Infection resistant medical devices and process

• US 5,492,763 A
• Filed: 02/10/1994
• Issued: 02/20/1996
• Est. Priority Date: 06/08/1992
• Status: Expired due to Term

• Current Assignee: Spire Corporation
• Original Assignee: Spire Corporation
• Inventors: Barry, John E., Sioshansi, Piran
• Primary Examiner(s): Ryan, Pastrick J.
• Assistant Examiner(s): Jewik, Patrick
• Application Number:
  US08/194,788
• Time in Patent Office: 740 Days
• Field of Search: 428/209, 428/461, 428/465, 428/435, 428/457, 428/458, 428/459, 428/460, 428/434, 428/35.7, 428/35.8, 428/35.1, 428/34.7, 604/264, 604/265, 604/268, 604/280, 604/905
• US Class Current: 428/457
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• 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: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable
• CPC Class Codes: Y10T 428/1321 Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/1331 Single layer [continuous layer]
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/1355 Elemental metal containing [e.g., substrate, foil, film, coating, etc.]
• CPC Class Codes: Y10T 428/31678 Of metal

Abstract

A medical device provided with a subsurface bacteriostatic/bactericidal stratum to a predetermined depth is disclosed. The bacteriostatic/bactericidal stratum is introduced into the medical device by ion implantation of sufficient concentration to impart thereto the desired bacteriostatic/bactericidal property. The acquired bacteriostatic/bactericidal property has a useful life coterminal with the device. The treated medical device remains biocompatible, is non-leaching and, depending on the specific device, also is thromboresistant.

Claims

1. A biomedical implant for insertion within a subject, comprising an implantable biocompatible structure formed from a unitary polymeric material having a tissue-engaging outer surface, the tissue-engaging outer surface having embedded therein atoms of a bactericidal material to form a substantially nonleaching bactericidal subsurface stratum, the atoms extending only partially through the implantable biocompatible structure to a predetermined depth from the tissue engaging outer surface.

2. The biomedical implant of claim 1 wherein the atoms of the bactericidal material extend below the tissue-engaging outer surface to a depth less than about 2.0 microns.

3. The biomedical implant of claim 1 wherein the atoms of the bactericidal material are embedded within the tissue-engaging outer surface by implantation of ions with a current density of at least about 0.01 μ

A/cm².

4. The biomedical implant of claim 1 wherein the atoms of the bactericidal material comprise metal atoms.

5. The biomedical implant of claim 1 wherein the atoms of the bactericidal material comprise at least one of silver, gold, copper, platinum, iridium, magnesium, and palladium atoms.

6. A biomedical implant for insertion within a subject, comprising an implantable member formed from a unitary polymeric .material having a tissue-engaging outer surface having embedded therein atoms of a bactericidal material, the atoms being embedded by ion implantation, and being secured within the member and extending into the tissue-engaging outer surface to a depth between about 0.01 microns and about 2.0 microns, whereby the atoms of the bactericidal material remain effective for the useful life of the implantable member.

7. The biomedical implant of claim 6 wherein the atoms of the bactericidal material have a concentration of at least 10¹⁵ ions/cm³.

8. The biomedical implant of claim 6 wherein the atoms of the bactericidal material comprise metal atoms.

9. The biomedical implant of claim 6 wherein the atoms of the bactericidal material comprise at least one of silver, gold, copper, platinum, iridium, magnesium and palladium atoms.