Systems and methods for ambulatory monitoring of physiological signs

• US 20030135127A1
• Filed: 01/29/2003
• Published: 07/17/2003
• Est. Priority Date: 04/17/2000
• Status: Active Grant

• Current Assignee: Adidas AG
• Original Assignee: VivoMetrics, Inc.
• Inventors: Inman, Dana Michael, Sackner, Marvin A.
• Granted Patent: US 7,670,295 B2
• Time in Patent Office: Days
• US Class Current: 600/536
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/0806 by whole-body plethysmography measuring blood flow using plethysmography A61B5/0295; impedance plethysmography A61B5/053; measuring volume of the body or parts thereof A61B5/1073
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/1073 Measuring volume, e.g. of limbs
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/7232 : involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/7239 : using differentiation including higher order derivatives
• CPC Class Codes: A61B 7/003 : Detecting lung or respiration noise
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

The present invention relates to the field of ambulatory and non-invasive monitoring of a plurality of physiological parameters of a monitored individual. The invention includes a physiological monitoring apparatus with an improved monitoring apparel worn by a monitored individual, the apparel having attached sensors for monitoring parameters reflecting pulmonary function, or parameters reflecting cardiac function, or parameters reflecting the function of other organ systems, and the apparel being designed and tailored to be comfortable during the individual'"'"'s normal daily activities. The apparel is preferably also suitable for athletic activities. The sensors preferably include one or more ECG leads and one of more inductive plethysmographic sensor with conductive loops positioned closely to the individual to preferably monitor at least basic cardiac parameters, basic pulmonary parameters, or both. The monitoring apparatus also includes a unit for receiving data from the sensors, and for storing the data in a computer-readable medium. The invention also includes systems comprising a central data repository for receiving, storing, and processing data generated by a plurality of physiological monitored apparatus, and for making stored data available to the individual and to health care providers.

Claims

1. A monitoring apparatus for non-invasively monitoring physiological parameters of an individual comprising:

a monitoring garment comprising a shirt for the torso of the individual to be monitored,

one or more inductive plethysmographic (IP) sensors, each IP sensor comprising an inductance sensor including at least one conductive loop arranged to closely encircle the torso, wherein the inductance of the conductive loop is responsive to the cross-sectional area of the torso enclosed by the loop,

a cardiac cycle sensor for generating signals responsive to occurrence of cardiac ventricular contractions,

a signal cable for carrying signals from said sensors, and

a microprocessor unit comprising a microprocessor for receiving signals from said signal cable and for recording digital data derived from all received signals in a removable computer-readable memory media.

2. The apparatus of claim 1 wherein said cardiac cycle sensor comprises at least one electrocardiogram (ECG) electrode attached to said individual to be monitored.

3. The apparatus of claim 1 wherein said cardiac cycle sensor comprises at least one IP sensor closely fitting about the neck of said individual to be monitored, wherein signals the inductance of the IP sensor is responsive to cardiac ventricular contractions because the cross-sectional area of the neck is responsive to carotid artery pulsations generated by cardiac ventricular contractions and the inductance of the IP sensor is responsive to the cross-sectional area of the neck.

4. The apparatus of claim 1 wherein the computer-readable medium comprises a magnetic disk.

5. The apparatus of claim 1 wherein the computer-readable medium comprises a flash memory module.

6. The apparatus of claim 5 wherein the flash memory module has a capacity of 64 MB or more.

7. The apparatus of claim 1

wherein said monitoring garment further comprises a band for the neck of the individual to be monitored,

wherein said IP sensors comprise a neck inductive plethysmographic sensor operatively arranged for generating signals responsive to jugular venous pulse, carotid arterial pulse, respiration-related intra-pleural pressure changes, contraction of neck muscles, and swallowing deflections, and

wherein the signal cable further comprises an attachment to the conductive loop of the neck IP sensor.

8. The apparatus of claim 1 wherein said IP sensors comprise at least one abdominal IP sensor including one or more conductive loops and at least one rib cage IP sensor including one or more conductive loops operatively arranged for measuring breathing patterns of the patient.

9. The apparatus of claim 1 wherein said IP sensors comprise at least one thoracic IP sensor including one or more conductive loops operatively arranged for measuring ventricular stroke volume.

10. The apparatus of claim 1 wherein said IP sensors comprise at least one lower abdominal IP sensor operatively arranged for measuring intra-lower-abdominal contractions and dilations.

11. The apparatus of claim 1 wherein said IP sensors comprise one or two hemithoracic IP sensors operatively arranged for measuring breathing and paradoxical motion between two hemithoraces of the patient.

12. The apparatus of claim 1 further comprising one or more further sensors attached to the signal cable and selected from a group comprising a body position sensor for indicating a posture of the individual, a pulse oximeter for indicating arterial oxygenation saturation, and a throat microphone for indicating talking and snoring.

13. The apparatus of claim 12 further comprising at least two body position sensors, a first body position sensor mounted on said garment and a second body position sensor mounted elsewhere on the individual.

14. The apparatus of claim 1 wherein said IP inductive plethysmographic sensors are attached to said garment as an integral part of said garment via an attachment consisting of one of sewing, embroidering, embedding, weaving and printing said inductive plethysmographic sensor into said garment.

15. The apparatus of claim 1 wherein said microprocessor unit further comprises an audio device for generating audio indications to the individual being monitored.

16. The apparatus of claim 1 wherein said microprocessor unit further comprises a display unit for displaying viewable messages to the individual being monitored.

17. The apparatus of claim 1 wherein said microprocessor unit further comprises an input unit for the individual being monitored to input information or commands to said microprocessor unit.

18. The apparatus of claim 1 wherein said microprocessor unit further comprises a memory accessible to the microprocessor, and wherein the memory comprises encoded software instructions for causing the microprocessor to read input data and to write output data derived from the input data in the removable computer-readable memory media.

19. The apparatus of claim 18 wherein the memory further comprises encoded software instructions for causing the microprocessor to determine significant physiological events in the individual being monitored and to indicate audibly determined significant events to the individual.

20. The apparatus of claim 19 wherein the microprocessor unit comprises components for wirelessly transmitting determined events.

21. The apparatus of claim 18 wherein the memory further comprises encoded software instructions for causing the microprocessor to determine significant temporal physiological trends in the individual being monitored and to indicate audibly determined significant trends to the individual.

22. The apparatus of claim 21 wherein the microprocessor unit comprises components for wirelessly transmitting determined significant trends.

23. The apparatus of claim 18 wherein the memory further comprises encoded software instructions for causing the microprocessor to compress data before writing to the removable computer-readable memory media.

24. The apparatus of claim 1 wherein the microprocessor unit further comprises circuitry for deriving digital data from non-digital data received from the signal cable.

25. The apparatus of claim 1 wherein said monitoring apparatus further comprises circuitry for generating a variable-frequency signal from each IP sensor, the generated frequency being responsive to the inductance of the conductive loop of the IP sensor, and wherein the microprocessor unit further comprises circuitry for deriving digital data from the generated variable-frequency signals, the digital data comprising encoding of the variable frequency of the signals with errors of 100 ppm or less.

26. A monitoring apparatus for non-invasively monitoring physiological parameters of an individual comprising:

a monitoring garment comprising a shirt for the torso of the individual to be monitored,

one or more inductive plethysmographic (IP) sensors, each IP sensor comprising

(i) a longitudinal band of elastic material attached to said garment for closely encircling the torso,

(ii) an inductance sensor including at least one flexible conductive loop attached to the longitudinal band, wherein the inductance of the conductive loop is responsive to the cross-sectional area of the torso enclosed by the loop, and

(iii) a tightening device for adjusting circumferential tightness of the IP sensor to substantially prevent longitudinal movement of the IP sensor along the torso, and a microprocessor unit comprising a microprocessor for receiving signals from said IP sensors and for recording digital data derived from all received signals in a removable computer-readable memory media.

27. The apparatus of claim 26 wherein longitudinal motion of each IP sensor is substantially prevented when the physiological parameters indicated by the inductance of the conductive loop of the sensor do not measurably change.

28. The apparatus of claim 26 wherein the monitoring garment comprises excess fabric arranged to permit longitudinal stretching of the torso without applying force to the IP sensors sufficient to cause substantial longitudinal motion.

29. The apparatus of claim 28 wherein longitudinal motion of each IP sensor is substantial if physiological parameters indicated by the inductance of the conductive loop of the sensor change as the monitoring garment is worn by the individual.

30. The apparatus of claim 26 wherein the monitoring garment comprises fabric with sufficient longitudinal elasticity to permit longitudinal stretching of the torso without applying force to the IP sensors sufficient to cause substantial longitudinal motion.

31. The apparatus of claim 26 wherein the tightening device comprises a cinch band and a gripping device for releasably gripping excess cinch band under tension.

32. The apparatus of claim 26 wherein the tightening device comprises a drawstring.

33. The apparatus of claim 26 further comprising a cardiac timing sensor for generating signals responsive to cardiac ventricular contractions, and wherein said microprocessor unit further records digital data derived from signals received from said cardiac timing sensor.

34. The apparatus of claim 26 further comprising a signal cable for carrying signals from said sensors to said microprocessor unit.

35. A monitoring apparatus for non-invasively monitoring physiological parameters of an individual comprising

a monitoring garment comprising a shirt for the torso of the individual to be monitored and a longitudinal fastener for opening and closing the shirt,

one or more inductive plethysmographic (IP) sensors, each IP sensor comprising an inductance sensor including at least one flexible conductive loop arranged to closely encircle the torso, wherein the inductance of the conductive loop is responsive to the cross-sectional area of the torso enclosed by the loop,

a cardiac timing sensor for generating signals responsive to occurrence of cardiac ventricular contractions,

a signal cable for carrying signals from said sensors comprising at least one module, wherein the module is coupled to and electrically completes the conductive loops of the IP sensors, wherein termini of the conductive loops may be uncoupled from module, and wherein the module comprises circuitry for generating signals responsive to the IP sensors, and

a microprocessor unit comprising a microprocessor for receiving signals from said signal cable and for recording digital data derived from all received signals in a removable computer-readable memory media.

36. The apparatus of claim 35 wherein at least one IP sensor further comprises a tightening device for adjusting circumferential tightness of the IP sensor to substantially prevent longitudinal movement of the IP sensor along the torso, and wherein the tightening device can be arranged not to impede unfastening of the shirt.

37. The apparatus of claim 35 wherein the conductive loops of the IP sensors and the module further comprise mating connectors so that the conductive loops may be connected and disconnected from the module.

38. The apparatus of claim 35 wherein the signals generated by the module in response to each IP sensor comprise digital data encoding the frequency of an oscillator responsive to the inductance of the conductive loop of the IP sensor, the frequency being encoded with errors of 100 ppm or less.

39. The apparatus of claim 38 wherein errors of frequency encoding are 10 ppm or less.

40. The apparatus of claim 35 wherein the signals generated by the module in response to each IP sensor comprise signals of variable frequency, the frequency being responsive to the inductance of the conductive loop of the IP sensor.

41. The apparatus of claim 40 wherein the microprocessor unit further comprises circuitry for deriving digital data from the variable-frequency signals generated from each IP sensor, the digital data comprising encoding of the variable frequency of the signals with errors of 100 ppm or less.

42. The apparatus of claim 41 wherein the microprocessor unit further comprises multiplex circuitry for permitting single deriving circuitry to derive digital data from a plurality of variable-frequency signals.

43. A monitoring apparatus for non-invasively monitoring physiological parameters of an individual comprising:

a monitoring garment comprising a shirt for the torso of the individual to be monitored,

one or more inductive plethysmographic (IP) sensors, each IP sensor comprising an inductance sensor including at least one flexible conductive loop arranged to closely encircle the torso, wherein the inductance of the conductive loop is responsive to the cross-sectional area of the torso enclosed by the loop,

a cardiac timing sensor for generating signals responsive to occurrence of cardiac ventricular contractions,

a signal cable for carrying signals directly from the conductive loops of said IP sensors and for carrying signals from said sensor,

electronic circuitry comprising (i) a multiplexing switch for connecting the conductive loop of any one of the IP sensors to an oscillator, the oscillator having an oscillation frequency responsive to the inductance of the conductive loop connected by the multiplexing switch, and (ii) a demodulator operatively coupled to the oscillator and outputting digital data responsive to the oscillation frequency, and

a microprocessor unit comprising a microprocessor for receiving signals from said signal cable and for receiving digital data from said electronic circuitry and for recording digital data from received inputs in a removable computer-readable memory media.

44. The apparatus of claim 43 wherein the digital data responsive to the oscillation frequency has errors of 100 ppm or less.

45. The apparatus of claim 43 wherein the digital data responsive to the oscillation frequency has errors of 10 ppm or less.

46. The apparatus of claim 43 wherein said electronic circuitry is housed in said microprocessor unit.

47. The apparatus of claim 43 wherein the resistance of the data signal cables and the multiplexing switch from the conductive loop of any IP sensor to the oscillator is less than 1 Ω

.

48. The apparatus of claim 43 wherein the multiplexing switch is controlled so that oscillator is periodically connected to the conductive loop of each IP sensor for the duration of a sampling period.

49. The apparatus of claim 48 wherein the sampling period is 1 msec or less.

50. The apparatus of claim 48 wherein the digital data output by the demodulator comprises digital data encoding a count of a number cycles of the oscillator occurring within a sampling period and digital data encoding a count of a number of periods of a clock occurring within the counted oscillator cycles.

51. The apparatus of claim 50 wherein said microprocessor unit further comprises a memory accessible to the microprocessor, and wherein the memory comprises encoded software instructions for causing the microprocessor to determine the actual oscillator frequency by dividing the count of the number of oscillator cycles by the count of the number of clock periods.

52. The apparatus of claim 51 wherein the memory further comprises software instructions for causing the microprocessor to determine an more accurate frequency by combining the counts of a plurality of sampling periods.

53. A monitoring apparatus for non-invasively monitoring physiological parameters of an individual comprising:

a monitoring garment comprising a shirt for the torso of the individual to be monitored,

a plurality of sensors, said sensors comprising

(i) one or more inductive plethysmographic (IP) sensors, each IP sensor comprising an inductance sensor including at least one flexible conductive loop arranged to closely encircle the torso, wherein the inductance of the conductive loop is responsive to the cross-sectional area of the torso enclosed by the loop,

wherein at least one sensor comprises a transmitter for wirelessly transmitting signals generated by the sensor within the vicinity of said physiological monitoring apparatus,

a microprocessor unit comprising (i) a receiver for receiving signals wirelessly transmitted from said sensors, and (ii) a microprocessor for accepting the received signals and for recording digital data derived from the received signals in a removable computer-readable memory media.

54. The apparatus of claim 53 wherein at least one sensor generates output signals in a digital form, and wherein the transmitter transmits the generated digital signals.

55. The apparatus of claim 54 wherein the transmitter and the receiver conform to the Bluetooth standard.

56. The apparatus of claim 53 wherein at least one sensor generates variable-frequency analog output signals, and wherein the transmitter output is modulated by generated variable-frequency analog signal.

57. The apparatus of claim 53 wherein all sensors comprise a transmitter for wirelessly transmitting signals generated by the sensor within the vicinity of said physiological monitoring apparatus.

58. The apparatus of claim 53 further comprising a signal cable, wherein the output of at least one sensor is carried to said microprocessor unit by a signal cable, and wherein said microprocessor records digital data derived from signals carried by said signal cable.

59. The apparatus of claim 53 wherein said sensors further comprise a cardiac timing sensor for generating signals responsive to occurrence of cardiac ventricular contractions.

60. A system for the non-invasive physiological monitoring of physiological parameters of at least one individual comprising:

at least one physiological monitoring apparatus comprising a monitoring garment worn on the torso of an individual being monitored, wherein the monitoring apparatus stores in a digital form in a removable computer-readable memory media data, wherein the data is by sensors comprising generated from (i) one or more inductive plethysmographic (IP) sensors flexibly attached to the monitoring garment, and (ii) a cardiac timing sensor for generating signals responsive to cardiac ventricular contractions, and

a data repository for reading data from the removable computer-readable memory media that has been recorded by said physiological monitoring apparatus and for storing read data in a data archive, said data repository being remotely located from said physiological monitoring apparatus.

61. The system of claim 60 wherein said physiological monitoring apparatus further transmits data wirelessly, and wherein said data repository further receives data wirelessly that has been transmitted by said physiological monitoring apparatus, and then stores the received data.

62. The system of claim 61 wherein said physiological monitoring apparatus further comprises a microprocessor for processing the generated data for determining physiological events and alarms, and wherein the data wirelessly transmitted comprises the determined physiological events and alarms.

63. The system of claim 61 further comprising a local data repository co-located with said physiological monitoring apparatus, wherein the local data repository receives data wirelessly transmitted by said physiological monitoring apparatus and stores received data in a local data archive, and wherein the local data repository comprises display terminals for making stored data available to local health care professionals.

64. The system of claim 60 wherein said data repository further comprises display terminals for making stored data available to health care professionals and to users monitoring the operation of said system.

65. The system of claim 60 further comprising a plurality of physiological monitoring apparatus, each apparatus for monitoring a different individual, and wherein said data repository reads data from removable computer-readable memory media recorded by said plurality of physiological monitoring apparatus.

67. A computer readable medium comprising data recorded in digital form, wherein the recorded digital data comprises data responsive with errors of 100 ppm or less to the frequency of an oscillator connected to at least one conductive loop of at least one inductive plethysmographic sensor.