WO2001052770A1 - Assemblage extenseur-greffe et procede de fabrication correspondant - Google Patents

Assemblage extenseur-greffe et procede de fabrication correspondant Download PDF

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Publication number
WO2001052770A1
WO2001052770A1 PCT/GB2001/000177 GB0100177W WO0152770A1 WO 2001052770 A1 WO2001052770 A1 WO 2001052770A1 GB 0100177 W GB0100177 W GB 0100177W WO 0152770 A1 WO0152770 A1 WO 0152770A1
Authority
WO
WIPO (PCT)
Prior art keywords
covering
wire
stent
pattern
graft assembly
Prior art date
Application number
PCT/GB2001/000177
Other languages
English (en)
Inventor
David Granville Stevenson
Linda Ann O'donnell
Kerry Elizabeth Flynn
Karl James Healy
Original Assignee
Sulzer Vascutek Limited
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 Sulzer Vascutek Limited filed Critical Sulzer Vascutek Limited
Priority to AU2001228628A priority Critical patent/AU2001228628A1/en
Publication of WO2001052770A1 publication Critical patent/WO2001052770A1/fr

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
    • A61F2/02—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
    • A61F2/07—Stent-grafts
    • 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
    • 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
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching

Definitions

  • the present application concerns an endoluminal graft, more particularly a stent-graft assembly for placement into a stenotic or diseased lumen, especially a vascular lumen.
  • a method of manufacturing the stent-graft assembly is also described.
  • Stents can be defined as expandable endoprosthesis devices designed for placement into a lumen (such as a blood vessel, bile duct or the like) of a patient's body.
  • the stent reinforces the lumen and maintains its patency. Stents are thus generally used to treat clinical problems such as occluded lumens or weakened lumen walls.
  • the stents are expandable devices, being inserted in unexpanded form usually by means of a catheter. Once the stent has been correctly located by the surgeon the stent will be deployed and will adopt its expanded form.
  • the stent may be mechanically expanded (for example by use of a balloon catheter which is inflated from within the lumen of the stent) or alternatively expansion may be achieved through use of a shape memory material, such as nitinol.
  • stents Numerous designs of stents have been reported, each aiming to achieve the desired balance of flexibility (to accommodate the natural curvature of the target vessels) with the rigidity required to ensure that the luminal area is maintained.
  • Examples of commercially available stents include the Wallstent (see Sigivant et al, N. Engl . J. Med. , 1987, 316:701-706; and Serruys et al . , N. Engl. J. Med., 1991, 334:13-7), the Palmaz-Schatz stent (see Serruys et al . , N. Engl. J. Med., 1994, 331:489-95; and Fischman et al . , N. Engl. J.
  • Stent-graft is the term used in the art to refer to metal stents at least partially covered with a lining or sleeve. Stent-grafts were first used clinically in 1991 to treat abdominal aortic aneurysms (see Parodi et al . , Am. Vase Surg., 1991, 5:419-499). The lining or sleeve was introduced to reduce thrombosis and restrict tissue ingrowth that may be caused by scarring the internal walls of the lumen. Suitable materials for the sleeve or lining include Dacron (TM) , nylon, polyester, polytetrafluoroethylene, polyurethene and silicone.
  • Dacron TM
  • Stent-graft assemblies are described in, for example, US-A-5, 123 , 917 to Lee; US-A-5 , 507 , 771 to Gianturco; 5,628,788 to Pinchuk; US-A-5 , 637 , 113 to Tartaglia; and EP-A-0 , 938 , 879 to Medtronic.
  • the stent members are formed and are then sewn or glued onto or otherwise affixed to a covering, such as a lining and/or sleeve. Whilst this approach ensures that the stent shape and size is pre-selected exactly as required it is however difficult to achieve a correctly tensioned fit of the covering across the stent scaffold.
  • wire is a shape-memory material (such as nitinol) there is no need to heat set the wire to the required stent pattern prior to assembly of the stent-graft assembly.
  • shape-memory material such as nitinol
  • the present invention provides a stent-graft assembly comprising a flexible covering in tubular form held in tension by a wire-like member attached thereto.
  • the wire-like member need not be heat-set.
  • the wire can instead be shaped into stent form in situ during its application to the covering.
  • the present invention provides a method of manufacture of a stent-graft assembly, said method comprising the steps of:
  • the shaping and affixing of the wire-like member creates a radial tension in the covering along the path of the wire-like member forcing the covering to form pleats or crimps in an ordered fashion, according to said pre-determined pattern.
  • the invention provides a stent-graft assembly comprising at least one flexible covering having a tubular form, said covering being held in tension by a stent skeleton which comprises at least one wire-like member provided according to a stent pattern, contact between the wire-like member and said covering creating a tension in the covering forcing said covering to form pleats or crimps in an ordered fashion, according to the stent pattern.
  • the substantially straight wire-like member will be a metal wire.
  • the metal wire may be of shape-memory material (for example may be nitinol) and in this case the ability to use non-heat set wire offers a considerable advantage in efficiency of production. Other materials (for example stainless steel) may be used where suitable.
  • the wire-like member may be formed from one or more plastics materials.
  • the stent- graft assembly may comprise only a single wire-like member or may comprise several separate wire-like members (for example up to 10 wire-like members or more, usually 2, 3, 4, 5 or 6 wire-like members) and multiple wire-like members may be required by the stent pattern.
  • the stent-graft assembly may have a plurality of wire-like members running in parallel or formed as a wire braid. This arrangement will allow the resilience of the wire to be maintained while increasing the strength and thus the tensioning force on the fabric covering.
  • the wire-like member is preferably substantially straight prior to shaping and affixing to the covering.
  • the term "straight" as used herein means that the wire-like member at the time of use will have no kinks or bends along its length that would adversely affect its ability to follow the pre- selected stent pattern.
  • the wire-like member may be wound around a drum or spool, but any curvature due to that winding will be of a temporary nature and/or will have a radius of curvature which would not prevent the wire being formed into the pattern required during production of the stent-graft assembly.
  • tubular used in the description includes multi-tubular conduits, for example "Y" shaped bifurcated conduits used especially to repair specific kind of aneurisms.
  • the wire-like member will usually be of circular or rounded cross- section, but this is not exclusive and, where appropriate, members of other cross-sectional shapes may be selected.
  • the wire-like member will be a non-preheat set nitinol wire of rounded cross- section and having a diameter of from 0.05mm to 0.5mm, preferably of from 0.12mm to 0.14mm.
  • the covering may be formed from any biocompatible material and mention may be made of polyester, nylon, polytetrafluoroethylene (including expanded PTFE) , polyurethane, silicone and the like. Polyester is preferred.
  • the covering may be formed from planar material sewn or otherwise formed (for example using glue or the like) into a tube.
  • the covering may be woven or knitted in a seamless tubular form.
  • the covering will include a longitudinal marker so that any twisting of it during manufacture, on the mandrel or through incorrect attachment of the wire-like member is made readily apparent and can be avoided.
  • the covering may be of any suitable length. Conveniently long lengths of the covering may be formed and then divided into multiple pieces of appropriate length.
  • the diameter of the covering lumen will determine the diameter of the stent-graft assembly. Accordingly, the diameter of the covering lumen will be chosen carefully to accord with the body lumen to be treated. Exemplary sizes include diameters of 5 to 40mm, preferably 8 to 34mm.
  • the covering may be of uniform diameter, it may alternatively be desirable to include a taper at one or both ends of the covering or along the length of the covering.
  • the covering is used as a lining, that is to say the wire-like member is attached to the external surface of the covering.
  • the stent skeleton formed by the wire- like member is located on the external surface of the stent-graft assembly.
  • the covering it is also possible for the covering to be a sleeve with the wire-like member being attached to the internal surface of the covering so that the sleeve forms the external surface of the stent-graft assembly.
  • the tubular covering is stretched onto a mandrel .
  • a template depicting the selected stent pattern may then be mounted over the covering.
  • the template will be a stencil and the stent pattern will normally be marked onto the covering using an erasable marker so that the stencil can be removed from the stent-graft assembly.
  • the template may alternatively be a guiding means which is held in place during attachment of the wire-like member.
  • the stent pattern may be programmed into a suitable computer controlled device for positioning the wire. The currently preferred method of attachment of the wire-like member in the pre-selected pattern is by sewing, and for accuracy this will usually be done by hand.
  • the wire-like member may be attached to the covering by adhesive, for example silicone, polyurethane, fluorinated ethylene propylene and the like. It may be desirable to coat the wire-like member prior to attachment to the covering, for example with an anti-coagulant agent, antibiotic or the like.
  • adhesive for example silicone, polyurethane, fluorinated ethylene propylene and the like.
  • an anti-coagulant agent for example antibiotic or the like.
  • One of the advantages of the present invention is that coating the wire-like member immediately prior to formation of the stent-graft assembly is simple to conduct. Alternatively the whole stent-graft assembly may be coated, if required, for example by dipping or spraying.
  • a second sleeve may be desirable, so that the stent skeleton formed by the wire-like member is completely enclosed.
  • the second sleeve may be stitched to or otherwise attached to the stent and/or the covering as appropriate.
  • Fig. 1A represents a side-view of a bifurcated stent-graft assembly of the invention, depicting the pattern followed by the wire-like member.
  • Fig. IB depicts the stencil for the stent scaffold pattern for the stent-graft assembly of Fig. 1A.
  • Fig. 2 represents a side-view of a peripheral stent-graft assembly of the invention, again showing the pattern of the wire-like member .
  • Fig. 3 shows a stent-graft assembly according to the invention and illustrates the regular crimps achieved in the covering material .
  • Fig. 4 illustrates the flexibility of the stent- graft assembly of Fig. 3.
  • FIGS 1A, IB and 2 there is shown a stent-graft assembly 1 where one selected stent pattern 2 is depicted on the covering 3 for the correct positioning of the wire-like member 4.
  • Other stent patterns may alternatively be used. It may be desirable (for ease of manufacture) for the pattern to involve only a single continuous length of wire, but for certain stent patterns, several separate lengths of wire may be required.
  • Suitable exemplary specifications for a stent-graft assembly according to Fig. 1 are as follows:
  • a 500mm length of nitinol wire 4 was used to form the stent scaffold in each case. Following attachment of the wire 4 to the covering 3 by handstitching, the bifurcate stitching 5 which extends part way up the length of the stent-graft assembly 1 was inserted.
  • Suitable exemplary specifications for a peripheral stent-graft assembly 1 according to Fig. 2 are as follows :
  • the stent wire 4 was hand-sewn onto the covering 3 with 1.0 wax suture and was sewn twice to achieve the required number of stitches per mm.
  • stent-graft assembly 1 In both Figs. 1A and 2 the crimping of the material achieved by the tension in the covering at the wire- attachment points is not shown, for clarity.
  • the stent-graft assembly 1 illustrated in Figs. 3 and 4 clearly shows the crimps 6 in covering 3.
  • the crimps 6 occur in an ordered fashion and, as is shown best in Fig. 3, the ordered pattern of the crimps is determined by the selected stent pattern 4 since the increased tension in the covering at the wire attachment points creates the crimps .
  • An important benefit of the stent-graft assembly 1 of the present invention is the creation of the ordered crimps 6 in the covering 3 through the radial tension in the covering 3 along the path of the wire and at the wire attachment points. As shown in Fig. 4 the multiple ordered crimps 6 allow the covering 3 (and thus stent-graft assembly 1) to flex in a controlled manner to accommodate the curvature of the target body lumen.

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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

Procédé de fabrication d'un assemblage extenseur-greffe comportant au moins deux extrémités, ledit procédé consistant en ce qui suit: a) fournir une enveloppe tubulaire; et b) fixer au moins un élément en forme de fil droit à ladite enveloppe selon un schéma prédéterminé pour former une structure d'extenseur tubulaire. L'invention concerne aussi un ensemble extenseur-greffe comprenant au moins une enveloppe souple tubulaire comportant au moins deux extrémités. L'enveloppe est précontrainte par une structure d'extenseur qui comprend au moins un élément en forme de fil adapté à la structure d'extenseur, ledit élément en forme de fil étant attaché à ladite enveloppe dans des points d'attache, ce qui crée une contrainte dans l'enveloppe et, partant, crée des ondulations et des plis sur l'enveloppe selon un motif régulier qui suit le schéma de l'extenseur.
PCT/GB2001/000177 2000-01-19 2001-01-18 Assemblage extenseur-greffe et procede de fabrication correspondant WO2001052770A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001228628A AU2001228628A1 (en) 2000-01-19 2001-01-18 Stent-graft assembly and method of making the same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0001102.3 2000-01-19
GBGB0001102.3A GB0001102D0 (en) 2000-01-19 2000-01-19 Prosthesis

Publications (1)

Publication Number Publication Date
WO2001052770A1 true WO2001052770A1 (fr) 2001-07-26

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Country Status (3)

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AU (1) AU2001228628A1 (fr)
GB (1) GB0001102D0 (fr)
WO (1) WO2001052770A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005052226A1 (de) * 2005-09-30 2007-04-12 Friebe, Michael, Dr. Stent zum Einführen in menschliche Körperhöhle, insbesondere in Blutgefäße
WO2010088467A1 (fr) 2009-01-31 2010-08-05 Cook Incorporated Préforme pour prothèse endoluminale
US8858613B2 (en) 2010-09-20 2014-10-14 Altura Medical, Inc. Stent graft delivery systems and associated methods
GB2517689A (en) * 2013-08-26 2015-03-04 Vascutek Ltd Stent-Graft
US9107741B2 (en) 2007-11-01 2015-08-18 Cook Medical Technologies Llc Flexible stent graft
US9572652B2 (en) 2009-12-01 2017-02-21 Altura Medical, Inc. Modular endograft devices and associated systems and methods
US9737426B2 (en) 2013-03-15 2017-08-22 Altura Medical, Inc. Endograft device delivery systems and associated methods
US10271974B2 (en) 2011-06-24 2019-04-30 Cook Medical Technologies Llc Helical stent
US10285833B2 (en) 2012-08-10 2019-05-14 Lombard Medical Limited Stent delivery systems and associated methods

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4580568A (en) 1984-10-01 1986-04-08 Cook, Incorporated Percutaneous endovascular stent and method for insertion thereof
US5123917A (en) 1990-04-27 1992-06-23 Lee Peter Y Expandable intraluminal vascular graft
US5507771A (en) 1992-06-15 1996-04-16 Cook Incorporated Stent assembly
US5628788A (en) 1995-11-07 1997-05-13 Corvita Corporation Self-expanding endoluminal stent-graft
US5637113A (en) 1994-12-13 1997-06-10 Advanced Cardiovascular Systems, Inc. Polymer film for wrapping a stent structure
US5897587A (en) * 1996-12-03 1999-04-27 Atrium Medical Corporation Multi-stage prosthesis
WO1999037242A1 (fr) * 1998-01-26 1999-07-29 Anson Medical Limited Greffon renforce
EP0938879A2 (fr) 1998-02-25 1999-09-01 Medtronic Ave, Inc. Stent-greffe et méthode de manufacture
US5980565A (en) * 1997-10-20 1999-11-09 Iowa-India Investments Company Limited Sandwich stent

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4580568A (en) 1984-10-01 1986-04-08 Cook, Incorporated Percutaneous endovascular stent and method for insertion thereof
US5123917A (en) 1990-04-27 1992-06-23 Lee Peter Y Expandable intraluminal vascular graft
US5507771A (en) 1992-06-15 1996-04-16 Cook Incorporated Stent assembly
US5637113A (en) 1994-12-13 1997-06-10 Advanced Cardiovascular Systems, Inc. Polymer film for wrapping a stent structure
US5628788A (en) 1995-11-07 1997-05-13 Corvita Corporation Self-expanding endoluminal stent-graft
US5897587A (en) * 1996-12-03 1999-04-27 Atrium Medical Corporation Multi-stage prosthesis
US5980565A (en) * 1997-10-20 1999-11-09 Iowa-India Investments Company Limited Sandwich stent
WO1999037242A1 (fr) * 1998-01-26 1999-07-29 Anson Medical Limited Greffon renforce
EP0938879A2 (fr) 1998-02-25 1999-09-01 Medtronic Ave, Inc. Stent-greffe et méthode de manufacture

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8231668B2 (en) 2005-09-30 2012-07-31 Michael Friebe Stent for introducing into human body cavities, in particular into blood vessels
DE102005052226B4 (de) * 2005-09-30 2014-09-11 Michael Friebe Stent zum Einführen in menschliche Körperhöhlen, insbesondere in Blutgefäße
DE102005052226A1 (de) * 2005-09-30 2007-04-12 Friebe, Michael, Dr. Stent zum Einführen in menschliche Körperhöhle, insbesondere in Blutgefäße
US9107741B2 (en) 2007-11-01 2015-08-18 Cook Medical Technologies Llc Flexible stent graft
US10028849B2 (en) 2007-11-01 2018-07-24 Cook Medical Technologies Llc Flexible stent graft
WO2010088467A1 (fr) 2009-01-31 2010-08-05 Cook Incorporated Préforme pour prothèse endoluminale
US8926687B2 (en) 2009-01-31 2015-01-06 Cook Medical Technologies Llc Preform for and an endoluminal prosthesis
US9572652B2 (en) 2009-12-01 2017-02-21 Altura Medical, Inc. Modular endograft devices and associated systems and methods
US8858613B2 (en) 2010-09-20 2014-10-14 Altura Medical, Inc. Stent graft delivery systems and associated methods
US10271974B2 (en) 2011-06-24 2019-04-30 Cook Medical Technologies Llc Helical stent
US10285833B2 (en) 2012-08-10 2019-05-14 Lombard Medical Limited Stent delivery systems and associated methods
US9737426B2 (en) 2013-03-15 2017-08-22 Altura Medical, Inc. Endograft device delivery systems and associated methods
GB2517689A (en) * 2013-08-26 2015-03-04 Vascutek Ltd Stent-Graft

Also Published As

Publication number Publication date
GB0001102D0 (en) 2000-03-08
AU2001228628A1 (en) 2001-07-31

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