Skin barrier for use by ostomates

• US 4,775,374 A
• Filed: 06/24/1987
• Issued: 10/04/1988
• Est. Priority Date: 11/27/1981
• Status: Expired due to Term

• Current Assignee: E R Squibb & Sons Incorporated Lawrenceville-Princeton RD Princeton NJ 08543-4000
• Original Assignee: E R Squibb & Sons Incorporated
• Inventors: Cilento, Rudolfo D., Smith, Edward C. Jr., Freeman, Frank M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rose, Sharon
• Application Number:
  US07/065,114
• Time in Patent Office: 468 Days
• Field of Search: 604/332-345
• US Class Current: 604/344
• 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: A61F 5/448 Means for attaching bag to seal ring
• CPC Class Codes: A61L 24/043 Mixtures of macromolecular materials
• CPC Class Codes: A61L 2400/14 Adhesives for ostomy devices
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/38 Impulse heating
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/4825 Pressure sensitive adhesives
• CPC Class Codes: B29C 65/4875 being spherical, e.g. particles or powders
• CPC Class Codes: B29C 65/488 being longitudinal, e.g. fibres
• CPC Class Codes: B29C 66/112 Single lapped joints
• CPC Class Codes: B29C 66/1222 comprising at least a lapped joint-segment
• CPC Class Codes: B29C 66/1224 comprising at least a butt joint-segment
• CPC Class Codes: B29C 66/131 Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/24221 being circular B29C66/51 takes precedence
• CPC Class Codes: B29C 66/30223 said melt initiators being rib-like
• CPC Class Codes: B29C 66/47421 said spouts comprising flanges
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/723 : being multi-layered B29C66/7292, B29C66/72941 take precedence
• CPC Class Codes: B29C 66/727 : being porous, e.g. foam
• CPC Class Codes: B29C 66/73793 : soluble, e.g. water-soluble
• CPC Class Codes: B29C 66/7392 : characterised by the material of at least one of the parts being a thermoplastic
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29K 2001/00 : Use of cellulose, modified cellulose or cellulose derivatives, e.g. viscose, as moulding material
• CPC Class Codes: B29K 2023/00 : Use of polyalkenes or derivatives thereof as moulding material
• CPC Class Codes: B29K 2023/04 : Polymers of ethylene
• CPC Class Codes: B29K 2023/10 : Polymers of propylene
• CPC Class Codes: B29K 2023/12 : PP, i.e. polypropylene
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7148 : Blood bags, medical bags

Abstract

A composite skin barrier including a first adhesive component which fits around the stoma, a coupling element, and a second adhesive component which is flexible, light, and has a degree of porosity. The second adhesive component contacts the skin at a distance from the stoma.

Claims

1. A composite skin barrier for use by ostomates including a first component comprising an adhesive layer and an outer polymeric film said first component having a centrally located stomal opening adapted to fit the skin barrier around a stoma, an intermediate component comprising a microporous adhesive layer and an outer porous backing layer said intermediate component also having a centrally located stomal opening in alignment with the stomal opening in said first component said microporous adhesive layer bonded to and covering at least a portion of the outer polymeric film of said first component and wherein said intermediate component extends beyond the borders of said first component, and a coupling component comprising an outwardly extending flange permanently affixed to said porous backing layer in an area surrounding said stomal opening and a cylindrical rib extending in an upward direction perpendicularly from said flange.

2. A skin barrier according to claim 1 wherein the adhesive layer of said first component comprises a homogeneous blend of one or more pressure sensitive natural or synthetic viscous or elastomeric adhesive substances which can optionally include one or more thermoplastic elastomers and having dispersed therein one or more water soluble hydrocolloid gums which can optionally include one or more water swellable or inert natural or synthetic fibrous cohesive strengthening agents and other optional ingredients selected from the group consisting of anti-oxidants, preservatives, and plasticizers.

3. A skin barrier according to claim 2 wherein the adhesive layer of said first component comprises a homogeneous blend of from about 30% to about 70% by weight of a pressure sensitive substance selected from the group consisting of natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, and low molecular weight polyisobutylene and one or more optional thermoplastic elastomers selected from the group consisting of medium molecular weight polyisobutylene, butyl rubber, and styrene copolymers and having dispersed therein from about 35% to about 65% by weight of one or more water soluble hydrocolloids selected from the group consisting of sodium carboxymethylcellulose, pectin, gelatin, guar gum, locust bean gum, and gum karaya and one or more optional water swellable or inert cohesive strengthening agents selected from the group consisting of cross-linked sodium carboxymethylcellulose, starch-acrylonitrile graft copolymer, cross-linked dextran, purified wood cellulose, and cotton.

4. A skin barrier according to claim 3 wherein the adhesive layer of said first component comprises a homogeneous blend of from about 40% to about 50% by weight of low molecular weight polyisobutylene and one or more optional thermoplastic elastomers selected from the group consisting of medium molecular weight polyisobutylene, butyl rubber, and styrene isoprene copolymers and having dispersed therein from about 45% to about 60% by weight of one or more water soluble hydrocolloids selected from the group consisting of sodium carboxymethylcellulose, pectin, gelatin, guar gum, locust bean gum, and gum karaya and one or more water swellable or inert cohesive strengthening agents selected from the group consisting of cross-linked sodium carboxymethylcellulose, starch-acrylonitrile graft copolymer, cross-linked dextran, purified wood cellulose, and cotton.

5. A skin barrier according to claim 4 wherein said first component comprises an adhesive layer consisting of a blend of about 40% by weight of polyisobutylene, about 20% by weight of sodium carboxymethylcellulose, about 20% by weight of pectin, and about 20% by weight gelatin and said polymeric film is polyethylene.

6. A skin barrier according to claim 1 wherein said intermediate component microporous adhesive layer has a porosity of from about 1 to 100 cc/sec/in² and comprises a homogeneous blend of one or more pressure sensitive natural or synthetic viscous or elastomeric adhesive substances which can optionally include one or more thermoplastic elastomers and having dispersed therein one or more water soluble hydrocolloid gums which can optionally include one or more water swellable cohesive strengthening agents and other optional ingredients selected from the group consisting of antioxidants, preservatives, plasticizers, and tackifiers and said intermediate component porous backing layer comprises woven or non-woven fabric, an open mesh polymeric substance, a polymeric foam, or a non-woven material made from polyester fibers, polypropylene fibers, nylon fibers, composite olefin fibers, or cellulose fibers.

7. A skin barrier according to claim 6 wherein the microporous adhesive layer of said intermediate component comprises a homogeneous blend of from about 30% to about 60% by weight of a pressure sensitive adhesive substance selected from the group consisting of natural rubber, silicone rubber, acrylonitrile rubber, polyurethane rubber, and low molecular weight polyisobutylene and one or more optional thermoplastic elastomers selected from the group consisting of medium molecular weight polyisobutylene, butyl rubber, and styrene copolymers, from about 20% to about 65% by weight of one or more water soluble hydrocolloids selected from the group consisting of sodium carboxymethylcellulose, pectin, gelatin, guar gum, locust bean gum, and gum karaya and one or more optional water swellable cohesive strengthening agents selected from the group consisting of cross-linked sodium carboxymethylcellulose, starch-acrylonitrile graft copolymers, and cross-linked dextran, up to 10% by weight of mineral oil, and up to 25% by weight of terpene resin.

8. A skin barrier according to claim 7 wherein the microporous adhesive layer of said intermediate component comprises a homogeneous blend of from about 35% to about 50% by weight of a blend of low molecular weight and medium molecular weight polyisobutylenes having dispersed therein from about 30% to about 60% by weight of one or more water soluble hydrocolloids selected from the group consisting of sodium carboxymethylcellulose, pectin, gelatin, guar gum, locust bean gum, and gum karaya and one or more optional water swellable cohesive strengthening agents selected from the group consisting of cross-linked sodium carboxymethylcellulose, starch-acrylonitrile graft copolymer, and cross-linked dextran, up to 10% by weight of mineral oil, and up to 25% by weight of terpene resin.

9. A skin barrier according to claim 8 wherein said intermediate component comprises a microporous adhesive layer consisting of a blend of about 18% by weight of low molecular weight polyisobutylene, about 20% by weight of medium molecular weight polyisobutylene, about 18% by weight of sodium carboxymethylcellulose, about 15% by weight of gelatin, about 20% by weight of terpene resin, about 8.5% by weight of mineral oil, and about 0.5% by weight of butylated hydroxytoluene and said porous backing is spun bonded polyester fiber.