Method and apparatus to monitor physiologic and biometric parameters using a non-invasive set of transducers

• US 10,092,268 B2
• Filed: 06/19/2014
• Issued: 10/09/2018
• Est. Priority Date: 06/19/2013
• Status: Active Grant

• Current Assignee: Innovital LLC
• Original Assignee: Innovital LLC
• Inventors: Krimsky, William, Purekar, Ashish, Hiemenz, Gregory
• Primary Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US14/309,347
• Publication Number:
  US 20140378849A1
• Time in Patent Office: 1,573 Days
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 7/026 comprising more than one sound collector

Abstract

Method and apparatus for quantitative and qualitative determination of heart rate, stroke volume, cardiac output, and central fluid volume. Phonocardiography based technique using multiple transducers and multi-sensor processing algorithms provides a non-invasive method of evaluating the output of the heart. This basic system coupled with additional sensor elements provides a wide range of potential capabilities. A system comprising these techniques in a wearable form provides a non-invasive method of determining hydration status and blood volume status. Phonocardiography augmented with multi-sensor signal processing techniques improves signal quality to analyze heart sounds and associated features (e.g. S1 and S2, amongst others). Noise compensation and cancellation techniques for phonocardiography further improve signal to noise ratio to reject external disturbances.

Claims

1. A system to non-invasively monitor the cardiac cycle of a patient and quantify changes in blood volume of said patient over time therefrom, comprising:

a phonocardiography transducer configured to measure pressure waves originating from said patient'"'"'s heart function during said cardiac cycle and generate an analog audio signal waveform corresponding to said cardiac cycle;

a data acquisition unit configured to condition said analog audio signal waveform, convert said analog audio signal waveform to digital data, store said digital data, and communicate said digital data;

a processor including a non-transitory computer-readable storage device storing a waveform analysis software module comprising a series of computer-readable instructions for analyzing the signal waveforms by the steps of,

automatically identifying and extracting time based heart sound features and heartbeat period from said digital data over a time interval,

computing a phonocardiographic systolic time interval (PSTI) metric comprising a function of said extracted time based heart sound features and heart beat period and storing a log of said computed PSTI metric over said time interval;

monitoring said log of said computed PSTI metric over said time interval to establish a baseline and detect changes from said baseline;

and

presenting said changes in PSTI as a surrogate for changes in blood volume to guide therapeutic treatment.

2. The system according to claim 1, further comprising a secondary transducer employing a non-audio sensing modality configured for generating a complimentary waveform corresponding to said cardiac cycle.

3. The system according to claim 2, wherein said secondary transducer comprises an electrocardiogram transducer to generate an electrical signal waveform corresponding to said cardiac cycle;

and

said waveform analysis software module comprising a series of computer-readable instructions for analyzing the signal waveforms by the additional steps of,

extracting one or more time based features from said electrical signal waveform, and

computing a metric comprising a time-based function of the identified time based features from said electrical waveform.

4. The system according to claim 2, wherein said one or more time based features from said phonocardiographic waveform comprise intra-cyclic features and said one or more time based features from said secondary transducer comprise inter-cyclic features.

5. The system of claim 1 further comprising one or more additional transducers for increasing sensitivity.

6. The system of claim 5 whereas said one or more additional transducers includes any one from among a group consisting of thoracic impedance sensor, inertial measurement sensor, respiration sensor, blood oxygen sensor, internal temperature sensor, and surface temperature sensor.

7. The system according to claim 1, wherein said step of extracting time based heart sound features from said digital data comprises S3 or S4 heart sound features.

8. The system according to claim 1, wherein said time based features comprise both intra-cyclic features and inter-cyclic features.

9. The system according to claim 1, wherein said time based features from said phonocardiographic waveform comprises any three or more from among a group consisting of S1, S2, S3, S4, murmurs, rubs, and gallop.

10. The system according to claim 1, wherein said step of extracting time based heart sound features S and S2 from said digital data comprises data binning.

11. The system according to claim 1, wherein said step of analyzing said computed PSTI metric over time comprises a Fourier analysis.

12. The system according to claim 1, wherein said step of analyzing said computed PSTI metric over time comprises curve fitting.

13. The system of claim 1 wherein said phonocardiography transducer comprises a plurality of phonocardiography transducers arrayed in an integrated wearable form.

14. The system of claim 1, further comprising a step of matching said computed PSTI metric to predetermined statistical patterns.

15. The system according to claim 1, wherein said phonocardiography transducer comprises a dual transducer for eliminating noise.

16. The system according to claim 1, wherein said data acquisition unit and said processor are combined in a portable package.

17. The system according to claim 1, wherein said step of extracting one or more time based features from said digital data further comprises identifying the absence of a heart sound chosen from among a group consisting of S1, S2, S3, S4, gallop, rub, &

murmurs.