Antimicrobial fitting for medical catheters and method for their application

• US 5,049,140 A
• Filed: 01/22/1990
• Issued: 09/17/1991
• Est. Priority Date: 05/22/1989
• Status: Expired due to Fees

• Current Assignee: Firma Carl Freudenberg
• Original Assignee: Firma Carl Freudenberg
• Inventors: Brenner, Otto, Josefiak, Christoph, Schuhmacher, Gunter
• Primary Examiner(s): Bahr, Robert
• Assistant Examiner(s): Reichard, Lynne A.
• Application Number:
  US07/467,951
• Time in Patent Office: 603 Days
• Field of Search: 604/264, 604/265, 604/266, 604/267, 604/280, 604/282, 604/283
• US Class Current: 604/266
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 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: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A tube or ring-shaped, elastic cuff is used as a antimicrobial fitting for medical catheters. The fitting is manufactured from organic silicon/polyurethane elastomer including an antimicrobial agent. The fitting is annularly disposed on a catheter and held in place by radial tension. The fitting has very high tensile strength and resistance to tearing and preferably has a wall thickness of about 0.1 mm; may be cut into segments of 2 to 10 cm long; and can be drawn onto a catheter as individual segments.

Claims

1. An antimicrobial fitting for a catheter, comprising:

a tubular member having a Shore A hardness between about 80 and 95 fabricated from a silcone/polyurethane elastomer comprised of less than about 50% wt. organic silicone polymer having a molecular weight of about 500 to 10,000, and about 1 to 15% wt. of an antimicrobial agent uniformly dispersed in said elastomer and wherein the tubular member has a tensible strength of about 20 MPa, a breaking elongation of about 500% and a surface roughness less than about 6 micrometers.

2. The fitting of claim 1, wherein:

the antimicrobial agent is selected from the group consisting of metals, metal salts, oxides, carbides and sulphates and organometalic compounds, that release metal ions from the silicone/polyurethane elastomer in antimicrobially effective amounts.

3. The fitting of claim 1, wherein:

the fitting is for a uretheral catheter and the tubular member has a wall thickness of about 0.1 micrometer, and interior diameter of about 1.5 to 7.5 mm.

4. The fitting of claim 3, wherein:

the antimicrobial agent is silver sulfate.

5. The fitting of claim 1, wherein:

said tubular member comprises a plurality of segments.

6. The fitting of claim 3, wherein:

said tubular member comprises a plurality of segments of about 2 to 10 cm in length.

7. A method for making a catheter having antimicrobial properties, comprising the steps of:

preparing a fitting comprising a tubular member fabricated with an organic silicone/polyurethane elastomer including less than about 50% wt organic silicone polymer having a molecular weight of about 500 to 10,000 and having an antimicrobial agent uniformly dispersed therein;

sizing said tubular member so that it has an inside diameter that is about equal to or less than the catheter'"'"'s outside diameter;

cutting said tubular member into segments; and

drawing a plurality of said segments onto a portion of the catheter which will be inserted into a body cavity.

8. The method of claim 7 wherein the inside diameter of said tubular member and the outside diameter of said catheter are in a ratio of about 1 :

1.2 to 1 ;

1.8;

said segments are about 5 cm long and are spaced abut 1 to 3 cm apart on said catheter.

9. The method of claim 8 wherein the segments cover at least about 50% of an exposed surface of the catheter portion.