Apparatus and method for noninvasive blood glucose monitoring

• US 5,139,023 A
• Filed: 06/02/1989
• Issued: 08/18/1992
• Est. Priority Date: 06/02/1989
• Status: Expired due to Term

• Current Assignee: Theratech, Inc. (Dynatronics Corporation), Stanley Research Foundation
• Original Assignee: Theratech, Inc. (Dynatronics Corporation), Stanley Research Foundation
• Inventors: Higuchi, William I., Zhang, Jie, Ebert, Charles D., Stanley, Theodore H.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Smith, Chalin
• Application Number:
  US07/360,876
• Time in Patent Office: 1,173 Days
• Field of Search: 128/760, 128/767, 128/632, 128/637, 128/763, 604/289, 604/290, 604/304, 604/307, 604/20, 604/896, 514/975
• US Class Current: 600/368
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

The present invention is directed to novel methods and apparatus for noninvasive blood glucose monitoring. Blood glucose is monitored noninvasively by correlation with amount of glucose which permeates an epithelial membrane, such as skin or a mucosal membrane, into a glucose receiving medium over a specified time period. The glucose receiving medium preferably includes a glucose permeation enhancer capable of increasing the glucose permeability across the epithelial membrane. The glucose receiving medium is positioned against the epithelial membrane so that the permeation enhancer alters the permeability of the membrane. After sufficient time delay, the glucose receiving medium is removed and analyzed for the presence of glucose using conventional analytical techniques.

The apparatus within the scope of the present invention includes means for supporting the glucose receiving medium. Such means for supporting the glucose receiving medium may include a housing defining a receiving chamber therein which holds the glucose receiving medium and an opening to the receiving chamber. The means for supporting the glucose receiving medium may also include a hydrogel. The apparatus also preferably includes means for temporarily positioning the glucose receiving medium against the epithelial membrane.

Claims

1. An apparatus for noninvasive blood glucose monitoring comprising:

a quantity of glucose receiving medium comprising a permeation enhancer capable of increasing the glucose permeability across an epithelial membrane;

means for supporting the glucose receiving medium comprising a housing defining a receiving chamber therein and an opening to said receiving chamber;

means for temporarily positioning the glucose receiving medium against the epithelial membrane; and

a handle attached to the housing to facilitate positioning of the apparatus against the epithelial membrane and removal of the apparatus.

2. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the means for supporting the glucose receiving medium and the means for temporarily positioning the glucose receiving medium against the mucosal membrane comprise a hydrogel.

3. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the permeation enhancer comprises a natural bile salt.

4. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the glucose receiving medium comprises water.

5. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the glucose receiving medium comprises a cream.

6. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the glucose receiving medium comprises a suspension.

7. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the glucose receiving medium comprises an emulsion.

8. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the glucose receiving medium comprises a semisolid composition.

9. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, wherein the glucose receiving medium comprises a composition capable of reacting with glucose to form a substantially insoluble product.

10. An apparatus for noninvasive blood glucose monitoring as defined in claim 1, further comprising means for regulating the glucose permeation rate in order to provide a calibrated permeation rate despite variations in glucose permeation from patient to patient and from time to time.

11. An apparatus for noninvasive blood glucose monitoring comprising:

a quantity of glucose receiving medium comprising a permeation enhancer capable of increasing the glucose permeability across a mucosal membrane within a patient'"'"'s mouth;

means for supporting the glucose receiving medium;

means for temporarily positioning the glucose receiving medium against the mucosal membrane such that a quantity of glucose, which directly correlates on a real time basis with a patient'"'"'s actual blood glucose value, is capable of permeating the mucosal membrane into the glucose receiving medium; and

means for preventing contamination of the glucose receiving medium by saliva and other fluids present in the patient'"'"'s mouth.

12. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the means for supporting the glucose receiving medium comprises a housing defining a receiving chamber therein and an opening to said receiving chamber.

14. An apparatus for noninvasive blood glucose monitoring as defined in claim 12, further comprising means for accessing the receiving chamber such that glucose receiving medium may be introduced into the receiving chamber or removed therefrom while the housing is positioned against the mucosal membrane.

15. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the means for supporting the glucose receiving medium and the means for temporarily positioning the glucose receiving medium against the mucosal membrane comprise a hydrogel.

16. An apparatus for noninvasive blood glucose monitoring as defined in claim 15, wherein the hydrogel comprises hydroxypropylcellulose.

17. An apparatus for noninvasive blood glucose monitoring as defined in claim 15, wherein the hydrogel comprises carbopol.

18. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises a natural bile salt.

19. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises sodium cholate.

20. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises sodium dodecyl sulfate.

21. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises sodium deoxycholate.

22. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises taurodeoxycholate.

23. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises sodium glycocholate.

24. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises a fatty acid.

25. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises a saturated fatty acid.

26. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises an unsaturated fatty acid.

27. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises a surfactant.

28. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises an ionic surfactant.

29. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises a nonionic surfactant.

30. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the permeation enhancer comprises a synthetic permeation enhancer.

31. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the glucose receiving medium comprises water.

32. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the glucose receiving medium comprises a cream.

33. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the glucose receiving medium comprises a suspension.

34. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the glucose receiving medium comprises an emulsion.

35. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the glucose receiving medium comprises a semisolid composition.

36. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, wherein the glucose receiving medium comprises a composition capable of reacting with glucose to form a substantially insoluble product.

37. An apparatus for noninvasive blood glucose monitoring as defined in claim 11, further comprising means for regulating the glucose permeation rate in order to provide a calibrated permeation rate despite variations in glucose permeation from patient to patient and from time to time.

13. An apparatus for noninvasive blood glucose monitoring comprising:

a quantity of glucose receiving medium comprising a permeation enhancer capable of increasing the glucose permeability across a mucosal membrane;

means for supporting the glucose receiving medium comprising a housing defining a receiving chamber therein and an opening to said receiving chamber;

means for temporarily positioning the glucose receiving medium against the mucosal membrane; and

a handle attached to the housing to facilitate positioning of the apparatus against the mucosal membrane and removal of the apparatus.

38. An apparatus for noninvasive blood glucose monitoring comprising:

a quantity of glucose receiving medium comprising a permeation enhancer capable of increasing the glucose permeability across skin;

means for supporting the glucose receiving medium comprising a housing defining a receiving chamber therein and an opening to said receiving chamber;

means for temporarily positioning the glucose receiving medium against the skin; and

means for accessing the receiving chamber such that glucose receiving medium may be introduced into the receiving chamber or removed therefrom while the housing is positioned against the skin.

39. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the permeation enhancer comprises a natural bile salt.

40. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the permeation enhancer comprises DMSO.

41. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the permeation enhancer comprises ethanol.

42. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the permeation enhancer comprises a fatty acid.

43. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the permeation enhancer comprises a surfactant.

44. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the permeation enhancer comprises a synthetic permeation enhancer.

45. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the glucose receiving medium comprises water.

46. An apparatus for noninvasive, blood glucose monitoring as defined in claim 38, wherein the glucose receiving medium comprises a cream.

47. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the glucose receiving medium comprises a suspension.

48. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the glucose receiving medium comprises an emulsion.

49. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the glucose receiving medium comprises a semisolid composition.

50. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, wherein the glucose receiving medium comprises a composition capable of reacting with glucose to form a substantially insoluble product.

51. An apparatus for noninvasive blood glucose monitoring as defined in claim 38, further comprising means for regulating the glucose permeation rate in order to provide a calibrated permeation rate despite variations in glucose permeation from patient to patient and from time to time.

52. An apparatus for noninvasive blood glucose monitoring comprising:

a housing defining a receiving chamber therein and an opening to said receiving chamber;

a quantity of glucose receiving medium located within the receiving chamber, said glucose receiving medium comprising a permeation enhancer capable of increasing the glucose permeability across a mucosal membrane within a patient'"'"'s mouth;

means for temporarily positioning the housing against the mucosal membrane, such that the opening to the receiving chamber is positioned over the mucosal membrane such that a quantity of glucose, which directly correlates on a real time basis with a patient'"'"'s actual blood glucose value, is capable of permeating the mucosal membrane into the glucose receiving medium; and

means for preventing contamination of the glucose receiving medium by saliva and other fluids present in the patient'"'"'s mouth.

53. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the glucose receiving medium comprises water.

54. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the glucose receiving medium comprises a hydrogel.

55. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the glucose receiving medium comprises a semisolid composition.

56. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the glucose receiving medium comprises a composition capable of reacting with glucose to form a substantially insoluble product.

57. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, further comprising means for regulating the glucose permeation rate in order to provide a calibrated permeation rate despite variations in glucose permeation from patient to patient and from time to time.

58. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the permeation enhancer comprises a natural bile salt.

59. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the permeation enhancer comprises a synthetic permeation enhancer.

60. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, further comprising means for accessing the receiving chamber such that glucose receiving medium may be introduced into the receiving chamber or removed therefrom while the housing is positioned against the epithelial membrane.

61. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the epithelial membrane comprises a mucosal membrane.

62. An apparatus for noninvasive blood glucose monitoring as defined in claim 52, wherein the epithelial membrane comprises skin.