Apparatus and method for analysis of ear pathologies by detecting fluid in the ear, measuring body temperature and/or determining a characteristic of a fluid

• US 6,126,614 A
• Filed: 01/12/1999
• Issued: 10/03/2000
• Est. Priority Date: 01/12/1998
• Status: Expired due to Term

• Current Assignee: Innovia Medical, LLC
• Original Assignee: MDI Instruments, Inc.
• Inventors: Kunen, David, Jenkins, Geoffrey, Kimball, Sandra
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/228,967
• Time in Patent Office: 630 Days
• Field of Search: 600/549, 600/559, 600/573, 600/584
• US Class Current: 600/549
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/121 evaluating hearing capacity

Abstract

An improved indication of a condition of an ear of a subject, such as a human or other mammal, is provided by combining two or more measurements such as body temperature, detection of fluid in the ear (for example by acoustic reflectance), and/or a characteristic of any fluid in the ear. Results of any two of these measurements may be combined to provide improved diagnostic information. The combination of measured body temperature and a determined likelihood that fluid is present in the ear provides improved diagnostic information regarding the risk of an ear infection. In particular, if a subject has an elevated body temperature and the likelihood is high that fluid is present in the ear, an indication of a risk of ear infection may be provided by the device. The presence of fluid may be detected using acoustic reflectometry, tympanometry, pneumatic otoscopy, otoacoustic emissions or other mechanism. If temperature is measured in the ear, for example by using radiation thermometry, the combined instrumentation may be used to improve alignment between the device and the tympanic membrane, thus improving the accuracy of both temperature measurement and fluid detection. Chemical sensing of characteristics of any fluid in the ear may be combined with the detection of fluid or measurement of body temperature, or both, to provide improved diagnosis of ear pathologies. Chemical sensing determines a characteristic of the fluid, such as whether a bacterium or a virus is present. The device may provide diagnostic information from sensed characteristics of the fluid, measured likelihood that fluid is present in the ear and/or measured body temperature to indicate the risk of an ear infection. For example, the device may determine whether any fluid present is infected, and/or may identify bacteria in the fluid.

Claims

1. A medical instrument for analyzing an ear of a subject, comprising:

a temperature sensor for measuring body temperature of the subject and providing a first signal indicative thereof;

a fluid detector for detecting presence of fluid in the ear to provide a second signal indicative thereof; and

a controller connected to the temperature sensor and the fluid detector to control acquisition of the first and second signals.

2. The medical instrument of claim 1, further comprising:

a processor connected to receive the first and second signals for determining, using the measured body temperature and the detected presence of fluid in the ear, an indication of a condition of the ear of the subject.

3. The medical instrument of claim 1, wherein the fluid detector comprises:

an acoustic transducer for generating acoustic energy in the ear; and

a microphone for detecting acoustic energy from the ear.

4. The medical instrument of claim 1, wherein the fluid detector is an acoustic reflectometer comprising an acoustic transducer for generating acoustic waves at a plurality of frequencies and a microphone for receiving acoustic signals reflected from the ear to provide an output signal.

5. The medical instrument of claim 1, wherein the temperature sensor is a radiation sensor for detecting thermal radiation from the ear and providing a signal indicative thereof.

6. The medical instrument of claim 1, further comprising:

means for indicating to the user whether both an elevated temperature and fluid are detected in the ear.

7. The medical instrument of claim 6, wherein the means for indicating includes:

means for combining temperature and fluid information to provide an indication of a risk of ear infection.

8. The medical instrument of claim 1, further comprising:

an array of chemical sensors responsive to a characteristic of the fluid to provide a third signal indicative thereof; and

wherein the controller is further connected to the array of chemical sensors to control acquisition of the third signal.

9. The medical instrument of claim 8, wherein the characteristic of the fluid is the presence of a bacterium in the fluid.

10. The medical instrument of claim 9, further comprising:

means for indicating to the user whether an elevated temperature and a bacterium are detected in the ear.

11. The medical instrument of claim 9, further comprising:

means for indicating to the user whether both fluid and a bacterium are detected in the ear.

12. The medical instrument of claim 8, wherein the characteristic of the fluid is the presence of a virus in the fluid.

13. The medical instrument of claim 12, further comprising:

means for indicating to the user whether an elevated temperature and a virus are detected in the ear.

14. The medical instrument of claim 12, further comprising:

means for indicating to the user whether both fluid and a virus are detected in the ear.

15. The medical instrument of claim 8, further comprising:

means for indicating to the user whether an elevated temperature and a negative characteristic of the fluid are detected in the ear.

16. The medical instrument of claim 8, further comprising:

means for indicating to the user whether both fluid and a negative characteristic of the fluid are detected in the ear.

17. The medical instrument of claim 8, further comprising:

means for analyzing the first, second and third signals to provide an indication of risk of ear infection according to detected temperature, any detected fluid and any detected characteristic of the fluid.

18. A process for analyzing an ear of a subject, comprising:

measuring body temperature of the subject and providing a first signal indicative thereof;

detecting presence of fluid in the ear and providing a second signal indicative thereof; and

determining, using the measured body temperature and the detected presence of fluid in the ear, an indication of a condition of the ear of the subject.

19. The process of claim 18, wherein the step of detecting fluid includes:

generating acoustic energy in the ear; and

detecting acoustic energy from the ear.

20. The process of claim 19, wherein the step of generating acoustic energy includes generating acoustic waves at a plurality of frequencies.

21. The process of claim 18, wherein the step of measuring body temperature includes detecting thermal radiation from the ear and providing a signal indicative thereof.

22. The process of claim 18, further comprising:

indicating to the user whether both an elevated temperature and fluid are detected in the ear.

23. The process of claim 22, wherein the step of indicating includes combining temperature and fluid information to provide an indication of a risk of ear infection.

24. The process of claim 18, further comprising:

detecting a characteristic of the fluid to provide a third signal indicative thereof; and

wherein the step of determining further uses the detected characteristic of the fluid.

25. The process of claim 24, wherein the characteristic of the fluid is the presence of a bacterium in the fluid.

26. The process of claim 25, further comprising:

indicating to the user whether an elevated temperature and a bacterium are detected in the ear.

27. The process of claim 25, further comprising:

indicating to the user whether both fluid and a bacterium are detected in the ear.

28. The process of claim 24, wherein the characteristic of the fluid is the presence of a virus in the fluid.

29. The process of claim 28, further comprising:

indicating to the user whether an elevated temperature and a virus are detected in the ear.

30. The process of claim 28, further comprising:

indicating to the user whether both fluid and a virus are detected in the ear.

31. The process of claim 24, further comprising:

indicating to the user whether an elevated temperature and a negative characteristic of the fluid are detected in the ear.

32. The process of claim 24, further comprising:

indicating to the user whether both fluid and a negative characteristic of the fluid are detected in the ear.

33. The process of claim 24, further comprising:

analyzing the first, second and third signals to provide an indication of risk of ear infection according to detected temperature, any detected fluid and any detected characteristic of the fluid.

34. A device for providing an indication of a condition of an ear of a subject, comprising:

a first input for receiving a first signal indicative of a measured body temperature of the subject;

a second input for receiving a second signal indicative of a likelihood of presence of fluid in the ear of the subject; and

a processor connected to receive the first and second inputs for determining, using the measured body temperature and the likelihood of presence of fluid in the ear, the indication of the condition of the ear of the subject.

35. The device of claim 34, further comprising:

a third input for receiving a third signal indicative of a determined characteristic of any fluid in the ear of the subject; and

wherein the processor is connected to receive the third input and determines the indication of the condition of the ear of the subject further using the determined characteristic of any fluid in the ear of the subject.

36. A medical instrument for analyzing an ear of a subject, comprising:

an array of chemical sensors responsive to a characteristic of any fluid in the ear to provide a first signal indicative thereof; and

a fluid detector for detecting presence of fluid in the ear to provide a second signal indicative thereof; and

a controller connected to the array of chemical sensors and the fluid detector to control acquisition of the first and second signals.

37. The medical instrument of claim 36, wherein the characteristic of the fluid is the presence of a bacterium in the fluid.

38. The medical instrument of claim 37, further comprising:

means for indicating to the user whether both fluid and a bacterium are detected in the ear.

39. The medical instrument of claim 36, wherein the characteristic of the fluid is the presence of a virus in the fluid.

40. The medical instrument of claim 39, further comprising:

means for indicating to the user whether both fluid and a virus are detected in the ear.

41. The medical instrument of claim 36, further comprising:

means for indicating to the user whether both fluid and a negative characteristic of the fluid are detected in the ear.

42. The medical instrument of claim 36, further comprising:

a processor connected to receive the first and second signals for determining, using the detected presence of fluid in the ear and determined characteristic of the fluid, an indication of a condition of the ear of the subject.

43. The medical instrument of claim 36, wherein the fluid detector comprises:

an acoustic transducer for generating acoustic energy in the ear; and

a microphone for detecting acoustic energy from the ear.

44. The medical instrument of claim 36, wherein the fluid detector is an acoustic reflectometer comprising an acoustic transducer for generating acoustic waves at a plurality of frequencies and a microphone for receiving acoustic signals reflected from the ear to provide an output signal.

45. A medical instrument for analyzing an ear of a subject, comprising:

an array of chemical sensors responsive to a characteristic of the fluid to provide a first signal indicative thereof;

a temperature sensor for measuring body temperature of the subject and providing a second signal indicative thereof; and

a controller connected to the array of chemical sensors and the temperature sensor to control acquisition of the first and second signals.

46. The medical instrument of claim 45, wherein the characteristic of the fluid is the presence of a bacterium in the fluid.

47. The medical instrument of claim 46, further comprising:

means for indicating to the user whether an elevated temperature and a bacterium are detected in the ear.

48. The medical instrument of claim 45, wherein the characteristic of the fluid is the presence of a virus in the fluid.

49. The medical instrument of claim 48, further comprising:

means for indicating to the user whether an elevated temperature and a virus are detected in the ear.

50. The medical instrument of claim 45, further comprising:

means for indicating to the user whether an elevated temperature and a negative characteristic of the fluid are detected in the ear.

51. The medical instrument of claim 45, further comprising:

a processor connected to receive the first and second signals for determining, using the measured body temperature and the determined characteristic of fluid in the ear, an indication of a condition of the ear of the subject.

52. The medical instrument of claim 45, wherein the temperature sensor is a radiation sensor for detecting thermal radiation from the ear and providing a signal indicative thereof.