Collection assemblies, laminates, and autosensor assemblies for use in transdermal sampling systems

• US 6,438,414 B1
• Filed: 11/30/2001
• Issued: 08/20/2002
• Est. Priority Date: 05/13/1998
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Tierney, Michael J., Vijayakumar, Prema, Soni, Pravin L., Ford, Russell, Conn, Thomas E.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/006,625
• Publication Number:
  US 20020053637A1
• Time in Patent Office: 263 Days
• Field of Search: 604/20, 604/21, 604/500, 604/501, 604/504, 606/152, 606/153, 600/300, 600/309, 600/345-348, 600/362, 600/372, 600/365
• US Class Current: 604/20
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase

Abstract

The invention relates generally to consumable components of a device used for continually or continuously measuring the concentration of target chemical analytes present in a biological system. More particularly, the invention relates to collection assemblies, laminate structures, and autosensor assemblies, which are used in connection with a transdermal sampling device. In one aspect, the invention includes autosensor assemblies which include laminate structures, electrode assemblies, and support trays. One important application of the invention involves an autosensor assembly for use in a blood glucose monitoring device.

Claims

1. A collection assembly, for use in a iontophoretic sampling device useful to monitor glucose present in a biological system, said collection assembly comprising

a) a collection insert layer comprised of first and second hydrogels, each hydrogel comprising, (i) an ionically conductive material, (ii) first and second surfaces, and (iii) glucose oxidase;

b) a mask layer comprised of a material that is substantially impermeable to glucose, wherein the mask layer (i) has inner and outer faces and said outer face provides contact with said biological system and the inner face is positioned in facing relation with the first surface of each hydrogel, (ii) defines first and second openings that are aligned, respectively, with the first and second hydrogels of the collection insert layer, (iii) each opening exposes at least a portion of the first surface of the aligned hydrogel, and (iv) has a border which extends beyond the first surface of each hydrogel to provide an overhang; and

c) a retaining layer having (i) inner and outer faces wherein the inner face is positioned in facing relation with the second surface of each hydrogel, (ii) defines first and second openings that are aligned, respectively, with the first and second hydrogels of the collection insert layer, (iii) each opening exposes at least a portion of the second surface of the aligned hydrogel, and (iv) has a border which extends beyond the first surface of each hydrogel of the collection insert layer to provide an overhang.

2. The collection assembly of claim 1, wherein the inner face of the mask layer contacts the inner face of the retaining layer, and the overhangs provided by the mask and retaining layers sandwich the collection insert layer therebetween.

3. The collection assembly of claim 2, wherein the border of the mask layer defines perimeter, the border of the retaining layer defines a perimeter, and the perimeter of the mask layer is greater than the perimeter of the retaining layer, thus forming an overhang of the mask layer relative to the perimeter of the retaining layer.

4. The collection assembly of claim 1, wherein the mask layer is comprised of a material selected from the group consisting of high density polyethylene (HDPE), low density polyethylene (LDPE), very low density polyethylene (VLDPE), polyethylene copolymers, thermoplastic elastomers, silicon elastomers, polyurethane (PU), polypropylene (PP), (PET), nylon, flexible polyvinylchloride (PVC), natural rubber, synthetic rubber, and combinations thereof.

5. The collection assembly of claim 1, wherein the retaining layer is comprised of a material selected from the group consisting of high density polyethylene (HDPE), low density polyethylene (LDPE), very low density polyethylene (VLDPE), polyethylene copolymers, thermoplastic elastomers, silicon elastomers, polyurethane (PU), polypropylene (PP), (PET), nylon, flexible polyvinylchloride (PVC), natural rubber, synthetic rubber, and combinations thereof.

6. The collection assembly of claim 1, wherein the outer face of the retaining layer and exposed second surfaces of the hydrogels contact a first surface of a first removable liner.

7. The collection assembly of claim 6, wherein said first removable liner has a plow-fold shape.

8. The collection assembly of claim 1, wherein the outer face of the mask layer and exposed first surfaces of the hydrogels contact a first surface of a second removable liner.

9. The collection assembly of claim 1, further comprising a first removable liner attached to the outer face of the retaining layer, and a second removable liner attached to the outer face of the mask layer.

10. The collection assembly of claim 1, wherein the inner and/or outer face of the mask/layer comprises an adhesive.

11. The collection assembly of claim 10, wherein said adhesive comprises an adhesive selected from the group consisting of pressure sensitive adhesives, thermoset adhesives, cyanocrylate adhesives, epoxies, contact adhesives, and heat sensitive adhesives.

12. The collection assembly of claim 10, wherein said adhesive comprises an adhesive selected from the group consisting of starch-based adhesives, acrylate-based adhesives, styrene butadiene rubber-based adhesives, styrene-ethylene-butylene rubber-based adhesives, and silicone-based adhesives.

13. The collection assembly of claim 1, wherein the inner and/or outer face of the gel retaining layer comprises an adhesive.

14. The collection assembly of claim 13, wherein said adhesive comprises an adhesive selected from the group consisting of pressure sensitive adhesives, thermoset adhesives, cyanocrylate adhesives, epoxies, contact adhesives, and heat sensitive adhesives.

15. The collection assembly of claim 13, wherein said adhesive comprises an adhesive selected from the group consisting of starch-based adhesives, acrylate-based adhesives, styrene butadiene rubber-based adhesives, styrene-ethylene-butylene rubber-based adhesives, and silicone-based adhesives.

16. The collection assembly of claim 1, wherein the first and second openings in the mask layer are positioned in the collection assembly such that they are aligned with the first and second openings in the retaining layer and thereby define a plurality of flow paths through the collection assembly.

17. The collection assembly of claim 1, wherein the mask and retaining layers are contacted with each other along a central portion which separates the first and second openings in each layer such that said first and second hydrogels of the collection insert layer are individually sandwiched between the mask and retaining layers.

18. The collection assembly of claim 1, wherein said hydrogel comprises a hydrophilic material selected from the group consisting of polyethylene oxide, polyacrylic acid, and polyvinylalcohol.

19. The collection assembly of claim 18, wherein said hydrogel comprises polyethylene oxide.

20. A laminate comprising the collection assembly of claim 1.

21. A sealed package comprising the laminate of claim 20.

22. A sealed package comprising the collection assembly of claim 1.

23. The sealed package of claim 22, further comprising a hydrating insert.

24. An autosensor assembly for use in a iontophoretic sampling device useful to monitor glucose present in a biological system, said autosensor assembly comprising,

(I) a collection assembly said collection assembly comprising,

a) a collection insert layer comprised of first and second hydrogels, each hydrogel comprising (i) an ionically conductive material, and (ii) glucose oxidase;

b) a mask layer comprised of a substantially planar material that is substantially impermeable to glucose, wherein the mask layer (i) has inner and outer faces and said outer face provides contact with said biological system and the inner face is positioned in facing relation with the first surface of each hydrogel, (ii) defines first and second openings that are aligned, respectively, with the first and second hydrogels of the collection insert layer, (iii) each opening exposes at least a portion of the first surface of the aligned hydrogel, and (iv) has a border which extends beyond the first surface of each hydrogel to provide an overhang;

(c) a retaining layer having (i) inner and outer faces wherein the inner face is positioned in facing relation with the second surface of each hydrogel, (ii) defines first and second openings that are aligned, respectively, with the first and second hydrogels of the collection insert layer, (iii) each opening exposes at least a portion of the second surface of the aligned hydrogel, and (iv) has a border which extends beyond the first surface of each hydrogel to provide an overhang; and

(d) where the first and second openings in the mask layer are positioned in the collection assembly such that they are aligned with the first and second openings in the retaining layer and thereby define a plurality of flow paths through said collection assembly;

(II) an electrode assembly having an inner and outer face, the inner face comprising first and second bimodal electrodes, wherein the first and second bimodal electrodes are aligned, respectively, with the first and second openings in the retaining layer of the collection assembly; and

(III) a support tray that contacts the outer face of the electrode assembly.

25. The autosensor assembly of claim 24, wherein the inner face of the mask layer contacts the inner face of the retaining layer, and the overhangs provided by the mask and retaining layers sandwich the collection insert layer therebetween.

26. The autosensor assembly of claim 25, wherein the border of the mask layer defines a perimeter, the border of the retaining layer defines a perimeter, and the perimeter of the mask layer is greater than the perimeter of the retaining layer.

27. The autosensor assembly of claim 24, wherein the mask layer is comprised of a material selected from the group consisting of high density polyethylene (HDPE), low density polyethylene (LDPE), very low density polyethylene (VLDPE), polyethylene copolymers, thermoplastic elastomers, silicon elastomers, polyurethane (PU), polypropylene (PP), (PET), nylon, flexible polyvinylchloride (PVC), natural rubber, synthetic rubber, and combinations thereof.

28. The autosensor assembly of claim 24, wherein the retaining layer is comprised of a material selected from the group consisting of high density polyethylene (HDPE), low density polyethylene (LDPE), very low density polyethylene (VLDPE), polyethylene copolymers, thermoplastic elastomers, silicon elastomers, polyurethane (PU), polypropylene (PP), (PET), nylon, flexible polyvinylchloride (PVC), natural rubber, synthetic rubber, and combinations thereof.

29. The autosensor assembly of claim 24, wherein the outer face of the retaining layer and exposed second surfaces of the hydrogels contact a first surface of a first removable liner.

30. The autosensor assembly of claim 29, wherein said first removable liner has a plow-fold shape.

31. The autosensor assembly of claim 24, wherein the outer face of the mask layer and exposed first surfaces of the hydrogels contact a first surface of a second removable liner.

32. The autosensor assembly of claim 24, further comprising a first removable liner attached to the outer face of the retaining layer, and a second removable liner attached to the outer face of the mask layer.

33. The autosensor assembly of claim 24, wherein the inner and/or outer face of the mask layer comprises an adhesive.

34. The autosensor assembly of claim 33, wherein said adhesive comprises an adhesive selected from the group consisting of pressure sensitive adhesives, thermoset adhesives, cyanocrylate adhesives, epoxies, contact adhesives, and heat sensitive adhesives.

35. The autosensor assembly of claim 33, wherein said adhesive comprises an adhesive selected from the group consisting of starch-based adhesives, acrylate-based adhesives, styrene butadiene rubber-based adhesives, styrene-ethylene-butylene rubber-based adhesives, and silicone-based adhesives.

36. The autosensor assembly of claim 24, wherein the inner and/or outer face of the gel retaining layer comprises an adhesive.

37. The autosensor assembly of claim 36, wherein said adhesive comprises an adhesive selected from the group consisting of pressure sensitive adhesives, thermoset adhesives, cyanocrylate adhesives, epoxies, contact adhesives, and heat sensitive adhesives.

38. The autosensor assembly of claim 36, wherein said adhesive comprises an adhesive selected from the group consisting of starch-based adhesives, acrylate-based adhesives, styrene butadiene rubber-based adhesives, styrene-ethylene-butylene rubber-based adhesives, and silicone-based adhesives.

39. The autosensor assembly of claim 24, wherein the mask and retaining layers are contacted with each other along a central portion which separates the first and second openings in each layer such that said first and second hydrogels of the collection insert layer are individually sandwiched between the mask and retaining layers.

40. The autosensor assembly of claim 24, wherein said hydrogel comprises a hydrophilic material selected from the group consisting of polyethylene oxide, polyacrylic acid, and polyvinylalcohol.

41. The autosensor assembly of claim 40, wherein said hydrogel comprises polyethylene oxide.

42. The autosensor assembly of claim 24, wherein said first and second bimodal electrodes comprise Ag/AgCl.

43. The autosensor assembly of claim 24, wherein said inner face of said electrode assembly further comprises first and second working electrodes, wherein the first and second working electrodes are aligned, respectively, with the first and second openings in the retaining layer of the collection assembly.

44. The autosensor assembly of claim 43, wherein each working electrode comprises a reactive surface, said reactive surface comprising an electrically conductive material selected from the group consisting of platinum-group metals, nickel, copper, silver, carbon, oxides thereof, dioxides thereof, combinations thereof, and alloys thereof.

45. The autosensor assembly of claim 43, wherein said inner face of said electrode assembly further comprises first and second reference electrodes, wherein the first and second reference electrodes are aligned, respectively, with the first and second openings in the retaining layer of the collection assembly.

46. The autosensor assembly of claim 24, wherein said collection assembly is a laminate.

47. A sealed package comprising the autosensor assembly of claim 46.

48. The sealed package of claim 47, further comprising a hydrating insert.

49. A sealed package comprising the autosensor assembly of claim 24.

50. The sealed package of claim 49, further comprising a hydrating insert.