Ostomy composition

• US 4,204,540 A
• Filed: 04/26/1979
• Issued: 05/27/1980
• Est. Priority Date: 06/08/1977
• Status: Expired due to Term

• Current Assignee: E R Squibb & Sons Incorporated
• Original Assignee: E R Squibb & Sons Incorporated
• Inventors: Chen, James L., Hill, John A., Cilento, Rudolfo D., La Via, Anthony L.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Rosenbaum, C. F.
• Application Number:
  US06/033,352
• Time in Patent Office: 397 Days
• Field of Search: 128/155-156, 128/283, 128/295
• US Class Current: 604/336
• CPC Class Codes: A61F 5/443 having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums adhesives or sealing pads therefor A61L24/00
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/043 Mixtures of macromolecular materials
• CPC Class Codes: A61L 2400/14 Adhesives for ostomy devices
• CPC Class Codes: C08L 23/22 Copolymers of isobutene; Butyl rubber ; Homo- or copolymers of other iso-olefins
• CPC Class Codes: C08L 5/14 Hemicellulose; Derivatives thereof

Abstract

A composition adapted for use around the stoma consisting of a homogeneous mixture of a pressure sensitive adhesive component, mineral oil, and hydrocolloid gums or cohesive strengthening agents or a mixture of hydrocolloid gums and cohesive strengthening agents. By controlling the amount of mineral oil the resulting composition can be easily shaped according to the particular need.

Claims

1. The method of protecting the area of skin between the stoma and an attached appliance, faceplate, or skin barrier which comprises shaping and placing around the stoma the shaped mass which comprises a homogeneous mixture of mineral oil and a premix in a ratio of from about 1 to 10 to about 3.5 to 10 on a solids weight basis;

wherein said premix comprises a homogeneous mixture of (A) from about 40% to about 60% by weight of a mixture of a pressure sensitive adhesive and an optional elastomer wherein said adhesive is a low molecular weight polyisobutylene and said elastomer if present is a medium molecular weight polyisobutylene or butyl rubber at up to about 30% by weight of said low molecular weight polyisobutylene and (B) from about 40% to about 60% by weight of a second component which is a mixture of one or more hydrocolloid gums, a cohesive strengthening agent, or a mixture of hydrocolloid gums and cohesive strengthening agent wherein said hydrocolloid gums are up to about 40% by weight of guar gum, locust bean gum, or mixtures thereof and from 0% to about 25% by weight of pectin, gum karaya, or mixtures thereof; and

wherein said cohesive strengthening agent is finely divided cellulose, finely divided substantially water insoluble crosslinked dextran, finely divided substantially water insoluble sodium carboxymethycellulose, or finely divided substantially water insoluble starch-acrylonitrile graft copolymer.

2. The method of claim 1 wherein said pressure sensitive adhesive is a polyisobutylene having a viscosity average molecular weight of from about 36,000 to 58,000 on the Flory scale and said elastomer is a butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, said polyisobutylene and said butyl rubber being combined in a ratio of from about 3 to 1 to about 5 to 1 on a weight basis.

3. The method of claim 2 wherein said hydrocolloid gums if present are up to 40% by weight guar gum and from 0% to about 25% by weight pectin and said cohesive strngthening agent if present is purified wood cellulose.

4. The method of claim 3 wherein said premix comprises a homogeneous mixture of (A) from about 45% to about 55% by weight of a mixture of said low molecular weight polyisobutylene and said butyl rubber combined in a ratio of about 4 to 1 on a weight basis and (B) from about 45% to 55% by weight of a second component which is a mixture of hydrocolloid gums, purified wood cellulose, or a mixture of hydrocolloid gums and purified wood cellulose wherein said hydrocolloid gums are up to about 40% by weight of guar gum and from 0% to about 25% by weight of pectin.

5. The method of claim 4 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, about 30% by weight of guar gum, and about 20% by weight of finely divided purified wood cellulose.

6. The method of claim 5 wherein said mineral oil and said premix are combined in a ratio of about 1 to 4 on a solids weight basis.

7. The method of claim 4 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, about 30% by weight of guar gum, and about 20% by weight of pectin.

8. The method of claim 7 wherein said mineral oil and said premix are combined in a ratio of about 1 to 4 on a solids weight basis.

9. The method of calim 4 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscostiy average molecular weight of about 425,000 on the Flory scale, and about 50% by weight of finely divided purified wood cellulose.

10. The method of claim 9 wherein said mineral oil and said premix are combined in a ratio of from about 3.5 to 10 on a solids weight basis.

11. The method of providing a smooth abdominal surface around the stoma for attachment of a skin barrier or appliance which comprises shaping and applying over any rough areas in the abdominal surface the shaped mass which comprises a homogeneous mixture of mineral oil and a premix in a ratio of from about 1 to 10 to about 3.5 to 10 on a solids weight basis, wherein said premix comprises a homogeneous mixture of (A) from about 40% to about 60% by weight of a mixture of a pressure sensitive adhesive and an optional elastomer wherein said adhesive is a low molecular weight polyisobutylene and said elastomer if present is a medium molecular weight polyisobutylene or butyl rubber at up to about 30% by weight of said low molecular weight polyisobutylene and (B) from about 40% to about 60% by weight of a second component which is a mixture of one or more hydrocolloid gums, a cohesive strengthening agent, or a mixture of hydrocolloid gums and cohesive strengthening agent wherein said hydrocolloid gums are up to about 40% by weight of guar gum, locust bean gum, or mixtures thereof and from 0% to about 25% by weight of pectin, gum karaya, or mixtures thereof;

and wherein said cohesive strengthening agent is finely divided cellulose, finely divided substantially water insoluble crosslinked dextran, finely divided substantially water insoluble sodium carboxymethylcellulose, or finely divided substantially water insoluble starch-acrylonitrile graft copolymer.

12. The method of claim 11 wherein said pressure sensitive adhesive is a polyisobutylene having a viscosity average molecular weight of from about 36,000 to 58,000 on the Flory scale and said elastomer is a butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, said polyisobutylene and said butyl rubber being combined in a ratio of from about 3 to 1 to about 5 to 1 on a weight basis.

13. The method of claim 12 wherein said hydrocolloid gums if present are up to 40% by weight guar gum and from 0% to about 25% by weight pectin and said cohesive strengthening agent if present is purified wood cellulose.

14. The method of claim 13 wherein said premix comprises a homogeneous mixture of (A) from about 45% to about 55% by weight of a mixture of said low molecular weight polyisobutylene and said butyl rubber combined in a ratio of about 4 to 1 on a weight basis and (B) from about 45% to 55% by weight of a second component which is a mixture of hydrocolloid gums, purified wood cellulose, or a mixture of hydrocolloid gums and purified wood cellulose wherein said hydrocolloid gums are up to about 40% by weight of guar gum and from 0% to about 25% by weight of pectin.

15. The method of claim 14 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, about 30% by weight of guar gum, and about 20% by weight of finely divided purified wood cellulose.

16. The method of claim 15 wherein said mineral oil and said premix are combined in a ratio of about 1 to 4 on a solids weight basis.

17. The method of calim 14 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, about 30% by weight of guar gum, and about 20% by weight of pectin.

18. The method of calim 17 wherein said mineral oil and said premix are combined in a ratio of about 1 to 4 on a solids weight basis.

19. The method of calim 14 wherein said premix comprises about 40% by weight of polyisobutylene having a viscosity average molecular weight of from about 36,000 to about 45,000 on the Flory scale, about 10% by weight of butyl rubber having a viscosity average molecular weight of about 425,000 on the Flory scale, and about 50% by weight of finely divided purified wood cellulose.

20. The method of calim 19 wherein said mineral oil and said premix are combined in a ratio of from about 3.5 to 10 on a solids weight basis.