Hand-held medical apparatus

• US 7,364,551 B2
• Filed: 11/08/2002
• Issued: 04/29/2008
• Est. Priority Date: 11/09/2001
• Status: Expired due to Term

• Current Assignee: Invoy Holdings, Inc.
• Original Assignee: Kamata LLC
• Inventors: Schick, Reed A., Allen, Jeffrey R., Sun, Larry, Danowski, Kristine L., McIntyre, James A., Rosner, Bettina M., Cranley, Paul E.
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US10/492,953
• Publication Number:
  US 20040236244A1
• Time in Patent Office: 1,999 Days
• Field of Search: 600/529, 600/538, 600531-533, 128/921, 73/233
• US Class Current: 600/532
• CPC Class Codes: A61B 10/00 Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis vaccination prophylaxis, vaccination therapy A61B17/20; Sex determination; Ovulation-period determination menstruation tables G06C3/00; Throat striking implements
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: C12P 7/04 acyclic
• CPC Class Codes: C12P 7/28 Acetone-containing products

Abstract

The subject invention provides a hand-held medical apparatus (10) for detecting a predetermined component of user breath and producing a breath-component signal over a measurement time. Such breath-component signal may be correlated to a user fat metabolism indicator.

Claims

1. A hand-held medical apparatus comprising:

a. a housing;

b. an inlet for receiving a sample of user breath;

c. a sensor for detecting acetone in said user breath using a biomolecule and producing a breath-component signal over a measurement time;

d. a sensing electrical circuit in electrical communication with said sensor for sensing said breath-component signal, wherein the magnitude of said breath-component signal is a function of the concentration of said acetone in said breath sample to be received into said inlet;

e. an analog to digital converter in electrical communication with said sensing electrical circuit for converting said breath-component signal to a digital signal;

f. a microprocessor for processing said digital signal into at least one of a data signal and a user fat metabolism indicator; and

g. a display in electrical communication with said microprocessor for displaying said at least one of a data signal and a user fat metabolism indicator.

2. The hand-held medical apparatus of claim 1, wherein said sensor is an electrochemical biosensor.

3. The hand-held medical apparatus of claim 2, further comprising means for removably retaining said electrochemical biosensor therewithin.

4. The hand-held medical apparatus of claim 1, wherein said sensor comprises:

a. means for removably receiving a disposable test matrix comprising an enzyme that selectively targets acetone as a substrate to produce a colored product, wherein the amount of said colored product produced is a function of the concentration of acetone in said breath sample introduced into said inlet;

b. a light source to illuminate said disposable test matrix; and

c. a light detector to detect light reflected from said disposable test matrix and to create said breath-component signal.

5. The hand-held medical apparatus of claim 1, wherein said sensor comprises:

a. means for removably receiving a disposable test matrix comprising an enzyme that selectively targets acetone as a substrate to produce a luminescent product, wherein the amount of said luminescent product produced is a function of the concentration of acetone in said breath sample introduced into said inlet; and

b. a light detector to detect light emitted from said disposable test matrix and to create said breath-component signal.

6. The hand-held medical apparatus of claim 5, further comprising a light source to illuminate said disposable test matrix.

7. The hand-held medical apparatus of claim 5, wherein said disposable test matrix further comprises a working electrode, a counter electrode and a reference electrode.

8. The hand-held medical apparatus of claim 1, wherein said sensor is a thermosensor system.

9. The hand-held medical apparatus of claim 8, wherein said thermosensor comprises a reference thermosensor and working thermosensor.

10. The hand-held medical apparatus of any of claims 4-7, further comprising a compressible, porous material that is retained adjacent to said disposable test matrix and operable to transfer acetone to said disposable test matrix when said compressible, porous material is compressed.

11. The hand-held medical apparatus of any of claims 1-9, further comprising data storage means.

12. The hand-held medical apparatus of any of claims 1-9, further comprising a personal data assistant in electrical communication with said microprocessor.

13. The hand-held medical apparatus of claim 12, wherein said personal data assistant further comprises a clock for associating the time at which said breath-component signal is produced.

14. The hand-held medical apparatus of claim 12, wherein said personal data assistant further comprises user input means by which information may be inputted as user-input data, wherein said user-input data is stored and used to create a user fat metabolism indicator.

15. The hand-held medical apparatus of claim 12, wherein said personal data assistant further comprises at least one of the following:

a. outgoing communication means by which data is transmittable to a computer external to said personal data assistant; and

b. incoming communication means by which information from a computer is receivable by said personal data assistant device as computer input data.

16. The hand held medical apparatus of claim 1, wherein said inlet comprises a removable mouthpiece.

17. The hand-held medical apparatus of claim 16, wherein the removable mouthpiece is disposable.

18. The hand-held medical apparatus of any of claims 1-9 or 16, wherein said microprocessor integrates said digital signal as a function of said measurement time to generate said data signal.

19. The hand-held medical apparatus of claim 1, wherein the inlet is disposable.

20. The hand-held medical apparatus of claim 1, wherein said sensor comprises an enzyme that selectively targets acetone.

21. The hand-held medical apparatus of claim 20, wherein:

at least a portion of said sensor is supported by a disposable strip comprising a gel or polymeric medium; and

said enzyme is immobilized in said gel or polymeric medium.

22. The hand-held medical apparatus of claim 1, wherein at least a portion of said sensor is supported by a disposable physical support.

23. The hand-held medical apparatus of claim 22, wherein said disposable physical support is a disposable substrate, and said sensor comprises:

a support layer, in which an enzyme that targets acetone is immobilized, positioned on said disposable substrate; and

at least two electrodes, each having an end disposed in said support layer, wherein said two electrodes are electrically coupled to provide said breath component signal.

24. The hand-held medical apparatus of claim 23, wherein said support layer comprises a moisture-absorbing material.

25. The hand-held medical apparatus of claim 24, wherein said support layer is a gel layer.

26. The hand-held medical apparatus of claim 22, wherein:

said housing comprises a conduit through which at least a portion of said user breath flows; and

said disposable physical support is removable from said conduit for replacement after each use of the hand-held medical apparatus.

27. The hand-held medical apparatus of claim 22, wherein said sensor comprises at least two electrodes supported by said disposable physical support.

28. The hand-held medical apparatus of claim 27, wherein said two electrodes are screen-printed onto said disposable physical support.

29. The hand-held medical apparatus of claim 22, wherein said disposable physical support is a disposable strip.

30. The hand-held medical apparatus of claim 29, wherein said disposable strip is a plastic strip.

31. The hand-held medical apparatus of claim 1, wherein said sensor comprises means for removably receiving a disposable test matrix comprising an enzyme that selectively targets the acetone and wherein said disposable test matrix further comprises a working electrode, a counter electrode and a reference electrode.

32. A breath analysis apparatus comprising:

a housing including a conduit through which a sample of user breath flows;

a sensor, for detecting acetone in at least a portion of said sample and producing a breath-component signal, wherein said sensor comprises a biomolecule;

a sensing circuit in electrical communication with said sensor for sensing said breath-component signal, wherein the magnitude of said breath-component signal is a function of the concentration of said acetone; and

a processor for processing an output from said sensing circuit, corresponding to said breath-component signal, into a data signal.

33. The breath analysis apparatus of claim 32, wherein said biomolecule is an enzyme.

34. The breath analysis apparatus of claim 32, wherein at least a portion of said sensor is supported by a disposable physical support.

35. The breath analysis apparatus of claim 32, wherein said sensor is an electrochemical biosensor.

36. The breath analysis apparatus of claim 32, wherein said processor is a microprocessor.

37. The breath analysis apparatus of claim 32, wherein said sensor further comprises an electrode and said breath analysis apparatus further comprises a compressible, porous material that is retained adjacent to said electrode and operable to transfer said acetone to said electrode when said compressible, porous material is compressed.

38. A hand-held medical apparatus comprising:

a. a housing;

b. an inlet for receiving a sample of user breath;

c. an electrochemical biosensor for detecting a component of said user breath using an enzyme that selectively targets acetone and producing a breath-component signal over a measurement time;

d. a sensing electrical circuit in electrical communication with said sensor for sensing said breath-component signal, wherein the magnitude of said breath-component signal is a function of the concentration of said component in said breath sample to be received into said inlet;

e. an analog to digital converter in electrical communication with said sensing electrical circuit for converting said breath-component signal to a digital signal;

f. a microprocessor for processing said digital signal into at least one of a data signal and a user fat metabolism indicator; and

g. a display in electrical communication with said microprocessor for displaying said at least one of a data signal and a user fat metabolism indicator.

39. A breath analysis apparatus for detecting acetone in a person'"'"'s breath, the a apparatus comprising:

a conduit through which a sample of a person'"'"'s breath flows;

an electrochemical biosensor positioned to be exposed to at least a portion of said sample and adapted to generate a signal when exposed to acetone, said biosensor comprising;

a disposable physical support, adapted for insertion into and removal from said breath analysis apparatus by a user; and

an enzyme able to selectively detect acetone in said sample, wherein said enzyme is supported by said disposable physical support; and

a processor, coupled to said electrochemical biosensor, adapted to process an output from said electrochemical biosensor into a data signal.