Apparatus and methods of bioelectrical impedance analysis of blood flow

• US 6,292,689 B1
• Filed: 12/08/1999
• Issued: 09/18/2001
• Est. Priority Date: 04/17/1996
• Status: Expired due to Term

• Current Assignee: Ecom Med Inc.
• Original Assignee: Imagyn Medical Technologies, Inc.
• Inventors: Shmulewitz, Ascher, Wallace, Arthur W.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/458,186
• Time in Patent Office: 650 Days
• Field of Search: 600/547, 600/587, 600/595
• US Class Current: 600/547
• 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 5/0538 invasively, e.g. using a catheter

Abstract

Apparatus and methods are provided for monitoring cardiac output using bioelectrical impedance techniques in which three orthogonal pairs of sense electrodes are placed in the trachea or esophagus in the vicinity of the aorta, while an excitation current is injected into the intervening tissue mass via a current electrode, so that bioelectrical impedance measurements based on the voltage drop sensed by the sense electrodes reflect voltage changes induced primarily by blood flow dynamics. Methods are provided for computing cardiac output from bioelectrical impedance values using a multi-parameter algorithm derived using stepwise multiple linear regression or other optimization techniques. Apparatus and methods are also provided so that the measured cardiac output may be used to control administration of intravenous fluids or medication to an organism or to optimize a heart rate controlled by a pacemaker.

Claims

1. Apparatus for computing a metric corresponding to a patient'"'"'s cardiac output, the apparatus comprising:

a bioelectrical impedance recorder;

a tube having a proximal portion, and a distal portion;

an expandable member disposed on the distal portion;

three orthogonal pairs of sense electrodes disposed on the expandable member and electrically coupled to the bioelectrical impedance recorder;

a current electrode for injecting a current into the patient'"'"'s thorax; and

a ground electrode;

wherein the three orthogonal pairs of sense electrodes generate signals corresponding to the bioelectrical impedance of blood flow through the aorta and the signals are provided to the bioelectrical impedance recorder.

2. The apparatus as defined in claim 1 wherein the current electrode is disposed on the expandable member.

3. The apparatus as defined in claim 1 wherein the ground electrode is disposed on the tube.

4. The apparatus as defined in claim 1 wherein the expandable member comprises an inflatable cuff, and the apparatus further comprises a lumen for inflating the inflatable cuff.

5. The apparatus as defined in claim 1 wherein at least one sense electrode belongs to at least two of the three orthogonal pairs of sense electrodes.

6. The apparatus as defined in claim 5 wherein the three orthogonal pairs of sense electrodes comprise five sense electrodes.

7. The apparatus as defined in claim 1 wherein the tube is an endotracheal tube, and wherein the expandable member is adapted to urge the three orthogonal pairs of sense electrodes into contact with the patient'"'"'s tracheal mucosa.

8. The apparatus as defined in claim 7 wherein the tube is adapted to be inserted in the trachea of the patient through the mouth, a nasal passageway, or a tracheotomy port.

9. The apparatus as defined in claim 1 wherein the tube is an esophageal tube, and wherein the expandable member is adapted to urge the three orthogonal pairs of sense electrodes into contact with an interior of the patient'"'"'s esophagus.

10. The apparatus as defined in claim 9 further comprising a stethoscope balloon disposed on the distal portion, the stethoscope balloon permitting the apparatus to be used as an esophageal stethoscope.

11. The apparatus as defined in claim 10 further comprising a thermister disposed in the distal portion, the thermister providing a signal indicative of temperature within the esophagus.

12. The apparatus as defined in claim 1 wherein the apparatus further comprises reference marks on the proximal end of the tube to determine circumferential orientation of the tube.

13. The apparatus as defined in claim 1 wherein the current electrode is electrically coupled to the impedance recorder, and wherein the impedance recorder injects an alternating current having a predetermined frequency through the current electrode.

14. The apparatus as defined in claim 1 further comprising a computer coupled to the impedance recorder, the computer receiving a digitized signal generated from the signals corresponding to the bioelectrical impedance of blood flow through the aorta.

15. The apparatus as defined in claim 14 wherein the computer is programmed to use a multi-parameter algorithm to calculate a metric for ventricular stroke volume from the digitized signal.

16. The apparatus as defined in claim 15 wherein the computer is further programmed to calculate the metric corresponding to the patient'"'"'s cardiac output from the metric for ventricular stroke volume.

17. The apparatus as defined in claim 1 further comprising a fluid administration system for injecting a fluid into the vascular system of the patient, wherein the fluid administration system is responsive to the metric corresponding to the cardiac output.

18. The apparatus as defined in claim 1 further comprising a drug administration system for injecting a medication into the vascular system of the patient, wherein the drug administration system is responsive to the metric corresponding to the cardiac output.

19. The apparatus as defined in claim 18 wherein the medication comprises one or more of dobutamine, dopamine, epinephrine, norepinephrine, and nitroprusside.

20. The apparatus as defined in claim 1 further comprising a pacemaker controlling the heart rate of the patient, wherein the pacemaker is responsive to the metric corresponding to the cardiac output.

21. A method of measuring the cardiac output of an organism comprising steps of:

positioning three orthogonal pairs of sense electrodes within the organism in the vicinity of the aorta;

injecting a current into the thorax of the organism through a current electrode;

applying a voltage between the current electrode and a ground electrode so that a current flows through the tissues of the organism disposed between the current electrode and the ground electrode; and

detecting voltages developed across the three orthogonal pairs of sense electrodes caused by the current flowing in the tissues of the organism, the voltages varying in accordance with changes in the bioelectrical impedance of the tissues.

22. The method as defined in claim 21 wherein positioning three orthogonal pairs of sense electrodes comprises positioning three orthogonal pairs of sense electrodes within the organism'"'"'s trachea, so that the three orthogonal pairs of sense electrodes contact the organism'"'"'s tracheal mucosa in a position near the aorta.

23. The method as defined in claim 21 wherein positioning three orthogonal pairs of sense electrodes comprises positioning three orthogonal pairs of sense electrodes within the organism'"'"'s esophagus, so that the three orthogonal pairs of sense electrodes contact an interior surface of the organism'"'"'s esophagus at a position near the aorta.

24. The method as defined in claim 21 wherein injecting a current comprises injecting an alternating current having a predetermined frequency between the current electrode and the ground electrode.

25. The method as defined in claim 21 wherein the steps of applying a voltage between the current electrode and the ground electrode and detecting a voltage developed across the three orthogonal pairs of sense electrodes are performed continuously.

26. The method as defined in claim 21 further comprising computing a metric for ventricular stroke volume from the voltages detected by the three orthogonal pairs of sense electrodes using a multi-parameter algorithm.

27. The method as defined in claim 26 further comprising deriving the multi-parameter algorithm using a stepwise multiple linear regression technique.

28. The method as defined in claim 26 further comprising computing a metric for the cardiac output of the organism from the metric for ventricular stroke volume.

29. The method as defined in claim 21 further comprising steps of:

providing a fluid administration system for injecting a fluid intravenously into the organism'"'"'s vascular system; and

periodically actuating the fluid administration system responsive to the detected voltage developed across the three orthogonal pairs of sense electrodes.

30. The method as defined in claim 21 further comprising steps of:

providing a drug administration system for injecting a medication intravenously into the organism'"'"'s vascular system; and

periodically actuating the drug administration system responsive to the detected voltage developed across the three orthogonal pairs of sense electrodes.

31. The method as defined in claim 21 further comprising steps of:

providing a pacemaker electrically coupled to the heart of the organism to control heart rate; and

adjusting the heart rate responsive to voltage developed across the three orthogonal pairs of sense electrodes to optimize cardiac output.

32. The method as defined in claim 31 wherein the step of adjusting the heart rate comprises a step of lowering the heart rate to obtain either a predetermined minimum heart rate or until the cardiac output is measured to be decreasing.

33. Apparatus for detecting a three-dimensional bioimpedance field in the vicinity of a patient'"'"'s aorta, the apparatus comprising:

a tube having a proximal portion, and a distal portion;

an expandable member disposed on the distal portion;

three orthogonal pairs of sense electrodes disposed on the expandable member;

a current electrode for injecting a current into the patient'"'"'s thorax; and

a ground electrode;

wherein the three orthogonal pairs of sense electrodes generate signals corresponding to the bioelectrical impedance of blood flow through the aorta.

34. The apparatus as defined in claim 33 wherein the current electrode is disposed on the expandable member.

35. The apparatus as defined in claim 33 wherein the ground electrode is disposed on the tube.

36. The apparatus as defined in claim 33 wherein the expandable member comprises an inflatable cuff, and the apparatus further comprises a lumen for inflating the inflatable cuff.

37. The apparatus as defined in claim 33 wherein at least one sense electrode belongs to at least two of the three orthogonal pairs of sense electrodes.

38. The apparatus as defined in claim 37 wherein the three orthogonal pairs of sense electrodes comprise five sense electrodes.

39. The apparatus as defined in claim 33 wherein the tube is an endotracheal tube, and wherein the expandable member is adapted to urge the three orthogonal pairs of sense electrodes into contact with the patient'"'"'s tracheal mucosa.

40. The apparatus as defined in claim 39 wherein the tube is adapted to be inserted in the trachea of the patient through the mouth, a nasal passageway, or a tracheotomy port.

41. The apparatus as defined in claim 33 wherein the tube is an esophageal tube, and wherein the expandable member is adapted to urge the three orthogonal pairs of sense electrodes into contact with the interior of the patient'"'"'s esophagus.

42. The apparatus as defined in claim 41 further comprising a stethoscope balloon disposed on the distal portion, the stethoscope balloon permitting the apparatus to be used as an esophageal stethoscope.

43. The apparatus as defined in claim 38 further comprising a thermister disposed in the distal portion, the thermister providing a signal indicative of temperature within the esophagus.