Apparatus and method for determining respiratory mechanics...

Surgery – Respiratory method or device – Means for supplying respiratory gas under positive pressure

Reexamination Certificate

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C128S204230

Reexamination Certificate

active

06257234

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention pertains to a system and method for determining a respiratory condition of a patient and to a system and method for controlling a ventilation system based on the determined condition, and, in particular, to a system and method that non-invasively measures a patient's elastance and resistance and to a ventilator that employs such a method to measure elastance and resistance during ventilation so that the ventilatory assistance provided to the patient by the ventilator is automatically adjusted to suit the needs of the patient.
2. Description of Related Art
The related art will be described with reference to the following patents and other publications, the disclosures of which are hereby incorporated by reference in their entireties into the present disclosure. Throughout the description of the related art, these references will be cited by the first-named author and the year of publication, e.g., Jackson, 1974.
M. Franetzki et al, U.S. Pat. No. 4,051,843 (1977); U.S. Pat. No. 4,022,193 (1977); and U.S. Pat. No. 4,122,839 (1978).
M. M. Grunstein, U.S. Pat. No. 4,802,492 (1989).
P. H. Vooren, U.S. Pat. No. 4,259,967 (1981).
Y. Yoshitsugu, European Published Patent Application 0 521 515 A1 (1993).
P. J. Chowiency, C. P. Lawsom, et al, U.S. Pat. No. 5,233,998 (1993).
Bates, J. H. T., Daroczy, B., and Hantos, Z., “A Comparison of Interrupter and Forced Oscillation Measurements of Respiratory Resistance in the Dog,”
Journal of Applied Physiology
, Vol. 72, Iss. 1., pp. 46-52 (1992).
Bates, J. H. T., Decramer, M., Zin, W. A., Harf, A., “Respiratory Resistance with Histamine Challenge by Single-breath and Forced Oscillation Methods,”
Journal of Applied Physiology
, Vol. 61, No. 3, pp. 873-80 (1986).
Bates, J. H. T., Baconnier, P., Milic-Emili, J., “A Theoretical Analysis of Interrupter Technique for Measuring Respiratory Mechanics,”
Journal of Applied Physiology
, Vol. 64, No. 5, pp. 2204-14 (1988).
Calhoun, Karen H., House, William, et al, “Normal Nasal Airway Resistance in Noses of Different Kinds and Shapes,”
Otolaryngology Head and Neck Surgery
, Vol. 103, No. 4, pp. 605-9 (1990).
Chatburn, Robert L., “A New System for Understanding Mechanical Ventilators,”
Respiratory Care
, Vol. 36, No. 10, pp. 1123-55 (1991).
Chiang, S. T., Green, J., Gao Y. C., “Determination of Total Respiratory Resistance in Health and Disease by Added External Resistance,”
Chest
, Vol. 93, pp. 537-40 (1988).
Chowienczyk, P. J., Lawson, C. P., et al, “A Flow Interruption Device for Measurement of Airway Resistance,”
European Respiratory Journal
, Vol. 4, pp. 623-628, (1991).
Daroczy, B., Hantos, Z., “Generation of Optimum Pseudorandom Signals for Respiratory Impedance Measurements,”
International Journal of Biomedical Computation
, Vol. 25, pp. 21-31 (1990).
Frank, N. R., Mead, J., Whittenberger, “Comparative Sensitivity of Four Methods for Measuring Changes in Respiratory Flow Resistance in Man,”
Journal of Applied Physiology
, Vol. 31, No. 6 (December, 1971).
Green, J., Chiang, S. T., Yang Y. C., “Improved Computation of Respiratory Resistance as Measured by Transiently Increased Resistance,”
Medical
&
Biological Engineering
&
Computing
, Vol.28, pp. 50-53 (1990).
Gimeno, F., van der Weele, L. Th., “Variability of Forced Oscillation (Siemens Siregnost FD5) Measurements of Total Respiratory Resistance in Patients and Health Subjects,”
Annals of Allergy
, Vol. 71, pp. 56-60 (July, 1993).
Hantos, Z., Daroczy, B., Suki, B., “Forced Oscillatory Impedance of the Respiratory System at Low Frequencies,”
Journal of Applied Physiology
, Vol. 60, pp. 123-32 (1986).
Jackson, A. C., Milhom, H. T., and Norman, J. R., “A Reevaluation of the Interrupter Technique for Airway Resistance Measurement,”
Journal of Applied Physiology
, Vol. 36, No. 2 (December, 1974).
Lutchen, Kenneth, Yang, Kun, Kaczka, David W., “Optimal Ventilation Waveforms for Estimating Low-Frequency Respiratory Impedance,”
Journal of Applied Physiology
, Vol. 75, Iss. 1, pp. 478-88 (1993).
Lutchen, Kenneth., Kaczka, David W., Suki, Bela, “Low-frequency Respiratory Mechanics Using Ventilator-driven Forced Oscillations,”
Journal of Applied Physiology
, Vol. 75, No. 6, pp. 2549-60 (1993).
Mayewski, Raymond J., Hyde, Richard W., “Measurement of Static Pressure-Volume Relationships of the Lung and Thorax,”
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, E. Leslie Chusid, ed., Futura Publishing Co., New York (1983).
Morozoff, Paul E., Evans, Ron W., “Real-Time Display of Flow-Pressure-Volume Loops,”
Biomedical Instrumentation
&
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(July/August, 1992).
Neild, J. E., “The Repeatability and Validity of Respiratory Resistance Measured by the Forced Oscillation Technique,”
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, Vol. 83, pp. 111-18 (1989).
Petak, F., Hantos, Z., Adamicza, A., “Partitioning of Pulmonary Impedance: Modeling vs. Alveolar Capsule Approach,”
Journal of Applied Physiology
, Vol. 75, No. 2, pp. 513-521 (1993).
Romero, P. V., Sato, J., Shardonfsky, F., “High-frequency Characteristics of Respiratory Mechanics Determined by Flow Interruption,”
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, Vol. 69, No. 5, pp. 1682-88 (1990).
Suki, Bela, Lutchen, Kenneth R., “Pseudorandom Signals to Estimate Apparent Transfer and Coherence Functions of Nonlinear Systems: Applications to Respiratory Mechanics,”
IEEE Transactions on Biomedical Engineering
, Vol. 39, No. 11 (November, 1992).
Suki, B., Hantos, Z., “Nonlinearity and Harmonic Distortion of Dog Lungs Measured by Low-Frequency Forced Oscillations,”
Journal of Applied Physiology
, Vol. 71, pp. 69-75 (1991).
Suki, B., Peslin, R., Duvivier, C., “Lung Impedance in Health Humans Measured by Forced Oscillations from 0.01 to 0.1 Hz,”
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To understand how a machine can be controlled to replace or supplement the natural function of breathing, it is necessary to understand the mechanical nature of the respiratory system. The study of the mechanical behavior of the respiratory system requires analyzing the elastance and resistance properties of the patient's pulmonary system, which includes the airways, lung and thoracic cage. In clinical practice, respiratory resistance R
rs
and elastance E
rs
are essential information necessary to describe the behavior of the lung and the chest wall in health and disease states, and, in particular, to describe characteristics of that behavior, such as inspiratory vital capacity (IVC) and the forced expiratory volume in one second (FEV1). Furthermore, the use of state-of-the-art mechanical ventilation techniques, such as proportional assist ventilation (PAV), which is disclosed in U.S. Pat. Nos. 5,107,830 and 5,044,362 both to Younes, the contents of which are also incorporated herein by reference, requires knowledge of the patient's respiratory resistance and elastance.
Measuring the respiratory resistance and elastance of a spontaneously breathing patient is not a simple task. Conventional techniques for measuring resistance and elastance are somewhat invasive in that they are performed in a clinical or hospital setting and require placing a device for measuring esophageal pressures, such as an esophageal balloon, within the patient. Therefore, R
rs
and E
rs
are typically not measured on a routine basis. In order to perform these measurements more routinely, there is a need for an efficient and reliable technique that is as non-invasive as possible and requires little or no patient cooperation for spontaneously obtaining R
rs
and E
rs
, especially inspiratory R
rs
and E
rs
.
Respiratory mechanics takes into consideration the forces, displacement, rate of change (first time derivative) of displacement, and acceleration (second time derivative) of displacement. In respiratory physiology, force is measured in terms of pressure P, displacement is measured as volume V, rate of change of displacement is measured as flow {dot over (V)} (first time derivative), and acceleration of displacement is measured as the

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