the bodily vessel/graft (e.g., similarly to a bracelet-cuff) using closing means, such as clips, hooks, adhesives, sewing means, zipping means, and/or may be deformablely closed by applying enough force.
  • the formable tubular support is provided as plurality of coupling members or "building blocks" to modularly form a shaped tubular implant in-situ.
  • the coupling members are provided in different shapes, e.g., bent, curved and/or maintain any other non-tubular shapes, some may vary in diameter.
  • the operator may couple at least two coupling members over a target vessel/graft periphery and may choose specific shaped coupling members in order to set a specific chosen course.
  • some or any of the coupling members may be rigid, elastic and/or plastic but may not be bounded to include plastically deformable members as previously described.
  • springback from stretching support 100 may range from 0.5% - 50%, for example, 0.5% - 5%, 2% - 10%, 2% - 20%, 2% - 30%, 2% - 40%
  • springback in radial elasticity may range from 2% to 50%, for example, 2% - 5%, 2% - 10%, 2% - 20%, 2% - 30%, 2% - 40%
  • plastically deformable fiber 102 may have an average diameter in the range of 20 to l,000 ⁇ m, optionally between 50 to 200 ⁇ m, optionally approximately 75 ⁇ m, optionally approximately 150 ⁇ m.
  • support 500 may be a braided support including at least one plastically deformable strut 502.
  • struts 502 may define openings 506 that can be of any shape, including but not limited to polygonal shapes, optionally quadrangular.
  • struts 502 may include similar plastically deformable characteristics to those of fiber 102 shown in Fig. 1.
  • support 500 may include any other type of support, including but not limited to bare metal/polymeric support, drug eluting support that may or may not be produced by one of more of the followings methods; laser cutting, EDM, chemical etching, micromachining, photo-etching and water-jet laser cutting.
  • At least one of the anastomosed ends and/or its close-by surroundings are covered and/or supported by at least part of support 700 (not shown).
  • support 700 can then be manipulated to adjust a chosen contour to at least part of the covered segment of graft 721.
  • support 700 fully stretched is firm enough to substantially maintain the applied contour either permanently or for a prolonged period of time after end of the surgical procedure, optionally over 1 week, optionally over 1 month, optionally over 1 year, optionally over 10 years, or higher or lesser or intermediate.
  • vein support 1200 may be the same as vein support 100 shown in Fig. 1.
  • vein support 1200 may be the same as that shown in Figs. 2, 3, 4, 5A, 7A, 8A, or 9B at 200, 300, 400, 500, 700, 800 or 900, respectively.
  • extension 1301 is added to support 1300 as an elastic end portion specifically designed to fit over anastomosis area.
  • Extension 1301 is optionally connected to an end portion of support 1300 only after the latter has been mounted and/or stretched and/or shaped to fit a target vessel.
  • Extension 1301 may be made from a flat mesh including elastic fibers 1304 as shown in Fig. 13A which is cut at one end so that, when the mesh is rolled to form the extension, on angled opening 1301B includes the angle 0 relative to an axis 1308 of the support.
  • Photographs have been included as Fig. 17A and Fig. 17B depicting a portion of an exemplary extended support and an enlarged view of a section of support, respectively, in accordance with some embodiments of the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Prostheses (AREA)
PCT/IL2009/001105 2008-11-24 2009-11-24 External stent Ceased WO2010058406A1 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
AU2009318772A AU2009318772B2 (en) 2008-11-24 2009-11-24 External stent
JP2011537010A JP5855460B2 (ja) 2008-11-24 2009-11-24 外部ステント
EP09796098.3A EP2361059B1 (en) 2008-11-24 2009-11-24 External stent
DK09796098.3T DK2361059T3 (da) 2008-11-24 2009-11-24 Ekstern stent
CN200980155497.1A CN102307542B (zh) 2008-11-24 2009-11-24 外部支架
US13/130,760 US8734503B2 (en) 2008-11-24 2009-11-24 External stent
CA2743803A CA2743803C (en) 2008-11-24 2009-11-24 External stent
ZA2011/03750A ZA201103750B (en) 2008-11-24 2011-05-23 External stent
IL213111A IL213111A (en) 2008-11-24 2011-05-24 External support
US14/287,030 US9265632B2 (en) 2008-11-24 2014-05-25 Methods of supporting a vein
US15/008,929 US9949852B2 (en) 2008-11-24 2016-01-28 Implant for supporting bodily conduits such as blood vessels or/and grafted vessels

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US19339808P 2008-11-24 2008-11-24
US61/193,398 2008-11-24
US18604609P 2009-06-11 2009-06-11
US61/186,046 2009-06-11
US24413809P 2009-09-21 2009-09-21
US61/244,138 2009-09-21

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US13/130,760 A-371-Of-International US8734503B2 (en) 2008-11-24 2009-11-24 External stent
US14/287,030 Continuation US9265632B2 (en) 2008-11-24 2014-05-25 Methods of supporting a vein

Publications (1)

Publication Number Publication Date
WO2010058406A1 true WO2010058406A1 (en) 2010-05-27

Family

ID=41665678

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2009/001105 Ceased WO2010058406A1 (en) 2008-11-24 2009-11-24 External stent

Country Status (10)

Country Link
US (3) US8734503B2 (https=)
EP (1) EP2361059B1 (https=)
JP (1) JP5855460B2 (https=)
CN (1) CN102307542B (https=)
AU (1) AU2009318772B2 (https=)
CA (1) CA2743803C (https=)
DK (1) DK2361059T3 (https=)
IL (1) IL213111A (https=)
WO (1) WO2010058406A1 (https=)
ZA (1) ZA201103750B (https=)

Cited By (9)

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WO2012143922A1 (en) 2011-04-18 2012-10-26 Vascular Graft Solutions Ltd External support for elongated bodily vessels
WO2013017639A1 (en) * 2011-08-01 2013-02-07 Laminate Medical Technologies Ltd Vessel shaping devices and methods
US8734503B2 (en) 2008-11-24 2014-05-27 Vascular Graft Solutions Ltd. External stent
US20140303715A1 (en) * 2011-07-25 2014-10-09 Neograft Technologies, Inc. Vessel treatment methods and devices for use in a graft device
US10052218B2 (en) 2011-04-18 2018-08-21 Vascular Graft Solutions Ltd. Devices and methods for deploying implantable sleeves over blood vessels
EP2814425B1 (en) * 2012-02-14 2019-02-13 Neograft Technologies, Inc. Kink resistant graft devices
US10299794B2 (en) 2012-08-01 2019-05-28 Laminate Medical Technologies Ltd. Apparatus for configuring an arteriovenous fistula
CN109833521A (zh) * 2017-11-29 2019-06-04 郑州大学 一种制备人工血管的方法及装置
CN120036955A (zh) * 2025-04-27 2025-05-27 鼎科医疗技术（苏州）有限公司 一种血管外支架

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JP6711486B2 (ja) * 2016-07-04 2020-06-17 泉工医科工業株式会社 血管縫縮部材及び血管縫縮装置
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CN114929163B (zh) 2019-11-01 2026-04-03 林弗洛公司 用于增加对远侧四肢的血液灌注的装置和方法
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CN115666445A (zh) 2020-04-08 2023-01-31 莱兰斯坦福初级大学评议会 防止自体和异种移植失败的系统、装置和方法
US11628052B2 (en) * 2020-05-13 2023-04-18 Jt Godfrey, Llc Device for use with body tissue sphincters
CN111803273B (zh) * 2020-08-20 2024-09-13 北京大学第三医院（北京大学第三临床医学院） 一种schlemm氏管扩张支架及扩张方法
KR102368874B1 (ko) * 2020-09-16 2022-03-03 재단법인 아산사회복지재단 생체관용 그래프트 및 그 시스템
CN112022461B (zh) * 2020-09-16 2023-11-24 北京美迪微科技有限责任公司 一种应用于颈动脉的血管支架
KR102428943B1 (ko) * 2020-10-08 2022-08-03 연세대학교 산학협력단 약물 전달 스텐트, 이의 제조 방법 및 이를 이용한 약물 전달 방법
US11291565B1 (en) * 2021-04-22 2022-04-05 Vascular Graft Solutions Ltd. Asymmetric external support for stabilizing a vein graft used in a coronary arterial bypass graft (CABG) procedure, and applications thereof
CN118119363A (zh) * 2021-10-12 2024-05-31 波士顿科学国际有限公司 可调整长度的支架
JP2023179847A (ja) * 2022-06-08 2023-12-20 テルモ株式会社 人工血管
CN115429372B (zh) * 2022-10-27 2023-02-03 北京华脉泰科医疗器械股份有限公司 瘤腔内密封支架
JP2025541157A (ja) 2022-12-06 2025-12-18 メディカル ２１、インコーポレイテッド 複合インプラント
CN115969593A (zh) * 2022-12-06 2023-04-18 中国人民解放军空军军医大学 载药型3d打印可降解静脉外支架及其构建方法
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