MXPA00002073A - Viscosity measuring apparatus and method of use - Google Patents

Abstract

A blood viscosity measuring system and method that monitors the rising head of a column of fluid representing a living being's blood in vivo to determine the blood viscosity over a range of shears. The system includes a capillary tube, at least a portion of which is located within the vascular system of the being, and a riser tube, having a liquid therein coupled to the capillary tube. A sensor and associated microprocessor are provided to determine the change in the height of the liquid in the riser tube at plural points along the length of the tube from which the viscosity is calculated.

Description

VISCOSITY METER DEVICE AND METHOD OF USE BACKGROUND OF THE INVENTION This invention relates in general 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 shear stresses. The importance to determine the viscosity of blood is well known. Fibrogen, Viscosity and White Blood Cell Count Are Maior Risk Factors for Ischemic Heart Disease, by Yarnell et al., Circulation, Vol. 83, No. 3, March 1991; Postprandial Chanqes 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, 1997; Effects of Lipoproteins on Plasma Viscositv, by Seplowitz, et al., Atherosclerosis 38, 89-95, 1981; Hyperviscosity Syndrome in a Hypercholesterolemic Patient with Primarv Biliary Cirrhosis, Rosenson, et al., Gastroenterology, Vol. 98, No 5, 1990; Blood Viscosity and Risk of Cardiovascular Events: the Edinburgh Arter Studv, by Lowe et al., Bri tish Journal of Hematology, 96, 168-171, 1997; Blood Rheoloqy 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 to determine 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 Viscositv bv Capillary Viscometer, by Cooke, et al., Journal of Clinical Pathology 41, 1213-1216, 1988; A Novel Computerized Viscometer / Rheometer by Jiménez and Kostic, Rev. Scientific Instruments 65, Vol. I. January 1994; A New Instrument for the Measurement of Plasma-Viscosity, by John Harkness, The Lancet, pp. 280-281, August 10, 1963; Blood Viscositv and Ravnaud's Disease, by Pringle, and collaborators, 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. In addition there are several patents related to apparatus and methods of measuring blood viscosity. See, for example, U.S. Patent Nos .: 3,342,063 (Smythe et al.); 3,720,097 (Kron); 3,999,538 (Philpot, Jr.); 4,083,363 (Philpot); 4,149,405 (Ringrose); 4,165,632 (Weber, et al.); 4,517,830 (Gunn, deceased, and collaborators); 4,519,239 (Kiesewetter, et al.); 4,554,821 (Kiesewetter, et al.); 4,858,127 (Kron, et al.); 4,884,577 (Merrill); 4,947,678 (Hory et al.); 5,181,415 (Esvan et al.); 5,257,529 (Taniguchi et al.); 5,271,398 (Schlain et al.); and 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 describes a method and apparatus for determining blood viscosity using a flowmeter, a pressure source and a pressure transducer. Nevertheless, the apparatus and method of the '097 patent suffers from, among other things, inaccuracies in trying to measure the viscosity of the blood using a pressure transducer, especially at low shear rates. The Philpot '538 patent describes a method for determining the viscosity of the blood by drawing blood from the vein at a constant pressure for a predetermined period of time and the volume of blood drawn. The Philpot '363 patent describes an apparatus for determining the viscosity of blood using a hollow needle, a means for extracting and collecting blood from the vein via the hollow needle, a device that measures negative pressure and a device that measures the weather. The Ringrose '405 patent describes 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 time. frequency and amplitude given. The Weber '632 patent discloses a method and apparatus for determining the fluidity of blood by drawing blood through a capillary tube by measuring the cells in a container and then returning the blood back through the tube at a constant flow rate and the difference in pressure between the ends of the capillary tube being directly related to the viscosity of the blood. The Gunn '830 patent discloses an apparatus for determining the viscosity of blood using a transparent hollow tube, a needle at one end, a plunger at the other end to create a vacuum to extract a predetermined amount and an open weight member It moves inside the tube and moves by gravity at a speed that is a function of the viscosity of the blood. The Kiesewetter patent '239 describes an apparatus for determining the cutting force of the flow of suspensions, mainly blood, using a measuring chamber composed of a passage configuration that simulates the natural microcirculation of the capillary passages in a living being. The Kiesewetter patent '821 describes another apparatus for determining the viscosity of fluids, particularly blood, which includes the use of two parallel branches of a flow cycle in combination with a flow rate measuring device for measuring flow in a of the branches to determine the viscosity of the blood. The Kron '127 patent describes an apparatus and method for determining the viscosity of blood from a blood sample over a wide range of shear rates. However, the apparatus and method of the '127 patent suffers, among other things, that the blood is static, that is, a sample of blood is used, not blood circulating. As a result, an accurate determination of the viscosity of the circulating blood of the patient is not achieved. The Merrill '577 patent describes an apparatus and method for determining the viscosity of blood and 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 inside the column. The Hori '678 patent discloses a method for measuring the change in viscosity of the blood by arranging a temperature sensor in the blood flow and stimulating the blood to use a change in viscosity. The Esvan '415 patent discloses an apparatus that detects the change in viscosity of a blood sample based on a relative slip of a conduction element and a driven element, which maintains the blood sample, which are rotated. The Taniguchi '529 patent discloses a method and apparatus for determining the viscosity of liquids, for example, a blood sample, using a pair of vertically aligned tubes coupled together via thin tubes while using a pressure sensor for measure the change of an internal tube pressure over time and the change of the flow velocity of the blood. The Bedingham '328 patent discloses an intravascular blood parameter sensor system using a catheter and a probe having a plurality of sensors (e.g., an oxygen sensor, a CO2 sensor, etc.) to measure particular blood parameters in vivo. The Schlain '398 patent discloses an intravascular method and an apparatus for detecting the undesirable wall effect in blood parameter sensors to move these sensors to reduce or eliminate the wall effect. The Davis' 440 patent describes an apparatus for conducting a variety of tests that respond to a change in the viscosity of a sample fluid eg, blood.

The devices and methods for measuring viscosity for fluids in general are well known. See, for example, the United States of America Patents numbers: 1,810,992 (Dallwitz-Wegner); 2,343,061 (Irany); 2,696,734 (Brunstrum et al.); 2,700,891 (Shafer); 2,934,944 (Eolkin); 3,071,961 (Heigl et al.); 3,116,630 (Piros); 3,137,161 (Lewis et al.); 3,138,950 (Welty et al.); 3,277,694 (Cannon et al.); 3,286,511 (Harkness); 3,435,665 (Tzentis); 3,520,179 (Reed); 3,604,247 (Gramain et al.); 3,666,999 (Moreland, Jr., and collaborators); 3,680,362 (Geerdes et al.); 3,699,804 (Gassmann et al.); 3,713,328 (Aritomi); 3,782,173 (Van Vessem et al.); 3,864,962 (Stark et al.); 3,908,441 (Virloget); 3,952,577 (Hayes et al.); 3,990,295 (Renovanz et al.); 4,149,405 (Ringrose); 4,302,965 (Johnson et al.); 4,426,878 (Price and collaborators); 4,432,761 (Dawe); 4,616,503 (Plungis et al.); 4,637,250 (Irvine, Jr., et al.); 4,680,957 (Dodd); 4,680,958 (Ruelle et al.); 4,750,351 (Ball); 4,856,322 (Langrick et al.); 4,899,575 (Chu et al.); 5,142,899 (Park et al.); 5,222,497 (Ono); 5,224,375 (You et al.); 5,257,529 (Taniguchi et al.); 5,327,778 (Park); and 5,365,776 (Lehmann et al.). Price '878's patent describes a viscometer that uses an electrically conductive fluid whose velocity of motion is used to determine the viscosity of an unknown fluid. However, the apparatus of the '878 patent among other things, is designed for the determination of high shear rate (300 s), not low shear index as required in the determination of blood viscosity. In addition, the underlying mathematics for determining fluid viscosity are limited to Newtonian fluids while blood is a non-Newtonian fluid. The following United States Patents of North America describes viscosity or flow measurement devices, or liquid level detection devices using optical monitoring: US Pat. Nos. 3,908,441 (Virloget); 5,099,698 (Kath, et al.); 5,333,497 (Br nd Dag A., et al.). The Virloget '441 patent describes a device for use in a viscometer that detects the level of a liquid in a transparent tube using photodetection. The Kath '698 patent discloses an apparatus for optically scanning a flowmeter rotameter and determining the position of a float therein. The Br nd Dag A. '497 patent describes a method and apparatus for the continuous measurement of the liquid flow velocity of two vertical tubes by means of a coupled charge device (CCD) sensor. U.S. Patent No. 5,421,328 (Bedingham) discloses a sensor system for intravascular blood parameters. A statutory invention record, H93 (Matta et al.) Discloses an apparatus and method for measuring the elongation viscosity of a test fluid using a film or video camera to monitor a drop of fluid under test. The following publications discuss the deformability of red blood cells and / or the devices used to determine this: Measurement of Human Red Blood Cell Deformability Using a Single Micropore on a Thin SigN ^ Film, by Ogura et al., IEEE Transactions on Biomedical Engineering, Vol. 38, No 8, August 1991; the Pall BPF4 High Efficiency Leukocyte Removal Blood Processing Filter System, Pall Biomedical Products Corporation, 1993. Regardless of the existence of the prior technology, an apparatus and method to obtain the viscosity of the blood of a living being, in vivo and over a range of shear rates and for the provision of these data in a short time, is still needed. OBJECTS OF THE INVENTION In accordance with the above, the general object of the present invention is to provide an apparatus and method for satisfying that need. It is another object of this invention to provide the viscosity measurement an apparatus and method for determining the viscosity of various fluids, for example, blood over a range of shear stresses. It is still another object of this invention to provide an apparatus and method for determining the viscosity of a fluid, for example, the blood of a living being in vivo without the need to directly measure pressure, flow and volume. It is still another object of this invention to provide the viscosity of the blood of a living being in a short time. It is another object of this invention to provide an apparatus and methods for measuring the viscosity of blood in a living being in vivo and with minimal invasion. It is still another object of the present invention to provide an apparatus and methods for measuring the viscosity of the blood of a living being that does not require the use of anticoagulants, or other chemical or biologically active materials. It is still another object of the present invention to provide an apparatus and methods that measure the viscosity of the blood of a living being in vivo comprising disposable portions to maintain a sterile, easy to use and repeatedly test environment. It is still another object of the present invention to provide a viscosity measuring apparatus and methods for determining the thixotropic point of blood.

It is still another object of the present invention to provide a viscosity measuring apparatus and methods that can be used to determine the viscosity of other materials. It is still another object of this invention to provide an apparatus and methods for determining the effect of vibratory energy on the viscosity of the blood of a living being. It is still another object of this invention to provide apparatus and methods for applying vibratory energy to the body of a living being to affect a beneficial change in the viscosity of a person's blood. COMPENDIUM OF THE INVENTION These and other objects of this invention are achieved by providing apparatuses and methods for effecting the in vivo measurement of the viscosity of the blood (or blood plasma) of a living being, or for effecting the viscosity measurement of others. non-Newtonian fluids, cosmetics, oil, grease, etc., at different rates of shear stress. According to one aspect of the invention the apparatus comprises an element for sampling blood and a calculation element. The blood sampling element, for example, a capillary tube of predetermined internal diameter and predetermined length, at least a portion of which is adapted to be placed in the body of the living being, for example, to be placed intravenously, for exposure to blood of the living being so that it flows through it. The calculation element, for example, a vertical tube having a column of liquid therein, an associated coupled charge device sensor, and a microprocessor, is coupled to the blood sampling element. The calculation element is arranged to determine the viscosity of the blood of the living being at different shear rates. For example, in an exemplary aspect of the invention the apparatus is used to determine the viscosity of the blood of the living being by selectively placing the blood sampling element, for example, the capillary tube, with respect to the calculation element, for example, the vertical tube, and selectively coupling the flow of blood between them, for example, selectively allowing blood to flow through the capillary tube and coupling that flow to the column of liquid in the vertical tube, to cause the fluid column change height under the influence of gravity. The calculation element, for example, the coupled charge device sensor and the associated microprocessor, monitors the change in height of the fluid column at different points along at least a portion of the length of the vertical tube and calculates the viscosity of the blood according to a predetermined algorithm. According to another aspect of this invention vibratory energy, for example, energy which is adjustable in amplitude and / or frequency, is applied to a portion of the body of the living being before and / or during the determination of the viscosity of the blood of the being. I live to provide information regarding the effect of this vibrational energy on the viscosity of the blood. This information can be used to provide vibratory energy of therapy to the body of the living being to alter the viscosity of the blood of the living being in the interest of improving blood circulation. These and other objects of this invention are also achieved by providing an apparatus for determining the viscosity of a flowable material (eg, a fluid that is not blood) at different rates of shear stress. The apparatus is characterized by elements for receiving the material and calculation elements, wherein the element receiving the material comprises an inlet tube configured to be introduced into the material to allow the material to flow therein. The calculation element is coupled to the material receiving element and adapted to calculate the viscosity of the material within the input tube at different shear rates and provide a signal representative thereof. The calculation element comprises a column of fluid and monitoring elements and wherein the fluid in the column is adapted to be coupled to the material within the inlet tube. When the fluid column changes height, the monitoring element is arranged to monitor the height of the fluid inside the column at different points along the height thereof as the fluid column changes in height and also calculates the viscosity of the material therefrom. The different shear rates include at least one high shear rate and at least one low shear rate. These and other objects of this invention are also achieved by providing an apparatus for determining the viscosity of a first flowable material (e.g., blood, blood plasma or fluid other than blood) at different shear rates. The apparatus is characterized by a first tube, a second elongated tube, a sensor, and calculation elements. The first tube is adapted to receive the first flowable material to allow the first flowable material to flow therein. The second tube is coupled to the first tube and adapted to receive a second flowable material (e.g., a transfer fluid) and wherein the second flowable material forms a fluid column in the second tube and the fluid column is adapted to change height. The sensor is adapted to monitor the height of the fluid column at different points along the length of the second tube as the fluid column changes in height and provides a first signal indicative of the same. The calculation element responds to the first signal to calculate the viscosity of the first flowable material at different shear rates within the first type and provides an output signal representative thereof. The different shear rates include at least one high shear rate and at least one low shear rate. DESCRIPTION OF THE DRAWINGS Other objects and many of the anticipated advantages of this invention will readily be appreciated when best understood by reference to the following detailed description when considered in connection with the accompanying drawings in which: Figures 1A and IB form an illustration and functional diagram of a modality of a system for measuring in vivo the viscosity of a human's blood. Figure 2A is an isometric view of a portion of the system shown in Figure 1, namely, a portion of media receiving blood and monitoring means. Figure 2B is an isometric view of another portion of the system shown in Figure 1, namely, an exemplary test station. Figure 3 is an illustration of the construction and function of the element receiving blood. Figure 4 is a graph of a parameter measured by the system of Figure 1, namely, the "head" of the fluid column plotted against time.

Figures 5A-5G are illustrations of a portion of the system shown in Figure 1 showing the operative sequence thereof. Figure 6 is an enlarged isometric view of a portion of the system, namely a capillary tube. Figure 7 is a view similar to that of Figure 6, but showing an alternative embodiment of the capillary tube. Figure 8A is a view similar to Figure 6 and 7, but showing an alternative embodiment of the capillary tube. Figure 8B is a very enlarged cross-sectional view taken along line 8B-8B of Figure 8A. Figure 9 is an enlarged cross-sectional view of yet another alternative embodiment of the capillary tube. Figure 10 is an enlarged sectional view through a portion of the components shown in Figure 3 to include elements, for example, a damping piston at the blood / transmission fluid interface to isolate the blood of a living being of the transmission fluid used by the system. Figure 11 is a block diagram of a portion of the system shown in Figure 1, namely the sensor element. Figure 12 is an enlarged cross-sectional view of the sensor element taken along line 12-12 of Figure 2A. Figure 13 is an illustration of a calibration test equipment for use with the system of Figure i; and Figure 14 is a graph similar to Figure 4 showing the head of the fluid column plotted against time to show a thixotropic characteristic of the blood. DETAILED DESCRIPTION OF THE PREFERRED MODALITIES Referring now in greater detail to several Figures of the drawing, in which like reference characters refer to equal parts, is shown in Figures 1A and IB with a liquid viscosity measuring system constructed in accordance with the present invention. The system 20 has particular utility for measuring in vivo the viscosity of the blood of a living being. Although the apparatus 20 has many applications, the preferred embodiment of the apparatus 20 is used to measure the viscosity of the blood anywhere in the vascular system of a patient, for example, veins, arteries, pulmonary system, left atrium, right ventricle, and so on. . It should be understood that blood is a non-Newtonian fluid. A Newtonian fluid can be defined as one in which the viscosity does not vary with the shear rate within the range of turbulent flow, while a non-Newtonian fluid, such as blood, has a viscosity that is variable with the rate of shear. Shear stress in the non-turbulent flow range. As a result, when the viscosity of a non-Newtonian fluid is plotted as a function of the shear rate, a curve is produced, rather than a straight line. Therefore, to obtain a precise determination of the viscosity of the blood, it is necessary to obtain a measurement of the viscosity in a range of shear stresses. The concept of the present invention is to monitor, in a substantially continuous manner, the raised head of an externally placed column of fluid coupled to a portion of the patient's body in which the blood flows, thus effectively monitoring the patient's blood in vivo. . The data of this elevated head is used to calculate the viscosity of the blood at a large multiplicity of points of the column elevation for different flow velocities, thereby providing a viscosity of the blood over a range of shear stresses. The monitoring of the vertical column solves the problem of generating a range of shear forces necessary to obtain an accurate measurement of the viscosity of the blood. As shown in Figures 1A and IB, the apparatus 20 basically comprises a blood sampling element 22 and a calculation element 24 which are coupled together to provide the viscosity measurement. The blood sampling element 22 comprises a catheter 26, which in a preferred embodiment comprises a capillary tube. The catheter 26 has an inner diameter Dj and a length L ^. The catheter 26 is introduced into the body 28 of the living being (patient) at an internal site 30 (e.g., a vein, artery, etc.) to allow blood 31 to flow into the catheter 26. Thus, the catheter 26 It serves as a blood receptor element. The catheter 26 is connected via a hub 32 to a conduit element 34 having an internal diameter Ü2- A first valve member 36 (eg, a three-way valve) selectively couples an injector element 38 to the conductive element 34. injector element 38 comprises a container 40 for containing an indicator or transmission fluid 41 (for example, a liquid such as a saline solution, alcohol, or any sterile water type liquid) which, when injected into the conduit element 34, it forms a column of fluid 42 (which will be discussed below) that can be monitored (eg, optically monitored - an optimal dye can be used to color the transmission fluid to maximize readability by an optical sensor). The other end of the duct element 34 is coupled to a vertical tube 44. The inner hollow of the vertical 44 forms a lumen that allows the level of the fluid column 42 to be detected as a function of time. The vertical tube 44 has an inner diameter of D3. The upper end of the vertical tube 44 comprises a second valve member 46 (eg, a two-way valve) which vents the vertical tube 44 to the atmosphere when the valve 46 is opened. The first valve member 36 and the second valve member 46 preferably include hydrophobic vents (not shown) to eliminate blood spillage. It should be understood that the optimum selection of tube sizes for the capillary tube 26, the conduit element 34 and the vertical tube 44 minimizes the viscosity and surface tension effects of the transmission fluid 41. It should also be understood that it is preferable to have the tube capillary 26 fully inserted into the vascular system, i.e., capillary tube 26 is inserted such that a continuation of duct element 34 of diameter D2 is also disposed in the vascular system. The fluid column 42 is monitored by monitoring elements 48. The monitoring element 48 comprises a sensor element 50 (eg, a coupled charge device, CCD, including the associated electronics, Figure 11 and an associated power supply 51) coupled to a microprocessor element 52 (e.g., a personal computer) further comprising appropriate diagnostic software 54. The monitoring element 48 monitors the height of the fluid column 42 as it rises over the entire length of the vertical 44 during the test or run to determine the blood viscosity of the patient. A peripheral indicating element 56, for example, a visual display 58, a counter element 60, a printer 62, provides data and / or graphics belonging to the viscosity / shear rate measurements. In addition, a modem 64 may be connected to the monitoring element 48 to provide all relevant data to a remote location, for example, via the Internet or the World Wide Web 66. In accordance with a preferred aspect of this invention, the visual display 58 and / or the printer 62 serve to present graphic representations of medical parameters such as viscosity versus shear stress, or viscosity versus height of the fluid column ("head"), or diagnostics. The counter element 60 is used to numerically display points such as the viscosity at a particular shear stress and / or the head at which the velocity of the fluid column is zero, for example, the thixotropic point (to be discussed later) . The viscosity / shear index data can be stored in the microprocessor element 52 and compared to databases 54 (in compact disc read-only memory (CD-ROM)), diskette or personal computer cards) to present possible diagnoses to the doctor. Figure 2A depicts a portion of the implementation of the system 20. As shown, the injector element 38, a portion of the conduit element 34, the first valve member 36, the standpipe 44, and the second valve member 46 are they mount on a support plate 68 to form a tubing assembly 69. The tubing assembly 69 is configured to be removably mounted inside a housing 70 which contains the sensor element 50 and the power supply 51. The support plate 68 is mounted on the housing 70 with the appropriate connections in order to place the vertical tube 44 vertically and directly opposing the sensor element 50 for proper monitoring. In addition, during insertion of the tube assembly 69, suitable valve control connections 72 are made so that the first valve member 36 and the second valve member 46 can be suitably controlled automatically in sequence. The locating pins 73 and the locating holes 75 are provided to ensure that the support plate 68 is properly aligned, thereby arranging the vertical tube 44 directly opposite the sensing element 50. The support plate 68 comprises a transparent material that allows that the sensor element 50 optically monitors the fluid column 42. It should be understood that the injector element 38 is pre-charged with the transmission fluid 41 which is held captive in the container 40 by the 3-way valve 36. Only when the valve 36 is oriented properly, the transmission fluid 41 flows out of the injector element 38 and into the conduit element 34. As soon as the pipe assembly 69 is secured in the housing 70, a door 74 can be releasably secured to create an environment sufficiently dark to support the illumination of the suitable column 76 and the detection of the level by the sensor element 50 during the co laugh As soon as a viscosity or run measurement method is completed, the pipe assembly 69 is removed, disconnected from the capillary tube 26, and then discarded. To run another test, a new tube assembly 69 is connected to the capillary tube 26 and reinstalled in the housing 70. It should be understood that it is within the broader scope of this invention that the first 36 and the second valve elements 46 can be Manually controlling, that is, the proper operation of the apparatus 20 does not require automatic control of the first and second valve elements 36 and 46 respectively. An exemplary test station is shown in Figure 2B. It should be understood that although the apparatus 20 is shown with the capillary 26 inserted into the arm of a patient, the apparatus 20 is not limited in use to that portion of the patient's body. Other configurations of stations could be used where the capillary 26 is inserted into other portions of the patient's body so that blood flows into the capillary tube 26.

With the test station shown in Figure 2B, patient 78 sits with his arm arranged on a horizontal surface 80. Capillary 26 is inserted percutaneously into the patient's arm to its distal end, and preferably its entire length L ^, is inside a desired vessel, for example, a vein. The conduit element 34 couples the capillary 26 to the housing 70. The housing 70 is releasably disposed on a fixed vertical surface 82. The vertical surface 82 comprises adjustment elements 84 which allow the entire housing 70 to be moved manually in one direction vertically and then releasably secured to any desired vertical height. The important point is that the operator can change the relative vertical position of the housing 70 with respect to the vertical position of the portion of the patient in which the capillary tube 26 has been inserted for a reason that will be understood later. The microprocessor element 52, the visual display 58 and the printer 62 are also displayed in the station. Figure 3 is a functional diagram of the apparatus 20. With respect to Figure 3, the basic operation of the apparatus 20 is shown in Figure 3. As the blood 31 flows into and through the capillary tube 26 and into the conduit element 34 , the blood 31 finds the transmission fluid 41 and displaces the transmission fluid 41 upwards towards the vertical tube 44, thereby forming the fluid column 42.

The sensing element 50 (e.g., a coupled charge device array) monitors the elevation of the fluid column 42 in real time by detecting the interface between the upper part of the transmission fluid column 42 and the gas (e.g. air) in the vertical tube above the fluid. This optical interface (e.g., meniscus) is easily detected by the sensor element 50. The operation of the first valve member 36 and the second valve member 46 is discussed below. If the following assumptions are made, in particular, Di is much less than D2; and Dj is much smaller than D3 so it can be shown that the viscosity (771 (t)) and the shear rate (range? (t)) of the blood in the capillary tube 26 are given by: PsgtDj4 1 i? l (t) = (). 32L? D3- Loo ln (- l 00 -h (t) psgt where T?? (t) represents the viscosity; range -? (t) represents the shear rate; ps represents the density of the transmission or indicator fluid; g represents the gravitational constant; t represents the measurement time, Dj represents the internal diameter of the capillary tube; L ^ represents the length of the capillary tube; D3 represents the internal diameter of the transmission column or indicator fluid; h8 represents the final height of the transmission column or indicator fluid; and h (t) represents the instantaneous height of the transmission column or indicator fluid. The viscosity, tjj (t), of the blood is plotted as shown in Figure 4. To increase the range of shear stress, a longer capillary tube 26 can be used (i.e., increase Lj). The operation of the apparatus 20 is depicted in Figures 5A-5H and is as follows: The portion of the vascular system of the patient (e.g., vein, artery, etc.) into which the capillary tube 26 is to be inserted is disposed in the 80 horizontal surface.

This point of entry into the patient becomes the reference of "DATA" and represents a vertical height reference. Figures 5A-5B: a guidewire 86 is inserted into the patient's vascular system via a perforator 88. The perforator 88 is removed, leaving the guidewire 86 in place. The following steps are preferably automated so that when the capillary tube 26 is inserted into the patient, the operator only needs to activate a switch (not shown) of a controller (not shown) that would automatically carry out the following steps: Figure 5C: the first valve element 36 is opened so that ports A and B are in communication while ports A to C and B to C are closed; the second valve element 46 is closed. The capillary 26 is then flooded. Figure 5D: the first valve element 36 is completely closed and the capillary 26 is entangled on the guide wire 86 and is arranged in the vascular system of the patient. The DATA level is set for the capillary tube 26 and the vertical tube 44. A DATA mark is made on the fixed vertical surface 82. Figure 5E: the guide wire 86 is removed and the DATA level is set for the capillary tube 26 and the vertical tube 44. A "0" mark is created in the vertical tube 44 which is aligned with the DATA level. Figure 5F: the first valve member 36 moves to open the communication between ports A and C and the second valve member 46 moves to open the communication between ports D and E. The operator then presses the plunger 90 into the injection element 38 for filling the vertical tube 44 with transmission fluid or indicator fluid to the "0" or DATA mark. Both the first valve member 36 and the second valve member 46 are then closed. Figure 5F: allowing the blood pressure to pressurize the fluid column 42. The operator opens the first valve member 36 so that ports B and C are in communication, thereby allowing the blood to flow (approximately 0.5 cubic centimeters) of blood) in the conduit element 34. The fluid column 42 will rise from the 0 mark to the new level. The operator then manually moves the housing 70 down until it aligns to the new level with the DATA mark on the fixed vertical surface 82. This action allows the determination of the static pressure of the blood (eg, venous) using the tube vertical closed 44 as a "barometer". Figure 5G: to avoid overflow of the vertical tube 44 during the run, it is necessary to calculate the approximate final level or head, ha, of the fluid column 42 and lower the housing 70 by this amount. The Boyle's Law is used to estimate the equal elevation h8 of the fluid column 42 in step 5F. The housing 70 goes down by the amount h ^. The housing 70 is secured at that height to prepare the sensor element 50 to monitor the elevation of the fluid column 42. The second valve member 46 then opens and the fluid column 42 begins to rise. If the test is to be run again, the tube assembly 69 is discarded and a new tube assembly 69 is installed in the housing. If the transmission fluid 41 in the injector element 38 is of a biocompatible material, a portion of transmission fluid 41 can be used to flood the apparatus 20, all the way from the top of the capillary tube 26, as shown in FIG. Figure 5C. Before a run is run to measure the viscosity as part of the automated procedure discussed above, a current barometric pressure reading is obtained (for example, from a barometer not shown, internal to the computing element 24) and is provided to the microprocessor element 52. Thus, the apparatus 20 calculates the appropriate viscosity / shear index chart based on the existing actual atmospheric pressure. In addition, vents can be provided throughout the apparatus 20 to minimize the effect on the accuracy of the calculated viscosity. It should be understood that the process described above could also be carried out with the use of a hemostasis valve (eg, a "Heparin Padlock") between the capillary tube 26 and the conduit element 34. This allows the capillary tube 26 Leave it in place when you have to do several runs. In addition, a hemostasis valve having a "Y" joint could be disposed close to the point at which the capillary tube 28 enters the vessel in order to allow passage of a guide wire 86 after the apparatus 20 is flooded without obtaining air bubbles. The capillary tube 26 should be constructed of, or be coated with, a material or materials that prevent blood 31 from adhering to the inner walls of the capillary, for example, an antithrombogenic material, such as heparin, and / or antithrombolytic coatings, by For example, phosphoryl choline, etc., can be used to minimize blood clotting. The phosphoryl choline compounds are available from Biocompatibles, Ltd., Uxbridge, UK. This construction or coatings facilitate long-term placement of the capillary tube 26 within the patient's vascular system. Further, as shown more clearly in Figure 6, the tip of the capillary tube 26 preferably comprises a plurality of ports 92. This ensures that if the tip of the capillary tube 26 protrudes from any portion of the interior of the vessel as soon as it is inserted into the vessel. Vascular system of the patient, the blood flow will enter the capillary tube 26 will not be obstructed or prevented. An alternative embodiment of the capillary tube 26 is shown in Figure 7 and includes an intravascular capillary with a controlled lumen or resistor for the viscometer function and with another for measuring the pressure. For example, the capillary tube 126 comprises a first lumen 96 for transmitting blood 31 as discussed above and comprises a second lumen 98 which is coupled to a pressure transducer (not shown) which is coupled to the calculation element 24. Of this Thus, the second lumen 98 provides a continuous reference to the blood pressure of the patient to the calculation element 24. Unlike the process described above, whereby the operator determines the blood pressure of the patient before he runs the test, using this second lumen 98, the calculation element 24 is provided with a continuous blood pressure reference throughout the run. In some patients, the pressure of real blood may change during the run. These variations of blood pressure or pulsations need to be explained to determine the proper viscosity / shear stress curve versus time. Thus, a constant reference blood pressure can be compensated during the determination of the viscosity / shear stress. Another alternative embodiment of the capillary tube 26 is shown in Figures 8A-8B and 9. This embodiment includes an intravascular capillary with a controlled lumen or tube with alternative resistive members., such as several small capillary tubes in a bundle (Figures 8A-8B). Alternatively, the tube is filled with very small spheres (Figure 9), or a sintered column (not shown). With respect to the embodiment as shown in Figures 8A-8B, the capillary tube 226 comprises a plurality of small capillaries 100, each having different internal diameters (dj, d2, dg, etc.). The use of small capillaries not only allows the length Li to be smaller but also allows the reach of very small shear stresses. When these diameters are less than the average diameters of a typical red blood cell, the system 20 can be used to determine the blood pressure at which the blood flow begins. This action provides an indication of the deformability of the red blood cells of the living being since those cells have to be deformed to pass through the small capillaries 100. In the alternative embodiment of the capillary tube shown in Figure 9, the capillary tube 326 it includes very small spheres 102 within it to create interstices that are smaller than the average diameter of a red blood cell, so that these cells will have to deform to pass through it. To eliminate or at least minimize the possible miscibility / contamination between the transmission fluid / blood interface in the conduit element 34, a damping piston can be used as shown in Figure 10. This piston can be of any convenient construction, for example, a piece of carbon to isolate the blood 31 from the transmission fluid 41 at its interface. In particular, the piston 104, having a specific gravity of about 1.0, transmits the movement or flow of the blood 31 towards the capillary tube to the transmission fluid 41 at the same time as isolating or separating these two fluids from each other. Alternatively, although not shown, a buffer fluid could be introduced at the interface between the blood 31 and the transmission fluid 41 to reduce any miscibility / contamination problem. Figure 11 is a block diagram of the sensor element 50, while Figure 12 shows its construction, i.e., a cross-sectional view taken along line 12-12 of Figure 2A but with the support plate 68 already secured to the housing 70. Thus, as will be seen, an exemplary implementation of the sensor element 50 comprises a linear array of illuminators 76 (see Figures 2A and 12), rod lenses 106, and sensor chips 108 mounted on a PCB 110 substrate. A particularly useful commercial device incorporating its components is the SV200A4 model sold by Sean Vision, Inc. of San Jose, CA. The sensor element 50 includes a glass cover 112 that embeds the vertical tube 44 when the support 68 is installed, as described above. An integrated lens 114 can be disposed on the opposite side of the glass cover 112 to better see the rod lens 106. In order for the system 20 to operate properly, it is necessary that the calculation element 24 take into account the resistance of the tube assembly fluid 69 which is mounted in the housing 70. To accomplish this a test equipment is used. Figure 13 depicts exemplary test equipment 116 for the tube assembly 69 of the system 20. A bar code 118 is provided on the support plate 68 (Figures 2A and 13) which contains a calibration factor for that tube assembly particular 69. Thus, just before a viscosity run is made, an automatic scanner 119, coupled to the personal computer 52, scans the bar code 118 and loads the personal computer 52 with the particular calibration factor. To determine the calibration factor, the pipe assembly under calibration, A2, is attached to the test equipment 116, as shown in Figure 13. An air supply 120 delivers clean dry air at a predetermined pressure, ]? AS (for example, 689,476 Pascals) that can be regulated (via a REG regulator) up to 76.20 centimeters of water. The air supply 120 delivers the flow through the calibrated orifice, Ai, which has a known resistance. The input of the pipe assembly under test A2 is coupled to the output of A ^ and the output of the pipe assembly under test A2 is vented to the atmosphere. When the air supply 120 administers air flow, depending on the resistance of the internal fluid of the tube assembly under test A2, a PTA pressure appears at the inlet of the tube assembly under test, A2. A pair of open-ended manometers 122A and 122B are coupled to the input of A ^ and the output of j, respectively, to monitor represents the calibration factor. This calibration factor is encoded in the bar code 118. In this way, each time a tube assembly 69 is mounted in the housing 70 and the bar code 118 is read in the personal computer 52, the calculation element 24 can make a viscosity determination based on the specific fluid resistance of the assembled tube assembly 69. According to another aspect of the present invention and to minimize measurement errors, the system 20 includes the element for controlling the formation of a meniscus. (Figure 3) in the upper part of the transmission fluid column 42. In particular, the coatings for the lifting tube 44 can be introduced to control the surface tension accurately providing controlled surface energy, thus flattening the meniscus 124. Meniscus 124 can be further controlled by changing the molecular configuration of vertical tube 44, with transmission fluid 41 and gas being used. of the fluid column 42. Further, to make the surface energy repeatable and predictable, the inner surfaces of the vertical tube 44 can be vapor deposited with surfactants, e.g., silicone. Including suitable surfactants, such as silicone, in extrusions the surfactants migrate to the surface in a predictable manner. Another embodiment (not shown) of the apparatus 20 includes a vertical tube 44 that is inclined to increase sensitivity. In particular, if the vertical tube 44 were angularly deviated from the vertical orientation, for each millimeter elevation in the vertical height of the fluid column 42, there will be more than one millimeter displacement of the fluid column 42 in the vertical tube 44 According to another aspect of the present invention, the element 124 (Figure 2B) can be provided to apply vibratory energy in the patient to determine its effect on the viscosity of the patient's blood and the developed data can then be used to provide therapy vibration suitable for the client to provide beneficial effects. The particular, this aspect of the invention makes use of a source of. vibration 124 that generates vibratory energy whose amplitude and frequency can be controlled by the operator. This vibratory energy is applied either before or during a viscosity measurement run. Although the vibratory energy is shown in Figure 2B as applied to the patient's arm only, it is within the broader scope of the invention that the vibrational energy can be applied to all or only a portion of the patient's body.

The vibration can also be applied to the fluid column 42 and / or to the capillary tube 26 to obtain a smoother flow of fluid. Another important feature of the system 20 is its ability to monitor the level of the fluid column 42 at which the velocity becomes zero, that is, the thixotropic point of the blood flow. The thixotropic point represents a shear stress that is supported at zero speed, as represented graphically in Figure 14. The presentation of the cut or head in which the flow restarts after a fixed time in zero motion provides an indication of the characteristic of coagulation of the patient. It should be understood that the diagnostic software 54 allows the dynamic effects of deceleration of the fluid column 42 and the viscous effects of different diameters of blood tubes 31 and transmission fluid. 41 pass through the system 20. It should be understood that another implementation of the system 20 comprises a channel system molded or etched as a substitute for the tube discussed above. As mentioned above, the apparatus 20 has other applications, such as viscosity measurements or other flowable materials, for example, oils, paints and cosmetics. Without further elaboration, the foregoing will fully illustrate our invention and others, applying current or future knowledge, will easily be able to adapt it for use in various service conditions.

Claims (139)

1. Apparatus for performing the live measurement of the viscosity of the blood of a living being, the apparatus comprising a blood sampling element and a calculation element, when at least a portion of the blood sampling element is configured to be placed on the body of the living being to expose it to the blood of the living being, the calculation element is coupled to the blood sampling element and is configured to determine the viscosity of the blood of the living being at different rates of shear stress.

The apparatus of claim 1 wherein the blood sampling element comprises a blood receiving element for receiving the blood, the blood receiving element is configured to be introduced into the body of the living being at an internal site to allow that the blood flows in the element of blood reception in that place.

The apparatus of claim 2 wherein the calculation element is coupled to the blood receiving element and configured to calculate the viscosity of the blood adjacent to the site at different shear rates and provide a signal representative thereof.

The apparatus of claim 2 wherein the blood receiving element comprises a catheter in which the blood of the living being is allowed to flow, and wherein the calculation element comprises a fluid column and a monitoring element, the fluid in the column and the blood in the catheter are configured to mate with each other so that the blood flow in the catheter causes the fluid column to change in height, the monitoring element is configured to monitor the height of the Fluid column at different points along the length of it to calculate the viscosity of the blood.

The apparatus of claim 4 wherein the catheter comprises a capillary tube having a predetermined length and a predetermined internal diameter.

6. The apparatus of claim 5 wherein the fluid column has a predetermined diameter.

The apparatus of claim 4 wherein the monitoring element comprises a sensor element for determining the height of the fluid column along a multitude of points along the same.

8. The apparatus of claim 7 further comprising a microprocessor element coupled to the sensor element.

The apparatus of claim 8 wherein the catheter comprises a capillary tube having a predetermined length, and a predetermined internal diameter.

10. The apparatus of claim 9 wherein the fluid column has a predetermined diameter.

The apparatus of claim 8 wherein the sensor element comprises a coupled charge device sensor.

The apparatus of claim 2 wherein the blood receiving element and the calculation element are releasably connected to each other to allow the blood receiving element to be disconnected from the calculation element for disposal.

13. The apparatus of claim 4 wherein the • blood receiving element and the calculation element are releasably connected to each other to allow the blood receiving element to disconnect from the fluid column, and the fluid column is disconnected from the monitoring element for the disposal of the blood receptor element and from the fluid column.

14. The apparatus of claim 1 wherein the apparatus also determines various rates of shear stress of the blood of the living being.

15. The apparatus of claim 6 wherein the apparatus also determines various rates of shear stress of the blood of the living being.

16. The apparatus of claim 4 wherein the blood flow in the catheter which causes the fluid column to change in height is effected by gravity.

17. The apparatus of claim 16 wherein the relative height of the catheter for the fluid column is adjustable, after which the catheter is disposes above the portion of the fluid column so that gravity causes the fluid column to change in height.

The apparatus of claim 17 further comprising a first valve member coupled between the catheter and the fluid column to selectively allow blood to flow through the catheter to cause the fluid column to change in height.

19. The apparatus of claim 18 wherein the fluid column is located within a vertical tubethe vertical tube having a lower portion to which the catheter is attached by its first valve element.

The apparatus of claim 19 wherein the vertical tube includes an upper portion having a second valve member located therein, the second valve element being selectable to allow air to flow in the upper portion of the vertical tube.

21. The apparatus of claim 20 further comprises an injector element for selectively introducing the fluid that forms the fluid column in the standpipe.

22. The apparatus of claim 21 wherein the injector element comprises a fluid container and a plunger.

The apparatus of claim 20 wherein the monitoring element comprises a sensor element for determining the height of the fluid column along multiple points along the same.

24. The apparatus of claim 23 further comprising a microprocessor element coupled to the sensor element.

25. The apparatus of claim 24 wherein the sensing element comprises a charging device coupled.

26. The apparatus of claim 24 further comprising an indicating element to provide a signal representing that viscosity.

27. The apparatus of claim 26 wherein the indicating element comprises a visual display.

28. The apparatus of claim 26 wherein the indicating element comprises a printer.

29. The apparatus of claim 26 wherein the indicating element comprises a visual display and a printer.

30. The apparatus of claim 17 further comprising a conduit element connected between the catheter and the fluid column.

31. The apparatus of claim 30 wherein the catheter comprises a capillary tube having a predetermined length, and a predetermined internal diameter.

32. The apparatus of claim 31 wherein the fluid column has a predetermined diameter.

33. The apparatus of claim 32 wherein the conduit member has an internal diameter substantially greater than the predetermined internal diameter of the catheter.

34. The apparatus of claim 33 wherein the conduit member has an internal diameter substantially greater than the predetermined diameter of the fluid column.

35. The apparatus of claim 34 wherein the fluid column is visually perceptible.

36. The apparatus of claim 1 wherein the blood sample element comprises elements for sampling blood plasma, wherein the apparatus performs the in vivo measurement of the viscosity of the blood plasma.

37. The apparatus of claim 36 wherein the blood sampling element comprises a blood-receiving element for receiving the blood plasma, the blood-receiving element being configured to be introduced into the body of the living being at an internal site to allow that blood plasma without red blood cells flows into the blood plasma receptor element at that site.

38. The apparatus of claim 37 wherein the blood sampling element comprises a blood cell filter and a catheter coupled thereto in which the blood plasma of the living being is allowed to flow, and wherein the calculation element comprising a fluid column and a monitoring element, said fluid from said column and said blood plasma in the catheter are configured to be coupled together so that the flow of blood plasma in the catheter causes the fluid column to change in height , the monitoring element is configured to monitor the height of the fluid column at different points along the length thereof to calculate the viscosity of the blood plasma.

39. The apparatus of claim 38 wherein the catheter comprises a capillary tube having a predetermined length, and a predetermined internal diameter.

40. The apparatus of claim 39 wherein the fluid column has a predetermined diameter.

41. The apparatus of claim 40 wherein the apparatus also determines various rates of shear stress of the blood plasma of the living being.

42. The apparatus of claim 7 wherein the fluid column is located within the vertical tube, and wherein a gas is located in the vertical tube above the fluid column, the upper part of the fluid column forming a detectable interface with the gas.

43. The apparatus of claim 42 wherein the sensor element detects the interface.

44. The apparatus of claim 43 wherein the sensing element comprises a coupled charging device.

45. The apparatus of claim 44 wherein the coupled loading device extends along a substantial portion of the vertical tube.

46. The apparatus of claim 7 wherein the fluid column is located within a vertical tube, the vertical tube being vertically oriented.

47. The apparatus of claim 7 wherein the fluid column is located within a vertical tube, the vertical tube being oriented at an acute angle with respect to the vertical.

48. The apparatus of claim 7 wherein the fluid column is located within a vertical tube, the vertical tube being configured to have its orientation adjusted.

49. The apparatus of claim 42 wherein the fluid column comprises a column of liquid, with the upper part of the liquid tending to form meniscus at the interface with the gas, wherein the apparatus includes an element for controlling the shape of the meniscus along a substantial length of the vertical tube.

50. The apparatus of claim 49 wherein the vertical tube includes a coating on the inner surface thereof, the coating tending to flatten the meniscus.

51. The apparatus of claim 4 wherein the catheter comprises a capillary tube, the capillary tube including an element therein to prevent the blood from coagulating.

52. The apparatus of claim 51 wherein the last mentioned element comprises an antithrombolytic coating.

53. The apparatus of claim 1 further comprising an element for applying vibrational energy, for applying vibrational energy to a portion of the body of the living being.

54. The apparatus of claim 53 wherein the apparatus determines the viscosity of the blood of the living being resulting from the application of vibratory energy to the body of the living being.

55. The apparatus of claim 53 wherein the vibrational energy application element is adjusted to adjust the amplitude and / or frequency of the vibrational energy.

56. The apparatus of claim 54 wherein the vibrational energy application element is adjustable to adjust the amplitude and / or frequency of the vibrational energy.

57. The apparatus of claim 4 wherein the catheter comprises a capillary tube, the capillary tube having a distal end that includes plural ports that provide fluid access to the interior of the capillary tube.

58. The apparatus of claim 4 wherein the apparatus is adapted to provide an indication of the deformability of red blood cells.

59. The apparatus of claim 58 wherein the catheter comprises a plurality of lumens each with an internal diameter smaller than the average diameter of a red blood cell.

60. The apparatus of claim 4 wherein the apparatus is adapted to provide an indication of blood pressure in the placement of the catheter.

61. The apparatus of claim 1 wherein the apparatus is adapted to determine blood viscosities at shear stresses approaching zero.

62. The apparatus of claim 1 wherein the apparatus is adapted to determine a point supporting a shear stress at zero fluid velocity.

63. The apparatus of claim 1 wherein the apparatus is adapted to determine the point at which the blood becomes thixotropic and / or coagulates.

64. The apparatus for determining the viscosity of a fluid material at various rates of shear stress, the apparatus being characterized by material receiving element and calculation element, the material receiving element comprises an input tube configured to introduce the material to allow the material flows therein, the calculation element is coupled to the material receiving element and is configured to calculate the viscosity of the material within the input tube at different shear rates and provide a signal representative thereof, the calculation element comprises a fluid column and a monitoring element, the fluid in the column is configured to mate with the material inside the inlet tube, after which the fluid column changes in height, the monitoring element is configured to monitor the fluid height within the column at various points along the height of the column as the fluid column changes in height and calculate the viscosity of the material therefrom, including shear rates at least a high shear rate and at least a low shear rate.

65. The apparatus of claim 64 wherein the flowable material is configured to flow in the inlet tube under the force of gravity, after which the height of the fluid column changes.

66. The apparatus of claim 65 wherein the relative height of the inlet tube to the fluid column is adjustable, after which the inlet tube is arranged on top of a fluid column portion so that gravity causes the column of fluid changes height.

67. The apparatus of claim 66 further comprising a first valve element coupled between the inlet tube and the fluid column to selectively allow the flowable material to flow through the inlet tube to cause the fluid column to change. height.

68. The apparatus of claim 67 wherein the fluid column is located within a vertical tube, the vertical tube having a lower portion to which the tube is coupled by the first valve member.

69. The apparatus of claim 68 wherein the riser includes an upper portion having a second valve member located therein, the second valve element being selectable to allow air to flow in the upper portion of the riser.

70. The apparatus of claim 69 further comprising an injector element for selectively introducing the fluid forming the fluid column into the standpipe.

71. The apparatus of claim 70 wherein the injector element comprises a fluid container and a plunger.

72. The apparatus of claim 69 wherein the monitoring element comprises a sensor element for determining the height of the fluid column along a multitude of points along the same.

73. The apparatus of claim 72 further comprising a microprocessor element coupled to the sensor element.

74. The apparatus of claim 72 wherein the sensing element comprises a coupled charging device.

75. The apparatus of claim 73 wherein the sensing element comprises a coupled charging device.

76. The apparatus of claim 73 further comprising an indicating element to provide a visual indication of the viscosity.

77. The apparatus of claim 76 wherein the indicating element comprises a visual display.

78. The apparatus of claim 76 wherein the indicating element comprises a printer.

79. The apparatus of claim 76 wherein the indicating element comprises a visual display and a printer.

80. A method for effecting the in vivo measurement of the viscosity of the blood of a living being, the method comprising the steps of: (a) providing a blood sampling element in the body of the living being for its exposure to blood of the living being, (b) capturing a parameter related to the blood while the sampling element is inside the body of the living being, and (c) using the captured parameter to determine the viscosity of the blood of the living being at various stress indices cutting.

81. The method of claim 80 wherein the blood sampling element comprises a catheter, wherein the parameter comprises the flow of blood through the catheter, and wherein the method comprises introducing the catheter into the body of the living being in an internal site and allow the blood of the living being to enter and through at least a portion of the catheter.

82. The method of claim 81 further comprising the steps of: (d) providing a fluid column, (e) selectively coupling the fluid column with the catheter so that the flow of blood through that portion of the catheter causes the fluid column to change in height, and (f) monitoring the changing height of the fluid column at different points along the length of it to calculate the viscosity of the blood.

83. The method of claim 82 comprising the step of: (g) using gravity to allow blood to flow through the catheter portion to cause the fluid column to change height.

84. The method of claim 83 wherein the fluid column has a predetermined diameter, and wherein the portion of the catheter comprises a capillary tube, the capillary tube having a predetermined length and a predetermined internal diameter.

85. The method of claim 84 further comprising the step of: (h) locating the capillary tube and fluid column with respect to each other so that the capillary tube is disposed at a higher elevation than the portion of the fluid column.

86. The method of claim 84 further comprising the step of: (h) providing a valve member for selectively coupling the blood in the capillary tube with the fluid column.

87. The method of claim 85 further comprising the step of: (i) providing a valve member for selectively coupling the blood in the capillary tube in the fluid column.

88. The method of claim 80 further comprising the step of: (d) determining the blood pressure in the blood sampling element.

89. The method of claim 82 wherein the catheter comprises a capillary tube and wherein the method further comprises the steps of: (i) providing a vertical tube in which the fluid column is located, (j) placing the capillary tube and the vertical tube in a first position with respect to each other so that the upper part of the fluid column within the vertical tube is substantially at the elevation of the capillary tube to establish a reference level in the vertical tube before allowing the blood flows through the capillary tube to mate with the fluid column, (k) selectively allow blood to flow through the capillary tube and couple the flow with the vertical tube so that the upper part of the fluid column changes from height in response to the blood pressure in the capillary tube, (1) change the relative elevation of the capillary tube and the vertical tube one with respect to the other so that the upper part of the fluid column is at the reference level, (m) changing the relative elevation of the capillary tube and the vertical tube with respect to each other and configuring the upper part of the fluid column to a source of pressure lower than the blood pressure, under the influence of gravity after which the height of the fluid column in the vertical tube changes, and (n) monitor the height change of the fluid column to determine the viscosity of the blood.

90. The method of claim 80 wherein the method comprises determining the viscosity of the blood plasma of the living being.

91. The method of claim 80 wherein the method comprises determining the viscosity of the blood plasma of the living being.

92. The method of claim 91 wherein the blood sampling element comprises a catheter and an element for allowing only blood plasma to pass through the catheter, wherein the parameter comprises the flow of blood plasma through the catheter, and wherein the method comprises introducing the catheter into the body of the living being at an internal site and allowing the blood plasma of the living being to enter and through at least a portion of the catheter.

93. The method of claim 92 further comprising the steps of: (d) providing a fluid column, (e) selectively coupling the fluid column with the catheter so that the flow of blood plasma through the portion of the catheter causes the fluid column to change in height, and (f) monitor the changing height of the fluid column at different points along the length of the column to calculate the viscosity of the blood plasma.

94. The method of claim 93 comprising the step of: (g) using gravity to allow blood plasma to flow through the catheter portion to cause the fluid column to change in height.

95. The method of claim 82 wherein the catheter portion comprises a plurality of capillary tubes, each of which having an internal diameter less than the average diameter of red blood cells, wherein the method comprises determining the deformability of the red blood cells of the living being.

96. The method of claim 81 wherein the method determines the deformability of the red blood cells of the living being.

97. A method for medically diagnosing the physiological conditions of a living being comprising the step of measuring the viscosity of the blood of the living being in vivo at different rates of shear stress.

98. The method of claim 97 further comprising providing some treatment to the living being based on measuring the viscosity of the blood of the living being.

99. The method of claim 97 further comprising the step of providing vibrational energy to a portion of the body of the living being.

100. The method of claim 99 wherein the vibrational energy is provided to a portion of the body of the living being shortly before and / or during the determination of the viscosity of the blood of the living being.

101. The method of claim 100 further comprising providing some treatment to the living being based on measuring the viscosity of the blood of the living being.

102. The method of claim 99 wherein the vibrational energy is variable in amplitude and / or frequency.

103. The method of claim 100 wherein the vibrational energy is provided to improve blood circulation through at least a portion of the body of the living being.

104. The method of claim 99 wherein vibrational energy is provided to determine its effect on the viscosity of the blood of the living being.

105. The method of claim 104 further comprising the step of selecting a specific vibrational energy therapy to improve blood circulation through at least a portion of the body of the living being based on that effect.

106. The method of claim 99 further comprising providing the vibrational energy therapy specific to a portion of the body of the living being either during or after the determination of the viscosity.

107. Apparatus for providing vibratory energy to a portion of the body of a living being to effect a beneficial change in the viscosity of the blood of the living being.

108. The apparatus of claim 107, wherein the amplitude of the vibrational energy is variable.

109. The apparatus of claim 107, wherein the frequency of vibratory energy is variable.

110. The apparatus of claim 107, wherein the amplitude and frequency of the vibrational energy are variable.

111. The apparatus of claim 107 further comprising viscosity determining elements for determining the viscosity of the blood of the living being.

112. The apparatus of claim 111, wherein the viscosity determining element determines the viscosity of the blood of the living being, in vivo.

113. The apparatus of claim 111, wherein the apparatus provides the vibrational energy to the body portion of the living being after a determination of the viscosity of the blood of the living being has been carried out.

114. The apparatus of claim 111, wherein the apparatus provides vibratory energy to a portion of the body of the living being while the viscosity determining element determines the viscosity of the blood of the living being.

115. A method for providing a beneficial medical treatment to a living being, comprising the step of applying vibratory energy to a portion of the body of the living being to effect a beneficial change in the viscosity of the person's blood.

116. The method of claim 115, wherein the amplitude of the applied vibrational energy is variable.

117. The method of claim 115, wherein the frequency of the applied vibrational energy is variable.

118. The method of claim 115, where the amplitude and frequency of the applied vibratory energy is variable.

119. The method of claim 115 further comprising the step of determining the viscosity of the blood of the living being.

120. The method of claim 119, wherein the determination of the viscosity of the blood of the living being is carried out in vivo.

121. The method of claim 119, wherein the vibrational energy is applied to the body portion of the living being after a determination of the viscosity of the blood of the living being has been carried out.

122. The method of claim 119, wherein the vibrational energy is applied to the body portion of the living being while the determination of the viscosity of the blood of the living being is being carried out.

123. The method of claim 119, wherein the vibrational energy is applied to the portion of the human body while the determination of the viscosity of the blood of the living being is being carried out, and where the vibrational energy is applied. to a portion of the body of the living being after the determination of the viscosity of the blood of the human being was carried out, the vibratory energy applied to the body portion of the living being after it has been carried out the determination of the viscosity is selectable to provide by it a beneficial treatment to the living being.

124. The method of claim 123 wherein the vibrational energy applied to the body portion of the living being after the determination of the blood viscosity of the human being has been carried out is selected from variable vibratory energy.

125. The method of claim 124 wherein the vibrational energy is variable in amplitude.

126. The method of claim 124 wherein the vibrational energy is variable in frequency.

127. The method of claim 124 wherein the vibrational energy is variable in amplitude and frequency.

128. The apparatus (20) for determining the viscosity of a first flowable material (31) at different shear rates, this apparatus (20) being characterized by a first tube (22), a second elongated tube (44), a sensor (50), and a calculation element (24), the first tube (22) being configured to receive the first flowable material (31) to allow the first flowable material (31) to flow therein, the second tube being coupled (44) to the first tube (22) and being configured to receive a second flowable material (41), the second flowable material (41) forming a column of fluid (42) in the second tube (44), the fluid column (42) is adapted to change in height, the sensor (50) being configured to continuously monitor the height of the fluid column (42) at several points along the length of the second tube (44) as the fluid column (42) changes in height and to provide a first signal indicative of the same, the calculation element (24) responds to that first signal to calculate the viscosity of the first flowable material (31) at various rates of shear stress within the first tube (22) and provide a signal For a representative output of the same, different shear rates include at least a high shear rate and at least a low shear rate.

129. The apparatus (20) of claim 128 characterized in that the second flowable material (41) is a different material than the first flowable material (31).

130. The apparatus (20) of claim 128 characterized in that the second flowable material (41) is also the first flowable material (31).

131. The apparatus (20) of claim 128, characterized in that the sensor (50) comprises a video image forming device.

132. The apparatus (20) of claim 131, characterized in that the video image forming device comprises a coupled charge device (CCD).

133. The apparatus (20) of claim 128 characterized in that the sensor (50) comprises a charging device coupled.

134. The apparatus (20) of claim 128, characterized in that the first tube (22) comprises a capillary tube (26).

135. The apparatus (20) of claim 134, characterized in that the capillary tube (26) is configured to mate with the interior of a blood vessel of a living being, wherein the blood can flow into the capillary tube (26).

136. The apparatus (20) of claim 129, characterized in that the first tube (22) comprises a capillary tube (26).

137. The apparatus (20) of claim 136 characterized in that the capillary tube (26) is configured to mate with the interior of the blood vessel of a living being, where the blood can flow into the capillary tube (26).

138. The apparatus (20) of claim 128 characterized in that the height of the fluid column (42) is configured to change in response to a force applied thereto.

139. The apparatus (20) of claim 138 characterized in that the apparatus (20) includes an element (46) to selectively allow gravity to apply force to the fluid column (42), where the height of the fluid column (42) changes in response to it.