Coated combination vaso-occlusive device

• US 20030004568A1
• Filed: 05/06/2002
• Published: 01/02/2003
• Est. Priority Date: 05/04/2001
• Status: Abandoned Application

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Ken, Christopher G.M., Patel, Tina J.
• Application Number:
  US10/138,781
• Publication Number:
  US 20030004568A1
• Time in Patent Office: Days
• US Class Current: 623/1.46
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 24/04 containing macromolecular materials
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• 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

Abstract

Methods, compositions and apparatus are disclosed for treating abnormal conditions within a body. The apparatus includes vaso-occlusion devices each comprising a core formed of a metal, metal alloy, or non-metal material. Each core is coated with a polymer material that can include a bioactive agent. The methods include treating patients having abnormal blood flow at a site in their body by implanting such a coated vaso-occlusive device into the body at the site of the abnormal blood flow. The methods also include a method of making the vaso-occlusion devices. The composition includes a coating for the vaso-occlusive devices.

Claims

1. A vaso-occlusive device for implantation into the vasculature of a patient to occlude abnormal blood flow therein comprising:

a member formed of a biocompatible material and coated with a composition comprising a polymer and a bioactive agent capable of reactivity at the site of implantation, wherein said member assumes a first, pre-implantation shape prior to being placed within said patient and a second, vaso-occlusive shape upon implantation in the patient, said first shape being different from said second shape.

2. A vaso-occlusive device as in claim 1, wherein the biocompatible material comprises a metal or metal alloy selected from the group consisting of platinum, stainless steel, nickel-titanium alloy, tungsten, gold, rhenium, palladium, rhodium, ruthenium, titanium, nickel, and alloys thereof.

3. A vaso-occlusive device as in claim 1, wherein the biocompatible material comprises a non-metal and the non-metal material is covered by at least one polymer, at least one copolymer or two or more polymers in a blend.

4. A vaso-occlusive device as in claim 1, wherein the coating polymer is selected from the group consisting of polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene carbonate, Poly(β

-hydroxybutyrate), Poly(g-ethyl glutamate), Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate), Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene, Polyethyleneoxide (PEO), Polyethylglycol (PEG), Polyacrylacid (PAA), Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone (PVP), polyglycolic lactic acid (PGLA), copolymers thereof, and blends of polymers thereof.

5. A vaso-occlusive device as in claim 1, wherein the coating polymer is a natural polymer.

6. A vaso-occlusive device as in claim 5, wherein the natural polymer is selected from the group consisting of collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin pectin, elastin, keratin, copolymers thereof, and blends of polymers thereof.

7. A vaso-occlusive device as in claim 1, wherein the bioactive agent is selected from the group consisting of a protein factor, a growth factor, an inhibiting factor, an endothelization factor, an extracellular matrix-forming factor, a cell adhesion factor, a tissue adhesion factor, an immunological factor, a healing factor, a vascular endothelial growth factor, a scarring factor, a tumor suppressor, an antigen-binding factor, an anti-cancer factor, a monoclonal antibody, a monoclonal antibody against a growth factor, a drug, a drug producing cell, a cell regeneration factor, a progenitor cell of the same type as vascular tissue, and an a progenitor cell that is histiologically different from vascular tissue.

8. A vaso-occlusive device as in claim 7, wherein the bioactive agent is a tissue adhesion factor, and the tissue adhesion factor is selected from the group consisting of fibrin, collagen, albumin, cyanoacrylate, fibrinogen, chitosan, and gelatin-genipin.

9. A vaso-occlusive device as in claim 1, wherein the bioactive agent is integrated into the coating polymer.

10. A vaso-occlusive device as in claim 1, wherein the coating polymer is coated onto the metal or non-metal and the bioactive agent is coated onto the polymer coating.

14. A method of making a vaso-occlusive device as in claim 10, wherein the coating polymer is selected from the group consisting of polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNiPAM), poly (vinylmethylether), poly (ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene carbonate, Poly(β

-hydroxybutyrate), Poly(gethyl glutamate), Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate), Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene, Polyethyleneoxide (PEO), Polyethylglycol (PEG), Polyacrylacid (PAA), Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone (PVP), polyglycolic lactic acid (PGLA), copolymers thereof, and blends of polymers thereof.

11. A method of making a vaso-occlusive device comprising:

coating a member formed of a biocompatible material with a composition comprising a polymer and a bioactive agent, said member being formed of a material that assumes a pre-implantation shape prior to being introduced into a body and a vaso-occlusive shape when implanted with the body.

12. A method of making a vaso-occlusive device as in claim 11, wherein the coating step comprises spraying, dipping, jacketing, weaving, braiding, spinning, ion implantation, plasma deposition, and vapor deposition.

13. A method of making a vaso-occlusive device as in claim 11, wherein the biocompatible material comprises a metal or metal alloy material selected from the group consisting of platinum, stainless steel, nickel-titanium alloy, tungsten, gold, rhenium, palladium, rhodium, ruthenium, titanium, nickel, and alloys thereof.

15. A method of making a vaso-occlusive device as in claim 11, wherein the polymer is a natural polymer.

16. A method of making a vaso-occlusive device as in claim 15, wherein the natural polymer is selected from the group consisting of collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin pectin, elastin, keratin, copolymers thereof, and blends of polymers thereof.

17. A method of making a vaso-occlusive device as in claim 11, wherein the bioactive agent is selected from the group consisting of a protein factor, a growth factor, an inhibiting factor, an endothelization factor, an extracellular matrix-forming factor, a cell adhesion factor, a tissue adhesion factor, an immunological factor, a healing factor, a vascular endothelial growth factor, a scarring factor, a tumor suppressor, an antigen-binding factor, an anti-cancer factor, a monoclonal antibody, a monoclonal antibody against a growth factor, a drug, a drug producing cell, a cell regeneration factor, a progenitor cell of the same type as vascular tissue, and an a progenitor cell that is histiologically different from vascular tissue.

18. A method of making a vaso-occlusive device as in claim 17, wherein the bioactive agent is a tissue adhesion factor, and the tissue adhesion factor is selected from the group consisting of fibrin, collagen, albumin, cyanoacrylate, fibrinogen, chitosan, and gelatin-genipin.

19. A method of making a vaso-occlusive device as in claim 11, wherein coating comprises first coating the biocompatible material with the coating polymer, and then coating or integrating a bioactive agent onto or into the coating polymer.

20. A method as in claim 11, wherein the coating is accomplished during a process of implantation of the device in the body.

21. A method of treating a patient having abnormal blood flow at a site, comprising:

providing a vaso-occlusive device comprising a biocompatible material coated with a composition comprising a polymer and a bioactive agent, said vaso-occliusive device having a pre-implantation shape;

implanting said vaso-occlus ive device at the site;

changing the shape of said vaso-occlusive device from said pre-implantation shape to a vaso-occlusive shape; and

allowing the bioactive agent to react at said site.

22. A method of treating a patient as in claim 21, wherein the biocompatible material comprises a metal or metal alloy material selected from the group consisting of platinum, stainless steel, nickel-titanium alloy, tungsten, gold, rhenium, palladium, rhodium, ruthenium, titanium, nickel and alloys thereof.

23. A method of treating a patient as in claim 21, wherein the biocompatible material comprises a non-metal and the non-metal material is a polymer or two or more polymers in a blend or copolymer.

24. A method of treating a patient as in claim 21, wherein the coating polymer is selected from the group consisting of polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene carbonate, Poly(β

-hydroxybutyrate), Poly(g-ethyl glutamate), Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate), Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene, Polyethyleneoxide (PEO), Polyethylglycol (PEG), Polyacrylacid (PAA), Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone (PVP), polyglycolic lactic acid (PGLA), copolymers thereof, and blends of polymers thereof.

25. A method of treating a patient as in claim 21, wherein the polymer is a natural polymer.

26. A method of treating a patient as in claim 25, wherein the natural polymer is selected from the group consisting of collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin pectin, elastin, keratin, copolymers thereof, and blends of polymers thereof.

27. A method of treating a patient as in claim 21, wherein the bioactive agent is selected from the group consisting of a protein factor, a growth factor, an inhibiting factor, an endothelization factor, an extracellular matrix-forming factor, a cell adhesion factor, a tissue adhesion factor, an irmmunological factor, a healing factor, a vascular endothelial growth factor, a scarring factor, a tumor suppressor, an antigen-binding factor, an anti-cancer factor, a monoclonal antibody, a monoclonal antibody against a growth factor, a drug, a drug producing cell, a cell regeneration factor, a progenitor cell of the same type as vascular tissue, and an a progenitor cell that is histiologically different from vascular tissue.

28. A method of treating a patient as in claim 27, wherein the bioactive agent is a tissue adhesion factor, and the tissue adhesion factor is selected from the group consisting of fibrin, collagen, albumin, cyanoacrylate, fibrinogen, chitosan, and gelatin-genipin.

29. A method of treating a patient as in claim 21, wherein the bioactive agent is int egrated into the coating polymer.

30. A method of treating a patient as in claim 21, wherein the coating polymer is coated onto the biocompatible material and the bioactive agent is coated onto or integrated into the polymer coating.

31. A composition comprising a degradable or carrier polymer capable of being coated on a metal, metal alloy, or non-metal material and a bioactive agent integral to said degradable or carrier polymer for release at a site of implantation.

32. A composition as in claim 31, wherein the degradable or carrier polymer is selected from the group consisting of consisting of polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene carbonate, Poly(β

-hydroxybutyrate), Poly(gethyl glutamate), Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate), Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene, Polyethyleneoxide (PEO), Polyethylglycol (PEG), Polyacrylacid (PAA), Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone (PVP), polyglycolic lactic acid (PGLA), copolymers thereof, and blends of polymers thereof.

33. A composition as in claim 31, wherein the degradable or carrier polymer is a natural polymer and the natural polymer is selected from the group consisting of collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin pectin, elastin, keratin, copolymers thereof, and blends of polymers thereof.

34. A composition as in claim 31, wherein the bioactive agent is selected from the group consisting of a protein factor, a growth factor, an inhibiting factor, an endothelization factor, an extracellular matrix-forming factor, a cell adhesion factor, a tissue adhesion factor, an immunological factor, a healing factor, a vascular endothelial growth factor, a scarring factor, a tumor suppressor, an antigen-binding factor, an anti-cancer factor, a monoclonal antibody, a monoclonal antibody against a growth factor, a drug, a drug producing cell, a cell regeneration factor, a progenitor cell of the same type as vascular tissue, and an a progenitor cell that is histiologically different from vascular tissue.