Method of forming a membrane especially a latex or polymer membrane including multiple discrete layers

• US 5,965,276 A
• Filed: 08/13/1997
• Issued: 10/12/1999
• Est. Priority Date: 07/17/1987
• Status: Expired due to Fees

• Current Assignee: Alec Beck
• Original Assignee: Biomerieux B.V. (Compagnie Merieux Alliance SAS)
• Inventors: Plamthottam, Sebastian S., Solomons, Clive C., Lester, David J., Shlenker, Robin Renee Thill
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/917,050
• Time in Patent Office: 790 Days
• Field of Search: 2/168, 2/161.7, 128/844, 128/837, 424/404, 424/411, 424/424, 424/432, 424/485, 427/2.3, 427/407.1, 215/11.1, 428/36.8, 428/36.91, 428/320.2, 428/321.1, 428/492, 604/264, 604/265, 604/289, 604/292, 604/304, 604/327, 604/338, 604/349
• US Class Current: 428/492
• CPC Class Codes: A01N 25/10 Macromolecular compounds
• CPC Class Codes: A01N 25/34 Shaped forms, e.g. sheets, not provided for in any other sub-group of this main group
• CPC Class Codes: A41D 19/0058 Three-dimensional gloves
• CPC Class Codes: A41D 19/0096 Means for resisting mechanical agressions, e.g. cutting or piercing
• CPC Class Codes: A41D 31/245 using layered materials
• CPC Class Codes: A61B 42/00 Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
• CPC Class Codes: A61B 42/10 Surgical gloves
• CPC Class Codes: A61F 6/04 Condoms, sheaths or the like , e.g. combined with devices protecting against contagion
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/442 Colorants, dyes
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A62D 5/00 Composition of materials for coverings or clothing affording protection against harmful chemical agents
• CPC Class Codes: B32B 27/18 characterised by the use of special additives
• CPC Class Codes: Y10T 428/1386 Natural or synthetic rubber or rubber-like compound containing
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/249994 Composite having a component wherein a constituent is liquid or is contained within preformed walls [e.g., impregnant-filled, previously void containing component, etc.]
• CPC Class Codes: Y10T 428/249995 Constituent is in liquid form
• CPC Class Codes: Y10T 428/31826 Of natural rubber

Abstract

Single and multiple layer membranes such as gloves and condoms include one or more deactivating barrier layers and/or indicating layers to indicate to a user membrane breach or the presence of a harmful substance in blood or body fluids. A membrane may include one or more permeable or semipermeable layers to disperse contained substances such as lubricants, biocides, spermicides, or indicators outwardly, and may also include permeable or semipermeable layers to allow transmission of body fluids or other environmental fluids inwardly into contact with an indicating or treating substance. An intermediate layer of a multi-layer membrane may include a substance to wipe, cleanse, sterilize, or otherwise treat a piercing needle. A membrane may include a sealing or coating to entrap indicators or other agents such as biocides therein. A method of making membranes such as gloves results in a double glove having discrete inner or outer layers joined only in a cuff region. Admixing of gentian violet with latex prior to membrane formation provides biocidal properties, anti-aging effects prolonging shelf-life and tear resistance, and reduces allergic reactions in latex-allergic users.

Claims

1. A latex article having a biocide barrier comprising:

a first layer consisting essentially of cured liquid latex and substantially free of biocide;

a second layer consisting essentially of a biocide effective as a coagulant for liquid latex, said second layer coating said first layer;

a third layer consisting essentially of a cured liquid latex and substantially free of biocide, said third layer coating said second layer wherein said second layer is at least partially bonded to said first layer and said third layer.

2. The latex article according to claim 1, wherein:

said third layer is thicker than said first layer.

3. The latex article according to claim 1, wherein:

said biocide of said second layer has a concentration of 0.10 to 5 percent by weight.

4. The latex article according to claim 1, wherein:

said biocide is selected form chlorhexidine, dextran sulfate, triclosan, benzalkonium, betadyne, gentian violet, acriflavine and acridine dyes, mercurochrome, silver salts, and an extract of blue-green algae.

5. The latex article according to claim 1, wherein:

said second layer has a weight ratio to said first layer of 0.05 to 0.3.

6. The latex article according to claim 1, wherein:

said second layer has a weight ratio to said third layer of 0.05 to 0.3.

7. The latex article according to claim 1, wherein:

said latex article is selected from the group of gloves, condoms, diaphragms, slippers, overshoes, sterile bands, catheters, tubings, drapes, gut openings, mouthpieces, nipples, intra gastric nasal tubes, kidney shunts, dams for teeth, braces for teeth, sub-clavian vein and artery shunts, and colostomy bags.

8. The latex article according to claim 1, wherein said first and third layers are discrete.

9. The latex article according to claim 1, wherein said article comprises a glove.

10. The latex article according to claim 1, wherein said article comprises a condom.

11. The latex article according to claim 1, further comprising a substance selected from the group consisting of sealants, biocides, indicators, spermicides, antiseptics, gels, hydrogels, pituitous substances, cleansing agents, surfactants, detergents, abrasives, coating agents, wiping agents, fibers, tactile enhancing objects, needle treating materials, tactile enhancing liquids, tactile enhancing gels, lubricants, and sheet forming agents, substantially contained between said first and third layers.

12. The article according to claim 1, further comprising an indicator operably associated with said article for providing to a user an indication of the presence of a pathogen.

13. The article according to claim 1, further comprising an indicator operably associated with said article for providing to a user an indication of membrane breach.

14. The article according to claim 1, further comprising a substance disposed and substantially contained between said first and third layers, said substance effective to contact and at least partially treat a needle or other instrument breaching at least one of said layers.