CA2483967A1 - Elastomerically recoverable eptfe for vascular grafts - Google Patents

Elastomerically recoverable eptfe for vascular grafts Download PDF

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Publication number
CA2483967A1
CA2483967A1 CA002483967A CA2483967A CA2483967A1 CA 2483967 A1 CA2483967 A1 CA 2483967A1 CA 002483967 A CA002483967 A CA 002483967A CA 2483967 A CA2483967 A CA 2483967A CA 2483967 A1 CA2483967 A1 CA 2483967A1
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CA
Canada
Prior art keywords
eptfe
elastomeric
fibrils
pores
compressed
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.)
Granted
Application number
CA002483967A
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French (fr)
Other versions
CA2483967C (en
Inventor
Krzysztof Sowinski
Ronald Rakos
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.)
Boston Scientific Ltd Barbados
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Individual
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 Individual filed Critical Individual
Publication of CA2483967A1 publication Critical patent/CA2483967A1/en
Application granted granted Critical
Publication of CA2483967C publication Critical patent/CA2483967C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/16Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/249921Web or sheet containing structurally defined element or component
    • Y10T428/249924Noninterengaged fiber-containing paper-free web or sheet which is not of specified porosity
    • Y10T428/249933Fiber embedded in or on the surface of a natural or synthetic rubber matrix

Abstract

This invention relates to an elastomerically recoverable PTFE material that includes a longitudinally compressed fibrils of ePTFE material penetrated by elastomeric material within the pores defining the elastomeric matrix. The elastomeric matrix and the compressed fibrils cooperatively expand and recover without plastic deformation of the ePTFE material. This invention was used for various prosthesis, such as vascular prosthesis like a patch, a graft and an implantable tubular stents. Furthermore, this invention discloses a method of producing the elastomerically recoverable PTFE material which include the steps of: providing the specified ePTFE, defined by the nodes and fibrils, to meet the desired end use; longitudinally compressing the fibrils of the ePTFE, the pore size sufficiently enough to permit penetration of the elastomeric material; applying the elastomeric material within the pores to provide a structurally integral elastomerically recoverable PTFE material defining an elastomeric matrix. The elastomeric material is applied to the ePTFE by dip, brush or spray coating techniques. The compression step and the application steps are interchangeable to produce the desired properties for the end use material. Finally, the elastomeric material is dried within the pores of the longitudinally compressed ePTFE to solidify the elastomeric matrix.

Claims (21)

WHAT IS CLAIMED IS:
1. An elastomerically recoverable PTFE material comprising:
(a) an ePTFE material defined by nodes and fibrils, said fibrils being in longitudinally compressed state and defining pores of a size sufficient to permit penetration of an elastomeric material; and (b) an elastomeric matrix within said pores; said compressed fibrils and elastomeric matrix cooperatively permitting longitudinal expansion and elastomeric recovery without plastic deformation of said ePTFE material.
2. A vascular prosthesis comprising:
(a) an ePTFE material defined by nodes and fibrils, said fibrils being in longitudinally compressed state and defining pores of a size sufficient to permit penetration of an elastomeric material; and (b) an elastomeric matrix within said pores; said compressed fibrils and elastomeric matrix cooperatively permitting longitudinal expansion and elastomeric recovery without plastic deformation of said ePTFE material.
3. The vascular prosthesis of claim 2 wherein said vascular prosthesis is a patch.
4. The vascular prosthesis of claim 2 wherein the vascular prosthesis is a graft.
5. An implantable tubular stent graft comprising:
(a) an ePTFE material deformed by nodes and fibrils, said fibrils being in longitudinally compressed state and defining pores of a size sufficient to permit penetration of an elastomeric material;

(b) an elastomeric matrix within said pores; said compressed fibrils and elastomeric matrix cooperatively permitting longitudinal expansion and elastomeric recovery without plastic deformation of said ePTFE material; and (c) a longitudinally expandable stent.
6. A method of producing an elastomerically recoverable PTFE structure comprising the steps of:
(a) providing an ePTFE material defined by nodes, fibrils and pores, wherein said pore size is a space defined by the distance between said nodes and distance between said fibrils; and (b) compressing said fibrils longitudinally wherein said pore size is sufficient to permit penetration of elastomeric material; and (c) applying said elastomeric material within said pores to provide a structurally integral elastomerically recoverable PTFE material
7. The method according to claim 6 further comprising the step of permitting the elastomeric material to dry within said pores while said fibrils are still longitudinally compressed defining the elastomeric matrix.
8. The method according to claim 6 wherein said ePTFE material is a tube, having an internal diameter and an external diameter.
9. The method according to claim 8 wherein said compressing step includes the steps of:
(a) pulling the ePTFE tube over a mandrel having an outer diameter of approximately the same dimensions as the internal diameter of the ePTFE tube;
and (b) compressing at least a portion of the ePTFE tube along the longitudinal axis of the tube while the tube is supported by the mandrel.
10. The method according to claim 6 wherein said applying step includes the step of dip coating at least the compressed portion of the ePTFE material into a container of elastomeric material.
11. The method according to claim 6 wherein said applying step includes the step of spray coating at least the compressed portion of the ePTFE material with the elastomeric material.
12. The method according to claim 6 wherein said applying step includes the step of brushing the elastomeric material onto at least the compressed portion of the ePTFE material.
13. The method according to claim 6 wherein said compressing step includes the step of compressing the ePTFE material uniformly along its entire length, and wherein said applying step includes the applying elastomeric material over the entire longitudinally compressed ePTFE material.
14. A method of producing an elastomerically recoverable PTFE structure comprising the steps of:
(a) providing an ePTFE material defined by nodes, fibrils and pores, wherein said pore size is a space defined by the distance between said nodes and distance between said fibrils; and (b) applying said elastomeric material to said pores; and (c) compressing said fibrils longitudinally wherein said pore size is sufficient to permit penetration of elastomeric material pores to provide a structurally integral elastomerically recoverable PTFE material.
15. The method according to claim 14 further comprising the step of permitting the elastomeric material to dry within said pores while said fibrils are still longitudinally compressed defining the elastomeric matrix.
16. The method according to claim 14 wherein said ePTFE material is a tube, having an internal diameter and an external diameter.
17. The method according to claim 14 wherein said compressing step includes the steps of:
(a) pulling the ePTFE tube over a mandrel having an outer diameter of approximately the same dimensions as the internal diameter of the ePTFE tube;
and (b) compressing at least a portion of the ePTFE tube along the longitudinal axis of the tube while the tube is supported by the mandrel.
1~. The method according to claim 14 wherein said applying step includes the step of dip coating at least the compressed portion of the ePTFE material into a container of elastomeric material.
19. The method according to claim 14 wherein said applying step includes the step of spray coating at least the compressed portion of the ePTFE material with the elastomeric material.
20. The method according to claim 14 wherein said applying step includes the step of brushing the elastomeric material onto at least the compressed portion of the ePTFE material.
21. The method according to claim 14 wherein said applying step comprises the step of applying elastomeric material over the entire longitudinally compressed ePTFE
material, and wherein the compressing step comprises the step of compressing the ePTFE
material uniformly along its entire length.
CA2483967A 2002-06-25 2003-05-01 Elastomerically recoverable eptfe for vascular grafts Expired - Fee Related CA2483967C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/179,484 2002-06-25
US10/179,484 US7789908B2 (en) 2002-06-25 2002-06-25 Elastomerically impregnated ePTFE to enhance stretch and recovery properties for vascular grafts and coverings
PCT/US2003/013747 WO2004000375A1 (en) 2002-06-25 2003-05-01 Elastomerically recoverable eptfe for vascular grafts

Publications (2)

Publication Number Publication Date
CA2483967A1 true CA2483967A1 (en) 2003-12-31
CA2483967C CA2483967C (en) 2011-11-01

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2483967A Expired - Fee Related CA2483967C (en) 2002-06-25 2003-05-01 Elastomerically recoverable eptfe for vascular grafts

Country Status (6)

Country Link
US (2) US7789908B2 (en)
EP (1) EP1526878B1 (en)
JP (1) JP2005530549A (en)
AU (1) AU2003237158A1 (en)
CA (1) CA2483967C (en)
WO (1) WO2004000375A1 (en)

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US20060259133A1 (en) 2006-11-16
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US7789908B2 (en) 2010-09-07
JP2005530549A (en) 2005-10-13

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