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

• US 6,393,318 B1
• Filed: 05/11/1999
• Issued: 05/21/2002
• 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:
  US09/309,616
• Time in Patent Office: 1,106 Days
• Field of Search: 604/19-20, 607/1-3, 607/152, 607/115, 607/501, 607/503, 607/504, 600/573
• 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 a selected analyte or derivatives thereof present in a biological system, said collection assembly comprising

a) a collection insert layer comprised of first and second collection inserts, each collection insert comprising, (i) an ionically conductive material, and (ii) first and second surfaces,

b) a mask layer comprised of a material that is substantially impermeable to the selected analyte or derivatives thereof, 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 collection insert, (ii) defines first and second openings that are aligned, respectively, with the first and second collection inserts of the collection insert layer, (iii) each opening exposed at least a portion of the first surface of the aligned collection insert, and (iv) has a border which extends beyond the first surface of each collection insert 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 collection insert, (ii) defines first and second openings that are aligned, respectively, with the first and second collection inserts of the collection insert layer, (iii) each opening exposes at least a portion of the second surface of the aligned collection insert, and (iv) has a border which extends beyond the first surface of each collection insert 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 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 thus forming an overhang of the mask layer relative to the perimeter of the retaining layer.

4. The collection assembly of claim 1, wherein said collection insert layer further comprises a gasket layer and the gasket layer is between the mask layer and the retaining layer.

5. The collection assembly of claim 4, wherein (i) said gasket layer has first and second parts, each part comprising a substantially planar material having a top face, a bottom face, and an opening extending between said top and bottom faces, wherein the top face of each gasket layer part contacts the inner face of the mask layer, the bottom face of each gasket layer part contacts the inner face of the retaining layer, and the openings of the first and second parts are each axially aligned, respectively, with the first and second openings in the mask and retaining layers, and (ii) within each gasket layer part a collection insert is arranged and substantially fills each opening in each gasket layer part.

6. The collection assembly of claim 5, wherein each opening of the retaining layer exposes the entire second surface of each collection insert, thus creating a gasket.

7. 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.

8. The collection assembly of claim 3, 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.

9. The collection assembly of claim 1, wherein at least one collection insert comprises an enzyme.

10. The collection assembly of claim 9, wherein at least one of the collection inserts comprises glucose oxidase.

11. The collection assembly of claim 1, wherein each collection insert comprises a hydrogel.

12. The collection assembly of claim 1, wherein the retaining layer has an outer face that is adhesive.

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

14. The collection assembly of claim 13, wherein said first removable liner has a plow-fold shape.

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

16. 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.

17. The collection assembly of claim 1, wherein the outer face of the mask layer comprises an adhesive.

18. The collection assembly of claim 1, wherein the outer face of the retaining layer comprises an adhesive.

19. 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.

20. 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 collection inserts of the collection insert layer are individually sandwiched between the mask and retaining layers.

21. The collection assembly of claim 1, where said analyte is glucose.

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

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

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

25. An autosensor assembly for use in a iontophoretic sampling device useful to monitor an analyte 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 collection inserts, each collection insert comprising (i) an ionically conductive material, and (ii) first and second surfaces,

b) a mask layer comprised of a substantially planar material that is substantially impermeable to the selected analyte or derivatives thereof, 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 collection insert, (ii) defines first and second openings that are aligned, respectively, with the first and second collection inserts of the collection insert layer, (iii) each opening exposes at least a portion of the first surface of the aligned collection insert, and (iv) has a border which extends beyond the first surface of each collection insert 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 collection insert, (ii) defines first and second openings that are aligned, respectively, with the first and second collection inserts of the collection insert layer, (iii) each opening exposes at least a portion of the second surface of the aligned collection insert, and (iv) has a border which extends beyond the first surface of each collection insert 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.

26. The autosenor assembly of claim 25, wherein at least one collection insert comprises an enzyme.

27. The autosensor assembly of claim 25, 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.

28. The autosensor assembly of claim 27, 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.

29. The autosensor assembly of claim 25, wherein the mask layer in 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.

30. The autosensor assembly of claim 25, 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.

31. The autosensor assembly of claim 26, wherein at least one of the collection inserts comprises glucose oxidase.

32. The autosensor assembly of claim 25, wherein each collection insert comprises a hydrogel.

33. The autosensor assembly of claim 25, wherein the retaining layer has an outer face that is adhesive.

34. The autosensor assembly of claim 25, wherein the outer face of the retaining layer and exposed second surfaces of the collection inserts contact a first surface of a first removable liner.

35. The autosensor assembly of claim 34, wherein said first removable liner has a plow-fold shape.

36. The autosensor assembly of claim 25, wherein the outer face of the mask layer and exposed first surfaces of the collection inserts contact a first surface of a second removable liner.

37. The autosensor assembly of claim 25, 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.

38. The autosensor assembly of claim 25, wherein the outer face of the mask layer comprises an adhesive.

39. The autosensor assembly of claim 25, wherein the outer face of the retaining layer comprises an adhesive.

40. The autosensor assembly of claim 25, 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 collection inserts of the collection insert layer are individually sandwiched between the mask and retaining layers.

41. The autosensor assembly of claim 25, wherein said analyte is glucose.

42. The autosensor assembly of claim 25, wherein said collection assembly is a laminate.

43. A sealed package comprising the autosensor assembly of claim 42.

44. The sealed package of claim 43, further comprising a hydrating insert.

45. A sealed package comprising the autosensor assembly of claim 25.

46. The sealed package of claim 45, further comprising a hydrating insert.