Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/14535—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring haematocrit
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
  • A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Definitions

• the present invention relates generally to reflected light analysis. More particularly, the invention relates to the use of reflected spectral imaging to determine a quantity of visualizable components within a fluid flowing in a tubular system. Still more particularly, the invention relates to the use of reflected spectral imaging to determine a quantity of components within the blood of a mammalian, especially human, vascular system.
• CBC+Diff white blood cell differential
• CBC+Diff also includes the number and types of white blood cells and the number of platelets.
• the CBC+Diff is one of the most frequently requested diagnostic tests with about two billion done in the United States per year.
• a conventional CBC+Diff test is done in an "invasive" manner in which a sample of venous blood is drawn from a patient through a needle, and submitted to a laboratory for analysis.
• aphlebotomist an individual specially trained in drawing blood collects a sample of venous blood into a tube containing an anticoagulant to prevent the blood from clotting.
• the sample is then sent to a hematology laboratory to be processed, typically on automated, multiparameter analytical instruments, such as those manufactured by Beckman- Coulter Diagnostics of Miami, Florida.
• the CBC+Diff test results are returned to the requesting physician, typically on the next day.
• Invasive techniques pose particular problems for newborns because their circulatory system is not yet fully developed.
• Blood is typically drawn using a "heel stick" procedure wherein one or more punctures are made in the heel of the newborn, and blood is repeatedly squeezed out into a collecting tube.
• This procedure is traumatic even for an infant in good health. More importantly, this procedure poses the risk of having to do a blood transfusion because of the low total blood volume of the infant.
• the total blood volume of the newborn infant is 60-70 cc/kg body weight.
• the total blood volume of low birth weight infants (under 2500 grams) cared for in newborn intensive care units ranges from 45-175 cc.
• the demarcation between the physical findings of the patient and the laboratory findings are, in general, the result of technical limitations. For instance in the diagnosis of anemia, it is frequently necessary to quantify the hemoglobin concentration or the hematocrit in order to verify the observation of pallor. Pallor is the lack of the pink color of skin which frequently signals the absence or reduced concentration of the heavily red pigmented hemoglobin. However, there are some instances in which pallor may result from other causes, such as constriction of peripheral vessels, or being hidden by skin pigmentation. Because certain parts of the integument are less affected by these factors, clinicians have found that the pallor associated with anemia can more accurately be detected in the mucous membrane of the mouth, the co ⁇ junctivae, the lips, and the nail beds.
• a device which is able to rapidly and non-invasively quantitatively diagnose anemia directly from an examination of one or more of the foregoing areas would eliminate the need to draw a venous blood sample to ascertain anemia. Such a device would also eliminate the delay in waiting for the laboratory results in the evaluation of the patient. Such a device also has the advantage of added patient comfort.
• Soft tissue such as mucosal membranes or unpigmented skin, does not absorb light in the visible spectra and regions in the near-infrared. In particular, soft tissue does not absorb light in the spectral region where hemoglobin absorbs light. This allows vascularization to be differentiated by spectral absorption from surrounding soft tissue background.
• the surface of soft tissue strongly reflects light and the soft tissue itself effectively scatters light after penetration of only 100-500 microns. Therefore, in vivo visualization of the circulation is generally impractical because of the complexities involved in either finding suitable areas and/or compensating for multiple scattering and for specular reflection from the surface.
• the Winkelman device uses image analysis and reflectance spectrophotometry to measure individual cell parameters such as cell size and number. Measurements are taken only within small vessels, such as capillaries where individual cells can be visualized. Because the Winkelman device takes measurements only in capillaries, measurements made by the Winkelman device will not accurately reflect measurements for larger vessels.
• the Winkelman device is not capable of measuring the central or true hematocrit, or the total hemoglobin concentration.
• the Winkelman device measures the number of white blood cells relative to the number of red blood cells by counting individual cells as they flow through a micro-capillary.
• the Winkelman device depends upon accumulating a statistically reliable number of white blood cells in order to estimate the concentration.
• blood flowing through a micro-capillary will contain approximately 1000 red blood cells for every white cell, making this an impractical method.
• the Winkelman device does not provide any means by which platelets can be visualized and counted. Further, the Winkelman device does not provide any means by which the capillary plasma can be visualized, or the constituents of the capillary plasma quantified.
• the Winkelman device also does not provide a means by which abnormal constituents of blood, such as tumor cells, can be detected.
• the '120 patent and in commonly assigned U.S. Patent Application No.09/401,859, filed September 22, 1999 in the names of Christopher Cook and Mark M. Meyers, and entitled “Method and Apparatus for Providing High Contrast Imaging” (hereinafter referred to as “the '859 application”).
• the disclosure of the '120 patent and the '859 application is incorporated herein by reference as though set forth in its entirety.
• the devices of the ' 120 patent and the ' 859 application provide for complete non-invasive in vivo analysis of a vascular system.
• the devices of the '120 patent and the '859 application allow quantitative determinations to be made for blood cells, normal and abnormal contents of blood cells, as well as for normal and abnormal constituents of blood plasma.
• the devices of the '120 patent and the '859 application capture a raw reflected image of a blood sample, and normalize the image with respect to the background to form a corrected reflected image.
• An analysis image is segmented from the corrected reflected image to include a scene of interest for analysis.
• the method and apparatus disclosed in the '120 patent and the '859 application employ Beer's law to determine such characteristics as the hemoglobin concentration per unit volume of blood.
• the reflected images obtained with the devices of the '120 patent and the '859 application can also be useful in determining the number of white blood cells per unit volume of blood, a mean cell volume, the number of platelets per unit volume of blood, and the ratio of the cellular volume of blood to its total volume which is generally called the hematocrit.
• Beer's law to quantitatively measure components of a blood vessel in a spectral image requires the components to be uniformly distributed throughout the vessel. For instance, Beer's law can be used to determine the hemoglobin concentration from in vivo measurements of optical density at an isobestic wavelength of the hemoglobin absorption spectrum. However, this technique presupposes the blood vessel is uniformly filled with red blood cells. Since the measurements are taken from a spectral image, it is paramount that this image contains a representative sample of blood components, i.e. red blood cells.
• the spectral image would most likely not contain a representative sample of blood components. Moreover, the optical density measurements would fluctuate widely overtime and individual measurements would not accurately reflect the subject's true hemoglobin concentration.
• the size of the vessel diameter directly influences the distribution of blood components.
• red blood cells and hence the hemoglobin they contain, are uniformly distributed along and within the vessel. Therefore, a spectral image of a large blood vessel is prone to contain a representative sample of blood components, i.e. an average number of red blood cells. Beer's law, in this instance, can be used to produce an accurate measurement of hemoglobin concentration.
• the variation in the number of red blood cells is more prominent.
• a lesser number of red blood cells are able to pass side by side through the vessel, hi the smallest vessels, only a single stream of red blood cells is able to pass.
• the number of red blood cells in a spectral image is likely to vary significantly over both time and length along the vessel. As a result, it is difficult to get a representative image of the subject's blood vessel. Therefore, the optical density and hemoglobin measurements from Beer's law are limited by imprecision.
• the red blood cell count can be measured as an alternative to calculating the hemoglobin concentration. This can be accomplished by counting the number of red blood cells per unit length in ablood vessel. This technique is effective in the smallest vessels where only a single stream of red blood cells is able to pass.
• the present invention is directed to analyzing reflected spectral images of a microcirculatory system to measure the volume and concentration of a blood vessel, including arteries, veins and capillaries.
• the method and system of the present invention quantitatively analyzes a fluid stream having a non-uniform distribution of cellular components.
• the present invention can be used to evaluate the cellular concentration in an unfilled blood vessel.
• the method and system of the present invention measures the vessel diameter and optical density at various locations along the axis of the vessel.
• the coefficient of variation in the diameter and/or optical density measurements are used to estimate blood characteristics, such as the hematocrit.
• the method is used to perform in vivo analyses of blood in vessels from a spectral image.
• the method of the present invention can also be used to perform in vitro analyses by imaging blood in, for example, a narrow tube or flow cell.
• the method of the present invention can also be used to analyze other types of fluids containing visible suspended particles.
• the spectral imaging system canbe used to analyze fluids for particulate impurities. It is only necessary that the walls of the fluid path be sufficiently transparent to permit light to pass through to image the fluid and any impurities flowing in the path.
• a feature of the present invention is that it can be used to determine characteristics, such as the hematocrit through the use of reflected spectral imaging.
• Another feature of the present invention is that it can be used to determine blood characteristics in vessels having a non-uniform distribution of blood components.
• An advantage of the present invention is that it provides a means for the rapid, non-invasive measurement of clinically significant parameters of the CBC+Diff test. It advantageously provides immediate results. As such, it canbe used for point-of-care testing and diagnosis.
• a further advantage of the present invention is that it eliminates the invasive technique of drawing blood. This eliminates the pain and difficulty of drawing blood from newborns, children, elderly patients, burn patients, and patients in special care units.
• the present invention is also advantageous in that it mitigates the risk of exposure to ADDS, hepatitis, and other blood-borne diseases.
• a still further advantage of the present invention is that it provides for overall cost savings by eliminating sample transportation, handling, and disposal costs associated with conventional invasive techniques.
• a still further advantage of the present invention is that it provides for the measurement of the hematocrit without having to individually count the red blood cells. As such, the present invention can precisely determine the red blood cell count even if the individual red blood cells cannot be clearly imaged.
• FIG. 1 a shows a cross-sectional view of a medium blood vessel containing red blood cells
• FIG. lb shows a cross-sectional view of a small blood vessel containing red blood cells
• FIG. lc shows a cross-sectional view of a large blood vessel containing red blood cells
• FIG. 2 illustrates vessel diameter measurements being taken by an embodiment of the present invention
• FIG. 3 illustrates intensity measurements being taken by an embodiment of the present invention
• FIG. 4 shows a flow chart representing the general operational flow for measuring the hematocrit from the variation in diameter measurements according to an embodiment of the present invention
• FIG. 5 shows a flow chart representing the general operational flow for . measuring the hematocrit from variations in optical density measurements according to an embodiment of the present invention
• FIG. 6 compares hematocrit measurements according to the present invention versus in vitro hematocrit measurements; and FIG. 7 shows a block diagram of an example computer system useful for implementing the present invention.
• the present invention is directed to a method and system for performing quantitative analyses, particularly non-invasive, in vivo analyses of a subject's vascular system.
• the in vivo measurements discussed herein can also be performed in vitro by imaging blood in, for example, a tube or flow cell, as would be apparent to a person skilled in the relevant art(s).
• the images can be obtained from a spectral imaging apparatus preferably, but not necessarily, of the type described in the '120 patent or the '859 application. Nonetheless, the image can be obtained from any type of imaging apparatus designed to produce a contrast image of a suspension of particles in a vascular system in either transmitted or reflected light.
• the spectral imaging apparatus includes a light source that is used to illuminate the portion of the subj ect' s vascular system to be imaged.
• the reflected light is captured by an image capturing means.
• Suitable image capturing means include, but are not limited to, a camera, a film medium, a photocell, a photodiode, or a charge coupled device camera.
• An image correcting and analyzing means such as a computer, is coupled to the image capturing means for carrying out image correction, scene segmentation, and blood characteristic analysis.
• the in vivo method of the present invention is carried out by imaging a portion of the subject's vascular system.
• the image can be created from a sub-surface region of a subject's tissues or organs.
• the tissue covering the imaged portion is thus preferably transparent to light, and relatively thin, such as the mucosal membrane on the inside of the lip or the sclera of the eyeball of a human subject.
• light refers generally to electromagnetic radiation of any wavelength, including the infrared, visible, and ultraviolet portions of the spectrum.
• a particularly preferred portion of the spectrum is that portion where there is relative transparency of tissue due to absences of water abortion, such as in visible and near-infrared wavelengths.
• red blood cells erythrocytes
• white blood cells leukocytes
• platelets erythrocytes
• red blood cells contain hemoglobin that carries oxygen from the lungs to the tissues of the body.
• White blood cells are of approximately the same size as red blood cells, but do not contain hemoglobin. A normal healthy individual will have approximately
• CBC complete blood count
• Hb hemoglobin
• Hct red blood cell count
• RBC mean cell volume
• MHC mean cell hemoglobin concentration
• WBC white blood cell count
• Pit platelet count
• Hb is the hemoglobin concentration per unit volume of blood.
• Hct is the volume of cells per unit volume of blood. Hct can be expressed as a percentage, i.e.,:
• RBC is the number of red blood cells per unit volume of blood.
• WBC is the number of white blood cells per unit volume of blood.
• Pit is the number of platelets per unit volume of blood.
• Red blood cell indices (MCV, MCH, and MCHC) are cellular parameters that depict the volume, hemoglobin content, and hemoglobin concentration, respectively, of the average red blood cell.
• the red blood cell indices can be determined by making measurements on individual cells, and averaging the individual cell measurements. Red blood cells do not change volume or lose hemoglobin as they move through the vascular system. Therefore, red blood cell indices are constant throughout the circulation, and can be reliably measured in small vessels.
• the three red blood cell indices are related by the equation:
• values for the six RBC parameters listed above the following two criteria must be met. First, three of the parameters must be independently measured or determined. That is, three of the parameters must be measured or determined without reference to any other of the six parameters. Second, at least one of the three independently measured or determined parameters must be a concentration parameter (per unit volume of blood). Therefore, values for the six key parameters can be determined by making three independent measurements, at least one of which is a concentration measurement which cannot be made in a small vessel. As disclosed in the ' 120 patent or the '859 application, Hb and Hct can be directly measured by reflected spectral imaging of large vessels, while MCV and MCHC can be directly measured by reflected spectral imaging of small vessels. In this manner, three parameters are independently measured, and two of the parameters (Hb and Hct) are concentration parameters measured per unit volume of blood. As such, the six RBC parameters listed above can be determined in the following manner:
• Hb canbe directly measured by reflected spectral imaging of large vessels, and MCV and MCHC can be directly measured by reflected spectral imaging of small vessels.
• MCV and MCHC can be directly measured by reflected spectral imaging of small vessels.
• three parameters are independently measured, and one of the parameters (Hb) is a concentration parameter measured per unit volume of blood.
• the six RBC parameters listed above can be determined in the following manner:
• Hemoglobin is the main component of red blood cells. Hemoglobin is a protein that serves as a vehicle for the transportation of oxygen and carbon dioxide throughout the vascular system. Hemoglobin absorbs light at particular absorbing wavelengths, such as 550 nm, and does not absorb light at other non- absorbing wavelengths, such as 650 nm. Under Beer's law, the negative logarithm of the measured transmitted light intensity is linearly related to concentration. As explained more fully in the ' 120 patent or the ' 859 application, a spectral imaging apparatus can be configured so that reflected light intensity follows Beer's law.
• the concentration of hemoglobin in a particular sample of blood is linearly related to the negative logarithm of reflected light absorbed by hemoglobin.
• the more 550 nm light absorbed by a blood sample the lower the reflected light intensity at 550 nm, and the higher .the concentration of hemoglobin in that blood sample.
• the concentration of hemoglobin can be computed by taking the negative logarithm of the measured reflected light intensity at an absorbing wavelength such as 550 nm. Therefore, if the reflected light intensity from a particular sample of blood is measured, the concentration in the blood of such components as hemoglobin can be directly determined.
• the method and system of the present invention can be used to directly measure the hematocrit and can be used to quantitatively analyze a vascular system even if the measured components are not uniformly distributed.
• the present invention can be used to measure the hematocrit of a blood vessel that does not have a uniform distribution of red blood cells.
• Vessel 100 has a discrete number (N) of red blood cells.
• the hematocrit (Hct) of vessel 100 can be expressed as NV B ⁇ ( ⁇ /4)D 2 L, where V B is the mean volume of a red blood cell.
• the hematocrit for any region of vessel 100 can be expressed by the following probability function:
• ⁇ is a parameter that varies along the vessel length L at any given time, and also varies in time, at any given point along the vessel length L.
• the distribution of the variable ⁇ is best described by the poisson distribution wherein the variance is proportional to the square root of the variable. For instance, at any given time, a section of blood vessel 100 would have an average number of red blood cells measured by:
• N (Hct)( ⁇ /4)D 2 L ⁇ N B (Eqn. 4)
• the standard deviation of the mean N is proportional to the square root of N , and the coefficient of variation (CN.) canbe calculated as the standard deviation over the mean, or:
• the coefficient of the variation of N is a function of the Hct and the vessel diameter.
• This variation will be manifested as a variation in the optical density or the diameter along an image formed of the vessel. Alternatively, it will manifest as a variation in either the diameter or the optical density in a time series of images of any one point in the vessel.
• FIG. lb illustrates a typical small blood vessel of diameter D. Small blood vessels are those having a diameter less than 6 microns. The dimensions of the vessels in this range are comparable to the dimensions of the red blood cells (shown as diameter d).
• Red blood cell concentration can only be determined by counting red blood cells along the vessel.
• the high variation (e.g., 10-20%) indicates a non- uniform distribution of Hb and complicates the use of Beer's law to estimate the
• the vessel size is large enough to permit multiple streams of red blood cells which impair the use of spectrophotometry to determine precise measures of RBC by counting individual cells.
• vessels in this range can be as large as 2 to 15 red blood cells in diameter.
• the method and system of the present invention can be used to estimate the Hct from the coefficient of variation and vessel diameter.
• FIG. lc illustrates a typical large vessel of diameter D.
• D discrete measurements of reflective properties, andhence spectrophotometry (i.e.,
• Beer's law can be used to estimate the Hb.
• the high variation in the number of red blood cells imposes a profound effect on estimating Hb as a function of the optical density measured from a reflected spectral image.
• FIG. 2 illustrates a vessel's diameter being measured. As shown, "m" diameter measurements (202, 204, 206 and 208) are made along the axis of vessel 100.
• FIG. 3 illustrates a vessel's intensity being measured. As shown, "m” intensity measurements are made along the axis of vessel 100. The original light
• flowchart 400 represents the general operational flow of the present invention. More specifically, flowchart 400 shows an example of a control flow for measuring the hematocrit of a blood vessel.
• FIG. 4 begins at step 401.
• an image is retrieved from a memory source or image directory.
• the images can be obtained from an input file stored in a temporary or permanent memory location on a hard disk drive or removable storage device, such as a floppy diskette, magnetic tape, optical disks, or the like, as would be apparent to a person skilled in the relevant art(s).
• the input file also includes the subject number or other data used to identify the subject.
• the images can be obtained in real time from an imaging apparatus preferably, but not necessarily, of the type described in the ' 120 patent or the '859 application.
• step 410 multiple measurements are taken along the axis of the vessel to calculate the diameter at different segments.
• "m" diameter measurements (202, 204, 206 and 208) are made along the axis of vessel 100. As would be apparent to a person skilled in the relevant art(s), the number of measurements or segments should be sufficient to obtain an accurate measurement of the diameter.
• the diameter measurements are analyzed to determine the coefficient of variation.
• the fractional volume of a cellular component (e.g., red blood cell) is determined for the vessel.
• Two methods can be used to determine the fractional volume. Under the first method, the fractional volume of the cellular component is determined at each segment by taking the reciprocal of the product of the coefficient of variation and the diameter measurements for each segment. Under the second method, the fractional volume of the cellular component can be determined by taking the reciprocal of the product of the coefficient of variation and the average of the diameter measurements.
• the Hct is calculated from the mean fractional volume. If the first method is used to determine the fractional volume, the average of all the fractional volume measurements is calculated and used to estimate the Hct. If, however, the second method is used, the mean fractional volume calculated at step 420 would be used to estimate the Hct. After the Hct is calculated, the control flow of flowchart 400 ends as indicated by step 495.
• flowchart 500 represents the general operational flow of another embodiment of the present invention. More specifically, flowchart 500 shows an example of a control flow for using optical density to measure the hematocrit of a blood vessel.
• FIG. 5 begins at step 501.
• the control flow proceeds to step 405 through step 410 as discussed above with reference to FIG. 4.
• the vessel is illuminated at multiple sections along its axis to measure the original and attenuated light intensities.
• "m" intensity measurements are made along the axis of vessel 100.
• An intensity profile is created by computing the negative logarithm of the ratio of the measured attenuated light intensity and the original light intensity to produce the optical density.
• the number of measurements or segments should be sufficient to obtain an accurate measurement of the optical density.
• the optical density measurements are analyzed to determine the coefficient of variation.
• the fractional volume of the cellular component is determined at each segment by taking the reciprocal of the product of the coefficient of variation and the diameter measurements from each segment. As discussed in reference to FIG. 4, the fractional volume of the cellular component can also be determined at each segment by taking the reciprocal of the product of the coefficient of variation and the average of the diameter measurements.
• step 525 the average of all the fractional volume measurements is calculated to estimate the Hct. If, however, the second method is used to determine the fractional volume, the mean fractional volume determined at step 520 would be used to estimate the Hct.
• the control flow of flowchart 500 ends as indicated by step 595.
• FIG. 6 shows the results of a comparative study that implements the methods and systems of the present invention.
• in vitro measurements of blood samples were taken from nine subjects and used to determine their hematocrit.
• in vivo images from the eye i.e., sclera
• in vivo images from the eye i.e., sclera
• orthogonal polarization spectroscopy as described in the '120 patent or the ' 859 application.
• the results from the in vivo and in vitro measurements are shown in FIG. 6.
• the ordinate axis represents the hematocrit determined from the in vitro measurements
• the abscissa represents the hematocrit from the in vivo measurements.
• the slope for the hematocrit calculation is 0.91, which suggests that the in vivo measurements are close approximations for the in vitro measurements.
• the present invention was developed primarily to analyze blood components in a non-invasive manner.
• the invention has application outside the medical area and can be used generally to quantitatively analyze visualizable components in a fluid flowing in any vascular system, such as a tube, the walls of which are transparent to transmitted and reflected light.
• the present invention is most effective for analyzing vessels having diameters between 6 to 60 microns, which represents the most likely sized vessel to be detected with spectrophotometry.
• a preferred range is 15 to 50 microns where the coefficient of variation averages 10 to 20%.
• the present invention can be implemented using hardware, software or a combination thereof and can be implemented in one or more computer systems or other processing systems. In fact, in an embodiment, the invention is directed toward one or more computer systems capable of carrying out the functionality described herein.
• Computer system 700 includes one or more processors, such as processor 704.
• the processor 704 is connected to a communication infrastructure 706 (e.g., a communications bus, cross-over bar, or network).
• a communication infrastructure 706 e.g., a communications bus, cross-over bar, or network.
• Computer system 700 can include a display interface 702 that forwards graphics, text, and other data from the communication infrastructure 706 (or from a frame buffer not shown) for display on the display unit 730.
• Computer system 700 also includes a main memory 708, preferably random access memory (RAM), and can also include a secondary memory 710.
• main memory 708 preferably random access memory (RAM)
• secondary memory 710 preferably random access memory (RAM)
• the secondary memory 710 can include, for example, a hard disk drive 712 and/or a removable storage drive 714, representing a floppy disk drive, a magnetic tape drive, an optical disk drive, etc.
• the removable storage drive 714 reads from and/or writes to a removable storage unit 718 in a well-known manner.
• Removable storage unit 718 represents a floppy disk, magnetic tape, optical disk, etc. which is read by and written to removable storage drive 714.
• the removable storage unit 718 includes a computer usable storage medium having stored therein computer software and/or data.
• secondary memory 710 can include other similar means for allowing computer programs or other instructions to be loaded into computer system 700.
• Such means can include, for example, a removable storage unit 722 and an interface 720. Examples of such can include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as an EPROM, or PROM) and associated socket, and other removable storage units 722 and interfaces 720 which allow software and data to be transferred from the removable storage unit 722 to computer system 700.
• Computer system 700 can also include a communications interface 724.
• Communications interface 724 allows software and data to be transferred between computer system 700 and external devices. Examples of communications interface 724 can include a modem, a network interface (such as an Ethernet card), a communications port, a PCMCIA slot and card, etc.
• Software and data transferred via communications interface 724 are in the form of signals 728 which can be electronic, electromagnetic, optical or other signals capable of being received by communications interface 724. These signals 728 are provided to communications interface 724 via a communications path (i.e., channel) 726.
• This channel 726 carries signals 728 and can be implemented using wire or cable, fiber optics, a phone line, a cellular phone link, an RF link and other communications channels.
• computer program medium and “computer usable medium” are used to generally refer to media such as removable storage drive 714, a hard disk installed in hard disk drive' 712, and signals 728.
• These computer program products are means for providing software to computer system 700.
• the invention is directed to such computer program products.
• Computer programs also called computer control logic
• Computer programs are stored in main memory 708 and/or secondary memory 710.
• Computer programs can also be received via communications interface 724.
• Such computer programs when executed, enable the computer system 700 to perform the features of the present invention as discussed herein.
• the computer programs when executed, enable the processor 704 to perform the features of the present invention. Accordingly, such computer programs represent controllers of the computer system 700.
• the software can be stored in a computer program product and loaded into computer system 700 using removable storage drive 714, hard drive 712 or communications interface 724.
• the control logic when executed by the processor 704, causes the processor 704 to perform the functions of the invention as described herein.
• the invention is implemented primarily in hardware using, for example, hardware components such as application specific integrated circuits (ASICs).
• ASICs application specific integrated circuits
• the invention is implemented using a combination of both hardware and software.

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