Apparatus for monitoring a level of a chemical species in a body fluid

• US 6,479,015 B1
• Filed: 03/03/1998
• Issued: 11/12/2002
• Est. Priority Date: 03/03/1998
• Status: Expired due to Term

• Current Assignee: Pepex Biomedical, Inc.
• Original Assignee: Pepex Biomedical, LLC
• Inventors: Peper, Eric A., Long, Nathan R., Vreeke, Mark S., Say, James L.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/033,767
• Time in Patent Office: 1,715 Days
• Field of Search: 436/169, 436/811, 436/174, 436/166, 436/177, 422/56, 422/58, 422/61, 600/306, 600/309, 600/346, 600/362
• US Class Current: 422/419
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/32 involving dehydrogenase
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

An apparatus for monitoring a level of a chemical species in a body fluid includes a fluid collection layer adapted for receiving the body fluid. The fluid collection layer is dry prior to being brought into contact with the body fluid. A catalyst is provided in, on, or near the fluid collection layer so as to be in contact with the body fluid in the fluid collection layer. The catalyst facilitates a reaction of the chemical species in the body fluid. An indicator, responsive to the reaction of the chemical species, is also provided in, on, or near the fluid collection layer. A characteristic of the indicator changes in response to the reaction of the chemical species, thereby indicating the level of the chemical species in the body fluid. This apparatus can be used, for example, to monitor the level of lactate in perspiration during activities, such as exercise or other athletic exertions.

Claims

1. An apparatus for application to skin to monitor a level of a chemical species in a body fluid, the apparatus comprising:

a fluid collection layer adapted for collecting the body fluid when the apparatus is applied to the skin, wherein the fluid collection layer is dry prior to being brought into contact with the body fluid;

a catalyst disposed in contact with the fluid collection layer so as to be in contact with the body fluid in the fluid collection layer, the catalyst facilitating a reaction of the chemical species; and

an indicator disposed in contact with the catalyst so as to be responsive to the reaction of the chemical species, wherein the indicator is selected to have a characteristic that changes in response to the reaction of the chemical species while the apparatus is applied to the skin, thereby indicating the level of the chemical species in the body fluid.

2. The apparatus of claim 1, further comprising an adhesive layer disposed on the fluid collection layer for adhering the apparatus to an animal.

3. The apparatus of claim 1, wherein the characteristic of the indicator which changes in response to the reaction of the chemical species is a color of the indicator.

4. The apparatus of claim 1, wherein the characteristic of the indicator which changes in response to the reaction of the chemical species is a luminescence of the indicator.

5. The apparatus of claim 1, wherein the fluid collection layer comprises a first sublayer in which the catalyst is disposed and a second sublayer disposed over the first sublayer and containing the indictor.

6. The apparatus of claim 1, wherein the catalyst is disposed in the fluid collection layer.

7. The apparatus of claim 1, wherein the catalyst is disposed over the fluid collection layer.

8. The apparatus of claim 1, wherein the indicator is disposed in the fluid collection layer.

9. The apparatus of claim 1, wherein the fluid collection layer comprises a fibrous substrate.

10. The apparatus of claim 1, wherein the apparatus is solvent-free prior to being brought into contact with the body fluid.

11. The apparatus of claim 1, wherein the characteristic of the indicator changes in response to a level of a product compound formed in the reaction of the chemical species.

12. The apparatus according to claim 1, wherein the catalyst covers a majority of the fluid collection layer.

13. The apparatus of claim 1, wherein the change in the characteristic is reversible.

14. The apparatus of claim 13, further comprising a competing compound in the fluid collection layer, wherein the competing compound reverses the change in the characteristic as the level of the chemical species decreases.

15. The apparatus of claim 1, further comprising a base layer adapted for placement on an animal.

16. The apparatus of claim 15, wherein an adhesive is disposed on the base layer for adhering the apparatus to the animal.

17. The apparatus of claim 15, wherein the base layer has a plurality of openings to allow body fluid through the base layer to the fluid collection layer.

18. The apparatus of claim 1, further comprising a cover layer disposed over the fluid collection layer.

19. The apparatus of claim 18, wherein the cover layer comprises a window through which the fluid collection layer is viewable.

20. The apparatus of claim 19, wherein the window is formed in the shape of a letter, numeral, or symbol.

21. The apparatus according to claim 18, wherein the cover layer is larger than the fluid collection layer and an underside of the cover layer has an adhesive, the adhesive adapted to attach the cover layer to the fluid collection layer and to attach the apparatus to the skin.

22. The apparatus of claim 1, wherein the catalyst is an enzyme.

23. The apparatus of claim 22, wherein the catalyst is an oxidase.

24. The apparatus of claim 22, wherein the catalyst is a dehydrogenase.

25. The apparatus of claim 22, further comprising a reactant compound disposed in the substrate, the reactant compound reacts with the chemical species in the presence of the enzyme to form an intermediate compound, the intermediate compound reacting to form a product compound.

26. The apparatus of claim 25, wherein the reactant compound is NAD₊or NADP₊and the intermediate compound is NADH or NADPH, respectively.

27. An apparatus for application to skin to monitor a level of lactate in perspiration, the apparatus comprising:

a base layer adapted for placement on the skin of an animal,

a reaction layer disposed on the base layer, the reaction layer comprising an enzyme for catalyzing a reaction of the lactate in the perspiration to form a product compound;

an indicator layer disposed on the reaction layer, the indicator layer comprising an indicator responsive to the product compound, wherein the indicator is selected to change color in the presence of the product compound while the apparatus is applied to the skin of the animal; and

a cover layer disposed over the indicator layer, the cover layer having a window for viewing the underlying indicator layer;

wherein the reaction layer and indicator layer are dry prior to being brought into contact with the perspiration.

28. The apparatus of claim 27, wherein the reaction layer and the indicator layer form a fluid collection layer with the indicator compound and the catalyst disposed therein.

29. The apparatus according to claim 27, wherein the catalyst covers a majority of the base layer.

30. An apparatus for application to skin to monitor a level of a chemical species in a body fluid, the apparatus comprising:

a fibrous substrate adapted for collecting the body fluid when the apparatus is applied to the skin;

a catalyst disposed in contact with the fibrous substrate so as to be in contact with the body fluid in the fibrous substrate, the catalyst facilitating a reaction of the chemical species in the body fluid; and

an indicator disposed in contact with the catalyst so as to be responsive to the reaction of the chemical species, wherein the indicator is selected to have a characteristic that changes in response to the reaction of the chemical species while the apparatus is applied to the skin, thereby indicating the level of the chemical species in the body fluid.

31. The apparatus according to claim 30, wherein the catalyst covers a majority of the fibrous substrate.

32. An apparatus for application to skin to monitor a level of a chemical species in a body fluid, the apparatus comprising:

a base layer adapted for placement on an animal, said base layer adapted to allow flow of body fluid through the base layer;

a fluid collection layer adapted for collecting the body fluid flowing through the base layer when the apparatus is applied to the skin, the fluid collection layer being positioned above the base layer;

a catalyst layer, the catalyst being selected to facilitate the reaction of the chemical species, the catalyst layer being positioned above the fluid collection layer; and

an indicator layer positioned above the catalyst layer, the indicator layer selected to have a characteristic that changes in response to a reaction of the chemical species while the apparatus is applied to the skin, thereby indicating the level of the chemical species in the body fluid;

wherein the body fluid from the fluid collection layer must pass through the catalyst layer to reach the indicator layer.

33. The apparatus according to claim 32, wherein the fluid collection layer is absorbent.

34. The apparatus according to claim 32, wherein the catalyst layer covers a majority of the fluid collection layer.

35. The apparatus according to claim 32, wherein the characteristic of the indicator which changes in response to the reaction of the chemical species is a color of the indicator.

36. The apparatus according to claim 32, wherein the characteristic of the indicator which changes in response to the reaction of the chemical species is a luminescence of the indicator.

37. The apparatus according to claim 32, wherein the characteristic of the indicator changes in response to a level of product compound formed in the reaction of the chemical species.

38. The apparatus according to claim 32, wherein the base layer is an adhesive layer applied to the fluid collection layer.

39. The apparatus of claim 32, wherein the layers form a patch.

40. The apparatus according to claim 32, further comprising an adhesive layer applied to the base layer.

41. The apparatus according to claim 32, wherein the catalyst is an enzyme.

42. The apparatus according to claim 41, wherein the catalyst is an oxidase.

43. The apparatus according to claim 41, wherein the catalyst is a dehydrogenase.