Drug coating with topcoat

• US 20050187611A1
• Filed: 04/27/2005
• Published: 08/25/2005
• Est. Priority Date: 04/19/1995
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Helmus, Michael N., Ding, Ni
• Application Number:
  US11/116,256
• Publication Number:
  US 20050187611A1
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/141 Plasticizers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 71/02 : Polyalkylene oxides
• CPC Class Codes: C08L 83/00 : Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen or carbon only; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 83/04 : Polysiloxanes
• CPC Class Codes: C08L 83/08 : containing silicon bound to organic groups containing atoms other than carbon, hydrogen and oxygen

Abstract

A coating and method for a coating an implantable device or prostheses are disclosed. The coating includes an undercoat of polymeric material containing an amount of biologically active material, particularly heparin, dispersed herein. The coating further includes a topcoat which covers less than the entire surface of the undercoat and wherein the topcoat comprises a polymeric material substantially free of pores and porosigens. The polymeric material of the topcoat can be a biostable, biocompatible material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material.

Claims

1-50. -50. (canceled)

51. A medical device comprising:

a metallic intravascular stent comprising an open lattice sidewall structure and designed for permanent implantation into a blood vessel of a patient;

a first quantity of a first polymer composition applied to at least a portion of said stent and conforming to said open lattice sidewall structure so as to preserve the open lattice sidewall structure of said stent, wherein said first polymer composition comprises a first biostable polymer and a biologically active material; and

a second quantity of a second polymer composition applied to at least a portion of said first quantity and conforming to said stent so as to preserve the open lattice sidewall structure of said stent, wherein said second polymer composition comprises a second biostable polymer that is different from said first biostable polymer, and wherein said second polymer composition is non-thrombogenic and substantially free of the biologically active material or other elutable material,

wherein when in use, the biologically active material is released from the stent to the blood vessel at a first rate that is different from a second rate, wherein the second rate is the rate of release of the same biologically active material from the stent had the second quantity of the second polymer composition not been applied to the first quantity of the first polymer composition.

52. The medical device of claim 51, wherein the metallic intravascular stent is a stainless steel intravascular stent.

53. The medical device of claim 51, wherein the first quantity of first polymer composition is different from the second quantity of second polymer composition.

54. The medical device of claim 51, wherein the first biostable polymer comprises a hydrophobic elastomeric material, an ethylene vinyl acetate copolymer material, or a mixture thereof.

55. The medical device of claim 51, wherein the biologically active material is an antithrobotic agent, anticoagulant, antibiotic, antiplatelet agent, thrombolytic agent, antiproliferative agent, steroidal antiinflammatory agent, nonsteroidal antiinflammatory agent, agent that inhibits hyperplasia, smooth muscle cell inhibitor, growth factor, growth factor inhibitor, cell adhesion inhibitor, cell adhesion promoter, drug that enhances the formation of healthy neointimal tissue, or a mixture thereof.

56. The medical device of claim 51, wherein the biologically active material is an antibiotic.

57. The medical device of claim 51, wherein the biologically active material inhibits smooth muscle cell.

58. The medical device of claim 51, wherein the biologically active material inhibits restenosis.

59. The medical device of claim 51, wherein the second biostable polymer remains non-thrombogenic during and after release of the biologically active material.

60. The medical device of claim 51, wherein the stent releases the biologically active material over a period of time.

61. A method of treating restenosis comprising implanting the medical device of claim 51 into the blood vessel of the patient.

62. A medical device comprising:

a metallic intravascular stent comprising an open lattice sidewall structure and designed for permanent implantation into a blood vessel of a patient;

a first quantity of a first polymer composition applied to at least a portion of said stent and conforming to said open lattice sidewall structure so as to preserve the open lattice sidewall structure of said stent, wherein said first polymer composition comprises an ethylene vinyl acetate copolymer material and an antibiotic; and

a second quantity of a second polymer composition applied to at least a portion of said first quantity and conforming to said stent so as to preserve the open lattice sidewall structure of said stent, wherein said second polymer composition comprises a second biostable polymer that is different from the ethylene vinyl acetate copolymer material of said first polymer composition, and wherein said second polymer composition is non-thrombogenic and substantially free of the antibiotic of the first polymer composition or other elutable material,

wherein when in use, the antibiotic is released from the stent to the blood vessel at a first rate that is different from a second rate, wherein the second rate is the rate of release of the same antibiotic from the stent had the second quantity of the second polymer composition not been applied to the first quantity of the first polymer composition.

63. The medical device of claim 62, wherein the metallic intravascular stent is a stainless steel intravascular stent.

64. The medical device of claim 62, wherein the first quantity of first polymer composition is different from the second quantity of second polymer composition.

65. The medical device of claim 62, wherein the antibiotic inhibits smooth muscle cell.

66. The medical device of claim 62, wherein the antibiotic inhibits restenosis.

67. The medical device of claim 62, wherein the second biostable polymer remains non-thrombogenic during and after release of the antibiotic.

68. The medical device of claim 62, wherein the stent releases the antibiotic over a period of time.

69. A method of treating restenosis comprising implanting the medical device of claim 62 into the blood vessel of the patient.