CA2426974A1 - Coated medical devices - Google Patents
Coated medical devices Download PDFInfo
- Publication number
- CA2426974A1 CA2426974A1 CA002426974A CA2426974A CA2426974A1 CA 2426974 A1 CA2426974 A1 CA 2426974A1 CA 002426974 A CA002426974 A CA 002426974A CA 2426974 A CA2426974 A CA 2426974A CA 2426974 A1 CA2426974 A1 CA 2426974A1
- Authority
- CA
- Canada
- Prior art keywords
- graft
- stent
- implantation
- treatment site
- living organism
- 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
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Classifications
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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
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- 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
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- 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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
Abstract
Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.
Claims (65)
1. A stent-graft for implantation into a treatment site of a living organism comprising:
a scaffold structure for maintaining luminal patency;
a graft material secured to at least a portion of the scaffold structure;
a biocompatible vehicle affixed to at least one of the scaffold structure and graft material; and at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of a disease condition.
a scaffold structure for maintaining luminal patency;
a graft material secured to at least a portion of the scaffold structure;
a biocompatible vehicle affixed to at least one of the scaffold structure and graft material; and at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of a disease condition.
2. The stent-graft for implantation into a treatment site of a living organism according to Claim 1, wherein the scaffold structure comprises a stent.
3. The stent-graft for implantation into a treatment site of a living organism according to Claim 2, wherein the stent is a self-expanding stent.
4. The stent-graft for implantation into a treatment site of a living organism according to Claim 2, wherein the graft material comprises a polymeric material.
5. The stent-graft for implantation into a treatment site of a living organism according to Claim 4, wherein the graft material comprises pleats.
6. The stent-graft for implantation into a treatment site of a living organism according to Claim 5, wherein the biocompatible vehicle comprises a polymeric matrix.
7. The stent-graft for implantation into a treatment site of a living organism according to Claim 6, wherein the polymeric matrix comprises polyethylene-co-vinylacetate) and polybutylmethacrylate.
8. The stent-graft for implantation into a treatment site of a living organism according to Claim 7, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of at least one of the scaffold structure and graft material and comprising a solution of polyethylene-co-vinylacetate) and polybutylmethacrylate, and the second layer comprising polybutylmethacrylate.
9. The stent-graft for implantation into a treatment site of a living organism according to Claim 8, wherein the at least one agent is incorporated into the first layer.
10. The stent-graft for implantation into a treatment site of a living organism according to Claim 6, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible vehicle with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.
11. The stent-graft for implantation into a treatment site of a living organism according to Claim 10, wherein the polyfluoro copolymer comprises from about fifty to about ninety-two weight percent of the polymerized residue of the first moiety copolymerized with from about fifty to about eight weight percent of the polymerized residue of the second moiety.
12. The stent-graft for implantation into a treatment site of a living organism according to Claim 10, wherein said polyfluoro copolymer comprises from about fifty to about eighty-five weight percent of the polymerized residue of vinylidenefluoride copolymerized with from about fifty to about fifteen weight percent of the polymerized residue of the second moiety.
13. The stent-graft for implantation into a treatment site of a living organism according to Claim 10, wherein said copolymer comprises from about fifty-five to about sixty-five weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about forty-five to about thirty-five weight percent of the polymerized residue of the second moiety.
14. The stent-graft for implantation into a treatment site of a living organism according to Claim 10, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.
15. The stent-graft for implantation into a treatment site of a living organism according to Claim 10, wherein the second moiety is hexafluoropropylene.
16. The stent-graft for implantation into a treatment site of a living organism according to Claim 1, wherein the at least one agent comprises an anti-proliferative.
17. The stent-graft for implantation into a treatment site of a living organism according to Claim 1, wherein the at least one agent comprises an anti-inflammatory.
18. The stent-graft for implantation into a treatment site of a living organism according to Claim 1, wherein the at least one agent comprises an anti-coagulant.
19. The stent-graft for implantation into a treatment site of a living organism according to Claim 1, wherein the at least one agent comprises rapamycin.
20. The stent-graft for implantation into a treatment site of a living organism according to Claim 1, wherein the at least one agent comprises heparin.
21. A stent-graft for implantation into a treatment site of a living organism comprising:
first and second scaffold structures for maintaining luminal patency;
a graft material sandwiched between the first and second scaffold structures;
a biocompatible vehicle affixed to at least one of the first and second scaffold structures and the graft material; and at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of a disease condition.
first and second scaffold structures for maintaining luminal patency;
a graft material sandwiched between the first and second scaffold structures;
a biocompatible vehicle affixed to at least one of the first and second scaffold structures and the graft material; and at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of a disease condition.
22. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, wherein the first and second scaffold structures comprise stents.
23. The stent-graft for implantation into a treatment site of a living organism according to Claim 22, wherein the stents are self-expanding.
24. The stent-graft for implantation into a treatment site of a living organism according to Claim 22, wherein the graft material comprises a polymeric material.
25. The stent-graft for implantation into a treatment site of a living organism according to Claim 22, wherein the biocompatible vehicle comprises a polymeric matrix.
26. The stent-graft for implantation into a treatment site of a living organism according to Claim 25, wherein the polymeric matrix comprises poly(ethylene-co-vinylacetate) and polybutylmethacrylate.
27. The stent-graft for implantation into a treatment site of a living organism according to Claim 26, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of at least one of the first and second scaffold structures and graft material and comprising a solution of poly(ethylene-co-vinylacetate) and polybutylmethacrylate and the second layer comprising polybutylmethacrylate.
28. The stent-graft for implantation into a treatment site of a living organism according to Claim 27, wherein the at least one agent is incorporated into the first layer.
29. The stent-graft for implantation into a treatment site of a living organism according to Claim 25, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible vehicle with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.
30. The stent-graft for implantation into a treatment site of a living organism according to Claim 29, wherein the polyfluoro copolymer comprises from about fifty to about ninety-two weight percent percent of the polymerized residue of the first moiety copolymerized with from about fifty to about eight weight percent of the polymerized residue of the second moiety.
31. The stent-graft for implantation into a treatment site of a living organism according to Claim 29, wherein the polyfluoro copolymer comprises from about fifty to about eighty-five weight percent of the polymerized residue of vinylidenefluoride copolymerized with from about fifty to about fifteen weight percent of the polymerized residue of the second moiety.
32. The stent-graft for implantation into a treatment site of a living organism according to Claim 29, wherein said copolymer comprises from about fifty-five to about sixty-five weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about forty-five to about thirty-five weight percent of the polymerized residue of the second moiety.
33. The stent-graft for implantation into a treatment site of a living organism according to Claim 29, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.
34. The stent-graft for implantation into a treatment site of a living organism according to Claim 29, wherein the second moiety is hexafluoropropylene.
35. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, wherein the at least one agent comprises an anti-proliferative.
36. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, wherein the at least one agent cvomprises an anti-inflammatory.
37. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, wherein the at least one agent comprises an anti-coagulant.
38. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, wherein the at least one agent comprises rapamycin.
39. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, wherein the at least one agent comprises heparin.
40. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, further comprising cuffs formed by folding and securing at least one end of the graft material over an end of one of the first and second scaffold stuctures.
41. The stent-graft for implantation into a treatment site of a living organism according to Claim 40, wherein the at least one therapeutic agent is encapsulated within the cuffs.
42. The stent-graft for implantation into a treatment site of a living organism according to Claim 21, wherein the at least one therapeutic agent is impregnated into the graft material.
43. A system for bypassing an aneurysm comprising:
at least one prosthesis for establishing a fluid flow path through an aneurysmal section of artery;
an anchoring element operatively associated with the at least one prosthesis for securing and sealing the at feast one prosthesis upstream of the aneurysmal section of artery;
a biocompatible vehicle affixed to at least one of the anchoring element and the at least one prosthesis; and at least one agent in therapeutic dosages incorporated into the biocompatible material for treatment of a disease condition.
at least one prosthesis for establishing a fluid flow path through an aneurysmal section of artery;
an anchoring element operatively associated with the at least one prosthesis for securing and sealing the at feast one prosthesis upstream of the aneurysmal section of artery;
a biocompatible vehicle affixed to at least one of the anchoring element and the at least one prosthesis; and at least one agent in therapeutic dosages incorporated into the biocompatible material for treatment of a disease condition.
44. The system for bypassing an aneurysm according to Claim 43, wherein the at least one prosthesis comprises a stent-graft.
45. The system for bypassing an aneurysm according to Claim 44, wherein the stent-graft comprises a stent and a graft material secured to at least a portion of the stent.
46. The system for bypassing an aneurysm according to Claim 45, wherein the stent is self-expanding.
47. The system for bypassing an aneurysm according to Claim 46, wherein the graft material comprises a polymeric material.
48. The system for bypassing an aneurysm according to Claim 47, wherein the anchoring element comprises a scaffold structure at least partially covered with a gasket material substantially impervious to blood.
49. The system for bypassing an aneurysm according to Claim 48, wherein the biocompatible vehicle comprises a polymeric matrix.
50. The system for bypassing an aneurysm according to Claim 49, wherein the polymeric matrix comprises polyethylene-co-vinylacetate) and polybutylmethacrylate.
51. The system for bypassing an aneurysm according to Claim 50, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of at least one of the stents, graft material and anchoring element and comprising a solution of polyethylene-co-vinylacetate) and polybutylmethacrylate and the second layer comprises polybutylmethacrylate.
52. The system for bypassing an aneurysm according to Claim 51, wherein the at least one agent is incorporated into the first layer.
53. The system for bypassing an aneurysm according to Claim 49, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible vehicle with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.
54. The system for bypassing an aneurysm according to Claim 53, wherein the polyfluoro copolymer comprises from about fifty to about ninety-two weight percent of the polymerized residue of the first moiety copolymerized with from about fifty to about eight weight percent of the polymerized residue of the second moiety.
55. The system for bypassing an aneurysm according to Claim 53, wherein said polyfluoro copolymer comprises from about fifty to about eighty-five weight percent of the polymerized residue of vinylidenefluoride copolymerized with from about fifty to about fifteen weight percent of the polymerized residue of the second moiety.
56. The system for bypassing an aneurysm according to Claim 53, wherein said copolymer comprises from about fifty-five to about sixty-five weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about forty-five to about thirty-five weight percent of the polymerized residue of the second moiety.
57. The system for bypassing an aneurysm according to Claim 53, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.
58. The system for bypassing an aneurysm according to Claim 53, wherein the second moiety is hexafluoropropylene.
59. The system for bypassing an aneurysm according to Claim 43, wherein the at least one agent comprises an anti-proliferative.
60. The system for bypassing an aneurysm according to Claim 43, wherein the at least one agent comprises an anti-inflammatory.
61. The system for bypassing an aneurysm according to Claim 43, wherein the at least one agent comprises an anti-coagulant.
as
as
62. The system for bypassing an aneurysm according to Claim 43, wherein the at least one agent comprises rapamycin.
63. The system for bypassing an aneurysm according to Claim 43, wherein the at least one agent comprises heparin.
64. The system for bypassing an aneurysm according to Claim 47, wherein the at least therapeutic agent is impregnated into the graft material.
65. The system for bypassing an aneurysm according to Claim 48, wherein the at feast one therapeutic agent is impregnated into the gasket material.
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US10/136,569 US20030065377A1 (en) | 2001-09-28 | 2002-04-30 | Coated medical devices |
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CA2426974C CA2426974C (en) | 2011-03-15 |
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ATE219693T1 (en) * | 1998-04-27 | 2002-07-15 | Surmodics Inc | BIOACTIVE ACTIVE COATINGS |
US20020188037A1 (en) * | 1999-04-15 | 2002-12-12 | Chudzik Stephen J. | Method and system for providing bioactive agent release coating |
CA2358296A1 (en) * | 1999-01-05 | 2000-07-13 | Anthony P. Adamis | Targeted transscleral controlled release drug delivery to the retina and choroid |
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ES2246431T3 (en) * | 2000-03-18 | 2006-02-16 | Polyzenix Gmbh | DENTAL IMPLANTS THAT HAVE BACTERIAL RESISTANCE. |
JP2004500918A (en) * | 2000-04-11 | 2004-01-15 | ポリゼニックス ゲーエムベーハー | Poly-tri-fluoro-ethoxy polyphosphazene covering and film |
US20050002986A1 (en) * | 2000-05-12 | 2005-01-06 | Robert Falotico | Drug/drug delivery systems for the prevention and treatment of vascular disease |
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US20030065377A1 (en) | 2003-04-03 |
JP2004000586A (en) | 2004-01-08 |
AU2003203891A1 (en) | 2003-11-20 |
CA2426974C (en) | 2011-03-15 |
AU2003203891B2 (en) | 2008-01-10 |
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