Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
2000-05-18
2002-06-11
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
C073S001730
Reexamination Certificate
active
06402703
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to an apparatus and method for measuring the viscosity of liquids, and more particularly, an apparatus and methods for measuring the viscosity of the blood of a living being in-vivo and over a wide range of shears.
The importance of determining the viscosity of blood is well-known.
Fibrogen, Viscosity and White Blood Cell Count Are Major Risk Factors for Ischemic Heart Disease
, by Yarnell et al., Circulation, Vol. 83, No. 3, March 1991
; Postprandial Changes in Plasma and Serum Viscosity and Plasma Lipids and Lipoproteins After an Acute Test Meal
, by Tangney, et al., American Journal for Clinical Nutrition, 65:36-40, 1997
; Studies of Plasma Viscosity in Primary Hyperlipoproteinaemia
, by Leonhardt et al., Atherosclerosis 28, 29-40, 1977
; Effects of Lipoproteins on Plasma Viscosity
, by Seplowitz,t al., Atherosclerosis 38, 89-95, 1981
; Hyperviscosity Syndrome in a Hypercholesterolemic Patient with Primary Biliary Cirrhosis
, Rosenson, et al., Gastroenterology, Vol. 98, No. 5, 1990
; Blood Viscosity and Risk of Cardiovascular Events:the Edinburgh Artery Study
, by Lowe et al., British Journal of Hematology, 96, 168-171,1997
; Blood Rheology Associated with Cardiovascular Risk Factors and Chronic Cardiovascular Diseases: Results of an Epidemiologic Cross
-
Sectional Study
, by Koenig, et al., Angiology, The Journal of Vascular Diseases, November 1988
; Importance of Blood Viscoelasticity in Arteriosclerosis
, by Hell, et al., Angiology, The Journal of Vascular Diseases, June, 1989
; Thermal Method for Continuous Blood
-
Velocity Measurements in Large Blood Vessels, and Cardiac
-
Output Determination
, by Delanois, Medical and Biological Engineering, Vol. 11, No. 2, March 1973
; Fluid Mechanics in Atherosclerosis
, by Nerem, et al., Handbook of Bioengineering, Chapter 21, 1985.
Much effort has been made to develop apparatus and methods for determining the viscosity of blood.
Theory and Design of Disposable Clinical Blood Viscometer
, by Litt et al., Biorheology, 25, 697-712, 1988
; Automated Measurement of Plasma Viscosity by Capillary Viscometer
, by Cooke, et al., Journal of Clinical Pathology 41, 1213-1216, 1988
; A Novel Computerized Viscometer/Rheometer
by Jimenez and Kostic, Rev. Scientific Instruments 65, Vol 1, January 1994
; A New Instrument for the Measurement of Plasma
-
Viscosity
, by John Harkness, The Lancet, pp. 280-281, Aug. 10, 1963
; Blood Viscosity and Raynaud's Disease
, by Pringle, et al., The Lancet, pp. 1086-1089, May 22, 1965
; Measurement of Blood Viscosity Using a Conicylindrical Viscometer
, by Walker et al., Medical and Biological Engineering, pp. 551-557, September 1976.
One reference, namely,
The Goldman Algorithm Revisited: Prospective Evaluation of a Computer
-
Derived Algorithm Versus Unaided Physician Judgment in Suspected Acute Myocardial Infarction
, by Qamar, et al., Am Heart J 138(4):705-709, 1999, discusses the use of the Goldman algorithm for providing an indicator to acute myocardial infarction. The Goldman algorithm basically utilizes facts from a patient's history, physical examination and admission (emergency room) electrocardiogram to provide an AMI indicator.
In addition, there are a number of patents relating to blood viscosity measuring apparatus and methods. See for example, U.S. Pat. No.: 3,342,063 (Smythe et al.); U.S. Pat. No. 3,720,097 (Kron); U.S. Pat. No. 3,999,538 (Philpot, Jr.); U.S. Pat. No. 4,083,363 (Philpot); U.S. Pat. No. 4,149,405 (Ringrose); U.S. Pat. No. 4,165,632 (Weber, et. al.); U.S. Pat. No. 4,517,830 (Gunn, deceased, et. al.); U.S. Pat. No. 4,519,239 (Kiesewetter, et. al.); U.S. Pat. No. 4,554,821 (Kiesewetter, et. al.); U.S. Pat. No. 4,858,127 (Kron, et. al.); U.S. Pat. No. 4,884,577 (Merrill); U.S. Pat. No. 4,947,678 (Hori et al.); U.S. Pat. No. 5,181,415 (Esvan et al.); U.S. Pat. No. 5,257,529 (Taniguchi et al.); U.S. Pat. No. 5,271,398 (Schlain et al.); and U.S. Pat. No. 5,447,440 (Davis, et. al.).
The Smythe '063 patent discloses an apparatus for measuring the viscosity of a blood sample based on the pressure detected in a conduit containing the blood sample. The Kron '097 patent discloses a method and apparatus for determining the blood viscosity using a flowmeter, a pressure source and a pressure transducer. The Philpot '538 patent discloses a method of determining blood viscosity by withdrawing blood from the vein at a constant pressure for a predetermined time period and from the volume of blood withdrawn. The Philpot '363 patent discloses an apparatus for determining blood viscosity using a hollow needle, a means for withdrawing and collecting blood from the vein via the hollow needle, a negative pressure measuring device and a timing device. The Ringrose '405 patent discloses a method for measuring the viscosity of blood by placing a sample of it on a support and directing a beam of light through the sample and then detecting the reflected light while vibrating the support at a given frequency and amplitude. The Weber '632 patent discloses a method and apparatus for determining the fluidity of blood by drawing the blood through a capillary tube measuring cell into a reservoir and then returning the blood back through the tube at a constant flow velocity and with the pressure difference between the ends of the capillary tube being directly related to the blood viscosity. The Gunn '830 patent discloses an apparatus for determining blood viscosity that utilizes a transparent hollow tube, a needle at one end, a plunger at the other end for creating a vacuum to extract a predetermined amount and an apertured weight member that is movable within the tube and is movable by gravity at a rate that is a function of the viscosity of the blood. The Kiesewetter '239 patent discloses an apparatus for determining the flow shear stress of suspensions, principally blood, using a measuring chamber comprised of a passage configuration that simulates the natural microcirculation of capillary passages in a being. The Kiesewetter '821 patent discloses another apparatus for determining the viscosity of fluids, particularly blood, that includes the use of two parallel branches of a flow loop in combination with a flow rate measuring device for measuring the flow in one of the branches for determining the blood viscosity. The Kron '127 patent discloses an apparatus and method for determining blood viscosity of a blood sample over a wide range of shear rates. The Merrill '577 patent discloses an apparatus and method for determining the blood viscosity of a blood sample using a hollow column in fluid communication with a chamber containing a porous bed and means for measuring the blood flow rate within the column. The Hori '678 patent discloses a method for measurement of the viscosity change in blood by disposing a temperature sensor in the blood flow and stimulating the blood so as to cause a viscosity change. The Esvan '415 patent discloses an apparatus that detects the change in viscosity of a blood sample based on the relative slip of a drive element and a driven element, which holds the blood sample, that are rotated. The Taniguchi '529 patent discloses a method and apparatus for determining the viscosity of liquids, e.g., a blood sample, utilizing a pair of vertically-aligned tubes coupled together via fine tubes while using a pressure sensor to measure the change of an internal tube pressure with the passage of time and the change of flow rate of the blood. The Bedingham '328 patent discloses an intravascular blood parameter sensing system that uses a catheter and probe having a plurality of sensors (e.g., an O
2
sensor, CO
2
sensor, etc.) for measuring particular blood parameters in vivo. The Schlain '398 patent discloses a intra-vessel method and apparatus for detecting undesirable wall effect on blood parameter sensors and for moving such sensors to reduce or eliminate the wall effect. The Davis '440 patent discloses an apparatus for conducting a varie
Cho Young
Hogenauer William N.
Kensey Kenneth
Kim Sangho
Caesar, Rivise, Bernstein, Cohen & Polotilow, Ltd.
Nasser Robert L.
Visco Technologies, Inc.
Wingood Pamela
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