Medical devices, drug coatings and methods for maintaining the drug coatings thereon

• US 7,056,550 B2
• Filed: 08/07/2003
• Issued: 06/06/2006
• Est. Priority Date: 09/29/2000
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Narayanan, Pallassana V., Lentz, David Christian, Wilson, David J., Llanos, Gerard H., Roller, Mark B., Silver, James H., Trepanier, Christine, Scopelianos, Angelo George, Spaltro, John, Davila, Luis A., Shaw, William Douglas Jr., Scheidt, Karl K., Pelton, Alan Roy, Mendez, Jorge Orlando
• Primary Examiner(s): Cameron, Erma
• Application Number:
  US10/636,435
• Publication Number:
  US 20040102758A1
• Time in Patent Office: 1,034 Days
• Field of Search: None
• US Class Current: 427/2.24
• 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 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• 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 2300/416 : Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/608 : having two or more layers
• CPC Class Codes: A61L 2420/02 : Methods for coating medical devices
• 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 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: B05D 1/18 : performed by dipping
• CPC Class Codes: B05D 3/0254 : After-treatment
• CPC Class Codes: B05D 3/0493 : using vacuum
• 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: C08L 27/20 : Homopolymers or copolymers of hexafluoropropene

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. A method of coating a medical device with a therapeutic agent comprising the steps of:

creating a polymer utilizing vinylidene fluoride and hexafluoropropylene in a batch emulsion polymerization process;

priming the medical device with the polymer utilizing a dip coating process;

creating a polymer and therapeutic agent mixture;

applying the polymer and therapeutic agent mixture on a primer layer utilizing a spin coating process; and

drying the medical device in a vacuum oven for approximately sixteen hours at a temperature in the range of fifty to sixty degrees centigrade.

2. A method of coating a medical device with a therapeutic agent comprising the steps of:

creating a polymer utilizing vinylidene fluoride and hexafluoropropylene in a batch dispersion polymerization process;

priming the medical device with the polymer utilizing a dip coating process;

creating a polymer and therapeutic agent mixture;

applying the polymer and therapeutic agent mixture on a primer layer utilizing a spin coating process; and

drying the medical device in a vacuum oven for approximately sixteen hours at a temperature in the range of fifty to sixty degrees centigrade.