Method and device for inhibiting HIV, hepatitis B and other viruses and germs when using a catheter in a medical environment

• US 5,344,411 A
• Filed: 11/03/1993
• Issued: 09/06/1994
• Est. Priority Date: 02/27/1991
• Status: Expired due to Fees

• Current Assignee: Maryland Biopolymer Technologies, LLC
• Original Assignee: Leonard Bloom
• Inventors: Domb, Abraham J., Shikani, Alain H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/147,049
• Time in Patent Office: 307 Days
• Field of Search: 128/207.14, 128/207.15, 604/890.1, 604/891.1, 604/892.1, 604/96, 604/264, 604/265, 604/280, 623/1, 623/11, 623/12
• US Class Current: 604/265
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/106 Halogens or compounds thereof, e.g. iodine, chlorite
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/408 Virucides, spermicides
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters

Abstract

An anti-infective coating for a catheter or other medical device. The coating is insoluble in a biological medium and is bound to the surfaces of the catheter. The coating is a biocompatible, non-hydrogel polymer. One embodiment is a coating on the catheter which is complexed with an iodine solution to provide a programmed rapid release of iodine. A second embodiment is a solution of the biocompatible hydrogel polymer in which the iodine is dissolved and the solution containing iodine is coated in the catheter to provide a matrix having programmed sustained release of iodine. A coating with complexed iodine may be deposited over a coating with matrixed iodine to provide an anti-infective coating on a catheter with a rapid release and a sustained release of iodine over a period of weeks. A non-iodized polymer coating may be deposited on the complexed coating, the matrixed coating or the combined coating to provide protection to the sub coating and to further control the rate of release of iodine. The iodine containing coating provides a concentration of iodine that has sufficient activity and is available for a period of time which is long enough to allow the human immunodeficiency virus, bacteria, fungi and other germs to be inactivated. The coated device is stable and has long shelf life.

Claims

1. An anti-infective coating for a catheter having a surface, the catheter being disposed and maintained within a body of a patient having blood or other body fluids, the anti-infective coating being insoluble in a biological medium and being bound to the surface of the catheter during storage, use and initial disposal thereof, the anti-infective coating comprising a biocompatible, non-hydrogel polymer, said polymer being compatible with and being bound to the surface of the catheter, said polymer being soluble in an organic solvent, and iodine complexed with the coating for programmed rapid release of the iodine from the coating when the catheter is disposed and maintained in the body of the patient and contacts the blood or other body fluids and

further comprising a hydrophilic substance being added to the coating to increase the rate of release of the iodine from the coating,

wherein the hydrophilic substance is a polyethylene glycol.

2. An anti-infective coating for a catheter having a surface, the catheter being disposed and maintained within a body of a patient having blood or other body fluids, the anti-infective coating being insoluble in a biological medium and being bound to the surface of the catheter during storage, use and initial disposal thereof, the anti-infective coating comprising a biocompatible, non-hydrogel polymer, said polymer being compatible with and being bound to the surface of the catheter, said polymer being soluble in an organic solvent, and iodine complexed with the coating for programmed rapid release of the iodine from the coating when the catheter is disposed and maintained in the body of the patient and contacts the blood or other body fluids,

wherein the catheter is an implantable catheter.

3. The anti-infective coating of claim 2, wherein replication of human immunodeficiency virus is at least 98% inhibited in approximately 15 minutes by the coating.

4. The anti-infective coating of claim 2, wherein the polymer is selected from the group consisting of polyurethane and polyurea.

5. The anti-infective coating of claim 2, wherein the solvent is selected from the group consisting of alcohols, ketones, ethers, halogenated aliphatic hydrocarbons and aromatic hydrocarbons.

6. The anti-infective coating of claim 2, wherein the iodine loading is approximately 0.01% to 40% iodine.

7. The anti-infective coating of claim 2, wherein the coating has a thickness, the thickness being approximately 0.1 to 0.22 mm.