Methods of producing collection assemblies, laminates, and autosensor assemblies for use in transdermal sampling systems

• US 6,341,232 B1
• Filed: 03/16/2001
• Issued: 01/22/2002
• Est. Priority Date: 05/13/1998
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Ford, Russell, Tierney, Michael J., Vijayakumar, Prema, Soni, Pravin L., Conn, Thomas E.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/810,917
• Publication Number:
  US 20020004640A1
• Time in Patent Office: 312 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 methods of producing consumable components of a device used for measuring the concentration of target chemical analytes present in a biological system. More particularly, the invention relates methods of producing collection assemblies, laminate structures, and autosensor assemblies, which are used in connection with a transdermal sampling device. In one aspect, the invention includes methods of producing autosensor assemblies which include laminate structures, electrode assemblies, and support trays. One important application of the invention involves methods of producing an autosensor assembly for use in a blood glucose monitoring device.

Claims

1. A method of producing a collection assembly, for use in an iontophoretic sampling device useful to monitor a selected analyte or derivatives thereof present in a biological system, said method comprising:

providing (a) first and second collection inserts each insert comprising an ionically conductive material having first and second surfaces;

(b) a mask comprising (i) a material that is substantially impermeable to the selected analyte or derivatives thereof, and (ii) inner and outer faces, wherein said mask defines first and second openings and a border; and

(c) a retaining layer, comprising inner and outer faces, wherein said retaining layer defines first and second openings and a border; and

positioning (a) the inner face of the mask in facing relation with the first surface of each collection insert, such that (i) said first and second openings of the mask are, respectively, aligned with the first and second collection inserts (ii) each opening of the mask exposes at least a portion of the first surface of the collection insert with which it is aligned, and (iii) said border extends beyond the first surface of each of the collection inserts to provide an overhang; and

(b) the inner face of the retaining layer in facing relation with the second surface of each collection insert, such that (i) said first and second openings of the retaining layer are, respectively, aligned with the first and second collection inserts, (ii) each opening of the retaining layer exposes at least a portion of the second surface of the collection insert with which it is aligned, and (iii) said border extends beyond the first surface of each of the collection inserts to provide an overhang, thereby resulting in production of said collection assembly.

2. The method of claim 1, wherein the inner face of the mask contacts the inner face of the retaining layer, and the overhang provided by the mask and the overhang provided by the retaining layer sandwich the collection inserts therebetween.

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

4. The method of claim 1, wherein the mask 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 method 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 method of claim 1, wherein at least one of the collection inserts comprises an enzyme.

7. The method of claim 6, wherein at least one of the collection inserts comprises glucose oxidase.

8. The method of claim 7, wherein both collection inserts comprise glucose oxidase.

9. The method of claim 1, wherein each collection insert comprises a hydrogel.

10. The method of claim 1, wherein the outer face of the retaining layer comprises an adhesive.

11. The method of claim 1, wherein before positioning said retaining layer and said collection inserts the outer face of the retaining layer is contacted with a first surface of a first removable liner.

12. The method of claim 11, wherein said first removable liner has a plow-fold shape.

13. The method of claim 1, wherein before positioning said mask and said collection inserts the outer face of the mask is contacted with a first surface of a second removable liner.

14. The method of claim 1, further comprising attaching a first removable liner to the outer face of the retaining layer, and a second removable liner to the outer face of the mask.

15. The method of claim 1, wherein the outer face of the mask comprises an adhesive.

16. The method of claim 1, wherein said positioning farther comprises aligning the first and second openings in the mask with the first and second openings in the retaining layer.

17. The method of claim 1, wherein after positioning the mask, retaining layer, and collection inserts, the mask and retaining layers are contacted along a central portion, wherein said central portion separates the first and second openings in each layer such that said first and second collection inserts are separately sandwiched between the mask and retaining layers.

18. The method of claim 1, wherein said analyte is glucose.

19. The method of claim 1, wherein after positioning the mask, retaining layer, and collection inserts, the mask is bonded to the retaining layer, thereby producing a laminate of the collection assembly.

20. The method of claim 1, further comprising packaging the collection assembly and sealing the package, thereby producing a packaged collection assembly.

21. The method of claim 19, further comprising packaging the collection assembly and sealing the package, thereby producing a packaged collection assembly.

22. The method of claim 20, further comprising adding a hydrating insert to the package before sealing.

23. The method of claim 1, wherein at least one of the collection inserts comprises an enzyme.

24. The method of claim 23, wherein at least one of the collection inserts comprises glucose oxidase.

25. The method of claim 24, wherein both collection inserts comprise glucose oxidase.

26. A method of producing an autosensor assembly, for use in an iontophoretic sampling device useful to monitor a selected analyte or derivatives thereof present in a biological system, said method comprising:

providing (a) first and second collection inserts each insert comprising an ionically conductive material having first and second surfaces;

(b) a mask comprising (i) a substantially planar material that is substantially impermeable to the selected analyte or derivatives thereof, and (ii) inner and outer faces, wherein said mask defines first and second openings and a border;

(c) a retaining layer, comprising inner and outer faces, wherein said retaining layer defines first and second openings and a border;

(d) first and second electrode assemblies, each electrode assembly comprising (i) first and second surfaces, and (ii) said first surface comprising an electrode; and

(e) a support tray; and

positioning (a) the inner face of the mask in facing relation with the first surface of each collection insert, such that (i) said first and second openings of the mask are, respectively, aligned with the first and second collection inserts, (ii) each opening of the mask exposes at least a portion of the first surface of the collection insert with which it is aligned, and (iii) said border extends beyond the first surface of each of the collection inserts to provide an overhang;

(b) the inner face of the retaining layer in facing relation with the second surface of each collection insert, such that (i) said first and second openings of the retaining layer are, respectively, aligned with the first and second collection inserts, (ii) each opening of the retaining layer exposes at least a portion of the second surface of the collection insert with which it is aligned, and (iii) said border extends beyond the first surface of each of the collection inserts to provide an overhang;

(c) said first and second electrode assemblies relative to the outer face of the retaining layer such that a first surface of the electrode of the first electrode assembly is aligned with the first opening in the retaining layer, and a first surface of the electrode of the second electrode assembly is aligned with the second opening in the retaining layer; and

(d) said support tray such that it contacts the second surface of each electrode assembly, thereby resulting in production of said autosensor assembly.

27. The method of claim 26, wherein the inner face of the mask contacts the inner face of the retaining layer, and the overhang provided by the mask and the overhang provided by the retaining layer sandwich the collection inserts therebetween.

28. The method of claim 27, wherein the border of said mask defines a perimeter and the border of the retaining layer defines a perimeter, and the perimeter of the mask is greater than the perimeter of the retaining layer thus forming an overhang of the mask relative to the perimeter of the retaining layer.

29. The method of claim 27, wherein after positioning the mask, retaining layer, and collection inserts, the mask and retaining layers are contacted along a central portion, wherein said central portion separates the first and second openings in each layer such that said first and second collection inserts are separately sandwiched between the mask and retaining layers.

30. The method of claim 26, wherein the mask 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 method of claim 26, 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.

32. The method of claim 26, wherein each collection insert comprises a hydrogel.

33. The method of claim 26, wherein the outer face of the retaining layer comprises an adhesive.

34. The method of claim 26, wherein before positioning said retaining layer and said collection inserts the outer face of the retaining layer is contacted with a first surface of a first removable liner.

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

36. The method of claim 26, wherein before positioning said mask and said collection inserts the outer face of the mask is contacted with a first surface of a second removable liner.

37. The method of claim 26, wherein before said positioning a first removable liner is attached to the outer face of the retaining layer, and a second removable liner is attached to the outer face of the mask.

38. The method of claim 26, wherein the outer face of the mask comprises an adhesive.

39. The method of claim 26, wherein said positioning further comprises aligning the first and second openings in the mask with the first and second openings in the retaining layer.

40. The method of claim 26, wherein after positioning the mask, retaining layer, and collection inserts, the mask and retaining layers are contacted along a central portion, wherein said central portion separates the first and second openings in each layer such that said first and second collection inserts are separately sandwiched between the mask and retaining layers.

41. The method of claim 26, wherein the electrode of each electrode assembly comprises a bimodal electrode.

42. The method of claim 41, wherein each electrode assembly further comprises a sensing electrode.

43. The method of claim 42, wherein each electrode assembly further comprises a reference electrode.

44. The method of claim 26, wherein said analyte is glucose.

45. The method of claim 26, wherein after positioning the mask, retaining layer, and collection inserts, the mask is bonded to the retaining layer, thereby producing a laminate of the collection assembly.

46. The method of claim 26, further comprising packaging the autosensor assembly and sealing the package, thereby producing a packaged autosensor assembly.

47. The method of claim 45, further comprising packaging the autosensor assembly and sealing the package, thereby producing a packaged autosensor assembly.

48. The method of claim 46, further comprising adding a hydrating insert to the package before sealing.

49. A method of producing an autosensor assembly, for use in an iontophoretic sampling device useful to monitor glucose present in a biological system, said method comprising:

providing (a) first and second collection inserts each insert comprising a hydrogel, each hydrogel comprising, (i) an ionically conductive material having first and second surfaces, and (ii) glucose oxidase;

(b) a mask comprising (i) a substantially planar material that is substantially impermeable to the selected analyte or derivatives thereof, and (ii) inner and outer faces, wherein said mask defines first and second openings and a border;

(c) a retaining layer, comprising inner and outer faces, wherein said retaining layer defines first and second openings and a border;

(d) first and second electrode assemblies, each electrode assembly comprising (i) first and second surfaces, and (ii) said first surface comprising a bimodal electrode, a reference electrode, and a sensing electrode; and

(e) a support tray; and

positioning (a) the inner face of the mask in facing relation with the first surface of each collection insert, such that (i) said first and second openings of the mask are, respectively, aligned with the first and second collection inserts, (ii) each opening of the mask exposes at least a portion of the first surface of the collection insert with which it is aligned, and (iii) said border extends beyond the first surface of each of the collection inserts to provide an overhang; and

(b) the inner face of the retaining layer in facing relation with the second surface of each collection insert, such that (i) said first and second openings of the retaining layer are, respectively, aligned with the first and second collection inserts, (ii) each opening of the retaining layer exposes at least a portion of the second surface of the collection insert with which it is aligned, and (iii) said border extends beyond the first surface of each of the collection inserts to provide an overhang;

(c) said first and second electrode assemblies relative to the outer face of the retaining layer such that the bimodal electrode, reference electrode, and sensing electrode, of the first electrode assembly are aligned with the first opening in the retaining layer, and the bimodal electrode, reference electrode, and sensing electrode of the second electrode assembly is aligned with the second opening in the retaining layer, and

(d) said support tray such that it contacts the second surface of each electrode assembly, thereby resulting in production of said autosensor assembly.

50. The method of claim 49, wherein the inner face of the mask contacts the inner face of the retaining layer, and the overhang provided by the mask and the overhang provided by the retaining layer sandwich the collection inserts therebetween.

51. The method of claim 50, wherein the border of said mask defines a perimeter and the border of the retaining layer defines a perimeter, and the perimeter of the mask is greater than the perimeter of the retaining layer thus forming an overhang of the mask relative to the perimeter of the retaining layer.

52. The method of claim 51, wherein after positioning the mask, retaining layer, and collection inserts, the mask is bonded to the retaining layer, thereby producing a laminate of the collection assembly.

53. The method of claim 52, wherein the mask 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.

54. The method of claim 52, 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.

55. The method of claim 52, wherein before positioning said retaining layer and said collection inserts the outer face of the retaining layer is contacted with a first surface of a first removable liner.

56. The method of claim 55, wherein said first removable liner has a plow-fold shape.

57. The method of claim 56, wherein before positioning said mask and said collection inserts the outer face of the mask is contacted with a first surface of a second removable liner.

58. The method of claim 57, further comprising packaging the autosensor assembly and sealing the package, thereby producing a packaged autosensor assembly.

59. The method of claim 58, further comprising adding a hydrating insert to the package before sealing.