Sealing material for ostomy devices

• US 4,231,369 A
• Filed: 05/17/1978
• Issued: 11/04/1980
• Est. Priority Date: 05/24/1977
• Status: Expired due to Term

• Current Assignee: Coloplast International A/S
• Original Assignee: Coloplast International A/S
• Inventors: Larsen, Hans-Ole, Sorensen, Erik L.
• Primary Examiner(s): Rosenbaum, C. Fred
• Application Number:
  US05/906,549
• Time in Patent Office: 902 Days
• Field of Search: 128/283
• 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 1/286 substituted with acid radicals, e.g. carboxymethyl cellulose [CMC] C08L1/282 takes precedence
• CPC Class Codes: C08L 2666/02 Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C08L 53/00 Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
• CPC Class Codes: C09K 2200/0447 Fats, fatty oils, higher fatty acids or derivatives thereof
• CPC Class Codes: C09K 2200/0615 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C09K 2200/0642 Copolymers containing at least three different monomers
• CPC Class Codes: C09K 3/1015 Polysaccharides or derivatives thereof

Abstract

The invention relates to a sealing material for use in connection with ostomy devices, particularly stoma pouches, to surround and protect a stoma in the human body. The improvement is that the material is a shaped, gel-like composition composed of a largely continuous phase consisting of a physically cross-linked elastomer or a mixture of such elastomers, and preferably, but optionally, one or more hydrocarbon tackifier resins and likewise optionally, but preferably, an oil extender; and distributed in the continuous phase one or more hydrocolloids. The gel-like composition has a low resistance to quick deformation and a rapid recovery to the original shape after deformation.

Claims

1. In an ostomy system for covering intestinal and similar stomas in a human body, comprising an ostomy device surrounding or covering said stoma and attached to the human body by sealing means, the improvement which comprises utilizing as a sealing means a shaped, gel-like composition comprising at least one physically cross-linked elastomer selected from the group consisting of styrene-olefin-styrene block copolymers and ethylene-propylene block copolymers, forming a continuous phase and at least one hydrocolloid dispersed therein, said hydrocolloid being selected from the group consisting of guar gum, pectin, sodium carboxymethyl cellulose, sodium polyacrylate, and mixtures thereof, said compositions also containing a hydrocarbon tackifier selected from the group consisting of polymers and copolymers of dicylopentadiene, alpha-pinene or beta-pinene, and wherein said gel-like composition has a low resistance to quick deformation and a rapid recovery to its original shape after deformation, whereby the seal between the ostomy device and epidermis of the human body as well as the seal between the stoma and the portion of epidermis exposable to discharge from the stoma are maintained intact, even under rapid body movement.

2. An ostomy system as claimed in claim 1, wherein the styrene-olefine-styrene block copolymer is a styrene-isopropene-styrene block copolymer.

3. An ostomy system as claimed in claim 1, wherein the physically cross-linked elastomer is an ethylene-propylene block copolymer.

4. An ostomy system as claimed in claim 1, wherein at least part of the hydrocolloid is sodium carboxymethyl cellulose.

5. An ostomy system as claimed in claim 1, wherein at least part of the hydrocolloid is guar gum.

6. An ostomy system as claimed in claim 1, wherein the gel-like composition further contains at least one oil extender which forms part of the continuous phase.

7. An ostomy system as claimed in claim 6, wherein the oil extender is selected from the class consisting of paraffin oils, polybutene and vegetable oils.

8. An ostomy system as claimed in claim 6, wherein the gel-like composition contains about 48-57% by weight of the hydrocolloid, about 9-10% by weight of the physically cross-linked elastomer, about 17-20% by weight of the hydrocarbon tackifier resin and about 15-25% by weight of the extender oil.

9. An ostomy system as claimed in claim 6, wherein the gel-like composition is composed of 9-10% by weight of styrene-isoprene-styrene block copolymer as the physically cross-linked elastomer, 17-20% by weight of fully hydrogenated poly-dicyclopentadiene tackifier resin, 17-20% by weight of liquid paraffin as oil extender, 33-39% by weight of sodium carboxymethyl cellulose as one and 15-17% by weight of guar gum as the other hydrocolloid.

10. An ostomy system as claimed in claim 1, wherein the gel-like composition further contains an antioxidant.

11. An ostomy system as claimed in claim 10, wherein the antioxidant is selected from the class consisting of butylated hydroxytoluenes.

12. An ostomy system as claimed in claim 10, wherein the amount of antioxidant in the gel-like composition does not exceed 2% by weight.

13. An ostomy system as claimed in claim 1, wherein the gel-like composition contains from about 20 to 80% by weight of the hydrocolloid, about 5-50% by weight of the hydrocarbon resin tackifier and about 2-40% by weight of the physically cross-linked elastomer.

14. An ostomy system as claimed in claim 13, wherein the gel-like composition contains about 40-65% by weight of the hydrocolloid, about 15-35% by weight of the hydrocarbon tackifier resin and 4-15% by weight of the physically cross-linked elastomer.

15. An ostomy system as claimed in claim 1, wherein the shaped gel-like composition is shaped as a polygonal to circular disc with a substantially circular opening substantially fitting the outer perimeter of a protruding stoma in a patient'"'"'s body.

18. An ostomy system as claimed in claim 12, wherein the oil extender is present in amount ranging in amount from 10-30% by weight.

16. In an ostomy system for covering intestinal and similar stomas in a human body, comprising an ostomy device surrounding or covering said stoma and attached to the human body by sealing means, the improvement which comprises utilizing as a sealing means a shaped, gel-like composition comprising at least one physically cross-linked elastomer selected from the group consisting of styrene-olefin-styrene block copolymers and ethylene-propylene block copolymers, forming a continuous phase and at least one hydrocolloid dispersed therein, said hydrocolloid being selected from the group consisting of guar gum, pectin, sodium carboxymethyl cellulose, sodium polyacrylate, and mixtures thereof, said compositions also containing a terpene resin tackifier, and wherein said gel-like composition has a low resistance to quick deformation and a rapid recovery to its original shape after deformation, whereby the seal between the ostomy device and epidermis of the human body as well as the seal between the stoma and the portion of epidermis exposable to discharge from the stoma are maintained intact, even under rapid body movement.

17. An ostomy system as claimed in claim 16, wherein the gel-like composition also contains an oil extender selected from the class consisting of paraffin oil, polybutene and vegetable oils.

19. An ostomy system as claimed in claim 17, wherein the gel-like composition contains from 48-57% by weight of the hydrocolloid, about 9-10% by weight of the physically cross-linked elastomer, about 17-20% of hydrocarbon resin tackifier and about 19-20% by weight of the oil extender.

20. An ostomy system as claimed in claim 16, wherein at least part of hydrocolloid is guar gum.

21. An ostomy system as claimed in claim 16, wherein at least part of the hydrocolloid is sodium carboxymethyl cellulose.

22. An ostomy system as claimed in claim 16, wherein the gel-like composition contains from about 2 to 40% by weight of the physically cross-linked block copolymer, about 5-50% by weight of a terpene resin tackifier and about 20-80% by weight of the hydrocolloid.