Surgery – Diagnostic testing – Respiratory
Reexamination Certificate
1999-05-28
2001-01-16
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Respiratory
C073S001020, C422S083000, C600S538000, C600S520000
Reexamination Certificate
active
06174289
ABSTRACT:
BACKGROUND OF THE INVENTION
The field of invention is cardiopulmonary exercise testing.
Exercise capacity is the best predictor of the future health of patients who suffer coronary artery disease or who have suffered heart failure. These diseases are the leading causes of hospitalization and mortality in the United States. Thus, exercise testing is a basic tool of clinicians, and is widely used. Analysis of expired gas during exercise is commonly known as cardiopulmonary exercise testing (“CPX”) or metabolic exercise testing, and is often referred to as exercise testing with gas analysis. CPX has been considered by many clinicians to be difficult and expensive to perform, and because of this many clinicians have foregone CPX in favor of less accurate tests that merely estimate the measurements made directly by CPX. Such tests typically require the patient to exercise under steady state conditions—that is, a constant work level—for a fixed period of time, at the end of which the patient's heart rate, breathing rate, and oxygen consumption ideally plateau out to constant levels. The constant work level is then increased to a higher constant work level for a fixed time, and the patient's measurements are again expected to plateau out at the end of that time. This process may be repeated several times.
The measurement {dot over (V)}O
2
is the patient's oxygen uptake; that is, the rate of oxygen consumption by a patient during an exercise test. This measurement is sometimes referred to in terms of Mets, which are multiples of resting {dot over (V)}O
2
, assumed to be 3.5 milliliters per kilogram per minute. Peak {dot over (V)}O
2
, which is the maximum rate of oxygen consumption by a patient during an exercise test, is a good objective measurement of a patient's aerobic exercise capacity, and usually reflects cardiac function. As commonly performed, exercise testing merely estimates peak {dot over (V)}O
2
from exercise duration on a treadmill, workload on a stationary bicycle or distance walked. Such estimates may be substantially influenced by factors other than the patient's medical condition, however, such as the degree of patient effort and motivation, the degree of patient familiarity with the test equipment (sometimes referred to as the training effect); the disparity between expected oxygen requirements and actual oxygen uptake widens as heart disease worsens. This gap is filled by anaerobic processes, which result in the production of lactic acid when carbohydrate is metabolized in the absence of oxygen uptake. This leads to errors when {dot over (V)}O
2
is estimated by assuming the whole exercise process is fueled by aerobic metabolism.
{dot over (V)}CO
2
is the rate of carbon dioxide production by a patient during exercise. {dot over (V)}CO
2
relative to {dot over (V)}O
2
is influenced by which substrate is metabolized (fat vs. carbohydrate) and whether anaerobic processes and lactic acid production occur. Therefore, {dot over (V)}CO
2
cannot be estimated. {dot over (V)}E (minute ventilation) is the volume of air breathed per minute by a patient, which varies proportionally to {dot over (V)}CO
2
. {dot over (V)}CO
2
relative to {dot over (V)}E is influenced by the presence of heart or lung disease. The calculation of {dot over (V)}O
2
and {dot over (V)}CO
2
by numerical integration of the product of expiratory airflow with O
2
and CO
2
concentrations over the duration of a breath is taught in the prior art.
Two different sources of error are commonly found in gas analysis equipment: delay time and response time. Delay time is the time taken for the physical transport of a gas sample from the mouth to the gas analyzers. On the other hand, response time, also known as rise time, is intrinsic to a gas analyzer. Response time is the time that elapses between exposure of a gas sample to a gas analyzer and an output signal from the gas analyzer achieving 67% of the full-scale signal that would correspond to the actual concentration of the gas. For example, if a gas sample containing carbon dioxide at a 10% concentration were exposed to a gas analyzer, the response time of that gas analyzer would be the time taken for that gas analyzer to output a signal indicating a 6.7% concentration of carbon dioxide. The errors introduced by the delay time and the response time prevent the accurate time synchronization of O
2
and CO
2
signals with separately-measured flow signals that do not experience delay time and response time errors, and thus prevent realtime measurement of {dot over (V)}O
2
and {dot over (V)}CO
2
and realtime calculation of derived parameters that depend on {dot over (V)}O
2
and {dot over (V)}CO
2
, such as {dot over (V)}E/{dot over (V)}O
2
and {dot over (V)}E/{dot over (V)}CO
2
.
Before calibrating a CPX system, it is often desirable to purge it of remnants of test gas or previous reference gas and ensure that ambient air is present in the system. This is essential for calibration, because if the system is not filled with ambient air before calibration, it will not be at a standard baseline state for the initiation of calibration.
Masks for collecting gas during exercise testing are known in the art, and may be used instead of the traditional mouthpiece and noseclip. However, tradeoffs are made between patient comfort during use, ease with which the operator can place the mask on the patient, and security of attachment to the patient. Typically masks which securely attach to the patient during exercise are difficult to put on the patient, and are uncomfortable; such discomfort can distract the patient during CPX and result in submaximal effort, or in early test termination due to patient discomfort.
SUMMARY OF THE INVENTION
The present invention is directed toward a method and apparatus for cardiopulmonary exercise testing.
In a first, separate aspect of the invention, a simulated breath, composed of a known volume of calibration gas containing known concentrations of oxygen, carbon dioxide and nitrogen approximating those of exhaled air, is released within a cardiopulmonary exercise testing apparatus at a flow rate and pressure profile similar to an exhaled breath. The cardiopulmonary exercise testing apparatus measures the flow rate and composition of this gas. Those measurements serve as input for a software program that calculates the necessary compensation and calibration factors for gas sensor delay time, gas sensor response time, gas sensor zero offset, gas sensor span adjustment, and flow sensor calibration. The software program uses these compensation and calibration factors to co-align the gas concentration measurement signals and the flow rate signals such that integration of flow and gas concentration signals can be accomplished breath by breath during exercise testing.
In a second, separate aspect of the invention, measurements of {dot over (V)}O
2
and {dot over (V)}CO
2
, exhaled breath flow rate ({dot over (V)}E), heart rate, and oxygen saturation, as well as derived factors of diagnostic importance, are displayed in a series of four charts that organize and present this information for ease of use and interpretation to facilitate diagnosis.
In a third, separate aspect of the invention, a single pump is used to both purge the cardiopulmonary exercise test apparatus of calibration gas before calibration or testing and to draw the sample gas through the gas analyzers during the calibration procedure or patient testing.
In a fourth, separate aspect of the invention, a face mask used to collect a patient's exhaled breath possesses a plurality of pins. Each headstrap contains a hole corresponding to a headstrap pin, and is attached to the face mask by placing the hole over the corresponding headstrap pin. Each headstrap can be adjusted and secured in a single step, and quickly and easily removed from its corresponding headstrap pin.
REFERENCES:
patent: 4368740 (1983-01-01), Binder
patent: 4443407 (1984-04-01), Wienberg et al.
patent: 4448058 (1984-05-01), Jaffe et al.
patent: 5185263 (1993-02-01), Kroneis e
Carter Ryan
Lyon & Lyon LLP
O'Connor Cary
Orca Diagnostics Corporation
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