Surgery – Diagnostic testing – Respiratory
Reexamination Certificate
2000-10-18
2002-07-02
Shaver, Kevin (Department: 3736)
Surgery
Diagnostic testing
Respiratory
C600S538000, C128S204230
Reexamination Certificate
active
06413226
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention pertains to a method and apparatus for determining the cardiac output of a patient, and, more particularly, to a method of determining cardiac output by analyzing the effect that an induced change in the patient's arterial oxygen concentration has on their oxygen uptake and fractional arterial oxygen concentration, and to an apparatus for use in implementing such a method.
2. Description of the Related Art
The are several generally accepted techniques for measuring cardiac output (CO), which is the total volumetric flow of blood through the heart, and, thus, through the body at any given time. These techniques include: thermodilution, dye dilution, the direct Fick method, and partial CO
2
rebreathing. Thermodilution involves injecting cold saline directly into the right atrium of the heart and measuring the temperature change downstream in the pulmonary artery using a temperature sensor placed in this artery. Cardiac output is determined based on this temperature change. Dye dilution is similar to thermodiluation except that a dye, rather than cold saline, is injected into the art. The amount of dye collected downstream is measured to determine the patient's cardiac output.
According to the direct Fick method, either the content of oxygen (O
2
) or the content of carbon dioxide (CO
2
) in both the arterial blood and mixed venous blood are measured. The Fick equation, written for oxygen, is: CO═O
2
uptake/(the content of O
2
in arterial blood—the content of O
2
in mixed venous blood). The Fick equation, written for carbon dioxide, is: CO═CO
2
excreted/(the content of CO
2
in mixed venous blood—the content of CO
2
in arterial blood). As noted above, the direct Fick method requires obtaining a mixed venous blood sample, which is only available in the pulmonary artery. See FIG.
1
.
It can thus be appreciated that thermodilution, dye dilution, and the direct Fick method for determining cardiac output all require insertion of a catheter into the patient at, near, or through the heart. More specifically, in implementing these cardiac output measurements, a catheter is usually floated through the chambers of the heart in order to insert the saline or dye or to obtain the necessary blood sample at the correct location. For this reason, either of the above cardiac output measurement techniques is very invasive. Indeed, it is known that an arrhythmia may result from the placement of the catheter in or through the heart. Therefore, these cardiac output measurement techniques are typically only performed in the most critical of situations, where the need to know the patient's cardiac output outweighs the risk to the patient in taking this measurement.
The partial CO
2
rebreathing technique for measuring cardiac output, on the other hand, is a noninvasive approach believed to have been developed by Novametrix Medical Systems, Inc. of Wallingford, Conn. (Novametrix). This method is implemented using a device referred to as a NICO™ sensor, which is distributed by Novametrix. The NICO sensor measures the flow of gas to and from the patient and the CO
2
content in the patient's exhaled gas.
The partial CO
2
rebreathing cardiac output measurement technique is based on the CO
2
Fick equation in conjunction with what is called partial CO
2
rebreathing. According to this partial CO
2
rebreathing technique, cardiac output is measured by comparing the patient's CO
2
excretion to the arterial CO
2
content during normal breathing and during rebreathing, in which the patient rebreathes expired gases for a period of time. Cardiac output is determined as: CO=the change in CO
2
excretion/the change in the arterial CO
2
content.
Arterial CO
2
is typically determined from a sample of arterial blood. However, in order to eliminate the need for a blood sample to measure the arterial CO
2
content, the partial CO
2
rebreathing technique substitutes end tidal CO
2
(ETCO
2
) for the required arterial CO
2
measurement. Therefore, the cardiac output equation becomes: CO=the change in CO
2
excretion/the change in the ETCO
2
.
This partial CO
2
rebreathing technique, however, has several disadvantages. Namely, the patient is preferably intubated or breathing through a trachea tube when taking the flow and CO
2
measurements to capture the total volume of CO
2
. In addition, the patient must be heavily sedated or unconscious so that he or she is not breathing spontaneously. If the patient is breathing spontaneously, the increased CO
2
level in the blood during the rebreathing phase would automatically trigger the patient's respiratory system to speed up or deepen the breaths to remove the excess CO
2
. It is well known that for most patient's the level of CO
2
, not the level of O
2
, is the mechanism for triggering ventilation. Such rapid or deep breathing prevents an accurate determination of cardiac output under this technique. It should also be noted that the use of end tidal CO
2
, as opposed the arterial CO
2
content, may introduce errors in determining cardiac output, because the are situations where the end tidal CO
2
may not correlate with the arterial CO
2
content. The partial CO
2
rebreathing cardiac output measurement technique is also disadvantageous because it does not adequately account for shunt blood flow, which is blood that is not oxygenated during the respiratory cycle. This flow cannot be directly measured, but must be estimated when using this conventional cardiac output measurement technique.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide a method of measuring cardiac output that overcomes the shortcomings of conventional cardiac output measurement techniques. This object is achieved according to one embodiment of the present invention by providing a cardiac output measurement method that includes quantitatively measuring a patient's airflow, a first parameter indicative of a percent oxygen inhaled and exhaled by the patient, and a second parameter indicative of the patient's fractional arterial oxygen concentration. The present method also includes inducing a change in the patient's arterial oxygen concentration and repeating these measurements to monitor the effects resulting from inducing the change in the patient's arterial oxygen concentration. The patient's cardiac output is determined based on the data collected.
It is yet another object of the present invention to provide an apparatus for non-invasively determining the cardiac output of a patient, including a spontaneously breathing patient, that does not suffer from the disadvantages associated with conventional cardiac measurement systems. This object is achieved by providing an apparatus that includes a patient flow measuring system capable of quantitatively measuring a patient's airflow, i.e., the flow of gas to and from a patient, an oxygen analyzing system adapted to measure a first parameter indicative of a percent oxygen inhaled and exhaled by such a patient, and means for measuring a second parameter indicative of the patient's fractional arterial oxygen concentration, such as a pulse oximeter. A processor determines the cardiac output based on the measured patient airflow, the first parameter, and the second parameter. In addition, an output device outputs the result indicative of the patient's cardiac output.
These and other objects, features and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose o
Kandis Mouhyieldin
Pennock Bernard
Starr Eric W.
Haas Michael W.
Natnithithadha Navin
Respironics Inc.
Shaver Kevin
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