Coated implantable medical device

• US 20040243225A1
• Filed: 06/17/2004
• Published: 12/02/2004
• Est. Priority Date: 06/07/1995
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Anthony H. Gershlick, Anthony O. Ragheb, Brian L. Bates, Neal E. Fearnot, Thomas G. Kosma, William D. Voorhees III
• Inventors: Kosma, Thomas G., Bates, Brian L., Fearnot, Neal E., Ragheb, Anthony O., Voorhees, William D. III, Gershlick, Anthony H.
• Granted Patent: US 7,410,665 B2
• Time in Patent Office: Days
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• 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 2300/602 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 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 : Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• 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: A61L 33/022 : Metal or alloys
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: C08L 65/04 : Polyxylenes

Abstract

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer is includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Claims

1-20. -20. (cancelled).

21. A method of producing a coated medical device, comprising the steps of:

selecting a structure having at least an outwardly facing surface;

selecting a bioactive material containing a peptide; and

positing a layer of the bioactive material containing a peptide onto the outwardly facing surface of the structure.

22. The method as set forth in claim 21, wherein the medical device is a stent.

23. The method as set forth in claim 21, wherein the bioactive material containing a peptide is a protein.

24. The method as set forth in claim 23, wherein the protein is antiplatelet GP IIb/IIIa antibody.

25. The method as set forth in claim 24, wherein the antiplatelet GP IIb/IIIa antibody is a chimeric monoclonal antibody.

26. The method as set forth in claim 25, wherein the antiplatelet GP IIb/IIIa antibody is c7E3 Fab antibody.

27. The method as set forth in claim 21, wherein the step of positing the layer of the bioactive material containing a peptide comprises passive deposition.

28. The method as set forth in claim 27, wherein the step of passive deposition comprises soaking the structure in a solution of the bioactive material containing a peptide.

29. The method as set forth in claim 27, further comprising the step of positing a layer of porous material over the layer of bioactive material containing a peptide, wherein the at least one layer of porous material includes an adsorbent or absorbent polymer and the polymer provides for a controlled release of the bioactive material containing a peptide therethrough.

30. The method as set forth in claim 21, further comprising the step of positing a layer of coating material upon the outwardly facing surface of the structure prior to positing the layer of bioactive material containing a peptide.

31. The method as set forth in claim 30, further comprising the step of applying to the outwardly facing surface of the medical device, an adhesion promotion layer prior to the step of positing the layer of coating material thereon to.

32. The method as set forth in claim 31, wherein the adhesion promotion layer is a thin layer of silane having a thickness in the range of 0.5 to 5,000 Angstoms.

33. The method as set forth in claim 32, wherein the silane is A-174 silane including a gamma-methacryloxypropyltrimethoxysilane.

34. The method as set forth in claim 31, wherein the outwardly facing surface of the structure is first cleaned.

35. The method as set forth in claim 30, wherein the step of positing the layer of bioactive material containing a peptide comprises placing the polymer coated structure into a buffered aqueous solution of antiplatelet GP IIb/IIIa antibody.

36. The method as set forth in claim 35, wherein the polymer is parylene.

37. The method as set forth in claim 35, further comprising the step of positing a layer of additional coating material over the layer of the bioactive material containing a peptide.

38. The method as set forth in claim 37, wherein the layer of additional coating material is cellulose.

39. A method of producing a coated medical device, comprising the steps of:

selecting a structure having a nonpolymeric base material and having at least an outwardly facing uncoated surface;

selecting a bioactive material containing a peptide; and

passively depositing a layer of the bioactive material directly onto the base material of the structure along the outwardly facing uncoated surface thereof.

40. The method as set forth in claim 39, wherein the step of passive deposition comprises soaking the structure in a solution of the bioactive material containing a peptide.