Non-invasive temperature monitoring device

• US 8,663,106 B2
• Filed: 03/22/2005
• Issued: 03/04/2014
• Est. Priority Date: 08/22/2002
• Status: Expired due to Fees

• Current Assignee: JB IP Acquisitions LLC
• Original Assignee: BodyMedia Incorporated (AliphCom Corp.)
• Inventors: Stivoric, John, Andre, David, Kasabach, Christopher, Hanlon, James, Vishnubhatla, Suresh, Pacione, Christopher, Boehmke, Scott, Teller, Eric, Gasbarro, James, Farringdon, Jonathan
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): SORIANO, BOBBY GILES
• Application Number:
  US11/088,002
• Publication Number:
  US 20050245839A1
• Time in Patent Office: 3,269 Days
• Field of Search: 600300-301, 128903-905, 128/920, 374163-166
• US Class Current: 600/301
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 2010/0019 based on measurement of temperature
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0008 Temperature signals
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: G01K 1/022 for recording
• CPC Class Codes: G01K 1/024 for remote indication
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A monitoring system comprises a module having at least one sensor and preferably skin and ambient temperature sensors within a housing. The device may be durable or disposable. The housing may be provided with certain surface features and shapes to facilitate mounting on and interface with the skin of the wearer for more accurate temperature measurement. A receiver may be provided to obtain and display data from the module. The module may also display the output data. The output data comprises both detected and derived data relating to physiological and contextual parameters of the wearer and may be transmitted directly to a local recipient or remotely over a communications network. The system is capable of deriving and predicting the occurrence of a number of physiological and conditional states and events and reporting the same as output data.

Claims

1. An apparatus for monitoring human status parameters, comprising:

a housing having a skin interface surface for creating an insulated interface with a wearer'"'"'s skin;

a skin temperature sensor that generates data indicative of a skin temperature of the wearer, said skin temperature sensor mounted within said housing and in thermal communication with said insulated interface;

a temperature sensor mounted on a side of the housing away from the wearer'"'"'s skin that generates data indicative of a temperature condition within a garment of the wearer, said garment surrounding said housing; and

a processor in electronic communication with said sensors for receiving said data indicative of the skin temperature of the wearer and said temperature condition within the garment and for generating a derived temperature-based parameter of the wearer.

2. The apparatus as described in claim 1, wherein said housing is further comprised of a convex skin interface surface.

3. The apparatus as described in claim 1, wherein said housing is further comprises a concave garment-facing surface.

4. The apparatus as described in claim 1, wherein said skin interface surface has a convex protrusion along a longitudinal axis.

5. The apparatus as described in claim 1, wherein said temperature sensors further comprise at least one thermistor.

6. The apparatus as described in claim 1 further comprising a heat flux sensor.

7. The apparatus as described in claim 6, wherein said housing further comprises an orifice extending from said skin interface surface to an ambient surface adjacent said heat flux sensor.

8. The apparatus as described in claim 1 further comprising an adhesive material for affixing said housing on the wearer'"'"'s skin.

9. The apparatus as described in claim 8, wherein said adhesive material further comprises at least one sensor.

10. The apparatus as described in claim 9, wherein said adhesive further comprises at least one electrical contact for electronic communication with said processor.

11. The apparatus as described in claim 1, wherein the temperature sensor is mounted on a side of the housing away from the skin interface surface.

12. The apparatus as described in claim 1, wherein said garment is a diaper.

13. The apparatus as described in claim 1 further comprising at least one of:

a motion sensor and a heart rate sensor.

14. The apparatus as described in claim 1 further comprising a sensor mounted remotely on a body of the wearer in electronic communication with said processor.

15. The apparatus as described in claim 1, wherein said derived temperature-based parameter is a core temperature of the wearer.

16. The apparatus as described in claim 1, wherein said derived temperature-based parameter is an event.

17. The apparatus as described in claim 16, wherein said event is one of:

urination and defecation.

18. The apparatus as described in claim 16, wherein said processor recognizes a signal prior in time to said event which is related to said event.

19. The apparatus as described in claim 18, wherein said processor causes a notification to be generated upon recognition of said signal.

20. The apparatus as described in claim 16, wherein said processor causes a notification to be generated upon occurrence of the event.

21. The apparatus as described in claim 1, wherein said derived temperature-based parameter is a physiological parameter.

22. The apparatus as described in claim 21, wherein said processor recognizes a signal prior in time to initiation of said physiological parameter.

23. The apparatus as described in claim 22, wherein said processor causes a notification to be generated upon recognition of said signal.

24. The apparatus as described in claim 21, wherein said processor causes a notification to be generated prior to or upon initiation of said physiological parameter.

25. The apparatus as described in claim 21, wherein said physiological parameter is selected from the group consisting of heart beat and energy expenditure.

26. The apparatus as described in claim 1, wherein said derived temperature-based parameter is an activity.

27. The apparatus as described in claim 26, wherein said processor recognizes a signal prior in time to initiation of said activity.

28. The apparatus as described in claim 27, wherein said processor causes a notification to be generated upon recognition of said signal.

29. The apparatus as described in claim 26, wherein said processor causes a notification to be generated upon initiation of said activity.

30. The apparatus as described in claim 26, wherein said processor causes a notification to be generated prior to initiation of said activity.

31. The apparatus as described in claim 1, wherein each of said sensors further comprises an array of sensors.

32. The apparatus as described in claim 1 further comprising input means for said wearer to input one of an additional physiological and additional demographic information, said additional information comprising input to the generation of said derived temperature-based parameter.

33. The apparatus as described in claim 32, wherein said temperature-based parameter is at least one of core temperature, body state, and activity.

34. The apparatus as described in claim 1, wherein said housing is mounted on a femoral region of said wearer.

35. The apparatus as described in claim 1, wherein said housing is mounted to at least one of:

an inguinal area of said wearer, an axillary area under an arm of said wearer, an upper arm of said wearer, an inside of a thigh of said wearer, a groin area of said wearer, an area behind an ear of said wearer, a forehead of said wearer, a sole of a foot of said wearer, a palm of said wearer, a finger of said wearer, a wrist of said wearer, an area between a corner of an eye and a side of a nose of said wearer, a chest of said wearer, and an area along a spine of said wearer.

36. The apparatus as described in claim 1, wherein said housing exerts pressure on the wearer'"'"'s skin.

37. The apparatus as described in claim 1, wherein said derived temperature-based parameter is utilized to predict one of:

ovulation, menstruation and hot flashes.

38. The apparatus as described in claim 1, wherein said derived temperature-based parameter is utilized to detect dislodgement of the housing from the body of said wearer.

39. The apparatus as described in claim 1, wherein at least a portion of said apparatus is disposable.

40. The apparatus as described in claim 1, wherein the entire apparatus is disposable.

41. The apparatus as described in claim 1, wherein said apparatus is affixed to one of:

a diaper and an article of clothing.

58. The apparatus according to claim 1 further comprising a sensor for sensing heart related parameters.

71. The apparatus according to any one of claims 1 and 42 further comprising a sensor for generating data indicative of a galvanic skin response sensor of the wearer.

72. The apparatus according to any one of claims 1 and 42 further comprising a sound sensor.

75. The apparatus according to any one of claims 1 and 42 further comprising a sensor selected from the group consisting of an accelerometer sensor, an ambient light sensor, an EMG sensor, an ECG sensor, and a skin impedance sensor.

77. The apparatus according to any one of claims 1 and 42 further comprising a proximity sensor.

79. The apparatus as described in claim 1 further comprising a galvanic skin response sensor.

42. An apparatus for monitoring human status parameters, comprising:

a module housing having a skin interface surface;

a skin temperature sensor that generates data indicative of a skin temperature of a wearer, said skin temperature sensor mounted within said housing and in thermal communication with said skin of said wearer;

a temperature sensor that generates data indicative of a temperature condition within a garment;

a first processor in electronic communication with said sensors for (i) receiving at least a portion of said data indicative of the skin temperature of the wearer and said temperature condition within the garment and (ii) transmitting at least a portion of said data indicative of said temperatures of said wearer to a receiver unit; and

a receiver unit having;

a receiver for receiving said transmitted data indicative of said temperatures of said wearer;

a second processor for generating a derived temperature-based parameter of said wearer; and

data output means for communication of said derived temperature-based parameter of said wearer, wherein said data output means provides an indication of a status of at least one of;

an event, an activity, and a body state.

43. The apparatus as described in claim 42, wherein said receiver and said module are adapted to be affixed to each other.

44. The apparatus as described in claim 42, wherein said data output means is at least one of:

a visual display, an audio speaker, a tactile signal generator, a haptic signal generator and a Braille display.

45. The apparatus as described in claim 42, wherein said receiver means further comprises an additional temperature sensor.

46. The apparatus as described in claim 42, further comprising a heat flux detector.

47. The apparatus as described in claim 42, wherein said indication comprises a prediction of at least one of an impending event, activity and body state.

48. The apparatus as described in claim 42, wherein said module and said receiver unit are capable of communication with only one another.

59. The apparatus according to claim 42 further comprising a sensor for generating data indicative of heart related parameters.

49. A system for monitoring human status parameters, comprising:

a housing comprising an insulated interface for a wearer'"'"'s skin;

a skin temperature sensor mounted on said housing that generates data indicative of the wearer'"'"'s skin temperature at said insulated interface;

a temperature sensor mounted on a side of the housing away from the wearer'"'"'s skin that generates data indicative of a temperature within a diaper of the wearer surrounding the housing; and

a processor in electronic communication with said sensors for receiving at a least a portion of said data indicative of the skin temperature of the wearer and said temperature in said diaper and for generating a status parameter of the wearer.

50. The system according to claim 49 further comprising a heart rate monitor mounted in the housing.

51. The system according to claim 49, wherein the status parameter is selected from the group consisting of a removal of the diaper, an activity period, a rest period, urination or defecation in the diaper, and dislodgement of the housing.

52. The system according to claim 50, wherein said processor is located in said housing.

53. The system according to claim 49, wherein said status parameter comprises a core body temperature.

54. The system according to claim 53, wherein the core body temperature is derived with an equation comprising a backward average of a temperature difference between the skin temperature and the temperature in the diaper.

55. The system according to claim 53, wherein the core body temperature is derived with an equation comprising a backward average of a temperature difference between the skin temperature and the temperature in the diaper and also comprising an average squared difference between the skin temperature and the temperature in the diaper.

56. The system according to claim 53, wherein said status parameter is derived using contextual information.

57. The system according to claim 49, wherein said processor is operable to generate a status parameter according to an algorithm, wherein said algorithm is modified by changes to said data indicative of skin temperature at said insulated interface and said data indicative of a temperature condition within an enclosed space.

60. The system according to claim 53, wherein the status parameter is derived using data from a heat flux detector.

61. The system according to claim 49 further comprising a sensor for generating data indicative of heart related parameters.

62. The system according to claim 49, wherein said status parameter is at least one of an event, an activity, or a body state.

63. The system according to claim 62, wherein said event is one of:

urination and defecation.

64. The system according to claim 62, wherein said processor recognizes a signal prior in time to said event, said signal being related to said event.

65. The system according to claim 62, wherein said processor recognizes a signal prior in time to said activity, said signal being related to said activity.

66. The system according to claim 62, wherein said processor recognizes a signal prior in time to initiation of said body state, said signal being related to said state.

67. The system according to any one of claims 64-66, wherein said processor causes a notification to be generated upon recognition of said signal.

68. The system according to claim 62, wherein said processor generates a signal upon initiation of said at least one of said event, said activity and said body state.

69. The system according to claim 62, wherein said processor generates a signal prior to initiation of said at least one of said event, said activity and said body state.

70. The system according to claim 49, wherein said insulated interface is created by pressing said skin temperature sensor against the wearer'"'"'s skin.

73. The system according to claim 49 further comprising a sensor for generating data indicative of a body potential of the wearer.

74. The system according to claim 49 further comprising a sound sensor.

76. The system according to claim 49 further comprising a sensor selected from the group consisting of an accelerometer sensor, an ambient light sensor, an EMG sensor, an ECG sensor, and a skin impedance sensor.

78. The system according to claim 49 further comprising a proximity sensor.