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

• US 5,679,399 A
• Filed: 06/07/1995
• Issued: 10/21/1997
• Est. Priority Date: 07/17/1987
• Status: Expired due to Term

• 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): LUSIGNAN, MICHAEL R
• Application Number:
  US08/476,843
• Time in Patent Office: 867 Days
• Field of Search: 2/167, 2/168, 128/844, 424/404, 427/2.25, 427/2.26, 427/2.29, 427/2.3, 427/2.31, 427/407.1, 604/96, 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: 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 method of making a multi-layer latex membrane including at least two discrete layers, comprising the steps of:

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

(b) treating at least a portion of said first layer with a separating agent;

(c) treating at least a portion of said first layer with a material effective as a coagulant for latex;

(d) depositing over at least a portion of said first layer on said former a second latex layer, said separating agent effective to substantially prevent fusing of said first and second layers in at least a portion of said membrane; and

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

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

3. The method of claim 2, wherein said biocide is admixed with said coagulant.

4. The method of claim 2, wherein said biocide is admixed with said release agent.

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

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

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

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

9. The method of claim 8, wherein said membrane comprises a glove.

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

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

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

13. The method of claim 1, further comprising the step of depositing a substance over at least a portion of said first layer on said former prior to step (d), wherein said substance is selected from the group consisting of lubricants, sealants, biocides, indicators, spermicides, antiseptics, gels, hydrogels, pituitous substances, cleansing agents, surfactants, detergents, abrasives, coating agents, wiping agents, fibers, tactile enhancing objects, scales, discs and other materials for inhibiting penetration of needles and other sharps, and sheet forming agents, such that said substance is substantially contained between said first latex layer and said second latex layer.

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

15. The method of claim 1, wherein said separating agent comprises zinc stearate.

16. 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 at least a portion of said first layer with a surfactant;

(c) depositing over at least a portion of 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 at least a portion of said first and second layers; and

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

17. The method of claim 16, further comprising the step of treating at least a portion of said first layer with a biocide prior to step (c).

18. The method of claim 17, wherein said biocide is admixed with said surfactant.

19. The method of claim 17, wherein said biocide comprises gentian violet.

20. The method of claim 17, wherein said biocide comprises Nonoxynol 9.

21. The method of claim 17, wherein said biocide comprises chlorhexidene.

22. The method of claim 16, wherein said surfactant deposited in step (b) 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 16, wherein said membrane comprises a glove.

24. The method of claim 16, 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 16, further comprising the step of depositing a substance over at least a portion of said first layer on said former prior to step (c), wherein said substance is selected from the group consisting of lubricants, sealants, biocides, indicators, spermicides, antiseptics, gels, hydrogels, pituitous substances, cleansing agents, surfactants, detergents, abrasives, scales, discs and other materials for inhibiting penetration of needles and other sharps, coating agents, wiping agents, fibers, tactile enhancing objects, and sheet forming agents, such that said substance is substantially contained between said first and second layers.

28. The method of claim 16, further comprising the step of depositing at least one additional layer over at least a portion of said second layer.

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

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

(b) treating at least a portion of said first layer with a separating agent;

(c) depositing over at least a portion of said first layer on said former a second latex layer, said separating agent effective to substantially prevent fusing of said first and second layers in at least a portion of said membrane; and

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