Coatings for medical devices

• US 6,746,773 B2
• Filed: 09/25/2001
• Issued: 06/08/2004
• Est. Priority Date: 09/29/2000
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson), Wyeth (Pfizer Inc.)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Roller, Mark B., Scopelianos, Angelo, Llanos, Gerard H., Narayanan, Pallassana
• Primary Examiner(s): ZACHARIA, RAMSEY E
• Application Number:
  US09/962,292
• Publication Number:
  US 20020094440A1
• Time in Patent Office: 987 Days
• Field of Search: 604/891.1, 604/890.1, 604/265, 623/1.42, 623/1.44, 623/1.43, 623/1.49, 523/105, 523/112, 523/113, 525/937, 524/546, 428/421, 428/422
• US Class Current: 428/421
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/54 Chiropodists' instruments , e.g. pedicure chiropractic devices A61H1/008
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 17/145 : Coating
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: C08L 27/12 : containing fluorine atoms
• CPC Class Codes: C08L 27/14 : Homopolymers or copolymers of vinyl fluoride
• CPC Class Codes: C08L 27/16 : Homopolymers or copolymers or vinylidene fluoride
• CPC Class Codes: Y10T 428/3154 : Of fluorinated addition polymer from unsaturated monomers

Abstract

The present invention includes biocompatible coatings and films for use on implantable medical devices and medical devices containing such coatings and films applied to a surface thereof, which coatings/films are present on the device in an amount effective to provide an inert surface to be in contact with body tissue of a mammal upon implantation of the device in the mammal, and contain a film-forming polyfluoro copolymer containing the polymerized residue of a moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene copolymerized with a second moiety other than the first moiety, wherein the relative amounts of the polymerized residue of the first and second moieties are effective to provide the coating and films with properties effective for use in coating implantable med devices.

Claims

1. An implantable medical device:

comprising,

a biocompatible film effective to provide an inert surface to be in contact with body tissue of a mammal upon implantation of said device in said mammal, said film comprising a polyfluoro copolymer comprising from about 50 to about 92 weight percent of polymerized residue of vinylidenefluoride and about 50 to about 8 weight percent of polymerized residue of hexafluoropropylene.

2. The device of claim 1, wherein said polyfluoro copolymer comprises from about 50 to about 85 weight percent of said polymerized residue of said vinylidenefluoride copolymerized with from about 50 to about 15 weight percent of said polymerized residue of said hexafluoropropylene.

3. The device of claim 1, wherein said copolymer comprises from about 55 to about 65 weight percent of said polymerized residue of said vinylidenefluoride copolymerized with from about 45 to about 35 weight percent of said polymerized residue of said hexafluoropropylene.

4. The implantable medical device of claim 1, wherein said film further comprises effective amounts of a therapeutic and/or pharmaceutical agent.

5. The implantable device of claim 1 wherein said polyfluoro copolymer is effective to provide said film with properties effective for use in coating said implantable medical device when said coated device is subjected to a maximum temperature of less than 100°

C.