Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing
Reexamination Certificate
1999-02-26
2001-05-08
Jones, Dameron L. (Department: 1619)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
C424S001110, C424S009600
Reexamination Certificate
active
06228344
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is in the field of measuring physiological function of a group of body cells.
2. Description of the Background Art
Current clinical practice for determining liver function includes deriving a CTC score, which is a compilation of laboratory data and clinical assessment of ascites and encephalopathy. D. A. Noe and R. C. Rock (eds),
Laboratory Medicine, The Selection and Interpretation of clinical Laboratory Studies
, Williams and Wilkins, 1994, Baltimore, Md., Chapter 5
, Assessment of Organ Function
, by D. A. Noe, p. 55-60, Chapter 19
, Liver and Biliary Tract
, by A. T. Blei, p. 363-379, Chapter 21
, The Kidneys
, by D. A. Oken and A. C. Schoolwerth, p. 401-410.
Another test involves the use of indocyanine green (ICG). ICG is known to be exclusively cleared from the bloodstream by the liver. Thus a measurement of the ICG blood clearance time profile is directly related to liver function. J. Caesar, S. Shaldon, L. Chiandussi, L. Guevara, and Sheila Sherlock, “The use of indocyanine green in the measurement of hepatic blood flow and as a test of hepatic function,”
Clin. Sci
. 21, 43-57 (1961).
The ICG test has undergone an evolution in technology. In its first incarnation, blood was withdrawn from the subject at several times following an IV bolus injection. The blood samples were then processed spectrophotometrically to determine ICG concentration. R. Jalan and P. C. Hayes, “Review article: quantitative tests of liver function,”
Aliment Pharmacol. Ther
. 9, 263-270 (1995); A. W. Hemming, C. H. Scudamore, C. R. Shackleton, M. Pudek, and S. R. Erb, “Indocyanine green clearance as a predictor of successful hepatic resection in cirrhotic patients,”
Am. J. Surg
. 163, 515-518 (1992); P. Ott, S. Keiding, and L. Bass, “Plasma elimination of indocyanine green in the intact pig after bolus injection and during constant infusion: comparison of spectrophotometry and high-pressure liquid chromatography for concentration analysis,”
Hepatology
18, 1504-1515 (1993). Subsequently, a non-invasive technique employing ear densitometry was developed. C. M. Leevy, F. Smith, J. Longueville, G. Paumgartner, and M. M. Howard, “Indocyanine green clearance as a test for hepatic function: Evaluation by dichromatic ear densitometry,”
Journal of Medicine
24, 10-27 (1993). Problems associated with the clinical development of this device recently led Japanese researchers to improve upon the ear densitometry technique. This newer method, termed the finger-piece method, employs transmitted light of two wavelengths measured throughout a finger to deduce ICG concentration. M. Kanda, K. Taniguchi, K. Awazu, Y. Ishigami, M. Masuzawa, and H. Abe, “Continuous monitoring of Cardiogreen removal by a diseased liver using an optical sensor,”
Proc. SPIE
904, 39-46 (1988); M. Nakayama, N. Kanaya, S. Fujita, and A. Namiki, “Effects of ephedrine on indocyanine green clearance during spinal anesthesia: Evaluation by the finger piece method,”
Anesth. Analg
. 77, 947-949 (1993); N. Kanaya, H. Iwasaki, and A. Namiki, “Noninvasive ICG clearance test for estimating hepatic blood flow during halothane and isoflurane anaesthesia,”
Can. J. Anaesth
. 42, 209-212 (1995); N. Kanaya, M. Nakayama, S. Fujita, and A. Namiki, “Comparison of the effects of sevoflurane, isoflurane and halothane on indocyanine green clearance,”
Br. J. Anaesth
. 74, 164-167 (1995); S. Shimizu, W. Kamiike, N. Hatanaka, Y. Yoshida, K. Tagawa, M. Miyata, and H. Matsuda, “New method for measuring ICG R
max
with a clearance meter,”
World J. Surg
. 19, 113-118 (1995).
Both ear densitometry and the finger-piece method involve measuring absorption (or transmission) of light by ICG.
Also of interest is that in vitro fluorometric determination of ICG in plasma has been demonstrated, B. Hollins, B. Noe, and J. M. Henderson, “Fluorometric determination of indocyanine green in plasma,”
Clin. Chem
. 33, 765-768 (1987).
Other references of general interest include: R. L. Sheridan, et al., “Burn depth estimation by indocyanine green fluorescence: Initial human trial,”
Journal of Burn Care & Rehabilitation
16, 602-604 (1995); M. A. O'Leary, D. A. Boas, B. Chance, and A. G. Yodh, “Reradiation and imaging of diffuse photon density waves using fluorescent inhomogeneities,”
Journal of Luminescence
60 & 61, 281-286 (1994); X. Li, B. Beauvoit, R. White, S. Nioka, B. Chance, and A. Yodh, “Tumor localization using fluorescence of indocyanine green (ICG) in rat models,”
Proc. SPIE
2389, 789-797 (1995).
There remains a need in the art for improved methods of measuring physiological function.
SUMMARY OF THE INVENTION
In accordance with the present invention, a method of measuring physiological function of a group of body cells, includes the step of selecting a detectable agent capable of emitting a measurable member comprising an electromagnetic emission. The agent is introduced into body fluid which contacts the group of body cells. The emission is measured, and physiological function is determined based on measurement of the emission. The emission can be measured using non-invasive or invasive techniques. Invasive techniques include using endoscopes and catheters inserted into the respective body portion. Non-invasive techniques include surface probes such as ear clips and finger probes.
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Awazu, K. et al. “The data processing function of the ICG clearance meter”, 1992; Abstract—1 page.
Bilheimer, D.W. et al. “Metabolic Studies in Familial Hypercholesterolemia”,J. Clin. Invest., Aug. 1979; 64:524-533.
Graham, B.H. et al. “Serial quantitative skin surface fluorescence: A new method for postoperative monitoring of vascular perfusion in revascularized digits”,The Journal of Hand Surgery, 1985; 10A:226-30.
Caesar, J. et al. “The Use of Indocyanine Green in the Measurement of Hepatic Blood Flow and as a Test of Hepatic Function”,Clin. Sci., 1961; 21:43-57.
Flock, S. T. et al. “Optical Properties of Intralipid: A Phantom Medium for Light Propagation Studies”,Lasers in Surgery and Medicine, 1992; 12:510-519.
Hemming, A.W. et al. “Indocyanine Green Clearance as a Predictor of Successful Hepatic Resection in Cirrhotic Patients”,The American Journal of Surgery, May 1992; 163:515-518.
Hollins, B. et al. “Fluorometric Determination of Indocyanine Green in Plasma”,Clin. Chem., 1987; 33(6):765-768.
Jalan, R. et al. “Review article: quantitative tests of liver function”,Aliment Pharmacol. Ther., 1995; 9:263-270.
Kanaya, N. et al. “Comparison of the effects of sevoflurane, isoflurane and halothane on indocyanine green clearance”,British Journal of Anaesthesia, 1995; 74:164-167.
Kanaya, N. et al. “Noninvasive ICG clearance test for estimating hepatic blood flow during halothane and isoflurane anaesthesia”,Can. J. Anaesth., 1995; 42(3):209-212.
Kanda, M. et al. “Continuous monitoring of Cardiogreen removal by a diseased liver using an optical sensor”,SPIE, 1988; 904:39-46.
Kudo, M. et al. “Receptor Index via Hepatic Asialoglycoprotein Receptor Imaging: Correlation with Chronic Hepatocellular Damage”,American Journal of Gastroenterology, 1992; 87(7):865-870.
Li, X. et al. “Tumor Localization Using Fluorescence of Indocyanine Green (ICG) in Rat Models”,SPIE, 1995; vol. 2389, pp. 789-797.
Mordon, S. et al. “Fluorescence measurement of diode (805nm) laser-induced release of 5,6-CF from DSPC liposomes for monitoring of temperature: an in-vivo study in rat liver using indocyanine green potentiation”,SPIE, 1995; vol. 2391, pp. 475-483.
Nakayama, M. et al. “Efffects of Ephedrine on Indocyanine Green Clearance During Spinal Anesthesia: Evaluation by
Achilefu Samuel
Bugaj Joseph Edward
Dorshow Richard Bradley
Rajagopalan Raghavan
Jones Dameron L.
Mallinckrodt Inc.
Rothwell Figg Ernst & Manbeck
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