MONITORING PHYSIOLOGICAL CONDITION AND DETECTING ABNORMALITIES

• US 20080194975A1
• Filed: 05/02/2007
• Published: 08/14/2008
• Est. Priority Date: 02/08/2007
• Status: Active Grant

• Current Assignee: Heart Force Medical, Inc.
• Original Assignee: Heart Force Medical, Inc.
• Inventors: Kaminska, Bozena, MacQuarrie, David
• Granted Patent: US 7,846,104 B2
• Time in Patent Office: Days
• US Class Current: 600/483
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/1102 Ballistocardiography
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle

Abstract

A system for monitoring an individual'"'"'s physiological condition and detecting abnormalities therein, comprising concurrently receiving at least a first signal and a second signal. The first and second signals are conditioned to minimize background extraneous noise after which, each signal is concurrently processed and analyzed to detect repeating cyclical patterns and further characterized to identify individual components of the repeating cycles. At least one individual component in one signal is selected as a reference marker for a selected component in the other signal. The two signals are then synchronized, outputs produced therefrom and stored in a database. The system is provided with a plurality of devices for acquiring, transmitting and conditioning at least two physiological signals, a software program cooperable with a microprocessor configured for receiving said transmitted signals and conditioned signals, and processing said signals to characterize and synchronize said signals and provide signal outputs derived therefrom, a database for storing said transmitted signals, conditioned signals, synchronized signals, and output signals derived therefrom. The output signals are useful for reporting and optionally for retransmission to the individual'"'"'s body and providing physiologically stimulatory signals thereto.

Claims

1. A system for monitoring an individual'"'"'s physiological condition and detecting abnormalities therein, the system comprising;

a first device comprising a device configured for at least receiving, displaying and transmitting a first plurality of signals comprising electrical signals;

a set of electrodes wherein each electrode is capable of detecting electrical activity associated with a physiological condition of the individual and producing a corresponding electrical signal, said set of electrodes configured for attachment to the individual'"'"'s body and for communicating with and cooperating with said first device;

a second device configured for receiving and transmitting a second plurality of signals from the individual'"'"'s body, said second plurality of signals selected from the group comprising seismic signals, acoustic signals, image signals, chemical signals, biochemical signals and electrical signals;

a third device capable of receiving therein the first plurality and the second plurality of signals, said third device configured for conditioning the first plurality of signals and the second plurality of signals, and for transmitting said conditioned first plurality of signals and said conditioned second plurality of signals;

a software program provided with at least one algorithm configured for processing and synchronizing said conditioned first plurality of signals and said conditioned second plurality of signals, and deriving an output from said synchronized signals;

a microprocessor capable of receiving said conditioned first plurality of signals and said conditioned second plurality of signals from the third device, said microprocessor configured to cooperate with the software program to process and synchronize said conditioned first plurality of signals and said conditioned second plurality of signals, and to generate an output derived therefrom said synchronized signals indicative of the individual'"'"'s physiological condition; and

a database provided for storing therein signals transmitted from the first, second and third devices, and outputs generated by the microprocessor.

2. A system according to claim 1, wherein the first device comprises an electrocardiograph configured for at least receiving, displaying and transmitting a first plurality of signals comprising ECG signals, and the set of electrodes comprises a plurality of electrodes capable of detecting electrical activity associated with the heart beat of an individual and producing corresponding ECG signals, said set of electrodes configured for attachment to the individual'"'"'s body and for communicating with and cooperating with said electrocardiograph.

3. A system according to claim 2, wherein the second device is selected from the group comprising ballistocardiographs and seismocardiographs, and is configured for at least receiving, displaying and transmitting a second plurality of signals comprising BCG signals produced in and on the individual'"'"'s body as a result of cardiovascular system function, said second device provided with at least one seismic sensor configured for communicating with the individual'"'"'s body.

4. A system according to claim 3, wherein the seismic sensor is an accelerometer.

5. A system according to claim 4, wherein the accelerometer is coupled to a charge amplifier.

6. A system according to claim 2, additionally provided with at least one device configured for measuring at least one physiological parameter selected from the group comprising blood pressure, heart rate, and blood oxygen concentration.

7. A system according to claim 2, additionally provided with a graphical user interface configured to enable an operator to input data into the database, and to access signals and outputs stored therein the database.

8. A system according to claim 2, wherein the first plurality of signals is conditioned by passing said signals through a filter provided with a high-pass cutoff frequency of about 40 Hz and a low-pass filter of about 1 Hz.

9. A system according to claim 3, wherein the second plurality of signals is conditioned by passing said signals through a filter provided with a high-pass cutoff frequency of about 25 Hz and a low-pass filter of about 1 Hz.

10. A system according to claim 3, wherein the software program is provided with a at least one algorithm configured to firstly, detect and mark a first reference peak in a repeating cycle of wave patterns comprising the conditioned first plurality of ECG signals, then secondly, detect and mark a selected second reference peak in a repeating cycle of wave patterns comprising the conditioned second plurality of BCG signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals and producing a synchronized paired ECG-BCG signal set therefrom.

11. A system according to claim 10, wherein the first reference peak is a R peak in the first plurality of ECG signals, and the second reference peak is a H peak in the second plurality of BCG signals.

12. A system according to claim 3, wherein the software program is provided with a plurality of algorithms, wherein:

a first algorithm is configured to firstly, detect and mark a first reference peak in a repeating cycle of wave patterns comprising the conditioned first plurality of ECG signals, then secondly, detect and mark a selected second reference peak in a repeating cycle of wave patterns comprising the conditioned second plurality of BCG signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals and producing a synchronized paired ECG-BCG signal set therefrom; and

a second algorithm is configured for analyzing the synchronized paired ECG-BCG signal set, deriving, identifying, marking, and characterizing therefrom;

(a) the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals, and (b) the individual wave components comprising the repeating cycles of the conditioned second plurality of BCG signals, and producing an output therefrom.

13. A system according to claim 12, wherein the first reference peak is a R peak in the first plurality of ECG signals, and the second reference peak is a H peak in the second plurality of BCG signals.

14. A system according to claim 12, wherein the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals comprise P-Q-R-S-T peaks, and the individual wave components comprising the repeating cycles of the conditioned second plurality of BCG signals comprise at least H-I-J-K-L peaks.

15. A system according to claim 3, wherein the software program is provided with a plurality of algorithms, wherein:

a first algorithm is configured to firstly, detect and mark a first reference peak in a repeating cycle of wave patterns comprising the conditioned first plurality of ECG signals, then secondly, detect and mark a selected second reference peak in a repeating cycle of wave patterns comprising the conditioned second plurality of BCG signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals and producing a synchronized paired ECG-BCG signal set therefrom;

a second algorithm is configured for analyzing the synchronized paired ECG-BCG signal set, deriving, identifying, marking, and characterizing therefrom;

(a) the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals, and (b) the individual wave components comprising the repeating cycles of the conditioned second plurality of BCG signals, and producing an output therefrom; and

a third algorithm is configured for comparing the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals produced by the second algorithm, with the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals of at least one selected synchronized paired ECG-BCG signal set stored in the database, and to produce an output therefrom, said output storable in the database.

16. A system according to claim 12, wherein the at least one selected synchronized paired ECG-BCG signal set stored in the database is the individual'"'"'s resting-stage ECG-BCG signal set, and the synchronized paired ECG-BCG signal set produced by the second algorithm is the individual'"'"'s post-exercise ECG-BCG signal set

17. A system according to claim 3, wherein the software program is provided with a plurality of algorithms, wherein:

a first algorithm is configured to firstly, detect and mark a first reference peak in a repeating cycle of wave patterns comprising the conditioned first plurality of ECG signals, then secondly, detect and mark a selected second reference peak in a repeating cycle of wave patterns comprising the conditioned second plurality of BCG signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals and producing a synchronized paired ECG-BCG signal set therefrom;

a second algorithm is configured for analyzing the synchronized paired ECG-BCG signal set, deriving, identifying, marking, and characterizing therefrom;

(a) the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals, and (b) the individual wave components comprising the repeating cycles of the conditioned second plurality of BCG signals, and producing an output therefrom; and

a third algorithm is configured for comparing the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals produced by the second algorithm, with the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals of a selected plurality of synchronized paired ECG-BCG signal sets stored in the database, and to produce an output therefrom, said output storable in the database.

18. A system according to claim 14, wherein the synchronized paired ECG-BCG signal set produced by the second algorithm is the individual'"'"'s resting-stage ECG-BCG signal set, and the selected plurality of synchronized paired ECG-BCG signal sets comprises stored in the database comprises a plurality of synchronized resting-stage paired ECG-BCG signal sets produced from the individual during a plurality of spaced apart testing periods.

19. A system according to claim 14, wherein the synchronized paired ECG-BCG signal set produced by the second algorithm is the individual'"'"'s resting-stage ECG-BCG signal set, and the selected plurality of synchronized paired ECG-BCG signal sets comprises stored in the database comprises synchronized resting-stage paired ECG-BCG signal sets produced from a plurality of individuals.

20. As system according to claim 3, additionally provided with a fourth device configured to receive therein the outputs generated from said synchronized signals and to derive and produce therefrom electrical signals, said fourth device capable of controllably transmitting said electrical signals;

and

a fifth device capable of receiving from the fourth device said electrical signals, said fifth device configured for controllably

21. A method, using the system of claim 1, for monitoring an individual'"'"'s physiological condition and detecting abnormalities therein, the method comprising;

attaching the set of electrodes to selected points on the individual'"'"'s body and interconnecting said electrodes with the first device;

additionally attaching to a selected point on the individual'"'"'s body at least one appropriate signal detection device configured for communication with the second device and interconnecting said signal detection device with the second device;

interconnecting the first and second devices with the third device, the microprocessor provided with the software program, and with the database;

recording, processing and storing at least one set of resting-stage data for a selected period of time while the individual is lying in a prone position;

disconnecting the first and second devices from the set of electrodes and signal detection device, and the subjecting the individual to a selected stress for a selected period of time;

reconnecting the first and second devices to the set of electrodes and signal detection device, and then recording, processing and storing at least one set of post-stress data for a selected period of time while the individual is lying in a prone position;

comparing the at least one set of post-stress data to the at least one set of resting-stage data.

22. A method according to claim 21, wherein the first device comprises an electrocardiograph configured for at least receiving, displaying and transmitting a plurality of signals comprising ECG signals, and the set of electrodes comprises a plurality of electrodes capable of detecting electrical activity associated with the heart beat of an individual and producing corresponding ECG signals.

23. A method according to claim 22, wherein the second device is selected from the group comprising ballistocardiographs and seismocardiographs, and is configured for at least receiving from an appropriate signal detection device, displaying and transmitting a plurality of signals comprising BCG signals produced in and on the individual'"'"'s body as a result of cardiovascular system function, said second device provided with at least one seismic sensor configured for communicating with the individual'"'"'s body.

24. A method according to claim 23, wherein the signal detection device is an accelerometer.

25. A method according to claim 24, wherein the accelerometer is coupled to a charge amplifier.

26. A method according to claim 23, wherein the system is additionally provided with at least one device configured for measuring at least one physiological parameter selected from the group comprising blood pressure, heart rate, and blood oxygen concentration.

27. A method according to claim 23, wherein a graphical user interface is provided to enable an operator to input data into the database, and to access signals and outputs stored therein the database.

28. A method according to claim 23 wherein the resting-stage

29. A method according to claim 23, wherein the first plurality of ECG signals is conditioned by passing said signals through a filter provided with a high-pass cutoff frequency of about 40 Hz and a low-pass filter of about 1 Hz.

30. A method according to claim 23, wherein the second plurality of BCG signals is conditioned by passing said signals through a filter provided with a high-pass cutoff frequency of about 25 Hz and a low-pass filter of about 1 Hz.

31. A method according to claim 23, wherein:

(a) the resting-stage data comprise a first plurality of conditioned ECG signals and a second plurality of conditioned BCG signals, and (b) the post-exercise data comprise a first plurality of conditioned ECG signals and a second plurality of conditioned BCG signals.

32. A method according to claim 31, wherein the resting-stage data and the post-exercise data are separately processed, analyzed and characterized by a software program provided with at least one algorithm configured to:

firstly, detect and mark a first reference peak in a repeating cycle of wave patterns comprising the conditioned first plurality of ECG signals, then

secondly, detect and mark a selected second reference peak in a repeating cycle of wave patterns comprising the conditioned second plurality of BCG signals, then

thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals and producing a synchronized paired ECG-BCG signal set therefrom;

thereby producing a first synchronized paired ECG-BCG signal set therefrom the resting-stage data, and a second synchronized paired ECG-BCG signal set therefrom post-exercise data.

33. A method according to claim 32, wherein the first reference peak is a R peak in the first plurality of ECG signals, and the second reference peak is a H peak in the second plurality of BCG signals.

34. A method according to claim 31, wherein the resting-stage data and the post-exercise data are separately processed, analyzed and characterized by a software program provided with a plurality of algorithms, wherein:

the first algorithm is configured to firstly, detect and mark a first reference peak in a repeating cycle of wave patterns comprising the conditioned first plurality of ECG signals, then secondly, detect and mark a selected second reference peak in a repeating cycle of wave patterns comprising the conditioned second plurality of BCG signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals and producing a synchronized paired ECG-BCG signal set therefrom, thereby producing a first synchronized paired ECG-BCG signal set therefrom the resting-stage data, and a second synchronized paired ECG-BCG signal set therefrom post-exercise data; and

the second algorithm is configured for analyzing the synchronized paired ECG-BCG signal sets, deriving, identifying, marking, and characterizing therefrom;

(a) the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals, and (b) the individual wave components comprising the repeating cycles of the conditioned second plurality of BCG signals, thereby producing first output from the resting-stage synchronized paired ECG-BCG signal set, and a second output from the post-exercise synchronized paired ECG-BCG signal set.

35. A method according to claim 34, wherein the first reference peak is a R peak in the first plurality of ECG signals, and the second reference peak is a H peak in the second plurality of BCG signals.

36. A method according to claim 34, wherein the individual wave components comprise the repeating cycles of the conditioned first plurality of ECG signals comprise P-Q-R-S-T peaks, and the individual wave components comprise the repeating cycles of the conditioned second plurality of BCG signals comprise at least H-I-J-K-L peaks.

37. A method according to claim 31, wherein the resting-stage data and the post-exercise data are separately processed, analyzed and characterized by a software program provided with a plurality of algorithms, wherein:

a first algorithm is configured to firstly, detect and mark a first reference peak in a repeating cycle of wave patterns comprising the conditioned first plurality of ECG signals, then secondly, detect and mark a selected second reference peak in a repeating cycle of wave patterns comprising the conditioned second plurality of BCG signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of ECG signals and the conditioned second plurality of BCG signals and producing a synchronized paired ECG-BCG signal set therefrom, thereby producing a first synchronized paired ECG-BCG signal set therefrom the resting-stage data, and a second synchronized paired ECG-BCG signal set therefrom post-exercise data;

a second algorithm is configured for analyzing the synchronized paired ECG-BCG signal sets, deriving, identifying, marking, and characterizing therefrom;

(a) the individual wave components comprising the repeating cycles of the conditioned first plurality of ECG signals, and (b) the individual wave components comprising the repeating cycles of the conditioned second plurality of BCG signals, thereby producing first output from the resting-stage synchronized paired ECG-BCG signal set, and a second output from the post-exercise synchronized paired ECG-BCG signal set; and

a third algorithm is configured for comparing the individual wave components comprising the repeating cycles of the conditioned resting-stage synchronized paired ECG-BCG signal set, with the individual wave components comprising the repeating cycles of the conditioned post-exercise synchronized paired ECG-BCG signal, and to produce an output therefrom, said output storable in the database.

38. A method according to claim 37, wherein the third algorithm is additionally configured for comparing the individual wave components comprising the repeating cycles of one of the conditioned resting-stage synchronized paired ECG-BCG signal set and the conditioned post-exercise synchronized paired ECG-BCG signal, with a plurality of synchronized paired ECG-BCG signals selected from the database, and to produce outputs therefrom,

39. A method according to claim 38, wherein the plurality of synchronized paired ECG-BCG signals selected from the database comprise a plurality of resting-stage and post-exercise conditioned synchronized paired ECG-BCG signal sets collected from the individual during a plurality of spaced apart testing periods.

40. A method according to claim 38, wherein the plurality of synchronized paired ECG-BCG signals selected from the database comprise a plurality of resting-stage and post-exercise conditioned synchronized paired ECG-BCG signal sets collected from a plurality of individuals.

42. A system according to claim 1, wherein the software program is provided with a at least one algorithm configured to firstly, detect and mark a selected reference peak in a cycle of the conditioned first plurality of signals, then secondly, detect and mark a selected reference peak in a cycle of the conditioned second plurality of signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of signals and the conditioned second plurality of signals and producing a synchronized paired signal set therefrom, said paired signal set storable in the database.

43. A system according to claim 1, wherein the software program is provided with a plurality of algorithms, wherein:

a first algorithm is configured to firstly, detect and mark a selected reference peak in a cycle of the conditioned first plurality of signals, then secondly, detect and mark a selected reference peak in a cycle of the conditioned second plurality of signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of signals and the conditioned second plurality of signals and producing a synchronized paired signal set therefrom; and

a second algorithm is configured for deriving, identifying, marking, and characterizing individual components of the synchronized signal wave pattern output, and producing an output therefrom, said output storable in the database.

44. A system according to claim 1, wherein the software program is provided with a plurality of algorithms, wherein:

a first algorithm is configured to firstly, detect and mark a selected reference peak in a cycle of the conditioned first plurality of signals, then secondly, detect and mark a selected reference peak in a cycle of the conditioned second plurality of signals, then thirdly, synchronize the first reference peak and the second reference peak thereby synchronizing the conditioned first plurality of signals and the conditioned second plurality of signals and producing a synchronized paired signal set therefrom;

a second algorithm is configured for deriving, identifying, marking, and characterizing individual components of the synchronized signal set, and producing an output therefrom, said output storable in the database; and

a third algorithm is configured for comparing the individual components of the synchronized signal set derived by the second algorithm, with the individual components of a synchronized signal set stored in the database, and produced an output therefrom, said output storable in the database.

45. A system according to claim 4, wherein the output from the second algorithm characterizes post-stress individual components of the synchronized signal set, and the individual components of the synchronized signal set stored in the database characterize a resting stage.

41. A device configured for concurrently receiving, conditioning, and processing at least two pluralities of physiological signals from an individual, and additionally configured for synchronizing the at least two pluralities of physiological signals and transmitting a synchronized set of physiological signals, the device comprising;

a motherboard;

at least one electronic device configured to concurrently receive at least two pluralities of physiological signals;

a microprocessor configured to concurrently and separately perform on the incoming signals, a plurality of functions selected from the group comprising processing, analyzing, optimizing, and transforming said incoming signals;

a software program configured to cooperate with the microprocessor, the software program provided with a first algorithm configured for processing and synchronizing data from the at least two physiological signals and producing therefrom a synchronized paired signal set comprising repeating cycles, a second algorithm configured for detecting, marking, identifying and characterizing the individual wave components comprising the repeating cycles of one of the synchronized paired signal set, and a third algorithm configured for comparing, analyzing and characterizing a plurality of synchronized paired signal sets;

a database configured for storing therein pluralities of physiological signal sets, and pluralities of synchronized paired signal sets; and

a graphical user interface configured configured to enable an operator to input data into the database, and to access signals and outputs stored therein the database.