WO2002098476A1 - Dispositifs medicaux bioresorbables - Google Patents

Dispositifs medicaux bioresorbables Download PDF

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Publication number
WO2002098476A1
WO2002098476A1 PCT/US2002/013686 US0213686W WO02098476A1 WO 2002098476 A1 WO2002098476 A1 WO 2002098476A1 US 0213686 W US0213686 W US 0213686W WO 02098476 A1 WO02098476 A1 WO 02098476A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
bioresorbabie
polymeric
monofilaments
monomer content
Prior art date
Application number
PCT/US2002/013686
Other languages
English (en)
Inventor
Balkrishna S. Jadhav
Robert C. Grant
Original Assignee
Ams Research Corporation
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 claimed from US09/920,871 external-priority patent/US20020188342A1/en
Application filed by Ams Research Corporation filed Critical Ams Research Corporation
Priority to EP02731592A priority Critical patent/EP1395308A1/fr
Publication of WO2002098476A1 publication Critical patent/WO2002098476A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541—Adjacent bands are arranged out of phase
    • 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
    • A61F2/91—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak

Definitions

  • Permanent stents are used where long term structural support or restenosis prevention is required, or in cases where surgical removal of the implanted stent is impractical. Permanent stents are usually made from metals such as Phynox, 316 stainless steel, MP35N alloy, and superelastic Nitinol (nickel-titanium).
  • FIG. 8 is an enlarged view of a partial segment of the bioresorbabie stent made in accordance with the teachings of the present invention.
  • FIG. 9 graphically depicts the bilateral self-expansion force of an alternate embodiment made in accordance with the teachings of the present invention versus UroLume® stents.
  • viscosity average is best suited for linear polymers such as those used in the foregoing examples. Therefore, for these reasons, the viscosity average method will be used throughout this specification to determine and denote the molecular weights.
  • EXAMPLE 3 Extrusion Process Polymer granules are loaded in the hopper 201 of the extruder 202.
  • the extruder screw 203 in the heated barrel melts the polymer and delivers it to metering pump (not shown) under pressure.
  • the metering pump pushes the melt through a spin head 204.
  • a spin head consists of a 'screen pack' to filter the melt and a spinneret die.
  • Molten monofilament strands are quenched in a water bath 205. The quenched strands pass over the rollers 206 of the first godet station 207.
  • the stent is then disposed on an annealing mandrel 28 having an outer diameter of equal to or less than the inner diameter of the stent and annealed at a temperature between about the polymer-glass transition temperature and the melting temperature of the polymer blend for a time period between about five minutes and 18 hours in air, an inert atmosphere or under vacuum 28.
  • the stent 50 (FIG. 7) is allowed to cool 29 and then cut as required 30.
  • the bioresorbabie stents of the present invention demonstrated greater radial self-expansion forces over the whole range of constrained stent diameters from 7mm to 15 mm as compared to the UroLume® stents.
  • the bioresorbabie stents displayed approximately 9 N to 11 N of radial self-expansion force at a constrained stent diameter of 7 mm as compared to 3 N and 5 N at 7 mm of radial self-expansion force for the UroLume® stents, as shown in Fig. 10.
  • the superior results are also illustrated by the graphical data in Fig. 11.
  • the monofilaments that comprise the bioresorbabie stent contract resulting in a different final braid-crossing angle.
  • the contraction of the monofilaments that comprise the braided stent is important in achieving the compression resistance and self-expansion forces for the stents of the present invention.
  • the final post-annealing braid angle ranges from approximately 125° to 150°, and more particularly a final braid angle ranging from approximately 130° to 145°.
  • the final post- annealing braid angle is dependent upon the desired properties and stent length. For instance, a 1.5 cm long stent would require a final post-annealing braid angle ranging from approximately 139° to 145° whereas a lesser braiding angle might be adequate for a longer stent.
  • 1 2W, 3W, 4W, 5W and 6W refer to the number of week strength is retained.
  • self-expanding stent may be utilized in the treatment of urethral stenoses. Accordingly, the present invention is not limited to that precisely as shown and described in the present invention.

Abstract

L'invention concerne un dispositif médical bio-compatible et biorésorbable. Plus précisément, l'invention concerne une endoprothèse poylmère conçue pour rétablir ou maintenir la perméabilité à la suite de procédures chirurgicales, d'une blessure traumatique ou de formation de structure. L'endoprothèse polymère est constituée d'un ou de plusieurs polymères qui sont soit extrudés sous forme de monofilament puis tissés dans une forme de type tresse, soit moulés par injection ou extrudés sous forme de tube doté de perforations dans la paroi. L'invention concerne également des procédés associés permettant de réguler la vie fonctionnelle in vivo des dispositifs médicaux par régulation de la teneur en monomère polymère et d'autres qualités structurelles polymères.
PCT/US2002/013686 2001-06-01 2002-04-29 Dispositifs medicaux bioresorbables WO2002098476A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP02731592A EP1395308A1 (fr) 2001-06-01 2002-04-29 Dispositifs medicaux bioresorbables

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US29532701P 2001-06-01 2001-06-01
US29529801P 2001-06-01 2001-06-01
US60/295,327 2001-06-01
US60/295,298 2001-06-01
US30459201P 2001-07-09 2001-07-09
US60/304,592 2001-07-09
US09/920,871 US20020188342A1 (en) 2001-06-01 2001-08-02 Short-term bioresorbable stents
US09/920,871 2001-08-02

Publications (1)

Publication Number Publication Date
WO2002098476A1 true WO2002098476A1 (fr) 2002-12-12

Family

ID=27501656

Family Applications (1)

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PCT/US2002/013686 WO2002098476A1 (fr) 2001-06-01 2002-04-29 Dispositifs medicaux bioresorbables

Country Status (2)

Country Link
EP (1) EP1395308A1 (fr)
WO (1) WO2002098476A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004080332A2 (fr) 2003-03-10 2004-09-23 Synecor Llc Protheses intraluminales contenant un materiau polymerique possedant une cristallinite selectivement modifiee et procedes de fabrication de celles-ci
WO2005065581A1 (fr) * 2003-12-22 2005-07-21 Medtronic Vascular Inc. Extenseur resorbable extra-plat
EP1891991A3 (fr) * 2006-07-26 2008-08-27 Cordis Corporation Procédé de contrôle d'élution d'un agent thérapeutique
US8298466B1 (en) 2008-06-27 2012-10-30 Abbott Cardiovascular Systems Inc. Method for fabricating medical devices with porous polymeric structures

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993006792A1 (fr) * 1991-10-04 1993-04-15 Scimed Life Systems, Inc. Extenseur vasculaire biodegradable pour administration d'un medicament
WO1999034750A1 (fr) * 1998-01-06 1999-07-15 Bioamide, Inc. Fibres bioabsorbables et composites renforces produits a partir de celles-ci
WO2000044309A2 (fr) * 1999-02-01 2000-08-03 Board Of Regents, The University Of Texas System Protheses endovasculaires tissees bifurquees et trifurquees et leurs procedes de fabrication
WO2000074744A1 (fr) * 1999-06-03 2000-12-14 American Medical Systems, Inc. Extenseur bioresorbable
EP1110561A2 (fr) * 1999-12-22 2001-06-27 Ethicon, Inc. Stent biodégradable

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993006792A1 (fr) * 1991-10-04 1993-04-15 Scimed Life Systems, Inc. Extenseur vasculaire biodegradable pour administration d'un medicament
WO1999034750A1 (fr) * 1998-01-06 1999-07-15 Bioamide, Inc. Fibres bioabsorbables et composites renforces produits a partir de celles-ci
WO2000044309A2 (fr) * 1999-02-01 2000-08-03 Board Of Regents, The University Of Texas System Protheses endovasculaires tissees bifurquees et trifurquees et leurs procedes de fabrication
WO2000074744A1 (fr) * 1999-06-03 2000-12-14 American Medical Systems, Inc. Extenseur bioresorbable
EP1110561A2 (fr) * 1999-12-22 2001-06-27 Ethicon, Inc. Stent biodégradable

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004080332A2 (fr) 2003-03-10 2004-09-23 Synecor Llc Protheses intraluminales contenant un materiau polymerique possedant une cristallinite selectivement modifiee et procedes de fabrication de celles-ci
EP1601524A2 (fr) * 2003-03-10 2005-12-07 Synecor, LLC Protheses intraluminales contenant un materiau polymerique possedant une cristallinite selectivement modifiee et procedes de fabrication de celles-ci
EP1601524A4 (fr) * 2003-03-10 2010-09-22 Synecor Llc Protheses intraluminales contenant un materiau polymerique possedant une cristallinite selectivement modifiee et procedes de fabrication de celles-ci
US7919162B2 (en) 2003-03-10 2011-04-05 Synecor, Llc Intraluminal prostheses having polymeric material with selectively modified crystallinity and methods of making same
US8906286B2 (en) 2003-03-10 2014-12-09 Synecor, Llc Intraluminal prostheses having polymeric material with selectively modified crystallinity and methods of making same
WO2005065581A1 (fr) * 2003-12-22 2005-07-21 Medtronic Vascular Inc. Extenseur resorbable extra-plat
EP1891991A3 (fr) * 2006-07-26 2008-08-27 Cordis Corporation Procédé de contrôle d'élution d'un agent thérapeutique
US8506984B2 (en) 2006-07-26 2013-08-13 Cordis Corporation Therapeutic agent elution control process
US8298466B1 (en) 2008-06-27 2012-10-30 Abbott Cardiovascular Systems Inc. Method for fabricating medical devices with porous polymeric structures

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Publication number Publication date
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