Anti-infective and anti-inflammatory releasing systems for medical devices

• US 5,512,055 A
• Filed: 09/30/1994
• Issued: 04/30/1996
• Est. Priority Date: 02/27/1991
• Status: Expired due to Term

• Current Assignee: Maryland Biopolymer Technologies, LLC
• Original Assignee: Leonard Bloom
• Inventors: Shikani, Alain, Maniar, Manoj, Domb, Abraham J., Haffer, Andrew S. T.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/316,067
• Time in Patent Office: 578 Days
• Field of Search: 128/207.14, 128/207.15, 604/890.1, 604/891.1, 604/892.1, 604/264, 604/280, 604/265, 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 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/408 Virucides, spermicides
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• 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 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

Devices are provided having a polymer coating incorporating compounds inhibiting inflammation and infection, along with subsequent tissue growth onto and around the device. Preferred embodiments include catheters, tubes, and implants that abut tissue following implantation into the body, especially for use in the naso-oto-pharyngeal areas of the body, where localized chronic infection/inflammation of the tissues surrounding the implant may be decreased by sustained release of antibiotics, antifungals, antivirals, anti-inflammatories, and other compounds, such as anticoagulants and anesthetics. Preferred polymeric coatings are thin, well adhered to the underlying device, and formed of a biocompatible, non-bioerodible polymer such as polyurethane or ethylene vinyl acetate. The drug is incorporated either by solvent casting or by absorption into the solidified polymer. The drug incorporated polymer can also be used to form devices, or portions of devices, for implantation.

Claims

1. A medical device for implantation into tissue comprising, in combination, the device having exterior surfaces, a biocompatible, nonbioerodible polymer dissolved in a solvent to form a solution, the solution being disposed on the exterior surface of the device and the solvent removed to form a uniform coating on the medical device, the polymer coating having a biologically active agent sorbed therein to be released over a period of at least twenty-four hours by diffusion when implanted in the tissue, wherein said biologically active agent is iodine.

2. The medical device of claim 1, wherein the polymer is selected from the group consisting of polyurethane, ethylene vinyl acetate, silicones, hydrogels, and polyvinyl chloride.

3. The medical device of claim 1, further comprising a second polymer coating disposed on the polymer coating having the biologically-active agent sorbed therein, the biologically active agent being absent in the second polymer coating, whereby release of the biologically-active agent by diffusion is further controlled.

4. The medical device of claim 1, wherein the biologically active agent is dissolved in a second solvent to form a second solution, and the polymer coated medical device being immersed in the second solution permitting the biologically active agent to be sorbed in the coating, thereby providing a controlled rapid release of the biologically active agent over a period of at least twenty-four hours.

5. The medical device of claim 1, wherein the solvent is selected from the group consisting of dichloromethane, tetrahydrofuran, methylene chloride and methyl chloroform.

6. A medical device for implantation into tissue comprising, in combination, the device having exterior surfaces, a biocompatible, nonbioerodible polymer dissolved in a solvent to form a solution, a biologically active agent dissolved in said solution, the solution being disposed on the exterior surface of the device, and the solvent removed to form a uniform coating on the medical device such that polymer coating having the biologically active agent solvent casted therein is released by diffusion over a period of at least two days when implanted in the tissue, wherein said biologically active agent is iodine.

7. The medical device of claim 6, wherein the polymer is selected from the group consisting of polyurethane, ethylene vinyl acetate, silicones, hydrogels, and polyvinyl chloride.

8. The medical device of claim 6, further comprising a second polymer coating disposed on the polymer coating having the biologically-active agent solvent casted therein the biologically active agent being absent in the second polymer coating, whereby release of the biologically-active agent by diffusion is further controlled.

9. A medical device for implantation into tissue comprising, in combination, the device having exterior surfaces, a biocompatible, nonbioerodible polymer, being dissolved in a solvent to form a solution, the solution further having a biologically active agent dissolved therein, the solution being disposed on the device, the solvent being removed and forming a single uniform coating on the device wherein the biologically active agent is released by diffusion when the coated device is in contact with the tissue, said release being controlled over a period of at least twenty-four hours and wherein said biologically active agent is iodine.