Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Patent
1995-05-08
2000-02-22
Lacyk, John P.
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
A61B 500
Patent
active
060290765
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND AND SUMMARY OF THE INVENTION
This invention relates to medical diagnostic equipment and methods and is particularly concerned with hollow viscus tonometry and remote electronic and optical sensing.
Until the advent of the tonometric method (see U.S. Pat. No. 4,643,192, issued Feb. 17, 1987) few considered any aspect of acid-base balance when attempting to monitor or maintain the adequacy of tissue oxygenation. Yet acid-base balance is primarily determined by the balance between the protons released during the release of energy by ATP hydrolysis and the resynthesis of ATP by oxidative phosphorylation. The hydrolysis of ATP generates 150,000 mmols of H+ each day in a resting 70 Kg man. All, but the 1% of this fixed acid load excreted by the kidneys each day, is presumed to be consumed in the resynthesis of ATP by oxidative phosphorylation. When the delivery of oxygen fails to satisfy the energy needs of the tissue the rate of ATP hydrolysis exceeds the rate of synthesis and the pH falls as the degree of unreversed ATP hydrolysis increases.
Information for determining global tissue oxygenation has been collected for many years. Eoda, D., "`Gastrotonometry` an Aid to the Control of Ventilation During Artificial Respiration," The Lance: (1959). However, it is now widely accepted that global measurements of oxygen delivery, consumption and extraction do not provide reliable information about the adequacy of local or even "global" tissue oxygenation in patients. The indirect measurement of gastric intramucosal pH (pHi) as described in U.S. Pat. Nos. 4,643,192; 5,158,083; 5,186,172 provides clinicians with a minimally invasive yet sensitive means of detecting the development of a tissue acidosis, and hence inadequacy of tissue oxygenation, in a region of the body that is one of the first to exhibit an inadequacy of tissue oxygenation in shock. Use of the measurement has revealed that some 50% to 60% of patients having major surgery and 80% of ICU patients develop an intramucosal acidosis during their illness despite the conventional appearance of being adequately resuscitated.
The degree and duration of the presence of a gastric intramucosal acidosis are highly sensitive measures of the risk of developing ischemic gut mucosal injury and its putative consequences, namely the translocation of bacteria and their toxins, cytokine release, organ dysfunctions and failures, and death from the organ failures. By providing an index of the adequacy of tissue oxygenation in one of the first parts of the body to exhibit dysoxia in shock the measurement of gastric intramucosal pH improves the opportunity to obtain advanced and accurate warning of impending complications and to intervene in time to prevent them. More importantly timely therapeutic measures that restore the intramucosal pH to normality and "gut-directed" therapies incorporating measures that reverse an intramucosal acidosis are associated with an improved outcome. "pH-directed" therapy has in addition been shown to improve outcome in a prospective randomized multicenter study of medical and surgical ICU patients.
The measurements of gastric intramucosal pH have revealed deficiencies in currently accepted practices. It has, for example, become apparent that empirical increases in global oxygen delivery may be redundant in some 40% to 50% of patients having major cardiovascular surgery who do not develop a gastric intramucosal acidosis and whose prognosis is excellent. It is further apparent that the vogue of increasing global oxygen delivery to supranormal levels cannot be relied upon to prevent or to reverse the presence of an intramucosal acidosis. Of particular concern is the intramucosal acidosis that may be induced by measures, notably the transfusion of red blood cells and dobutamine, that increase global oxygen delivery in patients who do not have an intramucosal acidosis but whose global oxygen delivery is considered too low.
THE TONOMETRIC METHOD
The measurement of pH in the most superficial layer of the mucosa is obtained indirectly by me
REFERENCES:
"Gastrotonometry" An Aid to the Control of Ventilation During Artificial Respiration, D. Boda, L. Muranyi, reprinted from The Lancet, Jan. 24, 1959, pp. 181-182.
Small Bowel Tonometry: Assessment of Small Gut Mucosal Oxygen Tension in Dog and Man, A. M. Dawson et al., Nature, vol. 206, pp. 944, May 29, 1965.
Determination of Tissue O.sub.2 Tensions by Hollow Visceral Tonometers: Effect of Breathing Enriched O.sub.2 Mixtures, E. H. Bergofsky, Journal of Clinical Investigation, vol. 43, No. 2, p. 193, 1964.
Elevated Systemic to Intrasmucosal Stomach Wall pH-Gap in Patients with Sepsis, Anzivino et al., Chest, 1990 Supplement.
Fiddian-Greene Richard G.
Holte Bo
Kent Joel C.
Instrumentarium Corp.
Lacyk John P.
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