Patent Document

RELATED APPLICATIONS  
       [0001]    This application is a Continuation-In-Part of application Ser. No. 09/789,350, filed Feb. 21, 2001, entitled Mass Detection Capillary Viscometer, which in turn is based on Provisional Application Serial No. 60/228,612 filed Aug. 29, 2000 entitled MASS DETECTION CAPILLARY VISCOMETER. This application is also a Continuation-in-Part of application Ser. No. 09/573,267 filed May 18, 2000, entitled DUAL RISER/SINGLE CAPILLARY VISCOMETER. The entire disclosures of all the above applications are incorporated by reference herein. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    A capillary viscometer is commonly used because of its inherent features such as simplicity, accuracy, similarity to process flows like extrusion dies, no free surface, etc. Viscous flow in capillary viscometry is firmly established both theoretically and experimentally. C. W. Macosko,  Rheology: Principles, Measurements, and Applications  (VCH, 1993). In fact, the capillary viscometer was the first viscometer and this device remains the most common for measuring viscosity for polymer solutions and other non-Newtonian fluids. However, most existing capillary viscometers produce viscosity measurement a shear rate at a time. In the case of Newtonian fluids the observation of the rate of flow at a single pressure drop is sufficient to define the flow behavior. However, in the case of non-Newtonian fluids, viscosity measurements need to be performed over a range of shear rates. In order to measure viscosity over a range of shear rates, it is necessary to repeat the measurement by varying either the driving pressure head or the capillary tube diameter, which leads to a time-consuming measurement requiring intensive labor. Hence, these methods are not suited for measuring the rheology of polymer fluids that may exhibit shear-dependent viscosities. Furthermore, application of such techniques often requires relatively large volumes of the test fluids. Therefore, there has been a need to develop a simple and labor-free viscometer which can measure the viscosity of fluids over shear rates at a time.  
           [0003]    In U.S. Pat. Nos. 6,019,735 (Kensey et al.) and U.S. Pat. No. 6,077,234 (Kensey et al.), which are assigned to the same Assignee, namely Visco Technologies, Inc., of the present invention, there is disclosed a scanning-capillary-tube viscometer for measuring the viscosity of a fluid, e.g., circulating blood of a living being. Among other things, this scanning capillary tube viscometer discloses an apparatus that monitors the changing height of a column of fluid versus time in a riser that is in fluid communication with a living being&#39;s circulating blood. A further improvement of this type of scanning capillary tube viscometer is disclosed in application Ser. No. 09/439,735 entitled DUAL RISER/SINGLE CAPILLARY VISCOMETER, which is assigned to the same Assignee as the present invention, namely, Visco Technologies, Inc. and whose entire disclosure is incorporated by reference herein. In that application, a U-shaped tube structure is utilized that generates a falling and rising column of test fluid that is driven by a decreasing pressure differential for moving these columns of fluid through a plurality of shear rates, which is necessary for non-Newtonian fluid (e.g., blood) viscosity determinations. Such an apparatus can produce viscosity data in a low shear range (e.g., approximately 0.02 s −1 ).  
           [0004]    However, there is a need for an alternative mechanism of monitoring the changing column of fluid over time, such as detecting the changing mass of the column of fluid, as set forth in the present application. The key principle of the mass-detection-capillary viscometer is that both flow rate and pressure drop at a capillary tube can be determined by a single measurement of collected fluid mass variation with time using a load cell. Thus, there also remains a need to develop a viscosity determination in a quasi-steady capillary flow and to measure the viscosity of non-Newtonian fluids (e.g., polymer solutions, circulating blood of a living being, etc.) over a range of shear rates.  
         SUMMARY OF THE INVENTION  
         [0005]    An apparatus for determining the viscosity of the circulating blood of a living being over plural shear rates using a decreasing pressure differential. The apparatus comprises: a lumen (e.g., a riser tube) being positioned at an angle to a horizontal reference greater than zero degrees, wherein the lumen comprises a first end and a second end and wherein the first end is exposed to atmospheric pressure and wherein the lumen comprises a first known dimension (e.g., the diameter of the lumen); a flow restrictor (e.g., a capillary tube) having an inlet and an outlet wherein the outlet is arranged to deliver any blood that passes therethrough to a collector, and wherein the flow restrictor includes some known dimensions (e.g., the length and diameter of the flow restrictor); a valve coupled to the vascular system of the living being at a first port and wherein the valve comprises a second port coupled to the second end and a third port is coupled to the inlet; a sensor for detecting the movement of the blood over time (e.g., a mass detector, a column level detector, etc.) through the apparatus and wherein the sensor generates data relating to the movement of the blood over time; a processor, the valve to create a column of blood in the first lumen and the flow restrictor and to establish a pressure differential between the first end and the outlet, and wherein the column of blood moves through the lumen and the flow restrictor at a first shear rate caused by the pressure differential and wherein the movement of the column of blood causes the pressure differential to decrease from the first shear rate for generating the plural shear rates; and wherein the processor calculates the viscosity of the blood based on the data relating to the movement of the column of blood over time, the first known dimension of the lumen and the some known dimensions of the flow restrictor.  
           [0006]    A method for determining the viscosity of the circulating blood of a living being over plural shear rates caused by a decreasing pressure differential. The method comprises the steps of: (a) providing a lumen having a first end and a second end and positioned at an angle to a horizontal reference greater than zero degrees, and wherein the lumen has a first known dimension (e.g., the diameter of the lumen) and wherein the first end is exposed to atmospheric pressure; (b) diverting a portion of the circulating blood into the lumen through the second end to form a column of blood therein; (c) coupling an inlet of a flow restrictor to the second end of the lumen to establish a pressure differential between the first end and the outlet and wherein the flow restrictor has an outlet that is arranged to deliver any blood that passes therethrough to a collector and wherein the flow restrictor has some known dimensions (e.g., the length and the diameter of the flow restrictor); (d) controlling the column of blood to form a continuous column of blood in the lumen and the flow restrictor, and wherein the column of blood moves through the lumen and the flow restrictor at a first shear rate caused by the pressure differential and wherein the movement of the column of blood causes the pressure differential to decrease from the first shear rate for generating the plural shear rates; (e) providing a sensor for detecting the movement of the column of blood over time (e.g., a mass detector, a column level detector, etc.) as the column of blood moves and passes from the outlet into the collector while maintaining the outlet submerged in blood that has collected in the collector, and wherein the sensor generates data regarding the movement; and (f) calculating the viscosity of the blood based on the generated data, the first known dimension and the some known dimensions.  
           [0007]    An apparatus for determining the viscosity of the circulating blood of a living being over plural shear rates using a decreasing pressure differential. The apparatus comprises: a lumen (e.g., a riser tube) being positioned at an angle to a horizontal reference greater than zero degrees, and wherein the lumen comprises a first end and a second end and wherein the lumen also comprises a first known dimension (e.g., the diameter of the lumen); a flow restrictor (e.g., a capillary tube) having an inlet and an outlet wherein the outlet is arranged to deliver any blood that passes therethrough to a collector and wherein the inlet is coupled to the second end and wherein the flow restrictor includes some known dimensions (e.g., the length and diameter of the flow restrictor); a valve coupled to the vascular system of the living being at a first port and wherein the valve comprises a second port coupled to the first end; a sensor for detecting the movement of the blood over time (e.g., a mass detector, a column level detector, etc.) through the apparatus and wherein the sensor generates data relating to the movement of the blood over time; a processor, coupled to the valve and the sensor wherein the processor is arranged to operate the valve to create a column of blood in the first lumen and the flow restrictor and to establish a pressure differential between the first end and the outlet and wherein the column of blood moves through the lumen and the flow restrictor at a first shear rate caused by the pressure differential and wherein the movement of the column of blood causes the pressure differential to decrease from the first shear rate for generating the plural shear rates; and wherein the processor calculates the viscosity of the blood based on the data relating to the movement of the column of blood over time, the first known dimension of the lumen and the some known dimensions of the flow restrictor.  
           [0008]    A method for determining the viscosity of the circulating blood of a living being over plural shear rates caused by a decreasing pressure differential. The method comprises the steps of: (a) providing a lumen (e.g., a riser tube) having a first end and a second end and positioned at an angle to a horizontal reference greater than zero degrees and wherein the lumen has a first known dimension (e.g., the diameter of the lumen); (b) coupling an inlet of a flow restrictor (e.g., a capillary tube) to said second end and arranging an outlet of the flow restrictor to deliver any blood that passes therethrough to a collector and wherein the flow restrictor has some known dimensions (e.g., the length and diameter of the flow restrictor); (c) diverting a portion of the circulating blood into the lumen through the first end to form a column of blood in the lumen and the flow restrictor and to establish a pressure differential between the first end and the outlet; (c) exposing the first end to atmospheric pressure to cause the column of blood to move through the lumen and the flow restrictor, wherein the movement of the column of blood causes the pressure differential to decrease from the first shear rate for generating the plural shear rates; (d) providing a sensor for detecting the movement of the column of blood over time (e.g., a mass detector, a column level detector, etc.) as the column of blood moves and passes from the outlet into the collector while maintaining the outlet submerged in blood that has collected in the collector and wherein the sensor generates data regarding the movement; and (e) calculating the viscosity of the blood based on the generated data, the first known dimension and the some known dimensions.  
           [0009]    An apparatus for determining the viscosity of the circulating blood of a living being over plural shear rates using a decreasing pressure differential. The apparatus comprises: a first lumen (a riser tube) being positioned at an angle to a horizontal reference greater than zero degrees and wherein the lumen comprises a first end and a second end and wherein the first end is exposed to atmospheric pressure and wherein the lumen comprises a first known dimension (e.g., the diameter of the first lumen); a flow restrictor (e.g., a capillary tube) having an inlet and an outlet wherein the inlet is coupled to the second end and wherein the flow restrictor includes some known dimensions (e.g., the length and diameter of the flow restrictor); a valve coupled to the vascular system of the living being at a first port wherein the valve comprises a second port coupled to the outlet and a third port coupled to an input of a second lumen (e.g., an adaptor, etc.) arranged to deliver any blood that passes therethrough to a collector through an output of the second lumen; a sensor for detecting the movement of the blood over time (e.g., a mass detector, a column level detector, etc.) through the apparatus and wherein the sensor generates data relating to the movement of the blood over time; a processor, coupled to the valve and the sensor and wherein the processor is arranged to operate the valve to create a column of blood in the first lumen and the flow restrictor and to establish a pressure differential between the first end and the output wherein the column of blood moves through the lumen and the flow restrictor at a first shear rate caused by the pressure differential and wherein the movement of the column of blood causes the pressure differential to decrease from the first shear rate for generating the plural shear rates; and wherein the processor calculates the viscosity of the blood based on the data relating to the movement of the column of blood over time, the first known dimension of the first lumen and the some known dimensions of the flow restrictor. 
       
    
    
     DESCRIPTION OF THE DRAWINGS  
       [0010]    The invention of this present application will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein:  
         [0011]    [0011]FIG. 1 is a block diagram of a single riser/single capillary (SRSC) blood viscometer using mass detection which is also referred to as a mass detection capillary blood viscometer (MDCBV);  
         [0012]    [0012]FIG. 1A is a height vs. time plot of the blood column in the riser tube of the MDCBV;  
         [0013]    [0013]FIG. 1B is a mass vs. time plot of the blood as it is collected in the collector of the MDCBV;  
         [0014]    [0014]FIG. 2 is a front view of an embodiment of the MDCBV;  
         [0015]    [0015]FIG. 3 is a side view of the MDCBV;  
         [0016]    [0016]FIG. 4 is a functional diagram of the MDCBV;  
         [0017]    [0017]FIG. 5A is a functional diagram of the valve activated to create a column of blood;  
         [0018]    [0018]FIG. 5B is a functional diagram of the valve activated to permit the column of blood to fall and be collected in a collector;  
         [0019]    [0019]FIG. 6 is a functional diagram of a second embodiment of the MDCBV having an alternative position of the capillary tube;  
         [0020]    [0020]FIG. 7 is a functional diagram of a third embodiment of the MDCBV having an alternative position of the valve mechanism;  
         [0021]    [0021]FIG. 8A is a functional diagram of the valve mechanism of FIG. 7 activated to create a column of blood;  
         [0022]    [0022]FIG. 8B is a functional diagram of the valve mechanism of FIG. 7 activated to permit the column of blood to move and be collected in a collector;  
         [0023]    [0023]FIG. 9 depicts a fourth embodiment of the MDCBV wherein the changing mass of falling column of blood is detected;  
         [0024]    [0024]FIG. 10 depicts the mass vs. time plot the falling column of blood for the fourth embodiment of FIG. 9;  
         [0025]    [0025]FIG. 11 is a block diagram of a SRSC blood viscometer using a column height detector known as a column height detection capillary (CHDC) blood viscometer wherein the changing height of a falling column of blood is monitored;  
         [0026]    [0026]FIG. 12 is a front view of an embodiment of the CHDC blood viscometer;  
         [0027]    [0027]FIG. 13 is a functional diagram of the CHDC blood viscometer;  
         [0028]    [0028]FIG. 14 is a functional diagram of a second embodiment of the CHDC blood viscometer having an alternative location of the flow restrictor; and  
         [0029]    [0029]FIG. 15 is a functional diagram of a third embodiment of the CHDC blood viscometer having an alternative location of the valve mechanism. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0030]    The present invention, generally referred to as a single riser/single capillary (SRSC) blood viscometer, uses a single riser tube and a single flow restrictor (e.g., a capillary tube) structure for determining the viscosity of the circulating blood of a living being.  
         [0031]    Although the SRSC blood viscometer can be implemented in a number of ways, two exemplary apparatus/methods are set forth below. The first implementation uses the SRSC structure along with mass detection and hence is hereinafter referred to as a mass detection capillary blood viscometer (MDCBV)  20 . The second implementation uses the SRSC structure along with column height detection and hence is hereinafter referred to as a column height detection capillary (CHDC) blood viscometer  1020 .  
         [0032]    Referring now in detail to the various figures of the drawing wherein like reference characters refer to like parts, there is shown at  920  a mass detecting capillary blood viscometer (MDCBV).  
         [0033]    The MDCBV  920  basically comprises a blood receiver  922  and an analyzer/output portion  924 . The patient is coupled to the MDCBV  920  through a circulating blood conveyor  926 , e.g., a needle, an IV needle, an in-dwelling catheter, etc., or any equivalent structure that can convey circulating blood from a patient to the MDCBV  920 . As will be discussed in detail later, the analyzer/output portion  924  provides a display  28  for presenting the viscosity information, as well as other information to the operator. The analyzer/output portion  924  may also provide this information to other suitable output means  330 , such as a datalogger  332 , other computer(s)  334 , a printer  336 , a plotter  338 , remote computers/storage  340 , to the Internet  342  or to other on-line services  344 .  
         [0034]    The blood receiver  922  basically comprises a valve mechanism  946  coupled to a riser tube R on one side and coupled to a flow restrictor  24  (e.g., a capillary tube) on the other side. The output of the flow restrictor  24  is directed into a fluid collector  26  via an adaptor  34 . When the blood conveyor  926  is coupled to the blood receiver  922 , the valve mechanism  946  controls the flow of blood into the blood receiver  922 , as will be discussed in detail later. The upper end of the riser tube R is exposed to atmospheric pressure. The riser tube R may be positioned at any non-zero angle to a horizontal reference position (e.g., the datum line as shown in FIG. 4); one exemplary position is at a vertical orientation with respect to the datum line as shown in FIG. 4.  
         [0035]    It should be understood that the blood receiver  922  may be disposable or non-disposable. As will be discussed in detail later, where the blood receiver  922  is disposable, the components (valve mechanism  946 , riser tube R and flow restrictor  24 ) are releasably secured in a blood receiver housing  962  that can be quickly and easily inserted, used during the viscosity test run and then quickly and easily removed for disposal; another disposable blood receiver  922  is then inserted in preparation for the next viscosity test run. On the other hand, where the blood receiver  922  is non-disposable, the components (valve mechanism  946 , riser tube Rand flow restrictor  24 ) can be thoroughly washed and cleaned in place in preparation for the next viscosity test run.  
         [0036]    It should be understood that the flow restrictor  24  does not necessarily have to be an elongated tube but may comprise a variety of configurations such as a coiled capillary tube.  
         [0037]    The analyzer/output portion  924  basically comprises a mass detector  28 , a level detector  400 , a processor  30 , the display  928 , a bar code reader  978 , an environmental control unit  980 , and overflow detector  981 , a first battery B 1  and a second back-up battery B 2 . The fluid collector  26  is positioned on top of the mass detector  28  which monitors the increasing mass of blood collecting in the fluid collector  26 . The overflow detector  981  ensures that when the column of blood is generated, no blood overflows the riser R. The processor  30  (e.g., a “386” microprocessor or greater, or any equivalent) is arranged to analyze the data from the mass detector  28  and to calculate the blood viscosity therefrom, as will also be discussed in detail later. Furthermore, the processor  30  also controls the display  928  for providing the viscosity information and the other information to the operator as well as to the other output means  330 . The processor  30  also controls the valve mechanism  946  based on the data from the mass detector  28 , as will be discussed later. Battery B 1  provides all of the requisite power to the analyzer/output portion  24 , with battery B 2  serving as a back-up power supply. The bar code reader  978 , the environmental control unit  980  and the level detector  400  will be described later.  
         [0038]    In general, via the use of the valve mechanism  946 , a column of blood  38  is initially generated in the riser R and then that column of blood  38  is permitted to fall through the riser tube R, through the flow restrictor  24  and into the fluid collector  26 . This movement of blood can be represented by a height vs. time relationship (FIG. 1A) with regard to the column of blood in the riser R and by a mass vs. time relationship (FIG. 1B) with regard to the blood being received in the fluid collector  26 .  
         [0039]    As shown more clearly in FIGS.  2 - 3 , the preferred embodiment of the MDCBV  920  comprises the blood receiver  922  and the analyzer/output portion  924  contained in respective housings  960  and  962 , each of which can be releasably secured to a common frame, e.g., a conventional intravenous (IV) pole  48 . In this configuration, the analyzer/output portion  924  can be positioned in an inclined orientation (see FIG. 3) to facilitate user operation and viewing of the display  928 . However, it should be understood that the respective housing constructions are exemplary, and others can be incorporated without limiting the scope of this invention.  
         [0040]    The display  928  may comprise any suitable conventional devices, e.g., an ELD (electroluminescent display) or LCD (liquid crystal display) that permits the visualization of both text and graphics. The resolution of this display  928  is preferably 800×600 VGA or above. Furthermore, while the preferred embodiment utilizes a touch screen display which incorporates, among other things:  
         [0041]    graphical display  961   
         [0042]    instruction, and/or data, display  965  (which also includes the command line display shown as “RUN TEST”; e.g., “TESTING”, “TEST IN PROGRESS,” etc.)  
         [0043]    alphanumeric keypad  968   
         [0044]    emergency stop button  970   
         [0045]    battery status indicators,  972 A and  972 B  
         [0046]    function buttons  974 ,  
         [0047]    it should be understood that any equivalent display device is within the broadest scope of the invention. Thus, any number of user interfaces and buttons may be available through the display  928 . Therefore the invention  920  is not limited to the embodiment that is shown in FIG. 2. Moreover, the display  928  can be operated to minimize or maximize, or overlay any particular graphic or text screen, as is available in any conventional object-oriented operating system, such as Microsoft® WINDOWS.  
         [0048]    The lower housing  960  comprises the blood receiver  922  and the mass detector  28 . In the preferred embodiment, the mass detector  28  may comprise a precision balance, or load cell, such as The Adventurer™ by Ohaus Corporation of Florham Park, N.J. Thus, as the collector  26  collects more of the blood during the viscosity test run, the changing mass value is transmitted to the processor  30  from the mass detector  28  for viscosity determination; in particular, the mass detector  28  generates an electrical signal that corresponds to the mass variation in time. It should be understood that the term “mass” may be interchanged with the term “weight” for purposes of this invention. It should also be understood that the connection between the mass detector  28  and the processor  30  is bi-directional; this allows the processor  30  to reset the mass detector  28  in preparation for a new test run.  
         [0049]    It should also be understood that although it is preferable to have the riser tube R in a vertical position, it is within the broadest scope of this invention to have the riser tube R oriented at any angle greater than zero degrees, with respect to a horizontal reference (e.g., datum line shown in FIG. 4).  
         [0050]    Where the blood receiver  922  is disposable, it is releasably secured in the housing  960  such that once a test run is completed and/or a new patient is to be tested, all of the lumens (e.g., the riser tube R, the capillary  24 , the adaptor  34  and the valve mechanism  946 ) can be easily/quickly removed, disposed of and a new set inserted. For example, a bracket  147  (FIG. 2) may be used to releasably secure the upper portion of the riser tube R.  
         [0051]    A door  976  (which can be vertically or horizontally hinged to the housing  960 ) is provided to establish a temperature-controlled environment during the test run. In particular, the door  976  also supports an environmental control unit  980  (e.g., a heater, fan and/or thermostat) such that when it is closed in preparation for the test, the flow restrictor  24  is then heated (or cooled) and maintained throughout the test run at the same temperature and environment as the living being. Prior to the run, the living being&#39;s temperature is taken and the operator enters this temperature (via the touch screen display  928 ). The environmental control unit  980  then operates to achieve and maintain this temperature. It should be noted that it is within the broadest scope of this invention to include a environmental control unit  980  that achieves and maintains the entire blood receiver  922  at the patient&#39;s temperature during the run. By properly maintaining the temperature throughout the test run, the effects of any temperature variation in the viscosity measurement is minimized.  
         [0052]    The door  976  may also support the bar code reader  978 . The bar code reader  978  automatically reads a bar code (not shown) that is provided on the riser tube R. The bar code contains all of the predetermined data regarding the characteristics of the flow restrictor  24  (e.g., its length and diameter) and the characteristics of the riser tube R. This information is passed to the processor  30  which is then used to determine the viscosity.  
         [0053]    The batteries B 1 /B 2  may each comprise a 12 VDC, 4 amp-hour battery, or any equivalent power supply (e.g., batteries used in conventional lap-top computers such as lithium ion batteries). The display  928  provides the status indicators  972 A/ 972 B for each battery in the MDCBV  920 . In particular, when the MDCBV  920  is operating off of battery B 1 , the two battery indicators  972 A/ 972 B appear on the display  928 . However, once battery B 1  is depleted, the battery B 1  indicator  972 A disappears and the battery B 2  indicator  972 B blinks to warn the operator that the MDCBV  920  is now operating off of the back-up battery B 2  and re-charge of battery B 1  is necessary.  
         [0054]    The preferred fluid collector  26  of the present invention is similar to that disclosed in application Ser. No. 09/789,350. In particular, the collector  26  comprises an inner circular wall  35  that divides the collector  26  into a central portion  31  and an annular portion  39 . The central portion  31  collects the blood as it enters the collector  26 . The column of blood  38  falls through the riser tube R, the flow restrictor  24 , the adaptor  34  and then into the central portion  31 . Any overflow spills into the annular portion  39 .  
         [0055]    It should be understood that the phrase “column of blood  38 ” is meant to cover the continuous element of blood that occupies the riser tube R as well as the blood that occupies the flow restrictor  24  and the adaptor  34 .  
         [0056]    To minimize any surface tension effects that would normally occur if an open end  36  of the adaptor was positioned above the level of collected blood  300  in the central portion  31 , it is necessary to begin collecting mass vs. time data only when the open end  36  of the adaptor  34  is submerged within the collected blood  300 . This is shown most clearly in FIG. 4. In order to accomplish this, the open end  36  of the adaptor  34  is placed appropriately below the datum line (e.g., the top edge  37  of the inner wall  35  of the preferred collector  26 ) and the level detector  400  is provided for detecting when the collected blood  300  has reached the datum level. The level detector  400  informs the processor  30  when this event has occurred. Thus, the processor  30  is able to determine those mass vs. time data points where surface tension effects are minimized. The level detector  400  can be implemented in various ways known to those skilled in art, e.g., float sensors, tuning fork sensors, ultrasonic sensors, optical sensors, proximity sensors, capacitance sensors, etc. and all of which generate an electrical signal when a particular fluid level has been reached. An exemplary sensor is the ColeParmer EW-20603-22 Capacitive Level Sensor.  
         [0057]    It should be understood that the output side  3  of the flow restrictor  24  can be integrally formed with the input side  5  of the adaptor  34 .  
         [0058]    The concept of the blood viscosity determination using the MDCBV  920  is that a portion of the circulating blood of the living being is diverted from the living being using the blood conveyor  926  into the blood receiver  922  to create a column of blood  38  (FIG. 4) in the riser tube R. Next, the column of blood  38  is allowed to fall and collect in the fluid collector  26  over time, whereby the changing mass of this collector  26  is monitored over time. From this mass vs. time data and based on the characteristics of the flow restrictor  24  and the riser tube R, the circulating blood viscosity can be determined. In addition, where the blood exhibits yield stress, τ y , a residual amount of the column of blood  38  remains in the riser tube R after a long period of time at the end of the viscosity test run; furthermore, there are surface tension effects that also contribute to this residual amount of the column of blood  38  as a result of the gas-liquid interface  23  (FIG. 4). The height of this residual column of fluid is known as Δh ∞ , where Δh=h(t)−datum level and where h(t) represents the height of the column of blood  38  in the riser tube R at any time; the term h ∞  (FIG. 1A) represents the final height of the column of blood  38  in the riser tube R at the end of the test run after a long period of time. As will also be discussed later, the viscosity determination of the blood can be determined using the MDCBV  920  without the need to determine h(t) or the initial position, h i , of the column of blood  38  in the riser tube R at which data is collected.  
         [0059]    To obtain accurate data, it is important to “wet” all of the lumens, namely, the riser tube R, the valve mechanism  946 , the flow restrictor  24  and the adaptor  34  before data is taken. As a result, in order to generate the column of blood  38  and then allow it to fall, the valve mechanism  946  must be operated as follows: When the viscosity test run is initiated, the processor  30  activates the valve mechanism  946  by commanding a valve driver  986  (e.g., a 500 mA solenoid, or stepper motor, etc.) which rotates the valve into the position shown in FIG. 5A. This allows the diverted portion of the circulating blood to flow up into the riser tube R to create the column of blood  38 . When the overflow detector  981  detects a predetermined height, h 0 , of the column of blood  38 , the overflow detector  981  informs the processor  30  which then commands the valve driver  986  to rotate the valve into the position shown in FIG. 5B. As a result, the column of blood  38  begins to fall through the riser tube R, through the valve mechanism  946 , into the flow restrictor  24 , through the adaptor  34  and into the central portion  31  of the fluid collector  26 . As mentioned earlier, the processor  30  is informed by the level detector  400  when the open end  36  of the adaptor  34  is submerged under the level of the collected blood  300  in order to minimize any surface tension effects. Next, the valve driver  986  is commanded by the processor  30  into the position shown in FIG. 5C which halts all motion of the column of blood  38 . The initial position of the column of blood, hi, is thereby established for viscosity determination purposes, as will be discussed later. Finally, the processor  30  commands the valve driver  986  to rotate the valve into the position shown in FIG. 5D and the column of blood  38  begins falling while data is collected.  
         [0060]    The overflow detector  981  may comprise an optical source  981 A, e.g., a light emitting diode (LED) and a photodetector  981 B for detecting emitted light from the optical source  981 A; once the upper end of the column of blood  38  interrupts the emitted light, the photodetector  981 B informs the processor  30  which operates the valve mechanism  946 , as discussed previously. It should be understood that this implementation of the overflow detector  981  is exemplary only and that it is within the broadest scope of this invention to include all methods of level detection known to those skilled in the art of detecting the level of the column of blood  38  in the riser tube R.  
         [0061]    [0061]FIG. 6 depicts a second embodiment of the MDCBV  920  wherein the flow restrictor  24  forms the lower end of the riser tube R, rather than being located on the other side of the valve mechanism  946 . As a result, the input side  5  of the adaptor  34  is coupled to the valve mechanism  946 . For proper operation, the datum line needs to be above the input side  7  of the flow restrictor  24 , as shown in FIG. 6. Other than that, the operation of this variation is governed by the same equations for the first embodiment as will be discussed below.  
         [0062]    [0062]FIG. 7 depicts a third embodiment of the MDCBV  920  wherein the valve mechanism  946 ′ is positioned at the top of the riser tube R, rather than at the bottom. The advantage of this valve mechanism  946 ′ position is that there is no need to first fill the riser tube R to a predetermined level before proceeding with the test run; instead, in accordance with the valve mechanism  946 ′ operation as shown in FIGS.  8 A- 8 B, the test run proceeds with the processor  30  commanding the valve driver  986  to rotate the valve to the position shown in FIG. 8A and then the processor  30  stops any more input flow from the blood conveyor  926  as shown in FIG. 8B. In particular, as used in this embodiment, the blood conveyor  926  is coupled to the valve mechanism  946 ′ at a port  763 ; the top end of the riser tube R is coupled to the valve mechanism  946 ′ at a port  765 . The valve mechanism  946 ′ also includes a vent coupler  762  that couples the top of the riser R to a third port  764  that is exposed to atmospheric pressure; thus when the valve is rotated into the position shown in FIG. 8B, the blood in the riser tube R will flow downwards. Again, it should be emphasized that to minimize any surface tension effects, the level detector  400  informs the processor  30  when the open end of the adaptor  34  is submerged in the collected blood  300 . Other than that, the operation of this variation is governed by the same equations mentioned previously.  
         [0063]    MDCBV Theory of Operation  
         [0064]    The concept of the blood viscosity determination using the MDCBV  920  is based on the discussion of determining the viscosity of non-Newtonian fluids, such as blood, as discussed in detail in application Ser. No. 09/789,350, whose entire disclosure is incorporated by reference herein. The MDCBV  920  basically comprises a cylinder (i.e., the riser tube R) having a diameter, φ R , into which a portion of the circulating blood of the living being is diverted for viscosity analysis. The bottom of the riser tube R is coupled to the flow restrictor  24  (e.g., a capillary tube), having a diameter φ c  and a length L c . It is preferable that the diameter of the adaptor  34  be similar to the diameter of the riser tube R, φ R .  
         [0065]    Using this configuration of riser tube R and flow restrictor  24 , once the column of blood  38  is generated (as shown in FIG. 4), when the valve mechanism  946  is rotated to the position shown in FIG. 5B, the column of blood  38  is subjected to a decreasing pressure differential that moves the column  38  through a plurality of shear rates (i.e., from a high shear rate at the beginning of the test run to a low shear rate at the end of the test run, as can be clearly seen in the column height change—FIG. 1A and the mass accumulating in the collector  26 ′—FIG. 1B), which is especially important in determining the viscosity of non-Newtonian fluids, such as blood. In particular, once the desired height, h i  is achieved by the column of blood  38  and with the upper end of the riser tube R exposed to atmospheric pressure, a pressure differential is created between the column of fluid  38  and the outlet  36  of the adaptor  34 . As a result, the column of blood  38  flows down the riser tube R, through the flow restrictor  24 , through the adaptor  34  and into the collector  26 ′. As the column of blood  38  flows through these components, the movement of column of blood  38  causes the pressure differential to decrease, thereby causing the movement of the column of blood  38  to slow down. This movement of the column of blood  38 , initially at a high shear rate and diminishing to a low shear rate, thus covers the plurality of shear rates. However, it should be understood that it is within the broadest scope of this invention to include any other configurations where the column of blood  38  can be subjected to a decreasing pressure differential in order to move the column of blood  38  through a plurality of shear rates.  
         [0066]    The rate of flow through the flow restrictor  24  is equal to the rate of change of the mass of the blood  300  collected on the mass detector  28 . Hence, the corresponding flow rate in the flow restrictor  24  can be expressed as:  
               Q        (   t   )       =       1   ρ                          m          t                 (   1   )                               
 
         [0067]    where ρ is the density of the blood.  
         [0068]    In order to determine the viscosity of the blood, it is necessary to know the pressure drop across the flow restrictor  24 . What is measured using the MDCBV  20  is the total pressure drop between the riser tube R and the flow restrictor  24  including not only the pressure drop across the flow restrictor or capillary tube  24  (ΔP c ) but also the pressure drop occurring at the inlet and outlet (ΔP e ) of the capillary tube  24 . One of the accurate methods for determining (ΔP e ) is to make a Bagley plot (see C. W. Macosko,  Rheology: Principles, Measurements, and Applications  (VCH, 1993)) with at least two short capillary tubes (not shown) of the same diameter. Hence, the pressure drop occurring at the inlet and at the outlet of the capillary tube  24  has to be subtracted from the total pressure difference (ΔP t ). Considering these pressure drops, the pressure drop across the capillary tube  24  can be described as  
         Δ P   c   =ΔP   t   −ΔP   e    (2) 
         [0069]    It should be noted that the contribution from the second term on the right hand side (ΔP e ) in Eq. (2) is less than 0.5%; hence this term can be neglected for all practical purposes, and as a result, equation 2 reduces to:  
         Δ P   c   =ΔP   t    (3) 
         [0070]    An expression, therefore, for the total pressure as well as the pressure across the capillary tube  24  is:  
         Δ P   t   =ΔP   c   =ρg[h   i   −Δh ( t )− h   ∞   ]=ρg[h   i   −h   ∞   Δh ( t )]  (4), 
         [0071]    where Δh(t) represents the changing height of the falling column of blood  38  and is given by the following equation:  
               Δ                   h        (   t   )         =       4        m        (   t   )           ρπ                   φ   R   2                 (   5   )                               
 
         [0072]    and where:  
         [0073]    h i  is the initial height of the column of blood  38 ;  
         [0074]    h ∞  is the final height of the column of blood  38  after a long period of time; and  
         [0075]    m(t) is the mass of the collector  26  over time.  
         [0076]    In addition, the final mass after a long period of time, m ∞ , can be expressed in terms of the height of the column of blood  38  as follows:  
                   m   ∞     -     m   i       =       ρ        (       πφ   R   2     4     )                       (       h   i     -     h   ∞       )         ;           (   6   )                               
 
         [0077]    and solving equation 6 for (h i −h ∞ ),  
               (       h   i     -     h   ∞       )     =       4        (       m   ∞     -     m   i       )         ρπφ   R   2               (   7   )                               
 
         [0078]    Thus, making the substitution of equations 5 and 7 into equation 4,  
                     Δ                   P   c       =     ρ                   g        [         4        (       m   ∞     -     m   i       )         ρπ                   φ   R   2         -       4        m        (   t   )           ρπφ   R   2         ]                     =         4      g       πφ   R   2            [       m   ∞     -     m   i     -     m        (   t   )         ]                     (   8   )                               
 
         [0079]    It is assumed that any surface tension effects are constant with time and throughout the test run, e.g., the surface tension experienced at h i  is similar to the surface tension effect experienced at h ∞ .  
         [0080]    The significance of equation 8 includes, among other things, that in order to determine the pressure across the capillary tube  24 , only the final mass, m ∞ , the diameter of the riser R and the mass data detected by the mass detector  28 , m(t), need be known; the initial height of the blood column  38 , h i , nor the final height, h ∞ , nor the initial mass, m i , need to be known. Furthermore, equation 8 also represents, in accordance with the assumption that the surface tension is constant, a surface tension-free capillary.  
         [0081]    Non-Newtonian Fluids  
         [0082]    The shear rate dependent viscosity for a non-Newtonian fluid, such as blood, flowing in the capillary tube  24  is obtained from experimental data with some mathematical treatment, and the necessary equations can be found in any standard handbook (e.g., C. W. Macosko). The shear rate at the capillary tube  24  wall is obtained form the classical Weissenberg-Rabinowitsch equation (see S. L. Kokal, B. Habibi, and B. B. Maini, Novel Capillary Pulse Viscometer for non-Newtonian Fluids, Review of Scientific Instrument, 67(9), pp. 3149-3157 (1996)):  
                             γ   .     w          (   t   )       =     -            V   z            r                  r   =   R                 =       1   4              γ   .     aw          [     3   +                       ln                   Q            ln                     τ   w           ]                       (   9   )                               
 
         [0083]    where {dot over (γ)} aw  is the apparent or Newtonian shear rate at the wall and where φ c  is the diameter of the capillary tube  24 .  
                   γ   .     aw          (   t   )       =       32                   Q        (   t   )           πφ   c   3               (   10   )                               
 
         [0084]    and the shear stress at the wall is given by:  
                 τ   w          (   t   )       =       Δ                   P        (   t   )            φ   c         4        L   c                 (   11   )                               
 
         [0085]    Thus, the viscosity corresponding to the wall shear rate is calculated in the form of a generalized Newtonian viscosity:  
                   η   =         τ   w         γ   .     w       =           πφ   c   4        Δ                 P       32        QL   c                (     3   +                       ln                   Q            ln                     τ   w           )       -   1                       =         ρ                 g                   φ   c   4         8        L   c          φ   R   2                [       m   ∞     -     m   i     -     m        (   t   )         ]         (          m          t       )                     (     3   +     1     n   ′         )                         (   12   )                               
 
         where                   1     n   ′         =                         ln                   Q            ln                     τ   w         .                           
 
         [0086]    Thus, Equation 12 represents the viscosity of the blood in terms of the mass measured by the MDCBV  920 .  
         [0087]    The viscosity versus shear rate information can be obtained from equations 9-12 by measuring the mass of the collected fluid with respect to the time from which the pressure drop and flow rate can be calculated. The values of R and L c  must be obtained by calibration. Since equation (9) is non-linear, the procedure to calculate the shear rate and the corresponding viscosity is not straightforward. One of the approaches to obtain the viscosity from the general equations presented above is to adopt a finite difference technique for differentiation of equation (9). If there is enough data near the point of interest, it is possible to evaluate the derivative as:  
               1     n   ′       =              ln                   Q            ln                     τ   w         =     1   n               (   13   )                               
 
         [0088]    where n is simply the exponent of the power law constitutive equation. Even though the power-law exponent is used in the above equations, this does not limit the capability of the present measurement for power-law fluids. The rigorous approach can still be taken for obtaining a viscosity versus shear rate relationship for any fluid (see S. L. Kokal, B. Habibi, and B. B. Maini, “Novel Capillary Pulse Viscometer for non-Newtonian fluids, Review of Scientific Instrument, 67(9), 3149-3157 (1996)).  
         [0089]    In application Ser. No. 09/789,350 there is a figure, namely, FIG. 7, which illustrates the viscosity results using a mass detector viscometer for blood and which shows an excellent agreement with those from a conventional rotating viscometer, e.g., the Physica UDS-200 over a range of shear rates.  
         [0090]    As mentioned earlier FIGS. 1A and 1B provide a summary of the height vs. time characteristic, and the mass vs. time characteristic , of the falling column of blood  38  during the viscosity test run. As can be seen in FIG. 8A, the level of the column of blood  38  initially is at h i . During the test run, the column of blood  38  falls and arrives at a final column height of h ∞  after a long period of time (e.g., 2-5 minutes after the column of blood  38  begins to fall). As also mentioned earlier, this final height h ∞  can be attributed to both the surface tension effect of the gas-liquid interface  23  (FIG. 4) as well as any yield stress, τ y , exhibited by the blood. With regard to the change in mass, m(t), as shown in FIG. 8B, the mass climbs quickly and then slows down towards a final mass value, m ∞  after a long period of time. As mentioned earlier, what is important here is that the viscosity of the blood can be determined using the MDCBV  920  without the need to know h i  and h ∞ .  
         [0091]    [0091]FIG. 9 depicts a fourth embodiment of the MDCBV  920  wherein the changing mass of the riser R and flow restrictor  24  are detected, rather than detecting the change in mass of the collected blood  300  in the collector  26 . Thus, rather than obtaining an increasing mass with time, the mass detector  28  detects the decreasing mass of the riser R/flow restrictor  24  assembly with time, as shown in FIG. 10. The empty weight of the riser R, flow restrictor  24  and a base  29  (upon which the flow restrictor  24  is disposed) are taken into account before the test run is conducted. As a result, the expression for the pressure drop across the capillary tube  24  is:  
               Δ                   P   c       =           4      g       πφ   R   2            [       (       m   i     -     m   ∞       )     -     m        (   t   )         ]       .             (   14   )                               
 
         [0092]    Other than that, the theory of operation of this fourth embodiment of the MDCBV  920  is similar to that discussed above with regard to the other embodiments of the MDCBV  920 .  
         [0093]    A column height detection capillary (CHDC) blood viscometer  1020  is discussed next.  
         [0094]    The CHDC blood viscometer  1020  utilizes the same structure, for example, the riser tube R and the flow restrictor  24 , but with the mass detector  28  and the overflow detector  981  replaced by column level detector  1056 . As a result, the viscosity of the circulating blood of the living being can be determined using the CHDC viscometer  1020 . In particular, it can be shown that the viscosity of the circulating blood, η, is given by:  
       η   =         ρ                 g                   φ   c   4         8        L   c          φ   R   2              (         h   i     -     h   ∞     -     Δ                   h        (   t   )                      h        (   t   )              t            (     3   +     1     n   ′         )         )                             
 
         [0095]    The column level detector  1056  is similar to the one disclosed in application Ser. No. 09/573,267 whose entire disclosure is incorporated by reference herein. The column level detector  1056  detects the level of the column of blood in the riser tube R and may comprise and LED array  1064  and a CCD  1066  arrangement (FIG. 12). To that end, the CHDC blood viscometer  1020  basically comprises the blood receiver  922  and an analyzer/output portion  1024 .  
         [0096]    It should be emphasized that it is within the broadest scope of this invention to include all ways known in the art for detecting the level of the column of blood and the present invention is not limited, in any way, to the use of optical detection.  
         [0097]    As with the MDCBV  920 , the output side  3  of the flow restrictor  24  can be integrally formed with the input side  5  of the adaptor  34 .  
         [0098]    [0098]FIG. 12 depicts one embodiment of the CHDC blood viscometer  1020  which operates similarly to the MDCBV  920  except that the level of the column of blood  38  is monitored rather than the changing mass in the collector  26 . In addition, the function of the overflow detector  981  in the MDCBV  920  is accomplished by the column level detector  1056 , thereby informing the processor  30  when to operate the valve mechanism  960  to allow the column of blood  38  to fall. As a result, the CHDC blood viscometer  1020  utilizes height vs. time data, as shown in FIG. 1A, to determine the blood viscosity. FIG. 13 is a functional diagram of the CHDC blood viscometer  1020  that depicts the operation of the CHDC blood viscometer  1020 , including the use of the submerged end  36  of the adaptor  34  and the level detector  400 .  
         [0099]    [0099]FIG. 14 is a second embodiment of the CHDC blood viscometer  1020  wherein the flow restrictor  24  forms the lower end of the riser tube R, rather than being located on the other side of the valve mechanism  946 . As a result, the input side  5  of the adaptor  34  is coupled to the valve mechanism  946 . For proper operation, the datum line needs to be above the input side  7  of the flow restrictor  24 , as shown in FIG. 14. Other than that, the operation of this variation is governed by the same equations for the first embodiment of the CHDC blood viscometer  1020  as will be discussed below.  
         [0100]    [0100]FIG. 15 depicts a third embodiment of the CHDC blood viscometer  1020  wherein the valve mechanism  946 ′ is positioned at the top of the riser tube R, rather than at the bottom. The same discussion that applies to the third embodiment of the MDCBV  920  that was discussed earlier, applies here for the CHDC blood viscometer  1020 .  
         [0101]    Without further elaboration, the foregoing will so fully illustrate our invention and others may, by applying current or future knowledge, readily adapt the same for use under various conditions of service.

Technology Category: 3