Apparatus and methods of bioelectrical impedance analysis of blood flow

• US 6,095,987 A
• Filed: 09/19/1997
• Issued: 08/01/2000
• Est. Priority Date: 04/17/1996
• Status: Expired due to Term

• Current Assignee: Ecom Med Inc.
• Original Assignee: Imagyn Medical Technologies, Inc.
• Inventors: Wallace, Arthur A., Shmulewitz, Ascher
• Primary Examiner(s): Lacyk, John P.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US08/934,036
• Time in Patent Office: 1,047 Days
• Field of Search: 600/546, 600/547, 600/508, 600/509, 600/587, 600/506
• US Class Current: 600/547
• 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 first and second electrodes are placed in the trachea and/or bronchus in the vicinity of the ascending aorta, while an excitation current is injected into the thorax via first and second current electrodes, so that bioelectrical impedance measurements based on the voltage drop sensed by the first and second electrodes reflect voltage changes induced primarily by blood flow dynamics, rather than respiratory or non-cardiac related physiological effects. Additional sense electrodes may be provided, either internally, or externally, for which bioelectrical impedance values may be obtained. Methods are provided for computing cardiac output from bioelectrical impedance values. Apparatus and methods are also provided so that the measured cardiac output may be used to control administration of intravenous fluids 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;

an endotracheal tube having a proximal portion, a distal portion, and a longitudinal axis, the endotracheal tube is adapted to be inserted in the trachea of the patient through one of the mouth, a nasal passageway, or a tracheotomy port;

first and second sense electrodes disposed on the distal portion and electrically coupled to the bioelectrical impedance recorder, the first and second sense electrodes spaced apart a first distance along the longitudinal axis;

means for urging the first and second sense electrodes against an interior wall of the patient'"'"'s airway;

first and second current electrodes electrically coupled to the bioelectrical impedance recorder for injecting a current into the patient'"'"'s thorax, the first and second current electrodes spaced apart a second distance greater than the first distance,

wherein the first and second sense electrodes generate a signal corresponding to the bioelectrical impedance of blood flow through the aorta and the signal is provided to the bioelectrical impedance recorder.

2. The apparatus as defined in claim 1 further comprising an external sense electrode coupled to the bioelectrical impedance recorder, one of the first and second sense electrodes and the external sense electrode generating an alternate signal corresponding to the bioelectrical impedance of blood flow through the aorta, the alternate signal being provided to the bioelectrical impedance recorder.

3. The apparatus as defined in claim 1 wherein at least one of the first and second current electrodes are disposed on the endotracheal tube.

4. The apparatus as defined in claim 1 wherein the first and second sense electrodes are arranged so that a line intersecting the first and second sense electrodes forms an angle α

relative to the longitudinal axis of the endotracheal tube.

5. The apparatus as defined in claim 4 wherein the angle α

is a range of 25 to 45 degrees.

6. The apparatus as defined in claim 4 wherein the second sense electrode is disposed distal to the first sense electrode, the apparatus further comprising a third sense electrode disposed distal to, but circumferentially spaced apart from, the first sense electrode and a fourth sense electrode disposed proximal to, but circumferentially spaced apart from, the second sense electrode, so that a line intersecting the third and fourth sense electrodes is orthogonal to a line intersecting the first and second sense electrodes.

7. The apparatus as defined in claim 1 wherein the endotracheal tube comprises at least first and second lumens, the first and second sense electrodes comprising first and second wires disposed for sliding movement through the first and second lumens, respectively.

8. The apparatus as defined in claim 7 wherein the first and second wires include pre-stressed portions that cause the first and second sense electrodes to deflect outwardly when extended from the first and second lumens, respectively, the pre-stressed portions constituting the means for urging.

9. The apparatus as defined in claim 1 wherein the endotracheal tube further comprises an expandable member for retaining the endotracheal tube at a desired location in the passageway.

10. The apparatus as defined in claim 9 wherein the expandable member constitutes the means for urging.

11. The apparatus as defined in claim 10 wherein the first and second sense electrodes are disposed upon the expandable member.

12. The apparatus as defined in claim 9 wherein the expandable member is an inflatable cuff, and the endotracheal tube further comprises a lumen for inflating the inflatable cuff.

13. The apparatus as defined in claim 1 wherein at least one of the first and second current electrodes is disposed on an inflatable cuff.

14. 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 endotracheal tube within the patient'"'"'s trachea.

15. The apparatus as defined in claim 1 further comprising a fluid administration system for injecting a bolus of fluid into the vascular system of the patient, the fluid administration system coupled to the circuitry for processing and responsive to the metric corresponding to the cardiac output.

16. The apparatus as defined in claim 1 further comprising a pacemaker controlling the heart rate of the patient, the pacemaker coupled to the circuitry for processing and responsive to the metric corresponding to the cardiac output.

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

providing a bioelectrical impedance recorder;

providing an endotracheal tube having first and second sense electrodes disposed thereon, the first and second sense electrodes spaced apart a first distance;

inserting the endotracheal tube in the trachea of the organism through a nasal passageway, the mouth of the organism, or a tracheotomy port to position first and second sense electrodes within an airway of the organism in the vicinity of the ascending aorta;

coupling first and second current electrodes to inject a current into the thorax of the organism, the first and second current electrodes spaced apart a second distance greater than the first distance;

applying a voltage from the bioelectrical impedance recorder between the first and second current electrodes so that a current flows through the tissues of the organism disposed along the second distance between the first and second current electrodes; and

detecting with the bioelectrical impedance recorder a voltage developed across the first and second sense electrodes caused by the current flowing in the tissues of the organism, the voltage varying in accordance with changes in the bioelectrical impedance of the tissues.

18. The method as defined in claim 17, further comprising a step of aligning the first and second sense electrodes with an axis of the ascending aorta of the organism.

19. The method as defined in claim 17, wherein the step of positioning the first and second current electrodes comprises a step of positioning the first and second current electrodes on an external surface of the organism.

20. The method as defined in claim 17 wherein the steps of applying a voltage between the first and second current electrodes and detecting a voltage developed across the first and second sense electrodes are performed continuously.

21. The method as defined in claim 17, further comprising steps of:

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

periodically actuating the fluid administration system responsive to the detected voltage developed across the first and second sense electrodes.

22. The method as defined in claim 21, wherein the step of periodically actuating the fluid administration system is performed every 15 minutes only while the cardiac output is measured to be increasing.

23. The method as defined in claim 17 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 first and second sense electrodes to optimize cardiac output.

24. The method as defined in claim 23, 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.

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

a bioelectrical impedance recorder,

an endotracheal tube having a proximal portion, a distal portion, and a longitudinal axis;

first and second sense electrodes disposed on the distal portion and electrically coupled to the bioelectrical impedance recorder, the first and second sense electrodes spaced apart a first distance along the longitudinal axis;

means for urging the first and second sense electrodes against an interior wall of the patient'"'"'s airway;

first and second current electrodes electrically coupled to the bioelectrical impedance recorder for injecting a current into the patient'"'"'s thorax, the first and second current electrodes spaced apart a second distance greater than the first distance, at least one of the first or second current electrodes disposed on the endotracheal tube,

wherein the first and second sense electrodes generate a signal corresponding to the bioelectrical impedance of blood flow through the aorta and the signal is provided to the bioelectrical impedance recorder.

26. The apparatus as defined in claim 25, wherein the second sense electrode is disposed distal to the first sense electrode, the apparatus further comprising a third sense electrode disposed distal to, but circumferentially spaced apart from, the first sense electrode and a fourth sense electrode disposed proximal to, but circumferentially spaced apart from, the second electrode, so that a line intersecting the third and fourth sense electrodes is orthogonal to a line intersecting the first and second sense electrodes.

27. The apparatus as defined in claim 26, wherein the first and second sense electrodes are arranged so that a line intersecting the first and second sense electrodes forms an angle α

relative to the longitudinal axis of the endotracheal tube.

28. The apparatus as defined in claim 25, wherein the endotracheal tube further comprises an expandable member for retaining the endotracheal tube at a desired location in the passageway.

29. The apparatus as defined in claim 28 wherein the expandable member constitutes the means for urging.

30. The apparatus as defined in claim 29, wherein the first and second sense electrodes are disposed upon the expandable member.

31. The apparatus as defined in claim 30, wherein the expandable member is an inflatable cuff, and the endotracheal tube further comprises a lumen for inflating the inflatable cuff.

32. The apparatus as defined in claim 25, wherein at least one of the first and second current electrodes is disposed on an inflatable cuff.

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

a bioelectrical impedance recorder;

an endotracheal tube having a proximal portion, a distal portion, and a longitudinal axis;

first, second, third and fourth sense electrodes disposed on the distal portion and electrically coupled to the bioelectrical impedance recorder, the first and second sense electrodes spaced apart a first distance along the longitudinal axis, the third and fourth sense electrodes circumferentially spaced apart so that a line intersecting the first and second sense electrodes is substantially orthogonal to a line intersecting the third and fourth sense electrodes;

means for urging the first, second, third and fourth electrodes against an interior wall of the patient'"'"'s airway;

first and second current electrodes electrically coupled to the bioelectrical impedance recorder for injecting a sense current into the patient'"'"'s thorax, the first and second current electrodes spaced apart a second distance greater than the first distance,

wherein the first, second, third and fourth sense electrodes generate a signal corresponding to the bioelectrical impedance of blood flow through the aorta and the signal is provided to the bioelectrical impedance recorder.

34. The apparatus as defined in claim 33 wherein at least one of the first and second current electrodes is disposed on the endotracheal tube.

35. The apparatus as defined in claim 33, wherein the second sense electrode is located circumferentially away from the first sense electrode, so that a line intersecting the first and second sense electrodes forms an angle α

relative to the longitudinal axis of the endotracheal tube.

36. The apparatus as defined in claim 33, wherein the endotracheal tube further comprises an expandable member for retaining the endotracheal tube at a desired location in the passageway.

37. The apparatus as defined in claim 36, wherein the expandable member constitutes the means for urging.

38. The apparatus as defined in claim 37, wherein the first and second sense electrodes are disposed upon the expandable member.