Abstract:
An apparatus for monitoring the vital status of a biological material in which a pair of sensors are held in a housing for sensing separate respective stimulus of a biological material. A controller operatively communicates with the pair of sensors for receiving signals reflective of the respective stimulus measured by the sensors. An evaluator generates a status signal representative of the state of the biological material based on the signals, and a reporter displays the status signal, so that the vital status of the biological material can be monitored. A method of monitoring the vital status and adjusting delivery of a medicant is disclosed.

Description:
TECHNICAL FIELD 
     The present invention relates to apparatus and methods of evaluating the status of vital life activity of biological materials. More particularly, the present invention relates to apparatus and methods of evaluating and monitoring stimuli of vital life activity of biological materials for diagnosis, monitoring, and treatment. 
     BACKGROUND OF THE INVENTION 
     In studying the dynamics of changes in materials and substances made up of groups or systems that are comprised of numerous similar units, scientists have relied on measuring state variables of the groups. These state variable include pressure, volume, temperature, and internal energy of a group or system, and related to time and spatial relationships (position) of the units in the group. Another state variable known as entropy can be determined with the measured pressure and temperature state variables in combination with temporal relationship, but heretofore the entropy state variable has not been used in studying the vitality of biological material. 
     Entropy can be defined as the number of possible arrangements for the units in the group being studied relative to position and velocity of the units of the group. Because entropy is a state variable, entropy evaluations provides information in thermodynamics analysis useful to describe the groups, systems and processes being observed. Under identical conditions, a system or group always has the same entropy. 
     It is known by observation that living things, which by definition are continually changing and growing in a demonstrated cyclical fashion, have various degrees of health or vitality associated with their state. State variables, such as temperature and pressure, fluctuate relative to the vitality of the thing. The entropy of a living thing also fluctuates, because entropy essentially dictates the relationship between the temperature and the pressure of the group during a temporal period. Entropy in some way may therefore be considered as bridging between temperature and pressure. The changes in the arrangement of the units in the group and the other possible arrangements of the group (its entropy) produce the measurable temperature and pressure of the group. Entropy can be considered a bridge between the heat component (temperature) and the work component (pressure) of the total energy of the group. As noted above, under identical conditions a system or group has the same entropy. Accordingly, the vitality of a dynamic living group correlates to the entropy of the living group and changes in entropy correlate to changes in vitality of the living group. 
     Measuring the entropy and changes in entropy while the life processes progress provides information useful to a better understanding of the health and vitality of living things, because entropy measurements reflect the actual changes taking place in the living group, rather than the consequences of the changes. 
     Life functions are supported by various cycles of oxidation and reduction as described in the Krebs cycle. Life functions are maintained and reproduced through divisions of cells and chromosomes and replication of organized structures such as DNA and RNA as described in the Watson and Crick model. The nature of these cycles defines organized and repeated states at the cellular level. The proper progression of these processes requires organized groups. Because all processes have some degree of tolerance, significant fluctuations, as well as subtle differences, from normal or optimum organization or entropy in the living group can provide early indications of malfunctions. Heretofore, it has not been recognized that monitoring of the entropy or organization of the group can be used in diagnosis, prognosis and developing and monitoring therapies or treatments for living groups. 
     Nature has a preferred direction for the course of spontaneous events, which is described in the second law of thermodynamics. That is, when left alone, groups tend to seek the lowest state of energy and the highest state of disorder. In terms of entropy, the second law may be expressed—if an isolated system undergoes a change, the system will change in such a way that the entropy of the system will increase or at best, remain constant. This can be re-stated as—if a system is allowed to undergo spontaneous change, the system will change in such a way that its disorder will increase, or at best, not decrease. For example, a dead body decays and turns to dust; but the elements do not spontaneously reform the body in the reverse process. Life vitality is the property of plants and animals that allows them to take in food, get energy from it, grow, adapt themselves to their surroundings and reproduce themselves—in essence, build order or reduce entropy. Considered in light of the second law of thermodynamics, living materials behave differently then dead materials relative to entropy and yet heretofore, entropy has not been measured or evaluated in monitoring the vital status of living things. 
     Accordingly, there is a need in the art for an improved method and apparatus for monitoring and evaluating the vital status of biological materials for health monitoring, diagnosis, and treatment. It is to such that the present invention is directed. 
     BRIEF SUMMARY OF THE PRESENT INVENTION 
     The present invention meets the need in the art by providing an apparatus for monitoring a vital status indicator of a biological material, in which a temperature sensor senses periodically a temperature of a biological material to be monitored for determining an indicator of a vital status of the biological material, the temperature sensor adapted to create a first electrical signal representative of the sensed temperature, and a pressure sensor senses periodically a pressure of the biological material substantially contemporaneously with the sensing by the temperature sensor, the pressure sensor adapted to create a second electrical signal representative of the sensed pressure. A signal transmitting pathway transmits the first and second electrical signals to a signal receiver adapted to receive at least two of the first and second electrical signals for processing of the signals. An evaluator compares the difference in the two first electrical signals representative of temperatures sensed at a first time and a second time with the difference in the two second electrical signals representative of the pressures sensed, to determine the indicator of the vital status as a representative value indicative of the state of the biological material. A reporter communicates the indicator of the vital status of the biological material, for monitoring the vital status of the biological materially. 
     In another aspect, the present invention provides a method of diagnosing the vital status of a biological material, comprising the steps of: 
     (a) providing a temperature sensor for sensing periodically a temperature of a biological material to be monitored for determining an indicator of a vital status of the biological material, said temperature sensor adapted to create a first electrical signal representative of the sensed temperature; 
     (b) providing a pressure sensor for sensing periodically a pressure of the biological material and adapted to create a second electrical signal representative of the sensed pressure substantially contemporaneously with the sensing by the temperature sensor; 
     (c) communicating by a signal transmitting pathway said first and second electrical signals to a signal receiver adapted to receive at least two of said first and second electrical signals for processing of the signals; 
     (d) comparing the difference in the two first electrical signals representative of temperatures sensed at a first time and a second time with the difference in the two second electrical signals representative of the pressures sensed, to determine the indicator of the vital status as a representative value indicative of the state of the biological material; and 
     (e) reporting the indicator of the vital status of the biological material, whereby the vital status of the biological material can be monitored. 
     Objects, advantages and features of the present invention will become apparent from a reading of the following detailed description of the invention and claims in view of the appended drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 illustrates a perspective view of a back side of a measuring and display apparatus according to the present invention. 
     FIG. 2 illustrates a front view of the measuring and display apparatus shown in FIG.  1 . 
     FIG. 3 illustrates a schematic diagram of an entropy measuring and display apparatus according to the present invention. 
     FIG. 4 illustrates a schematic diagram of the entropy measuring and display apparatus shown in FIG. 3 used with an adjustable medicant delivery for treatment of a patient. 
     FIG. 5 illustrates a plan view of an entropy measuring sheet in accordance with the present invention. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In accordance with the present invention, entropy of a group under examination is measured and compared with standards as an indicator of the vital status of the group. The measuring of the entropy of biological materials provides a vital status indicator that can be used for diagnosis, prognosis, and monitoring and improving treatments and therapies. Accordingly, the present invention provides methods and apparatus of measuring the entropy of biological materials. The method according to the present invention makes basic assumptions and provides only a general measure of entropy. However, the measuring and monitoring of entropy allows an observer insight to the dynamics of the processes being observed rather then only considering the consequences of the processes. Stated another way, observing the relationships of the state variables of a group in a selected time frame rather than separately allows an observer to monitor the changes of the group moving toward equilibrium rather than just observing the group at an equilibrium. 
     It follows that an entropy measurements could be used in genetic engineering, biologic engineering, drug engineering and device engineering. By detecting consequences of treatments or therapies early, adjustments can be made to optimize the treatments or therapies to achieve the desired results. 
     Entropy evaluation is not only available for biological materials at the molecular or cellular levels, but also at organ, tissue, and system levels as well, because entropy provides a state variable relative to the changes in the group being observed. For example, blood is a group of similar cells that make up an organ of the body. The heart, the cardiovascular system, the liver, the kidney, the lungs, the brain, the skin, the bones, tissues, and essentially all organs and systems in the body are comprised of groups of similar cells that work together to form the living body. Each of these biological materials can be looked at independently or in combination with the other parts of the body. The appropriate measure of entropy depends on the groups or systems being studied. 
     There are at least two perspectives that derive utility from monitoring entropy. One perspective considers the normal or optimal entropy or entropy changes of a living thing, or a sub-set of it, at rest or during elevated activity. Deviations from a baseline indicate changes in the state of health of the living thing. This provides a diagnostic and prognostic tool that can be used to detect, correct and/or prevent unhealthy or sub-optimal conditions and to direct growth toward healthy or optimal conditions. The second perspective applies to intervention into the life process and the resulting consequences. The interventional action and the resulting response can be correlated and adjusted until the desired result is achieved. This perspective according to the present invention deals with the monitoring and adjustment of treatments or therapies. 
     One definition of entropy can be mathematically derived from the first and second laws of thermodynamics by making several assumption to simplify the equation. These assumptions are: 
     1. The “Heat” part of the total energy of a system or group is measured at constant volume. 
     2. The “Work” part of the total energy of the system or group is measured at constant entropy. 
     3. The volume of the group is equal to one. 
     In view of these assumptions and with the total energy of the system or group being constant, the entropy of a group is generally described as: 
     
       
         
           s=dP/dT 
         
       
     
     where: 
     s=entropy of the group 
     dP=change in pressure of the group or P t1 -P t2    
     dT=change in temperature of the group or T t1   14  T t2    
     t 1 =time at measurement  1   
     t 2 =time at measurement  2   
     Although these assumptions do not agree with the nature of living materials, it is appreciated that corrections and compensations can be factored as required to increase the accuracy of the measurements for living materials. These assumptions however are satisfactory within the context of the present invention. Pressure and temperature measurements of a group made simultaneously in real time permit evaluation of the approximate entropy of the group in real time, by repeating the measurements and calculation for each point in time. The determined entropy value, or vital status value, can be displayed on a display device as a running value or can be monitored for treatment of life activity. 
     The calculated unit of measure (entropy) provides more information than either temperature in time or pressure in time alone or independently from each other, because entropy considers the relationship between temperature and pressure and changes over time for the group. As is defined by the laws of thermodynamics, pressure and temperature of a group are different measures of components of the total energy of the group and are relative to the arrangement and possible arrangements of the group. Pressure and temperature are functions of the entropy and total energy of the group. 
     Referring now in more detail to the drawings in which like parts have like identifiers, FIG. 1 illustrates a back side of a measuring and display apparatus  10  according to the present invention. The apparatus  10  includes a housing  12  with a bottom side  14  from which a temperature sensor  16  and a pressure transducer  18  extend. The temperature sensor  16  and the pressure transducer  18  bear against a skin surface of person wearing the apparatus on a wrist. This is accomplished by providing a pair of bands  20 ,  22  which attach on opposing sides of the housing  12 . The bands  20 ,  22  have connectors at respective distal ends for wrapping around the wrist of the person using the apparatus  10  for measuring and displaying information about the person&#39;s health status. In the illustrated embodiment, the bands  20 ,  22  have respective patches  24 ,  26  of matingly engagable material such as Velcro brand hook-and-loop connector patches. 
     The temperature sensor  16  connects to a controller  30  that mounts within the housing  12 . The controller  30  receives a signal from the sensor  16  representative of the temperature of the skin surface in contact with the sensor. The controller  30  also receives a signal from the pressure transducer  18  representative of the pressure measured by the transducer bearing against the skin surface of the person wearing the apparatus  10 . The controller  30  connects to switches  32 ,  34 , and  36 . The switch  32  communicates a signal to the controller to start and stop the temperature and pressure monitoring by the apparatus  10 . The switch  34  communicates a signal to the controller  30  to set the baseline indicator for the person using temperature and pressure data collected over a predetermined interval. In the illustrated embodiment, the data is collected over a ten second interval after the switch  34  is actuated. The switch  36  is used to cyclically change a display of measured temperature, pressure, or computed indicia based on the measured temperature and pressure, as discussed below. 
     FIG. 2 is a front view of the apparatus  10  illustrating display features on a front face  40  of the apparatus. The front face  40  includes a plurality of status display lights  44 ,  46 , and  48 , for a purpose discussed below. A display screen  50  connects to the controller  30 . The display screen  50  includes a numeric display portion  52  and a text display portion  54 . 
     The apparatus  10  is used for example by a person exercising. The apparatus  10  is strapped onto the wrist portion of the exerciser with the bottom side  14  against the skin. The bands  20 ,  22  are joined together with the connectors  24 ,  26 . The temperature sensor  16  and the pressure transducer  18  press against the skin surface. Preferably, the pressure transducer  18  bears against a portion of the wrist having a blood vessel. The temperature sensor  16  communicates a signal representative of the temperature of the skin to the controller  30 . The pressure transducer  18  communicates a second signal representative of the sensed pressure to the controller  30 . These signals are evaluated by the controller for computing the entropy of the exerciser. The switch  32  is actuated to communicates a signal to the controller to start the temperature and pressure monitoring by the apparatus  10 . The controller  30  uses the temperature and pressure signals cooperatively with a clock to compute the changes in temperature and pressure over time. The computed changes in the temperature and pressure are then evaluated to compute the entropy measure. The display  50  displays in the numeric portion  52  either the temperature, the pressure, or the computed entropy measure, depending on the display selected using the switch  36 . The text display  54  provides a text message appropriate for the particular data being displayed on the numeric portion  52 . The switch  36  is selectively actuated to cycle through the displayable temperature, pressure, or entropy measure. At an appropriate time, the switch  34  is actuated, to set the computed entropy measure as a baseline value for the exerciser. 
     The controller  30  compares the baseline value with the computed entropy measure using the recent temperature and pressure signals. The baseline value is selectively the historical entropy of the measure system for the patient or the standard considered by health authorities as normal for persons or organs of similar characteristics, for example, age, weight, height, or gender. In the illustrated embodiment, one of the status display lights  44 ,  46 ,  48  is activated by the controller  30  to provide a visual indication of the computed entropy measure relative to the baseline value. In a preferred embodiment, the status display light  44  corresponds to a computed measure considered superior to the baseline value while the display light  48  corresponds to a computed measure considered as inferior to the baseline value. The display light  46  corresponds to a computed measure considered substantially equivalent to the baseline value. In a preferred embodiment, the particular display light  44 ,  46 , or  48  is determined by the computed entropy measure being within a predetermined range of the baseline value, for example, within 10 percent above or below the baseline. If the difference between the computed entropy measure and the baseline value exceeds 10 percent of the baseline value, then the light  44  is activated. If the difference between the computed entropy measure and the baseline value is less than 10 percent of the baseline value, then the light  48  is activated. In the illustrated embodiment, the display lights  44 ,  46 ,  48  are disposed in a line which from the exerciser&#39;s view approximates a vertical line, to provide a further visual display of the computed entropy value relative to the baseline value. In another embodiment, the lights  44  and  46  are green while the light  48  is amber. 
     FIG. 3 illustrates a schematic diagram of a device  70  for measuring and monitoring the entropy state of a biologically active organ according to the present invention. The device  70  provides a catheter  72  connected by multi wire line  74  to a controller  76 . The catheter  72  includes a temperature sensor  78 , such as a thermistor, and a pressure transducer  80 . These are conventionally disposed within lumens, or pathways, of the catheter  72  and communicate signals representative of the detected stimulus. The catheter  72  provides a probe for positioning the sensors in a biological material. In an alternate embodiment, the detecting sensors  78 ,  80  are disposed in a needle for positioning near an organ or biological material for observation of stimuli. 
     The signals from the temperature sensor  78  and the pressure sensor  80  communicate by the line  74  to the controller  76 . The controller  76  includes a display device  82  for displaying selectively the particular measured stimulus  84 , together with a baseline value  86 . Switches  88  enable selective display of the measured temperature, pressure, and/or computed entropy of the measured biological material. The controller  76  further provides a data storage device  90  that includes baseline values for comparing the measured states. These baseline values include measured values of these state variables for the particular biological material (or patient) being monitored, as well as baseline values for biological materials of similar age, weight, height, gender, and baseline values for normative comparisons. In an alternate embodiment, a pair of the catheters  72  are provided for use in monitoring an organ based on changes upstream and downstream of fluid flow to the organ. 
     FIG. 4 illustrates a schematic diagram of the entropy measuring and display apparatus  70  shown in FIG. 3 used with an adjustable medicant delivery device  96  for treatment of a patient  97 . The medicant delivery device  96  has a supply  98  of a medicant for communication to the patient  97  at a selected rate. The controller  76  communicates a control signal to a rate controller  100 , such as a variable valve, of the medicant delivery device  96 . The control signal directs the rate controller  100  to modify the delivery of the medicant based on the measured entropy of the patient. Thereby the medicant flow is increased, decreased, or left unchanged in response to measuring and evaluating the entropy of the biological material under examination. In the practice of the present invention, the measurements are preferably made at one-tenth second intervals over a one-second period. For example, measurements can be made during successive beats of the heart of the patient. The present invention enables observation of the changes in the state of the patient during a heart beat, rather than the resulting steady-state value, which is useful for diagnosis and treatment. 
     For example, the liver performs a blood filtering function for living animals. As illustrated in FIG. 4, a pair of the catheters  72  are positioned in appropriate arterial and vascular blood vessels that supply and remove blood from the liver, The catheters  72  monitor and report the state variables of the incoming blood and the filtered blood. The determined entropy is displayed on the display  82 . The controller  76  compares the entropy with baseline values. Based on these comparisons, the rate controller  100  is changed to adjust the flow of the medicant from the supply  98  to the patient  97 . Comparing the entropy of the blood both before and after the filtration by the liver may provide useful information as to the health and vitality of the liver and the blood after passing through the liver of the patient being examined. As noted above, the entropy measurements are readily compared with measurements stored on a database. In a preferred embodiment, the entropy measurements are selectively compared with normal values for healthy persons (for example, selection based on common age, weight, height, or ranges of such, state of health, and/or gender) or previous measurements for the particular patient. In this manner, the vital status of the patient&#39;s liver (or other organ or system under evaluation) can be evaluated in terms of norms for all persons or for the particular patient. Diagnoses and treatment improvements are thereby provided by the present invention. 
     FIG. 5 illustrates in plan view an entropy measuring sheet  110  in accordance with the present invention. The sheet  110  includes at least one pair  112  of sensors  114 ,  116  for detecting temperature and pressure stimuli respectively. In the illustrated embodiment, the sheet  110  includes a plurality of pairs  112  of the sensors  114 ,  116 . Each pair  112  communicate via paired wire lines  118  in a web  120  to appropriate inputs to the controller  72 . The controller  72  determines the vital status of the biological material across the sheet and displays determined values on the screen  82 . For example, the sheet  110  can be placed over a wound, in order to track the progress of healing and to modify treatments. 
     It is thus seen that apparatus and methods of computing and evaluating biological activity is provided. While this invention has been described in detail with particular reference to the preferred embodiments thereof, the principles and modes of operation of the present invention have been described in the foregoing specification. The invention is not to be construed as limited to the particular forms disclosed because these are regarded as illustrative rather than restrictive. Moreover, modifications, variations and changes may be made by those skilled in the art without departure from the spirit and scope of the invention as described by the following claims.