Device-system and method for monitoring multiple physiological parameters (MMPP) continuously and simultaneously

• US 5,511,553 A
• Filed: 10/28/1994
• Issued: 04/30/1996
• Est. Priority Date: 02/15/1989
• Status: Expired due to Fees

• Current Assignee: Jacob Segalowitz
• Original Assignee: Jacob Segalowitz
• Inventors: Segalowitz, Jacob
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/330,526
• Time in Patent Office: 550 Days
• Field of Search: 128/696, 128/903, 128/639, 128/640, 128/641, 128/644
• US Class Current: 600/508
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A device, system and method for monitoring continuously and simultaneously multiple physiological parameters from a patient, comprising a precordial strip-patch having first and second surfaces and multi-layer flexible structure permitting telemetering data by radio frequency or single wire or fiberoptic to hardware recording and display monitor. A plurality of conductive contact elements (CCEs) and microsensors are mounted in spaced apart positions on said strip-patch device-system permitting simultaneously and continuously detection, microprocessing and transmission of microsensored and detected physiological data for monitoring standard 12-lead ECG, cardiac output, respiration rate, peripheral blood oximetry, temperature of a patient, and electrocardiographic fetal heart monitoring, via a single wavelength of radio frequency transmission or single-wire or single fiberoptic connection to recording hardware or display monitor.

Claims

1. An electrode structure for use in a wireless patient monitoring system, including:

a) non-conductive strip means of selected length and width for supporting a signal transmitter on one side thereof and a plurality of conductive element pairs on the other side thereof, each of said conductive element pairs being in spaced relationship to each other and exposed on said other side of said strip means;

b) battery means having at least one voltage terminal and a ground terminal carried on said strip means;

c) microchip amplifier means carried on said strip means for amplifying signals and having signal input terminal means coupled to a first conductive element of each pair of conductive elements for receiving physiological signals therefrom and having output terminal means,

d) microchip multiplexer means carried on said strip means having input terminal means coupled to the output terminal means of the amplifier means for receiving the physiological signals therefrom and multiplexing same and having output terminal means,

e) a microchip encoder-modulator carried on said strip means for encoding and modulating multiplexed signals and having input terminal means coupled to said output terminal means of said multiplexer means and having output terminal means;

f) microchip transmitter carried by said strip means for transmitting coded-modulated signals and having input terminal means and output terminal means, said input terminal means of said transmitter being coupled to said output terminal means of said encoder-modulator means;

g) a wireless-signal radiator having input terminal means coupled to said output terminal means of said microchip transmitter means for radiating the coded-modulated signals;

h) means for applying operating potentials from said battery to said microchip amplifier means, encoder-modulator and transmitter means; and

i) means for coupling said ground terminal of said battery to said second conductive element of each pair of conductive elements.

2. An electrode structure according to claim 1 wherein said amplifier means includes noise coil means coupled to the second conductive element of the corresponding pair of conductive elements for detecting background noise, differential input amplifier means having a non-inverting input terminal coupled to said first conductive element of the corresponding pair of conductive elements and an inverting terminal coupled to said noise coil means for subtracting the background noise signal from the signal present on said first conductive element of the corresponding pair of conductive elements.

3. An electrode structure for use in a wireless patient monitoring system, including:

a) non-conductive strip means of selected length and width for supporting a signal transmitter on one side thereof and a plurality of conductive element pairs on the other side thereof, each of said conductive element pairs being in spaced relationship to each other and exposed on said other side of said strip means;

b) battery means having at least one voltage terminal and a ground terminal carried on said strip means;

c) a microchip amplifier carried on said strip means and having a signal input terminal coupled to a first conductive element of a corresponding pair of conductive elements for receiving heart signals therefrom and having an output terminal,

d) a microchip multiplexer carried on said strip means and having an input terminal coupled to the output terminal of said amplifier and having an output terminal,

e) a microchip encoder-modulator carried on said strip means and having an input terminal coupled to said output terminal of said amplifier and having an output terminal;

f) a microchip transmitter carried by said strip means and having an input terminal coupled to said output terminal of said encoder-modulator and an output terminal;

g) a wireless-signal radiator having an input terminal coupled to said output terminal of said microchip transmitter;

h) means for applying operating potentials from said battery to said microchip amplifier, encoder-modulator and transmitter; and

i) means for coupling said ground terminal of said battery to said second conductive element of each pair of conductive elements.

4. A strip assembly for placement on a patient having a heart with a precordium lying thereover, skin and right and left arms and legs comprising an elongate strip having first and second surfaces, a plurality of conductive contact elements being mounted in spaced apart position along the length of said strip, and being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin, a reference contact element mounted on said strip and serving as a common reference for each of said plurality of conductive contact elements, said reference contact element being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin, said contact elements capable of detecting psychological signals from said patient to produce a plurality of such physiological signals correlated with multiple physiological parameters of the patient;

conductor means connected to said plurality conductive contact elements and said reference contact element to permit electrical transmission of said detected signals, and microchip means carried by said strip coupled to said conductor means for amplifying multiplexing and transmitting the detected signals.

5. A strip assembly according to claim 4 wherein said strip is substantially continuous between said plurality of conductive elements.

6. A strip assembly according to claim 4 wherein the microchip means encodes and modulates the multiplexed detected signals.

7. A strip assembly according to claim 6 wherein the encoding and modulating is effected by pulse code modulation.

8. A strip assembly for placement on the chest of a patient having a heart with a precordium lying thereover, skin and right and left arms and legs comprising an elongate strip having first and second surfaces, six conductive contact elements identified as V₁ through V₆ being mounted in spaced apart position along the length of said strip, said V₁ through V₆ conductive contact elements being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s precordium, additional conductive contact elements identified respectively as LA and LL mounted on said strip near said V₆ conductive contact element, said LA and LL conductive contact elements being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin near said left arm and left leg respectively, an additional conductive contact element identified as RA mounted on said strip near said V₁ conductive contact element, said RA conductive contact element being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin near said right arm, said strip being substantially continuous between said conductive contact elements, a reference contact element mounted on said strip and serving as a common reference for each of said V₁ through V₆, LA, LL and RA conductive contact elements, said reference contact element being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin, said contact elements capable of detecting heart signals from said patient to produce a twelve-lead electrocardiogram, conductor means connected to said conductive contact elements and said reference contact element to permit electrical transmission of said detected heart signals, and microchip means carried on said strip including amplifier means coupled to said conductor means for amplifying detected heart signals, multiplexer means for multiplexing amplified detected heart signals, encoder-modulating means for encoding and modulating the multiplexed signals and transmitter means for transmitting the encoded and modulated multiplexed signals.

9. A strip assembly for use on a patient having a heart with a precordium lying thereover, skin and right and left arms and legs comprising an elongate strip having first and second surfaces, a plurality of conductive contact elements mounted in spaced apart positions along the length of said strip, said conductive contact elements being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin for detecting physiological signals from said patient indicative of multiple physiological parameters when said strip assembly is placed on the skin of the patient, a microchip mounted on said strip and conductor means electrically connecting said contact elements to said microchip, said microchip including means for transmitting a radio frequency signal which carries a multiplex of the signals detected by said contact elements.

10. A strip assembly according to claim 9 wherein the physiological parameters include at least one of cardiac function, respiration rate, peripheral blood oximetry, temperature, fetal heart function and thoracic impedance.

11. A strip assembly according to claim 10 wherein the physiological parameters include at least two of the listed parameters.

12. A strip assembly according to claim 11 wherein the physiological parameters include cardiac function and one other listed parameter.

13. A precordial strip assembly for use on a patient having a heart with a precordium lying thereover, skin and right and left arms and legs comprising an elongate strip having first and second surfaces, six conductive contact elements identified as V₁ through V₆ mounted in spaced apart positions along the length of said strip, said conductive contact elements being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin for detecting heart signals from said patient when said precordial strip assembly is placed on the precordium of the patient, a microchip mounted on said strip and conductor means electrically connecting said contact elements to said microchip, said microchip including means for transmitting a radio frequency signal which carries a multiplex of the heart signals detected by said contact elements.

14. A strip assembly for use on a patient having a heart with precordium lying thereover, skin and right and left arms and legs comprising an elongate strip having first and second surfaces, a plurality of conductive contact elements mounted in spaced apart positions along the length of said strip, said conductive contact elements being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin for detecting physiological signals from said patient indicative of multiple physiological parameters when said strip assembly is placed on the skin of the patient, junction means carried in a single region by said strip and electrically connected to said conductive contact elements and a microchip mounted on said strip in contact with said junction means, said microchip including means for transmitting a radio frequency signal which carries a multiplex of the signals detected by said contact elements.

15. A strip assembly for use on a patient having a heart with a precordium lying thereover, skin and right and left arms and legs comprising an elongate strip having first and second surfaces, six conductive contact elements identified as V₁ through V₆ mounted in spaced apart positions along the length of said strip, said conductive contact elements being exposed on the first surface of said strip and being adapted to contact said patient'"'"'s skin for detecting heart signals from said patient when said precordial strip assembly is placed on the precordium of the patient, junction means carried in a single region by said strip and electrically connected to said conductive contact elements and a microchip mounted on said junction means, said microchip including means for transmitting a radio frequency signal which carries a multiplex of the heart signals detected by said contact element.

16. An electrode assembly for use on a patient having a heart in a body comprising a layer of insulating material having first and second surfaces, a sufficient number of conductive contact elements for obtaining signals indicative of multiple physiological parameters mounted in spaced apart positions on said layer of insulating material, said contact elements being exposed on the first surface of said layer of insulating material and being adapted to contact said patient'"'"'s body for detecting physiological signals therefrom, a microchip mounted on said layer of insulating material and conductor means electrically connecting said contact elements to said microchip, said microchip including means for transmitting a radio frequency signal which carries a multiplex of the signals detected by said contact elements.

17. An electrode assembly for use on a patient having a heart in a body comprising a layer of insulating material having first and second surfaces, a sufficient number of conductive contact elements for obtaining a twelve-lead electrocardiogram mounted in spaced apart positions on said layer of insulating material, said contact elements being exposed on the first surface of said layer of insulating material and being adapted to contact said patient'"'"'s body for detecting heart signals therefrom, a microchip mounted on said layer of insulating material and conductor means electrically connecting said contact elements to said microchip, said microchip including means for transmitting a radio frequency signal which carries a multiplex of the heart signals detected by said contact elements.

18. A self-contained electrode structure for use in a wireless patient monitoring system for receiving physiological signals from the body of a patient comprising a layer of insulating material having first and second sides, a plurality of conductive elements carried by said layer of insulating material and disposed on said first side of said layer of insulating material, a battery carried on said second side of said layer of insulating material, microchip amplifier, multiplexing and transmitter means carried on said second side of said layer of insulating material and being coupled to said battery and to said conductive elements for receiving physiological signals from the body of the patient, and for amplifying same, multiplexing the amplified signals and transmitting multiplexed wireless signals in accordance with signals received.

19. A self contained electrode structure according to claim 18 wherein the plurality of conductive elements monitor simultaneously multiple at least two different physiological parameters.

20. A self-contained electrode structure for use in a wireless patient monitoring system for receiving signals from the heart in a body of a patient comprising a layer of insulating material having first and second sides, a plurality of conductive elements carried by said layer of insulating material and disposed on said first side of said layer of insulating material, a battery carried on said second side of said layer of insulating material, microchip amplifier, multiplexing and transmitter means carried on said second side of said layer of insulating material and being coupled to said battery and to said conductive elements for receiving heart signals from the heart of the patient and for transmitting amplified multiplexed wireless signals in accordance with heart signals received.

21. A self-contained electrode structure wherein a part of said conductive elements receive signals from the body of the patient correlated to a different physiological parameter.

22. A method of electrocardiographic monitoring on a patient having a body with a heart therein and a precordium lying over the heart comprising the steps of placing an electrode assembly on the precordium of said patient, said electrode assembly having an elongate strip with first and second surfaces and six conductive contact elements identified as V₁ through V₆ mounted in spaced apart positions along the length of said strip and a microchip mounted on said strip in electrical contact with said V₁ through V₆ conductive contact elements, placing conductive contact elements identified as LA, LL, and RA and a reference contact element on the body of said patient in electrical contact with said microchip, detecting heart signals from said patient through said contact elements, processing the heart signals in said microchip to produce a multiplex of twelve-lead electrocardiogram signals and transmitting a radio frequency signal which carries said multiplex of twelve-lead electrocardiogram signals.

23. A method of physiological monitoring a patient having a body with a heart therein and a precordium lying over the heart comprising the steps of placing an electrode assembly on the body of said patient, said electrode assembly having an elongate strip with first and second surfaces and a plurality of conductive contact elements mounted in spaced apart positions along the length of said strip and a microchip mounted on said strip in electrical contact with said conductive contact elements, placing a reference contact element on the body of said patient in electrical contact with said microchip, detecting multiple physiological signals from said patient through said contact elements, processing the detected signals in said microchip to produce a multiplex of the multiple physiological signals and transmitting said multiplexed signals.

24. The method of claim 23 wherein the step of transmitting uses a radio frequency signal.

25. The method of claim 23 wherein the step of transmitting uses an optic fiber.

26. An electrode assembly for use on a patient having a body comprising a plurality of layers of insulating material having first and second surfaces, a sufficient number of conductive contact elements for obtaining a twelve-lead electrocardiogram mounted on said layers of insulating material, at least one conductive contact element being mounted on each said layer of insulating material, said contact elements being exposed on the first surface of said layers of insulating material and being adapted to contact said patient'"'"'s body for detecting heart signals therefrom, a microchip mounted on one of said layers of insulating material and conductor means electrically connecting said contact elements to said microchip, said microchip including means for transmitting a radio frequency signal which carries a multiplex of the heart signals detected by said contact elements.

27. An electrode assembly for use on a patient having a body comprising a plurality of layers of insulating material having first and second surfaces, a sufficient number of conductive contact elements for obtaining signals indicative of multiple physiological parameters mounted on said layers of insulating material, at least one conductive contact element being mounted on each said layer of insulating material, said contact elements being exposed on the first surface of said layers of insulating material and being adapted to contact said patient'"'"'s body for detecting signals therefrom, indicative of multiple physiological parameters, a microchip mounted on one of said layers of insulating material and conductor means electrically connecting said contact elements to said microchip, said microchip including means for transmitting a signal which carries a multiplex of the multiple physiological parameter signals detected by said contact elements.

28. An electrode assembly according to claim 27 wherein the physiological parameters include at least one, correlated with cardiac function, respiration rate, peripheral blood oximetry, temperature, fetal heart function and thoracic impedance.

29. A method of electrocardiographic monitoring on a patient having a body with a heart therein comprising the steps of selecting an electrode assembly having a sufficient number of conductive contact elements for producing a twelve-lead electrocardiogram and a microchip electrically connected to said contact elements, placing said electrode assembly on the body of said patient, detecting heart signals from said patient through said contact elements and transmitting from said microchip a signal which carries a multiplex of the heart signals detected by said contact elements.

30. The method of claim 29 wherein the step of transmitting uses a radio frequency signal.

31. The method of claim 29 wherein the step of transmitting uses an optic fiber.

32. The method of claim 29 wherein the steps of transmitting is carried out telephonically.

33. A method of physiologically monitoring a patient having a body with a heart therein comprising the steps of selecting an electrode assembly having a sufficient number of conductive contact elements for producing signals indicative of at least two physiological parameters and a microchip electrically connected to said contact elements, placing said electrode assembly on the body of said patient, detecting signals from said patient through said contact elements and transmitting from said microchip a signal which carries a multiplex of the at least two physiological parameters detected by said contact elements.

34. The method of claim 33 wherein at least one of the physiological parameters is correlated with one of cardiac function, respiration rate, peripheral blood oximetry, temperature, fetal heart function and thoracic impedance.

35. The method of claim 33 including the further step of encoding and modulating the multiplex prior to transmitting.

36. The method of claim 35 wherein pulse code modulation is used for the step of encoding and modulating.

37. The method of claim 33 wherein the step of transmitting uses a radio frequency.

38. The method of claim 33 wherein the step of transmitting uses an optical fiber.

39. The method of claim 33 wherein the step of transmitting is effected telephonically.