U.S. patent application number 13/673056 was filed with the patent office on 2013-03-14 for system and method for analyzing a biological sample.
The applicant listed for this patent is David Baltimore. Invention is credited to David Baltimore.
Application Number | 20130065316 13/673056 |
Document ID | / |
Family ID | 47148015 |
Filed Date | 2013-03-14 |
United States Patent
Application |
20130065316 |
Kind Code |
A1 |
Baltimore; David |
March 14, 2013 |
System and Method for Analyzing a Biological Sample
Abstract
A system and method for analyzing a biological substance, the
device comprising: a specimen input device; at least one pumping
device in flow communication with a chemical reservoir and said
specimen input device; and at least one flow cell in flow
communication with said at least one pumping device via at least
one flow valve, wherein said at least one flow cell is configured
to contain said specimen and includes a sensing device configured
to sense at least one characteristic of said specimen.
Inventors: |
Baltimore; David; (Newtown,
CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Baltimore; David |
Newtown |
CT |
US |
|
|
Family ID: |
47148015 |
Appl. No.: |
13/673056 |
Filed: |
November 9, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12589234 |
Oct 20, 2009 |
8313643 |
|
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13673056 |
|
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61196659 |
Oct 20, 2008 |
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Current U.S.
Class: |
436/43 ;
422/81 |
Current CPC
Class: |
Y10T 436/11 20150115;
G01N 33/487 20130101 |
Class at
Publication: |
436/43 ;
422/81 |
International
Class: |
G01N 35/00 20060101
G01N035/00 |
Claims
1. A method for analyzing a biological specimen from a human
subject using an analyzing device, wherein the analyzing device
includes a specimen input device, at least one pumping device in
flow communication with a chemical reservoir and a specimen input
device and at least one flow cell in flow communication with the at
least one pumping device via at least one flow valve, wherein the
at least one flow cell is configured to contain the specimen and at
least one sensing device which includes at least one of a pH
sensing device, an oxidation sensing device, a conductivity sensing
device, an ammonium and nitrate sensing device and a refractometer
sensing device configured to sense characteristics of the specimen
responsive to the pH, oxidation, conductivity, ammonium content,
nitrate content and refractometry of the specimen, the method
comprising: introducing the biological specimen into the specimen
input device; operating the analyzing device to cause the
biological specimen within the specimen input device to flow to the
flow cell, such that the biological specimen is contained within a
flow cell cavity; sensing at least one characteristic of the
biological specimen contained within the flow cell cavity, wherein
the characteristic includes at least one of the pH, oxidation,
conductivity, ammonium content, nitrate content and refractometry
of the biological specimen; flushing the specimen contained with
the flow cell cavity into a waste container after sensing the at
least one characteristic; and cleaning the analyzing device by
causing a cleaning fluid to flow through the analyzing device into
the waste container.
2. The method of claim 1, further including, calibrating the
analyzing device.
3. The method of claim 2, wherein said calibrating includes
calibrating at least one of the pH sensing device, the oxidation
sensing device, the conductivity sensing device, the ammonium and
nitrate sensing device and the refractometer sensing device.
4. The method of claim 3, wherein said calibrating includes
introducing a plurality of predetermined solutions into the
analyzing device such that each of said plurality of predetermined
solutions flows through the analyzing device to contact the at
least one sensing device.
5. The method of claim 4, wherein the plurality of predetermined
solutions are introduced into the analyzing device and are
responsive to the at least one sensing device.
6. The method of claim 1, wherein at least one of said introducing,
operating, sensing, flushing and cleaning are controlled via a
processing device, wherein the processing device is communicated
with at least one of the chemical reservoir, the pumping device,
the flow valve and the flow cell.
7. The method of claim 1, wherein said cleaning includes cleaning
the analyzing device at least one of before or after each use.
8. The method of claim 1, wherein at least one of the specimen
input device, the pumping device, the chemical reservoir, the flow
valve and the sensing device is controllably configurable via a
processing device.
9. A computer-readable storage medium encoded with machine-readable
computer program code, the program code including instructions for
causing a controller to implement at least a portion of a method
for analyzing a biological sample from a human subject using an
analyzing device, wherein the analyzing device includes a specimen
input device, at least one pumping device in flow communication
with a chemical reservoir and a specimen input device and at least
one flow cell in flow communication with the at least one pumping
device via at least one flow valve, wherein the at least one flow
cell is configured to contain the specimen and at least one sensing
device which includes at least one of a pH sensing device, an
oxidation sensing device, a conductivity sensing device, an
ammonium and nitrate sensing device and a refractometer sensing
device configured to sense characteristics of the specimen
responsive to the pH, oxidation, conductivity, ammonium content,
nitrate content and refractometry of the specimen, the method
comprising: introducing the biological specimen into the specimen
input device; operating the analyzing device to cause the
biological specimen within the specimen input device to flow to the
flow cell, such that the biological specimen is contained within a
flow cell cavity; sensing at least one characteristic of the
biological specimen contained within the flow cell cavity, wherein
the characteristic includes at least one of the pH, oxidation,
conductivity, ammonium content, nitrate content and refractometry
of the biological specimen; flushing the specimen contained with
the flow cell cavity into a waste container after sensing the at
least one characteristic; and cleaning the analyzing device by
causing a cleaning fluid to flow through the analyzing device into
the waste container.
10. The machine-readable computer program code of claim 9, wherein
the machine-readable computer program code is at least partially
encoded onto a tangible medium, wherein the tangible medium
includes at least one of an optical medium and a magnetic
medium.
11. The machine-readable computer program code of claim 9, wherein
the method further includes, calibrating the analyzing device.
12. The machine-readable computer program code of claim 11, wherein
said calibrating includes calibrating at least one of the pH
sensing device, the oxidation sensing device, the conductivity
sensing device, the ammonium and nitrate sensing device and the
refractometer sensing device.
13. The machine-readable computer program code of claim 12, wherein
said calibrating includes introducing a plurality of predetermined
solutions into the analyzing device such that each of said
plurality of predetermined solutions flows through the analyzing
device to contact the at least one sensing device.
14. The machine-readable computer program code of claim 13, wherein
the plurality of predetermined solutions are introduced into the
analyzing device and are responsive to the at least one sensing
device.
15. The machine-readable computer program code of claim 9, wherein
at least one of said introducing, operating, sensing, flushing and
cleaning are controlled via a processing device, wherein the
processing device is communicated with at least one of the chemical
reservoir, the pumping device, the flow valve and the flow
cell.
16. The machine-readable computer program code of claim 9, wherein
said cleaning includes cleaning the analyzing device at least one
of before or after each use.
17. The machine-readable computer program code of claim 9, wherein
at least one of the specimen input device, the pumping device, the
chemical reservoir, the flow valve and the sensing device is
controllably configurable via a processing device.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation (divisional) application
of U.S. patent application Ser. No. 12/589,234 filed Oct. 20, 2009
and claims the benefit of priority to U.S. Provisional Patent
Application No. 61/196,659, filed Oct. 20, 2008 and U.S. patent
application Ser. No. 12/589,234, the contents of both of which are
incorporated herein by reference in their entireties.
FIELD OF THE INVENTION
[0002] This invention relates generally to analyzing a biological
sample and more particularly to a system and method for analyzing a
Bio-Cellular sample.
BACKGROUND OF THE INVENTION
[0003] Bio-Cellular analysis is well known and is used in the
health/nutrition industry to examine key health indicators that can
provide an in-depth view into the overall health of a person or
animal. Some of these indicators include pH levels, ORP
(oxidation-reduction potential) and conductivity/resistivity of
bodily fluids (e.g. Saliva, Urine), as well as Nitrate Nitrogen
(Urine), Ammonium Nitrogen (Urine) and refractometry (Urine). Since
the ultimate goal of preventive medicine is to optimize
homeostasis, Bio-Cellular analysis serves as a sensitive and
invaluable way to monitor the optimization progress. Analysis of
these key health indicators can help the health care professional
assess the condition of the patient and determine/address any
underlying causes of any health issues that may be present. For
example, based upon the results of the Bio-Cellular analysis, the
health care professional may make recommendations or changes to a
patient's therapy in order to address imbalances that may have
shown up in their Bio-Cellular Analysis test. Another example would
be that this information can be used to recommend lifestyle and
nutrition changes which would help the patient restore and maintain
the vitality of the body. This may be accomplished with the use of
nutritional supplements, as well as attention to lifestyle changes,
diet, the amount of exercise the patient is getting, proper
breathing, and the stress in their life. All of these things
greatly affect the terrain of the body, and its ability to keep
homeostasis.
[0004] Once the results of the Bio-Cellular analysis have been
obtained, they are typically compared with a set of guideline or
optimum values that are used to determine which indicators are
unstable. This will guide the health care professional in his/her
recommendations. For example, consider the pH (Potential of
Hydrogen) level of a bodily fluid. The pH level is a measurement of
the acidity or alkalinity of a solution or bodily fluid, which is
dependent upon the number of hydrogen ions present in the solution
or bodily fluid (acidic solutions typically have an acidity level
between 0 and 6.99, while alkaline solutions typically have an
alkalinity between 7.01 and 14.00). Solutions which measure at
7.00, water for example, are considered to be neither acidic nor
alkaline and are thus neutral. For venous blood, the pH level is
reflective of three factors: 1) respiratory rate; 2) tissue oxygen
absorption; and 3) how effective the tissue is using the oxygen to
generate energy as well as maintaining good bone density and enzyme
and hormone utilization. Respiratory rate is affected because
chronic stress combined with improper breathing results in chronic
respiratory alkalosis. When tissue oxygen absorption is poor, a
higher percentage of oxygen remains in the venous blood resulting
in an increase of the pH level of the venous blood. And when tissue
is not effectively using oxygen to generate energy, the production
of carbon dioxide decreases which lowers the hydrogen concentration
in the blood thus raising the pH level of the venous blood.
[0005] Unfortunately, current methods for isolating and analyzing
these indicators involves conducting multiple individual tests on
several fluid samples, resulting in an inefficient process which is
both time consuming and expensive. Current methods and systems do
not use a synergistic approach to measure and evaluate across the
markers to a new conclusion of therapy.
SUMMARY OF THE INVENTION
[0006] A system for analyzing a biological substance, the device
comprising: a specimen input device; at least one pumping device in
flow communication with a chemical reservoir and said specimen
input device; and at least one flow cell in flow communication with
said at least one pumping device via at least one flow valve,
wherein said at least one flow cell is configured to contain said
specimen and includes a sensing device configured to sense at least
one characteristic of said specimen.
[0007] A method for analyzing a biological sample using an
analyzing device, wherein the analyzing device includes a specimen
input device, at least one pumping device in flow communication
with a chemical reservoir and a specimen input device and at least
one flow cell in flow communication with the at least one pumping
device via at least one flow valve, wherein the at least one flow
cell is configured to contain the specimen and includes a sensing
device configured to sense at least one characteristic of the
specimen, the method comprising: introducing a specimen to be
analyzed into the specimen input device; operating the analyzing
device to cause the specimen within the specimen input device to
flow to the flow cell, such that the specimen is contained within a
flow cell cavity; sensing at least one characteristic of the
specimen contained within the flow cell cavity; flushing the
specimen contained with the flow cell cavity into a waste
container; and cleaning the analyzing device by causing a cleaning
fluid to flow through the analyzing device into the waste
container.
[0008] A computer-readable storage medium encoded with
machine-readable computer program code, the program code including
instructions for causing a controller to implement a method for
analyzing a biological sample using an analyzing device, wherein
the analyzing device includes a specimen input device, at least one
pumping device in flow communication with a chemical reservoir and
a specimen input device and at least one flow cell in flow
communication with the at least one pumping device via at least one
flow valve, wherein the at least one flow cell is configured to
contain the specimen and includes a sensing device configured to
sense at least one characteristic of the specimen, the method
comprising: introducing a specimen to be analyzed into the specimen
input device; operating the analyzing device to cause the specimen
within the specimen input device to flow to the flow cell, such
that the specimen is contained within a flow cell cavity; sensing
at least one characteristic of the specimen contained within the
flow cell cavity; flushing the specimen contained with the flow
cell cavity into a waste container; and cleaning the analyzing
device by causing a cleaning fluid to flow through the analyzing
device into the waste container.
[0009] A method for analyzing a biological specimen from a human
subject using an analyzing device is provided, wherein the
analyzing device includes a specimen input device, at least one
pumping device in flow communication with a chemical reservoir and
a specimen input device and at least one flow cell in flow
communication with the at least one pumping device via at least one
flow valve. The at least one flow cell is configured to contain the
specimen and at least one sensing device which includes at least
one of a pH sensing device, an oxidation sensing device, a
conductivity sensing device, an ammonium and nitrate sensing device
and a refractometer sensing device configured to sense
characteristics of the specimen responsive to the pH, oxidation,
conductivity, ammonium content, nitrate content and refractometry
of the specimen. The method includes introducing the biological
specimen into the specimen input device, operating the analyzing
device to cause the biological specimen within the specimen input
device to flow to the flow cell, such that the biological specimen
is contained within a flow cell cavity, sensing at least one
characteristic of the biological specimen contained within the flow
cell cavity, wherein the characteristic includes at least one of
the pH, oxidation, conductivity, ammonium content, nitrate content
and refractometry of the biological specimen, flushing the specimen
contained with the flow cell cavity into a waste container after
sensing the at least one characteristic and cleaning the analyzing
device by causing a cleaning fluid to flow through the analyzing
device into the waste container.
[0010] A computer-readable storage medium encoded with
machine-readable computer program code is provided, wherein the
program code includes instructions for causing a controller to
implement at least a portion of a method for analyzing a biological
sample from a human subject using an analyzing device, wherein the
analyzing device includes a specimen input device, at least one
pumping device in flow communication with a chemical reservoir and
a specimen input device and at least one flow cell in flow
communication with the at least one pumping device via at least one
flow valve. The at least one flow cell is configured to contain the
specimen and at least one sensing device which includes at least
one of a pH sensing device, an oxidation sensing device, a
conductivity sensing device, an ammonium and nitrate sensing device
and a refractometer sensing device configured to sense
characteristics of the specimen responsive to the pH, oxidation,
conductivity, ammonium content, nitrate content and refractometry
of the specimen. The method includes introducing the biological
specimen into the specimen input device, operating the analyzing
device to cause the biological specimen within the specimen input
device to flow to the flow cell, such that the biological specimen
is contained within a flow cell cavity, sensing at least one
characteristic of the biological specimen contained within the flow
cell cavity, wherein the characteristic includes at least one of
the pH, oxidation, conductivity, ammonium content, nitrate content
and refractometry of the biological specimen, flushing the specimen
contained with the flow cell cavity into a waste container after
sensing the at least one characteristic and cleaning the analyzing
device by causing a cleaning fluid to flow through the analyzing
device into the waste container.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The foregoing and other features and advantages of the
present invention will be more fully understood from the following
detailed description of illustrative embodiments, taken in
conjunction with the accompanying drawings in which like elements
are numbered alike:
[0012] FIG. 1 is schematic block diagram of a system for analyzing
a biological sample in accordance with the present invention.
[0013] FIG. 2 is a block diagram illustrating a method for
implementing the system of FIG. 1, in accordance with the present
invention.
[0014] FIG. 3 is a schematic block diagram of the system in FIG. 1
illustrating one embodiment of an operational flow of specimen
through the system.
[0015] FIG. 4 is a schematic block diagram of the system in FIG. 1
illustrating one embodiment of an operational flow of specimen
through the system.
[0016] FIG. 5 is a schematic block diagram of the system in FIG. 1
illustrating one embodiment of an operational flow of specimen
through the system.
[0017] FIG. 6 is a schematic block diagram of the system in FIG. 1
illustrating one embodiment of an operational flow of specimen
through the system.
[0018] FIG. 7 is a schematic block diagram of the system in FIG. 1
illustrating one embodiment of an operational flow of specimen
through the system.
[0019] FIG. 8 is block diagram illustrating one embodiment of how
to determine acid/alkaline balance or buffer depletion in
accordance with the present invention.
[0020] FIG. 9 is a block diagram illustrating one embodiment of how
to determine oxidative stress in accordance with the present
invention.
[0021] FIG. 10 is block diagram illustrating one embodiment of how
to evaluate electrolytes in accordance with the present
invention.
[0022] FIG. 11 is a block diagram illustrating one embodiment of
how to measure carbohydrate metabolism in accordance with the
present invention.
[0023] FIG. 12 is a block diagram illustrating how protein intake
may be measured of the ION Nitrate Nitrogen and the protein
metabolism in accordance with the present invention.
[0024] FIG. 13 is a block diagram illustrating how protein intake
may be measured of the ION Nitrate Nitrogen and the protein
metabolism in accordance with the present invention.
[0025] FIG. 14 is a block diagram illustrating one embodiment of
how cell respiration is determined in accordance with the
invention.
[0026] FIG. 15 is a block diagram illustrating one embodiment of
how hydration is determined in accordance with the invention.
[0027] FIG. 16 is a block diagram illustrating one embodiment of
how to determine liver stress/toxicity in accordance with the
invention.
[0028] FIG. 17 is a block diagram illustrating one embodiment of
how to determine kidney stress in accordance with the
invention.
[0029] FIG. 18 is a block diagram illustrating one embodiment of
how to determine adrenal stress in accordance with the
invention.
[0030] FIG. 19 is a block diagram illustrating one embodiment of
how to determine anabolic/catabolic values in accordance with the
invention.
[0031] FIG. 20 is a block diagram illustrating one embodiment of
how to determine inflammation in accordance with the invention.
[0032] FIG. 21 is a general block diagram illustrating one
embodiment of pH calibration in accordance with the invention.
[0033] FIG. 22 is a general block diagram illustrating one
embodiment of Redox calibration in accordance with the
invention.
[0034] FIG. 23 is a general block diagram illustrating one
embodiment of Conductivity/Resistivity calibration in accordance
with the invention.
[0035] FIG. 24 is a general block diagram illustrating one
embodiment of ION calibration in accordance with the invention.
[0036] FIG. 25 is a general block diagram illustrating one
embodiment of Refractometer calibration in accordance with the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0037] In accordance with the present invention, an analyzer is
disclosed which measures several characteristics of a sample, such
as blood, urine, saliva, etc. These characteristics include, but
are not limited to, ions (such as pH (percentage of hydrogen),
Nitrate Nitrogen, Ammonium Nitrogen, Chloride, Nitrite, Iodide),
Redox (oxidation/reduction potential), conductivity/resistivity,
refractometry and surface tension. It should be appreciated that
when combined, the tests performed add up to a powerful diagnostic
instrument capable of looking at the metabolic efficiency of the
whole human body at a cellular level. One analogy is that of a car
dynamometer or tune up meter which measures Spark, Oxygen, Fuel,
Torque and Exhaust. By themselves each only gives part of the
picture on a pass/fail basis. However, when combined the dynamic
opens up the efficiency of the engine itself and opens up a method
of tuning the engine to the highest order of efficiency. Each value
is related to the overall power/performance of the engine, the
overall input of fuel, air and spark to the cleanness of the
exhaust and greatest power and speed to the wheels. The same
concept can be applied to "tuning" a human being at a cellular
level. The smallest common denominator in the body is the cell. The
human body is made up of organs, each with having its own set of
functions, but common to all organs is the cell. If you think of
the cell as the engine of the body, we are looking at the factors
that affect the performance of the body at a cellular level. The
invention measures various inputs and outputs of the body. When
triangulated and optimized, the core physiologic health is
optimized. As with automotive measurements, each measurement alone
is only a pass/fail measurement, but when combined into a cohesive
analysis, the overall, "wellness", performance and vitality of the
person can be optimized to a fine degree. In essence, the invention
is a unique and synergistic approach at examining multiple
parameters providing a cumulative measurement across the
parameters.
[0038] Referring to FIG. 1, a schematic block diagram illustrating
a system 100 for analyzing at least one biological sample is shown,
in accordance with the present invention. The system 100 includes a
processing device 102, at least one specimen input device 104, a
pumping device 106, a flow valve 108 and at least one flow cell
110, wherein at least one specimen input device 104 may include one
or more specimen input devices and the at least one flow cell 110
may include one or more flow cells. It should be appreciated each
of the specimen input devices 104 are operably connected with each
of the flow cells 110 via the at least one pumping device 106 and
the at least one flow valve 108 to allow for the controlled flow of
specimen between the specimen input devices 104 and the flow cells
110. Accordingly, the specimen can be controllably directed to flow
between any of the specimen input devices 104 and any of the flow
cells 110.
[0039] It should be appreciated that each of the specimen input
devices 104 defines a specimen input cavity 112 for containing a
specimen to be analyzed and each of the flow cells 110 define a
flow cell cavity 114 for containing at least a portion of the
specimen to be analyzed. The system 100 also includes a plurality
of sensors 116 associated with the flow cells 110 for analyzing at
least one characteristic of the specimen contained with each or one
of the flow cell cavities 114. System 100 further includes a
chemical reservoir 118 which is operably connected with each of the
flow cells 110 via the at least one pumping device 106 and the at
least one flow valve 108 to allow for the controlled flow of
chemical between the chemical reservoir 118 and the flow cells 110.
It is contemplated that the chemical reservoir may include any type
of substance suitable to the desired end purpose. Accordingly, the
chemical can be controllably directed to flow through any of the
valves of at least one flow valve 108 into any of the flow cells
110. Moreover, each of the flow cells 110 are in flow communication
with a waste container 120 for disposal of the chemicals and/or
specimen.
[0040] The processing device 102 is operably associated with at
least one of the specimen input devices 104, the pumping device
106, the flow valves 108, the flow cells 110 and the plurality of
sensors 116. This allows the processing device 102 to control
and/or transfer data between the at least one of the specimen input
devices 104, the pumping device 106, the flow valves 108, the flow
cells 110 and the plurality of sensors 116.
[0041] Referring to FIG. 2, a block diagram illustrating a method
200 for implementing the system 100 for analyzing at least one
biological sample is shown, in accordance with the present
invention. The method 200 includes placing a specimen to be
analyzed into at least one of the specimen input devices 104, as
illustrated in FIG. 3 and shown in operational block 202. The
specimen is then loaded into the system 100 for analysis, as
illustrated in FIG. 4 and shown in operational block 204. This may
be accomplished via a number of ways. For example, as illustrated
in FIG. 5, one embodiment might include a plunger engagement device
which is controlled by the processing device 102 to compress the
plungers of each of the specimen input devices 104 (singly or
together) to cause the specimen contained therein to flow into the
pumping device 106. The flow valves 108 may then be operated to
direct the specimen to the proper flow cell 110, as shown in
operational block 206. A second embodiment might include the
pumping device 106 being operated to draw the specimen (for example
via a vacuum) from each of the specimen input devices 104 (singly
or together). As above, the flow valves 108 may then be operated to
direct the specimen to the proper flow cell 110.
[0042] As discussed hereinabove, the specimen is flowingly directed
by the one or more of the flow valves 108 to one or more of the
flow cells 110 for analysis. Once the specimen is disposed in its
predetermined flow cell cavity 114, the plurality of sensors 116
are operated to sense at least one characteristic of the specimen,
as shown in operational block 208. These characteristics may
include, but not be limited to, pH, Nitrate Nitrogen,
oxidation/reduction potential, conductivity/resistivity and/or
refractometry. Other analyses may be performed as well, including
but not limited to Chloride ions, Nitrite ions, Iodide ion, Calcium
and surface tension. Essentially any measurements as desired may be
conducted. For example any measurements helpful in determining
and/or accessing the metabolic efficiency of the body at a cellular
level may be conducted. Is should be appreciated that the system
100 may include specialized circuitry (internal or external) to
control the flow valves 106, control the sensor devices 116 and/or
to interpret the results of the analysis.
[0043] The results from the analysis conducted by sensors 116 are
transmitted to processing device 102 for further analysis and/or
processing. For example, the data may be translated into ASCII data
for storage and interpretation by software, where the software may
evaluate the data and present the data in a desired format (e.g.
numerical and/or graphical "gauges") for a conceptual review. The
data may also be evaluated according to at least one software
algorithm to triangulate on what text recommendations to make to
create a comprehensive report.
[0044] Once the analysis of the specimen(s) is complete, the
specimen contained within the flow cell cavities 114 are then
"flushed" into the waste container 120, as illustrated in FIG. 6
and as shown in operational block 210. The system 100 may then be
`cleaned` for future use by injecting a cleaning solution through
the system 100, as shown in operational block 212. This may be
accomplished by operating the pumping device 106 to cause the
cleaning solution to flow out of the chemical reservoir 118 and
through the system 100, as shown in FIG. 7. In accordance with one
embodiment of the present invention, prior to calibration the
system may be cleaned using distilled H.sub.2O and/or an enzyme
solution suitable to the desired end purpose. The cleaning solution
can then be flushed into the waste container 120.
[0045] In accordance with the present invention, flow cells may not
be used. Rather the sensors may be disposed to contact the solution
flowing within the flow path. One example as to how the system may
function involves testing saliva and may include moving the
substance to be tested (for example, saliva) from the syringe to
the primary electrodes (i.e. sensors). These sensors read and store
values indicative of pH, Redox (i.e. reduction) and/or
conductivity/resistivity. The saliva is then moved to ion
electrodes (i.e. sensors) where the sensors read and store values
indicative of Nitrate, Nitrite and/or iodide levels. The saliva is
then removed to the waste container and the system (line, syringe
port) is rinsed with distilled water and/or an enzyme cleaning
solution. Another example involves testing urine and may include
moving the substance to be tested (for example, urine) from the
syringe to the primary pH, Redox and conductivity/resistivity
electrodes (i.e. sensors). These sensors read and store values
indicative of pH, Redox (i.e. reduction) and/or
conductivity/resistivity. The urine is then moved to ion electrodes
(i.e. sensors) where the sensors read and store values indicative
of Nitrate, Nitrite, Chloride, Iodide, Calcium and/or ammonium
levels. The urine is then moved to the refractometer, where the
refractive index, specific gravity and simple and/or complex sugars
are measured. The urine is then removed to the waste container and
the system (line, syringe port) is rinsed with distilled water
and/or an enzyme cleaning solution.
[0046] The obtained data is then examined and analyzed responsive
to predetermined values.
[0047] In accordance with the present invention, Acid/alkaline
balance or buffer depletion may be determined by evaluating saliva
and/or urine pH values. For example, if saliva pH is between 6.5
and 6.75 inclusive and urine pH is between 6.5 and 6.8 inclusive,
then Acid/alkaline balance and/or buffer depletion may be
considered optimal, whereas other value combinations may be
indicative of early alkaline reserve use, late alkaline reserve
use, early alkaline reserve loss and/or late state alkaline reserve
loss, as is shown in FIG. 8. Additionally, oxidative stress may be
determined by recognizing that rH2 is a modified Nernst equation
that factors pH and temperature into the reading of ORP (Oxidation
Reduction Potential), as shown in FIG. 9. Furthermore, electrolytes
may be evaluated via the resistivity of saliva, as shown in FIG.
10, and carbohydrate metabolism may be measured using the
refractometer as shown in FIG. 11. Moreover, the protein intake may
be measured (in parts per million ppm) of the ION Nitrate Nitrogen
and the protein metabolism may be made more "granular" as shown in
FIG. 12 and FIG. 13, where the Nitrate number and/or the Ammonium
number is determined. The Nitrate number and the Ammonium number
may be added together to get a Total Urea number which may then be
gauged to be positive or negative.
[0048] In accordance with the present invention, cell respiration
and hydration may be determined, where cell respiration may be
based on the saliva pH, wherein optimal values are typically
centered on 6.4 pH as shown in FIG. 14, and hydration may be based
on the refractometry of the urine, as shown in FIG. 15.
Furthermore, liver stress/toxicity may be determined as shown in
FIG. 16, Kidney stress may be determined as shown in FIG. 17,
adrenal stress may be determined as shown in FIG. 18,
anabolic/catabolic values may be determined as shown in FIG. 19 and
inflammation may be determined as shown in FIG. 20. It should be
appreciated that the values and approaches discussed hereinabove
with regards to FIGS. 8-20 illustrate only one embodiment and may
be modified for particular situations and desired results
consistent with other embodiments that fall within the scope of the
invention. It should be appreciated that each (or selected)
parameter having a percentage score may be tallied and a percentage
may be given as an overall health score.
[0049] In accordance with the present invention, calibration may be
conducted (in addition to or separately) and are generally
illustrated in FIGS. 21-25. These approaches include pH calibration
(See FIG. 21), Redox Calibration (See FIG. 22),
Conductivity/Resistivity Calibration (See FIG. 23), ION Calibration
(See FIG. 24) and Refractometer Calibration (See FIG. 25).
[0050] It is contemplated that the system may be calibrated using a
two (2) point calibration method. It should be appreciated that the
system may be calibrated one or more times prior to and/or
following each use. In accordance with one embodiment of the
present invention, the system may be calibrated as follows. It
should be appreciated that the calibration procedure is discussed
in no particular order and may be conducted in any order desired.
Additionally, although the calibration procedure is discussed in
terms of a complete system calibration, all or only a portion of
the system may be calibrated as desired. For ease in explanation,
references made to `flow path` include the actual flow tube and
flow cell. First, a cleaning cycle is conducted by passing
distilled H.sub.2O and/or an appropriate enzyme solution through
the flow path for each of the sensing devices to remove any residue
that may be present from previously tested or stored material. For
example, the pH flow path is stored using a solution having a pH of
4. So this residue must be removed prior to calibration to achieve
a correct calibration.
[0051] Calibration of the pH sensor may include several cycles of
prewash (number of cycles is as desired suitable to the desired end
purpose), i.e. flushing the pH flow path with a solution. In this
case six (6) prewash cycles of the pH flow path are conducted
(volume and acidity of solution is as desired suitable to the
desired end purpose) with the first cycle using a solution having a
pH=7, the second cycle using a solution having a pH=4, the third
cycle using a solution having a pH=7, the fourth cycle using a
solution having a pH=4, the fifth cycle using a solution having a
pH=7 and the sixth cycle using a solution having a pH=4. At this
point, 1 cc (volume and acidity of solution is as desired suitable
to the desired end purpose) of solution having a pH=4 is then
injected into and held within the pH flow path. The pH sensor is
allowed to stabilize until a first stable pH=4 reading is achieved
and recorded. 3 cc's (volume and acidity of solution is as desired
suitable to the desired end purpose) of solution having a pH=4 is
then injected into and held within the pH flow path. The pH sensor
is allowed to stabilize until a second stable pH=4 reading is
achieved and recorded. These are the first set of pH calibration
reading points. A second calibration reading cycle is obtained by
repeating the above discussed prewash cycle and introducing 1 cc
(volume and acidity of solution is as desired suitable to the
desired end purpose) of solution having a pH=7 into the pH flow
path where the solution is held within the pH flow path until the
pH sensor stabilizes. Once the pH sensor is stabilized, a first
pH=7 calibration reading point is recorded. 3 cc's (volume and
acidity of solution is as desired suitable to the desired end
purpose) of solution having a pH=7 is then injected into and held
within the pH flow path. The pH sensor is allowed to stabilize
until a second stable pH=7 reading is achieved and recorded. These
are the second set of pH calibration reading points.
[0052] Once the pH calibration readings have been obtained, the
oxidation probe is calibrated by introducing into the oxidation
probe flow path solutions with known values and recording the
oxidation sensor readings. Although the invention is discussed as
no flushing being conducted between the pH calibration and the
oxidation calibration phases, flushing may be conducted as desired.
In this embodiment, 1 cc (volume and electrical characteristic of
solution is as desired suitable to the desired end purpose) of
solution having a 271 mV charge is then injected into and held
within the oxidation flow path. The oxidation sensor is allowed to
stabilize until a stable reading is achieved. This is the first 271
mV oxidation calibration reading point. 3 cc's (volume and
electrical characteristic of solution is as desired suitable to the
desired end purpose) of solution having a 271 mV charge is then
injected into and held within the oxidation flow path. The
oxidation sensor is again allowed to stabilize until a stable
reading is achieved. This is the second 271 mV oxidation
calibration reading point. These are the first set of oxidation
calibration reading points.
[0053] A second set of oxidation calibration reading points are
obtained by introducing 1 cc (volume and electrical characteristic
of solution is as desired suitable to the desired end purpose) of
solution having a 475 mV charge into the oxidation flow path and
holding the solution within the oxidation flow path. The oxidation
sensor is allowed to stabilize until a stable reading is achieved.
This is the first 475 mV oxidation calibration reading point. 3
cc's (volume and electrical characteristic of solution is as
desired suitable to the desired end purpose) of solution having a
475 mV charge is then injected into and held within the oxidation
flow path. The oxidation sensor is again allowed to stabilize until
a stable reading is achieved. This is the second 475 mV oxidation
calibration reading point. These are the second set of oxidation
calibration reading points.
[0054] Once the oxidation calibration readings have been obtained,
the system is flushed using an Iodine solution (volume as desired,
for example 5 cc's). At this point, 1 cc (volume and conductivity
of solution is as desired suitable to the desired end purpose) of
solution having a conductivity=3 k siemens is then injected into
and held within the conductivity flow path. The conductivity sensor
is allowed to stabilize until a stable conductivity reading is
achieved. This is the first 3 k siemens conductivity calibration
reading point. 3 cc's (volume and conductivity of solution is as
desired suitable to the desired end purpose) of solution having a
conductivity=3 k siemens is then injected into and held within the
conductivity flow path. The conductivity sensor is allowed to
stabilize until a stable conductivity reading is achieved. This is
the second 3 k siemens conductivity calibration reading point.
These are the first set of conductivity calibration reading points.
A second set of conductivity calibration reading points is obtained
by repeating the above with a solution having 30 k siemens
conductivity. Following the calibration of the conductivity flow
sensor, the system is flushed using distilled H.sub.2O (volume as
desired, for example 5 cc's), wherein approximately 5 cc's of
distilled H.sub.2O is `parked` in the conductivity probe.
[0055] Calibration of the ammonium and nitrate (AN) sensor is
achieved by first introducing 1 cc (volume of solution is as
desired suitable to the desired end purpose) of solution having 100
ppm of ammonium nitrogen and 100ppm of nitrate nitrogen into the AN
flow path as a pre-wash. At this point, 3 cc's (volume of solution
is as desired suitable to the desired end purpose) of solution
having 100 ppm of ammonium nitrogen and 100 ppm of nitrate nitrogen
is introduced into the AN flow path and held within the AN flow
path. The AN sensor is allowed to stabilize until a stable AN
reading is achieved. This is the 100 ppm AN calibration reading
point. A second calibration reading point is then obtained by
introducing 3 cc's (volume of solution is as desired suitable to
the desired end purpose) of solution having 1000 ppm of ammonium
nitrogen and 1000 ppm of nitrate nitrogen into the AN flow path and
holding the solution within the AN flow path until a stable AN
reading is achieved. This is the 1000 ppm AN calibration reading
point.
[0056] The AN sensor is then flushed with approximately 5 cc's of
distilled H.sub.2O and the refractometer sensor is then disposed in
approximately 5 cc's of distilled H.sub.2O. Using a reference=0, if
the refractometer sensor reading is 0 then the refractometer is
determined to be good. However, if the refractometer sensor reading
is 1 then the refractometer is determined to be bad.
[0057] In accordance with one embodiment of the present invention,
the obtained results may be evaluated as shown and discussed
herein. These results may be evaluated in whole or in part using at
least one processing device programmed to implement the procedure
as disclosed herein. In accordance with the invention, references
may be based on general or specific conditions as desired, such as
peak health of an ideal human group as opposed to two (2) standard
deviations of the general population. It should be appreciated that
the invention incorporates a synergistic approach and "looks"
across all (or some) variables on an "energy in" "energy out"
basis. By examining values on an "energy in" "energy out" basis at
the cellular level the invention evaluates proteins &
carbohydrates, metabolism efficiency, oxygen transport, rate of
aging, waste etc . . . to achieve a situation (condition and/or
treatment approach) where the body is maximizing energy and
minimizing wear, toxic overload and body function breakdown.
Accordingly, based on results achieved using the present invention,
lifestyle, exercise, health and nutritional recommendations can be
made.
[0058] It should be appreciated that a personal computer may be
provided to allow a user to control the functions of the system 100
via a Graphical User Interface. It should also be appreciated that
the processing device 102 may control all or some of the components
of the system 100 (such as the specimen input devices 104, the
pumping device 106, the flow valves 108, the flow cells 110, the
sensors 116 and the solution reservoir 118.
[0059] While the invention has been described with reference to an
exemplary embodiment, it will be understood by those skilled in the
art that various changes, omissions and/or additions may be made
and equivalents may be substituted for elements thereof without
departing from the spirit and scope of the invention. In addition,
many modifications may be made to adapt a particular situation or
material to the teachings of the invention without departing from
the scope thereof. Therefore, it is intended that the invention not
be limited to the particular embodiment disclosed as the best mode
contemplated for carrying out this invention, but that the
invention will include all embodiments falling within the scope of
the appended claims. Moreover, unless specifically stated any use
of the terms first, second, etc. do not denote any order or
importance, but rather the terms first, second, etc. are used to
distinguish one element from another.
[0060] In accordance with the present invention, it is contemplated
that multiple measurements may be made by each of the sensors in a
manner responsive to a desired end result. It is further
contemplated that obtained and /or processed data may be displayed
via any display device suitable to the desired end purpose, such as
a paper printout, a computer screen, a television, a plasma display
and/or a Liquid Crystal Display (LCD). System 100 may be operated
and/or monitored via a network connection, such as a wireless
network (cellular, pager, RF), Local Area Network, Wide Area
Network, Ethernet and/or Modem.
[0061] It is contemplated that the processing device may store
obtained and/or processed data and measurement results in a data
storage device and/or a volatile memory of the processing device
(e.g. RAM) and/or on a persistent storage device. It should also be
noted that data may be stored in a volatile and/or a non-volatile
memory location which may be disposed in any location suitable to
the desired end purpose, such as a remote server. In addition, the
data storage device may be used to store individual test data
and/or group test data which may be specific to a desired purpose,
such as data for a specific patient and/or test, wherein the data
may include a large range of information, such as patient specific
data and/or patient history data.
[0062] In accordance with an exemplary embodiment, system 100 may
advantageously be self-calibrating and automated for evaluating
multiple samples. Moreover, although system 100 discloses contact
sensors as its sensing devices, it is contemplated that any sensing
device and/or method may be implemented using system 100, for
example optical sensors. A machine-readable computer program code
and/or a medium encoded with a machine-readable computer program
code for measuring the characteristics of samples and processing
the measured data using system 100, the code and/or medium
including instructions for causing a controller to implement a
method including operating system 100 is contemplated.
[0063] In accordance with an exemplary embodiment, the processing
may be implemented by a controller disposed internal, external or
internally and externally to system 100. In addition, processing of
samples may be implemented through a controller operating in
response to a computer program. In order to perform the prescribed
functions and desired processing, as well as the computations
therefore (e.g. execution control algorithm(s), the control
processes prescribed herein, and the like), the controller may
includes, but not be limited to, a processor(s), computer(s),
memory, storage, register(s), timing, interrupt(s), communication
interface(s), and input/output signal interface(s), as well as
combination comprising at least one of the foregoing.
[0064] The invention may be embodied in the form of a computer or
controller implemented processes. The invention may also be
embodied in the form of computer program code containing
instructions embodied in tangible media, such as floppy diskettes,
CD-ROMs, hard drives, and/or any other computer-readable medium,
wherein when the computer program code is loaded into and executed
by a computer or controller, the computer or controller becomes an
apparatus for practicing the invention. The invention can also be
embodied in the form of computer program code, for example, whether
stored in a storage medium, loaded into and/or executed by a
computer or controller, or transmitted over some transmission
medium, such as over electrical wiring or cabling, through fiber
optics, or via electromagnetic radiation, wherein when the computer
program code is loaded into and executed by a computer or a
controller, the computer or controller becomes an apparatus for
practicing the invention. When implemented on a general-purpose
microprocessor the computer program code segments may configure the
microprocessor to create specific logic circuits.
[0065] While the invention has been described with reference to an
exemplary embodiment, it will be understood by those skilled in the
art that various changes may be made and equivalents may be
substituted for elements thereof without departing from the scope
of the invention. In addition, may modifications may be made to
adapt a particular situation or material to the teachings of the
invention without departing from the essential scope thereof.
Therefore, it is intended that the invention not be limited to the
particular embodiment disclosed as the best mode contemplated for
carrying out this invention.
* * * * *