Physiologic monitoring initialization systems and methods

• US 20070208232A1
• Filed: 03/03/2006
• Published: 09/06/2007
• Est. Priority Date: 03/03/2006
• Status: Abandoned Application

• Current Assignee: Physiowave, Inc. (Omron Corporation)
• Original Assignee: Physiowave, Inc. (Omron Corporation)
• Inventors: Kovacs, Gregory
• Application Number:
  US11/367,155
• Publication Number:
  US 20070208232A1
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses

Abstract

According to one aspect, physiologic monitor and/or firmware piracy are reduced by initializing physiologic monitors in the field, e.g. in medical facilities or user homes, upon verifying user authorization. A physiologic monitor may include sensors such as electrocardiogram (ECG) electrodes, accelerometers, respiratory and/or fluid load impedance electrodes, and a temperature sensor. The monitor may be connected to an initialization console, which activates and configures the monitor by transferring an authorization code, firmware, a set of enabled sensors and sampling rates, a set of customized voice messages, and other parameters, and/or by programming a programmable logic array. The initialization console may be a computer situated in a doctor'"'"'s office or user'"'"'s home, programmed with initialization and analysis software, and capable of connecting to an authorization server at a time of use. Physiologic monitoring and configuration/authorization data may be stored in a removable digital memory capable of use with multiple disposable monitors.

Claims

1. A physiologic monitoring method comprising:

storing a set of physiologic monitor configuration data in a removable digital memory;

employing a wearable physiologic monitor including the removable digital memory to perform a set of physiologic measurements according to the configuration data on a subject wearing the physiologic monitor; and

storing digital physiologic data generated by the set of physiologic measurements in the removable digital memory.

2. The method of claim 1, wherein the set of physiologic measurements includes a set of electrocardiogram measurements.

3. The method of claim 1, wherein the set of physiologic measurements includes a set of acceleration measurements.

4. The method of claim 1, wherein the set of physiologic measurements includes a set of measurements selected from respiratory impedance measurements and fluid load impedance measurements.

5. The method of claim 1, wherein the configuration data comprises an indicator of an enabled sensor subset selected from a set of sensors supported by the physiologic monitor.

6. The method of claim 1, wherein the configuration data includes a set of sampling rates for a set of physiologic monitor sensors.

7. The method of claim 1, further comprising storing a subject identifier in the removable digital memory.

8. The method of claim 1, further comprising storing in the removable digital memory an identifier of a payment transaction for a use of the physiologic monitor.

9. The method of claim 1, further comprising storing in the removable digital memory an encryption key to be used by the physiologic monitor to encrypt the digital physiologic data.

10. The method of claim 1, further comprising:

employing the physiologic monitor to perform a diagnostic self-test; and

storing a set of diagnostic self-test results in the removable digital memory.

11. The method of claim 10, wherein performing the diagnostic self-test includes performing a test selected from a physiologic monitor battery test, a removable digital memory test, and a physiologic monitor circuit test.

12. The method of claim 1, further comprising:

generating a set of calibration factors for the physiologic monitor; and

storing the calibration factors in the removable digital memory.

13. The method of claim 1, further comprising storing a set of subject feedback data in the removable digital memory.

14. The method of claim 13, wherein the subject feedback data includes a voice message to be played back by the physiologic monitor.

15. The method of claim 14, wherein the voice message is customized according to an identity of the subject.

16. The method of claim 14, wherein the voice message comprises a reminder for the subject to perform an action.

17. The method of claim 14, wherein the voice message comprises a reminder for the subject to take a medication.

18. The method of claim 14, wherein the voice message comprises an alert indicating that a subject physiologic parameter value determined by the physiologic monitor meets a predetermined condition.

19. The method of claim 14, wherein the voice message comprises an alert indicating a fault condition for a sensor of the physiologic monitor.

20. The method of claim 14, wherein the voice message comprises an alert indicating a condition of the removable digital memory.

21. The method of claim 13, wherein the subject feedback data includes audio volume customization data for a physiologic monitor speaker.

22. The method of claim 21 wherein the audio volume customization data includes data setting a dependence of a volume of the physiologic monitor speaker on a current time.

23. The method of claim 21 wherein the audio volume customization data includes data setting a dependence of a volume of the physiologic monitor speaker on a current ambient light intensity measured by the physiologic monitor.

24. The method of claim 1, comprising connecting the removable digital memory to an initialization console to store the set of physiologic monitor configuration data in the removable digital memory while the physiologic monitor is not connected to the initialization console.

25. The method of claim 1, further comprising employing the removable digital memory sequentially in a plurality of disposable, wearable physiologic monitors to configure each of the plurality of physiologic monitors and to store digital physiologic data recorded by each of the plurality of physiologic monitors.

26. A wearable physiologic monitoring system comprising:

a wearable physiologic monitor comprising a set of physiologic sensors, signal conditioning circuitry connected to the sensors, and digital control logic connected to the signal conditioning circuitry; and

a removable digital memory connected to the digital control logic and storing physiologic monitor configuration data for configuring a set of physiologic sensing operations performed by the physiologic monitor, and subject physiologic monitoring data recorded by the physiologic monitor.

27. A physiologic monitoring method comprising:

storing a set of physiologic monitor authorization data in a removable digital memory;

transitioning a wearable physiologic monitor from an un-initialized state to an initialized state using the physiologic monitor authorization data stored in the removable digital memory, wherein the physiologic monitor in the un-initialized state is not user-operable to record a set of physiologic monitoring data from a subject, and wherein the physiologic monitor in the initialized state is user-operable to record the set of physiologic monitoring data from the subject;

employing the physiologic monitor including the removable digital memory to record the set of physiologic monitoring data on the subject wearing the physiologic monitor; and

storing the set of physiologic monitoring data in the removable digital memory.

28. A physiologic monitoring kit comprising:

a removable digital memory storing a set of physiologic monitor authorization data and configured to receive a set of physiologic monitoring data; and

a plurality of disposable, wearable physiologic monitors in an un-initialized state;

wherein each physiologic monitor is configured to connect to the removable digital memory and to transition from the un-initialized state to an initialized state upon receiving the physiologic monitor authorization data from the digital memory, wherein each physiologic monitor in the un-initialized state is not user-operable to record the set of physiologic monitoring data from a subject, and wherein each physiologic monitor in the initialized state is user-operable to record the set of physiologic monitoring data from the subject.

29. A physiologic monitoring method comprising:

upon verifying that a subject'"'"'s use of a wearable physiologic monitor is authorized, employing an initialization console to perform an activation of the physiologic monitor, wherein the activation transitions the physiologic monitor from a un-initialized state to an initialized state, wherein the physiologic monitor in the un-initialized state is not user-operable to perform a set of physiologic measurements, wherein the physiologic monitor in the initialized state is user-operable to perform the set of physiologic measurements; and

using the physiologic monitor to perform a set of physiologic measurements on the subject and store digital physiologic data generated by the physiologic measurements in a digital memory of the physiologic monitor.

30. The method of claim 29, wherein the set of physiologic measurements includes a set of electrocardiogram measurements.

31. The method of claim 29, wherein the set of physiologic measurements includes a set of acceleration measurements.

32. The method of claim 29, wherein the set of physiologic measurements includes a set of measurements selected from respiratory impedance measurements and fluid load impedance measurements.

33. The method of claim 29, wherein performing the activation comprises transferring from the initialization console to the physiologic monitor a set of firmware code enabling the physiologic monitor to perform the set of physiologic measurements.

34. The method of claim 29, wherein performing the activation comprises programming at least part of a programmable logic array of the physiologic monitor.

35. The method of claim 29, wherein performing the activation comprises enabling the physiologic monitor to record data sensed by a subset of a set of sensors supported by the physiologic monitor.

36. The method of claim 29, further comprising employing the initialization console to store a subject identifier in the digital memory.

37. The method of claim 29, further comprising employing the initialization console to store in the digital memory an identifier of a payment transaction for the subject'"'"'s use of the physiologic monitor.

38. The method of claim 29, further comprising storing in the digital memory an encryption key to be used by the physiologic monitor to encrypt the digital physiologic data.

39. The method of claim 29, further comprising employing the initialization console to store a set of subject feedback data in the digital memory.

40. The method of claim 39, wherein the subject feedback data includes a voice message to be played back by the physiologic monitor.

41. The method of claim 40, wherein the voice message is individually customized according to an identity of the subject.

42. The method of claim 40, wherein the voice message comprises a reminder for the subject to perform an action.

43. The method of claim 40, wherein the voice message comprises a reminder for the subject to take a medication.

44. The method of claim 40, wherein the voice message comprises an alert indicating that a subject physiologic parameter value determined by the physiologic monitor meets a predetermined condition.

45. The method of claim 40, wherein the voice message comprises an alert indicating a fault condition for a sensor of the physiologic monitor.

46. The method of claim 40, wherein the voice message comprises an alert indicating a condition of the digital memory.

47. The method of claim 39, wherein the subject feedback data includes audio volume customization data for a physiologic monitor speaker.

48. The method of claim 47 wherein the audio volume customization data includes data setting a dependence of a volume of the physiologic monitor speaker on a current time.

49. The method of claim 47 wherein the audio volume customization data includes data setting a dependence of a volume of the physiologic monitor speaker on a current ambient light intensity measured by the physiologic monitor.

50. A physiologic monitor initialization console comprising:

a server authorization unit for connecting to an authorization server over a wide area network to verify that a subject'"'"'s use of a wearable physiologic monitor is authorized; and

a physiologic monitor authorization unit connected to the server authorization unit, for performing an activation of the physiologic monitor upon verifying that the subject'"'"'s use of the wearable physiologic monitor is authorized, wherein the activation transitions the physiologic monitor from a un-initialized state to an initialized state, wherein the physiologic monitor in the un-initialized state is not user-operable to perform a set of physiologic measurements, wherein the physiologic monitor in the initialized state is user-operable to perform the set of physiologic measurements.

51. A physiologic monitoring method comprising:

receiving a set of authorization data for a wearable physiologic monitor, the authorization data identifying a subset of authorized monitoring uses of the physiologic monitor selected from a set of monitoring uses supported by the physiologic monitor; and

in response to receiving the authorization data, programming the physiologic monitor to enable the subset of authorized uses.

52. A physiologic monitoring method comprising:

upon verifying that a subject'"'"'s use of a wearable physiologic monitor is authorized, employing an initialization console to perform a configuration of the physiologic monitor, wherein the configuration defines a set of physiologic sensing operations to be performed by the physiologic monitor; and

using the physiologic monitor to perform a set of physiologic measurements on the subject and store digital physiologic data generated by the physiologic measurements in a digital memory of the physiologic monitor.

53. The method of claim 52, wherein the set of physiologic measurements include a set of electrocardiogram measurements.

54. The method of claim 52, wherein the set of physiologic measurements include a set of acceleration measurements.

55. The method of claim 52, wherein the set of physiologic measurements include a set of measurements selected from respiratory impedance measurements and fluid load impedance measurements.

56. The method of claim 52, wherein performing the configuration comprises specifying an enabled sensor subset selected from a set of sensors supported by the physiologic monitor.

57. The method of claim 52, wherein performing the configuration comprises setting a set of sampling rates for a set of physiologic monitor sensors.

58. The method of claim 52, wherein performing the configuration comprises transferring from the initialization console to the physiologic monitor a current real-time for setting a real-time clock of the physiologic monitor.

59. The method of claim 52, further comprising employing the initialization console to store a subject identifier in the digital memory.

60. The method of claim 52, further comprising employing the initialization console to store in the digital memory an identifier of a payment transaction for the subject'"'"'s use of the physiologic monitor.

61. The method of claim 52, further comprising storing in the digital memory an encryption key to be used by the physiologic monitor to encrypt the digital physiologic data.

62. The method of claim 52, further comprising employing the initialization console to store a set of subject feedback data in the digital memory.

63. The method of claim 62, wherein the subject feedback data includes a voice message to be played back by the physiologic monitor.

64. The method of claim 63, wherein the voice message is individually customized according to an identity of the subject.

65. The method of claim 63, wherein the voice message comprises a reminder for the subject to perform an action.

66. The method of claim 63, wherein the voice message comprises a reminder for the subject to take a medication.

67. The method of claim 63, wherein the voice message comprises an alert indicating that a subject physiologic parameter value determined by the physiologic monitor meets a predetermined condition.

68. The method of claim 63, wherein the voice message comprises an alert indicating a fault condition for a sensor of the physiologic monitor.

69. The method of claim 63, wherein the voice message comprises an alert indicating a condition of the digital memory.

70. The method of claim 62, wherein the subject feedback data includes audio volume customization data for a physiologic monitor speaker.

71. The method of claim 70 wherein the audio volume customization data includes data setting a dependence of a volume of the physiologic monitor speaker on a current time.

72. The method of claim 70 wherein the audio volume customization data includes data setting a dependence of a volume of the physiologic monitor speaker on a current ambient light intensity measured by the physiologic monitor.

73. A physiologic monitor initialization console comprising:

a server authorization unit for connecting to an authorization server over a wide area network to verify that a subject'"'"'s use of a wearable physiologic monitor is authorized; and

a physiologic monitor configuration unit connected to the server authorization unit, for performing a configuration of the physiologic monitor upon verifying that the subject'"'"'s use of the wearable physiologic monitor is authorized, wherein the configuration defines a set of physiologic sensing operations to be performed by the physiologic monitor.

74. A physiologic monitoring method comprising:

receiving a payment from a payor for a subject-specific set of authorized monitoring uses of a wearable physiologic monitor;

activating the set of authorized monitoring uses of the physiologic monitor by programming a set of configuration data in a digital memory of the physiologic monitor;

employing the physiologic monitor including the digital memory to perform a set of physiologic measurements according to the configuration data on the subject while the subject wears the physiologic monitor; and

storing digital physiologic data generated by the physiologic measurements in the digital memory.

75. The method of claim 74, wherein the set of physiologic measurements include a set of electrocardiogram measurements.

76. The method of claim 74, wherein the set of physiologic measurements include a set of acceleration measurements.

77. The method of claim 74, wherein the set of physiologic measurements include a set of measurements selected from respiratory impedance measurements and fluid load impedance measurements.

78. The method of claim 74, wherein the set of authorized monitoring uses is a subset of a set of monitoring uses supported by the physiologic monitor.

79. The method of claim 74, wherein receiving the payment and activating the subset of authorized uses comprises connecting the physiologic monitor to an initialization console, employing the initialization console to perform the payment, and employing the initialization console to program the set of configuration data in the digital memory.

80. The method of claim 74, further comprising storing a subject identifier in the digital memory.

81. The method of claim 74, further comprising storing in the digital memory an identifier of a transaction of the payment.

82. The method of claim 74, further comprising storing in the digital memory an encryption key to be used by the physiologic monitor to encrypt the digital physiologic data.

83. A physiologic monitoring method comprising:

connecting a digital memory of a wearable physiologic monitor to an initialization console;

employing the initialization console to perform an activation and a configuration of the physiologic monitor, wherein the activation transitions the physiologic monitor from a un-initialized state to an initialized state, wherein the physiologic monitor in the un-initialized state is not user-operable to perform a set of physiologic measurements, wherein the physiologic monitor in the initialized state is user-operable to perform the set of physiologic measurements, and wherein the configuration defines a set of physiologic sensing operations to be performed by the physiologic monitor;

disconnecting the digital memory from the initialization console, and thereafter employing the physiologic monitor to record subject physiologic data and to store subject physiologic monitoring data in the digital memory; and

employing the initialization console to display and analyze the subject physiologic monitoring data.