Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
2001-05-13
2003-06-03
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Cardiovascular
C600S300000, C600S301000, C600S508000, C600S544000, C128S920000
Reexamination Certificate
active
06572558
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to non-invasive and/or indirect determination of a person's current functional state and state of homeostasis. The present invention also monitors adaptive response to a stress.
BACKGROUND OF THE INVENTION
The human body is constantly being stressed (
The Stress of Life
, Hans Selye, M D, McGraw Hill, rev. ed., (1978)). Positive adaptation to stress can lead to an improved physical state (e.g., athletic training), while a breakdown in adaptation can result in the onset of significant medical conditions (e.g., heart attack, etc.).
Monitoring changes in a person's functional state and state of homeostasis provides an understanding of that person's adaptation to stress. In order to see changes in a person's functional state and state of homeostasis, testing must be done on a frequent basis and must include test of the major systems in the human body. These include the systems that regulate cardiac activity, energy metabolism, the central nervous system, the gas exchange and cardio-pulmonary (circulatory) system, the detoxification system and the homonal (adrenal) system.
Various invasive and non-invasive tests are known for assessing the functional state of a person. Invasive tests include blood tests and biopsies, etc., that damage tissue in carrying out the test. Disadvantages of invasive tests include pain, tissue damage, risk of infection and inability to perform the test with high frequency (due to the associated tissue damage). Invasive tests also tend to be relatively expensive and often require a visit to a medical facility (as opposed to home or field use).
Pseudo-invasive tests include tests that are not literally invasive, but which cannot be repeated with high regularity due to deleterious effects on the body. Examples include X-rays (excess radiation) and VO2 maximum treadmill tests which require a person to run to exhaustion (this may be difficult or impossible for person in a weakened physical state to perform regularly). With the exception of direct tissue damage, pseudo-invasive tests tend to suffer from the same disadvantages listed above for invasive tests.
In contrast to invasive tests, non-invasive tests tend to have much lower incidence of tissue damage or the like and, therefore, they can be practiced with higher frequency. Examples include temperature and blood pressure testing. While non-invasive tests are beneficial in that they can be practiced more regularly and tend to be less expensive, they are also disadvantageous in that they tend to provide a limited, direct measurement of a physical condition parameter. For example, a blood pressure reading simply states the current blood pressure, but does not provide information on what body system or systems are functioning improperly and causing the blood pressure to be high or low.
In order to better assess a person's health and adaptive response, it is desirable and part of the present invention to obtain and generate more information about that person's current functional state. This can be done in part by making indirect assessment of a person's health based on directly measured parameters. It can also be done by testing a greater number of body systems and/or strategically selecting or designing tests that provide comprehensive assessment data from a small number of tests.
While the present invention (as discussed in more detail below) provides a patentably distinct testing apparatus and method, prior art techniques for indirectly assessing functional state are known. For example, it is known to calculate VO2 maximum from heart rate response in a step test or from a differential ECG.
While some non-invasive, indirect tests and testing procedures are known in the art, prior teachings in this area are disadvantageous in that they fail to recognize that specific combinations of tests can provide more comprehensive, efficient and inexpensive assessment of current functional state and/or adaptive response. As a result, the prior art fails to address the problems discussed in the initial paragraphs above, amongst other problems.
A need thus exists for an apparatus and a method that provide a combination of non-invasive tests that more comprehensively, efficiently and inexpensively assess a person's current functional state and their state of homeostasis. A need also exists for an apparatus and a method that permit frequent testing due at least in part to non-invasive and non-stressful testing practices.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide comprehensive, efficient and inexpensive assessment of a person's current functional state. This may include their adaptive response to a stress and/or potential for physical work.
It is another object of the present invention to provide this assessment in a non-invasive manner.
It is another object of the present invention to develop indirectly determined parameters or conclusions from non-invasively measured data.
It is another object of the present invention to provide or perform specific combinations of non-invasive tests to facilitate targeted assessment of functional state.
It is also an object of the present invention to provide this assessment in a manner that permits frequent testing.
These and related objects of the present invention are achieved by use of an apparatus and method of non-invasive measurement of current functional state and adaptive response in humans as described herein.
In one embodiment, the present invention includes a sensed data receiving circuit or logic and processing logic coupled thereto. The processing logic preferably conducts at least two body system functional state tests from the group of tests including: heart rate variability, differential ECG, brain wave, jump and stimulus response tests. The processing logic preferably processes received sensed data and generated signals representative of a textual conclusion of the functional state of a body system that corresponds to a given text.
In another embodiment, the present invention includes processing logic that monitors both cardiac activity and brain wave activity in assessing the functional state of one or more body systems.
In another embodiment, the present invention includes processing logic that uses rules-based analysis to interpret sensed data, and may further utilize the rules-bases analysis to generate textual or graphical conclusions of functional state.
Processing logic with the present invention may generate indices from sensed data and then interpret one or more indices to generate a particular conclusion regarding the functional state of a corresponding body system.
The present invention includes both apparatus and method embodiments of carrying out these, related and other features.
The attainment of the foregoing and related advantages and features of the invention should be more readily apparent to those skilled in the art, after review of the following more detailed description of the invention taken together with the drawings.
REFERENCES:
patent: 5771897 (1998-06-01), Zufrin
patent: 5941820 (1999-08-01), Zimmerman
Larionov Vladimir Borisovich
Masakov Leonid Vasilyevich
Adamson Steven J.
Hindenburg Max F.
Natnithithadha N.
OmegaWave, LLC
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