Apparatus and method for determining cardiac output in a living subject

• US 6,602,201 B1
• Filed: 07/10/2001
• Issued: 08/05/2003
• Est. Priority Date: 07/10/2000
• Status: Expired due to Term

• Current Assignee: FUJIFILM SonoSite, Inc. (Fujifilm Holdings Corporation)
• Original Assignee: Cardiodynamics International Corporation (Fujifilm Holdings Corporation)
• Inventors: Elf, James O., Hepp, Dennis G., Ng, Sau Kuen, Malecha, Jeremy Robert, Baura, Gail D.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/903,473
• Time in Patent Office: 756 Days
• Field of Search: 600/509, 600/527, 600/513, 600/483, 600/547, 600/526
• US Class Current: 600/526
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• 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 5/726 using Wavelet transforms

Abstract

An improved apparatus and method for determining the cardiac output of a living subject. The improved apparatus generally comprises one or more electrode assemblies or patches affixed to the skin of the subject in the vicinity of the thoracic cavity. In one embodiment, the apparatus comprises a constant current source impedance cardiography (ICG) monitor adapted as a stand-alone system. In another embodiment, the apparatus comprises a module adapted for use with a host monitoring system, the latter providing ECG, blood pressure, and/or other inputs to the module. Method of detecting a loss of electrical continuity in one or more of the terminals of the electrode patch, and selecting between a plurality of signal inputs based on signal quality, are also disclosed.

Claims

1. A system for determining the cardiac output of a living subject, comprising:

a plurality of electrode assemblies, each electrode assembly having a plurality of terminals, at least two of said plurality of terminals being spaced from one another by a predetermined distance;

a current source capable of generating a substantially constant current;

a plurality of electrical leads connecting said current source with individual ones of said terminals of said electrode assemblies,

a first circuit adapted to measure the difference in voltage at said terminals resulting from the flow of said current through said subject and said terminals under varying cardiac conditions of said subject;

a second circuit adapted to measure ECG potentials from at least one of said electrode assemblies; and

at least one processing circuit adapted to process said voltage and ECG potentials and develop an estimate of cardiac output therefrom.

2. The system of claim 1, further comprising a third circuit adapted to measure the difference in the impedance of at least two of said terminals as a function of time, said difference being compared to a first value to evaluate the electrical continuity of at least one of said terminals.

3. The system of claim 1, wherein said at least one processing circuit comprises:

(i) at least one analog-to-digital converter; and

(ii) at least one digital processor in data communication with said at least one converter, said at least one digital processor having at least one computer program running thereon.

4. The system of claim 3, further comprising apparatus operatively coupled to said second circuit and adapted for automatic selection between a plurality of said ECG potentials based on at least one parameter.

5. The system of claim 1, wherein said second circuit comprises a circuit adapted to measure body surface potentials between at least two of said terminals in order to identify a plurality of QRS complex events within said subject.

6. The system of claim 5, wherein said QRS complex events are identified at least in part using a wavelet transform.

7. The system of claim 1, wherein said terminals each comprise:

a central axis;

a sidewall portion substantially parallel to said axis; and

a top portion, said top portion having a diameter greater of that of said vertical sidewall portion.

8. The system of claim 7, wherein said electrical leads each comprise a connector, said connector being adapted to form an electrical conduction path between said connector and a respective one of said terminals, said connector further comprising a plurality of electrically conductive arms biased against said sidewall portion of said terminal when said connector is mated with said terminal.

9. The system of claim 1, further comprising at least one monitoring device in data communication with said at least one processing circuit, and adapted to interface therewith, for displaying information related to said estimate of cardiac output.

10. The system of claim 9, wherein at least one of said at least one monitoring devices is physically remote from said system, said system further comprising a data network interface in data communication with said at least one processing circuit to facilitate transmission of said information to said at least one remote monitoring device.

11. A method of providing an input waveform to a processing device, comprising:

receiving a plurality of input waveforms at said processing device, each of said waveforms having a plurality of features associated therewith;

generating a plurality of parameters relating to said plurality of features of each of said waveforms;

generating a sum of said plurality of parameters for each of said waveforms; and

selecting one of said plurality of waveforms for further processing within said processing device based at least in part on the value of said sums.

12. The method of claim 11, wherein said input waveforms comprise electrocardiograph (ECG) waveforms having at least one QRS complex, and said features are selected from the group comprising:

(i) R-wave amplitude;

(ii) QR interval difference; and

(iii) RR interval difference.

13. The method of claim 12, wherein said act of determining R-wave amplitude comprises:

summing the amplitudes of those R points found in a predetermined time window which includes a first R point value; and

averaging said summed amplitudes to determine a mean R wave signal amplitude.

14. The method of claim 11, further comprising normalizing each of said sums of said plurality of parameters to a predetermined value.

15. The method of claim 14, wherein said act of selecting comprises:

ranking each of said normalized sums; and

selecting said one waveform for further processing based at least in part on said ranking.

16. The method of claim 15, wherein said act of selecting further comprises utilizing a hierarchical process to select said one waveform when said ranking of two or more of said waveforms is equivalent.

17. A method of processing an input waveform in a cardiac output determination apparatus, comprising:

receiving a plurality of input waveforms at said apparatus, each of said waveforms having a plurality of fiducial points associated therewith;

identifying said fiducial points;

generating a plurality of parameters relating to said plurality of fiducial points of each of said waveforms;

generating a sum of said plurality of parameters for each of said waveforms;

selecting one of said plurality of waveforms for further processing within said processing device based at least in part on the value of said suns; and

processing said one selected waveform in conjunction with an impedance waveform to determine cardiac output.

18. The method of claim 17, wherein said act of identifying comprises utilizing a wavelet transform to detect at least one of said fiducial points in each of said waveforms.

19. The method of claim 17, further comprising converting each of said waveforms to the digital domain for said processing.

20. Cardiac measuring apparatus, comprising:

a stimulation source adapted to produce a stimulation current;

a first interface adapted to receive;

(i) first signals from a first signal source, said first signals being related at least in part to the thoracic impedance of a living subject, said impedance being related at least in part to said stimulation current;

(ii) ECC signals; and

(iii) blood pressure signals received from a dialysis system; and

a second interface adapted to at least provide output data to a monitoring device.

21. The apparatus of claim 20, wherein said dialysis system and said cardiac measuring apparatus are substantially co-located and adapted to operate contemporaneously.

22. The apparatus of claim 20, wherein said monitoring devices in data communication with said dialysis system and said cardiac measuring apparatus, such that data from both the dialysis unit and cardiac measuring apparatus may be monitored using said monitoring device.

23. Cardiac output measuring apparatus, comprising:

a first interface adapted to receive;

(i) first signals, said first signals being related at least in part to the thoracic impedance of a living subject; and

(ii) a plurality of second signals, said second signals being useful in the determination of cardiac output;

apparatus adapted to select one of said plurality of second signals based at least in part on the quality of said signals;

at least one analog-to-digital converter adapted to convert at least a portion of said first and second signals to the digital domain;

a digital processor operatively coupled to said at least one converter and adapted to determine cardiac output based at least in part on said first signals and said selected one of said second signals and generate data relating thereto; and

a second interface adapted to at least provide said cardiac output data to a monitoring device.

24. The apparatus of claim 23, further comprising a software architecture having at least first, second, and third software modules adapted to boot the apparatus, control the communication of data via said second interface, and control the operation of said digital processor, respectively.

25. A data storage device adapted for use with a digital computer, said storage device comprising a storage medium, said medium having a plurality of data stored thereon, said plurality of data comprising a computer program, said computer program being adapted to providing an input waveform to a processing device according to the method comprising:

recognizing a plurality of input waveforms at said processing device, each of said waveforms having a plurality of features associated therewith;

generating a plurality of parameters relating to said plurality of features of each of said waveforms;

generating a sum of said plurality of parameters for each of said waveforms; and

selecting one of said plurality of waveforms for further processing within said processing device based at least in part on the value of said sums.

26. The storage device of claim 25, wherein said computer program is further adapted to process said one selected waveform in conjunction with at least one impedance waveform to determine cardiac output.

27. Cardiac output measuring apparatus, comprising:

a stimulation source adapted to produce a stimulation current;

a first interface adapted to receive;

(i) first signals from a first signal source, said first signals being related at least in part to said stimulation current; and

(ii) ECG waveforms from a plurality of sources, said ECG waveforms having a plurality of features associated therewith and being useful in the determination of cardiac output; and

a second interface adapted for selecting between said ECG waveforms based on at least one parameter and at least providing output data to a monitoring device, said act of selecting comprising;

generating a plurality of parameters relating to said plurality of features of each of said ECG waveforms;

generating a sum of said plurality of parameters for each of said waveforms; and

selecting one of said plurality of waveforms for further processing based at least in part on the value of said sums.

28. A method of determining the cardiac output of a living subject, comprising:

applying said electrical current to at least a portion of said living subject;

measuring an impedance waveform generated by said electrical current passing through said living subject;

selecting one from a plurality of electrocardiographic (ECG) waveform inputs obtained from said subject during at least a portion of said act of measuring, said act of selecting comprising;

(i) evaluating each ECG waveform for signal quality based upon at least one parameter;

(ii) ranking each ECG waveform based on said act of evaluating; and

(iii) selecting said one ECG waveform based at least in part on said ranking;

converting at least a portion of said impedance and electrocardiographic waveforms to the digital domain;

determining stroke volume from the measured voltage; and

determining cardiac output based at least in part on said stroke volume.

29. The method of claim 28, wherein said act of evaluating comprises evaluating each waveform with a predetermined window of time, said window of time corresponding to at least a minimum number of cardiac beats.

30. The method of claim 29, wherein said act of selecting further comprises utilizing a hierarchical process to select said one waveform when said ranking of two or more of said waveforms is equivalent.

31. The method of claim 28, wherein said at least one parameter comprises R-wave signal amplitude.

32. The method of claim 31, wherein said R-wave signal amplitude is determined by:

identifying a first R point value; and

subtracting the previous local minimum point value.

33. The method of claim 32, further comprising:

summing the amplitudes of those R points found in a predetermined time window which includes said first R point value; and

averaging said summed amplitudes to determine a mean R wave signal amplitude.

34. The method of claim 28, wherein said at least one parameter is selected from the group consisting of:

(i) R-wave amplitude;

(ii) QR interval difference; and

(iii) RR interval difference.

35. The method of claim 28, further comprising determining cardiac rate at least in part from said one selected ECG waveform.

36. The method of claim 28, further comprising outputting said stroke volume and/or said cardiac output determinations to a monitoring device according to a communications protocol.

37. The method of claim 28, further comprising outputting said stroke volume and/or said cardiac output determinations via a network interface to a remote monitoring device.

38. A method of determining the cardiac output of a living subject, comprising:

generating an electrical current;

applying said electrical current to at least a portion of said living subject;

measuring an impedance waveform generated by said electrical current passing through said living subject;

selecting one from a plurality of electrocardiographic (ECG) waveforms obtained from said subject, said act of selecting comprising generating a plurality of parameters relating to the signal quality of said ECG waveform inputs;

converting at least a portion of said impedance and cardiographic waveforms to the digital domain;

determining stroke volume from the measured voltage; and

determining cardiac output based at least in part on said stroke volume.

39. The method of claim 38, wherein said plurality of parameters are selected from the group consisting of:

(i) R-wave amplitude;

(ii) QR interval difference; and

(iii) RR interval difference.

40. The method of claim 38, further comprising:

generating a sum of said plurality of parameters for each ECG waveform input;

normalizing said sums; and

selecting the ECG input waveform with the highest value of said sum.

41. Yoke apparatus adapted to measure cardiac output in a living subject, comprising:

a stimulation source adapted to produce a stimulation current;

a first interface adapted to receive;

(i) first signals from at least one electrodes, said first signals being related to the thoracic impedance of said subject resulting from the application of said stimulation current thereto; and

(ii) second signals from at least one electrode, said second signals being related to the ECG of said subject;

a second interface adapted to at least provide output data to a monitoring device; and

an outer housing adapted to receive at least one electronic module therein;

wherein said yoke apparatus is adapted to be physically separable from said monitoring device.

42. The yoke apparatus of claim 41, wherein said at least one electronic module comprises an ECG module.

43. The yoke apparatus of claim 41, wherein said at least one electronic module comprises a network interface module.

44. The yoke apparatus of claim 41, wherein said at least one electronic module comprises wireless transceiver module.

45. The yoke apparatus of claim 41, wherein said second interface comprises a LAN interface card (NIC).

46. The yoke apparatus of claim 41, wherein said second interface comprises a wireless transceiver.

47. Yoke apparatus adapted to measure cardiac output in a living subject, comprising:

a stimulation source adapted to produce a stimulation current;

a first interface adapted to receive;

(i) first signals from at least one electrodes, said first signals being related to the thoracic impedance of said subject resulting from the application of said stimulation current thereto; and

(ii) second signals from at least one electrode, said second signals being related to the ECG of said subject;

apparatus adapted to automatically select from a plurality of said second signals based upon the quality thereof; and

a second interface adapted to at least provide output data to a monitoring device;

wherein said yoke apparatus is adapted to be physically separable from said monitoring device.

48. The yoke apparatus of claim 47, wherein said second interface comprises a LAN interface card (NIC).

49. The yoke apparatus of claim 47, wherein said second interface comprises a wireless transceiver.

50. Cardiac output measuring apparatus, comprising:

means for producing a stimulation current;

first interface means adapted for receiving;

(i) first signals from a first signal source, said first signals being related at least in part to said stimulation current; and

(ii) ECG waveforms from a plurality of sources, said ECG waveforms having a plurality of features associated therewith and being useful in the determination of cardiac output; and

second interface means adapted for selecting between said ECG waveforms based on at least one parameter, and at least providing output data to a monitoring device, said act of selecting comprising the steps of;

generating a plurality of parameters relating to said plurality of features of each of said ECG waveforms;

generating a sum of said plurality of parameters for each of said waveforms; and

selecting one of said plurality of waveforms for further processing based at least in part on the value of said sums.

51. Yoke apparatus adapted to measure cardiac output in a living subject, comprising:

means for producing a stimulation current;

first interface means adapted for receiving;

(i) first signals from at least one electrode means, said first signals being related to the thoracic impedance of said subject resulting from the application of said stimulation current thereto; and

(ii) second signals from at least one electrode means, said second signals being related to the ECG of said subject;

means for automatically selecting from a plurality of said second signals based upon the quality thereof; and

second interface means adapted for at least providing output data to a monitoring means;

wherein said yoke apparatus is adapted to be physically separable from said monitoring means.