CA2575459A1 - Bioabsorbable self-expanding endolumenal devices - Google Patents

Bioabsorbable self-expanding endolumenal devices Download PDF

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Publication number
CA2575459A1
CA2575459A1 CA002575459A CA2575459A CA2575459A1 CA 2575459 A1 CA2575459 A1 CA 2575459A1 CA 002575459 A CA002575459 A CA 002575459A CA 2575459 A CA2575459 A CA 2575459A CA 2575459 A1 CA2575459 A1 CA 2575459A1
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CA
Canada
Prior art keywords
medical device
implantable medical
framework
bioactive agent
bioabsorbable
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
CA002575459A
Other languages
French (fr)
Other versions
CA2575459C (en
Inventor
Joseph R. Armstrong
Paul C. Begovac
Robert L. Cleek
Edward H. Cully
Charles Flynn
Byron K. Hayes
Ray V. Peterson
Michael J. Vonesh
Charles F. White
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.)
WL Gore and Associates Inc
Original Assignee
Gore Enterprise Holdings, Inc.
Joseph R. Armstrong
Paul C. Begovac
Robert L. Cleek
Edward H. Cully
Charles Flynn
Byron K. Hayes
Ray V. Peterson
Michael J. Vonesh
Charles F. White
W. L. Gore & Associates, Inc.
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 Gore Enterprise Holdings, Inc., Joseph R. Armstrong, Paul C. Begovac, Robert L. Cleek, Edward H. Cully, Charles Flynn, Byron K. Hayes, Ray V. Peterson, Michael J. Vonesh, Charles F. White, W. L. Gore & Associates, Inc. filed Critical Gore Enterprise Holdings, Inc.
Publication of CA2575459A1 publication Critical patent/CA2575459A1/en
Application granted granted Critical
Publication of CA2575459C publication Critical patent/CA2575459C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time

Abstract

The present invention is directed to bioabsorbable self-expanding medical devices for use inside or outside body conduits that self-expand at, or below, normal human body temperature without requisite for a polymeric thermal transition.

Claims (36)

1. An implantable medical device comprising:
an integral framework delimiting a multiplicity of fenestrations, said framework comprising a non-blended hydrolyzable polymeric material; and wherein said framework is substantially tubular in shape and radially expands from a compressed first diameter to an uncompressed second diameter equal to or greater than 1.5 times said first diameter within two minutes following application and release of a compressive force while immersed in an aqueous medium at 37 degrees centigrade without requisite for an extrinsically applied force and without requisite for a thermal transition.
2. The implantable medical device of claim 1 wherein said integral framework does not change axial length significantly as said integral framework expands radially.
3. The implantable medical device of claim 1 wherein the device is a stent.
4. The implantable medical device of claim 1 wherein said integral framework has elements with different cross-sectional dimensions.
5. The implantable medical device of claim 1 wherein said integral framework has elements comprising bioabsorbable material having different chemical compositions.
6. The implantable medical device of claim 2 wherein the stent has a fenestration pattern substantially as shown in Figure 1.
7. The implantable medical device of claim 1 wherein the non-blended hydrolyzable polymeric material is a tri-block co-polymer of poly(glycolide) and poly(trimethylenecarbonate).
8. The implantable medical device of claim 1 further comprising a bio-absorbable coating on at least a portion of said integral framework.
9. The implantable medical device of claim 8 further comprising a bioactive agent incorporated in said bio-absorbable coating.
10. The implantable medical device of claim 9 wherein the bioactive agent is dexamethasone.
11. The implantable medical device of claim 1 further comprising a material covering said tubular construction.
12. The implantable medical device of claim 11 wherein said material is non-bioabsorbable.
13. The implantable medical device of claim 12 wherein said non-bioabsorbable material is a polytetrafluoroethylene material.
14. The implantable medical device of claim 13 wherein said polytetrafluoroethylene material is porous expanded polytetrafluoroethylene.
15. The implantable medical device of claim 12 further comprising a bioactive agent incorporated in said covering.
16. The implantable medical device of claim 11 wherein said covering is a bioabsorbable material.
17. The implantable medical device of claim 11 further comprising a bioactive agent in combination with said material.
18. The implantable medical device of claim 1 wherein said integral tubular framework is tapered and connected together at one end to form a filter, wherein fluid can flow through said fenestrations.
19. An implantable medical device comprising:

an integral framework delimiting a multiplicity of fenestrations, said framework comprising a non-blended hydrolyzable polymeric material; and wherein said framework has an axial length and a shape that is circular in cross-section and radially expands from a compressed first diameter to an uncompressed second diameter equal to or greater than 1.5 times said first diameter within two minutes following application and release of a compressive force while immersed in an aqueous medium at 37 degrees centigrade without requisite for an extrinsically applied force and without requisite for a thermal transition.
20. The implantable medical device of claim 19 wherein said circular cross-section varies in diameter along said axial length.
21. The implantable medical device of claim 19 wherein said integral framework does not change axial length significantly as said integral framework expands radially.
22. The implantable medical device of claim 19 wherein the device is a stent.
23. The implantable medical device of claim 19 wherein said integral framework has elements with different cross-sectional dimensions.
24. The implantable medical device of claim 19 wherein said integral framework has elements comprising bioabsorbable material having different chemical compositions.
25. The implantable medical device of claim 19 wherein the stent has a fenestration pattern substantially as shown in Figure 1.
26. The implantable medical device of claim 19 wherein the non-blended hydrolyzable polymeric material is a tri-block co-polymer of poly(glycolide) and poly(trimethylenecarbonate).
27. The implantable medical device of claim 19 further comprising a bio-absorbable coating on at least a portion of said integral framework.
28. The implantable medical device of claim 27 further comprising a bioactive agent incorporated in said bio-absorbable coating.
29. The implantable medical device of claim 28 wherein the bioactive agent is dexamethasone.
30. The implantable medical device of claim 19 further comprising a material covering said tubular construction.
31. The implantable medical device of claim 30 wherein said material is non-bioabsorbable.
32. The implantable medical device of claim 31 wherein said non-bioabsorbable material is a polytetrafluoroethylene material.
33. The implantable medical device of claim 32 wherein said polytetrafluoroethylene material is porous expanded polytetrafluoroethylene.
34. The implantable medical device of claim 30 further comprising a bioactive agent incorporated in said covering.
35. The implantable medical device of claim 30 wherein said covering is a bioabsorbable material.
36. The implantable medical device of claim 35 further comprising a bioactive agent in combination with said material.
CA2575459A 2004-08-02 2005-07-29 Bioabsorbable self-expanding endolumenal devices Expired - Fee Related CA2575459C (en)

Applications Claiming Priority (3)

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US10/910,502 2004-08-02
US10/910,502 US20060025852A1 (en) 2004-08-02 2004-08-02 Bioabsorbable self-expanding endolumenal devices
PCT/US2005/026892 WO2006020425A1 (en) 2004-08-02 2005-07-29 Bioabsorbable self-expanding endolumenal devices

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WO2006020425A1 (en) 2006-02-23
JP4988570B2 (en) 2012-08-01
AU2005274097A1 (en) 2006-02-23
AU2009200326B2 (en) 2012-02-02
JP2008508073A (en) 2008-03-21
EP1773250A4 (en) 2011-05-25
US20060025852A1 (en) 2006-02-02
EP1773250A1 (en) 2007-04-18
EP1773250B1 (en) 2016-06-08
US20080281393A1 (en) 2008-11-13
US9005269B2 (en) 2015-04-14
AU2005274097B2 (en) 2008-12-18
CA2575459C (en) 2010-09-28

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