Diagnostic patch and method for diagnosis using the same

• US 6,063,029 A
• Filed: 04/29/1996
• Issued: 05/16/2000
• Est. Priority Date: 12/07/1992
• Status: Expired due to Fees

• Current Assignee: Hisamitsu Pharmaceutical Company Incorporated
• Original Assignee: Hisamitsu Pharmaceutical Company Incorporated
• Inventors: Ohta, Shigeo, Okayama, Akira, Yonemura, Keishi, Saita, Masaru, Mukai, Mizue, Shimozono, Yuji, Imayama, Shuhei
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): CARTER, RYAN CHRISTOPHER
• Application Number:
  US08/454,113
• Time in Patent Office: 1,478 Days
• Field of Search: 128/632, 128/636, 128/760, 128/771, 129/637
• US Class Current: 600/309
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15

Abstract

A diagnostic patch comprising at least an adsorption carrier adsorbing a substance secreted from a living body, which is useful particularly for the diagnosis of mammary cancer or atopic dermatitis, and a method for the diagnosis of mammary cancer or atopic dermatitis with said preparation.

Claims

1. A diagnostic patch for adsorbing a substance secreted from a living body comprising a support, said support being a transparent or translucent one having an expression for discrimination made thereon and having a surface, a pressure-sensitive adhesive spread over at least a part of said surface of said support, and a liquid permeable adsorption carrier which is stuck on said pressure-sensitive adhesive, said adsorption carrier adsorbing said substance and having a pore size of 0.01 to 100 μ

m.

5. The diagnostic patch as set forth in claim 1 wherein the pore size of said adsorption carrier is 0.01 to 50 μ

m.

9. The diagnostic patch as set forth in claim 1 wherein said adsorption carrier is made of at least one member selected from the group consisting of a cellulose derivative, porous gels, fibrous matrixes, paper, cloth and ceramics and wherein said cellulose derivative constituting said adsorption carrier is at least one member selected from the group consisting of cellulose, carboxymethylcellulose, carboxymethylcellulose salts, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, cellulose acetate, cellulose nitrate, cellulose acetate phthalate and hydroxypropylmethylcellulose phthalate.

13. The diagnostic patch as set forth in claim 1 wherein said support is a member selected from the group consisting of paper, cloth, nonstretchable or stretchable films made of a polyester resin, silicone resin, urethane resin, polyethylene resin, ethylene-vinyl acetate copolymer, flexible polyvinyl chloride and an aluminum foil and has a releasable cover attached to said adsorption carrier.

2. A diagnostic patch for adsorbing a substance secreted from a living body comprising a support, said support having a surface, a pressure-sensitive adhesive spread over at least a part of said surface of said support, a liquid-permeable adsorption carrier which is stuck on said pressure-sensitive adhesive, said adsorption carrier adsorbing said substance and having a pore size of 0.01 to 100 μ

m, and a water-absorbing and adsorbent member, said water-absorbing and adsorbent member being made of at least one member selected from the group consisting of polyacrylic acid, salts of polyacrylic acid, isobutylene-maleic acid copolymer, starch-acrylic acid graft copolymer, polyethylene oxide, saponified vinyl acetate-unsaturated dicarboxylic acid copolymer, carboxymethylcellulose, saponified starch-acrylic acid graft copolymer, alginate, cellulose, carboxymethylcellulose, carboxymethylcellulose salts, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, cellulose acetate, cellulose nitrate, cellulose acetate phthalate, hydroxypropylmethylcellulose phthalate, poly-2-hydroxyethyl methacrylate, polyacrylic acid, polyvinyl alcohol-polyacrylic acid composite, polyurethane, polyester, polyethylene, polyvinyl chloride, filter paper and cloths.

6. The diagnostic patch as set forth in claim 2 wherein the pore size of said adsorption carrier is 0.01 to 50 μ

m.

10. The diagnostic patch as set forth in claim 2 wherein said adsorption carrier is made of at least one member selected from the group consisting of a cellulose derivative, porous gels, fibrous matrixes, paper, cloth, ceramics and wherein said cellulose derivative constituting said adsorption carrier is at least one member selected from the group consisting of cellulose, carboxymethylcellulose, carboxymethylcellulose salts, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, cellulose acetate, cellulose nitrate, cellulose acetate phthalate and hydroxypropylmethylcellulose phthalate.

14. The diagnostic patch as set forth in claim 2 wherein said support is a member selected from the group consisting of paper, cloth, nonstretchable or stretchable films made of a polyester resin, silicone resin, urethane resin, polyethylene resin, ethylene-vinyl acetate copolymer, flexible polyvinyl chloride and an aluminum foil and has a releasable cover attached to said adsorption carrier.

17. A method for the diagnosis of mammary cancer including cancer free of phyma comprises applying a diagnostic patch according to claim 2 to a breast of a living body including nipples, said diagnostic patch adsorbing a substance secreted from said living body, keeping said patch adhering to the breast of said living body for a predetermined period of time, making a papillary secretion adsorbed and immobilized on said adsorption carrier, then peeling said patch, wherein the papillary secretion is a tumor-associated antigen or tumor marker selected from the group consisting of carcinoembryonic antigen, melanoma cell, melanoma marker, neuroblastoma, malignin, α

-fetoprotein, pepsinogen, basic fetoprotein, fetoprealbumin, carbohydrate antigen, pancreatic cancer associated antigen, cancer antigen, squamous cell carcinoma, seminoprotein, prostate-specific antigen, ferritin and then conducting the assay of said papillary secretion adsorbed to determine the presence of mammary cancer.

3. A diagnostic patch for adsorbing a substance secreted from a living body comprising a support, said support having a surface, a pressure-sensitive adhesive spread over at least a part of said surface of said support, a liquid-permeable adsorption carrier which is stuck on said pressure-sensitive adhesive, said adsorption carrier adsorbing said substance and having a pore size of 0.01 to 100 μ

m, and a water-absorbing and adsorbent member being incorporated in said pressure-sensitive adhesive wherein said water-absorbing and adsorbent member is made of at least one member selected from the group consisting of polyacrylic acid, salts of polyacrylic acid, isobutylene-maleic acid copolymer, starch-acrylic acid graft copolymer, polyethylene oxide, saponified vinyl acetate-unsaturated dicarboxylic acid copolymer, carboxymethylcellulose, saponified starch-acrylic acid graft copolymer, alginate, cellulose, carboxymethylcellulose, carboxymethylcellulose salts, hydroxyethylcellulose, hydroxypropycellulose, methylcellulose, ethylcellulose, carboxymethylethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, cellulose acetate, cellulose nitrate, cellulose acetate phthalate, hydroxypropylmethylcellulose phthalate, poly-2-hydroxyethyl methacrylate, polyacrylic acid, polyvinyl alcohol-polyacrylic acid composite, polyurethane, polyester, polyethylene, polyvinyl chloride, filter paper and cloths and an additional adhesive adheres to said member, said adsorption carrier being bonded to said additional adhesive.

7. The diagnostic patch as set forth in claim 3 wherein the pore size of said adsorption carrier is 0.01 to 50 μ

m.

11. The diagnostic patch as set forth in claim 3 wherein said adsorption carrier is made of at least one member selected from the group consisting of a cellulose derivative, porous gels, fibrous matrixes, paper, cloth and ceramics and wherein said cellulose derivative constituting said adsorption carrier is at least one member selected from the group consisting of cellulose, carboxymethylcellulose, carboxymethylcellulose salts, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, cellulose acetate, cellulose nitrate, cellulose acetate phthalate and hydroxypropylmethylcellulose phthalate.

15. The diagnostic patch as set forth in claim 3 wherein said support is a member selected from the group consisting of paper, cloth, nonstretchable or stretchable films made of a polyester resin, silicone resin, urethane resin, polyethylene resin, ethylene-vinyl acetate copolymer, flexible polyvinyl chloride and an aluminum foil and has a releasable cover attached to said adsorption carrier.

4. A diagnostic patch for adsorbing a substance secreted from a living body comprising a support, said support having a surface, a pressure-sensitive adhesive spread over at least a part of said surface of said support, a liquid-permeable adsorption carrier which is stuck on said pressure-sensitive adhesive, said adsorption carrier adsorbing said substance and having a pore size of 0.01 to 100 μ

m, and a water-absorbing and adsorbent member stuck on said pressure-sensitive adhesive wherein said water-absorbing and adsorbent member is made of at least one member selected from the group consisting of polyacrylic acid, salts of polyacrylic acid, isobutylene-maleic acid copolymer, starch-acrylic acid graft copolymer, polyethylene oxide, saponified vinyl acetate-unsaturated dicarboxylic acid copolymer, carboxymethylcellulose, saponified starch-acrylic acid graft copolymer, alginate, cellulose, carboxymethylcellulose, carboxymethylcellulose salts, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, cellulose acetate, cellulose nitrate, cellulose acetate phthalate, hydroxypropylmethylcellulose phthalate, poly-2-hydroxyethyl methacrylate, polyacrylic acid, polyvinyl alcohol-polyacrylic acid composite, polyurethane, polyester, polyethylene, polyvinyl chloride, filter paper and cloths, said adsorption carrier being laminated on said water absorbing and adsorption member.

8. The diagnostic patch as set forth in claim 4 wherein the pore size of said adsorption carrier is 0.01 to 50 μ

m.

12. The diagnostic patch as set forth in claim 4 wherein said adsorption carrier is made of at least one member selected from the group consisting of a cellulose derivative, porous gels, fibrous matrixes, paper, cloth and ceramics and wherein said cellulose derivative constituting said adsorption carrier is at least one member selected from the group consisting of cellulose, carboxymethylcellulose, carboxymethylcellulose salts, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, ethylcellulose, carboxymethylethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, cellulose acetate, cellulose nitrate, cellulose acetate phthalate and hydroxypropylmethylcellulose phthalate.

16. The diagnostic patch as set forth in claim 4 wherein said support is a member selected from the group consisting of paper, cloth, nonstretchable or stretchable films made of a polyester resin, silicone resin, urethane resin, polyethylene resin, ethylene-vinyl acetate copolymer, flexible polyvinyl chloride and an aluminum foil and has a releasable cover attached to said adsorption carrier.

18. A method for the diagnosis of atopic dermatitis, which comprises applying a diagnostic patch to the skin, mucosa or affected site of a human body, said diagnostic patch adsorbing secretory immunoglobulin A secreted from a living body and comprising a support, said support having a surface, a pressure-sensitive adhesive spread over at at least a part of said surface of said support, and a liquid-permeable adsorption carrier which is stuck on said pressure-sensitive adhesive, said adsorption carrier adsorbing said secretory immunoglobulin A and having a pore size of 0.01 to 100 μ

m, making a secretion therefrom adsorbed and immobilized on said adsorption carrier and then analyzing the secretion adsorbed for said secretory immunoglobulin A by immunoassay to determine the presence of atopic dermatitis.