Non-invasively measuring physiological process

• US 8,652,063 B2
• Filed: 07/05/2010
• Issued: 02/18/2014
• Est. Priority Date: 07/06/2009
• Status: Expired due to Fees

• Current Assignee: Heard Systems Pty Ltd.
• Original Assignee: Heard Systems Pty Ltd.
• Inventors: Gargiulo, Gaetano, Shephard, Richard William, Tapson, Jonathan Craig
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Flory, Christopher A
• Application Number:
  US13/382,877
• Publication Number:
  US 20120108989A1
• Time in Patent Office: 1,324 Days
• Field of Search: 600/453, 600/508, 600/511
• US Class Current: 600/508
• CPC Class Codes: A61B 2503/40 Animals
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/344 Foetal cardiography
• CPC Class Codes: A61B 5/4343 Pregnancy and labour monitoring, e.g. for labour onset detection
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 7/00 Instruments for auscultation

Abstract

Equipment (10) for non-invasively measuring a physiological process includes at least one receiver (12) to be placed relative to a body of a subject being examined to detect at least one signal from the body of the subject. A discrimination unit (20.1) determines if the at least one signal is a signal of interest associated with the physiological process. A processor (20) processes the signal of interest to enhance the signal of interest and suppresses other received signals that are not of interest.

Claims

1. A method of non-invasively measuring a physiological process to determine the presence of a foetal cardiac signal to detect pregnancy of a subject, the method comprising:

placing a receiver relative to a body of the subject being examined and using the receiver to detect a plurality of signals from the body of the subject, wherein the receiver comprises a plurality of different type of sensors detecting different types of signals;

determining whether at least one signal of the plurality of signals is a foetal cardiac signal; and

pre-processing the at least one signal to enhance the signal and to suppress other received signals that are not of interest,

wherein determining whether the at least one signal is a foetal cardiac signal further comprises;

using a plurality of predefined techniques in parallel, combining outputs of the applied plurality of predefined techniques, using a classifier to make a final decision whether or not the signal of interest is a foetal cardiac signal; and

outputting, as part of the decision, data relating to a measure of confidence in the decision.

15. The method of claim 1 further comprising effecting pre-processing enhancement of the signal of interest by using a combination of low-pass, band-pass, and high-pass filtering.

2. The method of claim l further comprising determining the presence of at least one foetal cardiac signal within naturally radiated signals obtained from the placement of one or more receivers against or near the body of the subject being examined.

3. The method of claim 2 further comprising detecting the presence of one or more cardiac signals by determining whether rates of periodic repetitions are consistent with heart rates.

4. The method of claim 3 further comprising once the presence of one or more cardiac signals has been detected, determining if a foetal cardiac signal is present.

5. The method of claim 4 further comprising determining from receiver data received from the one or more receivers that there is more than one cardiac signal present and, if more than one cardiac signal at different rates is found in the receiver data, confirming pregnancy of the subject.

6. The method of claim 3 further comprising if only one cardiac signal is detected, determining whether the detected signal is maternal or foetal.

7. The method of claim 6 further comprising measuring a maternal heart rate separately.

8. The method of claim 7 further comprising measuring the maternal heart rate by at least one of (a) applying the at least one receiver to a region where the maternal cardiac signal is known to be strong and foetal cardiac signals are known to be absent or weak, and (b) measuring the maternal heart rate by means other than the use of the at least one receiver.

9. The method of claim 3 further comprising processing the received signals to determine signal quality.

10. The method of claim 9 further comprising monitoring and evaluating variations in signal quality in real time and feeding data relating to the signal quality back to an operator.

11. The method of claim 10 further comprising once the data have been obtained, automating said determination of the presence of a foetal cardiac signal using the predetermined techniques.

12. The method of claim 11 further comprising effecting pre-processing enhancement of the signal of interest prior to applying the at least one technique.

13. The method of claim 3 further comprising combining historical data with data obtained from the a least one receiver to produce an updated estimate of pregnancy status, number of foetuses, foetal age and predicted time until parturition for a number of subjects being investigated.

14. The method of claim 3 further comprising transferring multi-field data in a format suitable for inclusion with computer software.

16. Equipment for non-invasively measuring a physiological process to detect pregnancy of a subject comprising:

a receiver to be placed relative to a body of a subject being examined to detect a plurality of signals from the body of the subject, wherein the receiver comprises a plurality of different type of sensors detecting different types of signals;

a discrimination unit for determining whether at least one signal of the plurality of signals is a signal of interest of being a foetal cardiac signal;

a pre-processing module for pre-processing the at least one signal to enhance the at least one signal and to suppress other received signals that are not of interest;

a processor, in communication with the pre-processing module to diagnose the presence of the foetal cardiac signal using a plurality of predefined techniques in parallel;

a combining module controlled by the processor for combining outputs of the applied plurality of predefined techniques; and

a classifier in communication with the combining module for making a final decision whether or not the at least one signal is a foetal cardiac signal, and outputting, as part of the decision, data relating to a measure of confidence in the decision,

17. The equipment of claim 16 further comprising a receiver pack comprising a plurality of receivers operable to detect different types of signals.

18. The equipment of claim 17 wherein the receiver pack includes at least two of the following types of receivers:

at least one audio receiver for receiving sound wave information from the subject being examined;

at least one electrical receiver for receiving muscle and nerve electrical activity signals from the subject being examined; and

at least one pressure receiver for receiving kinetic information from the subject being examined.

19. The equipment of claim 17 in which the processor is in communication with the receiver pack for processing the received signals, performing computations to enhance the signal of interest and to filter noise and other signals not of interest to provide refined signals.

20. The equipment of claim 19 in which the processor employs algorithms to interpret the refined signals and provide an output in the form of information on the physiological process.

21. The equipment of claim 16 in which the discrimination unit comprises a pre-processing module for effecting pre-processing of the signal of interest.

22. The equipment of claim 16 in which the pre-processing module uses a combination of low-pass, band-pass and high-pass filtering.

23. The equipment of claim 16 in which the processor includes an evaluation module for monitoring and evaluating variations in signal quality in real time.

24. The equipment of claim 23 further comprising an enunciator for alerting an operator to the signal quality.

25. The equipment of claim 16 further comprising a data storage system for recording and accessing data from multiple subjects and events,

26. The equipment of claim 16 further comprising a portable power supply,

27. The equipment of claim 16 further comprising a data input and processing system for combining historical and current data.

28. The equipment of claim 16 further comprising an output system for transferring multi-field data in a format suitable for inclusion with computer software.