Systems and methods for ambulatory monitoring of physiological signs

• US 7,670,295 B2
• Filed: 01/29/2003
• Issued: 03/02/2010
• Est. Priority Date: 04/17/2000
• Status: Expired due to Fees

• Current Assignee: Adidas AG
• Original Assignee: VivoMetrics, Inc.
• Inventors: Sackner, Marvin A., Inman, Dana Michael
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US10/354,212
• Publication Number:
  US 20030135127A1
• Time in Patent Office: 2,589 Days
• Field of Search: 600/536, 600/547, 600/529, 600/534, 600/481, 600/483, 600508-509, 600388-390, 600/587, 600/595, 600/300, 600/386
• US Class Current: 600/483
• 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 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• 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 5/308 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• 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 device for ambulatory and non-invasive physiological monitoring comprising:

one or more inductive plethysmographic (IP) sensors for sensing changes in the size or shape of a selected portion of an ambulatory subject, where at least one such selected portion varies with the subject'"'"'s respiration; and

electronic unit sized to be carried by the subject and further comprising analog oscillator circuitry coupled to the IP sensors that generates analog signals with varying frequencies responsive to the changes sensed by the IP sensors, and digital counter circuitry coupled to the analog oscillator circuitry that receives the generated analog signals having varying frequencies, that counts complete cycles of the varying-frequency analog signals, that counts pulses of a digital clock signal occurring within the counted, complete cycles of the varying-frequency analog signals, and that outputs digital data representing the frequencies of the received, varying-frequency analog signals determined from the counts of digital-clock pulses and complete analog-signal cycles.

2. The apparatus of claim 1 wherein the electronic circuitry further comprises means that determines the received analog signal frequency by dividing the count of the digital clock pulses and the count of the complete analog signal cycles.

3. The device of claim 1 wherein the electronic unit further comprises multiplexing means so that the output digital data is responsive to each of a plurality of IP sensors one at a time.

4. The device of claim 1 wherein the electronic unit further comprises a processing means for processing the digital data to obtain one or more of a physiological parameter, a trend in a physiological parameter, and a physiological alarm condition.

5. The device of claim 1 further comprising retaining means for stably retaining at least one IP sensor with respect to an ambulatory subject.

6. The device of claim 1 wherein complete cycles of the varying-frequency analog signals that occur within pre-selected sampling periods are counted, the sampling periods being determined by counting the pulses of the digital clock signal.

7. The device of claim 1 wherein derived digital data has a frequency error of approximately 10 ppm or less.

8. The device of claim 1 wherein the clock signal has a frequency of approximately 96 MHz.

9. The device of claim 1 wherein the clock signal has a frequency between approximately 120 Mhz and up to the capabilities of the implementing logic circuitry.

10. The device of claim 1 wherein said IP sensors further comprise one or more conductive loops arranged about the torso so as to monitor beat-by-beat ventricular volume.

11. A monitoring apparatus for ambulatory and non-invasive physiological monitoring comprising:

one or more inductive plethysmographic (IP) sensors for sensing changes in the size or shape of a selected portion of an ambulatory subject, where at least one such selected portion varies with the subject'"'"'s respiration;

a garment adapted to fit about one or more selected portions of an ambulatory subject so as to stably retain the IP sensors with respect to the subject; and

electronic unit sized to be carried by the subject and further comprising analog oscillator circuitry coupled to the IP sensors that generates analog signals with varying frequencies responsive to the changes sensed by the IP sensors, and digital counter circuitry coupled to the analog oscillator circuitry that receives the generated analog signals having varying frequencies, that counts complete cycles of the varying-frequency analog signals, that counts pulses of a digital clock signal occurring within the counted, complete cycles of the varying-frequency analog signals, and that outputs digital data representing the frequencies of the received, varying-frequency analog signals determined from the counts of digital-clock pulses and complete analog-signal cycles.

12. The apparatus of claim 11 wherein at least one IP sensor comprises a band of elastic material with one or more conductive elements configured and arranged therein so that their configuration or arrangements vary in response to changes in the size or shape of a selected portion of the band.

13. The apparatus of claim 11 wherein at least one IP sensor is attached to the garment by sewing, embroidering, embedding, weaving, or printing.

14. The apparatus of claim 11 wherein the electronic unit further comprises circuitry for recording digital data, or processed data, or both, in a removable computer-readable media, the computer-readable medium comprising one or more of a removable magnetic disk memory, a removable optical disk memory, and a removable semiconductor memory.

15. The apparatus of claim 11 wherein the electronic unit further comprises circuitry for transmitting wirelessly digital data, or processed data, or both.

16. The apparatus of claim 11 wherein the electronic unit further comprises a processing means for determining, in response to input signals, one or more of a physiological parameter, a trend in a physiological parameter, and a physiological alarm condition.

17. The apparatus of claim 11 wherein the electronic unit further comprises input/output facilities for interacting with an ambulatory subject.

18. The apparatus of claim 11 further comprising a housing for the electronic circuitry that is sized and configured so as to be carried by an ambulatory subject.

19. The apparatus of claim 11 further comprising a plurality of housings for the electronic circuitry that are sized and configured so as to be carried by an ambulatory subject, at least one pair of which is interconnected by a signal cable, or a short distance radio link, or both.

20. The apparatus of claim 11 further comprising one or more of a body position sensor for sensing posture, a pulse oximeter for sensing an oxygen saturation, a throat microphone for sensing a sound, and an electrocardiogram (ECG) electrode for sensing an ECG signal.

21. The apparatus of claim 11 wherein the selected portions of an ambulatory subject comprise one or more of a selected portion of the rib cage that varies in size or shape during respiratory activity, a selected portion of the left rib cage that varies in size or shape during respiratory activity of the left lung, a selected portion of the thorax that varies in size or shape during cardiac activity, a selected portion of the right rib cage that varies in size or shape during respiratory activity of the left right lung, a selected portion of the abdomen that varies in size or shape during respiratory activity, a selected portion of an extremity that varies in size or shape during vascular activity, a selected portion of the neck that varies in size or shape during vascular activity, and a selected portion of the lower abdomen that varies in size or shape during gastrointestinal activity.

22. The device of claim 11 wherein complete cycles of the varying-frequency analog signals that occur within pre-selected sampling periods are counted, the sampling periods being determined by counting the pulses of the digital clock signal.

23. The device of claim 11 wherein said IP sensors further comprise one or more conductive loops arranged about the torso so as to monitor beat-by-beat ventricular volume.

24. A system for ambulatory and non-invasive physiological monitoring comprising:

a plurality of physiological monitoring apparatus, each apparatus comprising

one or more inductive plethysmographic (IP) sensors for sensing changes in the size or shape of a selected portion of an ambulatory subject, where at least one such selected portion varies with the subject'"'"'s respiration;

retaining means for stably retaining at least one IP sensor on an ambulatory subject, and

electronic unit sized to be carried by the subject and further comprising analog oscillator circuitry coupled to the IP sensors that generates analog signals with varying frequencies responsive to the changes sensed by the IP sensors, and digital counter circuitry coupled to the analog oscillator circuitry that receives the generated analog signals having varying frequencies, that counts complete cycles of the varying-frequency analog signals, that counts pulses of a digital clock signal occurring within the counted, complete cycles of the varying-frequency analog signals, and that outputs digital data representing the frequencies of the received, varying-frequency analog signals determined from the counts of digital-clock pulses and complete analog-signal cycles, and

a data repository for receiving the digital data from the physiological monitoring apparatus, and storing the digital data in a data archive.

25. The apparatus of claim 24 wherein the electronic unit further comprises circuitry for recording the digital data in a removable computer-readable media and wherein the data repository further comprises circuitry for reading the digital data from the removable computer-readable, or wherein the electronic unit further comprises circuitry for transmitting wirelessly digital data, or processed data, or both and wherein the data repository further comprises circuitry for receiving wirelessly transmitted digital data, or both.

26. The apparatus of claim 24 wherein the data repository further comprises means to process the received data, the processing comprising determining one or more of a physiological parameter, a trend in at least one physiological parameter, and a physiological alarm condition.

27. The device of claim 24 wherein said IP sensors further comprise one or more conductive loops arranged about the torso so as to monitor beat-by-beat ventricular volume.