Portable remote patient telemonitoring system using a memory card or smart card

• US 6,454,708 B1
• Filed: 06/09/2000
• Issued: 09/24/2002
• Est. Priority Date: 04/15/1999
• Status: Expired due to Fees

• Current Assignee: Clearpath Partners, LLC
• Original Assignee: Nexan Limited
• Inventors: Place, John D., Lay, Graham, Llewellyn, Mike, Ferguson, Pete, Kumar, Harpal
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): MCCROSKY, DAVID J
• Application Number:
  US09/591,597
• Time in Patent Office: 837 Days
• Field of Search: 600/300, 600/301, 600/390, 600/393, 600/508, 600/509, 128/903, 128/904, 705/1, 705/2, 705/3, 607/77
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: G16H 10/65 stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10S 128/903 Radio telemetry
• CPC Class Codes: Y10S 128/904 Telephone telemetry

Abstract

A system and method for monitoring health parameters and capturing data from a subject. The system is characterized by a cordless, disposable sensor band with sensors for measuring full waveform ECG, full waveform respiration, skin temperature, and motion, and a connector which accepts a memory card or a smart card for storage of the measured data. After a predetermined period of time, such as when the sensor band is removed, the memory card or smart card is removed and inserted into a monitoring device which reads the stored health parameter data of the subject. The monitoring device includes a base station that includes a memory/smart card reader and is connected to conventional phone lines for transferring the collected data to a remote monitoring station. The base station may also capture additional clinical data, such as blood pressure data, and to perform data checks. Subject safety is enhanced by the ability of the base station to compare clinical data, e.g. ECG, against given profiles and to mark events when appropriate or when the base station is programmed to do so. The remote monitoring station allows the presentation and review of data (including events) forwarded by the sensor band. ECG analysis software and a user-friendly graphical user interface are provided to remotely analyze the transmitted data and to permit system maintenance and upkeep. In alternative embodiments, a smart card includes the sensor band'"'"'s electronics and/or signal transmission circuitry in conjunction with a portable data logger so that the electronics may be reused from one disposable sensor band to the next without limiting the patient'"'"'s range of movement. The system of the invention has useful application to the collection of subject clinical data during drug trials and medical testing for regulatory approvals as well as management of subjects with chronic diseases.

Claims

1. A health parameter data collection and monitoring system, comprising:

a smart card which stores said health parameter data;

a sensor band having a sensor assembly for application to a subject, said sensor assembly sensing health parameter data indicative of values of at least one health parameter of the subject, said sensor band further comprising a connector which accepts said smart card, said smart card comprising a memory and a microprocessor operable to drive said sensor assembly, receive signals comprising said health parameter data from said sensor assembly, and store said health parameter data in said memory; and

a monitoring station including a smart card reader which is adapted to read said health parameter data from said smart card.

2. A system as in claim 1, wherein said monitoring station comprises a base station unit connected to a remote monitoring station via a communications link, said base station unit including said smart card reader and a memory which stores health parameter data read from said smart card until at least one of said health parameter data and a summary of said health parameter data is transmitted to said remote monitoring station via said communications link.

3. A system as in claim 2, wherein said remote monitoring station requests transmission of health parameter data stored in said base station unit at predetermined times or conditions or on demand.

4. A system as in claim 3, wherein said remote monitoring station includes an interface which allows a user to set said predetermined times or conditions for said transmission of said health parameter data to said remote monitoring station.

5. A system as in claim 4, wherein said interface allows the user of the remote monitoring station to select a subject for review of at least that subject'"'"'s health parameter data.

6. A system as in claim 4, wherein said interface allows the user to simultaneously review and compare time synchronized health parameter data for a plurality of health parameters for a particular subject.

7. A system as in claim 4, wherein said interface permits the user to select at least one of unprocessed health parameter data and summary data for display to the user of the remote monitoring station.

8. A system as in claim 1, further comprising a database accessible by said monitoring station to store health parameter data for a plurality of subjects.

9. A system as in claim 8, wherein said monitoring station includes software which generates case record forms from at least the health parameter data stored for a subject in said database.

10. A system as in claim 1, wherein said sensor band is adapted for attachment to a chest of the subject and said sensor assembly senses health parameter data indicative of at least one of ECG, respiration, skin temperature, SpO₂ and subject motion.

11. A system as in claim 10, wherein said sensor band comprises a plurality of ECG sensor electrodes.

12. A system as in claim 11, wherein said sensor band further comprises an optional sensor band connector for accepting at least an additional ECG sensor electrode.

13. A system as in claim 10, wherein said smart card is adapted to store at least 24 hours'"'"' worth of said health parameter data.

14. A system as in claim 10, wherein said sensor band comprises signal processing circuitry that processes said health parameter data for storage on said smart card.

15. A system as in claim 14, wherein said smart card further comprises FM signal transmission circuitry, said system further comprising a data logger in range of said signal transmission circuitry so as to receive and store transmitted health parameter data for a period of time until said health parameter data may be downloaded to said monitoring station.

16. A system as in claim 15, wherein at least one of said smart card and said data logger comprises data compression circuitry that compresses received health parameter data.

17. A system as in claim 15, wherein said FM signal transmission circuitry inserts an identifier that identifies at least one of said smart card and said sensor band as the source of the transmitted health parameter data.

18. A system as in claim 10, wherein said smart card comprises signal processing circuitry for processing said signals comprising health parameter data.

19. A system as in claim 18, wherein said smart card further comprises FM signal transmission circuitry, said system further comprising a data logger in range of said signal transmission circuitry so as to receive and store transmitted health parameter for a period of time until said health parameter data may be downloaded to said monitoring station.

20. A system as in claim 19, wherein at least one of said smart card and said data logger comprises data compression circuitry that compresses received health parameter data.

21. A system as in claim 19, wherein said FM signal transmission circuitry inserts an identifier that identifies at least one of said smart card and said sensor band as the source of the transmitted health parameter data.

22. A system as in claim 1, wherein said connector comprises a battery, said battery providing electrical energy to said sensor band.

23. A system as in claim 1, wherein said smart card is rechargeable.

24. The system as in claim 1, wherein said smart card is adapted to receive health parameter data from at least a second sensing device.

25. The system as in claim 24, wherein said at least a second sensing device is adapted to collect health parameter data indicative of at least one of SpO₂, blood pressure, temperature, and subject motion.

26. A health parameter data collection and monitoring system, comprising:

a smart card which stores said health parameter data;

a sensor band having a sensor assembly for application to a subject, said sensor assembly sensing health parameter data indicative of values of at least one health parameter of the subject, said sensor band further comprising a connector which accepts said smart card, said smart card comprising a memory and a microprocessor operable to drive said sensor assembly, receive signals comprising said health parameter data from said sensor assembly, and store said health parameter data in said memory;

a base station unit including a smart card reader and a memory which stores health parameter data read from said smart card; and

a remote monitoring station connected to said base station unit via a communications link, said remote monitoring station uploading, via said communications link, health parameter data stored in said memory of said base station unit.

27. A system as in claim 26, wherein said base station unit includes a processor which calculates physiological parameter data including at least one of a subject'"'"'s heart rate and a subject'"'"'s respiration rate from said health parameter data and stores a summary of said physiological parameter data in said memory for transmission to said remote monitoring station.

28. A system as in claim 26, wherein said memory of said base station unit is a rolling first-in-first-out (FIFO) memory which stores said health parameter data irrespective of whether said health parameter data has been transmitted to said remote monitoring station.

29. A system as in claim 26, wherein said base station unit comprises at least one input connection for accepting auxiliary data input from an auxiliary health parameter sensor and said memory stores said auxiliary data input for transmission to said remote monitoring station.

30. A system as in claim 29, wherein said at least one input connection is operable for accepting auxiliary data from a plurality of devices, and said base station unit is operable to identify which of said plurality of devices is connected to said at least one input connection at any given time.

31. A system as in claim 29, wherein said base station unit time stamps said health parameter data and said auxiliary data and manages independently said auxiliary data and said health parameter data while stored in said memory of said base station unit.

32. A system as in claim 29, wherein said auxiliary health parameter sensor is at least one of a blood pressure sensor, a spirometer, a weigh scale, an oximeter, and a blood glucose meter.

33. A system as in claim 29, wherein said base station unit detects abnormal physiological conditions in said auxiliary data and indicates an event condition and stores event data indicating a significant physiological event in said memory when an abnormal physiological condition is detected.

34. A system as in claim 33, wherein said base station unit time stamps said health parameter data, said auxiliary data, and event data and manages independently said auxiliary data and said health parameter data while stored in said memory of said base station unit.

35. A system as in claim 29, wherein said base station unit includes a processor which calculates physiological auxiliary parameter data from said auxiliary data and stores a summary of said physiological auxiliary parameter data in said memory at said base station unit for transmission to said remote monitoring station.

36. A system as in claim 35, wherein said processor further performs ECG analysis of said health parameter data and stores ECG analysis data in said memory.

37. A system as in claim 35, wherein said memory separately stores said health parameter data and said calculated physiological auxiliary parameter data.

38. A system as in claim 35, wherein said remote monitoring station comprises a monitoring station processor and a monitoring station memory, said monitoring station processor performing ECG analysis of said health parameter data and stores ECG analysis data in said monitoring station memory.

39. A system as in claim 35, wherein said remote monitoring station comprises a monitoring station processor and a monitoring station memory, said monitoring station processor performing respiratory rate analysis of said health parameter data and stores respiratory rate analysis data in said monitoring station memory.

40. A system as in claim 35, wherein said remote monitoring station comprises a monitoring station processor and a monitoring station memory, said monitoring station processor performing SpO₂ analysis of said health parameter data and stores SpO₂ analysis data in said monitoring station memory.

41. A system as in claim 29, wherein said remote monitoring station includes an interface which allows a user to schedule auxiliary health parameter sensor measurements at said base station unit if such measurements are required.

42. A system as in claim 26, wherein said base station unit compares received health parameter data with predetermined ranges for detected physiological variables and detects abnormal physiological conditions in said health parameter data, said base station unit indicating an event condition and storing event data indicating a significant physiological event in said memory when said received health parameter data is outside said predetermined ranges or when an abnormal physiological condition is detected.

43. A system as in claim 42, wherein said memory of said base station unit is a rolling first-in-first-out (FIFO) memory which stores at least said health parameter data irrespective of whether said health parameter data has been transmitted to said remote monitoring station.

44. The system of claim 43, wherein said rolling first-in-first-out memory further stores event data irrespective of whether said event data has been transmitted to said remote monitoring station.

45. A system as in claim 42, wherein said remote monitoring station includes an interface which allows a user to set at least one of said predetermined ranges of said base station unit.

46. A system as in claim 42, wherein said remote monitoring station includes software which checks received data for event data and an interface which allows a user to view such event data, whereby if event data is detected, said interface allows the user of said remote monitoring station to view a desired amount of health parameter data before, during, and after an occurrence of an event condition indicated by said event data.

47. A system as in claim 26, wherein said communications link is a telecommunications link.

48. A system as in claim 47, wherein said remote monitoring station initiates a connection with said base station unit, and once the connection is established, said remote monitoring station and base station unit listen for commands.

49. A system as in claim 48, wherein said commands include a data request command from said remote monitoring station requesting health parameter data in a designated time range from said base station unit.

50. A system as in claim 26, wherein an ID of said base station unit is checked by said remote monitoring station before data is transmitted via said communications link.

51. A system as in claim 26, further comprising a database accessible by said remote monitoring station to capture and store health parameter data for a plurality of subjects and said remote monitoring station further includes an interface through which a user of the remote monitoring station may select a subject for review of at least that subject'"'"'s health parameter data.

52. The system of claim 51, wherein said interface is operable to maintain an audit trail of actions performed by the user when using said interface and of actions performed by said remote monitoring station.

53. A system as in claim 26, wherein said remote monitoring station is adapted to receive health parameter data transmitted by at least two base station units.

54. A system as in claim 53, wherein said remote monitoring station includes a server which controls the receipt and storage of health parameter data from said at least two base station units.

55. A health parameter data collection and monitoring system, comprising:

an insertable card including an FM signal transmitter;

a sensor band having a sensor assembly for application to a subject, said sensor assembly sensing health parameter data indicative of values of at least one health parameter of the subject, said sensor band further comprising a connector which accepts said insertable card, said insertable card operable to receive said health parameter data from said sensor assembly and transmit said health parameter data using said FM signal transmitter; and

a remote monitoring station including a radio module which is adapted to receive transmitted health parameter data from said insertable card and to store said health parameter data in a database.

56. A system as in claim 55, further comprising a portable data logger that receives transmitted health parameter data from said insertable card and stores said health parameter data until said data logger may download the received health parameter data to said remote monitoring station.

57. A system as in claim 56, wherein said sensor band comprises signal processing circuitry that processes said health parameter data for transmission to said portable data logger.

58. A system as in claim 56, wherein said insertable card comprises signal processing circuitry that processes said health parameter data for transmission to said portable data logger.

59. A method of collecting health parameter data, comprising the steps of:

providing a sensor band for application to a subject, said sensor band having a sensor assembly that produces health parameter data indicative of values of at least one health parameter of the subject;

providing a smart card for insertion into a connector of said sensor band, said smart card comprising a memory and a microprocessor operable to drive said sensor assembly, receive signals comprising said health parameter data from said sensor assembly, and store said health parameter data in said memory; and

providing a monitoring station including a smart card reader which is adapted to read said health parameter data from said smart card for storage in a database.

60. A method as in claim 59, wherein said monitoring station comprises a base station unit connected to a remote monitoring station via a communications link, said method comprising the additional step of storing said health parameter data in said base station unit until a designated time for transmission of said health parameter data to said remote monitoring station via said communications link.

61. A method of claim 59, wherein said monitoring station comprises a base station unit connected to a remote monitoring station via a communications link, said method comprising the additional step of storing said health parameter data in said base station unit until at least one of said health parameter data and a summary of said health parameter data is transmitted to said remote monitoring station via said communications link.

62. A method as in claim 60, comprising the additional step of transmitting said health parameter data to said remote monitoring station at said designated time, in response to a certain condition, or on demand.

63. A method as in claim 62, comprising the further step of allowing a user to set said designated time and certain condition for said transmission of said health parameter data to said remote monitoring station.

64. A method as in claim 63, comprising the further step of accessing said health parameter data stored in said database for medical diagnosis or analysis.

65. A method as in claim 64, wherein said step of accessing said health parameter data comprises the step of using the remote monitoring station to select a subject for review of at least that subject'"'"'s health parameter data.

66. A method as in claim 65, wherein said step of accessing said health parameter data comprises the step of simultaneously reviewing and comparing time synchronized health parameter data for a plurality of health parameters for the selected subject.

67. A method as in claim 64, wherein said step of accessing said health parameter data step comprises the step of permitting the user to select at least one of unprocessed health parameter data and summary data for display.

68. A method as in claim 64, comprising the further step of generating case record forms from at least the health parameter data stored for a subject in said database.

69. A method as in claim 59, comprising the further steps of determining whether the subject moved during a measurement of said health parameter data and deleting or ignoring health parameter data collected during a time the subject moved if such movement may have corrupted the health parameter data.

70. A method as in claim 69, wherein corruption of the health parameter data is determined by comparing motion data to at least one of an ECG waveform and a respiration waveform.

71. A method of collecting health parameter data, comprising the steps of:

providing a sensor band for application to a subject, said sensor band having a sensor assembly that produces health parameter data indicative of values of at least one health parameter of the subject;

providing a smart card for insertion into a connector of said sensor band, said smart card adapted receive said health parameter data from said sensor assembly and to transmit said health parameter data from said sensor assembly; and

providing a monitoring station including a receiver which is adapted to receive said transmitted health parameter data from said smart card for storage in a database.

72. A method as in claim 71, wherein said smart card comprises FM signal transmission circuitry, said method comprising the further steps of providing a data logger in range of said signal transmission circuitry so as to receive and store transmitted health parameter for a period of time until said health parameter data may be downloaded to said monitoring station.

73. A method as in claim 71, comprising the further step of compressing said transmitted health parameter data prior to transmission and storage.

74. A method as in claim 71, comprising the additional step of transmitting an identifier with said health parameter data that identifies at least one of said smart card and said sensor band as the source of the transmitted health parameter data.

75. A method of collecting health parameter data, comprising the steps of:

providing a sensor band for application to a subject, said sensor band having a sensor assembly that produces health parameter data indicative of values of at least one health parameter of the subject;

providing an insertable card including an FM signal transmitter for insertion into a connector of said sensor band, said insertable card adapted to receive said health parameter data from said sensor assembly and transmit said health parameter data from said sensor assembly; and

providing a monitoring station including a receiver which is adapted to receive said transmitted health parameter data from said insertable card for storage in a database.

76. A method of continuously monitoring a subject'"'"'s health parameters during a drug/therapy trial, comprising the steps of:

applying a sensor band having a sensor assembly to a subject whereby said sensor assembly produces health parameter data indicative of values of at least one health parameter of the subjects;

providing a drug/therapy to the subject and electronically providing event data indicating that the drug/therapy has been provided and when;

inserting a smart card into said sensor band, said smart card comprising a memory and a microprocessor operable to drive said sensor assembly, receive signals comprising said health parameter data from said sensor assembly, and store said health parameter data in said memory;

removing said smart card after a predetermined period of time; and

inserting said removed smart card into a remote monitoring station that captures said health parameter data and said event data for storage in a database as a continuous record of the subject'"'"'s health parameters during a trial period of said drug/therapy, whereby said subject'"'"'s physiological condition during said trial period may be monitored remotely.

77. A method as in claim 76, comprising the further step of electronically providing event data marking (1) that the subject feels ill and (2) when the subject feels ill.

78. A method as in claim 77, comprising the further step of collecting health parameter data at times before, during, and after the timing of an event marked by said event data and providing a display of any changes in said health parameter data as a result of said drug/therapy or of the subject feeling ill.