Systems and methods for signal acquisition and visualization

• US 10,485,485 B1
• Filed: 02/08/2019
• Issued: 11/26/2019
• Est. Priority Date: 05/09/2018
• Status: Active Grant

• Current Assignee: BioSig Technologies, Inc.
• Original Assignee: BioSig Technologies, Inc.
• Inventors: Drakulic, Budimir S., Fakhar, Sina, Foxall, Thomas G., Vlajinic, Branislav
• Primary Examiner(s): Foxx, Chico A
• Application Number:
  US16/271,466
• Publication Number:
  US 20190343463A1
• Time in Patent Office: 291 Days
• Field of Search: None
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 2562/223 Optical cables therefor
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/308 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7217 : of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61B 5/7221 : Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7225 : Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7246 : using correlation, e.g. template matching or determination of similarity
• 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 40/63 : for local operation
• CPC Class Codes: H01L 2924/14335 : Digital signal processor [DSP]
• CPC Class Codes: H02H 9/04 : responsive to excess voltage lightning arrestors H01C7/12, H01C8/04, H01G9/18, H01T
• CPC Class Codes: H02H 9/045 : adapted to a particular application and not provided for elsewhere
• CPC Class Codes: H03F 2200/129 : there being a feedback over the complete amplifier
• CPC Class Codes: H03F 2200/171 : A filter circuit coupled to the output of an amplifier
• CPC Class Codes: H03F 2200/234 : the input amplifying stage being one or more operational amplifiers
• CPC Class Codes: H03F 2200/375 : Circuitry to compensate the offset being present in an amplifier
• CPC Class Codes: H03F 2200/451 : the amplifier being a radio frequency amplifier
• CPC Class Codes: H03F 2203/45116 : Feedback coupled to the input of the differential amplifier
• CPC Class Codes: H03F 2203/45528 : the FBC comprising one or more passive resistors and being coupled between the LC and the IC
• CPC Class Codes: H03F 2203/45601 : the IC comprising one or more passive resistors by feedback
• CPC Class Codes: H03F 3/45 : Differential amplifiers differential sense amplifiers G11C7/062
• CPC Class Codes: H03F 3/45475 : using IC blocks as the active amplifying circuit
• CPC Class Codes: H03F 3/68 : Combinations of amplifiers, e.g. multi-channel amplifiers for stereophonics power amplifiers using a combination of several semiconductor amplifiers H03F3/211; combinations of amplifiers using coupling networks with distributed constants H03F3/602
• CPC Class Codes: H03H 2017/0298 : DSP implementation
• CPC Class Codes: H03K 5/125 : Discriminating pulses measuring characteristics of individual pulses G01R29/02; separation of synchronising signals in television systems H04N5/08
• CPC Class Codes: H04B 1/0014 : using DSP [Digital Signal Processor] quadrature modulation and demodulation
• CPC Class Codes: H04B 1/0039 : using DSP [Digital Signal Processor] quadrature modulation and demodulation
• CPC Class Codes: H04L 43/02 : Capturing of monitoring data
• CPC Class Codes: H04L 47/50 : Queue scheduling

Abstract

Systems, apparatus, and methods are disclosed for bi-directionally conveying biomedical signals between a patient and signal acquisition and processing devices. An electrophysiology (EP) system includes an analog input protection and filtering stage with a differential circuit to process the biomedical signals to and from the patient; a signal amplification stage with a differential amplifier circuit to amplify an output of the differential circuit; an analog-to-digital converter stage to digitize an output of the differential amplifier circuit; a communication module to interface between the analog-to-digital converter stage and a digital processing stage having a plurality of signal modules; at least one processor to execute the plurality of signal modules, applying frequency-selective filtering and signal processing algorithms to the output from the analog-to-digital converter stage, to extract high-frequency and low-amplitude features of the biomedical signals in frequency ranges of interest; and a display for pattern- and time-aligned visualization of the biomedical signals.

Claims

1. A system for bi-directionally conveying biomedical signals between a patient and biomedical signal acquisition and processing devices, comprising:

an analog input protection and filtering stage, configured to be coupled to a plurality of electrodes that conduct the biomedical signals, the analog input protection and filtering stage comprising a differential circuit with two paths configured to process the biomedical signals in an analog domain to and from the patient;

a signal amplification stage comprising a differential amplifier circuit with a plurality of differential amplifier stages, wherein the differential amplifier circuit is coupled to each of the two paths of the differential circuit and is configured to amplify a first output of the differential circuit by an amplification factor of less than or equal to about 50 for the biomedical signals within a frequency range of about 0.01 Hz to about 1000 Hz;

an analog-to-digital converter stage comprising an analog-to-digital converter coupled to the differential amplifier circuit and configured to digitize a second output of the differential amplifier circuit, wherein the analog-to-digital converter has greater than 16-bit resolution;

a communication module, coupled to the analog-to-digital converter stage and configured to provide a digital communication interface between a digitized third output of the analog-to-digital converter stage and an input to a digital processing stage; and

the digital processing stage, coupled to the communication module, comprising;

a memory with a signal path module comprising a plurality of signal modules configured to apply filtering comprising frequency-selective filtering and signal processing algorithms to the digitized third output from the analog-to-digital converter stage to extract high-frequency and low-amplitude features of the biomedical signals; and

at least one processor configured to execute the plurality of signal modules, wherein the at least one processor filters the biomedical signals in frequency ranges of interest.

2. The system of claim 1, further comprising a voltage reference circuit, configured to couple to the plurality of electrodes and configured to return a processed analog signal to the patient,

wherein the voltage reference circuit provides a ground-equivalent electrode attached to the patient to remove common mode voltage, and

wherein the voltage reference circuit has a frequency resonator circuit configured to remove power mains harmonic noise from the biomedical signals.

3. The system of claim 1, wherein the differential circuit of the analog input protection and filtering stage further comprises an input protection circuit configured to shunt large signals.

4. The system of claim 1, wherein the differential circuit of the analog input protection and filtering stage further comprises a radio frequency filter circuit coupled to a low-frequency feedback circuit,

wherein the radio frequency filter circuit is configured to attenuate a respective amplitude of each of the biomedical signals between about 300 kHz and about 600 kHz, and

wherein the low-frequency feedback circuit is configured to drive a voltage of a ground plane of the radio frequency filter circuit to further attenuate the respective amplitude of each of the biomedical signals.

5. The system of claim 1, wherein the signal amplification stage further comprises a large-signal detection and clamp circuit, which is coupled to the differential amplifier circuit and is configured to:

feed a saturated signal back to the analog input protection and filtering stage; and

set a time constant over which to linearly remove signal saturation.

6. The system of claim 1, wherein the digital communication interface is a fiber optic link.

7. The system of claim 1, wherein the memory further comprises a configuration path module and a monitoring module.

8. The system of claim 7, wherein the signal path module is coupled to the digital communication interface at the input to the digital processing stage and is configured to:

receive the biomedical signals over the digital communication interface;

packetize the biomedical signals into respective packets of each of the biomedical signals;

store the respective packets of each of the biomedical signals into a respective queue for each of the biomedical signals; and

dispatch the respective packets to the plurality of signal modules for digital signal processing of the respective packets.

9. The system of claim 8, wherein the signal path module is further configured to synchronize the respective packets of the biomedical signals in near real-time, the synchronizing comprising:

processing the respective packets, wherein the processing introduces a processing delay for each of the respective packets, wherein a first processing delay is introduced for a first signal packet output from a first digital signal processor (DSP) of the signal path module and a second processing delay is introduced for a second signal packet output from a second DSP of the signal path module; and

presenting for display, approximately simultaneously, the processed first signal packet and the processed second signal packet.

10. The system of claim 9, wherein the configuration path module is coupled to the signal path module, and is configured to equalize the first processing delay of the first signal packet output from the first DSP with the second processing delay of the second signal packet output from the second DSP, wherein the equalizing causes the first DSP to complete processing of the first signal packet simultaneously with the second DSP completing the processing of the second signal packet.

11. The system of claim 7, wherein the monitoring module is coupled to the signal path module, and is configured to:

scan a queue in the signal path module;

determine a status of the queue during the scan; and

display an error status on a display device.

12. The system of claim 9, further comprising a display device having a graphical user interface (GUI) configured to approximately simultaneously display the processed first signal packet and the processed second signal packet.

13. A system for near real-time visualization of one or more biomedical signals emitted from a patient, comprising:

a differential circuit having two paths and configured to process the one or more biomedical signals in an analog domain, wherein the differential circuit is further configured to linearly attenuate a respective amplitude of the one or more biomedical signals within a first frequency range between about 350 kHz and about 600 kHz;

a differential amplifier module comprising a plurality of differential amplifier stages, wherein the differential amplifier module is coupled to each of the two paths of the differential circuit and is configured to amplify a first output of the differential circuit by an amplification factor, wherein the amplification factor is less than or equal to about 50 for the one or more biomedical signals within a second frequency range between about 0.01 Hz and about 1000 Hz;

an analog-to-digital converter module, coupled to the differential amplifier module and configured to digitize a second output of the differential amplifier module to produce a digitized third output of the analog-to-digital converter module, wherein the analog-to-digital converter module has greater than 16-bit resolution;

a processor comprising software, configured to apply filtering comprising frequency-selective filtering and signal processing algorithms to the digitized third output from the analog-to-digital converter module to extract high-frequency and low-amplitude features of the one or more biomedical signals, and output packets of processed signals and the one or more biomedical signals;

a plurality of synchronization delay elements configured to synchronize the processed signals with the one or more biomedical signals; and

a display device comprising a graphical user interface, configured to display the synchronized processed signals and the one or more biomedical signals.

14. The system of claim 13, configured to apply a tag to each packet of the processed signals and the one or more biomedical signals, wherein the system is further configured to assign a same tag to each packet associated with a first processed signal or a first biomedical signal to be synchronized at a same time with a second processed signal or a second biomedical signal.

15. The system of claim 14, wherein the assigned same tag is used by a display module to output to the display device the synchronized first processed signal and the synchronized second biomedical signal at the same time.

16. The system of claim 13, wherein the synchronized one or more biomedical signals are ready for display within about five milliseconds from a time that the one or more biomedical signals were emitted from the patient.

17. The system of claim 13, wherein the synchronized processed signals are ready for display within about 50 milliseconds from a time that the one or more biomedical signals were emitted from the patient.

18. The system of claim 13, wherein the plurality of synchronization delay elements are further configured to delay one of the synchronized processed signals to be displayed with another of the synchronized processed signals or with the one or more biomedical signals.

19. A system for visualization of one or more biomedical signals emitted from a patient, the system comprising:

a biomedical signal interface device for conveying the one or more biomedical signals to the system, comprising;

an input protection circuit to shunt a defibrillation signal;

a plurality of circuit board elements coupled to the input protection circuit, each of the plurality of circuit board elements comprising;

a differential circuit having two paths configured to process the one or more biomedical signals in an analog domain, wherein the differential circuit is further configured to linearly attenuate a respective amplitude of the one or more biomedical signals within a first frequency range between about 350 kHz and about 600 kHz;

a differential amplifier module comprising a plurality of differential amplifier stages, wherein the differential amplifier module is coupled to each of the two paths of the differential circuit and is configured to amplify a first output of the differential circuit by an amplification factor, wherein the amplification factor is less than or equal to about 50 for the one or more biomedical signals within a second frequency range between about 0.01 Hz and about 1000 Hz; and

an analog-to-digital converter module, coupled to the differential amplifier module, configured to digitize a second output of the differential amplifier module to produce a digitized third output of the analog-to-digital converter module, wherein the analog-to-digital converter module has greater than 16-bit resolution; and

a processor comprising software, communicatively coupled to each analog-to-digital converter module of the plurality of circuit board elements, wherein the processor is configured to process the respective digitized third output from each analog-to-digital converter module for display.

20. The system of claim 19, wherein the respective digitized third output from the analog-to-digital converter module is displayed in a raw format within about five milliseconds from a time that the one or more biomedical signals were received from the patient.

21. The system of claim 19, wherein the respective digitized third output from the analog-to-digital converter module is displayed in a processed format within about 50 milliseconds from a time that the one or more biomedical signals were received from the patient.

22. The system of claim 19, wherein the processor is coupled to each analog-to-digital converter module by a fiber optic link.

23. The system of claim 19, further comprising:

a plurality of synchronization delay elements configured to synchronize multiple digitized biomedical signals for simultaneous display; and

one or more display devices, each comprising a graphical user interface, configured to display the multiple digitized synchronized biomedical signals on the one or more display devices.

24. The system of claim 23, wherein a display device of the one or more display devices displays the multiple digitized synchronized biomedical signals in a time-aligned, non-overlapping stackable format.

25. The system of claim 23, wherein a display device of the one or more display devices displays the multiple digitized synchronized biomedical signals in a pattern-aligned, side-by-side format.

26. A system for visualization of one or more biomedical signals from a patient, the system comprising:

a medical signal interface device for conveying the one or more biomedical signals between the patient and monitoring or treatment devices, wherein the one or more biomedical signals have a recognized pattern, the medical signal interface device comprising;

a differential circuit having two paths configured to process the one or more biomedical signals in an analog domain, wherein the differential circuit is further configured to linearly attenuate a respective amplitude of the one or more biomedical signals within a first frequency range between about 350 kHz and about 600 kHz;

a differential amplifier module comprising a plurality of differential amplifier stages, wherein the differential amplifier module is coupled to each of the two paths of the differential circuit and is configured to amplify a first output of the differential circuit by an amplification factor, wherein the amplification factor is less than or equal to about 50 for the one or more biomedical signals within a second frequency range between about 0.01 Hz and about 1000 Hz; and

an analog-to-digital converter module, coupled to the differential amplifier module, configured to digitize a second output of the differential amplifier module to produce a digitized third output of the analog-to-digital converter module, wherein the analog-to-digital converter module has greater than 16-bit resolution; and

a processor comprising software, wherein the software comprises a digital processing function configured to identify a measure of deviation between the digitized third output of the analog-to-digital converter module and the recognized pattern of the one or more biomedical signals.

27. The system of claim 26, wherein the digital processing function is a mean absolute deviation algorithm to correlate the one or more biomedical signals and the recognized pattern based on at least a shape, an amplitude, or a time.

28. The system of claim 26, wherein the software comprises multiple digital processing functions for simultaneous application to the one or more biomedical signals to dynamically produce multiple digitally-processed versions of the one or more biomedical signals for simultaneous visualization.

29. The system of claim 26, wherein the software comprises a user interface that allows a user to set a threshold value to specify an amount that the deviation differs in time or amplitude from the recognized pattern, and wherein the deviation being equal to or greater than the threshold value triggers a display response.