Apparatus and method for monitoring the vital status of...

Surgery – Diagnostic testing

Reexamination Certificate

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Reexamination Certificate

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06409663

ABSTRACT:

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 m

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