Bioactive coating for vaso-occlusive devices

• US 6,231,590 B1
• Filed: 07/12/1999
• Issued: 05/15/2001
• Est. Priority Date: 11/10/1998
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Barry, James J., Eder, Joseph C., Wallace, Michael P., Abrams, Robert M., Slaikeu, Paul C.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US09/352,188
• Time in Patent Office: 673 Days
• Field of Search: 606/191, 606/190, 606/198, 606/108, 606/151, 606/1, 606/195, 606/200, 623/1, 623/12
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 65/04 Polyxylenes
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

This is a medical device for forming an embolism within the vasculature of a patient. More particularly, it is a vaso-occlusion device at least partially coated with a bioactive agent, a collagenous material, or a collagenous coating optionally containing or coated with other bioactive agents. A highly flexible vaso-occlusive device coated with such materials also forms a variation of the invention.

Claims

1. A vaso-occlusive device comprising:

a) a vaso-occlusive member;

b) an inner coating on at least a portion of said vaso-occlusive member, said inner coating being free from protein; and

c) a protein-based outer coating on said inner coating wherein said inner coating is not applied by plasma treatment.

2. The device of claim 1 wherein the protein-based outer coating is collagen-based.

3. The device of claim 1 wherein the vaso-occlusive member is a metallic element comprising an elongated helical coil.

4. The device of claim 3 wherein the coil is a cylindrical helical coil.

5. The device of claim 3 wherein the coil comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, titanium, nickel, and alloys thereof.

6. The device of claim 1 wherein the inner coating is a polymer-based agent.

7. The device of claim 6 wherein the inner coating is bonded to said vaso-occlusive member.

8. The device of claim 7 wherein the inner coating is applied by a procedure selected from the group consisting of applying a silane coupling agent, applying a acrylate-based coupling agent, applying a low molecular weight adhesive agent, vapor deposition, and polymer coating from a dilute solution.

9. The device of claim 1 wherein said outer coating is photo-polymerizable.

10. The device of claim 8 wherein the inner coating is paraxyxylene and deposited by vapor deposition.

11. The device of claim 1 further comprising a bioactive material selected from the group consisting of genes, growth factors, biomolecules, peptides, oligonucleotides, members of the integrin family, RGD-containing sequences, oligopeptides, e.g., fibronectin, laminin, vitronectin, hyaluronic acid, silk-elastin, elastin, infibrogen, and other basement membrane proteins with bioactive agents.

12. The device of claim 11 wherein said bioactive material is a coating on said protein-based outer coating.

13. The device of claim 11 wherein said bioactive material is intermixed with said protein-based outer coating.

14. A vaso-occlusive device comprising:

a) a vaso-occlusive member, and

b) an inner material on at least a portion of said vaso-occlusive member, said inner material being free from protein; and

c) a protein-based outer coating on said inner material wherein said inner material is not applied by plasma treatment.

15. The device of claim 14 wherein the protein-based outer coating is collagen-based.

16. The device of claim 14 wherein the vaso-occlusive member is a metallic element comprising an elongated helical coil.

17. The device of claim 16 wherein the coil is a cylindrical helical coil.

18. The device of claim 17 wherein the coil comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, titanium, nickle, and alloys thereof.

19. The device of claim 14 wherein said outer coating is photo-polymerizable.

20. The device of claim 14 further comprising a bioactive material selected from the group consisting of genes, growth factors, biomolecules, peptides, oligonucleotides, members of the integrin family, RGD-containing sequences, oligopeptides, e.g., fibronectin, laminin, vitronectin, hyaluronic acid, silk-elastin, elastin, infibrogen, and other basement membrane proteins with bioactive agents.

21. The device of claim 14 further comprising fibrous material attached to the vaso-occlusive member that is also at least partially covered by said protein-based outer coating.

22. The device of claim 21 wherein said inner material is an adhesive.

23. The device of claim 21 wherein said fibrous material is a gauze.

24. The device of claim 23 wherein said inner material is an adhesive.

25. The device of claim 17 further comprising fibrous material attached to the vaso-occlusive member that is also at least partially covered by said protein-based outer coating.

26. The device of claim 25 wherein said fibrous material comprises one or more polymers.

27. The device of claim 26 wherein said one or more polymers is selected from the group consisting of polyglycolic acid, polylactic acid, reconstituted collagen, poly-p-dioxanone, and their copolymers such as poly(glycolide-lactide) copolymer, poly(glycolide-trimethylene carbonate) copolymer, poly(glycolide-ε

-caprolactone) copolymer, glycolide-trimethylene carbonate triblock copolymer, and mixtures.

28. The device of claim 27 wherein said protein-based outer coating contains materials for reducing friction.

29. A vaso-occlusive device comprising:

a) a vaso-occlusive member having a flexibility; and

b) an inner material on at least a portion of said vaso-occlusive member, said inner material being free from protein; and

c) a protein-based outer coating on said inner material in such amount and thickness that the flexibility of the vaso-occlusive device is not more than 35% stiffer than said vaso-occlusive member wherein said inner material is not applied by plasma treatment.

30. The device of claim 29 wherein the protein-based outer coating is collagen-based.

31. The device of claim 30 wherein the vaso-occlusive device is not more than 10% stiffer than said vaso-occlusive member.

32. The device of claim 29 wherein the vaso-occlusive member is a metallic element comprising an elongated helical coil.

33. The device of claim 32 wherein the coil is a cylindrical helical coil.

34. The device of claim 32 wherein the coil comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, titanium, nickle, and alloys thereof.

35. The device of claim 29 wherein said outer coating is photo-polymerizable.

36. The device of claim 29 further comprising fibrous material attached to the vaso-occlusive member that is also at least partially covered by said protein-based outer coating.

37. The device of claim 29 further comprising a bioactive material selected from the group consisting of genes, growth factors, biomolecules, peptides, oligonucleotides, members of the integrin family, RGD-containing sequences, oligopeptides, e.g., fibronectin, laminin, bitronectin, hyaluronic acid, silcolastin, fibrogenin, and other basement proteins with bioactive agents.

38. The device of claim 37 wherein said bioactive material is a coating.

39. The device of claim 37 wherein said bioactive material is intermixed with said protein-based coating.

40. The device of claim 36 wherein said fibrous material comprises one or more polymers.

41. The device of claim 40 wherein said one or more polymers is selected from the group consisting of polyglycolic acid, polylactic acid, reconstituted collagen, poly-p-dioxanone, and their copolymers such as poly(glycolide-lactide) copolymer, poly(glycolide-trimethylene carbonate) copolymer, poly(glycolide-ε

-caprolactone) copolymer, glycolide-trimethylene carbonate triblock copolymer, and mixtures.

42. A vaso-occlusive device comprising:

a) a vaso-occlusive member;

b) an inner coating on at least a portion of said vaso-occlusive member, said inner coating being free from protein; and

c) a bioactive-material-based outer coating on said inner coating wherein said inner coating is not applied by plasma treatment.

43. The device of claim 42 wherein the vaso-occlusive member is a metallic element comprising an elongated helical coil.

44. The device of claim 42 wherein the coil is a cylindrical helical coil.

45. The device of claim 44 wherein the coil comprises a metal selected from gold, rhenium, platinum, palladium, rhodium, ruthenium, stainless steel, tungsten, titanium, nickle, and alloys thereof.

46. The device of claim 42 wherein the inner coating is applied by a procedure selected from the group consisting of applying a silane coupling agent, applying a acrylate-based coupling agent, applying a low molecular weight adhesive agent, vapor deposition, and polymer coating from a dilute solution.

47. The device of claim 46 wherein the inner coating is paraxyxylene and deposited by vapor deposition.

48. The device of claim 42 wherein the bioactive material is selected from the group consisting of genes, growth factors, biomolecules, peptides, oligonucleotides, members of the integrin family, RGD-containing sequences, oligopeptides, e.g., fibronectin, laminin, vitronectin, hyaluronic acid, silk-elastin, elastin, infibrogen, and other basement membrane proteins with bioactive agents.