CA2464197A1 - Green fluoropolymer tube and endovascular prosthesis formed using same - Google Patents

Green fluoropolymer tube and endovascular prosthesis formed using same Download PDF

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Publication number
CA2464197A1
CA2464197A1 CA002464197A CA2464197A CA2464197A1 CA 2464197 A1 CA2464197 A1 CA 2464197A1 CA 002464197 A CA002464197 A CA 002464197A CA 2464197 A CA2464197 A CA 2464197A CA 2464197 A1 CA2464197 A1 CA 2464197A1
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CA
Canada
Prior art keywords
tube
thickness
tubular member
less
prosthesis
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
CA002464197A
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French (fr)
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CA2464197C (en
Inventor
David J. Sogard
Jason P. Hill
Timothy S. Girton
Christopher B. Brodeur
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Boston Scientific Ltd Bermuda
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Individual
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Publication of CA2464197A1 publication Critical patent/CA2464197A1/en
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Publication of CA2464197C publication Critical patent/CA2464197C/en
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    • 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
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained 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
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B29C48/10—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels flexible, e.g. blown foils
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/92—Measuring, controlling or regulating
    • 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
    • A61F2/02—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
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • 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
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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    • B29C2793/009—Shaping techniques involving a cutting or machining operation after shaping
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C2948/92—Measuring, controlling or regulating
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
    • B29C48/475—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using pistons, accumulators or press rams
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C48/80—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling at the plasticising zone, e.g. by heating cylinders
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/90—Thermal treatment of the stream of extruded material, e.g. cooling with calibration or sizing, i.e. combined with fixing or setting of the final dimensions of the extruded article
    • B29C48/901—Thermal treatment of the stream of extruded material, e.g. cooling with calibration or sizing, i.e. combined with fixing or setting of the final dimensions of the extruded article of hollow bodies
    • B29C48/902—Thermal treatment of the stream of extruded material, e.g. cooling with calibration or sizing, i.e. combined with fixing or setting of the final dimensions of the extruded article of hollow bodies internally
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C55/22—Shaping by stretching, e.g. drawing through a die; Apparatus therefor of tubes
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    • B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
    • B29K2027/12—Use of polyvinylhalogenides or derivatives thereof as moulding material containing fluorine
    • B29K2027/18—PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
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    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses
    • B29L2031/7534—Cardiovascular protheses
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    • B29L2031/7542—Catheters
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article

Abstract

The present invention is directed to a green fluoropolymer tube which has a wall thickness of about 250 microns or less, preferably about 200 microns or less, and more preferably about 125 microns or less. With such thinness, the green tube may be formed into a tube of expanded fluoropolymer having a wall thickness of about 250 microns or less, preferably about 200 µm or less and more preferably about 125 microns of less. Such an expanded fluoropolymer tube is particularly well-suited for use as an endovascular prosthesis, such as a graft, or in a stent-graft, because of its flexibility and strength.

Claims (59)

1. A green fluoropolymer tube comprising a wall having an inner surface and an outer surface, a thickness being generally uniformly defined between said inner and outer surfaces, said thickness being in the range of up to about 250 µm.
2. A tube as in claim 1, wherein said wall is seamless.
3. A tube as in claim 1, wherein said tube is extruded.
4. A tube as in claim 1, wherein said tube is generally cylindrical, said inner surface having a diameter of about 1 mm to about 14 mm.
5. A tube as in claim 1, wherein said tube is generally cylindrical, said outer surface having a diameter of about 1 mm to about 14 mm.
6. A tube as in claim 1, wherein said tube is coreless.
7. A tube as in claim 1, wherein said fluoropolymer is PTFE.
8. A tube as in claim 1, wherein said thickness being in the range of up to about 200 µm.
9. A tube as in claim 8, wherein said thickness being in the range of up to about 125 µm.
10. An implantable tubular prosthesis comprising a first tube including a seamless first wall having a first inner surface and a first outer surface, a first thickness being defined between said first inner and first outer surfaces, said first thickness being in the range of about 250 µm or less, said first wall including an expanded fluoropolymer.
11. A prosthesis as in claim 10, wherein said first thickness is in the range of about 200 µm or less.
12. A prosthesis as in claim 11, wherein said first thickness is in the range of about 125 µm or less.
13. A prosthesis as in claim 10, wherein said first tube is extruded.
14. A prosthesis as in claim 10, wherein said fluoropolymer is PTFE.
15. A prosthesis as in claim 10 further comprising a distensible member concentrically disposed relative to said first tube.
16. A prosthesis as in claim 15, wherein said distensible member is disposed about said first tube.
17. A prosthesis as in claim 16, further comprising a second tube disposed about said distensible member.
18. A prosthesis as in claim 17, wherein said distensible member includes interstices, said first tube being bonded to said second tube through said interstices.
19. A prosthesis as in claim 18, wherein said distensible member is non-bondedly disposed between said first and second tubes.
20. A prosthesis as in claim 15, wherein said first tube is disposed about said distensible member.
21. A prosthesis as in claim 15, wherein said distensible member is at least partially recessed into said first tube.
22. A prosthesis as in claim 16 wherein the wall thickness of said prosthesis, exclusive of said distensible member, is about 120 µm or less.
23. A process for forming a prosthesis, comprising the step of:
extruding a fluoropolymer to form a tubular member having a wall with an inner surface and an outer surface, a thickness being defined between said inner and outer surfaces, said thickness being in the range of about 250 µm or less.
24. A process as in claim 23, wherein said fluoropolymer is PTFE.
25. A process as claim 23, wherein said tubular member is hollow upon extrusion.
26. A process as in claim 23 further comprising:
at least partially expanding said tubular member.
27. A process as in claim 23 further comprising:
disposing a distensible member concentrically relative to said expanded tubular member.
28. A process as in claim 27, wherein said distensible member is disposed in contiguous contact with said inner surface.
29. A process as in claim 27, wherein said distensible member is disposed in contiguous contact with said outer surface.
30. A process as in claim 27, wherein said distensible member is at least partially recessed within said expanded tubular member.
31. A process as in claim 27 further comprising extruding a fluoropolymer to form a second tubular member having a second wall with a second inner surface and a second outer surface, a second thickness being defined between said second inner and second outer surfaces, said second thickness being in the range of about 250 µm or less;
at least partially expanding said second tubular member; and disposing said second expanded tubular member concentrically relative to said expanded tubular member.
32. A process as in claim 31, wherein said fluoropolymer is PTFE.
33. A process as in claim 31, wherein said distensible member is interposed between said expanded tubular member and said second expanded tubular member.
34. A process as in claim 33, wherein said distensible member includes interstices, said expanded tubular member being bonded to said second expanded tubular member through said interstices.
35. A process as in claim 34, wherein said distensible member is non-bondedly disposed between said expanded tubular member and said second expanded tubular member.
36. A process as in claim 26, wherein said tubular member is expanded through about 500 to about 6000% of elongation.
37. A process as in claim 31, wherein said second tubular member is expanded through about 500 to about 6000% of elongation.
38. A process as in claim 23, wherein said thickness being in the range of about 200 µm or less.
39. A process as in claim 38, wherein said thickness being in the range of about 125 µm or less.
40. A process as in claim 23, wherein tension is applied to said tubular member during extruding.
41. A process for forming a green tube, said process comprising extruding a fluoropolymer to form a tubular member having a wall with an inner surface and an outer surface, a thickness being generally uniformly defined between said inner and outer surfaces, said thickness being in the range of about 250 µm or less.
42. A process as in claim 41, wherein said thickness is in the range of about 200 µm or less.
43. A process as in claim 42, wherein said thickness is in the range of about 125 µm or less.
44. A process as in claim 41, wherein said tube is cylindrical, said inner surface having a diameter of about 1 mm to about 14 mm.
45. A process as in claim 41, wherein said outer surface has an outer diameter of about 1 mm to about 14 mm.
46. A process as in claim 41, wherein said tubular member is hollow upon extrusion.
47. A process as in claim 41 further comprising injecting a stable medium inside of said inner surface to provide structural support for said tubular member.
48. A process as in claim 47, wherein said stable medium is air.
49. A process as in claim 41, wherein said fluoropolymer is PTFE.
50. A process as in claim 41, wherein tension is applied to said tubular member during extruding.
51. A method of forming a stent-graft device comprising the steps of:

forming an expandable fluoropolymeric tube from an extruded green fluoropolymer tube having a wall thickness of about 250 µm or less; and dispensing a distensible member concentrically thereabout.
52. A method as in claim 51 further comprising:
dispensing a second expandable fluoropolymeric tube formed from an extruded green fluoropolymer tube having a wall thickness of about 250 µm or less about said distensible member.
53. A method as in claim 51 further including the step of joining together said tubes.
54. A method as in claim 53 wherein said joining includes the use of heat and pressure.
55. A method as in claim 53 wherein said joining includes the use of adhesive.
56. A method as in claim 51, wherein said wall thickness is about 200 µm or less.
57. A method as in claim 56, wherein said wall thickness is about 125 µm or less.
58. A method as in claim 52, wherein said wall thickness of said second tube being about 200 µm or less.
59. A method as in claim 58, wherein said wall thickness of said second tube being about 125 µm or less.
CA2464197A 2001-10-30 2002-08-28 Green fluoropolymer tube and endovascular prosthesis formed using same Expired - Fee Related CA2464197C (en)

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