Method of forming a membrane, especially a latex or polymer membrane, including a deactivating barrier and indicating layer

• US 5,549,924 A
• Filed: 08/15/1994
• Issued: 08/27/1996
• Est. Priority Date: 07/17/1987
• Status: Expired due to Term

• Current Assignee: Alec Beck
• Original Assignee: Robin Renee Thill Shlenker
• Inventors: Shlenker, Robin R. T., Solomons, Clive C., Lester, David J.
• Primary Examiner(s): LUSIGNAN, MICHAEL R
• Application Number:
  US08/291,002
• Time in Patent Office: 743 Days
• Field of Search: 2/167, 2/168, 128/844, 424/404, 427/2.25, 427/2.26, 427/2.28, 427/2.3, 427/2.31, 427/407.1, 604/46, 604/332, 606/236
• US Class Current: 427/2.3
• 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: 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

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 method of making a multi-layer membrane including at least two discrete separated layers, comprising the steps of:

(a) depositing onto a former a first latex layer;

(b) treating said first layer with a material effective as a coagulant for latex;

(c) depositing over said first layer on said former a second latex layer, said coagulant effective to substantially prevent fusing of said first and second layers; and

(d) setting or curing said first and second layers.

2. The method of claim 1, further comprising the step of treating said first latex layer with a biocide prior to step (b).

3. The method of claim 2, wherein said biocide comprises gentian violet.

4. The method of claim 2, wherein said biocide comprises Nonoxynol 9.

5. The method of claim 2, wherein said biocide comprises chlorhexidene.

6. The method of claim 2, wherein said coagulant deposited in step (c) does not contact a circumferentially extending zone on said first layer such that said first and second layers fuse together in said zone.

7. The method of claim 6, wherein said membrane comprises a glove.

8. The method of claim 6, wherein said membrane comprises a condom.

9. The method of claim 1, wherein said membrane comprises a glove.

10. The method of claim 1, wherein said membrane comprises a condom.

11. The method of claim 1, further comprising the step of depositing a substance over said first layer on said former prior to step (c), wherein said substance is 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, such that said substance is substantially contained between said first latex layer and said second latex layer.

12. The method of claim 1, further comprising the step of depositing at least one additional layer over said second layer.

13. A multiple layer latex surgical or examination glove including at least two discrete separated latex layers fused in the absence of any adhesive or mechanical fasteners only in a cuff region of said glove.

14. The glove of claim 13, further comprising a substance disposed between said two discrete layers, said 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, such that said substance is substantially contained between said first latex layer and said second latex layer.

15. A multiple layer latex condom including at least two discrete separated latex layers fused in the absence of any adhesive or mechanical fasteners only in an open end region of said condom.

16. The condom of claim 15, further comprising a substance disposed between said two discrete layers, said 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, such that said substance is substantially contained between said first latex layer and said second latex layer.

17. A method of making a multi-layer membrane including at least two discrete layers, comprising the steps of:

(a) depositing onto a former a material selected from the group consisting of liquid polymers and polymers dissolved in a solvent to form a first layer;

(b) treating said first layer with a surfactant;

(c) depositing over said first layer on said former a material selected from the group consisting of liquid polymers and polymers dissolved in a solvent to form a second layer, said surfactant effective to substantially prevent fusing of said first and second layers; and

(d) setting or curing said first and second layers.

18. The method of claim 17, further comprising the step of treating said first layer with a biocide prior to step (b).

19. The method of claim 18, wherein said biocide comprises gentian violet.

20. The method of claim 18, wherein said biocide comprises Nonoxynol 9.

21. The method of claim 18, wherein said biocide comprises chlorhexidene.

22. The method of claim 17, wherein said surfactant deposited in step (c) does not contact a circumferentially extending zone on said first layer such that said first and second layers fuse together in said zone.

23. The method of claim 22, wherein said membrane comprises a glove.

24. The method of claim 22, wherein said membrane comprises a condom.

25. The method of claim 17, wherein said membrane comprises a glove.

26. The method of claim 17, wherein said membrane comprises a condom.

27. The method of claim 17, further comprising the step of depositing a substance over said first layer on said former prior to step (c), wherein said substance is 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, such that said substance is substantially contained between said first and second layers.

28. The method of claim 17, further comprising the step of depositing at least one additional layer over said second layer.

29. A multiple layer polymeric surgical or examination glove including at least two discrete layers fused in the absence of any adhesive or mechanical fasteners only in a cuff region of said glove.

30. The glove of claim 29, further comprising a substance disposed between said two discrete layers, said 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, such that said substance is substantially contained between said first and second layers.

31. A multiple layer polymeric condom including at least two discrete separated layers fused in the absence of any adhesive or mechanical fasteners only in an open end region of said condom.

32. The condom of claim 31, further comprising a substance disposed between said two discrete layers, said 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, such that said substance is substantially contained between said first and second layers.

33. A method of making a multi-layer membrane, comprising the steps of:

depositing onto a former a material selected from the group consisting of sealants, polymeric latex, a polymer dissolved in a solvent, and liquid polymers to form a first layer;

depositing over said first layer a material selected from the group consisting of 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 to form a second layer; and

depositing over said second layer a material selected from the group consisting of sealants, polymeric latex, a polymer dissolved in a solvent, and liquid polymers to form a third layer, substantially preventing fusing of said first and third layers, such that said first and third layers are discrete and separated and said second layer is substantially contained between said first and third layers.

34. A multiple layer latex surgical or examination glove including a body portion having at least two discrete separated latex layers and a cuff portion having a single integral latex layer.

35. A multiple layer latex condom including a body portion having at least two discrete separated latex layers and an open end region having a single integral latex layer.

36. A multiple layer polymeric surgical or examination glove including a body portion having at least two discrete separated layers and a cuff portion having a single integral layer.

37. A multiple layer polymeric condom including a body portion having at least two discrete separated layers and an open end region having a single integral layer.