U.S. patent application number 11/563676 was filed with the patent office on 2007-09-27 for method and apparatus for determining vascular health conditions.
This patent application is currently assigned to ENDOTHELIX, INC.. Invention is credited to Craig Jamieson, Mark C. Johnson, Morteza Naghavi, Timothy J. O'Brien.
Application Number | 20070225614 11/563676 |
Document ID | / |
Family ID | 38566926 |
Filed Date | 2007-09-27 |
United States Patent
Application |
20070225614 |
Kind Code |
A1 |
Naghavi; Morteza ; et
al. |
September 27, 2007 |
METHOD AND APPARATUS FOR DETERMINING VASCULAR HEALTH CONDITIONS
Abstract
The present invention provides methods and apparatus for
assessing a patient's vascular health including endothelial
function by monitoring changes in hemodynamic parameters responsive
to the introduction of a vasostimulant. The invention provides a
thermal energy measurement apparatus including a thermal energy
sensor adapted to measure temperature of a body part while not
substantially changing the temperature of the body part, and a
display or recorder coupled to the thermal energy sensor, wherein
the thermal energy sensor measures the temperature of the body part
before and subsequent to the provision of a vasostimulant, and the
display or recorder reports the temperature of the body part prior
to the provision of the stimulant and the temperature of the body
part after provision of the stimulant. Also provides are methods
and apparatus providing for a second thermal energy sensor on a
corresponding contralateral site to the site subject to the
vasostimulant and simultaneously monitoring and recording of
temperature of the contralateral site as a measure of neurovascular
status and microvascular reactivity.
Inventors: |
Naghavi; Morteza; (Houston,
TX) ; O'Brien; Timothy J.; (Anoka, MN) ;
Jamieson; Craig; (Houston, TX) ; Johnson; Mark
C.; (Houston, TX) |
Correspondence
Address: |
WONG, CABELLO, LUTSCH, RUTHERFORD & BRUCCULERI,;L.L.P.
20333 SH 249
SUITE 600
HOUSTON
TX
77070
US
|
Assignee: |
ENDOTHELIX, INC.
8275 El Rio, Suite 100
Houston
TX
77054
|
Family ID: |
38566926 |
Appl. No.: |
11/563676 |
Filed: |
November 27, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US05/18437 |
May 25, 2005 |
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11563676 |
Nov 27, 2006 |
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60585773 |
Jul 6, 2004 |
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60574255 |
May 26, 2004 |
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60626006 |
Nov 8, 2004 |
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60628173 |
Nov 15, 2004 |
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Current U.S.
Class: |
600/549 |
Current CPC
Class: |
A61B 8/488 20130101;
A61B 5/02416 20130101; A61B 5/1455 20130101; A61B 5/4035 20130101;
A61B 2560/0242 20130101; A61B 5/02007 20130101; A61B 5/0008
20130101; A61B 5/01 20130101; A61B 8/08 20130101 |
Class at
Publication: |
600/549 |
International
Class: |
A61B 5/01 20060101
A61B005/01; A61B 5/00 20060101 A61B005/00 |
Claims
1. A thermal energy measurement apparatus, comprising: a thermal
energy sensor adapted to measure temperature of a body part while
not substantially changing the temperature of the body part, and a
display or recorder coupled to the thermal energy sensor, wherein
the thermal energy sensor measures the temperature of the body part
before and subsequent to the provision of a vasostimulant, and the
display or recorder reports the temperature of the body part prior
to the provision of the stimulant and the temperature of the body
part after provision of the stimulant.
2. The apparatus of claim 1, where the vasostimulant is physical
such as an occlusive means for providing a reactive hyperemia
stimulant by interrupting the blood flow to the body part for a
period of time followed by ceasing the interruption of blood
flow.
3. The apparatus of claim 1, where the vasostimulant is chemical
such as a local or systemic administration of the stimulant for
inducing vascular dilation or constriction.
4. The apparatus of claim 1, wherein the vasostimulant is a
vascular or neurovascular stimulant.
5. The apparatus of claim 1, further comprising a plotting engine
that plots a temperature curve at least between the temperature of
the body part prior to the provision of the vasostimulant and the
temperature of the body part after provision of the
vasostimulant.
6. The apparatus of claim 1,wherein the apparatus records one or
more parameters selected from the group consisting of: lowest
temperature of the body part; the highest temperature of the body
part; the difference between the highest temperature of the body
part and the temperature of the body part prior to the provision of
the vasostimulant; the difference between the highest temperature
of the body part and the lowest temperature of the body part; the
time required for the temperature of the body part to stabilize
subsequent to the provision of the vasostimulant; the slope of the
temperature changes of the body part from the temperatures of the
body part upon the provision of the vasostimulant up to the lowest
temperature of the body part achieved; the slope of the temperature
changes of the body part from the lowest temperature of the body
part achieved up to the highest temperature of the body part
achieved; the area bounded by the temperature curve, the lower
temperature of the body part achieved, the time at which the lowest
temperature of the body part was achieved, and the time at which
the highest temperature of the body part was achieved.
7. The apparatus of claim 1, wherein the device further comprises a
unit for measuring a hemodynamic parameter such as blood flow
velocity using ultrasound Doppler.
8. The apparatus of claim 1, wherein the device further comprises a
unit for measuring a vascular physiologic parameter such as pulse
wave velocity.
9. The apparatus of claim 1, wherein the device further comprises a
unit for measuring and recording hemodynamic parameters using near
infrared light such as photoplethysmography.
10. The apparatus of claim 1, wherein the device further comprises
a unit for measuring a hemodynamic parameter using laser Doppler
flowmetry.
11. The apparatus of claim 1, wherein the device further comprises
a unit for measuring blood pressure.
12. The apparatus of claim 1, wherein the device further comprises
a unit for measuring vital signs such as body temperature, heart
rate, and blood oxygen.
13. The apparatus of claim 1, wherein the thermal energy sensor
comprises a plurality of thermal energy sensors.
14. The apparatus of claim 1, further comprising one or more
further monitoring units selected from a group consisting of a unit
for: skin color, nail capilloroscopy, ultrasound brachial artery
imaging, forearm plethysmography, fingertip plethysmography, oxygen
saturation change, blood pressure or vital signs monitoring device,
Doppler flow measurement, arterial pulse waveform analysis,
near-infrared spectroscopy measurement, peripheral arterial
tonometry, and aortic augmentation index.
15. The apparatus of claim 1, further comprising one or more units
for measuring room temperature measurement, core temperature
measurement, and combinations thereof.
16. The apparatus of claim 1, comprising a computer system that is
coupled to the thermal energy sensor by a wireless connection.
17. The apparatus of claim 16, wherein the wireless connection
comprises Bluetooth technology.
18. The apparatus of claim 16, wherein the computer system is
chosen from the group consisting of a cellular phone, a PDA, a
personal computing device, and combinations thereof.
19. The apparatus of claim 1, further comprising a unit for
measuring tissue metabolic rate.
20. The apparatus of claim 1, further comprising a unit for
measuring tissue heat capacity.
21. The apparatus of claim 16, wherein the computer system is
coupled to an alerting device.
22. The apparatus of claim 11, wherein the blood pressure of the
subject is measured using finger blood pressure and/or wrist blood
pressure.
23. The apparatus of claim 1, further comprising a pulse
oximeter.
24. The apparatus of claim 1, wherein the thermal energy sensor is
adapted to be coupled to a surface of the body part by an
attachment selected from a group consisting of a: mesh sleeve,
ring, non-insulating material, mesh, disposable adhesive, watch,
bracelet, or an article of clothing such as a glove.
25. The apparatus of claim 1, wherein the thermal energy sensor
comprises a probe operable to measure thermal energy of the surface
of the body part without contacting the body part.
26. The apparatus of claim 1, wherein the thermal energy sensor is
operable to measure thermal energy over a time period.
27. The apparatus of claim 1, further comprising a second thermal
energy sensor adapted for measurement of temperature of a
corresponding contralateral body part while not substantially
changing the temperature of the body part.
28. The apparatus of claim 27, is used to evaluate neurovascular
reactivity of the subject and thereby to evaluate vascular and
neurovascular health.
29. The apparatus of claim 1, wherein the thermal energy sensor is
selected from among a group consisting of: a thermocouple,
thermister, resistance temperature detector, heat flux detector,
liquid crystal sensor, thermopile, and an infrared sensor.
30. The apparatus of claim 1, further comprising a Doppler flow
measurement device and is capable of continuous monitoring of
Doppler flow velocity at an arterial site.
31. The apparatus of claim 1, further comprising a recording and
calculating computer for continuously evaluating temperatures
measured by the sensor in response to the vasostimulant, wherein
the computer calculates one or more vascular responsiveness
determinants selected from TF, TR, NP, SF and SR of the temperature
response to the vasostimulant.
32. A method for assessment of vascular reactivity in an individual
comprising: locating a thermal energy sensor on a target site on
the individual, wherein the thermal energy sensor does not alter
microcapillary flow, and establishing a stable baseline temperature
with the thermal energy sensor at the site; providing a
vasostimulant to the individual; determining a temperature response
to the vasostimulant; and establishing a vascular reactivity
assessment for the individual based on the temperature
response.
33. The method of claim 32, wherein the vasostimulant comprises
occluding a blood supply to the target site for a predetermined
period of time and ceasing occlusion thereafter.
34. The method of claim 32, wherein the target site is an
extremity.
35. The method of claim 32, further comprising measuring blood
pressure in the individual.
36. The method of claim 32, further comprising monitoring a
temperature response on a site remote from the target site.
37. The method of claim 32, comprising locating a second thermal
energy sensor on a corresponding contralateral site to the site
subject to the vasostimulant and simultaneously monitoring and
recording of temperature of the contralateral site.
38. The method of claim 32, wherein the temperature is monitored
successively from an establishment of the baseline until at least a
peak temperature response.
39. The method of claim 38, wherein the successively monitored
temperature is displayed as a plot of temperature versus time.
40. The method of claim 32, wherein one or more numerical values
are obtained from the temperature response, the values selected
from the group consisting of one or more of: TF, TR, NP, SF, SR,
and area under the curve.
41. The method of claim 32, wherein the health condition is
selected from the group consisting of: endothelial function,
autonomic nervous system function, risk for atherosclerotic
cardiovascular disorder, progression of heart failure, obesity,
high sympathetic reactivity, high blood pressure, white coat
hypertension, hypertension, smooth muscle cell dysfunction, status
and progression of diabetes, fitness, sleep disorders such as sleep
apnea, rheumatologic disease, Raynaud's, connective tissue
disorders, pulmonary hypertension, smoking, vascular stress, sleep
disorders, metabolic syndrome, subclinical hypothyroidism, vascular
dementia, Alzheimer's, portal hypertension, cancer, renal function,
cerebral vascular disease, stroke, memory loss, vision loss, heart
attack, angina, erectile dysfunction, peripheral arterial disease,
migraine headaches, Prinzmetal's angina, pregnancy and
preeclempsia, infections, HIV and AIDS, diabetic foot, anxiety and
excessive stress, and high cholesterol as well as monitoring
response to therapies for the aforementioned health conditions.
42. The method of claim 32, wherein the health condition is
selected from the group consisting of post surgery and vascular
interventions monitoring, monitoring wound healing and wound care
management, and assessment of neurovasculopathy.
43. The method of claim 32, further comprising considering the
vascular reactivity assessment in light of a status of the
individual for one or more additional tests selected from the group
consisting of: coronary calcium score, Framingham risk score,
cartoid intima-media thickness test, cardiac function test,
magnetic resonance imaging test, intravascular ultrasound;
assessing a endothelial function, including by an endothelial
driven microparticles test, a VCAM1 test, an ICAM1 test, a SELECTIN
test, a VWF test, c-reactive protein test, an Lp-PLA2 level, a CD54
test, and ankle-brachial blood pressure index test.
44. The method of claim 32, further comprising measuring a
hemodynamic parameter in the subject using optical
spectroscopy.
45. The method of claim 32, further comprising measuring and
recording a room temperature and/or a core temperature of the
subject.
46. The method of claim 32, further comprising measuring and
recording a tissue heat capacity and/or a tissue metabolic rate of
the subject.
47. The method of claim 32, further comprising measuring and
recording the blood pressure of the subject, including by Korotkoff
sounds and/or oscillometric methods.
48. The method of claim 32, further comprising determining an
oxygen saturation measurement at a fingertip.
49. The method of claim 32, further comprising measuring a blood
flow velocity through an artery of the subject which supplies blood
to the body part before, during, and after the provision of the
vasostimulant.
50. The method of claim 32, further comprising measuring and
recording the stiffness of an artery supplying blood to the body
part by arterial pulse waveform analysis.
51. The method of claim 32, wherein the device acquires a measure
of endothelium dependent vascular reactivity by the temperature
response to the vasostimulant; acquires a measure of endothelium
independent vascular reactivity by input of additional
non-endothelial related diagnosis techniques; calculates a ratio of
the measure of endothelium dependent vascular reactivity over the
measure of endothelium independent vascular reactivity; and thereby
determines a health condition of the subject.
52. The method of claim 32, further comprising determining one or
more health conditions by considering results of additional
diagnostic techniques selected from the group consisting of:
intravascular optical coherent tomography, coronary fractional flow
reserve, intravascular ultrasound radiofrequency backscatter
analysis or Virtual Histology, urinary albumin, serum fibrinogen,
IL6, CD40/CD40L, serum amyloid A, ankle brachial index, MRI,
coronary calcium score, caratoid intermedia thickness, Framingham
risk score, C-reactive protein tests, waist circumference, blood
insulin level, PAI-1 test, t-PA test, glucose tolerance tests,
fasting plasma glucose level, HDL cholesterol level, fasting plasma
insulin test, homeostasis model assessment, BMI, body fat level,
visceral fat test, subcutaneous fat test, white blood cell count,
Neutrophil/lymphocyte ratio, platelet function test, and
combinations thereof.
53. The method of claim 32, further comprising determining one or
more health conditions by considering results of additional
diagnostic techniques selected from the group consisting of: plasma
and urinary level of asymmetrical (ADMA) and symmetrical (SDMA)
dimethylarginine, exhaled nitric oxide, serum homosysteine, an
endothelial driven microparticles test, a VCAM1 test, an ICAM1
test, a SELECTIN test, a VWF test, a TF test, a CD54 test,
endothelial progenitor cells, myeolo-proxidase (MPO), increased
neutrophil/lymphocyte ratio, endothelin- 1, thrombomodulin, tissue
factor and tissue factor pathway inhibitor, markers of inflammation
such as, for example, granulocyte-macrophage colony-stimulating
factor (GM-CSF) and macrophage chemoattractant protein-1 (MCP-1)
nitric oxide and its metabolites nitrates and nitrites, almost
nitrosylated proteins, a selectin such as, for example, soluble
endothelium, leukocyte, and platelet selecting, markers of
oxidative stress including but not limited to free radical
measurements of the blood or through the skin, TBAR, and/or extra
cellular super oxide dismutase activity, vascular stiffness or
compliance, and combinations thereof.
54. The method of claim 32, further comprising performing one or
more additional diagnostic techniques in order to determine the
health condition of the patient, the techniques selected from the
group consisting of: skin color, nail capilloroscopy, ultrasound
brachial artery imaging, forearm plethysmography, fingertip
plethysmography, oxygen saturation change, pressure change,
near-infrared spectroscopy measurements, Doppler flow, peripheral
arterial tonometry, and combinations thereof.
55. A treatment for improving vascular function, wherein the
treatment is determined to be efficacious in improving vascular
function based on an increase in normalized TR, SlopeR and/or NP
digital thermal monitoring values as a consequence of the
treatment.
56. The treatment of claim 55, wherein the treatment is a drug
treatment.
57. The treatment of claim 55, wherein the treatment is a
nutritional program.
58. A method for determining influence of a treatment on vascular
function, comprising: determining one or more normalized values
selected from a TF, TR, SlopeR and/or NP value for a patient by
digital thermal monitoring; administering the treatment to the
patient; monitoring the patient for any change in one or more of
the normalized values by periodic repeat determinations in the
patient; establishing that the treatment influences vascular
function if a significant change in one or more of the normalized
values result from administration of the agent.
59. A computer program encoded on a computer-readable medium having
a computer program recorded thereon and arranged to be loaded into
a program memory of a computer and to cause the computer to execute
at least the following steps for determining one or more health
conditions: retrieving a plurality of temperature data from a
database, the temperature data derived from operation of the
apparatus of claim 1, and including a baseline temperature of a
target body part prior to administration of the vasostimulant and a
temperature at a set time after administration of the
vasostimulant; calculating a difference between the baseline
temperature and the temperature at a set time after administration
of the vasostimulant; and displaying the calculated difference.
60. The computer program of claim 59, wherein the temperature data
further comprises one or more values selected from the group
consisting of: a temperature drop from the baseline temperature
having a first slope; a lowest temperature achieved; a temperature
rise from the lowest temperature achieved having a second slope; a
peak temperature; and a stabilization temperature.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of, and claims
priority under 35 USC .sctn.120 to PCT application
PCT/US2005/018437, filed May 25, 2005, and published as
WO2005/118516, which claims priority under 35 USC .sctn.119 to U.S.
Provisional Application No. 60/574,255, filed May 26, 2004; U.S.
Provisional Application No. 60/585,773, filed July 6, 2004; U.S.
Provisional Application No. 60/626,006, filed Nov. 8, 2004, and
U.S. Provisional Application No. 60/628,173, filed Nov. 15, 2004,
the disclosures of which are incorporated herein by reference in
their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
assessing a patient's vascular health including endothelial
function by monitoring changes in hemodynamic parameters responsive
to the introduction of a vasostimulant.
BACKGROUND
[0003] The unpredictable nature of heart attack and the need for
cost-effective screening in large group of asymptomatic at-risk
populations is the major problem in cardiovascular healthcare.
Cardiovascular disease (CVD) remains as the number one killer in
the United States and most developed countries. The epidemic of CVD
is growing fast in under developed societies where advanced and
expensive therapies are unavailable. In the past 50 years over 200
risk factors of atherosclerosis have been reported, however,
individual prediction of cardiovascular events remains
problematic.
[0004] New developments in noninvasive imaging of atherosclerosis,
particularly molecular imaging, are very promising, however,
screening large populations to identify the subpopulation most in
need of sophisticated imaging modalities remains a major challenge.
Such a screening test must be low cost, highly sensitive (with
accepted specificity), and widely available. Presently, lipid
profiling (Total LDL, HDL, homocysteine, and, to a lesser degree,
C-Reactive Protein (CRP), have been adapted for coronary risk
assessment. New biochemical assays are also emerging. Although
these blood tests are essential in final risk stratification and
guiding therapy, given the increasing number of these tests and
their less-than-desirable predictive value, measurement of a
plurality of these tests for large scale screening purposes may be
prohibitively expensive. On this basis, the present inventors
sought a non-invasive non-imaging biomarker that would reflect the
cumulative effects of multiple risk factors.
[0005] Endothelial cells form the lining of the vasculature. In
addition to this barrier function, endothelial cells play a central
role in multiple regulatory systems including vasomotion,
inflammation, thrombosis, tissue growth and angiogenesis. When
there is increased demand for blood by certain organs of the body,
endothelial cells release nitric oxide (NO), which increases the
diameter of arteries and thereby increases blood flow. NO release
is important not only for the regulation of vascular tone but also
for the modulation of cardiac contractility, vessel injury and the
development of atherosclerosis. Presence of atherosclerosis hampers
the normal functioning of these cells, blocking NO-mediated
vasodilation and making the arteries stiffer and less able to
expand and contract. The loss of ability of an artery to respond to
increased and sudden demand is called endothelial dysfunction
(EDF). Endothelial dysfunction is the target organ damage of all
cardiovascular risk factors and endothelial failure is the end
stage that leads to clinical events in cardiovascular disease.
Numerous experimental, clinical, and epidemiologic studies have
shown that endothelial function is altered in presence of
established risk factors such as hypertension,
hypercholesterolemia, diabetes mellitus and emerging risk factors
such as hyperhomocysteinemia, CRP, and fibrinogen. There have also
been studies showing strong correlation with first cardiovascular
events and sub clinical markers such as carotid media thickness
(IMT), coronary calcium score (CSS), and ankle brachial index
(ABI).
[0006] Impaired endothelial function can be detected before the
development of angiographically significant plaque formation in the
coronary and peripheral vasculature by measuring the response to
pharmacological and physiological stressors. Endothelial function
tests not only predict risks but also reflect responses to
treatment. Pharmacological therapies and lifestyle changes aimed at
improving cardiovascular risk also improve vascular reactivity.
Flow-mediated brachial artery vasoreactivity has been shown to
improve with major treatment modalities such as statin and ACE
inhibitor therapy. The effect seems to be reproducible and also is
reversible and follows the course of the disease and risk factors.
Lastly, impaired endothelial function has been shown in the
presence of genetic factors and susceptibility to atherosclerosis
long before development of risk factors and clinical disease.
[0007] Atherosclerosis is a systemic metabolic-immune disease that
affects the total vascular bed. Coronary atherosclerosis due to
certain hemodynamic characteristics seems to pursue a faster
trajectory in the development of stenotic plaques. However,
stenotic plaques are considered only the tip of the iceberg.
Coronary atherosclerosis has been associated with the brachial
arthrosclerosis and impaired brachial artery reactivity strongly
correlates with impaired coronary artery reactivity. Measurement of
endothelial function in the brachial artery with noninvasive
techniques provides an opportunity to evaluate large patient
populations that is possible with coronary imaging.
[0008] To this end, various modalities have been used for the
assessment of endothelial function. Invasive modalities include
measuring the vasodilator response of coronary arteries to
acetylcholine or to a cold pressor test by invasive quantitative
coronary angiography. A second invasive technique involves
injecting the radioactive material, and then tracing the blood flow
with the help of gamma ray radiations. The invasive nature of these
tests limits widespread use, particularly in the asymptomatic
population.
[0009] Non-invasive methods include: measurement of the percent
change in diameter of the left main trunk induced by cold pressor
test with two-dimensional (2-D) echocardiography; the Dundee step
test measuring the blood pressure response of a person to exercise
(N Tzemos, et al. Q J Med 95 (2002) 423-429); laser Doppler
perfusion imaging and iontophoresis; high resolution B-mode
ultrasound to study vascular dimensions (T J Anderson, et al. J.
Am. Col. Cardiol. 26(5) (1995) 1235-41); occlusive arm cuff
plethysmography (S Bystrom, et al. Scand J Clin Lab Invest 58(7)
(1998) 569-76); and digital plethysmography or peripheral arterial
tonometry (PAT)(A Chenzbraun et al. Cardiology 95(3) (2001)
126-30).
[0010] Of these, brachial artery imaging with high-resolution
ultrasound (BAUS) during reactive hyperemia is considered the gold
standard method of determining peripheral vascular function. Arm
cuff inflation provides a suprasystolic pressure stimulus. Ischemia
reduces distal resistance and opening the cuff induces stretch in
the artery. Imaging of the diameter of the artery along with
measuring the peak flow defines endothelial function. However, this
method requires very sophisticated equipment and operators that are
only available in a few specialized laboratories worldwide. Thus,
despite widespread use of BAUS in clinical research, technical
challenges, poor reproducibility, and considerable operator
dependency have limited the use of this technique to vascular
research laboratories.
[0011] Venous occlusion plethysmography evaluates peripheral
vasomotor function by measuring volume changes in the forearm by
mercury strain gauges during hyperemia. This method is invasive and
cumbersome. Tissue doppler imaging or flowmetry of the hand can be
employed to continuously show skin perfusion before and after
hyperemia using single fiber / point Doppler measurement of flow at
finger tip. These techniques are also expensive and limit
availability.
[0012] Alternatively, peripheral arterial tonometry (PAT) can be
used to measure changes in the volume of finger as the indicator of
changes in blood flow which in turn reflects changes in the
diameter of brachial artery during hyperemia. This method is
non-invasive but is not inexpensive and is not conducive to
self-administration.
[0013] What is needed is a non-invasive, inexpensive and
reproducible test that provides an individualized measure of
cardiovascular risk assessment by measuring vascular reactivity and
correlates positively with known and accepted risk factors.
SUMMARY OF THE INVENTION
[0014] The disclosures herein relate generally to vascular health
and neurovascular conditions and more particularly to a method and
apparatus for determining vascular reactivity and thereby
determining one or more health conditions by monitoring changes in
temperature. According to one aspect of the invention, the pattern
of temperature change at a digit, such as a fingertip, is monitored
before and after release of an occlusion to the flow of blood to
the digit. It has been found that this inexpensive and reproducible
technology correlates with the BAUS gold standard for assessing
endothelial function. The technology is importantly conducive to
self administration and to individual
[0015] According to one aspect of the present disclosure, a thermal
energy measurement apparatus is provided comprising a thermal
energy sensor and means for coupling the thermal energy sensor to a
skin surface on a body part, the coupling means operable to couple
the thermal energy sensor to the skin surface on the body part
while not substantially changing the skin surface temperature of
the body part.
[0016] According to one aspect of the present disclosure, a method
for determining one or more health conditions is provided
comprising providing a subject, measuring the skin temperature of a
body part on the subject, providing a vasostimulant to the subject,
measuring the skin temperature changes of the body part during and
subsequent to the provision of the vasostimulant, and determining
one or more health conditions for the subject based upon at least
one of the skin temperature changes measured.
[0017] According to one aspect of the present disclosure, a method
for determining one or more health conditions is provided
comprising providing a subject, measuring the skin temperature of a
first body part on the subject, placing a second body part of the
subject in water, measuring the skin temperature changes of the
first body part during and subsequent to the placing of the second
body part in water, and determining one or more health conditions
for the subject based upon at least one of the skin temperature
changes measured.
[0018] According to one aspect of the present disclosure, a method
for determining one or more health conditions is provided
comprising providing a subject, providing a volume of a medium,
placing a body part of the subject in the volume of the medium,
measuring the temperature of the volume of the medium, providing a
vasostimulant to the subject, measuring the temperature changes of
the volume of the medium during and subsequent to the provision of
the vasostimulant, and determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured.
[0019] According to one aspect of the present disclosure, a
database for diagnosing health conditions is provided comprising
control data comprising a plurality of control temperature data
points and temperature data comprising a baseline temperature, a
temperature drop from the baseline temperature having a first
slope, a lowest temperature achieved, a temperature rise from the
lowest temperature achieved having a second slope, a peak
temperature, and a stabilization temperature. According to one
aspect of the present disclosure, a method for determining one or
more health conditions is provided comprising providing a subject,
measuring the baseline skin temperature of a body part on the
subject, providing a vasostimulant to the subject, measuring the
lowest skin temperature of the body part during and subsequent to
the provision of the vasostimulant, measuring the highest skin
temperature of the body part, and determining one or more health
conditions for the subject based upon at least one of the skin
temperature changes measured.
[0020] According to one aspect of the present disclosure, a
computer program for determining one or more health conditions is
provided comprising a retrieval engine adapted to retrieve a
plurality of temperature data from a database, the temperature data
comprising a baseline temperature, a temperature drop from the
baseline temperature having a first slope, a lowest temperature
achieved, a temperature rise from the lowest temperature achieved
having a second slope, a peak temperature, and a stabilization
temperature; a processing engine adapted to process data retrieved
by the retrieval engine, and a diagnosis engine operable to
determine one or more health conditions based upon the retrieved
temperature data.
[0021] According to one aspect of the present disclosure a method
for determining one or more health conditions is provided
comprising providing a subject, measuring the blood flow rate of
the subject, providing a vasostimulant to the subject, measuring
the blood flow rate changes of the subject during and subsequent to
the provision of the vasostimulant, and determining one or more
health conditions for the subject based upon at least one of the
blood flow rate changes measured.
[0022] According to one aspect of the present disclosure a method
for determining one or more health conditions is provided
comprising providing a subject, measuring the skin temperature of a
finger on the arm of the subject, detecting an equilibrium in the
skin temperature of the finger of the subject, automatically
providing a vasostimulant to the subject to substantially cease
blood flow to the finger, measuring the skin temperature changes of
the finger after provision of the vasostimulant, automatically
removing the vasostimulant to allow blood flow to the finger,
measuring the skin temperature changes of the finger after the
removal of the vasostimulant, and determining one or more health
conditions for the subject based upon at least one of the skin
temperature changes measured.
[0023] According to one aspect of the present disclosure a method
for selecting a medication for the treatment of a medical condition
in a subject is provided which includes administering a medication
to one or more subjects, determining the health condition of the
one or more subjects using the method of: measuring the skin
temperature of a body part on the one or more subjects, providing a
vasostimulant to the one or more subjects, measuring the skin
temperature changes of the body part during and subsequent to the
provision of the vasostimulant; and determining one or more health
conditions for the one or more subjects based upon at least one of
the skin temperature changes measured; determining whether the
medication is effective in the treatment of the one or more
subjects, and selecting the medication for use in treating the
medical condition in other subjects if the medication is determined
to be effective in the treatment of the one or more subjects.
[0024] According to one aspect of the present disclosure a method
for selecting a nutritional program for a subject is provided which
includes administering a nutritional program to one or more
subjects, determining the health condition of the one or more
subjects using the method of: measuring the skin temperature of a
body part on the one or more subjects, providing a vasostimulant to
the one or more subjects, measuring the skin temperature changes of
the body part during and subsequent to the provision of the
vasostimulant, and determining one or more health conditions for
the one or more subjects based upon at least one of the skin
temperature changes measured; determining whether the nutritional
program is effective for the one or more subjects, and selecting
the nutritional program for other subjects if the nutritional
program is determined to be effective for the one or more
subjects.
[0025] According to one aspect of the present disclosure a method
for selecting a medication, chemical substance, medical procedure,
health intervention program, and/or nutritional program for the
treatment of a medical condition in a subject is provided which
includes administering a medication, chemical substance, medical
procedure, health intervention program, and/or nutritional program
to one or more subjects, determining the health condition of the
one or more subjects using the method of: measuring the skin
temperature of a body part on the one or more subjects, providing a
vasostimulant to the one or more subjects, measuring the skin
temperature changes of the body part during and subsequent to the
provision of the vasostimulant, and determining one or more health
conditions for the one or more subjects based upon at least one of
the skin temperature changes measured; determining whether the
medication, chemical substance, medical procedure, health
intervention program, and/or nutritional program is effective in
the treatment of the one or more subjects, and selecting the
medication, chemical substance, medical procedure, health
intervention program, and/or nutritional program for use in
treating the medical condition in other subjects if the medication
is determined to be effective in the treatment of the one or more
subjects.
[0026] It is emphasized that this summary is not to be interpreted
as limiting the scope of these inventions which are limited only by
the claims herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 is a flowchart of an embodiment of a method of
endothelial function assessment/measurement.
[0028] FIG. 2 is a schematic view illustrating an exemplary
embodiment of an apparatus for determining one or more health
conditions.
[0029] FIG. 3 is a schematic view illustrating an exemplary
embodiment of a computer system used with the apparatus of FIG.
2.
[0030] FIG. 3a is a schematic view illustrating an exemplary
embodiment of a database used with the apparatus of FIG. 2.
[0031] FIG. 4a is a cut away perspective view illustrating an
exemplary embodiment of a computer system used with the apparatus
of FIG. 2.
[0032] FIG. 4b is a perspective view illustrating an exemplary
embodiment of a computer system used with the apparatus of FIG.
2.
[0033] FIG. 5 is a flow chart illustrating an exemplary embodiment
of the function of a thermal energy sensor engine used in the
computer system of FIG. 3.
[0034] FIG. 6 is a flow chart illustrating an exemplary embodiment
of the function of a vasostimulant engine used in the computer
system of FIG. 3.
[0035] FIG. 7 is a flow chart illustrating an exemplary embodiment
of the function of a plotting engine used in the computer system of
FIG. 3.
[0036] FIG. 8 is a flow chart illustrating an exemplary embodiment
of a method for determining one or more health conditions.
[0037] FIG. 9a is a perspective view illustrating an exemplary
embodiment of an apparatus for determining one or more health
conditions.
[0038] FIG. 9b is a cross sectional view illustrating an exemplary
embodiment of a thermal energy sensor used with the apparatus of
FIG. 9a.
[0039] FIG. 10a is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIGS. 9a and 9b.
[0040] FIG. 10b is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIGS. 9a and 9b.
[0041] FIG. 10c is a perspective view illustrating an exemplary
embodiment of the subject of FIG. 1 coupled to the apparatus of
FIGS. 9a and 9b.
[0042] FIG. 10d is a perspective view illustrating an exemplary
embodiment of the subject of FIG. 1 coupled to the apparatus of
FIGS. 9a and 9b.
[0043] FIG. 11a is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIGS. 9a and 9b.
[0044] FIG. 11b is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIGS. 9a and 9b.
[0045] FIG. 11c is a perspective view illustrating an exemplary
embodiment of the subject of FIG. 1 coupled to the apparatus of
FIGS. 9a and 9b.
[0046] FIG. 12a is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIGS. 9a and 9b.
[0047] FIG. 12b is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIGS. 9a and 9b.
[0048] FIG. 12c is a perspective view illustrating an exemplary
embodiment of the subject of FIG. 1 coupled to the apparatus of
FIGS. 9a and 9b.
[0049] FIG. 13 is a flow chart illustrating an exemplary embodiment
of a method for determining one or more health conditions using the
apparatus of FIG. 2.
[0050] FIG. 14 is a flow chart illustrating an exemplary embodiment
of a method for determining one or more health conditions using the
apparatus of FIG. 2.
[0051] FIG. 15 is a perspective view illustrating an exemplary
embodiment of an apparatus for determining one or more health
conditions.
[0052] FIG. 16 is a side view illustrating an exemplary embodiment
of a thermal energy sensor.
[0053] FIG. 17 is a front view illustrating an exemplary embodiment
of an apparatus for determining one or more health conditions.
[0054] FIG. 18a is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIG. 17.
[0055] FIG. 18b is a flow chart illustrating an exemplary
embodiment of a method for determining one or more health
conditions using the apparatus of FIG. 17.
[0056] FIG. 19 is a flow chart illustrating an exemplary embodiment
of a method for determining one or more health conditions.
[0057] FIG. 20 is a flow chart illustrating an exemplary embodiment
of a method for determining one or more health conditions.
[0058] FIG. 21 is a graph illustrating an exemplary embodiment of
temperature vs. time data obtained using the apparatus of FIGS. 2,
3, and 4 using the methods of FIGS. 8a and 8b.
[0059] FIG. 22 is a graph illustrating an exemplary experimental
embodiment of temperature vs. time data obtained using the
apparatus of FIGS. 2, 3, and 4 using the methods of FIGS. 8a and
8b.
[0060] FIG. 23 is a graph illustrating an exemplary experimental
embodiment of temperature vs. time data obtained using the
apparatus of FIGS. 2, 3, and 4 using the methods of FIGS. 8a and
8b.
[0061] FIG. 24 is a graph illustrating an exemplary experimental
embodiment of temperature vs. time data obtained using the
apparatus of FIGS. 2, 3, and 4 using the methods of FIGS. 8a and
8b.
[0062] FIG. 25 is a graph illustrating an exemplary experimental
embodiment of temperature vs. time data obtained using the
apparatus of FIGS. 2, 3, and 4 using the methods of FIGS. 8a and
8b.
[0063] FIG. 26 is a graph illustrating an exemplary experimental
embodiment of temperature vs. time data obtained using the
apparatus of FIGS. 2, 3, and 4 using the methods of FIGS. 8a and
8b.
[0064] FIG. 27 is a graph illustrating an exemplary experimental
embodiment of temperature vs. time data obtained using the
apparatus of FIGS. 2, 3, and 4 using the methods of FIGS. 8a and
8b.
[0065] FIG. 28 is a graph illustrating an exemplary experimental
embodiment of temperature vs. time data obtained using the
apparatus of FIGS. 2, 3, and 4 using the methods of FIGS. 8a and
8b.
[0066] FIG. 29 is a graph illustrating an exemplary experimental of
data obtained using the apparatus of FIGS. 2, 3, and 4 using the
methods of FIGS. 8a and 8b correlated to percentage change in
brachial artery diameter.
[0067] FIG. 30 is a graph illustrating an exemplary experimental
embodiment of data obtained using the apparatus of FIGS. 2, 3, and
4 using the methods of FIGS. 8a and 8b correlated to percentage
change in brachial artery diameter.
[0068] FIG. 31 is a perspective view illustrating an exemplary
embodiment of an apparatus for determining one or more health
conditions.
[0069] FIG. 32a is a flow chart illustrating an exemplary
embodiment of a portion of a method for determining one or more
health conditions using the apparatus of FIG. 31.
[0070] FIG. 32b is a flow chart illustrating an exemplary
embodiment of a portion of a method for determining one or more
health conditions using the apparatus of FIG. 31.
[0071] FIG. 32c is a perspective view illustrating an exemplary
embodiment of the apparatus of FIG. 31 being used on the subject of
FIG. 3 during the method of FIGS. 32a and 32b.
[0072] FIG. 32d is a graph illustrating an experimental embodiment
of the apparatus of FIG. 31 being used on the subject of FIG. 3
during the method of FIGS. 32a and 32b.
[0073] FIG. 33a is a top view illustrating an exemplary embodiment
of a thermal energy sensor.
[0074] FIG. 33b is a cross sectional view illustrating an exemplary
embodiment of the thermal energy sensor of FIG. 33a.
[0075] FIG. 33c is a cross sectional view illustrating an exemplary
embodiment of operation of the thermal energy sensor of FIG.
33b.
[0076] FIG. 34a is a top view illustrating an exemplary embodiment
of a thermal energy sensor.
[0077] FIG. 34b is a cross sectional view illustrating an exemplary
embodiment of the thermal energy sensor of FIG. 34a.
[0078] FIG. 34c is a cross sectional view illustrating an exemplary
embodiment of operation of the thermal energy sensor of FIG.
34b.
[0079] FIG. 35 is a perspective view illustrating an exemplary
embodiment of an apparatus for determining one or more health
conditions.
[0080] FIG. 36a is a top view illustrating an exemplary embodiment
of a thermal energy sensor.
[0081] FIG. 36b is a cross sectional view illustrating an exemplary
embodiment of the thermal energy sensor of FIG. 36a.
[0082] FIG. 36c is a cross sectional view illustrating an exemplary
embodiment of the operation of the thermal energy sensor of FIG.
36b.
[0083] FIG. 37a is a flow chart illustrating an exemplary
embodiment of a portion of a method for determining one or more
health conditions using the apparatus of FIG. 36a.
[0084] FIG. 37b is a flow chart illustrating an exemplary
embodiment of a portion of a method for determining one or more
health conditions using the apparatus of FIG. 36a.
[0085] FIG. 38a is a flow chart illustrating an exemplary
embodiment of a portion of a method for determining one or more
health conditions.
[0086] FIG. 38b is a flow chart illustrating an exemplary
embodiment of a portion of a method for determining one or more
health conditions.
[0087] FIG. 38c is a perspective view illustrating an exemplary
embodiment of the subject of FIG. 3 during the method of FIGS. 38a
and 38b.
[0088] FIG. 38d is a graph illustrating an experimental embodiment
of the subject not undergoing the method of FIGS. 38a and 38b.
[0089] FIG. 38e is a graph illustrating an experimental embodiment
of the subject undergoing the method of FIGS. 38a and 38b.
[0090] FIG. 39 is a flow chart illustrating an embodiment of a
method for determining the effectiveness of a medication.
[0091] FIG. 40 is a flow chart illustrating an embodiment of a
method for determining the effectiveness of a nutritional
program.
[0092] FIG. 41 is a perspective view illustrating an embodiment of
apparatus for determining health condition.
[0093] FIG. 42a is a flow chart illustrating an embodiment of a
portion of a method for determining health condition using the
apparatus of FIG. 41.
[0094] FIG. 42b is a flow chart illustrating an embodiment of a
portion of a method for determining health condition using the
apparatus of FIG. 41.
[0095] FIG. 42c is a perspective view illustrating an embodiment of
the apparatus of FIG. 41 on the subject of FIG. 1 during the method
of FIGS. 42a and 42b.
[0096] FIG. 43a is a graph illustrating an experimental embodiment
of the subject undergoing the method of FIGS. 42a and 42b.
[0097] FIG. 43b is a graph illustrating an experimental embodiment
of the subject undergoing the method of FIGS. 42a and 42b.
[0098] FIG. 43c is a graph illustrating an experimental embodiment
of the subject undergoing the method of FIGS. 42a and 42b.
[0099] FIG. 44a depicts DTM data (TF, TR and NP) from a second
cohort of 26 individuals. FIG. 44b depicts BAUS data from the same
cohort as FIG. 45a.
[0100] FIG. 45a depicts ROC curve analysis of FRS, NP, TR and slope
for the data of FIG. 44a.
[0101] FIG. 46a depicts the FRS scores comparing CHD with non-CHD
patients in the cohort of individuals of FIG. 44a, while FIG. 46b
depicts DTM TR values comparing CHD with non-CHD patients in the
same cohort as FIG. 46a.
[0102] FIG. 47a depicts the graded relationship observed between TR
values and FRS.
[0103] FIG. 47b depicts the differences in average TR values
between diabetics and non diabetics.
[0104] FIG. 48 shows that DTM outperforms FRS in females and
individuals <55 years of age.
[0105] FIG. 49a presents data correlating DTM results with CAD.
[0106] FIG. 49b figuratively depicts the appearance of possible
temperature response curved depending on baseline fingertip
temperature.
[0107] FIG. 50 depicts an embodiment of wiring for receiving
signals from thermocouple leads and sending them through an analog
to digital converter.
[0108] FIG. 51a depicts methods for functional assessment of
baseline and reactive capacity in accordance with an embodiment of
the invention.
[0109] FIG. 51b depicts a paradigm for comprehensive assessment of
vascular health including functional and structural individual
assessments as well as assessment based on epidemiologic risk
factors.
[0110] FIG. 52 represents infrared video imaging of the two hands
of the same individual before (A), during (B) and after (C)
occlusion by inflation of a blood pressure cuff on the right arm
(labeled occluded).
[0111] FIGS. 53a and 53b depict several views of embodiments of a
finger cuff and temperature sensor for ambulatory vascular
reactivity assessment.
[0112] FIG. 54 depicts temperature response parameters.
DETAILED DESCRIPTION
[0113] Referring now to FIG. 1, a method for assessing endothelial
function is provided that comprises providing a vasodilating
stimulant to a patient to stimulate hemodynamic activity in a
selected region of the patient's body, illustrated at block 10 in
FIG. 1, monitoring a change in a hemodynamic parameter at the
selected region, illustrated at block 11 in FIG. 1, and assessing
the patient's endothelial function based upon said monitoring,
illustrated at block 12 in FIG. 1. In a one embodiment, the
monitored hemodynamic parameter may be a parameter such as blood
temperature, blood oxygen content, blood flow rate, or the like, or
a combination thereof.
[0114] Providing a vasodilating stimulant may further comprise
compressing the patient's brachial artery for a predetermined
period of time and ceasing the compression after that predetermined
period of time. Providing a vasodilating stimulant may also
comprise occluding blood flow in the patient's arm.
[0115] Additionally, the change in temperature at one of the
patient's fingertips may be monitored as may the change in
temperature in the patient's arm. Monitoring the change in
temperature may be accomplished by placing at least two temperature
sensors, for example piezoelectric sensors, proximate, e.g. on, the
patient's forearm. The temperature sensors may be separated by a
known distance.
[0116] Providing a vasodilating stimulant may comprise occluding
blood flow in the patient's leg.
[0117] In one embodiment, a preferred method for measuring
endothelial function comprises providing a vasodilating stimulant
to a patient to stimulate hemodynamic activity in a selected region
of the patient's body, monitoring a change in blood oxygen content
at the selected region, and assessing the patient's endothelial
function based upon said monitoring.
[0118] Monitoring may be accomplished by taking measurements with a
pulse oximeter. The pulse oximeter may be placed proximate, e.g. on
the tip of one of the patient's fingers.
[0119] In one embodiment, a second preferred method for measuring
endothelial function comprises providing a vasodilating stimulant
to a patient to stimulate hemodynamic activity in a selected region
of the patient's body, monitoring a change in blood flow rate at
the selected region, and assessing the patient's endothelial
function based upon said monitoring.
[0120] Monitoring may be accomplished by taking measurements with a
photoplethysmograph placed proximate, e.g. on one of the patient's
fingers. Monitoring may also be accomplished by taking an
ultrasound Doppler measurement. Monitoring may occur from a time
prior to the beginning of the compression until a time after
ceasing, e.g. when blood flow has stabilized.
[0121] Providing a vasodilating stimulant may comprise compressing
one of the patient's arteries located in an outer extremity of the
patient's body for a predetermined period of time and ceasing the
compression after said predetermined period of time. The outer
extremity may be a leg, an arm, a wrist, and/or a finger.
[0122] The second preferred method for measuring endothelial
function may further comprise plotting measured blood flow as a
function of time and/or plotting the change in blood flow as a
function of time.
[0123] In one embodiment, a method is provided for assessing
endothelial function, comprising a providing a vasodilating
stimulant to a patient to stimulate hemodynamic activity in a
selected region of the patient's body; monitoring a change in a
hemodynamic parameter at the selected region; and assessing the
patient's endothelial function based upon said monitoring. In one
such embodiment, the hemodynamic parameter is at least one of (i)
blood temperature, (ii) blood oxygen content, or (iii) blood flow
rate. The vasodilating stimulant may comprise compressing the
patient's brachial artery or occluding blood flow in the patient's
arm for a predetermined period of time, and ceasing said
compression after the predetermined period of time. The monitoring
may further comprise monitoring a change in temperature at one of
the patient's fingertips. The vasodilating stimulant may comprise
occluding blood flow in the patient's leg.
[0124] In one embodiment, the monitoring comprises monitoring a
change in temperature in the patient's arm. In one embodiment, the
monitoring the change in temperature in the patient's arm is
accomplished by placing at least two temperature sensors proximate
the patient's forearm. In one embodiment, the temperature sensors
are piezoelectric sensors.
[0125] In another embodiment, the vasodilating stimulant comprises
occluding blood flow in the patients' leg.
[0126] In one embodiment, a method for measuring endothelial
function is provided, comprising: a) providing a vasodilating
stimulant to a patient to stimulate hemodynamic activity in a
selected region of the patient's body; b) monitoring a change in
blood oxygen content at the selected region; and c) assessing the
patient's endothelial function based upon said monitoring. In one
such embodiment, the monitoring is accomplished by taking
measurements with a pulse oximeter. In one such embodiment, the
pulse oximeter is placed proximate the tip of one of the patient's
fingers.
[0127] In one embodiment, a method is provided for measuring
endothelial function, comprising: a) providing a vasodilating
stimulant to a patient to stimulate hemodynamic activity in a
selected region of the patient's body; b) monitoring a change in
blood flow rate at the selected region; and c) assessing the
patient's endothelial function based upon said monitoring. In one
such embodiment, the monitoring is accomplished by taking
measurements with a photoplethysmograph placed proximate the tip of
one of the patient's fingers. Alternatively, monitoring is
accomplished by taking an ultrasound Doppler measurement. The
vasodilating stimulant may comprise compressing one of the
patient's arteries located in an outer extremity of the patient's
body for a predetermined period of time; and ceasing compression
after said predetermined period of time. In one embodiment, the
extremity is at least one of (i) a leg, (ii) an arm, (iii) a wrist,
or (iv) a finger. In one embodiment, the monitoring occurs from a
time prior to the beginning of said compression until a time after
said ceasing when said blood flow has stabilized. In one embodiment
the measured blood flow is plotted as a function of time. In
another embodiment, the change in blood flow is plotted as a
function of time.
[0128] Referring now to FIG. 2, in an exemplary embodiment, an
apparatus for determining one or more health conditions 100
includes a computer system 102 which is operably coupled to a
thermal energy sensor 104 and a vasostimulant 106. In an exemplary
embodiment, the computer system 102 may be, for example, a
conventional computer system known in the art. In an exemplary
embodiment, the thermal energy sensor 104 may be, for example, a
conventional thermal energy sensor known in the art. In an
exemplary embodiment, the thermal energy sensor 104 may be, for
example, a thermocouple, a thermister, a resistance temperature
detector, a heat flux sensor, a liquid crystal sensor, an infrared
sensor, a thermopile, or a variety of other thermal energy sensors
known in the art. In an exemplary embodiment, the thermal energy
sensor is an infrared sensor that measures the thermal energy of a
point on a surface. In an exemplary embodiment, thermal energy
sensor is an infrared sensor that measures the thermal energy of an
area on a surface. In an exemplary embodiment, the thermal energy
sensor 104 may be disposable. In an exemplary embodiment, the
vasostimulant 106 may be, for example, conventional vasostimulants
known in the art including mechanical vasostimulants such as cuffs
for compressing arteries, chemical vasostimulants such as
nitroglycerin or transdermal substances, sympathetic mimetic
agents, para-sympathetic mimetic agents, acetylcholine,
vasodilating nitrates such as, for example, nitroprusside or
glyceryl trinitrate, inhibitors of endothelium-derived contracting
factors such as, for example, ACE inhibitors or angiotensin II
receptor antagonists, cytoprotective agents such as, for example,
free radical scavengers such as superoxide dismutase endothelium
dependent agents such as, for example, acetylcholine, and/or
endothelium independent agents such as, for example, nitroprusside
or glycerin trinitrate, psychological vasostimulants such as
aptitude tests, mental arithmetic, visual stimulation,
physiological vasostimulants such as the Valsalva maneuver, a
tilting test, physical exercise, whole body warming, whole body
cooling, local warming, local cooling, contralateral handgrip,
contralateral hand cooling, and painful stimuli such as, for
example, nailbed compression, and a variety of others. In an
exemplary embodiment, the chemical vasostimulants may stimulate the
vessel either through the endothelium or bypass the endothelium and
directly affect the muscular part of the vessel wall, which is
endothelium independent. In an exemplary embodiment, the
vasostimulant 106 may be, for example, a neuro-vasostimulant, a
neurostimulant, a vasoconstrictor, a vasodialator, an endothermal
layer stimulant, or a smooth muscle cell or medial layer stimulant.
In an exemplary embodiment, a neuro-vasostimulant may include, for
example, having the subject drink a glass of ice water. In an
exemplary embodiment, the thermal energy sensor 104 and the
vasostimulant 106 are coupled to, monitored by, and/or controlled
by the computer system 102 through a wireless connection such as,
for example, a wireless connection including Bluetooth technology.
In an exemplary embodiment, the computer system 102 may be coupled
to a variety of convention medical devices known in the art such
as, for example, a conventional pulse oximeter or a conventional
blood pressure monitoring device.
[0129] Referring now to FIG. 3, in an exemplary embodiment, the
computer system 102 includes a database 102a. A thermal energy
sensor engine 102b is operably coupled to the database 102a. A
vasostimulant engine 102c is operably coupled to the database 102a
and the thermal energy sensor engine 102b. A plotting engine 102d
is operably coupled to the database 102a. In an exemplary
embodiment, the thermal energy sensor engine 102b, vasostimulant
engine 102c, and the plotting engine 102d may be, for example, a
variety of conventional software engines known in the art. In
several exemplary embodiment, the thermal energy sensor engine 102b
is adapted to control a thermal energy sensor such as, for example,
the thermal energy sensor 104 illustrated in FIG. 3, which is
operably coupled to the computer system 102. In several exemplary
embodiments, the vasostimulant engine 102c is adapted to control a
vasostimulant such as, for example, the vasostimulant 106
illustrated in FIG. 1, which is operably coupled to the computer
system 102. In several exemplary embodiments, the plotting engine
102d is adapted to retrieve data in database 102a and manipulate
the data in a variety of ways including, but not limited to,
sorting the data, plotting the data, and displaying the data. In an
exemplary embodiment, the computer system 102 is coupled to a
therapeutic device which may be operable to perform a therapeutic
function such as, for example, releasing oxygen. In an exemplary
embodiment, the computer system 102 is coupled to an alerting
device which may be, for example, operable to contact emergency
medical services.
[0130] Referring now to FIG. 3, in an exemplary embodiment, the
database 102a includes a plurality of data such as, for example, a
temperature at time A 102aa, a temperature at time B 102ab, a
temperature at time C 102ac, up to a temperature at time n 102ad.
In an exemplary embodiment, the temperature data may include
temperatures taken from one thermal energy sensor such as, for
example, the thermal energy sensor 104 illustrated in FIG. 3, or
from a plurality of thermal energy sensors.
[0131] Referring now to FIG. 4a, in an exemplary embodiment, the
computer system 102 includes a chassis 102e. A computer board 102f
is mounted to the chassis 102e and includes a thermal energy sensor
card 102g and a vasostimulant card 102h coupled to and extending
from the computer board 102f. A pump 102i is coupled to the
vasostimulant card 102h by a wire 102j. In an exemplary embodiment,
the chassis 102e may include wireless interface 102k for allowing
wireless communication to the computer board 102f. In an exemplary
embodiment, the chassis may include a plurality of communications
ports 102l mounted to a surface for allowing communication with the
computer board 102f. In an exemplary embodiment, the thermal energy
sensor card 102g is coupled to the thermal energy sensor 104,
illustrated in FIG. 2. In an exemplary embodiment, the
vasostimulant card 102h is coupled to the vasostimulant 106,
illustrated in FIG. 2, through the pump 102i.
[0132] Referring now to FIG. 4b, in an exemplary embodiment, the
computer system 102 is positioned on a chassis 102m. A plurality of
storage units 102na and 102nb extend from opposite sides of the
chassis 102m with the storage unit 102na providing storage for the
vasostimulant 106, described above with reference to FIG. 2, and
the storage unit 102nb providing storage for the thermal energy
sensor 104, described above with reference to FIG. 2. A display
102o is mounted to and positioned on top of the chassis 102m and
coupled to the computer system 102 in order to display data
collected by the computer system 102. An input device 102p is
mounted to the chassis 102m to provide input the computer system
102 and manipulate information displayed on the display 102o. In an
exemplary embodiment, the chassis 102m includes a plurality of
wheels 102q which are operable to allow moving of the chassis 102m.
In an exemplary embodiment, the computer system 102 is operable to
produce an output 102r which includes data collected by the
computer system 102.
[0133] Referring now to FIG. 5, in an exemplary embodiment, a
method for controlling a thermal energy sensor 200 is illustrated
in which a thermal energy sensor engine such as, for example, the
thermal energy sensor engine 102b illustrated in FIG. 3, is started
in step 202. Starting the thermal energy sensor engine 102b at step
202 allows the thermal energy sensor engine 102b to enter a standby
mode at step 204. At decision block 206, the thermal energy sensor
engine 102b determines whether it is time to start recording
temperature with a thermal energy sensor such as, for example, the
thermal energy sensor 104 illustrated in FIG. 2. If it is not time
to start recording temperature, the method 200 returns to step 204
where the thermal energy sensor engine 102b remains on standby.
[0134] If it is time to start recording temperature, the thermal
energy sensor engine 102b begins recording temperature at step 206
with the thermal energy sensor 104. The method 200 then proceeds to
step 208 where the thermal energy sensor engine 102b begins to
detect for temperature equilibrium in step 210. In an exemplary
embodiment, at step 210, the thermal energy sensor engine begins
comparing successive temperature measurements made by the thermal
energy sensor 104. At decision block 212, the thermal energy sensor
engine 102b determines whether temperature equilibrium has been
achieved. In an exemplary embodiment, temperature equilibrium is
achieved when temperature changes recorded by the thermal energy
sensor 104 are less than 0.1 degrees C. If the equilibrium has not
been achieved, the method 200 returns to step 210 where the thermal
energy sensor engine 102b detects for temperature equilibrium.
[0135] If equilibrium has been achieved, the method 200 proceeds to
step 214 where the thermal energy sensor engine 102b continues
recording temperature measurements made by the thermal energy
sensor 104. At decision block 216, the thermal energy sensor engine
102b determines whether to stop recording. In an exemplary
embodiment, the thermal energy sensor engine 102b will stop
recording when temperature measurements from the thermal energy
sensor 104 have stabilized. If it is not time to stop recording,
the method 200 returns to step 214 where the thermal energy sensor
engine 102b continues recording temperature measurements made by
the thermal energy sensor 104.
[0136] If it is time to stop recording, the method 200 proceeds to
step 218 where the thermal energy sensor engine 102b stops
recording temperature measurements made by the thermal energy
sensor 104. The method then proceeds to step 220 where the
temperature measurements recorded by the thermal energy sensor
engine 102b are saved to a database such as, for example, the
database 102 illustrated in FIG. 3. The method 200 then proceeds to
step 222 where the thermal energy sensor engine 200 is stopped.
[0137] Referring now to FIG. 6, in an exemplary embodiment, a
method for controlling a vasostimulant engine 300 is illustrated in
which a vasostimulant engine such as, for example, the
vasostimulant engine 102c illustrated in FIG. 3, is started in step
302. Starting the vasostimulant engine 102c at step 302 allows the
vasostimulant engine 102c to enter a standby mode at step 304. At
decision block 306, the vasostimulant engine 102c determines
whether to activate a vasostimulant such as, for example, the
vasostimulant 106 illustrated in FIG. 3. If it is not time to
activate the vasostimulant 106, the method 300 returns to step 304
where the vasostimulant engine 300 remains on standby.
[0138] If it is time to activate the vasostimulant 106, the method
300 proceeds to step 308 where the vasostimulant engine 102c
activates the vasostimulant 106. At decision block 310, the
vasostimulant engine 102c determines whether it is time to
deactivate the vasostimulant 106. If it is not time to deactivate
the vasostimulant 106, the method 300 returns to step 308 where the
vasostimulant engine 102c keeps the vasostimulant 106
activated.
[0139] If it is time to deactivate the vasostimulant 106, the
method 300 proceeds to step 312 where the vasostimulant engine 102c
deactivates the vasostimulant 106. The method 300 then proceeds to
step 314 where the vasostimulant engine 102c is stopped.
[0140] Referring now to FIG. 7, in an exemplary embodiment, a
method for controlling a plotting engine 400 is illustrated in
which a plotting engine such as, for example, the plotting engine
102d illustrated in FIG. 3, is started in step 402. Starting the
plotting engine 102d at step 402 allows the plotting engine 102d to
enter a standby mode at step 404. At decision block 406, the
plotting engine 102d determines whether it is time to plot data. If
it is not time to plot data, the method 400 returns to step 404
where the plotting engine 102d remains on standby.
[0141] If it is time to plot data, the method 400 proceeds to step
408 where the plotting engine 102d retrieves data from a database
such as, for example, the database 102a illustrated in FIG. 3. At
decision block 410, the plotting engine 102d determines whether all
of the data needed has been retrieved from database 102a. If all
the data has not been retrieved, the method 400 returns to step 408
where the plotting engine 102d continues to retrieve data from
database 102a.
[0142] If all the data needed has been retrieved from database
102a, the method proceeds to step 412 where the plotting engine
102d plots the data. The method 400 then proceeds to step 414 where
the plotting engine 102d is stopped.
[0143] Referring now to FIG. 8a and 8b, in an exemplary embodiment,
a method for determining one or more health conditions 500 is
illustrated which begins with a subject preparation at step 502.
Subject preparation at step 502 may include, for example, having a
subject such as, for example, the subject 10 illustrated in FIG. 3,
refrain from eating before carrying out the method 500, having the
subject 10 refrain from smoking before carrying out the method 500,
having the subject 10 refrain from ingesting alcohol or caffeine
before carrying out the method 500, or having the subject 10
refrain from taking any vascular medications before carrying out
the method 500, having the subject 10 refrain from exposure to cold
weather before carrying out the method 500, ensuring the subject 10
is not experiencing urinary urgency or full bladder before carrying
out the method 500, having the subject 10 refrain from physical or
mental exercise before carrying out the method 500, and a variety
of other factors that may temporarily affect vascular function
known in the art. In an exemplary embodiment, the subject
preparation at step 502 may begin at least 12 hours prior to the
method 500 proceeding to step 504.
[0144] At step 504, a thermal energy sensor such as, for example,
the thermal energy sensor 104 illustrated in FIG. 3, may be placed
on the subject 10. In an exemplary embodiment, the thermal energy
sensor 104 may be a conventional thermal energy sensor known in the
art. In an exemplary embodiment, the thermal energy sensor 104 is
designed such that there is a minimal area of contact between the
sensor and the subject 10. In an exemplary embodiment, when placed
on the subject 10, the thermal energy sensor 104 provides a minimal
pressure to the subject 10. In an exemplary embodiment, in
operation, the thermal energy sensor 104 measures thermal energy
only and does not introduce any signals into the subject 10. In an
exemplary embodiment, thermal energy measured by the thermal energy
sensor 104 is not effected by insulation or perspiration. In an
exemplary embodiment, the thermal energy sensor 104 does not alter
the microcapillary flow in the subject 10. In an exemplary
embodiment, the thermal energy sensor 104 does not restrict
movement of the subject 10 and thermal energy measurements are not
effected by subject 10 movement. In an exemplary embodiment, a
plurality of thermal energy sensor 104 may be positioned at
different locations on the subject 10. In an exemplary embodiment,
the thermal energy sensor 104 is positioned on a body part of the
subject 10 such as, for example, the finger 16, forearm, toe, leg,
an earlobe, a rectum, or a nose. In an exemplary embodiment, the
thermal energy sensor 104 may be placed on the subject 10 in order
to measure the thermal energy of distal resistant vessels on the
subject 10. In an exemplary embodiment, the thermal energy sensor
104 may allow the visualization of thermal response by infrared
thermal energy measuring devices such as, for example, cameras,
thermosensors, and/or thermocouples. In an exemplary embodiment,
the thermal energy sensor 104 minimizes the temperature changes
associated with the contact of the skin surface and thermal energy
sensor 104 and allows the thermal energy sensor 104 to be minimally
effected by factors and conditions that change skin temperature but
are not associated with changes in blood flow, subcutaneous blood
flow, tissue heat generation, and/or tissue heat transduction. In
an exemplary embodiment, the method 500 may be carried out
invasively and the thermal energy sensor 104 may placed beneath the
surface of the skin such as, for example, in the subcutaneous
region, the intramuscular region, the intravascular region, within
the surrounding tissue, and/or inside the body.
[0145] At step 506, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates a thermal energy sensor such as, for example, the
thermal energy sensor 104 illustrated in FIG. 3, to begin recording
the temperature of the subject 10. In an exemplary embodiment,
temperature data begins being recorded continuously. In an
exemplary embodiment, the thermal energy sensor 102b measures the
skin temperature of the subject's body on which it is placed such
as, for example, the hand, forearm, foot, leg, earlobe, rectum, or
nose. In an exemplary embodiment, the thermal energy sensor 102b
engages the skin of the subject 10 in order to measure temperature.
In an exemplary embodiment, the thermal energy sensor 102b measures
the skin temperature of the subject 10 without engaging the skin of
the subject 10. In an exemplary embodiment, the ambient temperature
is held constant around the thermal energy sensor 104. In an
exemplary embodiment, the fluid flow such as, for example, the
airflow, around the thermal energy sensor 104 is kept to a minimum.
In an exemplary embodiment, the thermal energy sensor 104 includes
an infrared thermal energy measurement device which measures the
thermal response of the face or other highly vascular areas.
[0146] At step 508, the thermal energy sensor engine 102b begins to
detect for equilibrium in the temperature of subject 10. In an
exemplary embodiment, at step 508, the thermal energy sensor engine
102b retrieves successive temperature measurements from the thermal
energy sensor 104.
[0147] At decision block 510, the thermal energy sensor engine 102b
determines whether the temperature of the subject 10 has reached
equilibrium. If the temperature of the subject 10 has not reached
equilibrium, the temperature sensor engine proceeds back to step
508 to detect for equilibrium. In an exemplary embodiment,
determining whether the temperature of the subject 10 has reached
equilibrium in step 510 may include, for example, determining
whether the temperature changes of a subject 10 are less than 0.1
degree C.
[0148] If the temperature changes in the subject 10 have reached
equilibrium, the method proceeds to step 512 where a vasostimulant
engine such as, for example, the vasostimulant engine 102c
illustrated in FIG. 3, activates a vasostimulant such as, for
example, the vasostimulant 106 illustrated in FIG. 3. In an
exemplary embodiment, the vasostimulant 106 may be an inflatable
cuff, and activating the vasostimulant 106 at step 512 may include,
for example inflating the cuff to 200 mm Hg systolic BP. In an
exemplary embodiment, the vasostimulant 106 may be a chemical such
as, for example, nitroglycerin, and activating the vasostimulant
106 at step 512 may include administering a predetermined amount of
the chemical to the subject 10. Further methods of providing a
chemical vasostimulant 106 include injecting it into a vein or
artery of the subject 10, having the subject 10 orally inject the
chemical vasostimulant 106, having the subject 10 inhale the
chemical vasostimulant 106, having the subject 10 sublingually
absorb the chemical vasostimulant 106, and/or having the subject 10
diffuse the chemical vasostimulant 106 through their skin such as,
for example, by having the subject diffuse 1% acetylcholine
chloride for endothelium dependent assessment and 1% sodium
nitroprusside for endothelium independent response. In an exemplary
embodiment, the vasostimulant 106 may be an aptitude test, and
activating the vasostimulant 106 at step 512 may include having the
subject 10 begin the aptitude test. In an exemplary embodiment,
providing the vasostimulant 106 may include rubbing a vasodilator
cream such as, for example, a 1% topical acetylcholine cream on the
skin of the subject 10 where significant subcutaneous fat exists
such as, for example, the abdominal area. The continued recording
of temperature may then include visualizing the thermal response of
the subject 10 with an infrared thermal measurement device. In an
exemplary embodiment, the provision of the vasostimulant 106 may
include provision of modifiers of vasostimulators such as, for
example, LNAME, which stops production of nitric oxide, or
L-Arginine, which increases the nitric oxide level of endothelial
cells.
[0149] At step 514, the vasostimulant engine 102c may deactivate
the vasostimulant 106. In an exemplary embodiment, the
vasostimulant 106 may be an inflatable cuff, and deactivating the
vasostimulant 106 at step 514 may include deflating the cuff. In an
exemplary embodiment, the vasostimulant 106 may be a chemical such
as, for example, nitroglycerin, and deactivating the vasostimulant
106 at step 514 may include providing an amount of the chemical in
step 512 such that the effects of the chemical on the subject 10
wear off in a predetermined amount of time. In an exemplary
embodiment, deactivating the vasostimulant 106 at step 514 may
include providing additional chemicals to the subject 10 to reverse
the effects of the vasostimulant chemicals provided in step 512. In
an exemplary embodiment, the vasostimulant 106 may be an aptitude
test, and deactivating the vasostimulant 106 at step 514 may
include having the subject 10 cease taking the aptitude test. In an
exemplary embodiment, the vasostimulant is deactivated anywhere
from 2 to 5 minutes after activation in step 512. In an exemplary
embodiment, the vasostimulant is deactivated less than 5 minutes
after activation in step 512, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 512, which
is less than the conventional deactivation time for tests involving
vasostimulation and provides a method which reduces the pain
sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 512, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 512,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject 10 may be asked to exercise the body part
on which thermal energy is being detected, which allows the method
500 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0150] At step 516, the thermal energy sensor engine 102b begins to
detect for equilibrium in the temperature of subject 10. In an
exemplary embodiment, at step 516, the thermal energy sensor engine
102b retrieves successive temperature measurement from the thermal
energy sensor.
[0151] At decision block 518, the thermal energy sensor engine 102b
determines whether the temperature of the subject 10 has reached
equilibrium. If the temperature of the subject 10 has not reached
equilibrium, the temperature sensor engine proceeds back to step
516 to detect for equilibrium. In an exemplary embodiment,
determining whether the temperature of the subject 10 has reached
equilibrium in step 518 may include, for example, determining
whether the temperature changes of a subject 10 are less than 0.1
degree C.
[0152] If the temperature changes in the subject 10 have reached
equilibrium, the method proceeds to step 520 where the temperature
sensor engine 102b stops recording the temperature of the subject
10.
[0153] At step 522, data acquired from measuring and recording
temperature changes which began at step 506 and continued
throughout the method 500 is saved by the temperature sensor engine
102b to a database such as, for example, the database 102a
illustrated in FIG. 3.
[0154] At step 524, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a.
[0155] At step 526, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained. In an
exemplary embodiment, the plotting engine 102d may retrieve data
taken from multiple positions on subject 10 and plot out an average
of that data over time. In an exemplary embodiment, the plotting
engine 102d may retrieve data taken from subject 10 at different
times and plot out an average of that data.
[0156] Referring now to FIGS. 9a and 9b, an alternative embodiment
of an apparatus for determining one or more health conditions 600
is substantially identical in design and operation to apparatus 100
described above with reference to FIGS. 1, 2, 3, 4, 5, 6, 7, 8a and
8b with the addition of a display 602, a plurality of output
buttons 604, a plurality of coupling wires 606, and vasostimulant
coupling member 608. Computer system 102 includes the display 602
and the plurality of display output buttons 604 on a surface. A
plurality of the thermal energy sensors 104a and 104b are coupled
to the computer system 102 by respective coupling wires 606. The
vasostimulator 106 is a pressure cuff and is coupled to the
computer system 102 by coupling wire 606. The pressure cuff
vasostimulator 106 includes a vasostimulant coupling member 608
along an edge of its length. In an exemplary embodiment, the
pressure cuff vasostimulator 106 may be adapted to measure a
subject's blood pressure. Thermal energy sensor 104a is
substantially similar to thermal energy sensor 104b and includes a
tubular housing 104aa with a hemispherical closed end 104ab and an
open end 104ac opposite the closed end 104ab. The housing 104aa
defines a passageway 104ad therein, and includes a thermal energy
measurement device 104ae positioned in the passageway 104ad and
adjacent the closed end 104ab. A coupling member 104af is
positioned in the passageway 104ad adjacent the open end 104ac.
[0157] Referring now to FIG. 10a, 10b, 10c, and 10d, in an
exemplary embodiment, a method for determining one or more health
conditions 700 using the apparatus 600 illustrated in FIGS. 9a and
9b is illustrated which begins with placing the pressure cuff
vasostimulant 106 on arm 12 of subject 10 at step 702. Pressure
cuff vasostimulant 106 may be secured to arm 12 by vasostimulant
coupling member 608 which may include a variety of adhesive
materials known in the art. In an exemplary embodiment, the subject
10 may be in a seated position during method 700.
[0158] At step 704, thermal energy sensor 104a may be placed on
finger 16 of the subject 10. Finger 16 is placed in passageway
104ad of thermal energy sensor 104a such that a distal end of the
finger 16 is coupled to thermal energy measurement device 104ae.
With finger 16 coupled to thermal energy measurement device 104ae,
coupling member 104af secures finger 16 in thermal energy sensor
104a.
[0159] At step 706, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates the thermal energy sensor 104a to begin recording the
skin temperature of the finger 16 of subject 10. In an exemplary
embodiment, temperature data begins being recorded continuously. In
an exemplary embodiment, the thermal energy sensor 104a engages the
skin of the finger 16 of subject 10 in order to measure
temperature. In an exemplary embodiment, the thermal energy sensor
104a measures the skin temperature of the finger 16 of subject 10
without engaging the skin of the finger 16 of subject 10. In an
exemplary embodiment, the ambient temperature is held constant
around the thermal energy sensor 104a. In an exemplary embodiment,
the fluid flow such as, for example, the airflow, around the
thermal energy sensor 104a is kept to a minimum.
[0160] At step 708, the thermal energy sensor engine 102b begins to
detect for equilibrium in the skin temperature of the finger 16 of
subject 10. In an exemplary embodiment, at step 508, the thermal
energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104a.
[0161] At decision block 710, the thermal energy sensor engine 102b
determines whether the skin temperature of finger 106 of subject 10
has reached equilibrium. If the skin temperature of finger 16 has
not reached equilibrium, the temperature sensor engine 102b
proceeds back to step 708 to detect for equilibrium. In an
exemplary embodiment, determining whether the skin temperature of
the finger 16 has reached equilibrium in step 710 may include, for
example, determining whether the temperature changes of the finger
16 are less than 0.1 degree C.
[0162] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 712 where a vasostimulant
engine such as, for example, the vasostimulant engine 102c
illustrated in FIG. 3, activates the pressure cuff vasostimulant
106. In an exemplary embodiment, activating the pressure cuff
vasostimulant 106 at step 712 may include, for example, inflating
the cuff to 200 mm Hg systolic BP.
[0163] At step 714, the vasostimulant engine 102c may deactivate
the pressure cuff vasostimulant 106. In an exemplary embodiment,
deactivating the pressure cuff vasostimulant 106 at step 714 may
include deflating the cuff. In an exemplary embodiment, the
pressure cuff vasostimulant 106 is deactivated anywhere from 2 to 5
minutes after activation in step 712. In an exemplary embodiment,
the vasostimulant is deactivated less than 5 minutes after
activation in step 712, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 712, which
is less than the conventional deactivation time for tests involving
vasostimulation and provides a method which reduces the pain
sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 712, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 712,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject 10 may be asked to exercise the body part
on which thermal energy is being detected, which allows the method
700 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0164] At step 716, the thermal energy sensor engine 102b begins to
detect for equilibrium in the skin temperature of the finger 16 of
subject 10. In an exemplary embodiment, at step 716, the thermal
energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104a.
[0165] At decision block 718, the thermal energy sensor engine 102b
determines whether the skin temperature of the finger 16 of subject
10 has reached equilibrium. If the skin temperature of the finger
16 has not reached equilibrium, the temperature sensor engine 102b
proceeds back to step 716 to detect for equilibrium. In an
exemplary embodiment, determining whether the skin temperature of
the finger 16 has reached equilibrium in step 718 may include, for
example, determining whether the temperature changes of the finger
16 are less than 0.1 degree C.
[0166] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 720 where the temperature
sensor engine 102b stops recording the skin temperature of the
finger 16 of subject 10.
[0167] At step 722, data acquired from measuring and recording
temperature changes of finger 16 which began at step 706 and
continued throughout the method 700 is saved by the temperature
sensor engine 102b to a database such as, for example, the database
102a illustrated in FIG. 3.
[0168] At step 724, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a.
[0169] At step 726, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained.
[0170] Referring now to FIGS. 9a, 9b, 11a, 11b, and 11c, in an
exemplary embodiment, a method for determining one or more health
conditions 800 using the apparatus 600 illustrated in FIGS. 9a and
9b is illustrated which begins with placing the pressure cuff
vasostimulant 106 on arm 12 of subject 10 at step 802. Pressure
cuff vasostimulant 106 may be secured to arm 12 by vasostimulant
coupling member 608 which may include a variety of adhesive
materials known in the art. In an exemplary embodiment, the subject
10 may be in a seated position during method 700.
[0171] At step 804, thermal energy sensor 104a may be placed on
finger 16 of the subject 10. Finger 16 is placed in passageway
104ad of thermal energy sensor 104a such that a distal end of the
finger 16 is coupled to thermal energy measurement device 104ae.
With finger 16 coupled to thermal energy measurement device 104ae,
coupling member 104af secures finger 16 in thermal energy sensor
104a.
[0172] At step 806, thermal energy sensor 104b may be placed on
contralateral finger 18 of the subject. Contralateral finger 18 is
placed in thermal energy sensor 104b in substantially the same
manner as finger 16 is place in thermal energy sensor 104a
described above with reference to FIGS. 9a, 9b, 10c and 10d. In an
exemplary embodiment, a plurality of thermal energy sensors similar
to thermal energy sensor 104, illustrated in FIG. 3, may be placed
on a plurality of contralateral body parts. In an exemplary
embodiment, a contralateral body part includes any body part on the
subject which is not directly affected by the vasostimlant
activated in step 814 such as, for example, any body part on the
subject which is not distal to the vasostimulant. In an exemplary
embodiment, the thermal energy sensor 104b may be placed on the toe
22 of the subject.
[0173] At step 808, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates the thermal energy sensors 104 to begin recording the
skin temperature of the finger 16 and contralateral finger 18 of
subject. In an exemplary embodiment, temperature data begins being
recorded continuously. In an exemplary embodiment, the thermal
energy sensors 104a and 104b engage the skin of the finger 16 and
contralateral finger 18 of subject in order to measure temperature.
In an exemplary embodiment, the thermal energy sensor 104a and 104b
measure the skin temperature of the finger 16 and contralateral
finger 18 of subject 10 without engaging the skin of the finger 16
and contralateral finger 18 of subject. In an exemplary embodiment,
the ambient temperature is held constant around the thermal energy
sensor 104a and 104b. In an exemplary embodiment, the fluid flow
such as, for example, the airflow, around the thermal energy sensor
104a and 104b is kept to a minimum.
[0174] At step 810, the thermal energy sensor engine 102b begins to
detect for equilibrium in the skin temperature of the finger 16 of
subject. In an exemplary embodiment, at step 810, the thermal
energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104a.
[0175] At decision block 812, the thermal energy sensor engine 102b
determines whether the skin temperature of finger 16 of subject has
reached equilibrium. If the skin temperature of finger 16 has not
reached equilibrium, the temperature sensor engine 102b proceeds
back to step 810 to detect for equilibrium. In an exemplary
embodiment, determining whether the skin temperature of the finger
16 has reached equilibrium in step 812 may include, for example,
determining whether the temperature changes of the finger 16 are
less than 0.1 degree C.
[0176] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 814 where a vasostimulant
engine such as, for example, the vasostimulant engine 102c
illustrated in FIG. 3, activates the pressure cuff vasostimulant
106. In an exemplary embodiment, activating the pressure cuff
vasostimulant 106 at step 814 may include, for example, inflating
the cuff to 200 mm Hg systolic BP.
[0177] At step 816, the vasostimulant engine 102c may deactivate
the pressure cuff vasostimulant 106. In an exemplary embodiment,
deactivating the pressure cuff vasostimulant 106 at step 816 may
include deflating the cuff. In an exemplary embodiment, the
pressure cuff vasostimulant 106 is deactivated anywhere from 2 to 5
minutes after activation in step 814. In an exemplary embodiment,
the vasostimulant is deactivated less than 5 minutes after
activation in step 814, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 814, which
is less than the conventional deactivation time for tests involving
vasostimulation and provides a method which reduces the pain
sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 814, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 814,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject 10 may be asked to exercise the body part
on which thermal energy is being detected, which allows the method
800 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0178] At step 818, the thermal energy sensor engine 102b begins to
detect for equilibrium in the skin temperature of the finger 16 of
subject 10. In an exemplary embodiment, at step 818, the thermal
energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104a. At decision block
820, the thermal energy sensor engine 102b determines whether the
skin temperature of the finger 16 of subject 10 has reached
equilibrium. If the skin temperature of the finger 16 has not
reached equilibrium, the temperature sensor engine 102b proceeds
back to step 818 to detect for equilibrium. In an exemplary
embodiment, determining whether the skin temperature of the finger
16 has reached equilibrium in step 820 may include, for example,
determining whether the temperature changes of the finger 16 are
less than 0.1 degree C.
[0179] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 822 where the temperature
sensor engine 102b stops recording the skin temperature of the
finger 16 of subject 10. At step 824, data acquired from measuring
and recording temperature changes of finger 16 and contralateral
finger 18 which began at step 808 and continued throughout the
method 800 is saved by the temperature sensor engine 102b to a
database such as, for example, the database 102a illustrated in
FIG. 3. At step 826, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a.
[0180] At step 828, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the data for
the finger 16 and contralateral finger 18 may be plotted on the
same graph. In an exemplary embodiment, the plotting engine 102d
may plot out data obtained from the temperature measurements
concurrent with the data being obtained. In an exemplary
embodiment, the temperature changes measured in the finger 16 may
be adjusted based on the temperature changes measured in the
contralateral finger 18. For example, the adjustment may include
subtracting the temperature changes measured in the contralateral
finger 18 from the temperature changes measured in the finger 16,
or vice versa.
[0181] Referring now to FIGS. 9a, 9b, 12a, 12b, and 12c, in an
exemplary embodiment, a method for determining one or more health
conditions 900 using the apparatus 600 illustrated in FIGS. 9a and
9b is illustrated which begins with placing the pressure cuff
vasostimulant 106 on a leg of subject 10 at step 902. Pressure cuff
vasostimulant 106 may be secured to a leg by vasostimulant coupling
member 608 which may include a variety of adhesive materials known
in the art. At step 904, thermal energy sensor 104a may be placed
on a toe of the subject 10. A toe is placed in thermal energy
sensor 104b in substantially the same manner as finger 16 is place
in thermal energy sensor 104a described above with reference to
FIGS. 9a, 9b, 10c and 10d.
[0182] At step 906, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates the thermal energy sensor 104a to begin recording the
skin temperature of the toe of a subject. In an exemplary
embodiment, temperature data begins being recorded continuously. In
an exemplary embodiment, the thermal energy sensor 104a engages the
skin of the toe in order to measure temperature. In an exemplary
embodiment, the thermal energy sensor 104a measures the skin
temperature of the toe without engaging the skin of the toe. In an
exemplary embodiment, the ambient temperature is held constant
around the thermal energy sensor 104a. In an exemplary embodiment,
the fluid flow such as, for example, the airflow, around the
thermal energy sensor 104a is kept to a minimum.
[0183] At step 908, the thermal energy sensor engine 102b begins to
detect for equilibrium in the skin temperature of the toe. In an
exemplary embodiment, at step 908, the thermal energy sensor engine
102b begins comparing successive temperature measurement from the
thermal energy sensor 104a.
[0184] At decision block 910, the thermal energy sensor engine 102b
determines whether the skin temperature of toe has reached
equilibrium. If the skin temperature of toe has not reached
equilibrium, the temperature sensor engine 102b proceeds back to
step 908 to detect for equilibrium. In an exemplary embodiment,
determining whether the skin temperature of the toe has reached
equilibrium in step 812 may include, for example, determining
whether the temperature changes of the toe are less than 0.1 degree
C.
[0185] If the temperature changes in the toe have reached
equilibrium, the method proceeds to step 912 where a vasostimulant
engine such as, for example, the vasostimulant engine 102c
illustrated in FIG. 3, activates the pressure cuff vasostimulant
106. In an exemplary embodiment, activating the pressure cuff
vasostimulant 106 at step 912 may include, for example, inflating
the cuff to 200 mm Hg systolic BP.
[0186] At step 914, the vasostimulant engine 102c may deactivate
the pressure cuff vasostimulant 106. In an exemplary embodiment,
deactivating the pressure cuff vasostimulant 106 at step 914 may
include deflating the cuff. In an exemplary embodiment, the
pressure cuff vasostimulant 106 is deactivated anywhere from 2 to 5
minutes after activation in step 912. In an exemplary embodiment,
the vasostimulant is deactivated less than 5 minutes after
activation in step 912, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 912, which
is less than the conventional deactivation time for tests involving
vasostimulation and provides a method which reduces the pain
sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 912, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 912,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject may be asked to exercise the body part on
which thermal energy is being detected, which allows the method 900
to simulate a longer vasostimulation in a shorter amount of time,
which can also reduce the pain sometimes associated with
vasostimulants.
[0187] At step 916, the thermal energy sensor engine 102b begins to
detect for equilibrium in the skin temperature of the toe. In an
exemplary embodiment, at step 916, the thermal energy sensor engine
102b retrieves successive temperature measurement from the thermal
energy sensor 104a. At decision block 918, the thermal energy
sensor engine 102b determines whether the skin temperature of the
toe has reached equilibrium. If the skin temperature of the toe has
not reached equilibrium, the temperature sensor engine 102b
proceeds back to step 916 to detect for equilibrium. In an
exemplary embodiment, determining whether the skin temperature of
the toe has reached equilibrium in step 918 may include, for
example, determining whether the temperature changes of the toe are
less than 0.1 degree C.
[0188] If the temperature changes in the toe has reached
equilibrium, the method proceeds to step 920 where the temperature
sensor engine 102b stops recording the skin temperature of the toe.
At step 922, data acquired from measuring and recording temperature
changes of toe 22 which began at step 906 and continued throughout
the method 900 is saved by the temperature sensor engine 102b to a
database such as, for example, the database 102a illustrated in
FIG. 3. At step 924, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a. At step 926, the plotting engine 102d may plot
out the data retrieved. In an exemplary embodiment, the data may be
plotted out as temperature vs. time. In an exemplary embodiment,
the plotting engine 102d may plot out data obtained from the
temperature measurements concurrent with the data being
obtained.
[0189] Referring now to FIG. 13, an alternative embodiment of a
method for determining one or more health conditions 1000 is
substantially identical in design and operation to method 500
described above with reference to FIGS. 8a and 8b, with the
addition of determining health condition at step 1002. In an
exemplary embodiment, determining health condition at step 1002 may
involved a health care professional analyzing the temperature data
in order to diagnose a variety of health conditions for the subject
10. In an several exemplary embodiments, determining a health
condition at step 1002 includes, for example, assessing the risk of
atherosclerotic cardiovascular disorder, monitoring the progression
of heart failure, managing obesity, screening for high sympathetic
reactivity, screening for high blood pressure, screening for white
coat hypertension, screening for smooth muscle cell dysfunction,
predicting the development of diabetes, determining a fitness
level, assessing the vascular effects of a rheumatologic disorder,
screening for Raynauld's phenomenon, predicting the risk of
connective tissue disorders, determining the risk for pulmonary
hypertension, monitoring a smoking cessation program, and
monitoring sleep disorders such as, for example, sleep apnea.
[0190] Referring now to FIG. 14, an alternative embodiment of a
method for determining one or more health conditions 1100 is
substantially identical in design and operation to method 500
described above with reference to FIGS. 8a and 8b, with the
addition of consulting additional diagnosis methods at step 1102
and determining health condition at step 1104. In an exemplary
embodiment, consulting additional diagnosis methods at step 1102
may involve measuring other parameters of subject 10 such as, for
example, blood pressure, glucose level, internal temperature, and a
variety of others. In an exemplary embodiment, determining health
condition at step 1104 may involved a health care professional
analyzing the temperature data along with data obtained from
additional diagnosis methods in order to diagnose a variety of
health conditions for the subject. In an several exemplary
embodiments, determining a health condition at step 1002 includes,
for example, assessing the risk of atherosclerotic cardiovascular
disorder, monitoring the progression of heart failure, managing
obesity, screening for high sympathetic reactivity, screening for
high blood pressure, screening for white coat hypertension,
screening for smooth muscle cell dysfunction, predicting the
development of diabetes, determining a fitness level, assessing the
vascular effects of a rheumatologic disorder, screening for
Raynauld's phenomenon, predicting the risk of connective tissue
disorders, determining the risk for pulmonary hypertension,
monitoring a smoking cessation program, and monitoring sleep
disorders such as, for example, sleep apnea.
[0191] Referring now to FIG. 15, an alternative embodiment of an
apparatus for determining one or more health conditions 1200 is
substantially identical in design and operation to apparatus 600
described above with reference to FIGS. 9a, 9b, 10a, 10b, 10c, and
10d, with the addition of a thermal energy sensor 1202. Thermal
energy sensor 1202 is coupled to computer system 102 by wire 606
and includes a glove 1202a including a plurality of thermal energy
measurement devices 1204a, 1204b, and 1204c, which are positioned
at different locations on the glove 1202a. Having the thermal
energy measurement devices 1204a, 1204b, and 1204c positioned at
different locations on the glove 1202a allows blood flow rate from
device to device to be calculated. In an exemplary embodiment,
glove 1202a may extend and cover the skin surface up to the
vasostimulant 106.
[0192] Referring now to FIG. 16, an alternative embodiment of an
apparatus for determining one or more health conditions 1300 is
substantially identical in design and operation to apparatus 600
described above with reference to FIGS. 9a, 9b, 10a, 10b, 10c, and
10d, with the addition of a thermal energy sensor 1302. Thermal
energy sensor 1302 is coupled to computer system 102 by wire 606
and includes a coupler 1304 operable to couple the thermal energy
sensor 1302 to subject 10 without substantially changing the
temperature of the subject 10. In an exemplary embodiment, the
coupler 1304 may be a mesh material or other similar materials that
limit thermal insulation of the subject 10. In an exemplary
embodiment, the coupler 1304 is operable to keep the thermal energy
sensor 1302 in contact with the skin surface with minimal pressure,
contact area, and insulation.
[0193] Referring now to FIG. 17, an alternative embodiment of an
apparatus for determining one or more health conditions 1400 is
substantially identical in design and operation to apparatus 600
described above with reference to FIGS. 9a, 9b, 10a, 10b, 10c, and
10d, with the addition of a support strap 1402. The support strap
1402 allows the apparatus 1400 to be coupled to the subject for
repeated use of the apparatus throughout a predetermined time
period such as, for example, 24 hours. In an exemplary embodiment,
support strap 902 allows ambulatory measurements to be taken of the
subject.
[0194] Referring now to FIGS. 9a, 9b, 17, 18a, and 18b, in an
exemplary embodiment, a method for determining one or more health
conditions 1500 using the apparatus 1400 illustrated in FIG. 17 is
illustrated which begins with placing the pressure cuff
vasostimulant 106 on arm 12 of subject 10 at step 1502. Pressure
cuff vasostimulant 106 may be secured to arm 12 by vasostimulant
coupling member 608 and with securing strap 1402, which keeps
pressure cuff vasostimulant 102 positioned properly on arm 12.
[0195] At step 1504, thermal energy sensor 104 may be placed on
finger 16 of the subject 10. Finger 16 is placed in passageway 104d
of thermal energy sensor 104 such that a distal end of the finger
16 is coupled to thermal energy measurement device 104e. With
finger 16 coupled to thermal energy measurement device 104e,
coupling member 104f secures finger 16 in thermal energy sensor
104.
[0196] At step 1506, computer system 102 may be positioned on
subject 10. In an exemplary embodiment, computer system 102 may be
positioned on subject 10 by coupling it to a belt, waistband, or
other article of clothing on subject 10.
[0197] At step 1508, the computer system 102 is placed on standby.
In an exemplary embodiment, when computer system 102 is on standby
at step 1508, the computer system 102 is powered on but not running
as to save power in the computer system 102.
[0198] At decision block 1510, the computer system 102 checks
whether the apparatus 1400 is scheduled to run. If the apparatus
1400 is not scheduled to run, the computer system is returned to
standby at step 1508. In an exemplary embodiment, the apparatus may
be scheduled to run periodically through a predetermined time
period such as, for example, 24 hours.
[0199] If the apparatus 1400 is scheduled to run, the method 1500
proceeds to step 1512 where a thermal energy sensor engine such as,
for example, the thermal energy sensor engine 102b illustrated in
FIG. 3, activates the thermal energy sensor 104 to begin recording
the skin temperature of the finger 16 of subject 10. In an
exemplary embodiment, temperature data begins being recorded
continuously. In an exemplary embodiment, the thermal energy sensor
104 engages the skin of the finger 16 of subject 10 in order to
measure temperature. In an exemplary embodiment, the thermal energy
sensor 104 measures the skin temperature of the finger 16 of
subject 10 without engaging the skin of the finger 16 of subject
10. In an exemplary embodiment, the ambient temperature is held
constant around the thermal energy sensor 104. In an exemplary
embodiment, the fluid flow such as, for example, the airflow,
around the thermal energy sensor 104 is kept to a minimum.
[0200] At step 1514, the thermal energy sensor engine 102b begins
to detect for equilibrium in the skin temperature of the finger 16
of subject 10. In an exemplary embodiment, at step 1514, the
thermal energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104.
[0201] At decision block 1516, the thermal energy sensor engine
102b determines whether the skin temperature of finger 106 of
subject 10 has reached equilibrium. If the skin temperature of
finger 16 has not reached equilibrium, the temperature sensor
engine 102b proceeds back to step 1514 to detect for equilibrium.
In an exemplary embodiment, determining whether the skin
temperature of the finger 16 has reached equilibrium in step 1516
may include, for example, determining whether the temperature
changes of the finger 16 are less than 0.1 degree C.
[0202] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 1518 where a vasostimulant
engine such as, for example, the vasostimulant engine 102c
illustrated in FIG. 2, activates the pressure cuff vasostimulant
106. In an exemplary embodiment, activating the pressure cuff
vasostimulant 106 at step 1518 may include, for example, inflating
the cuff to 200 mm Hg systolic BP.
[0203] At step 1520, the vasostimulant engine 102c may deactivate
the pressure cuff vasostimulant 106. In an exemplary embodiment,
deactivating the pressure cuff vasostimulant 106 at step 1520 may
include deflating the cuff. In an exemplary embodiment, the
pressure cuff vasostimulant 106 is deactivated anywhere from 2 to 5
minutes after activation in step 1518. In an exemplary embodiment,
the vasostimulant is deactivated less than 5 minutes after
activation in step 1518, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 1518,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 1518, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 1518,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject may be asked to exercise the body part on
which thermal energy is being detected, which allows the method
1500 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0204] At step 1522, the thermal energy sensor engine 102b begins
to detect for equilibrium in the skin temperature of the finger 16
of subject 10. In an exemplary embodiment, at step 1522, the
thermal energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104.
[0205] At decision block 1524, the thermal energy sensor engine
102b determines whether the skin temperature of the finger 16 of
subject 10 has reached equilibrium. If the skin temperature of the
finger 16 has not reached equilibrium, the temperature sensor
engine 102b proceeds back to step 1522 to detect for equilibrium.
In an exemplary embodiment, determining whether the skin
temperature of the finger 16 has reached equilibrium in step 1524
may include, for example, determining whether the temperature
changes of the finger 16 are less than 0.1 degree C.
[0206] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 1526 where the temperature
sensor engine 102b stops recording the skin temperature of the
finger 16 of subject 10. At step 1528, data acquired from measuring
and recording temperature changes of finger 16 which began at step
1512 and continued throughout the method 1500 is saved by the
temperature sensor engine 102b to a database such as, for example,
the database 102a illustrated in FIG. 3.
[0207] At decision block 1530, the computer system 102 checks
whether there are any more scheduled runs for apparatus 1400. If
there are more scheduled runs for apparatus 1400, the method 1500
returns to step 1508 where the computer system 102 goes on standby.
In an exemplary embodiment, the apparatus may be scheduled to run
periodically through a predetermined time period such as, for
example, 24 hours.
[0208] If there are no more scheduled runs for apparatus 1400, the
method proceeds to step 1532 where a plotting engine such as, for
example, the plotting engine 102d illustrated in FIG. 3, may
retrieve data from the database 102a.
[0209] At step 1534, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained.
[0210] Referring now to FIG. 19, in an exemplary embodiment, a
method for determining one or more health conditions 1600 is
illustrated which begins with a subject preparation at step 1602.
Subject preparation at step 1602 may include, for example, having a
subject refrain from eating before undergoing the method 1600,
having the subject refrain from smoking before undergoing the
method 1600, having the subject refrain from ingesting alcohol or
caffeine before undergoing the method 1600, or having the subject
refrain from taking any vascular medications before undergoing the
method 1600.
[0211] At step 1604, a thermal energy sensor such as, for example,
the thermal energy sensor 104 illustrated in FIG. 3, may be placed
on the subject. In an exemplary embodiment, the thermal energy
sensor 104 may be a conventional thermal energy sensor known in the
art. In an exemplary embodiment, the thermal energy sensor 104 is
designed such that there is a minimal area of contact between the
sensor and the subject. In an exemplary embodiment, when placed on
the subject, the thermal energy sensor 104 provides a minimal
pressure to the subject. In an exemplary embodiment, in operation,
the thermal energy sensor 104 measures thermal energy only and does
not introduce any signals into the subject. In an exemplary
embodiment, thermal energy measured by the thermal energy sensor
104 is not effected by insulation or perspiration. In an exemplary
embodiment, the thermal energy sensor 104 does not alter the
microcapillary flow in the subject. In an exemplary embodiment, the
thermal energy sensor 104 does not restrict movement of the subject
and thermal energy measurements are not effected by subject
movement. In an exemplary embodiment, a plurality of thermal energy
sensor 104 may be positioned at different locations on the subject.
In an exemplary embodiment, the thermal energy sensor 104 is
positioned on a body part of the subject such as, for example, a
finger, forearm, toe, leg, earlobe, or nose. In an exemplary
embodiment, the thermal energy sensor 104 may be placed on the
subject in order to measure the thermal energy of distal resistant
vessels on the subject.
[0212] At step 1606, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates a thermal energy sensor such as, for example, the
thermal energy sensor 104 illustrated in FIG. 3, to begin recording
the temperature of the subject. In an exemplary embodiment,
temperature data begins being recorded continuously. In an
exemplary embodiment, the thermal energy sensor 104 measures the
skin temperature of the subjects body on which it is placed such
as, for example, the hand, forearm, foot, leg, earlobe, or nose. In
an exemplary embodiment, the thermal energy sensor 104 engages the
skin of the subject in order to measure temperature. In an
exemplary embodiment, the thermal energy sensor 104 measures the
skin temperature of the subject without engaging the skin of the
subject. In an exemplary embodiment, the ambient temperature is
held constant around the thermal energy sensor 104. In an exemplary
embodiment, the fluid flow such as, for example, the airflow,
around the thermal energy sensor 104 is kept to a minimum.
[0213] At step 1608, the thermal energy sensor engine 102b begins
to detect for equilibrium in the subject. In an exemplary
embodiment, at step 1608, the thermal energy sensor engine 102b
retrieves successive temperature measurement from the thermal
energy sensor.
[0214] At decision block 1610, the thermal energy sensor engine
102b determines whether the subject has reached equilibrium. If the
subject has not reached equilibrium, the temperature sensor engine
proceeds back to step 1608 to detect for equilibrium. In an
exemplary embodiment, determining whether the subject 10 has
reached equilibrium in step 1610 may include, for example,
determining whether the temperature changes of a subject are less
than 0.1 degree C.
[0215] If the temperature changes in the subject have reached
equilibrium, the method proceeds to step 1612 where a second body
part of subject is placed in water. In an exemplary embodiment, the
water may be ice water.
[0216] At step 1614, the thermal energy sensor engine 102b
continues recording the temperature of the subject.
[0217] At step 1616, the thermal energy sensor engine 102b stops
recording the temperature of the subject after a predetermined
amount of time.
[0218] At step 1618, data acquired from measuring and recording
temperature changes which began at step 1606 and continued
throughout the method 1600 is saved by the temperature sensor
engine 102b to a database such as, for example, the database 102a
illustrated in FIG. 3.
[0219] At step 1620, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a.
[0220] At step 1622, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained.
[0221] At step 1624, a health professional may analyze the data
acquired through method 1600 in order to diagnose a variety of
health conditions in subject.
[0222] Referring now to FIG. 20a and 20b, in an exemplary
embodiment, a method for determining one or more health conditions
1700 is illustrated which begins with a subject preparation at step
1702. Subject preparation at step 1702 may include, for example,
having a subject refrain from eating before undergoing the method
1700, having the subject refrain from smoking before undergoing the
method 1700, having the subject refrain from ingesting alcohol or
caffeine before undergoing the method 1700, or having the subject
refrain from taking any vascular medications before undergoing the
method 1700.
[0223] At step 1704, a first body part of the subject is placed in
a medium. In an exemplary embodiment, the medium may be a medium
which has a minimum specific heat capacity and/or a maximum heat
conductivity in order to provide maximum heat transfer between the
body part of the subject and a thermal energy sensor such as, for
example, the thermal energy sensor 104 illustrated in FIG. 2.
[0224] At step 1706, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
2, activates a thermal energy sensor such as, for example, the
thermal energy sensor 104 illustrated in FIG. 3, to begin recording
the temperature of the medium.
[0225] At step 1708, the thermal energy sensor engine 102b begins
to detect for equilibrium in the medium. In an exemplary
embodiment, at step 1708, the thermal energy sensor engine 102b
retrieves successive temperature measurement from the thermal
energy sensor.
[0226] At decision block 1710, the thermal energy sensor engine
102b determines whether the medium has reached equilibrium. If the
medium has not reached equilibrium, the temperature sensor engine
102b proceeds back to step 1708 to detect for equilibrium. In an
exemplary embodiment, determining whether the medium has reached
equilibrium in step 1710 may include, for example, determining
whether the temperature changes of the medium are less than 0.1
degree C.
[0227] If the temperature changes in the medium have reached
equilibrium, the method proceeds to step 1712 where a vasostimulant
engine such as, for example, the vasostimulant engine 102c
illustrated in FIG. 3, activates a vasostimulant such as, for
example, the vasostimulant 106 illustrated in FIG. 2. In an
exemplary embodiment, the vasostimulant 106 may be an inflatable
cuff, and activating the vasostimulant 106 at step 1712 may
include, for example inflating the cuff to 200 mm Hg systolic BP.
In an exemplary embodiment, the vasostimulant 106 may be a chemical
such as, for example, nitroglycerin, and activating the
vasostimulant 106 at step 1712 may include administering a
predetermined amount of the chemical to the subject. In an
exemplary embodiment, the vasostimulant 106 may be an aptitude
test, and activating the vasostimulant 106 at step 1712 may include
having the subject begin the aptitude test.
[0228] At step 1714, the vasostimulant engine 102c may deactivate
the vasostimulant 106. In an exemplary embodiment, the
vasostimulant 106 may be an inflatable cuff, and deactivating the
vasostimulant 106 at step 1714 may include deflating the cuff. In
an exemplary embodiment, the vasostimulant 106 may be a chemical
such as, for example, nitroglycerin, and deactivating the
vasostimulant 106 at step 1714 may include providing an amount of
the chemical in step 1712 such that the effects of the chemical on
the subject wear off in a predetermined amount of time. In an
exemplary embodiment, deactivating the vasostimulant 106 at step
1714 may include providing additional chemicals to the subject to
reverse the effects of the vasostimulant chemicals provided in step
1712. In an exemplary embodiment, the vasostimulant 106 may be an
aptitude test, and deactivating the vasostimulant 106 at step 1714
may include having the subject cease taking the aptitude test. In
an exemplary embodiment, the vasostimulant is deactivated anywhere
from 2 to 5 minutes after activation in step 1714. In an exemplary
embodiment, the vasostimulant is deactivated less than 5 minutes
after activation in step 1714, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 1714,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 1714, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 1714,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject 10 may be asked to exercise the body part
on which thermal energy is being detected, which allows the method
1700 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0229] At step 1716, the thermal energy sensor engine 102b begins
to detect for equilibrium in the temperature of the medium. In an
exemplary embodiment, at step 1716, the thermal energy sensor
engine 102b retrieves successive temperature measurement from the
thermal energy sensor.
[0230] At decision block 1718, the thermal energy sensor engine
102b determines whether the temperature of the medium has reached
equilibrium. If the temperature of the medium has not reached
equilibrium, the temperature sensor engine proceeds back to step
1716 to detect for equilibrium. In an exemplary embodiment,
determining whether the temperature of the medium has reached
equilibrium in step 1718 may include, for example, determining
whether the temperature changes of medium are less than 0.1 degree
C.
[0231] If the temperature changes in the medium have reached
equilibrium, the method proceeds to step 1720 where the temperature
sensor engine 102b stops recording the temperature of the
medium.
[0232] At step 1722, data acquired from measuring and recording
temperature changes which began at step 1706 and continued
throughout the method 1700 is saved by the temperature sensor
engine 102b to a database such as, for example, the database 102a
illustrated in FIG. 3. At step 1724, a plotting engine such as, for
example, the plotting engine 102d illustrated in FIG. 3, may
retrieve data from the database 102a. At step 1726, the plotting
engine 102d may plot out the data retrieved. In an exemplary
embodiment, the data may be plotted out as temperature vs. time. In
an exemplary embodiment, the plotting engine 102d may plot out data
obtained from the temperature measurements concurrent with the data
being obtained.
[0233] At step 1728, a health professional may analyze the data
acquired through method 1700 in order to diagnose a variety of
health conditions in subject 10.
[0234] Referring now to FIG. 21, a representative experimental
graph 1800 of temperature vs. time is illustrated for a healthy
subject during the methods 500, 700, 800, 900, 1000, 1100, 1500,
1600, or 1700. In an exemplary embodiment, the graph 1800 may be
produced by the plotting engine 102d, illustrated in FIG. 3. A
baseline temperature 1802 is achieved when the subject reaches a
steady temperature after having a thermal energy sensor such as,
for example, the thermal energy sensor 104 illustrated in FIG. 3,
coupled to them. At time 1804, the vasostimulant is activated,
causing the temperature of the subject to drop, resulting in a
slope 1806. At time 1808, the vasostimulant is deactivated, causing
the temperature of the subject to rise, resulting in a slope 1810.
The temperature of the subject crosses the baseline temperature
1802 and reaches a peak temperature 1812, after which the
temperature returns back to the baseline temperature 1802. A number
of measurements can be made from the data shown in graph 1800
including, but not limited to, the fall temperature change TF
between the baseline temperature 1802 and the temperature recorded
at time 1808, the rebound temperature change TR between the
baseline temperature 1802 and the peak temperature 1812, the nadir
to peak temperature change TNP between the temperature recorded at
time 1808 and the peak temperature 1812, the time to fall
temperature TTF, the time to rebound temperature TTR, the time to
stabilized temperature TS, the steepness of the slopes 1806 and
1810, the area under the temperature curve bounded by the
temperature curve and the temperature reached at time 1808 and
between time equal zero and time 1808, the area under the
temperature curve bounded by the temperature curve and the
temperature reached at time 1808 and between time 1808 and the time
at peak temperature 1812, and the area under the temperature curve
bounded by the temperature curve and the temperature reached at
time 1808 and between time 1808 and the time at which the
temperature stabilizes.
[0235] In an exemplary embodiment, healthy vascular reactivity may
be indicated by a value of TNP which is greater than TF. In an
exemplary embodiment, unhealthy vascular reactivity may be
indicated by a value of TNP which is less than TF. In an exemplary
embodiment, unhealthy vascular reactivity may be indicated by a
negative value of TR. In an exemplary embodiment, several graphs
similar to graph 1800 may be taken from a subject and then averaged
to get an average graph for the subject which may indicate the
average response for the subject over a period of time.
[0236] In an exemplary embodiment, the value of TR may be
normalized using thermodynamic equations for calculating heat flow
based on the following parameters: baseline temperature 1802, fall
temperature change TF, ambient room temperature, core temperature,
tissue heat capacity, tissue metabolism rate, tissue heat
conduction, the mass of the testing volume, the location the method
is conducted, blood flow rate, the position of the subject during
the method, and a variety of other physical and/or physiological
factors that may effect the value of TR. In an experimental
embodiment of the method 500 described above with respect to FIGS.
8a and 8b, an ambient temperature of 22 degrees C. was measured. A
first subject was tested and found to have a baseline temperature
of 35 degrees C., a TF of 2 degrees C. and a TR of 0.5 degrees. A
subject like first subject has a baseline temperature which is
significantly greater than the ambient temperature, and it is
expected that such a subject will experience a higher than normal
TF and a lower than normal TR. Furthermore, a subject having a
baseline temperature which is significantly greater than the
subject's core temperature is expected to experience a higher than
normal TF and a lower than normal TR. A second subject was tested
and found to have a baseline temperature of 25 degrees C., a TF of
1 degrees C. and a TR of 3 degrees. A subject like second subject
has a baseline temperature which is close to the ambient
temperature, and it is expected that such a subject will experience
a lower than normal TF and a higher than normal TR. Furthermore, a
subject having a baseline temperature which is close to the
subject's core temperature is expected to experience a lower than
normal TF and a higher than normal TR.
[0237] Referring now to FIG. 22, in an exemplary experimental
embodiment EXP1, the method 500 was carried out on a subject, and a
graph EXP1A was obtained of data relating to temperature changes of
the skin on a finger of the subject. A pressure cuff was provided
as the vasostimulant, and vasostimulant activation at time 1804 and
deactivation at time 1808 was provided by inflating and deflating
the pressure cuff. The subject exhibited a baseline temperature
1802 of approximately 30 degrees C., a temperature at time 1808 of
approximately 29.1 degrees C., a peak temperature 1812 of
approximately 31 degrees C., and a rebound temperature change TR of
approximately 1 degree C. The subject showed presumably good
endothelial function due to, for example, the positive value of
rebound temperature change TR.
[0238] Referring now to FIG. 23, in an exemplary experimental
embodiment EXP2, the method 500 was carried out on a subject, and a
graph EXP2A was obtained of data relating to temperature changes of
the skin on a finger of the subject. A pressure cuff was provided
as the vasostimulant, and vasostimulant activation at time 1804 and
deactivation at time 1808 was provided by inflating and deflating
the pressure cuff. The subject exhibited a baseline temperature
1802 of approximately 31.2 degrees C., a temperature at time 1808
of approximately 30.6 degrees C., a peak temperature 1812 of
approximately 31.4 degrees C., and a rebound temperature change TR
of approximately 0.2 degree C. The subject showed presumably good
endothelial function due to, for example, the positive value of
rebound temperature change TR.
[0239] Referring now to FIG. 24, in an exemplary experimental
embodiment EXP3, the method 500 was carried out on a subject, and a
graph EXP3A was obtained of data EXP3AA relating to temperature
changes of the skin on a finger of the subject and including data
EXP3AB relating to the temperature of a contralateral finger for
use as a control. A pressure cuff was provided as the
vasostimulant, and vasostimulant activation at time 1804 and
deactivation at time 1808 was provided by inflating and deflating
the pressure cuff. Data EXP3AA exhibited a baseline temperature
1802 of approximately 34.5 degrees C., a temperature at time 1808
of approximately 33 degrees C., a peak temperature 1812 of
approximately 34 degrees C., and a rebound temperature change TR of
approximately negative 0.5 degrees C. Data EXP3AB exhibited a
control temperature of approximately 35 decrees C. The subject
showed presumably bad endothelial function due to, for example, the
negative value of rebound temperature change TR.
[0240] Referring now to FIG. 25, in an exemplary experimental
embodiment EXP4, the method 500 was carried out on a subject, and a
graph EXP4A was obtained of data EXP4AA relating to temperature
changes of the skin on a finger of the subject and including data
EXP4AB relating to the temperature of a contralateral finger for
use as a control. A pressure cuff was provided as the
vasostimulant, and vasostimulant activation at time 1804 and
deactivation at time 1808 was provided by inflating and deflating
the pressure cuff. Data EXP4AA exhibited a baseline temperature
1802 of approximately 30.5 degrees C., a temperature at time 1808
of approximately 29.5 degrees C., a peak temperature 1812 of
approximately 31.2 degrees C., and a rebound temperature change TR
of approximately 0.7 degrees C. Data EXP4AB exhibited a control
temperature of approximately 29.5 degrees C. The subject showed
presumably good endothelial function due to, for example, the
positive value of rebound temperature change TR.
[0241] Referring now to FIG. 26, in an exemplary experimental
embodiment EXP5, the method 500 was carried out on a subject, and a
graph EXP5A was obtained of data EXP5AA relating to temperature
changes of the skin on a finger of the subject and including data
EXP5AB relating to the temperature of a contralateral finger for
use as a control. A pressure cuff was provided as the
vasostimulant, and vasostimulant activation at time 1804 and
deactivation at time 1808 was provided by inflating and deflating
the pressure cuff. Data EXP5AA exhibited a baseline temperature
1802 of approximately 34 degrees C., a temperature at time 1808 of
approximately 31.5 degrees C., a peak temperature 1812 of
approximately 33.5 degrees C., and a rebound temperature change TR
of approximately negative 0.5 degree C. Data EXP5AB exhibited a
control temperature of approximately 34.5 degrees C. The subject
showed presumably bad endothelial function due to, for example, the
negative value of rebound temperature change TR.
[0242] Referring now to FIG. 27, in an exemplary experimental
embodiment EXP6, the method 500 was carried out on a subject, and a
graph EXP6A was obtained of data EXP6AA relating to temperature
changes of the skin on a finger of the subject and including data
EXP6AB relating to the temperature of a contralateral finger for
use as a control. A pressure cuff was provided as the
vasostimulant, and vasostimulant activation at time 1804 and
deactivation at time 1808 was provided by inflating and deflating
the pressure cuff. Data EXP6AA exhibited a baseline temperature
1802 of approximately 33.4 degrees C., a temperature at time 1808
of approximately 32.8 degrees C., a peak temperature 1812 of
approximately 33.8 degrees C., and a rebound temperature change TR
of approximately 0.4 degree C. Data EXP6AA exhibited a control
temperature of approximately 33.7 degrees C. The subject showed
presumably good endothelial function due to, for example, the
positive value of rebound temperature change TR.
[0243] Referring now to FIG. 28, in an exemplary experimental
embodiment EXP7, the method 500 was carried out on a subject, and a
graph EXP7A was obtained of data EXP7AA relating to temperature
changes of the skin on a finger of the subject and including data
EXP7AB relating to the temperature of a contralateral finger for
use as a control. A pressure cuff was provided as the
vasostimulant, and vasostimulant activation at time 1804 and
deactivation at time 1808 was provided by inflating and deflating
the pressure cuff. Data EXP7AA exhibited a baseline temperature
1802 of approximately 33.1 degrees C., a temperature at time 1808
of approximately 32.1 degrees C., a peak temperature 1812 of
approximately 33.1 degrees C., and a rebound temperature change TR
of approximately 0.0 degree C. Data EXP7AB exhibited a control
temperature of approximately 34 degrees C. The subject showed
presumably bad endothelial function due, for example, to the 0.0
degree value of rebound temperature change TR.
[0244] Referring now to FIG. 29, in an exemplary experimental
embodiment EXP8, the method 500 was carried out on a subject by
occluding the brachial artery of the subject and measuring the
temperature changes on the skin of the subjects finger before and
after occlusion. While carrying out the method 500, a conventional
endothelial function test was conducted which measure the
percentage change in brachial artery diameter before and after
occlusion of the brachial artery. A correlation graph was created
plotting rebound temperature change TR against the percentage
change in brachial artery diameter. A correlation factor R of 0.73
was found between rebound temperature change TR and percentage
change in brachial artery diameter, indicating that the method 500
can provide a diagnosis equivalent to the more expensive and
subjective brachial artery diameter test.
[0245] Referring now to FIG. 30, in an exemplary experimental
embodiment EXP9, the method 500 was carried out on a subject by
occluding the brachial artery of the subject and measuring the
temperature changes on the skin of the subjects finger before and
after occlusion. While carrying out the method 500, a conventional
endothelial function test was conducted which measure the
percentage change in brachial artery diameter before and after
occlusion of the brachial artery. A correlation graph was created
plotting nadir to peak temperature change TNP against percentage
change in brachial artery diameter. A correlation factor R of 0.74
was found between nadir to peak temperature change TNP and
percentage change in brachial artery diameter, indicating that the
method 500 can provide a diagnosis equivalent to the more expensive
and subjective brachial artery diameter test.
[0246] Referring now to FIG. 31, an alternative embodiment of an
apparatus for determining one or more health conditions 1900 is
substantially identical in design and operation to apparatus 600
described above with reference to FIGS. 9a and 9b, with the
provision of a Doppler probe 1902 replacing the thermal energy
sensor 104b. The Doppler probe 1902 is coupled to a wristband 1904
which includes a plurality of adhesive members 1904 and 1904b on
either end of the wristband 1904. In an exemplary embodiment, the
thermal probe 104b, illustrated in FIG. 9a, may be included on the
apparatus 1900 and the Doppler probe 1902 may be coupled to the
computer system 102 by an additional coupling wire 606.
[0247] Referring now to FIG. 3, 32a, 32b, 32c, 32d, and 32e, in an
exemplary embodiment, a method for determining one or more health
conditions 2000 using the apparatus 1900 illustrated in FIG. 31 is
illustrated which begins with placing the pressure cuff
vasostimulant 106 on arm 12 of subject 10 at step 2002. Pressure
cuff vasostimulant 106 may be secured to arm 12 by vasostimulant
coupling member 608 which may include a variety of adhesive
materials known in the art. The wristband 1904 including Doppler
probe 1902 is placed on a distal portion of the forearm 14 and may
be secured to the forearm 14 using adhesive members 1904a and
1904b. The Doppler probe 1902 is positioned such that it is
immediately adjacent an artery in forearm 14, as illustrated in
FIG. 32c.
[0248] At step 2004, thermal energy sensor 104a may be placed on
finger 16 of the subject 10. Finger 16 is placed in passageway
104ad of thermal energy sensor 104a such that a distal end of the
finger 16 is coupled to thermal energy measurement device 104ae.
With finger 16 coupled to thermal energy measurement device 104ae,
coupling member 104af secures finger 16 in thermal energy sensor
104a.
[0249] At step 2006, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates the thermal energy sensor 104a to begin recording the
skin temperature of finger 16. In an exemplary embodiment,
temperature data begins being recorded continuously. In an
exemplary embodiment, the thermal energy sensor 104a engages the
skin of finger 16 in order to measure temperature. In an exemplary
embodiment, the thermal energy sensor 104a measures the skin
temperature of finger 16 without engaging the skin of finger
16.
[0250] At step 2008, the thermal energy sensor engine 102b begins
to detect for equilibrium in the skin temperature of the finger 16
of subject 10. In an exemplary embodiment, at step 2008, the
thermal energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104a.
[0251] At decision block 2010, the thermal energy sensor engine
102b determines whether the skin temperature of finger 16 of
subject 10 has reached equilibrium. If the skin temperature of
finger 16 has not reached equilibrium, the temperature sensor
engine 102b proceeds back to step 2008 to detect for equilibrium.
In an exemplary embodiment, determining whether the skin
temperature of the finger has reached equilibrium in step 2010 may
include, for example, determining whether the temperature changes
of the finger 16 are less than 0.1 degree C.
[0252] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 2012 where a vasostimulant
engine such as, for example, the vasostimulant engine 102c
illustrated in FIG. 2, activates the pressure cuff vasostimulant
106. In an exemplary embodiment, activating the pressure cuff
vasostimulant 106 at step 2012 may include, for example, inflating
the cuff to 200 mm Hg systolic BP. The Doppler probe 1902 measures
the speed of the blood in an artery in the forearm 14, and, in an
exemplary embodiment, the readings from the Doppler probe 1902 may
be used to determine when the appropriate pressure is being applied
by the pressure cuff vasostimulant 106 by determining when blood
flow has substantially ceased flowing in the artery in forearm 14.
In an experimental embodiment 2012a, illustrated in FIG. 32d, the
Doppler probe 1902 showed that blood substantially ceased flowing
through the artery in forearm 14 at data point 2012b. In an
exemplary embodiment, the Doppler probe 1902 can aid in ensuring
that the pressure applied by the pressure cuff vasostimulant 106 is
no more than is necessary to conduct the method 2000, and prevents
the method 2000 from being interrupted due to pain in the
subject.
[0253] At step 2014, the vasostimulant engine 102c may deactivate
the pressure cuff vasostimulant 106. In an exemplary embodiment,
deactivating the pressure cuff vasostimulant 106 at step 2014 may
include deflating the cuff. In an exemplary embodiment, the
pressure cuff vasostimulant 106 is deactivated anywhere from 2 to 5
minutes after activation in step 2012. In an exemplary embodiment,
the vasostimulant is deactivated less than 5 minutes after
activation in step 2012, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 2012,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 2012, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 2012,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject may be asked to exercise the body part on
which thermal energy is being detected, which allows the method
2000 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants. In an experimental embodiment 2012a, illustrated in
FIG. 32d, the Doppler probe 1902 showed that blood substantially
increased in flow rate through the artery in forearm 14 at data
point 2012c.
[0254] At step 2016, the thermal energy sensor engine 102b begins
to detect for equilibrium in the skin temperature of the finger 16
of subject 10. In an exemplary embodiment, at step 2016, the
thermal energy sensor engine 102b retrieves successive temperature
measurement from the thermal energy sensor 104a.
[0255] At decision block 2018, the thermal energy sensor engine
102b determines whether the skin temperature of the finger 16 of
subject 10 has reached equilibrium. If the skin temperature of the
finger 16 has not reached equilibrium, the temperature sensor
engine 102b proceeds back to step 2016 to detect for equilibrium.
In an exemplary embodiment, determining whether the skin
temperature of the finger 16 has reached equilibrium in step 2018
may include, for example, determining whether the temperature
changes of the finger 16 are less than 0.1 degree C.
[0256] If the temperature changes in the finger 16 have reached
equilibrium, the method proceeds to step 2020 where the temperature
sensor engine 102b stops recording the skin temperature of the
finger 16 of subject 10.
[0257] At step 2022, data acquired from measuring and recording
temperature changes of finger 16 which began at step 2006 and
continued throughout the method 2000 is saved by the temperature
sensor engine 102b to a database such as, for example, the database
102a illustrated in FIG. 3.
[0258] At step 2024, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a.
[0259] At step 2026, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained.
[0260] Referring now to FIGS. 3, 9a, 33a, 33b, and 33c, an
alternative embodiment of an apparatus for determining one or more
health conditions 2100 is substantially identical in design and
operation to apparatus 600 described above with reference to FIGS.
9a, 9b, 10a, 10b, 10c, and 10d, with the addition of a thermal
energy sensor 2102 replacing the thermal energy sensors 104a and
104b. Thermal energy sensor 2102 is mounted to a lead 2104 which
electrically couples the thermal energy sensor 2102 to the computer
system 102. A circular adhesive 2106 defines a circular channel
2106a centrally located on the circular adhesive 2106 and is
positioned adjacent the thermal heat sensor 2102 such that the
thermal heat sensor 2102 is located in the circular channel 2106a
on the circular adhesive 2106. In operation, the finger 16 of
subject 10 is coupled to the apparatus 2100 by engaging the finger
16 with the circular adhesive 2106. With the finger 16 engaging the
circular adhesive 2106, there is contact between the skin surface
of the finger 16 and the thermal energy sensor 2102, which allows
the skin temperature of the finger 16 to be measured and recorded.
In an embodiment, the circular adhesive 2106 is positioned adjacent
the thermal heat sensor 2102 such that with the finger 16 engaging
the thermal energy sensor 2102, a minimum pressure is applied
across the finger 16 in order to not substantially change the skin
surface temperature of the finger 16. In an exemplary embodiment, a
minimum pressure is a pressure which is sufficient to couple the
thermal heat sensor 2102 to the skin surface of the finger 16 in
order to obtain accurate temperature measurements without impeding
underlying microcapillary circulation. In an embodiment, the
circular adhesive 2106 is designed such that with the finger 16
engaging the thermal energy sensor 2102, a minimum surface area of
the finger 16 is covered in order to not substantially change the
skin surface temperature of the finger 16. In an exemplary
embodiment, a minimum surface area is a surface area which is
sufficient to couple the thermal heat sensor 2102 to the skin
surface of the finger 16 in order to obtain accurate temperature
measurements without impeding the exchange of heat flow between the
ambient and the skin surface.
[0261] Referring now to FIGS. 3, 9a, 34a, 34b, and 34c, an
alternative embodiment of an apparatus for determining one or more
health conditions 2200 is substantially identical in design and
operation to apparatus 600 described above with reference to FIGS.
9a, 9b, 10a, 10b, 10c, and 10d, with the addition of a thermal
energy sensor 2202 replacing the thermal energy sensors 104a and
104b. Thermal energy sensor 2202 is mounted to a lead 2204 which
electrically couples the thermal energy sensor 2202 to the computer
system 102. FIG. 50 depicts an embodiment of wiring for receiving
signals from thermocouple leads and sending them through an analog
to digital converter.
[0262] A plurality of spaced apart rectangular adhesive members
2206a and 2206b are positioned adjacent the thermal heat sensor
2202 and on opposite sides of the thermal energy sensor 2202 such
that a plurality of airflow channels 2208a and 2208b are located on
opposite sides of the thermal energy sensor 2202. In operation, the
finger 16 of subject 10 is coupled to the apparatus 2200 by
engaging the finger 16 with the plurality of rectangular adhesive
members 2206a and 2206b. With the finger 16 engaging the
rectangular adhesive members 2206a and 2206b, there is contact
between the skin surface of the finger 16 and the thermal energy
sensor 2202 while allowing air to flow through the airflow channels
2208a and 2208b on either side of the thermal energy sensor 2202,
which allows the skin temperature of the finger 16 to be measured
and recorded while allowing air circulation past the finger 16 such
that the apparatus 2200 does not substantially change the skin
temperature of the finger 16. In an embodiment, the rectangular
adhesive members 2206a and 2206b are positioned adjacent the
thermal heat sensor 2202 such that with the finger 16 engaging the
thermal energy sensor 2202, a minimum pressure is applied across
the finger 16 in order to not substantially change the skin surface
temperature of the finger 16. In an exemplary embodiment, a minimum
pressure is a pressure which is sufficient to couple the thermal
heat sensor 2202 to the skin surface of the finger 16 in order to
obtain accurate temperature measurements without impeding
underlying microcapillary circulation. In an embodiment, the
rectangular adhesive members 2206a and 2206b are designed such that
with the finger 16 engaging the thermal energy sensor 2202, a
minimum surface area of the finger 16 is covered in order to not
substantially change the skin surface temperature of the finger 16.
In an exemplary embodiment, a minimum surface area is a surface
area which is sufficient to couple the thermal heat sensor 2202 to
the skin surface of the finger 16 in order to obtain accurate
temperature measurements without impeding the exchange of heat flow
between the ambient and the skin surface.
[0263] Referring now to FIG. 6a and 35, an alternative embodiment
of an apparatus for determining one or more health conditions 2300
is substantially identical in design and operation to apparatus 600
described above with reference to FIGS. 9a, 9b, 10a, 10b, 10c, and
10d, with the addition of a room temperature measurement device
2302 which is coupled to the computer system 102 by a coupling wire
606 and a core temperature measurement device 2304 which is coupled
to the computer system 102 by a coupling wire 606. In operation,
the room temperature measurement device 2302 may be a conventional
room temperature measurement device 2302 known in the art and is
used to measure the ambient temperature in a room where the
apparatus 2300 is being used. The core temperature measurement
device 2304 may be a conventional core temperature measurement
device 2304 such as, for example, a conventional thermometer, and
is used to measure the core temperature of the subject by, for
example, placing the thermometer in the mouth, under the arm,
and/or in the rectum of the subject 10.
[0264] Referring now to FIGS. 3, 9a, 36a, and 36b, an alternative
embodiment of an apparatus for determining one or more health
conditions 2400 is substantially identical in design and operation
to apparatus 2200 described above with reference to FIGS. 3, 9a,
34a, 34b, and 34c, with the addition of a thermal device 2402.
Thermal device 2402 is operable to heat up or cool down using
conventional heating and cooling elements known in the art.
[0265] Referring now to FIG. 37a, 37b, and 37c, in an exemplary
embodiment, a method for determining one or more health conditions
2500 is illustrated which begins with a subject preparation at step
2502. Subject preparation at step 2502 may include, for example,
having a subject refrain from eating before carrying out the method
2500, having the subject refrain from smoking, ingesting alcohol or
caffeine, or taking any vascular medications before carrying out
the method 2500.
[0266] At step 2504, a thermal energy sensor such as, for example,
the thermal energy sensor 2202 on apparatus 200, illustrated in
FIG. 36a and 36b, may be placed on the subject. The finger 16 is
coupled to the apparatus 2200 by engaging the finger 16 with the
plurality of rectangular adhesive members 2206a and 2206b. With the
finger 16 engaging the rectangular adhesive members 2206a and
2206b, there is contact between the skin surface of the finger 16
and the thermal energy sensor 2202 while allowing air to flow
through the airflow channels 2208a and 2208b on either side of the
thermal energy sensor 2202, which allows the skin temperature of
the finger 16 to be measured and recorded while allowing air
circulation past the finger 16 such that the apparatus 2200 does
not substantially change the skin temperature of the finger 16.
With the finger 16 engaging the rectangular adhesive members 2206a
and 2206b, there is also contact between the thermal device 2402
and the finger 16, as illustrated in FIG. 37c. In an embodiment,
the rectangular adhesive members 2206a and 2206b are positioned
adjacent the thermal heat sensor 2202 such that with the finger 16
engaging the thermal energy sensor 2202, a minimum pressure is
applied across the finger 16 in order to not substantially change
the skin surface temperature of the finger 16. In an exemplary
embodiment, a minimum pressure is a pressure which is sufficient to
couple the thermal heat sensor 2202 to the skin surface of the
finger 16 in order to obtain accurate temperature measurements
without impeding underlying microcapillary circulation. In an
embodiment, the rectangular adhesive members 2206a and 2206b are
designed such that with the finger 16 engaging the thermal energy
sensor 2202, a minimum surface area of the finger 16 is covered in
order to not substantially change the skin surface temperature of
the finger 16. In an exemplary embodiment, a minimum surface area
is a surface area which is sufficient to couple the thermal heat
sensor 2202 to the skin surface of the finger 16 in order to obtain
accurate temperature measurements without impeding the exchange of
heat flow between the ambient and the skin surface.
[0267] At step 2506, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates a thermal energy sensor 2402 to begin recording the
temperature of the subject. In an exemplary embodiment, temperature
data begins being recorded continuously. In an exemplary
embodiment, the thermal energy sensor 102b measures the skin
temperature of the subject's body on which it is placed such as,
for example, the hand, forearm, foot, leg, earlobe, rectum, or
nose.
[0268] At step 2508, the thermal energy sensor engine 102b
activates the thermal device 2402 in order to adjust the skin
surface temperature on the finger. The thermal device 2402 may be
activated to either heat or cool the skin surface of the finger in
order to adjust the skin surface temperature of the finger 16. In
an exemplary embodiment, at step 2508, the thermal energy sensor
engine 102b retrieves successive temperature measurements from the
thermal energy sensor 2202 to adjust the skin surface temperature
of the finger 16.
[0269] At decision block 2510, the thermal energy sensor engine
102b determines whether the desired skin surface temperature of the
finger 16 has been reached. If the desired temperature has not been
reached, the temperature sensor engine 102b proceeds back to step
2508 to adjust the skin temperature. In an exemplary embodiment,
determining whether the desired temperature of the subject has been
reached in step 2510 may include, for example, determining whether
the temperature changes of a subject are less than 0.1 degree
C.
[0270] If the desired temperature in the subject has been reached,
the method proceeds to step 2512 where a vasostimulant engine such
as, for example, the vasostimulant engine 102c illustrated in FIG.
3, activates a vasostimulant such as, for example, the
vasostimulant 106 illustrated in FIG. 3. In an exemplary
embodiment, the vasostimulant 106 may be an inflatable cuff, and
activating the vasostimulant 106 at step 2512 may include, for
example inflating the cuff to 200 mm Hg systolic BP. In an
exemplary embodiment, the vasostimulant 106 may be a chemical such
as, for example, nitroglycerin, and activating the vasostimulant
106 at step 2512 may include administering a predetermined amount
of the chemical to the subject. In an exemplary embodiment, the
vasostimulant 106 may be an aptitude test, and activating the
vasostimulant 106 at step 2512 may include having the subject begin
the aptitude test.
[0271] At step 2514, the vasostimulant engine 102c may deactivate
the vasostimulant 106. In an exemplary embodiment, the
vasostimulant 106 may be an inflatable cuff, and deactivating the
vasostimulant 106 at step 2514 may include deflating the cuff. In
an exemplary embodiment, the vasostimulant 106 may be a chemical
such as, for example, nitroglycerin, and deactivating the
vasostimulant 106 at step 2514 may include providing an amount of
the chemical in step 2512 such that the effects of the chemical on
the subject wear off in a predetermined amount of time. In an
exemplary embodiment, deactivating the vasostimulant 106 at step
2514 may include providing additional chemicals to the subject to
reverse the effects of the vasostimulant chemicals provided in step
2512. In an exemplary embodiment, the vasostimulant 106 may be an
aptitude test, and deactivating the vasostimulant 106 at step 2514
may include having the subject cease taking the aptitude test. In
an exemplary embodiment, the vasostimulant is deactivated anywhere
from 2 to 5 minutes after activation in step 2512. In an exemplary
embodiment, the vasostimulant is deactivated less than 5 minutes
after activation in step 2512, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 2512,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 2512, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 2512,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject may be asked to exercise the body part on
which thermal energy is being detected, which allows the method
2500 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0272] At step 2516, the thermal energy sensor engine 102b begins
to detect for equilibrium in the temperature of subject. In an
exemplary embodiment, at step 2516, the thermal energy sensor
engine 102b retrieves successive temperature measurement from the
thermal energy sensor.
[0273] At decision block 2518, the thermal energy sensor engine
102b determines whether the temperature of the subject has reached
equilibrium. If the temperature of the subject has not reached
equilibrium, the temperature sensor engine proceeds back to step
2516 to detect for equilibrium. In an exemplary embodiment,
determining whether the temperature of the subject has reached
equilibrium in step 2518 may include, for example, determining
whether the temperature changes of a subject are less than 0.1
degree C.
[0274] If the temperature changes in the subject have reached
equilibrium, the method proceeds to step 2520 where the temperature
sensor engine 102b stops recording the temperature of the
subject.
[0275] At step 2522, data acquired from measuring and recording
temperature changes which began at step 2506 and continued
throughout the method 2500 is saved by the temperature sensor
engine 102b to a database such as, for example, the database 102a
illustrated in FIG. 3.
[0276] At step 2524, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 2, may retrieve data from
the database 102a.
[0277] At step 2526, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained. In an
exemplary embodiment, the plotting engine 102d may retrieve data
taken from multiple positions on subject and plot out an average of
that data over time. In an exemplary embodiment, the plotting
engine 102d may retrieve data taken from subject at different times
and plot out an average of that data.
[0278] Referring now to FIG. 38a and 38b, in an exemplary
embodiment, a method for determining one or more health conditions
2600 is illustrated which begins with a subject preparation at step
2602. Subject preparation at step 2602 may include, for example,
having a subject refrain from eating before carrying out the method
2600, having the subject refrain from smoking before carrying out
the method 2600, having the subject refrain from ingesting alcohol
or caffeine before carrying out the method 2600, or having the
subject refrain from taking any vascular medications before
carrying out the method 2600.
[0279] At step 2604, a thermal energy sensor such as, for example,
the thermal energy sensor 104a on apparatus 600, illustrated in
FIG. 9a and 9b, may be placed on the finger 16 of subject and the
thermal energy sensor 104b may be placed on the contralateral
finger 18 of subject.
[0280] At step 2606, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates the thermal energy sensors 104a and 104b to begin
recording the skin temperature of the finger 16 and the
contralateral finger 18 of the subject. In an exemplary embodiment,
temperature data begins being recorded continuously.
[0281] At step 2608, the skin surface temperature on the finger 16
of subject is adjusted. The finger 16 of the subject is elevated,
as illustrated in FIG. 38c, such that blood flow to the finger 16
is decreased and the temperature of the skin surface of the finger
16 decreases. In an experimental embodiment 2608a, illustrated in
FIG. 38d, the subject did not elevate the finger 16 or the
contralateral finger 18 and the finger temperature 2608aa and the
contralateral finger temperature 2608ab both began the method 2600
at approximately 34.4 to 34.7 degrees Celsius. In an experimental
embodiment 2608b, illustrated in FIG. 38e, the subject elevated the
finger 16 and the finger temperature 2608aa was allowed to drop
such that it began the method 2600 at approximately 33.2 degrees
Celsius while the contralateral finger temperature 2608ab began the
method 2600 at approximately 35 degrees Celsius. The experimental
embodiments 2608a and 2608b show that the skin temperature of the
finger 16 may be adjusted by elevating the finger 16 of the
subject.
[0282] At decision block 2610, the thermal energy sensor engine
102b determines whether the desired skin surface temperature of the
finger 16 of subject has been reached. If the desired temperature
of the subject has not been reached, the temperature sensor engine
102b proceeds back to step 2608 to detect whether the desired
temperature has been reached. In an exemplary embodiment,
determining whether the desired temperature of the subject has been
reached in step 2610 may include, for example, determining whether
the temperature changes of a subject are less than 0.1 degree
C.
[0283] If the desired temperature in the subject has been reached,
the method proceeds to step 2612 where a vasostimulant engine such
as, for example, the vasostimulant engine 102c illustrated in FIG.
2, activates a vasostimulant such as, for example, the
vasostimulant 106 illustrated in FIG. 1. In an exemplary
embodiment, the vasostimulant 106 may be an inflatable cuff, and
activating the vasostimulant 106 at step 2612 may include, for
example inflating the cuff to 200 mm Hg systolic BP. In an
exemplary embodiment, the vasostimulant 106 may be a chemical such
as, for example, nitroglycerin, and activating the vasostimulant
106 at step 2612 may include administering a predetermined amount
of the chemical to the subject. In an exemplary embodiment, the
vasostimulant 106 may be an aptitude test, and activating the
vasostimulant 106 at step 2612 may include having the subject begin
the aptitude test.
[0284] At step 2614, the vasostimulant engine 102c may deactivate
the vasostimulant 106. In an exemplary embodiment, the
vasostimulant 106 may be an inflatable cuff, and deactivating the
vasostimulant 106 at step 2614 may include deflating the cuff. In
an exemplary embodiment, the vasostimulant 106 may be a chemical
such as, for example, nitroglycerin, and deactivating the
vasostimulant 106 at step 2614 may include providing an amount of
the chemical in step 2612 such that the effects of the chemical on
the subject wear off in a predetermined amount of time. In an
exemplary embodiment, deactivating the vasostimulant 106 at step
2614 may include providing additional chemicals to the subject to
reverse the effects of the vasostimulant chemicals provided in step
2612. In an exemplary embodiment, the vasostimulant 106 may be an
aptitude test, and deactivating the vasostimulant 106 at step 2614
may include having the subject cease taking the aptitude test. In
an exemplary embodiment, the vasostimulant is deactivated anywhere
from 2 to 5 minutes after activation in step 2612. In an exemplary
embodiment, the vasostimulant is deactivated less than 5 minutes
after activation in step 2612, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 2612,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 2612, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 2612,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject may be asked to exercise the body part on
which thermal energy is being detected, which allows the method
2600 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0285] At step 2616, the thermal energy sensor engine 102b begins
to detect for equilibrium in the temperature of subject. In an
exemplary embodiment, at step 2616, the thermal energy sensor
engine 102b retrieves successive temperature measurement from the
thermal energy sensor.
[0286] At decision block 2618, the thermal energy sensor engine
102b determines whether the temperature of the subject has reached
equilibrium. If the temperature of the subject has not reached
equilibrium, the temperature sensor engine proceeds back to step
2616 to detect for equilibrium. In an exemplary embodiment,
determining whether the temperature of the subject has reached
equilibrium in step 2618 may include, for example, determining
whether the temperature changes of a subject are less than 0.1
degree C.
[0287] If the temperature changes in the subject have reached
equilibrium, the method proceeds to step 2620 where the temperature
sensor engine 102b stops recording the temperature of the
subject.
[0288] At step 2622, data acquired from measuring and recording
temperature changes which began at step 2606 and continued
throughout the method 2600 is saved by the temperature sensor
engine 102b to a database such as, for example, the database 102a
illustrated in FIG. 3.
[0289] At step 2624, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a.
[0290] At step 2626, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained. In an
exemplary embodiment, the plotting engine 102d may retrieve data
taken from multiple positions on subject and plot out an average of
that data over time. In an exemplary embodiment, the plotting
engine 102d may retrieve data taken from subject at different times
and plot out an average of that data.
[0291] Referring now to FIG. 39, an embodiment of a method 2700 for
selecting a medication for the treatment of a medical condition in
a subject is substantially identical in design and operation to
method 500 described above with reference to FIGS. 8a and 8b, with
the addition of administering a medication to one or more subjects
at step 2702, determining whether the medication is effective in
treatment of the medical condition of the subject at step 2704,
and, if the medication is effective in treatment of the medical
condition of the subject, selecting the medication for use in
treating the medical condition in other subjects at step 2706. The
method 2700 begins as step 2702 where medication is administered to
one or more subjects at step 2702. In an exemplary embodiment, the
medication may be a drug which is being evaluated or screened to
determine its effectiveness in treating a medical condition of the
subjects. The method 2700 then proceeds to follow the method 500
where the health condition of the subject is determined as
described above with reference to FIGS. 8a and 8b. The method then
proceeds to step 2704 where it is determined whether the medication
is effective in treatment of the medical condition of the subject
at step 2704. The method 2700 then proceeds to step 2706 where, if
the medication is effective in treatment of the medical condition
of the subject, the medication is selected for use in treating the
medical condition in other subjects. In an exemplary embodiment,
the method 2700 may be used to evaluate the effectiveness of any
treatment given to a subject such as, for example, drugs, surgery,
physical therapy, exercise, cancer treatments, non-invasive
treatments, invasive treatments, nutritional regimens, and/or
combinations of the foregoing.
[0292] Referring now to FIG. 40, an embodiment of a method 2800 for
selecting a nutritional program for a subject is substantially
identical in design and operation to method 500 described above
with reference to FIGS. 8a and 8b, with the addition of
administering a nutritional program to one or more subjects at step
2802, determining whether the nutritional program is effective for
the subject at step 2804, and, if the nutritional program is
effective for the subject, selecting the nutritional program for
other subjects at step 2806. The method 2800 begins as step 2802
where a nutritional program is administered to one or more subjects
at step 2802. In an exemplary embodiment, the nutritional program
may a variety of diet and/or exercise programs which are being
evaluated or screened to determine their effectiveness for subjects
for example, to deal with general nutritional concerns or in
obesity management. The method 2800 then proceeds to follow the
method 500 where the health condition of the subject is determined
as described above with reference to FIGS. 8a and 8b. The method
then proceeds to step 2804 where it is determined whether the
nutritional program is effective for the subject at step 2804. In
an exemplary embodiment, the nutritional program may be determined
to be effective if the subject achieves a desired physical
condition such as, for example, a lower body weight, a lower body
fat percentage, a higher muscle mass, or a variety of other
physical conditions known in the art. The method then proceeds to
step 2806 where, if the nutritional program is effective for the
subject, the nutritional program is used for other subjects. In an
exemplary embodiment, the method 2800 may be used to evaluate the
effectiveness of any treatment given to a subject such as, for
example, drugs, surgery, physical therapy, exercise, cancer
treatments, non-invasive treatments, invasive treatments,
nutritional regimens, and/or combinations of the foregoing.
[0293] Referring now to FIGS. 41, an alternative embodiment of an
apparatus for determining one or more health conditions 2900 is
substantially identical in design and operation to apparatus 600
described above with reference to FIGS. 3, 4, 5, 6, 7, 8a, 8b, 9a,
and 9b with the addition of a wrist thermal energy sensor 2902 and
an additional finger thermal energy sensor 2904. The wrist thermal
energy sensor 2902 is coupled to the computer system 102 by a
coupling wire 606 and includes a wrist coupler 2902a having an
adhesive member 2902b on a distal end of the wrist coupler 2902a
which may adhere to the wrist coupler 2902a. The finger thermal
energy sensor 2904 is coupled to the computer system 102 by a
coupling wire 606 and includes a finger coupler 2904a having an
adhesive member 2904b on a distal end of the finger coupler 2904a
which may adhere to the finger coupler 2904a.
[0294] Referring now to FIG. 42a, 42b, and 42c, in an exemplary
embodiment, a method 3000 for determining one or more health
conditions using the apparatus 2900 illustrated in FIG. 41 is
illustrated which begins with placing the pressure cuff
vasostimulant 106 on arm 12 of subject at step 3002. Pressure cuff
vasostimulant 106 may be secured to arm 12 by vasostimulant
coupling member 608 which may include a variety of adhesive
materials known in the art. In an exemplary embodiment, the subject
may be in a seated position during method 3000.
[0295] At step 3004, the thermal energy sensor 104a may be placed
on finger 16 of the subject. The thermal energy sensor 104b may be
placed on a finger adjacent finger 16 of subject. The finger
thermal energy sensor 2904a may be also placed on finger 16 of
subject by adhering adhesive member 2904c to finger coupler 2904b,
as illustrated in FIG. 42c. The wrist thermal energy sensor 2902a
may be placed on the wrist of subject between the forearm 14 and
the finger 16 of subject by adhering adhesive member 2902c to wrist
coupler 2902b, as illustrated in FIG. 42c.
[0296] At step 3006, a thermal energy sensor engine such as, for
example, the thermal energy sensor engine 102b illustrated in FIG.
3, activates the thermal energy sensor 104a to begin recording the
skin temperature of the finger 16, the finger adjacent the finger
16, and the wrist between the forearm 14 and the finger 16, of
subject. In an exemplary embodiment, temperature data begins being
recorded continuously. In an exemplary embodiment, the thermal
energy sensor 104a engages the skin of the finger 16 of subject in
order to measure temperature. In an exemplary embodiment, the
thermal energy sensor 104a measures the skin temperature of the
finger 16 of subject without engaging the skin of the finger 16 of
subject. In an exemplary embodiment, the ambient temperature is
held constant around the thermal energy sensor 104a. In an
exemplary embodiment, the fluid flow such as, for example, the
airflow, around the thermal energy sensor 104a is kept to a
minimum.
[0297] At step 3008, the thermal energy sensor engine 102b begins
to detect for equilibrium in the skin temperature of the finger 16,
the finger adjacent the finger 16, and the wrist between the
forearm 14 and the finger 16, of subject. In an exemplary
embodiment, at step 3008, the thermal energy sensor engine 102b
retrieves successive temperature measurement from the thermal
energy sensor 104a.
[0298] At decision block 3010, the thermal energy sensor engine
102b determines whether the skin temperature of finger 16, the
finger adjacent the finger 16, and the wrist between the forearm 14
and the finger 16, of subject 10 has reached equilibrium. If the
skin temperature of finger 16, the finger adjacent the finger 16,
and the wrist between the forearm 14 and the finger 16, has not
reached equilibrium, the temperature sensor engine 102b proceeds
back to step 3008 to detect for equilibrium. In an exemplary
embodiment, determining whether the skin temperature of the finger
16, the finger adjacent the finger 16, and the wrist between the
forearm 14 and the finger 16, has reached equilibrium in step 710
may include, for example, determining whether the temperature
changes of the finger 16, the finger adjacent the finger 16, and
the wrist between the forearm 14 and the finger 16, are less than
0.1 degree C.
[0299] If the temperature changes in the finger 16, the finger
adjacent the finger 16, and the wrist between the forearm 14 and
the finger 16, have reached equilibrium, the method proceeds to
step 3012 where a vasostimulant engine such as, for example, the
vasostimulant engine 102c illustrated in FIG. 3, activates the
pressure cuff vasostimulant 106. In an exemplary embodiment,
activating the pressure cuff vasostimulant 106 at step 3012 may
include, for example, inflating the cuff to 200 mm Hg systolic
BP.
[0300] At step 3014, the vasostimulant engine 102c may deactivate
the pressure cuff vasostimulant 106. In an exemplary embodiment,
deactivating the pressure cuff vasostimulant 106 at step 3014 may
include deflating the cuff. In an exemplary embodiment, the
pressure cuff vasostimulant 106 is deactivated anywhere from 2 to 5
minutes after activation in step 3012. In an exemplary embodiment,
the vasostimulant is deactivated less than 5 minutes after
activation in step 3012, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated less than 4 minutes after activation in step 3012,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the vasostimulant is deactivated less than 3 minutes
after activation in step 3012, which is less than the conventional
deactivation time for tests involving vasostimulation and provides
a method which reduces the pain sometimes associated with
vasostimulants. In an exemplary embodiment, the vasostimulant is
deactivated approximately 2 minutes after activation in step 3012,
which is less than the conventional deactivation time for tests
involving vasostimulation and provides a method which reduces the
pain sometimes associated with vasostimulants. In an exemplary
embodiment, the subject may be asked to exercise the body part on
which thermal energy is being detected, which allows the method
3000 to simulate a longer vasostimulation in a shorter amount of
time, which can also reduce the pain sometimes associated with
vasostimulants.
[0301] At step 3016, the thermal energy sensor engine 102b begins
to detect for equilibrium in the skin temperature of the finger 16,
the finger adjacent the finger 16, and the wrist between the
forearm 14 and the finger 16, of subject 10. In an exemplary
embodiment, at step 3016, the thermal energy sensor engine 102b
retrieves successive temperature measurement from the thermal
energy sensor 104a.
[0302] At decision block 3018, the thermal energy sensor engine
102b determines whether the skin temperature of the finger 16, the
finger adjacent the finger 16, and the wrist between the forearm 14
and the finger 16, of subject 10 has reached equilibrium. If the
skin temperature of the finger 16, the finger adjacent the finger
16, and the wrist between the forearm 14 and the finger 16, has not
reached equilibrium, the temperature sensor engine 102b proceeds
back to step 3016 to detect for equilibrium. In an exemplary
embodiment, determining whether the skin temperature of the finger
16, the finger adjacent the finger 16, and the wrist between the
forearm 14 and the finger 16, has reached equilibrium in step 3018
may include, for example, determining whether the temperature
changes of the finger 16 are less than 0.1 degree C.
[0303] If the temperature changes in the finger 16, the finger
adjacent the finger 16, and the wrist between the forearm 14 and
the finger 16, have reached equilibrium, the method proceeds to
step 3020 where the temperature sensor engine 102b stops recording
the skin temperature of the finger 16, the finger adjacent the
finger 16, and the wrist between the forearm 14 and the finger 16,
of subject 10.
[0304] At step 3022, data acquired from measuring and recording
temperature changes of finger 16, the finger adjacent the finger
16, and the wrist between the forearm 14 and the finger 16, which
began at step 3006 and continued throughout the method 3000 is
saved by the temperature sensor engine 102b to a database such as,
for example, the database 102a illustrated in FIG. 3.
[0305] At step 3024, a plotting engine such as, for example, the
plotting engine 102d illustrated in FIG. 3, may retrieve data from
the database 102a.
[0306] At step 3026, the plotting engine 102d may plot out the data
retrieved. In an exemplary embodiment, the data may be plotted out
as temperature vs. time. In an exemplary embodiment, the plotting
engine 102d may plot out data obtained from the temperature
measurements concurrent with the data being obtained.
[0307] Referring now to FIG. 43a, 43b, and 43c, in a plurality of
exemplary experimental embodiments EXP1, EXP2, and EXP3, the method
3000 was carried out on a subject, and a plurality of graphs EXP1A,
EXP2A, and EXP3A, were obtained of data relating to temperature
changes of the skin on a wrist of the subject. A pressure cuff was
provided as the vasostimulant, and vasostimulant activation at time
1804 and deactivation at time 1808 was provided by inflating and
deflating the pressure cuff. In graph EXP1A, the temperature in a
wrist EXP1AA distal to the pressure cuff and the temperature in a
finger EXP1AB which was not distal to the pressure cuff were
measured. The temperature in the wrist EXP1AA distal to the
pressure cuff dropped as expected between times 1804 and 1808 and a
positive TR was measured after time 1808. In graph EXP2A, the
temperature in a wrist EXP2AA distal to the pressure cuff and the
temperature in a finger EXP2AB which was not distal to the pressure
cuff were measured. The temperature in the wrist EXP2AA distal to
the pressure cuff dropped as expected between times 1804 and 1808
and a positive TR was measured after time 1808. In graph EXP3A, the
temperature in a wrist EXP3AA distal to the pressure cuff and the
temperature in a finger EXP3AB which was not distal to the pressure
cuff were measured. The temperature in the wrist EXP3AA distal to
the pressure cuff dropped as expected between times 1804 and 1808
and a positive TR was measured after time 1808. The experimental
embodiments EXP1, EXP2, and EXP3, show that temperature data such
as that obtained from the methods 500, 700, 800, 900, 1000, 1100,
1500, 1600, 1700, 2000, 2500, or 2600 and/or the apparatus 100,
600, 1200, 1300, 1400, 1900, 2100, 2200, 2300, or 2400 may be
obtained which is substantially similar to the temperature data
described above with reference to FIGS. 22, 23, 24, 25, 26, 27, and
28, by obtaining such temperature data from temperature
measurements made at the wrist of the subject rather than at the
finger of the subject.
[0308] In several exemplary embodiment, the methods 500, 700, 800,
900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700, 2800,
and 3000 may be carried out along with a variety of other
diagnostic techniques known in the art in order to improve
diagnostic ability to assess cardiovascular health condition. For
example, magnetic resonance imaging may be carried out on the
subject. Intravascular diagnostic tools such as, for example,
intravascular ultrasound, may be used on the subject to diagnose
cardiovascular health condition of the subject. The blood flow rate
in the skin of the subject or the skin perfusion of the subject may
be measured using, for example, optical spectroscopy, near infrared
spectroscopy, and/or Doppler flowmetry. In an exemplary embodiment,
an optical spectroscopy tracer may be administered to subject
before using optical spectroscopy on the subject. In an exemplary
embodiment, the blood flow rate of the subject may be measured in
place of the skin temperature measurements of the subject. The
blood pressure of the subject may be measured and recorded using
methods such as, for example, Korotkoff sounds or oscillometric
methods, measuring the blood pressure at the fingertip, and/or
measuring the blood pressure at the wrist. In an exemplary
embodiment, the blood pressure of the subject may be taken before
the provision of the vasostimulant in methods 500, 700, 800, 900,
1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700, 2800, and
3000. In an exemplary embodiment, the blood pressure of the subject
may be taken after the provision of the vasostimulant in methods
500, 700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600,
2700, 2800, and 3000. In an exemplary embodiment, the blood
pressure of the subject may be taken before, after, and during the
provision of the vasostimulant in methods 500, 700, 800, 900, 1000,
1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700, 2800, and 3000.
Determining the blood pressure of the subject before and after the
provision of the vasostimulant such as, for example, a vasodilative
stimulant, allows for the determination of a vasodilative index or
vasoconstrictive index for the subject. A vasodilative index for a
subject results from a blood pressure drop after the provision of
the vasodilative stimulant which indicates dilation in the artery
after provision of the vasodilative stimulant and is indicative of
a healthy response in the subject. A vasoconstrictive index for a
subject results from a blood pressure rise and/or lack of change in
blood pressure after the provision of the vasodilative stimulant
which indicates no dilation in the artery after provision of the
vasodilative stimulant and is indicative of a unhealthy response in
the subject. In an exemplary embodiment, an ankle-brachial blood
pressure index test may be administered to the subject. A blood
marker of endothelial function may be used on the subject along
with the methods 500, 700, 800, 900, 1000, 1100, 1500, 1600, 1700,
2000, 2500, 2600, 2700, 2800, and 3000. The stiffness of the artery
supplying blood to the finger may be measured and recorded, for
example, using arterial pulse waveform analysis during the methods
500, 700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600,
2700, 2800, and 3000. In an exemplary embodiment, stiffness of the
artery may be measured and recorded before provision of the
vasostimulant in methods 500, 700, 800, 900, 1000, 1100, 1500,
1600, 1700, 2000, 2500, 2600, 2700, 2800, and 3000. In an exemplary
embodiment, stiffness of the artery may be measured and recorded
after provision of the vasostimulant in methods 500, 700, 800, 900,
1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700, 2800, and
3000. In an exemplary embodiment, stiffness of the artery may be
measured and recorded before, during, and after provision of the
vasostimulant in methods 500, 700, 800, 900, 1000, 1100, 1500,
1600, 1700, 2000, 2500, 2600, 2700, 2800, and 3000.
[0309] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of
atherosclerotic cardiovascular disorder in the subject may be
determined. It is well known that deficiencies in endothelial
function are indicative of atherosclerotic cardiovascular disorder.
Use of the methods 500, 700, 800, 900, 1000, 1100, 1500, 1600,
1700, 2000, 2500, 2600, 2700, 2800, and 3000 and/or the apparatus
100, 600, 1200, 1300, 1400, 1900, 2100, 2200, 2300, 2400, or 2900,
permits a health care professional to acquire temperature data
which may be analyzed to determine endothelial dysfunction. In an
exemplary embodiment, determining the status of atherosclerotic
cardiovascular disorder includes assessing the risk of
atherosclerotic cardiovascular disorder in the subject. In an
exemplary embodiment, determining the status of atherosclerotic
cardiovascular disorder includes monitoring the subject's response
to atherosclerotic cardiovascular disorder therapies. In an
exemplary embodiment, determining the status of atherosclerotic
cardiovascular disorder includes using conventional methods such
as, for example, a coronary calcium score, a Framingham risk score,
or a carotid intima-media thickness test, along with methods 500,
700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600,
2700, 2800, and 3000 and/or the apparatus 100, 600, 1200, 1300,
1400, 1900, 2100, 2200, 2300, 2400, or 2900 to assess the risk of
atherosclerotic cardiovascular disorder.
[0310] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of heart failure
in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of heart
failure. Use of the methods 500, 700, 800, 900, 1000, 1100, 1500,
1600, 1700, 2000, 2500, 2600, 2700, 2800, and 3000 and/or the
apparatus 100, 600, 1200, 1300, 1400, 1900, 2100, 2200, 2300, 2400,
or 2900 permits a health care professional to acquire temperature
data which may be analyzed to determine endothelial dysfunction. In
an exemplary embodiment, determining the status of heart failure
includes monitoring the progression of heart failure in the
subject. In an exemplary embodiment, determining the status of
heart failure includes monitoring the subject's response to heart
failure therapies. In an exemplary embodiment, determining the
status of heart failure includes using conventional methods such
as, for example, a cardiac function test, along with methods 500,
700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600,
2700, 2800, and 3000 and/or the apparatus 100, 600, 1200, 1300,
1400, 1900, 2100, 2200, 2300, 2400, or 2900 to monitor the
progression of heart failure in the subject.
[0311] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of obesity in the
subject may be determined. It is well known that deficiencies in
endothelial function are indicative of obesity. Use of the above
methods and/or apparatus permits a health care professional to
acquire temperature data which may be analyzed to determine
endothelial dysfunction. In an exemplary embodiment, determining
the status of obesity includes managing the subject's obesity by
determining the likelihood of the subject regaining lost weight. In
an exemplary embodiment, determining the status of obesity includes
using conventional methods along with the methods and/or the
apparatus of the present invention to monitor the progression of
obesity in the subject.
[0312] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of high
sympathetic reactivity in the subject may be determined. It is well
known that deficiencies in endothelial function are indicative of
high sympathetic reactivity. Use of these methods and/or apparatus
permits a health care professional to acquire temperature data
which may be analyzed to determine endothelial dysfunction. In an
exemplary embodiment, determining the status of high sympathetic
reactivity includes identifying whether the subject has high
sympathetic reactivity. In an exemplary embodiment, determining the
status of high sympathetic reactivity includes monitoring the
subject's response to hypersympathetic therapies. In an exemplary
embodiment, determining the status of heart failure includes using
conventional methods along with methods and/or the apparatus of the
present invention to identify whether the subject has high
sympathetic reactivity.
[0313] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of high blood
pressure in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of high blood
pressure. Use of these methods and/or apparatus permits a health
care professional to acquire temperature data which may be analyzed
to determine endothelial dysfunction. In an exemplary embodiment,
determining the status of high blood pressure includes screening
the subject for high blood pressure. In an exemplary embodiment,
determining the status of high blood pressure includes monitoring
the subject's response to high blood pressure therapies. In an
exemplary embodiment, determining the status of high blood pressure
includes using conventional methods along with the methods and/or
the apparatus of the present invention to screen the subject for
high blood pressure. In an exemplary embodiment, determining the
status of high blood pressure includes identifying whether the
subject is resistant to high blood pressure therapies. In an
exemplary embodiment, determining the status of high blood pressure
includes screening the subject for white coat hypertension. In an
exemplary embodiment, determining the status of high blood pressure
includes measuring the blood pressure of a subject and
distinguishing between the different stages of hypertensive
vascular disease.
[0314] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of smooth muscle
cell dysfunction in the subject may be determined. It is well known
that deficiencies in endothelial function are indicative of smooth
muscle cell dysfunction. Use of these methods and/or apparatus
permits a health care professional to acquire temperature data
which may be analyzed to determine endothelial dysfunction. In an
exemplary embodiment, determining the status of smooth muscle cell
dysfunction includes screening the subject for smooth muscle cell
dysfunction. In an exemplary embodiment, determining the status of
smooth muscle cell dysfunction includes monitoring the subject's
response to smooth muscle cell dysfunction therapies. In an
exemplary embodiment, determining the status of smooth muscle cell
dysfunction includes using conventional methods along with methods
and/or the apparatus of the present invention to screen the subject
for smooth muscle cell dysfunction.
[0315] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of diabetes in
the subject may be determined. It is well known that deficiencies
in endothelial function are indicative of diabetes. Use of these
methods and/or apparatus permits a health care professional to
acquire temperature data which may be analyzed to determine
endothelial dysfunction. In an exemplary embodiment, determining
the status of diabetes includes predicting whether the subject will
develop diabetes. In an exemplary embodiment, determining the
status of diabetes includes monitoring the status and progression
of diabetes in the subject. In an exemplary embodiment, determining
the status of diabetes includes monitoring the subject's response
to diabetes therapies. In an exemplary embodiment, determining the
status of diabetes includes using conventional methods such as, for
example, a hemoglobin A1C test or measuring the subjects glucose
level, along with methods and/or the apparatus of the present
invention to monitor the status and progression of diabetes in the
subject. In an exemplary embodiment, determining the status of
diabetes in the subject includes determining the status of type-2
diabetes in the subject.
[0316] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of fitness level
in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of fitness
level. Use of these methods and/or apparatus permits a health care
professional to acquire temperature data which may be analyzed to
determine endothelial dysfunction. In an exemplary embodiment,
determining the status of fitness level includes identifying the
fitness level of the subject. In an exemplary embodiment,
determining the status of fitness level includes monitoring the
subject's response to fitness program. In an exemplary embodiment,
determining the status of smooth muscle cell dysfunction includes
using conventional methods along with methods and/or the apparatus
of the present invention to identify the fitness level of the
subject.
[0317] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of rheumatologic
and/or connective tissue disorders in the subject may be
determined. It is well known that deficiencies in endothelial
function are indicative of rheumatologic and/or connective tissue
disorders. Use of these methods and/or apparatus permits a health
care professional to acquire temperature data which may be analyzed
to determine endothelial dysfunction. In an exemplary embodiment,
determining the status of rheumatologic and/or connective tissue
disorders includes assessing the subject for vascular effects due
to rheumatologic and/or connective tissue disorders. In an
exemplary embodiment, determining the status of rheumatologic
and/or connective tissue disorders includes monitoring the
subject's response to rheumatologic and/or connective tissue
disorder therapies. In an exemplary embodiment, determining the
status of rheumatologic and/or connective tissue disorders includes
using conventional methods along with methods and/or the apparatus
of the present invention to assess the subject for vascular effects
due to rheumatologic and/or connective tissue disorders.
[0318] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of pulmonary
hypertension in the subject may be determined. It is well known
that deficiencies in endothelial function are indicative of
pulmonary hypertension. Use of these methods and/or apparatus
permits a health care professional to acquire temperature data
which may be analyzed to determine endothelial dysfunction. In an
exemplary embodiment, determining the status of pulmonary
hypertension includes assessing whether the subject is at risk for
pulmonary hypertension. In an exemplary embodiment, determining the
status of pulmonary hypertension includes monitoring the status and
progression of pulmonary hypertension in the subject. In an
exemplary embodiment, determining the status of pulmonary
hypertension includes monitoring the subject's response to
pulmonary hypertension therapies. In an exemplary embodiment,
determining the status of pulmonary hypertension includes using
conventional methods along with methods and/or the apparatus of the
present invention to monitor the status and progression of
pulmonary hypertension in the subject.
[0319] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of smoking
cessation in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of smoking. Use
of these methods and/or apparatus permits a health care
professional to acquire temperature data which may be analyzed to
determine endothelial dysfunction. In an exemplary embodiment,
determining the status of smoking cessation includes assessing
whether the subject would respond positively to a smoking cessation
program. In an exemplary embodiment, determining the status of
smoking cessation includes monitoring the subject's success with a
smoking cessation program. In an exemplary embodiment, determining
the status of smoking cessation includes using conventional methods
along with methods and/or the apparatus of the present invention to
assess whether the subject would response positively to a smoking
cessation program.
[0320] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of vascular
stress in the subject may be determined without subjecting the
subject to physical activity. It is well known that deficiencies in
endothelial function are indicative of vascular stress. Use of
these methods and/or apparatus permits a health care professional
to acquire temperature data which may be analyzed to determine
endothelial dysfunction. In an exemplary embodiment, determining
the status of vascular stress includes monitoring the progression
of vascular stress in the subject. In an exemplary embodiment,
determining the status of vascular stress includes monitoring the
subject's response to vascular stress therapies. In an exemplary
embodiment, determining the status of vascular stress includes
using conventional methods along with methods and/or the apparatus
of the present invention to monitor the progression of vascular
stress in the subject.
[0321] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of sleep
disorders such as, for example, sleep apnea, in the subject may be
determined. It is well known that deficiencies in endothelial
function are indicative of sleep disorders. Use of these methods
and/or apparatus permits a health care professional to acquire
temperature data which may be analyzed to determine endothelial
dysfunction. In an exemplary embodiment, determining the status of
sleep disorders includes monitoring the progression of sleep
disorders in the subject. In an exemplary embodiment, determining
the status of sleep disorders includes monitoring the subject's
response to sleep disorder therapies. In an exemplary embodiment,
determining the status of sleep disorders includes using
conventional methods along with methods and/or the apparatus of the
present invention to monitor the progression of sleep disorder in
the subject.
[0322] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of metabolic
syndrome in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of metabolic
syndrome. Use of these methods and/or apparatus permits a health
care professional to acquire temperature data which may be analyzed
to determine endothelial dysfunction. In an exemplary embodiment,
determining the status of metabolic syndrome includes monitoring
the progression of metabolic syndrome in the subject. In an
exemplary embodiment, determining the status of metabolic syndrome
includes monitoring the subject's response to metabolic syndrome
therapies. In an exemplary embodiment, determining the status of
metabolic syndrome includes using conventional methods along with
methods and/or the apparatus of the present invention to monitor
whether the subject is at risk for metabolic syndrome.
[0323] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of subclinical
hypothyroidism in the subject may be determined. It is well known
that deficiencies in endothelial function are indicative of
subclinical hypothyroidism. Use of these methods and/or apparatus
permits a health care professional to acquire temperature data
which may be analyzed to determine endothelial dysfunction. In an
exemplary embodiment, determining the status of subclinical
hypothyroidism includes detecting subclinical hypothyroidism in the
subject. In an exemplary embodiment, determining the status of
subclinical hypothyroidism includes monitoring the subject's
response to subclinical hypothyroidism therapies. In an exemplary
embodiment, determining the status of subclinical hypothyroidism
includes using conventional methods along with methods and/or the
apparatus of the present invention to detect subclinical
hypothyroidism in the subject.
[0324] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of vascular
dementia and/or Alzheimer's disease in the subject may be
determined. It is well known that deficiencies in endothelial
function are indicative of vascular dementia and/or Alzheimer's
disease. Use of these methods and/or apparatus permits a health
care professional to acquire temperature data which may be analyzed
to determine endothelial dysfunction. In an exemplary embodiment,
determining the status of vascular dementia and/or Alzheimer's
disease includes screening for vascular dementia and/or Alzheimer's
disease in the subject. In an exemplary embodiment, determining the
status of vascular dementia and/or Alzheimer's disease includes
monitoring the subject's response to vascular dementia and/or
Alzheimer's disease therapies. In an exemplary embodiment,
determining the status of vascular dementia and/or Alzheimer's
disease includes using conventional methods along with methods
and/or the apparatus of the present invention to screen for
vascular dementia and/or Alzheimer's disease in the subject.
[0325] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of endothelial
function in the subject may be determined. Use of these methods
and/or apparatus, permits a health care professional to acquire
temperature data which may be analyzed to determine endothelial
dysfunction. In an exemplary embodiment, determining the status of
endothelial function includes using others tests related to
endothelial function such as, for example, an endothelial driven
microparticles test, a VCAM1 test, an ICAM1 test, a SELECTIN test,
a VWF test, a TF test, and/or a CD54 test, along with methods
and/or the apparatus of the present invention to assess endothelial
function.
[0326] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of autonomic
nervous system function in the subject may be determined. It is
well known that deficiencies in endothelial function are indicative
of autonomic nervous system function. Use of these methods and/or
apparatus permits a health care professional to acquire temperature
data which may be analyzed to determine endothelial dysfunction. In
an exemplary embodiment, determining the status of autonomic
nervous system function includes screening for autonomic nervous
system function in the subject. In an exemplary embodiment,
determining the status of autonomic nervous system function
includes using conventional methods along with methods and/or the
apparatus of the present invention to screen for autonomic nervous
system function in the subject.
[0327] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of portal
hypertension in the subject may be determined. It is well known
that deficiencies in endothelial function are indicative of portal
hypertension. Use of these methods and/or apparatus permits a
health care professional to acquire temperature data which may be
analyzed to determine endothelial dysfunction. In an exemplary
embodiment, determining the status of portal hypertension includes
determining whether the subject will develop portal hypertension.
In an exemplary embodiment, determining the status of portal
hypertension includes determining the status and progression of
portal hypertension in the subject. In an exemplary embodiment,
determining the status of portal hypertension includes determining
the response of the subject to portal hypertension disease
therapies. In an exemplary embodiment, determining the status of
portal hypertension includes using conventional methods along with
methods and/or the apparatus of the present invention to screen for
portal hypertension in the subject.
[0328] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of cancer in the
subject may be determined. It is well known that deficiencies in
endothelial function are indicative of cancer. Use of these methods
and/or apparatus permits a health care professional to acquire
temperature data which may be analyzed to determine endothelial
dysfunction. In an exemplary embodiment, determining the status of
cancer includes determining whether the subject will develop
cancer. In an exemplary embodiment, determining the status of
cancer includes determining the status and progression of cancer in
the subject. In an exemplary embodiment, determining the status of
cancer includes determining the response of the subject to cancer
disease therapies. In an exemplary embodiment, determining the
status of cancer includes using conventional methods along with
methods and/or the apparatus of the present invention to screen for
cancer in the subject.
[0329] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of renal function
in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of renal
function. Use of these methods and/or apparatus permits a health
care professional to acquire temperature data which may be analyzed
to determine endothelial dysfunction. In an exemplary embodiment,
determining the status of renal function includes determining
whether the subject will develop renal function. In an exemplary
embodiment, determining the status of renal function includes
determining the status and progression of renal function in the
subject. In an exemplary embodiment, determining the status of
renal function includes determining the response of the subject to
renal function disease therapies. In an exemplary embodiment,
determining the status of renal function includes using
conventional methods along with methods and/or the apparatus of the
present invention to screen for renal function in the subject.
[0330] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of hypertension
in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of
hypertension. Use of these methods and/or apparatus permits a
health care professional to acquire temperature data which may be
analyzed to determine endothelial dysfunction. In an exemplary
embodiment, determining the status of hypertension includes
determining whether the subject will develop hypertension. In an
exemplary embodiment, determining the status of hypertension
includes determining the status and progression of hypertension in
the subject. In an exemplary embodiment, determining the status of
hypertension includes determining the response of the subject to
hypertension disease therapies. In an exemplary embodiment,
determining the status of hypertension includes using conventional
methods along with methods and/or the apparatus of the present
invention to screen for hypertension in the subject.
[0331] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of cerebral
vascular disease in the subject may be determined. It is well known
that deficiencies in endothelial function are indicative of
cerebral vascular disease. Use of these methods and/or the
apparatus permits a health care professional to acquire temperature
data which may be analyzed to determine endothelial dysfunction. In
an exemplary embodiment, determining the status of cerebral
vascular disease includes determining whether the subject will
develop cerebral vascular disease. In an exemplary embodiment,
determining the status of hypertension includes determining the
status and progression of cerebral vascular disease in the subject.
In an exemplary embodiment, determining the status of cerebral
vascular disease includes determining the response of the subject
to stroke therapies. In an exemplary embodiment, determining the
status of cerebral vascular disease includes using conventional
methods along with methods and/or the apparatus of the present
invention to screen for cerebral vascular disease in the subject.
In an embodiment, cerebral vascular disease may include, for
example, strokes.
[0332] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of dementia
and/or memory loss in the subject may be determined. It is well
known that deficiencies in endothelial function are indicative of
dementia and/or memory loss. Use of these methods and/or the
apparatus permits a health care professional to acquire temperature
data which may be analyzed to determine endothelial dysfunction. In
an exemplary embodiment, determining the status of dementia and/or
memory loss includes determining whether the subject will develop
dementia and/or memory loss. In an exemplary embodiment,
determining the status of dementia includes determining the status
and progression of dementia and/or memory loss in the subject. In
an exemplary embodiment, determining the status of dementia and/or
memory loss includes determining the response of the subject to
dementia and/or memory loss disease therapies. In an exemplary
embodiment, determining the status of dementia and/or memory loss
includes using conventional methods along with methods and/or the
apparatus of the present invention to screen for dementia and/or
memory loss in the subject.
[0333] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of vision loss in
the subject may be determined. It is well known that deficiencies
in endothelial function are indicative of vision loss. Use of these
methods and/or the apparatus permits a health care professional to
acquire temperature data which may be analyzed to determine
endothelial dysfunction. In an exemplary embodiment, determining
the status of vision loss includes determining whether the subject
will develop vision loss. In an exemplary embodiment, determining
the status of vision loss includes determining the status and
progression of vision loss in the subject. In an exemplary
embodiment, determining the status of vision loss includes
determining the response of the subject to vision loss disease
therapies. In an exemplary embodiment, determining the status of
vision loss includes using conventional methods along with methods
and/or the apparatus of the present invention to screen for vision
loss in the subject.
[0334] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of heart attack
and/or angina in the subject may be determined. It is well known
that deficiencies in endothelial function are indicative of heart
attack and/or angina. Use of these methods and/or the apparatus
permits a health care professional to acquire temperature data
which may be analyzed to determine endothelial dysfunction. In an
exemplary embodiment, determining the status of heart attack and/or
angina includes determining whether the subject will develop heart
attacks and/or angina. In an exemplary embodiment, determining the
status of heart attack and/or angina includes determining the
status and progression of heart attacks and/or angina in the
subject. In an exemplary embodiment, determining the status of
heart attack and/or angina includes determining the response of the
subject to heart attack and/or angina therapies. In an exemplary
embodiment, determining the status of heart attack and/or angina
includes using conventional methods along with methods and/or the
apparatus of the present invention to screen for heart attacks
and/or angina in the subject.
[0335] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of erectile
dysfunction in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of erectile
dysfunction. Use of these methods and/or the apparatus permits a
health care professional to acquire temperature data which may be
analyzed to determine endothelial dysfunction. In an exemplary
embodiment, determining the status of erectile dysfunction includes
determining whether the subject will develop erectile dysfunction.
In an exemplary embodiment, determining the status of erectile
dysfunction includes determining the status and progression of
erectile dysfunction in the subject. In an exemplary embodiment,
determining the status of erectile dysfunction includes determining
the response of the subject to erectile dysfunction therapies. In
an exemplary embodiment, determining the status of erectile
dysfunction includes using conventional methods along with methods
and/or the apparatus of the present invention to screen for
erectile dysfunction in the subject.
[0336] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of peripheral
artery disease in the subject may be determined. It is well known
that deficiencies in endothelial function are indicative of
peripheral artery disease. Use of these methods and/or the
apparatus permits a health care professional to acquire temperature
data which may be analyzed to determine endothelial dysfunction. In
an exemplary embodiment, determining the status of peripheral
artery disease includes determining whether the subject will
develop peripheral artery disease. In an exemplary embodiment,
determining the status of peripheral artery disease includes
determining the status and progression of peripheral artery disease
in the subject. In an exemplary embodiment, determining the status
of peripheral artery disease includes determining the response of
the subject to peripheral artery disease therapies. In an exemplary
embodiment, determining the status of peripheral artery disease
includes using conventional methods along with methods and/or the
apparatus of the present invention to screen for peripheral artery
disease in the subject.
[0337] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of pregnancy in
the subject may be determined. It is well known that deficiencies
in endothelial function are indicative of pregnancy. Use of these
methods and/or the apparatus permits a health care professional to
acquire temperature data which may be analyzed to determine
endothelial dysfunction. In an exemplary embodiment, determining
the status of pregnancy includes determining the status and
progression of pregnancy in the subject. In an exemplary
embodiment, determining the status of pregnancy includes
determining the status of preeclampsia in the subject. In an
exemplary embodiment, determining the status of pregnancy includes
using conventional methods along with methods and/or the apparatus
of the present invention to screen for pregnancy in the
subject.
[0338] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of migraine
headaches in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of migraine
headaches. Use of these methods and/or the apparatus permits a
health care professional to acquire temperature data which may be
analyzed to determine endothelial dysfunction. In an exemplary
embodiment, determining the status of migraine headaches includes
determining whether the subject will develop migraine headaches. In
an exemplary embodiment, determining the status of migraine
headaches includes determining the status and progression of
migraine headaches in the subject. In an exemplary embodiment,
determining the status of migraine headaches includes determining
the response of the subject to migraine headaches therapies. In an
exemplary embodiment, determining the status of migraine headaches
includes using conventional methods along with methods and/or the
apparatus of the present invention to screen for migraine headaches
in the subject. In an exemplary embodiment, a migraine headache may
include headaches such as, for example, vascular headaches,
migraine variants, and a variety of other headaches known in the
art.
[0339] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of Prinzmetal's
angina in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of Prinzmetal's
angina. Use of these methods and/or the apparatus permits a health
care professional to acquire temperature data which may be analyzed
to determine endothelial dysfunction. In an exemplary embodiment,
determining the status of Prinzmetal's angina includes determining
whether the subject will develop Prinzmetal's angina. In an
exemplary embodiment, determining the status of Prinzmetal's angina
includes determining the status and progression of Prinzmetal's
angina in the subject. In an exemplary embodiment, determining the
status of Prinzmetal's angina includes determining the response of
the subject to Prinzmetal's angina therapies. In an exemplary
embodiment, determining the status of Prinzmetal's angina includes
using conventional methods along with methods and/or the apparatus
of the present invention to screen for Prinzmetal's angina in the
subject.
[0340] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of HIV in the
subject may be determined. It is well known that deficiencies in
endothelial function are indicative of HIV. Use of these methods
and/or the apparatus permits a health care professional to acquire
temperature data which may be analyzed to determine endothelial
dysfunction. In an exemplary embodiment, determining the status of
HIV includes determining whether the subject has contracted HIV. In
an exemplary embodiment, determining the status of HIV includes
determining the status and progression of HIV in the subject. In an
exemplary embodiment, determining the status of HIV includes
determining the response of the subject to HIV therapies. In an
exemplary embodiment, determining the status of HIV includes using
conventional methods along with methods and/or the apparatus of the
present invention to screen for HIV in the subject.
[0341] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the status of diabetic foot
in the subject may be determined. It is well known that
deficiencies in endothelial function are indicative of diabetic
foot. Use of these methods and/or the apparatus permits a health
care professional to acquire temperature data which may be analyzed
to determine endothelial dysfunction. In an exemplary embodiment,
determining the status of diabetic foot includes determining
whether the subject has diabetic foot. In an exemplary embodiment,
determining the status of diabetic foot includes determining the
status and progression of diabetic foot in the subject. In an
exemplary embodiment, determining the status of diabetic foot
includes determining the response of the subject to diabetic foot
therapies. In an exemplary embodiment, determining the status of
diabetic foot includes using conventional methods along with
methods and/or the apparatus of the present invention to screen for
diabetic foot in the subject. In an exemplary embodiment,
determining the status of diabetic foot includes measuring the
autonomic nervous systemic function in the subject such as, for
example, by looking at the changes in temperature in the
contralateral finger 18 on subject 10 after provision of the
vasostimulant. In an exemplary embodiment, an increase in
temperature in the contralateral finger 18 of subject 10 indicates
a healthy autonomic nervous system function in the subject.
[0342] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, the effectiveness of
cholesterol lowering medications in the subject may be determined.
It is well known that deficiencies in endothelial function are
indicative of the effectiveness of cholesterol lowering
medications. Use of these methods and/or the apparatus permits a
health care professional to acquire temperature data which may be
analyzed to determine endothelial dysfunction. In an exemplary
embodiment, determining the effectiveness of cholesterol lowering
medications includes determining the effectiveness of cholesterol
lowering medications from the family of statins such as, for
example, Lipitor and/or mevalonate.
[0343] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, additional diagnosis
techniques such as, for example, determining a coronary calcium
score, determining a Framingham risk score, determining a carotid
intima media thickness, conducting a c-reactive protein test,
determining a Lp-PLA2 level, and/or a variety of other techniques
which may be used to provide a comprehensive determination of
health condition with the methods of the present invention in order
to determine the health condition of the subject.
[0344] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, additional diagnosis
techniques such as, for example, change in oxygen saturation in the
body part in which temperature is being measured, change in Doppler
flow in the body part in which temperature is being measured,
change in pressure in the body part in which temperature is being
measured, and/or change in blood flow measured by near infrared
spectroscopy in the body part in which temperature is being
measured, may be used to provide a comprehensive determination of
health condition with the methods of the present invention in order
to determine the health condition of the subject.
[0345] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, additional risk assessment
methods such as, for example, intravascular optical coherent
tomography, coronary fractional flow reserve, intravascular
ultrasound radiofrequency backscatter analysis or Virtual
Histology, urinary albumin, serum fibrinogen, IL6, CD40/CD40L,
serum amyloid A, ankle brachial index, MRI, coronary calcium score,
carotid intima thickness, Framingham risk score, C-reactive protein
tests, waist circumference, blood insulin level, PAI-1 test, t-PA
test, glucose tolerance tests, fasting plasma glucose level, HDL
cholesterol level, fasting plasma insulin test, homeostasis model
assessment, BMI, body fat level, visceral fat test, subcutaneous
fat test, white blood cell count, Neutrophil/lymphocyte ratio,
platelet function test, combinations thereof, and/or a variety of
other cardiovascular risk assessment methods may be used to provide
a comprehensive determination of health condition with the methods
of the present invention in order to determine the health condition
of the subject. In an exemplary embodiment, ankle-brachial index is
the blood pressure measured at the ankle level over the blood
pressure measured at the arm level. A ratio of 0.9 or less is
considered unhealthy and an indication of peripheral artery
disease. Using the methods and/or the apparatus of the present
invention, temperature measurements at the ankle level and the arm
level can be used to create a ration substantially similar to the
ankle brachial index. Furthermore, multiple temperature
measurements of a subject using the methods and/or the apparatus of
the present invention at different body parts on the subject may
provide a more comprehensive assessment of health condition.
[0346] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, additional diagnostic
methods which include factors or markers related to endothelial
function, endothelial activation, or endothelial damage, such as,
for example, plasma and urinary level of asymmetrical (ADMA) and
symmetrical (SDMA dimethylarginine, exhaled nitric oxide, serum
homocysteine, an endothelial driven microparticles test, a VCAM1
test, an ICAM1 test, a SELECTIN test, a VWF test, a TF test, and/or
a CD54 test, endothelial progenitor cells, myelo-peroxidase (MPO),
increased neutrophil/lymphocyte ratio, endothelin-1,
thrombomodulin, tissue factor and tissue factor pathway inhibitor,
markers of inflammation such as, for example,
granulocyte-macrophage colony-stimulating factor (GM-CSF) and
macrophage chemoattractant protein-1 (MCP-1) nitric oxide and its
metabolites nitrates and nitrites, almost nitrosylated proteins, a
selectin such as, for example, soluble endothelium, leukocyte, and
platelet selecting, markers of oxidative stress including but not
limited to free radical measurements of the blood or through the
skin, TBAR, and/or extra cellular super oxide dismutase activity,
vascular stiffness or compliance, combinations thereof, and/or a
variety of other endothelial related techniques may be used to
provide a comprehensive determination of health condition with the
methods of the present invention in order to determine the health
condition of the subject.
[0347] In several exemplary embodiments, after acquiring and/or
plotting the temperature data obtained using the methods 500, 700,
800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700,
2800, and 3000 and/or the apparatus 100, 600, 1200, 1300, 1400,
1900, 2100, 2200, 2300, 2400, or 2900, additional diagnostic
methods which measure parameters which change in the subject during
these methods along with temperature such as, for example, skin
color, nail capilloroscopy, ultrasound brachial artery imaging,
forearm plethysmography, fingertip plethysmography, oxygen
saturation change, pressure change, near-infrared spectroscopy
measurements, Doppler flow change, peripheral arterial tomometry,
combinations thereof, and/or a variety of other endothelial related
techniques may be used to provide a comprehensive determination of
health condition with the methods of the present invention in order
to determine the health condition of the subject.
[0348] In several exemplary embodiments, additional diagnosis
techniques may be used to acquire a measure of endothelium
independent vascular reactivity along with the measure of
endothelium dependent vascular reactivity which may be acquired by
the methods 500, 700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000,
2500, 2600, 2700, 2800, and 3000, and a ratio of the endothelium
dependent vascular reactivity over the endothelium independent
vascular reactivity or a composite index of the endothelium
dependent vascular reactivity and the endothelium independent
vascular reactivity may be calculated to determine the health
condition of the subject. Additional diagnosis techniques may also
be used to acquire a measure of parameters which change in the
subject during these methods along with temperature along with the
measure of endothelium dependent vascular reactivity which may be
acquired by the methods, and a ratio of the parameters which change
in the subject during the methods along with temperature over the
endothelium dependent vascular reactivity or a composite index of
the parameters which change in the subject during the methods along
with temperature and the endothelium dependent vascular reactivity
may be calculated to determine the health condition of the subject.
In an exemplary embodiment, a ratio or composite index may include
variables determined using the methods 500, 700, 800, 900, 1000,
1100, 1500, 1600, 1700, 2000, 2500, 2600, 2700, 2800, and 3000 on a
variety of body parts on the subject. In an exemplary embodiment, a
ratio or composite index may include variables determined using
these methods and a variety of additional diagnostic methods such
as the diagnostic methods described above. In an exemplary
embodiment, a composite index is the operation of a plurality of
factors using any mathematical operator.
[0349] In several exemplary embodiments, along with acquiring
and/or plotting the temperature data obtained using the methods
500, 700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600,
2700, 2800, and 3000 and/or the apparatus 100, 600, 1200, 1300,
1400, 1900, 2100, 2200, 2300, 2400, or 2900, a medication may be
administered to the subject for the treatment of a medical
condition. These methods and/or the apparatus help to determine
whether the medication is effective in the treatment of the medical
condition and, if the medication is determined to be effective, the
medication may be selected in treating that medical condition in
other subjects.
[0350] In several exemplary embodiments, along with acquiring
and/or plotting the temperature data obtained using the methods
500, 700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600,
2700, 2800, and 3000 and/or the apparatus 100, 600, 1200, 1300,
1400, 1900, 2100, 2200, 2300, 2400, or 2900, a nutritional program
may be administered to the subject. The methods and/or the
apparatus of the present invention help to determine whether the
nutritional program is effective for the subject and, if the
nutritional program is determined to be effective, the nutritional
program may be selected for other subjects.
[0351] In several exemplary embodiments, along with acquiring
and/or plotting the temperature data obtained using the methods
500, 700, 800, 900, 1000, 1100, 1500, 1600, 1700, 2000, 2500, 2600,
2700, 2800, and 3000 and/or the apparatus 100, 600, 1200, 1300,
1400, 1900, 2100, 2200, 2300, 2400, or 2900, a chemical agent,
medical procedure, or health intervention program may be
administered to the subject for the treatment of a medical
condition. The methods and/or the apparatus of the present
invention help to study the effects of the chemical agent, medical
procedure and or health intervention program in treating the
subject for the medical condition. In an exemplary embodiment, a
health intervention program includes, but is not limited to, a
program of smoking cessation, a program of drinking cessation, a
dietary program, and/or an exercise program.
[0352] A thermal energy measurement apparatus has been described
that includes a thermal energy sensor and means for coupling the
thermal energy sensor to a skin surface of a body part, the
coupling means operable to couple the thermal energy sensor to the
skin surface of the body part while not substantially changing the
skin temperature of the body part. In an exemplary embodiment, the
means for coupling the thermal energy sensor to the skin surface of
the body part comprises a mesh. In an exemplary embodiment, the
means for coupling the thermal energy sensor to the skin surface of
the body part comprises a non-insulating material. In an exemplary
embodiment, the thermal energy sensor is adapted to measure skin
temperature. In an exemplary embodiment, the means for coupling the
thermal energy sensor to the skin surface of the body part is
operable to hold the thermal energy sensor in contact with skin
surface on the body part. In an exemplary embodiment, the thermal
energy sensor comprises a plurality of thermal energy sensors.
[0353] In an exemplary embodiment, a computer system is coupled to
the thermal energy sensor. In an exemplary embodiment, the computer
system is coupled to the thermal energy sensor by a wireless
connection. In an exemplary embodiment, the wireless connection
comprises Bluetooth technology. In an exemplary embodiment, the
computer system is chosen from the group consisting of a cellular
phone, a PDA, a personal computing device, and combinations
thereof.
[0354] In an exemplary embodiment, the computer system is coupled
to a therapeutic device, the therapeutic device operable to perform
a therapeutic function. In an exemplary embodiment, the therapeutic
function includes the release of oxygen. In an exemplary
embodiment, the computer system is coupled to an alerting device.
In an exemplary embodiment, the alerting device is operable to
contact emergency medical services. In an exemplary embodiment, the
computer system is coupled to a pulse oximeter. In an exemplary
embodiment, the computer system is coupled to a blood pressure
monitoring device. In an exemplary embodiment, the computer system
is coupled to a Doppler probe. In an exemplary embodiment, the
computer system is coupled to a room temperature measurement
device. In an exemplary embodiment, the computer system is coupled
to a core temperature measurement device.
[0355] In an exemplary embodiment, the means for coupling the
thermal energy sensor to the body part comprises a ring. In an
exemplary embodiment, the means for coupling the thermal energy
sensor to the body part comprises a watch. In an exemplary
embodiment, the means for coupling the thermal energy sensor to the
body part comprises a bracelet. In an exemplary embodiment, the
thermal energy sensor comprises a probe operable to measure thermal
energy of the skin surface of the body part without contacting the
body part. In an exemplary embodiment, the means for coupling the
thermal energy sensor to the body part comprises an article of
clothing. In an exemplary embodiment, the means for coupling the
thermal energy sensor to the body part comprises an adhesive. In an
exemplary embodiment, the means for coupling the thermal energy
sensor to the body part is disposable. In an exemplary embodiment,
the thermal energy sensor is operable to measure thermal energy
over a time period. In an exemplary embodiment, the means for
coupling the thermal energy sensor to a skin surface of a body part
comprises an adhesive. In an exemplary embodiment, the apparatus
further comprises an airflow channel defined by the means for
coupling the thermal energy sensor to a skin surface of a body part
located between the thermal energy sensor and the adhesive. In an
exemplary embodiment, the means for coupling the thermal energy
sensor to a skin surface of a body part is operable to apply a
minimum pressure across a body part in order to not substantially
change the skin surface temperature of the body part. In an
exemplary embodiment, the means for coupling the thermal energy
sensor to a skin surface of a body part is operable to couple to a
minimum surface area of the body part in order to not substantially
change the skin surface temperature of the body part.
[0356] In an exemplary embodiment, the apparatus further comprises
a second thermal energy sensor and a means for coupling the second
thermal energy sensor to a contralateral body part. In an exemplary
embodiment, the means for coupling the thermal energy sensor to the
skin surface of the body part comprises a glove. In an exemplary
embodiment, the means for coupling the thermal energy sensor to the
skin surface of the body part does not substantially change a
microcapillary blood flow underlying the skin surface. In an
exemplary embodiment, the apparatus further comprises a thermal
device operable to adjust the skin surface temperature of the body
part.
[0357] In an exemplary embodiment, the thermal energy sensor
comprises a thermocouple. In an exemplary embodiment, the thermal
energy sensor comprises a thermister. In an exemplary embodiment,
the thermal energy sensor comprises a resistance temperature
detector. In an exemplary embodiment, the thermal energy sensor
comprises a heat flux detector. In an exemplary embodiment, the
thermal energy sensor comprises a liquid crystal sensor. In an
exemplary embodiment, the thermal energy sensor comprises a
thermopile. In an exemplary embodiment, the thermal energy sensor
comprises a infrared sensor. In an exemplary embodiment, the
infrared sensor measures thermal energy of a point on a surface. In
an exemplary embodiment, the infrared sensor measures thermal
energy of an area on a surface.
[0358] A method for determining one or more health conditions has
been described that includes providing a subject, measuring the
skin temperature of a body part on the subject, providing a
vasostimulant to the subject, measuring the skin temperature
changes of the body part during and subsequent to the provision of
the vasostimulant, and determining one or more health conditions
for the subject based upon at least one of the skin temperature
changes measured. In an exemplary embodiment, the measuring the
skin temperature of the body part of the subject comprises coupling
a thermal energy measurement apparatus to the body part.
[0359] In an exemplary embodiment, the providing a vasostimulant
comprises providing a neuro-vasostimulant. In an exemplary
embodiment, the neuro-vasostimulant comprises the subject consuming
a glass of ice water. In an exemplary embodiment, the providing a
vasostimulant comprises providing a neurostimulant. In an exemplary
embodiment, the providing a vasostimulant comprises compressing an
artery on the subject for a period of time followed by ceasing the
compression. In an exemplary embodiment, the vasostimulant is
provided for 5 minutes or less. In an exemplary embodiment, the
vasostimulant is provided for 4 minutes or less. In an exemplary
embodiment, the vasostimulant is provided for 3 minutes or less. In
an exemplary embodiment, the vasostimulant is provided for
approximately 2 minutes. In an exemplary embodiment, the method
further includes having the subject exercise the body part on which
thermal energy is being measured after provision of the
vasostimulant.
[0360] In an exemplary embodiment, the skin temperature of the body
part is measured on a distal location to the artery. In an
exemplary embodiment, the artery comprises a brachial artery. In an
exemplary embodiment, the providing a vasostimulant comprises
administering a chemical agent to the subject which effects
vascular function. In an exemplary embodiment, the chemical agent
comprises a vasoconstrictor. In an exemplary embodiment, the
chemical agent comprises a vasodilator. In an exemplary embodiment,
the chemical agent comprises a neurostimulator. In an exemplary
embodiment, the chemical agent is nitroglycerin. In an exemplary
embodiment, the nitroglycerin is administered sublingually.
[0361] In an exemplary embodiment, the measuring the skin
temperature changes of the body part during and subsequent to the
provision of the vasostimulant comprises measuring the lowest skin
temperature of the body part. In an exemplary embodiment, the
measuring the skin temperature changes of the body part during and
subsequent to the provision of the vasostimulant comprises
measuring the time required to achieve the lowest skin temperature
of the body part. In an exemplary embodiment, the measuring the
skin temperature changes of the body part during and subsequent to
the provision of the vasostimulant comprises measuring the highest
skin temperature of the body part. In an exemplary embodiment, the
measuring the skin temperature changes of the body part during and
subsequent to the provision of the vasostimulant comprises
measuring the temperature difference between the highest skin
temperature of the body part and the skin temperature of the body
part prior to the provision of the vasostimulant. In an exemplary
embodiment, the difference between the highest skin temperature of
the body part and the skin temperature of the body part prior to
the provision of the vasostimulant is normalized based on the skin
temperature of the body part prior to the provision of the
vasostimulant. In an exemplary embodiment, the measuring the skin
temperature changes of the body part during and subsequent to the
provision of the vasostimulant comprises measuring the temperature
difference between the highest skin temperature of the body part
and the lowest skin temperature of the body part. In an exemplary
embodiment, the measuring the skin temperature changes of the body
part during and subsequent to the provision of the vasostimulant
comprises measuring the time required for the skin temperature of
the body part to stabilize subsequent to the provision of the
vasostimulant.
[0362] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises determining the slope of the
skin temperature changes of the body part from the skin
temperatures of the body part upon the provision of the
vasostimulant up to the lowest skin temperature of the body part
achieved. In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises determining the slope of the
skin temperature changes of the body part from the lowest skin
temperature of the body part achieved up to the highest skin
temperature of the body part achieved. In an exemplary embodiment,
the determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
plotting the temperature changes over time and measuring the area
bounded by the skin temperature curve, the lowest skin temperature
of the body part achieved, the time at which the vasostimulant was
provided, and the time at which the lowest skin temperature of the
body part was achieved.
[0363] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises plotting the temperature
changes over time and measuring the area bounded by the skin
temperature curve, the lower skin temperature of the body part
achieved, the time at which the lowest skin temperature of the body
part was achieved, and the time at which the highest skin
temperature of the body part was achieved.
[0364] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises determining endothelial
function.
[0365] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises screening for autonomic
nervous system function. In an exemplary embodiment, the
determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant in order to
assess cardiovascular risk for atherosclerotic cardiovascular
disorder. In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor the subject's
response to atherosclerotic cardiovascular disorder therapies. In
an exemplary embodiment, the determining one or more health
conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to assess cardiovascular risk for
atherosclerotic cardiovascular disorder. In an exemplary
embodiment, the additional diagnosis techniques comprise a coronary
calcium score. In an exemplary embodiment, the additional diagnosis
techniques comprise a Framingham risk score. In an exemplary
embodiment, the additional diagnosis techniques comprise a carotid
intima-media thickness test.
[0366] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor the progression
of heart failure in the subject. In an exemplary embodiment, the
determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant in order to
monitor the subject's response to heart failure therapies. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional diagnosis techniques in order
to monitor the progression of heart failure in the subject. In an
exemplary embodiment, the additional diagnosis techniques comprise
a cardiac function test.
[0367] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant for use in obesity management of the
subject. In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques for use in obesity management of the subject.
[0368] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to identify whether the
subject has high sympathetic reactivity. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
in order to monitor the subject's response to hypersympathetic
therapies. In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to identify whether the subject has high
sympathetic reactivity. In an exemplary embodiment, the determining
one or more health conditions for the subject based upon at least
one of the temperature changes measured comprises analyzing the
temperature response to the vasostimulant in order to screen the
subject for susceptibility to high blood pressure.
[0369] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor the subject's
response to high blood pressure therapies. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
along with additional diagnosis techniques in order to screen the
subject for susceptibility to high blood pressure. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
in order to identify whether the subject is resistant to high blood
pressure therapies.
[0370] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to screen the subject for
white coat hypertension. In an exemplary embodiment, the
determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to screen the subject for
white coat hypertension.
[0371] In an exemplary embodiment, the method further comprises
measuring and recording the blood pressure of the subject, wherein
the determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
distinguishing between different stages of hypertensive vascular
disease. In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to distinguish between different stages of
hypertensive vascular disease. In an exemplary embodiment, the
determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
screening the subject for smooth muscle cell (SMC) dysfunction.
[0372] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises monitoring the subject's
response to smooth muscle cell (SMC) dysfunction therapies. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional diagnosis techniques in order
to screen the subject smooth muscle cell (SMC) dysfunction.
[0373] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to predict whether the
subject will develop diabetes. In an exemplary embodiment, the
determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant in order to
monitor the status and progression of the subject's diabetes. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant in order to monitor the subject's response to
diabetes therapies. In an exemplary embodiment, the determining one
or more health conditions for the subject based upon at least one
of the temperature changes measured comprises analyzing the
temperature response to the vasostimulant along with additional
diagnosis techniques in order to monitor the status and progression
of the subject's diabetes. In an exemplary embodiment, the
additional diagnosis techniques comprise a hemoglobin A1C test. In
an exemplary embodiment, the additional diagnosis techniques
comprise measuring the subjects glucose level.
[0374] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to determine a fitness level
in the subject. In an exemplary embodiment, the determining one or
more health conditions for the subject based upon at least one of
the temperature changes measured comprises analyzing the
temperature response to the vasostimulant in order to determine a
the subject's response to a fitness program. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
along with additional diagnosis techniques in order to determine a
fitness level in the subject.
[0375] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises assessing the subject for
vascular effects due to a rheumatologic disorder. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises monitoring the subject's response to treatment for a
rheumatologic disorder. In an exemplary embodiment, the determining
one or more health conditions for the subject based upon at least
one of the temperature changes measured comprises analyzing the
temperature response to the vasostimulant along with additional
diagnosis techniques in order to assess the subject for vascular
effects due to a rheumatologic disorder. In an exemplary
embodiment, the body part is a finger, whereby the determining one
or more health conditions for the subject based upon at least one
of the temperature changes measured comprises screening the subject
for Raynauld's phenomenon. In an exemplary embodiment, the
determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to screen the subject for
Raynauld's phenomenon.
[0376] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises predicting whether the
subject is at risk for a connective tissue disorder. In an
exemplary embodiment, the connective tissue disorder is
presclerodema. In an exemplary embodiment, the determining one or
more health conditions for the subject based upon at least one of
the temperature changes measured comprises monitoring the subject's
response to treatment for presclerodema. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
along with additional diagnosis techniques in order to predict
whether the subject is at risk for a connective tissue
disorder.
[0377] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to determine whether the
subject is at risk for pulmonary hypertension. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
in order to monitor the status and progression of the subject's
pulmonary hypertension. In an exemplary embodiment, the determining
one or more health conditions for the subject based upon at least
one of the temperature changes measured comprises analyzing the
temperature response to the vasostimulant in order to monitor the
subject's response to pulmonary hypertension therapies. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional diagnosis techniques in order
to monitor the status and progression of the subject's pulmonary
hypertension.
[0378] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to determine whether the
subject would respond positively to a smoking cessation program. In
an exemplary embodiment, the determining one or more health
conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor the subject's
smoking cessation. In an exemplary embodiment, the determining one
or more health conditions for the subject based upon at least one
of the temperature changes measured comprises analyzing the
temperature response to the vasostimulant in order to monitor the
subject's success with a smoking cessation program. In an exemplary
embodiment, the determining one or more health conditions for the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
along with additional diagnosis techniques in order to determine
whether the subject would respond positively to a smoking cessation
program.
[0379] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor vascular stress
of the subject without subjecting the subject to physical
activity.
[0380] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor the progression
of sleep disorder in the subject. In an exemplary embodiment, the
determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant in order to
monitor the subject's response to sleep disorder therapy. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional diagnosis techniques in order
to monitor the progression of sleep disorder in the subject. In an
exemplary embodiment, the method further comprises measuring the
heart rate of the subject, wherein the measuring the heart rate and
the measuring the skin temperature changes of the body part are
performed at least partially while the subject is sleeping in order
to detect sleep disorders.
[0381] In an exemplary embodiment, the method is carried out a
plurality of times over a designated time interval. In an exemplary
embodiment, the method further comprises administering a magnetic
resonance imaging test to the subject. In an exemplary embodiment,
the method further comprises diagnosing an intravascular property
of the subject using intravascular diagnostic tools. In an
exemplary embodiment, the intravascular diagnostic tools comprise
intravascular ultrasound. In an exemplary embodiment, the method
further comprises measuring and recording a blood flow rate of the
subject. In an exemplary embodiment, the blood flow rate is
measured using optical spectroscopy. In an exemplary embodiment,
the blood flow rate is measured using near infrared spectroscopy.
In an exemplary embodiment, the method further comprises measuring
and recording a room temperature. In an exemplary embodiment, the
method further comprises measuring and recording a core temperature
of the subject. In an exemplary embodiment, the method further
comprises measuring and recording a tissue heat capacity of the
subject. In an exemplary embodiment, the method further comprises
measuring and recording a tissue metabolic rate of the subject.
[0382] In an exemplary embodiment, the method further comprises
measuring and recording the blood pressure of the subject. In an
exemplary embodiment, the blood pressure of the subject is measured
using Korotkoff sounds or oscillometric methods. In an exemplary
embodiment, the blood pressure of the subject is measured using
fingertip blood pressure. In an exemplary embodiment, the blood
pressure of the subject is measured using wrist blood pressure. In
an exemplary embodiment, the method further comprises determining a
vasodilative index for the subject. In an exemplary embodiment, the
method further comprises determining a vasoconstrictive index for
the subject. In an exemplary embodiment, the blood pressure of the
subject is measured before the provision of the vasostimulant. In
an exemplary embodiment, the blood pressure of the subject is
measured after the provision of the vasostimulant. In an exemplary
embodiment, the blood pressure of the subject is measured before,
during, and after the provision of the vasostimulant.
[0383] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor the subject's
response to mental stress. In an exemplary embodiment, the
monitoring the subject's response to mental stress comprises
detecting whether or not the subject is telling the truth. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional diagnosis techniques in order
to monitor the subject's response to mental stress.
[0384] In an exemplary embodiment, the method further comprises
providing a thermal measuring device operable to measure and record
the skin temperature of a body part. In an exemplary embodiment,
the thermal measuring device comprises a ring. In an exemplary
embodiment, the thermal measuring device comprises a watch. In an
exemplary embodiment, the thermal measuring device comprises a
bracelet.
[0385] In an exemplary embodiment, the method further comprises
measuring the skin temperature changes on a contralateral body part
of the subject. In an exemplary embodiment, the contralateral body
part comprises a plurality of contralateral body parts. In an
exemplary embodiment, the body part is a first hand on the subject,
and the contralateral body part is a second hand on the subject. In
an exemplary embodiment, the body part is a first foot on the
subject, and the contralateral body part is a second foot on the
subject. In an exemplary embodiment, the body part is a finger on
the subject, and the contralateral body part is a toe on the
subject.
[0386] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to monitor the progression
of metabolic syndrome in the subject. In an exemplary embodiment,
the determining one or more health conditions for the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant in order to
monitor the subject's response to metabolic syndrome therapy. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional indicative criteria in order to
detect whether the subject is at risk for metabolic syndrome.
[0387] In an exemplary embodiment, the body part comprises a
finger. In an exemplary embodiment, the body part comprises a hand.
In an exemplary embodiment, the body part comprises a forearm. In
an exemplary embodiment, the body part comprises a leg. In an
exemplary embodiment, the body part comprises a foot. In an
exemplary embodiment, the body part comprises an earlobe. In an
exemplary embodiment, the body part comprises a nose. In an
exemplary embodiment, the measuring and recording the skin
temperature of a body part comprises multiple temperature
measurement at different points on the body part.
[0388] In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant to detect subclinical hypothyroidism
in the subject. In an exemplary embodiment, the determining one or
more health conditions for the subject based upon at least one of
the temperature changes measured comprises analyzing the
temperature response to the vasostimulant in order to monitor the
subject's response to subclinical hypothyroidism therapy. In an
exemplary embodiment, the determining one or more health conditions
for the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional indicative criteria in order to
detect subclinical hypothyroidism in the subject.
[0389] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises a software program which
diagnoses the subject based on the temperature changes
measured.
[0390] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to screen the subject for
vascular dementia. In an exemplary embodiment, the determining one
or more health conditions of the subject based upon at least one of
the temperature changes measured comprises analyzing the
temperature response to the vasostimulant in order to monitor the
subject's response to treatment for vascular dementia. In an
exemplary embodiment, the determining one or more health conditions
of the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with other diagnostic methods in order to
screen the subject for vascular dementia.
[0391] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to screen the subject for
Alzheimer's disease. In an exemplary embodiment, the determining
one or more health conditions of the subject based upon at least
one of the temperature changes measured comprises analyzing the
temperature response to the vasostimulant along with other
diagnostic methods in order to screen the subject for Alzheimer's
disease.
[0392] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop portal hypertension. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises determining the status and progression of portal
hypertension in the subject. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the response of the subject to portal hypertension
disease therapies. In an exemplary embodiment, the determining one
or more health conditions of the subject based upon at least one of
the temperature changes measured comprises analyzing the
temperature response to the vasostimulant along with additional
diagnosis techniques in order to diagnose the subject for portal
hypertension.
[0393] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop cancer. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of cancer in the subject. In
an exemplary embodiment, the determining one or more health
conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to cancer disease therapies. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
along with additional diagnosis techniques in order to diagnose the
subject for cancer.
[0394] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop renal function. In an exemplary embodiment,
the determining one or more health conditions of the subject based
upon at least one of the temperature changes measured comprises
determining the status and progression of renal function in the
subject. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to renal function therapies. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises analyzing the temperature response to the vasostimulant
along with additional diagnosis techniques in order to diagnose the
subject for renal function.
[0395] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop hypertension. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of hypertension in the
subject. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to hypertension therapies. In an exemplary embodiment,
the determining one or more health conditions of the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to diagnose the subject
for hypertension.
[0396] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject is at risk for cerebral vascular disease. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises determining the response of the subject to stroke
therapies. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to determine whether the subject is at risk for
cerebral vascular disease.
[0397] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop dementia. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of dementia in the subject.
In an exemplary embodiment, the determining one or more health
conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to dementia therapies. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to diagnose the subject
for dementia.
[0398] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop memory loss. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of memory loss in the
subject. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to memory loss therapies. In an exemplary embodiment,
the determining one or more health conditions of the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to diagnose the subject
for memory loss.
[0399] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop vision loss. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of vision loss in the
subject. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to vision loss therapies. In an exemplary embodiment,
the determining one or more health conditions of the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to diagnose the subject
for vision loss.
[0400] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject is at risk for heart attack. In an exemplary embodiment,
the determining one or more health conditions of the subject based
upon at least one of the temperature changes measured comprises
determining the response of the subject to heart attack therapies.
In an exemplary embodiment, the determining one or more health
conditions of the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to determine whether the subject is at risk for
heart attack.
[0401] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop angina. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of angina in the subject. In
an exemplary embodiment, the determining one or more health
conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to angina therapies. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to diagnose the subject
for angina.
[0402] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop erectile dysfunction. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises determining the status and progression of erectile
dysfunction in the subject. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the response of the subject to erectile dysfunction
therapies. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to diagnose the subject for erectile
dysfunction.
[0403] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop peripheral arterial disease. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises determining the status and progression of peripheral
arterial disease in the subject. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the response of the subject to peripheral arterial
disease therapies. In an exemplary embodiment, the determining one
or more health conditions of the subject based upon at least one of
the temperature changes measured comprises analyzing the
temperature response to the vasostimulant along with additional
diagnosis techniques in order to diagnose the subject for
peripheral arterial disease.
[0404] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop migraine headaches. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises determining the status and progression of migraine
headaches in the subject. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the response of the subject to migraine headache
therapies. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to diagnose the subject for migraine
headaches.
[0405] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject will develop Prinzmetal's angina. In an exemplary
embodiment, the determining one or more health conditions of the
subject based upon at least one of the temperature changes measured
comprises determining the status and progression of Prinzmetal's
angina in the subject. In an exemplary embodiment, the determining
one or more health conditions of the subject based upon at least
one of the temperature changes measured comprises determining the
response of the subject to Prinzmetal's angina therapies. In an
exemplary embodiment, the determining one or more health conditions
of the subject based upon at least one of the temperature changes
measured comprises analyzing the temperature response to the
vasostimulant along with additional diagnosis techniques in order
to diagnose the subject for Prinzmetal's angina.
[0406] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject has contracted HIV. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of HIV in the subject. In an
exemplary embodiment, the determining one or more health conditions
of the subject based upon at least one of the temperature changes
measured comprises determining the response of the subject to HIV
therapies. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant along with additional diagnosis
techniques in order to diagnose the subject for HIV.
[0407] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
subject has diabetic foot. In an exemplary embodiment, the
determining one or more health conditions of the subject based upon
at least one of the temperature changes measured comprises
determining the status and progression of diabetic foot in the
subject. In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining the response of
the subject to diabetic foot therapies. In an exemplary embodiment,
the determining one or more health conditions of the subject based
upon at least one of the temperature changes measured comprises
analyzing the temperature response to the vasostimulant along with
additional diagnosis techniques in order to diagnose the subject
for diabetic foot.
[0408] In an exemplary embodiment, the method further comprises
administering an ankle-brachial blood pressure index test to the
subject. In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
temperature changes measured comprises analyzing the temperature
response to the vasostimulant in order to assess the subjects
endothelial function. In an exemplary embodiment, the determining
one or more health conditions for the subject based upon at least
one of the temperature changes measured comprises analyzing the
temperature response to the vasostimulant along with additional
diagnosis techniques in order to assess the subjects endothelial
function. In an exemplary embodiment, the additional diagnosis
techniques comprise using a blood marker of endothelial function.
In an exemplary embodiment, the additional diagnosis techniques
comprise an endothelial driven microparticles test. In an exemplary
embodiment, the additional diagnosis techniques comprise a VCAM1
test. In an exemplary embodiment, the additional diagnosis
techniques comprise an ICAM1 test. In an exemplary embodiment, the
additional diagnosis techniques comprise a SELECTIN test. In an
exemplary embodiment, the additional diagnosis techniques comprise
a VWF test. In an exemplary embodiment, the additional diagnosis
techniques comprise an oxygen saturation measurement at a
fingertip. In an exemplary embodiment, the additional diagnosis
techniques comprise a CD54 test.
[0409] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises monitoring the pregnancy of
the subject. In an exemplary embodiment, the monitoring the
pregnancy of the subject comprises diagnosing the subject for
preeclampsia.
[0410] In an exemplary embodiment, the method further comprises
measuring the blood pressure of the subject. In an exemplary
embodiment, the method further comprises changing the skin
temperature of the body part. In an exemplary embodiment, the
changing the skin temperature of the body part comprises heating
and/or cooling the body part with a thermal device. In an exemplary
embodiment, the changing the skin temperature of the body part
comprises elevating the body part. In an exemplary embodiment, the
method further comprises measuring a blood speed through an artery
of the subject which supplies blood to the body part. In an
exemplary embodiment, the blood speed is measured before, during,
and after the provision of the vasostimulant. In an exemplary
embodiment, the method further comprises measuring and recording
the stiffness of an artery supplying blood to the body part. In an
exemplary embodiment, the stiffness of the artery is measured and
recorded using arterial pulse waveform analysis. In an exemplary
embodiment, the stiffness of the artery is measured and recorded
before providing the vasostimulant. In an exemplary embodiment, the
stiffness of the artery is measured and recorded after providing
the vasostimulant. In an exemplary embodiment, the stiffness of the
artery is measured and recorded before, during, and after providing
the vasostimulant.
[0411] In an exemplary embodiment, the ambient temperature around
the thermal energy sensor is held constant. In an exemplary
embodiment, the fluid flow around the thermal energy sensor is kept
to a minimum. In an exemplary embodiment, the determining one or
more health conditions comprises determining a coronary calcium
score. In an exemplary embodiment, the determining one or more
health conditions comprises determining a Framingham risk score. In
an exemplary embodiment, the determining one or more health
conditions comprises determining a carotid intima media thickness.
In an exemplary embodiment, the determining one or more health
conditions comprises conducting a c-reactive protein test. In an
exemplary embodiment, the determining one or more health conditions
comprises determining an Lp-PLA2 level.
[0412] In an exemplary embodiment, the method further comprises
acquiring a measure of endothelium dependent vascular reactivity,
using additional non-endothelial related diagnosis techniques to
acquire a measure of endothelium independent vascular reactivity,
calculating a ratio of the measure of endothelium dependent
vascular reactivity over the measure of endothelium independent
vascular reactivity, and determining a health condition of the
subject. In an exemplary embodiment, the method further comprises
acquiring a measure of endothelium dependent vascular reactivity,
using additional diagnosis techniques to acquire a measure of
parameters other than temperature that change upon provision of the
vasostimulant, calculating a ratio of the measure of endothelium
dependent vascular reactivity over the measure of parameters other
than temperature that change upon provision of the vasostimulant,
and determining a health condition of the subject. In an exemplary
embodiment, the providing a vasostimulant comprises providing a
modifier of vasostimulators. In an exemplary embodiment, the
modifier of vasostimulators comprises an LNAME compound. In an
exemplary embodiment, the modifier of vasostimulators comprises an
L-Arginine compound.
[0413] In an exemplary embodiment, the determining one or more
health conditions of the subject based upon at least one of the
temperature changes measured comprises determining whether the
effectiveness of cholesterol lowering medications in the subject.
In an exemplary embodiment, the cholesterol lowering medications
are from the family of statins. In an exemplary embodiment, the
cholesterol lowering medications include Lipitor. In an exemplary
embodiment, the cholesterol lowering medications include
mevlonate.
[0414] In an exemplary embodiment, the method further includes
measuring the change in oxygen saturation of the body part. In an
exemplary embodiment, the method further includes measuring the
change in Doppler flow of the body part. In an exemplary
embodiment, the method further includes measuring the change in
pressure of the body part. In an exemplary embodiment, the method
further includes measuring the change in blood flow of the body
part by near infrared spectroscopy. In an exemplary embodiment, the
method further includes using an additional diagnostic techniques
in order to determine the health condition of the patient selected
from the group consisting of: intravascular optical coherent
tomography, coronary fractional flow reserve, intravascular
ultrasound radiofrequency backscatter analysis or Virtual
Histology, urinary albumin, serum fibrinogen, IL6, CD40/CD40L,
serum amyloid A, ankle brachial index, MR1, coronary calcium score,
carotid intima thickness, vascular stiffness tests, C-reactive
protein tests, waist circumference, blood insulin level, PAI-1
test, t-PA test, glucose tolerance tests, fasting plasma glucose
level, HDL cholesterol level, fasting plasma insulin test,
homeostasis model assessment, BMI, body fat level, visceral fat
test, subcutaneous fat test, white blood cell count,
Neutrophil/lymphocyte ratio, platelet function tests, and
combinations thereof
[0415] In an exemplary embodiment, the method further includes
using an additional diagnostic techniques in order to determine the
health condition of the patient selected from the group consisting
of: plasma and urinary level of asymmetrical (ADMA) and symmetrical
(SDMA) dimethylarginine, exhaled nitric oxide, serum homocysteine,
an endothelial driven microparticles test, a VCAM1 test, an ICAM1
test, a SELECTIN test, a VWF test, a TF test, a CD54 test,
endothelial progenitor cells, myelo-peroxidase (MPO), increased
neutrophil/lymphocyte ratio, endothelin-1, thrombomodulin, tissue
factor and tissue factor pathway inhibitor, markers of inflammation
such as, for example, granulocyte-macrophage colony-stimulating
factor (GM-CSF) and macrophage chemoattractant protein-1 (MCP-1)
nitric oxide and its metabolites nitrates and nitrites, almost
nitrosylated proteins, a selectin such as, for example, soluble
endothelium, leukocyte, and platelet selecting, markers of
oxidative stress including but not limited to free radical
measurements of the blood or through the skin, TBAR, and/or extra
cellular super oxide dismutase activity, vascular stiffness or
compliance, and combinations thereof.
[0416] In an exemplary embodiment, the method further includes
using an additional diagnostic techniques in order to determine the
health condition of the patient selected from the group consisting
of: skin color, nail capilloroscopy, ultrasound brachial artery
imaging, forearm plethysmography, fingertip plethysmography, oxygen
saturation change, pressure change, near-infrared spectroscopy
measurements, Doppler flow change, peripheral artery tomometry, and
combinations thereof. In an exemplary embodiment, the method
further includes acquiring a measure of endothelium dependent
vascular reactivity, using additional non-endothelial related
diagnosis techniques to acquire a measure of endothelium
independent vascular reactivity, calculating a composite index of
the measure of endothelium dependent vascular reactivity and the
measure of endothelium independent vascular reactivity, and
determining a health condition of the subject. In an exemplary
embodiment, the method further includes acquiring a measure of
endothelium dependent vascular reactivity, using additional
diagnosis techniques to acquire a measure of parameters other than
temperature that change upon provision of the vasostimulant,
calculating a composite index of the measure of endothelium
dependent vascular reactivity and the measure of parameters other
than temperature that change upon provision of the vasostimulant,
and determining a health condition of the subject.
[0417] A method for determining one or more health conditions has
been described comprising providing a subject, measuring the skin
temperature of a first body part on the subject, placing a second
body part of the subject in water, measuring the skin temperature
changes of the first body part during and subsequent to the placing
of the second body part in water, and determining one or more
health conditions for the subject based upon at least one of the
skin temperature changes measured.
[0418] A method for determining one or more health conditions has
been described comprising providing a subject, providing a volume
of a medium, placing a body part of the subject in the volume of
the medium, measuring the temperature of the volume of the medium,
providing a vasostimulant to the subject, measuring the temperature
changes of the volume of the medium during and subsequent to the
provision of the vasostimulant, and determining one or more health
conditions for the subject based upon at least one of the
temperature changes measured.
[0419] A database for diagnosing health conditions has been
described comprising control data comprising a plurality of control
temperature data points and temperature data comprising a baseline
temperature, a temperature drop from the baseline temperature
having a first slope, a lowest temperature achieved, a temperature
rise from the lowest temperature achieved having a second slope, a
peak temperature, and a stabilization temperature.
[0420] A method for determining one or more health conditions has
been described comprising providing a subject, measuring the
baseline skin temperature of a body part on the subject, providing
a vasostimulant to the subject, measuring the lowest skin
temperature of the body part during and subsequent to the provision
of the vasostimulant, measuring the highest skin temperature of the
body part, and determining one or more health conditions for the
subject based upon at least one of the skin temperature changes
measured. In an exemplary embodiment, the determining one or more
health conditions for the subject based upon at least one of the
skin temperature changes measured comprises diagnosing healthy
vascular reactivity due to the temperature difference between the
highest skin temperature measured and the lowest skin temperature
measured being greater than the difference between the baseline
temperature measured and the lowest skin temperature measured. In
an exemplary embodiment, the determining one or more health
conditions for the subject based upon at least one of the skin
temperature changes measured comprises diagnosing unhealthy
vascular reactivity due to temperature difference between the
highest skin temperature measured and the lowest skin temperature
measured being less than the difference between the baseline
temperature measured and the lowest skin temperature measured. In
an exemplary embodiment, the determining one or more health
conditions for the subject based upon at least one of the skin
temperature changes measured comprises diagnosing unhealthy
vascular reactivity due to temperature difference between the
highest skin temperature measured and the baseline temperature
measured being negative.
[0421] A computer program for determining one or more health
conditions has been described comprising a retrieval engine adapted
to retrieve a plurality of temperature data from a database, the
temperature data comprising a baseline temperature, a temperature
drop from the baseline temperature having a first slope, a lowest
temperature achieved, a temperature rise from the lowest
temperature achieved having a second slope, a peak temperature, and
a stabilization temperature; a processing engine adapted to process
data retrieved by the retrieval engine, and a diagnosis engine
operable to determine one or more health conditions based upon the
retrieved temperature data. In an exemplary embodiment, the
diagnosis engine may diagnose healthy vascular reactivity due to
the temperature difference between the peak temperature and the
lowest temperature being greater than the difference between the
baseline temperature and the lowest temperature. In an exemplary
embodiment, the diagnosis engine may diagnose unhealthy vascular
reactivity due to temperature difference between the peak
temperature and the lowest temperature being less than the
difference between the baseline temperature and the lowest
temperature. In an exemplary embodiment, the diagnosis engine may
diagnose unhealthy vascular reactivity due to temperature
difference between the peak temperature and the baseline
temperature being negative.
[0422] A method for determining one or more health conditions has
been described which includes providing a subject, measuring the
blood flow rate of the subject, providing a vasostimulant to the
subject, measuring the blood flow rate changes of the subject
during and subsequent to the provision of the vasostimulant, and
determining one or more health conditions for the subject based
upon at least one of the blood flow rate changes measured. In an
exemplary embodiment, the blood flow rate is measured using optical
spectroscopy. In an exemplary embodiment, the method further
comprises administering an optical spectroscopy tracer to the
subject.
[0423] A method for determining one or more health conditions has
been described which includes providing a subject, measuring the
skin temperature of a finger on the arm of the subject, detecting
an equilibrium in the skin temperature of the finger of the
subject, automatically providing a vasostimulant to the subject to
substantially cease blood flow to the finger, measuring the skin
temperature changes of the finger after provision of the
vasostimulant, automatically removing the vasostimulant to allow
blood flow to the finger, measuring the skin temperature changes of
the finger after the removal of the vasostimulant, and determining
one or more health conditions for the subject based upon at least
one of the skin temperature changes measured. In an exemplary
embodiment, the providing a vasostimulant comprises inflating an
inflatable cuff on an arm of the subject to a pressure which is
higher than a blood pressure of the subject. In an exemplary
embodiment, the blood pressure of the subject is a measured blood
pressure. In an exemplary embodiment, the blood pressure of the
subject is a known blood pressure. In an exemplary embodiment, the
blood pressure of the subject is an estimated blood pressure. In an
exemplary embodiment, the method further comprises measuring the
skin temperature of a contralateral body part on the subject.
[0424] A method for selecting a medication for the treatment of a
medical condition in a subject has been described which includes
administering a medication to one or more subjects, determining the
health condition of the one or more subjects using the method of:
measuring the skin temperature of a body part on the one or more
subjects, providing a vasostimulant to the one or more subjects,
measuring the skin temperature changes of the body part during and
subsequent to the provision of the vasostimulant; and determining
one or more health conditions for the one or more subjects based
upon at least one of the skin temperature changes measured;
determining whether the medication is effective in the treatment of
the one or more subjects, and selecting the medication for use in
treating the medical condition in other subjects if the medication
is determined to be effective in the treatment of the one or more
subjects.
[0425] A method for selecting a nutritional program for a subject
has been described which includes administering a nutritional
program to one or more subjects, determining the health condition
of the one or more subjects using the method of: measuring the skin
temperature of a body part on the one or more subjects, providing a
vasostimulant to the one or more subjects, measuring the skin
temperature changes of the body part during and subsequent to the
provision of the vasostimulant, and determining one or more health
conditions for the one or more subjects based upon at least one of
the skin temperature changes measured; determining whether the
nutritional program is effective for the one or more subjects, and
selecting the nutritional program for other subjects if the
nutritional program is determined to be effective for the one or
more subjects.
[0426] A system for selecting a medication for the treatment of a
medical condition in a subject has been described which includes
means for administering a medication to one or more subjects, means
for determining the health condition of the one or more subjects
comprising: means for measuring the skin temperature of a body part
on the one or more subjects, means for providing a vasostimulant to
the one or more subjects, means for measuring the skin temperature
changes of the body part during and subsequent to the provision of
the vasostimulant, and means for determining one or more health
conditions for the one or more subjects based upon at least one of
the skin temperature changes measured; means for determining
whether the medication is effective in the treatment of the one or
more subjects, and means for selecting the medication for use in
treating the medical condition in other subjects if the medication
is determined to be effective in the treatment of the one or more
subjects.
[0427] A system for selecting a nutritional program for a subject
has been described which includes means for administering a
nutritional program to one or more subjects, means for determining
the health condition of the one or more subjects comprising: means
for measuring the skin temperature of a body part on the one or
more subjects, means for providing a vasostimulant to the one or
more subjects, means for measuring the skin temperature changes of
the body part during and subsequent to the provision of the
vasostimulant, and means for determining one or more health
conditions for the one or more subjects based upon at least one of
the skin temperature changes measured; means for determining
whether the nutritional program is effective for the one or more
subjects, and means for selecting the nutritional program for other
subjects if the nutritional program is determined to be effective
for the one or more subjects.
[0428] A method for selecting a medication for the treatment of a
medical condition in a subject has been described which includes
administering a medication to one or more subjects, determining a
health condition of the one or more subjects using the apparatus of
any one of the claims 1 to 44, determining whether the medication
is effective in the treatment of the one or more subjects, and
selecting the medication for use in treating a medical condition in
other subjects if the medication is determined to be effective in
the treatment of the one or more subjects.
[0429] A method for selecting a nutritional program for a subject
has been described which includes administering a nutritional
program to one or more subjects, determining a health condition of
the one or more subjects using the apparatus of the present
invention, determining whether the nutritional program is effective
for the one or more subjects, and selecting the nutritional program
for other subjects if the nutritional program is determined to be
effective for the one or more subjects.
[0430] A method for selecting a chemical substance for the
treatment of a medical condition has been described which includes
administering a chemical substance to a subject, determining a
health condition of the one or more subjects using the method of
the present invention, and studying the effects of the chemical
substance on the subject.
[0431] A method for selecting a medical procedure for the treatment
of a medical condition has been described which includes performing
a medical procedure on a subject, determining a health condition of
the one or more subjects using the method of the present invention,
and studying the effects of the medical procedure on the
subject.
[0432] A method for selecting a health intervention program for the
treatment of a subject has been described which includes
administering a health intervention program on a subject,
determining a health condition of the one or more subjects using
the method of the present invention, and studying the effects of
the health intervention program on the subject.
[0433] A method for determining one or more health conditions has
been described which includes providing a subject, measuring the
temperature of a body part on the subject, providing a
vasostimulant to the subject, measuring the temperature changes of
the body part during and subsequent to the provision of the
vasostimulant, and determining one or more health conditions for
the subject based upon at least one of the temperature changes
measured.
Correlation with the Ultrasound Based Method of Measuring Brachial
Artery Reactivity
[0434] Change in brachial artery diameter (BAD) during reactive
hyperemia is conventionally used to assess endothelial function. A
hypothesis that changes in digit temperature would correlate with
brachial artery reactivity and thus provide a novel and simple
method for assessing endothelial function was tested.
[0435] Using a sensitive digital thermal monitoring (DTM) device,
changes were measured in temperature at the index fingertip of 30
healthy volunteers (mean age 42.+-.13, 15 males) before, during and
after brachial artery occlusion (200 mmHg, 2-5 minutes). Data was
analyzed on 26 of these volunteers. Simultaneously, maximum changes
in BAD and peak systolic flow velocity (PSV) by Brachial Artery
Ultrasound Scanning were measured. Several parameters including TF
(maximum temperature fall during cuff inflation), TR (maximum
temperature rebound post-deflation), NP (nadir to peak), TTR (time
to TR), TTF (time to TF) were measured and correlated with BAD.
Subjects were instructed to fast starting the night before the
testing and to refrain smoking, alcohol ingestion or caffeine and
taking any vasoactive medications the day of the testing.
[0436] The device comprised a computer-based thermometry system
(0.01.degree. F. thermal resolution), and two fingertip
thermocouple probes. Different designs of finger-tip probes such as
fingertip cap, pen-design, and flat-probe were tested in
preliminary experiments. In choosing the design, minimum area of
skin-probe contact, minimum pressure on fingertip, and minimum
change in the baseline temperature were considered as key factors
(i.e. does not change local temperature by insulation or
perspiration, does not firmly attach to the fingertip to minimize
alteration of the skin micro-capillary flow, does not restrict
movement of the finger and such movements do not interfere with
temperature measurement). The device measures temperature only and
does not introduce any signal to the body. See FIG. 11c and FIG.
16. The thermal probes were placed on the tip of index fingers on
each hand. The index finger of the right arm was used for the test
in all cases and the left index finger was used as control. The
temperature was continuously recorded and saved on a PC. After five
minutes equilibration period to reach stable baseline temperature
at the fingertip, the blood pressure cuff was inflated. Initially
it was planned for the cuff to be inflated to 50 mm Hg over
supra-systolic BP, however, the inflation pressure was later
standardized to 200 mm Hg. The temperature was continuously
recorded throughout the experiment. (Five minutes before occlusion
and up to three minutes deflation).
[0437] BAUS was performed following a standard protocol similar to
that described previously (Corretti, M. C., et al., J. Am Coll
Cardiol 39(2) (2002) 257-65). Longitudinal brachial artery images
were taken with a high resolution (14 MHz) linear array vascular
ultrasound scanning transducer (Vivid 7/Vivid 7 PRO, GE Medical
Systems). Subjects were studied under ambient conditions while in
the supine position in a temperature-controlled room. After a five
minute equilibration period to reach stable baseline temperature at
the fingertip, two baseline images of the brachial artery were
obtained approximately 4-5 cm above the antecubital fossa. A blood
pressure cuff (Hokanson, Bellevue, Wash.) placed proximal to the
imaging transducer on the upper arm was inflated to 200 mm Hg for
about 4 minutes. Brachial artery diameter was measured at four
adjacent points and an average measurement was used for analysis.
Peak Systolic Velocity (PSV) using pulse wave Doppler measurements
were obtained at baseline, before inflation and immediately after
deflation. Brachial artery dimensions were measured at 30, 60, 90,
120 and 180 seconds post-deflation.
[0438] Descriptive tables including central and peripheral
statistical measures were created based on information obtained
from twenty six cases. Multiple parameters were measured from each
test (BAUS and DTM). Student t-Test and Pearson correlation test
were used to compare and correlate numerical measurements.
[0439] The average age of 26 subjects (eleven male) was 42 years
(SD 13.21) with a Body Mass Index (BMI) of 25.6 (SD 4.56). Four
participants had risk factors including hypertension,
hyperlipidemia and family history of premature coronary artery
disease. However, due to very small sample size no sub-group
analysis could be made.
[0440] FIG. 21 shows a representative graph of temperature changes
at the fingertip during brachial artery hyperemia induced by cuff
inflation. As seen in the graph multiple parameters were defined as
following: TF (T.sub.F) denotes fall of temperature from baseline
to nadir. TTF (T.sub.TF) denotes time to reach the maximum TF. TR
(T.sub.R) denotes rebound of temperature above the baseline. TTR
(T.sub.TR) represents time to reach T.sub.R. NP (N.sub.P) denotes
temperature changes from nadir to peak. All temperature readings
were in Fahrenheit and time measurement was in seconds.
[0441] The cumulative results showed mean values of TF, TR, and NP
were 2.50.+-.1.03, 1.10.+-.3.05, and 3.60.+-.2.84.degree. F.,
respectively. Mean TTR was 114.+-.40 seconds. Mean changes in BAD
and PSV were 12.5.+-.10.1% and 109.+-.10%, respectively. TR was
negative in 10 cases, -4.78 to -0.05 (mean -1.08, SD -1.39) and NP
was negative in one case (case no 7 discussed as outlier). There
was a significant difference in average TR and NP between males (TR
0.76.+-.1.93, NP 3.44.+-.1.64) and females (TR 1.43.+-.3.70, NP
3.64.+-.3.64). TF in males was 2.78.+-.0.90 and in females was
2.16.+-.1.01. Also a correlation analysis between TR, NP, and TF
with age and BMI showed a significant trend towards lower TR and NP
but higher TF with increasing age. TTF and TTR were 237.+-.120 and
114.+-.40 respectively. Inflation time (TTF) varied due to the
tolerance factor of each subject.
[0442] As previously mentioned, the change in BAD correlated with
TR (r=0.73 as depicted in FIG. 29), NP (r=0.74 as depicted in FIG.
30), age (r=-0.23) and BMI (r=-0.43). Males showed significantly
lower TR (0.76 vs. 1.43) and less increase in BAD (12.35 vs. 15.09)
than females. All p values were less than 0.05. Mean change is PSV
was 109.+-.10%. FIG. 44b shows the distribution of percentage
changes in brachial artery diameter measured by USVR. An average
change of 12.50% (SD=10.10%) was recorded. The changes varied from
-22.22% to 41.37%. Such a relationship was not seen between the
diameter changes and TF (R=0.1252) indicating that the strong
correlation seen between the diameter changes and temperature
changes is only related to the reactivity of the artery that occur
after the deflation. For distribution of change in peak systolic
velocity before inflation and immediately after deflation, an
average change of 109% (SD=10%) was seen. The changes varied from
46% to 260%. There was a weak inverse correlation (R=0.3244) seen
between changes in peak systolic velocity and percentage changes in
brachial artery diameter. As expected, there was no correlation
seen between changes in peak systolic velocity changes and changes
in TF, TR, and NP. Males showed significantly lower TR (0.76 vs.
1.43) and less increase in BAD (12.35 vs. 15.09) than females. All
p values were less than 0.05.
[0443] As seen in FIG. 44a, case number 7 presented a severe
vasoconstrictive response to cuff inflation and deflation. Both
BAUS and DTM findings showed negative values for BAD (-22%), TR
(-4.78 F), and NP (-3.24 F). The subject was a 29 year old female
(BMI 20.02) with no documented risk factors. Data was analyzed with
and without the outlier. Removal of the outlier did not have a
significant change on TR and BAD correlation.
[0444] In conclusion in this study in 26 healthy looking
volunteers, the novel and simplified method of the invention for
assessment of endothelial function and vascular reactivity in the
arm was evaluated and compared with the traditional method
endothelial function measurement in the brachial artery.
Temperature changes at the fingertip showed a consistent pattern
throughout the study as illustrated in the FIG. 21. The pattern
starts with an initial fall (TF) during the cuff inflation followed
by a rebound (TR and NP). The measurements show the fact that skin
blood flow can be measured by monitoring temperature, and change in
blood flow strongly correlates with change in temperature. In the
study, TF shows lack of blood circulation while the cuff is
inflated that also affects local metabolism and heat production.
The overall effect is a gradual decline in fingertip temperature at
a rate of 0.5-2 degree F. per minute in normal room
temperature.
[0445] TR and NP indicate the hyperemia induced brachial artery
dilation as well as the vasodilatory capacity of the vascular bed
(small arteries and microvessels) distal to the cuff. TR
specifically denotes the ability of the arterial bed to compensate
for the duration of the ischemia and to create an overflow above
the baseline level. In normal conditions one would expect a
positive TR. The higher the TR, the higher the vasodilatory
response of the arterial bed. TR close to zero indicates a lack of
strong vasodilatory response and in case of negative TR it must
represent a vasospastic response or a complete lack of
vasodilation. NP and TR largely overlap and both show similar
information with TR being more sensitive marker of overflow.
[0446] In the comparison of BAUS and DTM, the percentage change in
brachial artery diameter (BAD) correlated well with TR (r=0.73) and
NP (r=0.74) as expected. Time to reach maximum TR (TTR) was
approximately two minutes (Mean 114.+-.40 seconds) and lasts for
1-2 minutes. This clearly explains the close correlation between
temperature changes and changes in BAD which is also well known to
max after the first minute. In the study, both showed a delayed
response starting in about 30 seconds after deflating the cuff. In
contrast, changes in peak systolic velocity (an indicator of distal
resistance) did not correlate with TR or NP (r=0.07) suggesting
that TR and NP may not represent microcapillary and resistant
vessels, instead they best correlated with changes in BAD as a
conduit artery. The significance of measuring vasoreactivity of
resistance vessels (microvascular) vs conduit vessels
(macrovascular) lies in the underlying physiology of the response.
It is thought that changes in BAD as a conduit artery purely
reflects the function of endothelial cells at brachial artery level
whereas Distal Resistant Vessel Response (PSV) reflects the
vascular tone in arterioles and microvessels which are largely
controlled by neurogenic mechanisms through media layer. The latter
is also called endothelial-independent vasoreactivity and can be
measured by vasodilating agents that directly affect smooth muscle
cells (nitrates).
[0447] Contemplating the relationship between BAD and PSV (Brachial
Response vs Distal Resistant Vessel Response), PSV is a known
measure of distal vascular resistance. In this study, a weak
correlation was found between PSV and BAD (r=0.32). Poor
correlation between BAD and PSV is known and was reported
previously by others. In our study we did not find any significant
correlation between TR or NP and PSV. One explanation would be that
the vasoreactivity response measured by TR and NP are most related
to BAD changes and least related to PSV. PSV increased in 100% of
the cases which can be easily explained by Bernoulli's law. The
temperature changes are more likely to reflect the response of
conduit arteries (i.e. brachial, radial, ulnar) than resistant
vessels (arterioles and microvessels).
[0448] This analysis showed no correlation between TF or TTF and
BAD, TR, NP, or PSV, indicating that within the range of cuff
inflation time used in our study, the longer inflation and ischemia
time did not result in higher reactivity. In our study the average
inflation time TTF was 237.+-.120 seconds. The variation was
permitted according to subject's comfort level. In cases of long
inflation time, one would expect higher TF and higher PSV and
possibly higher BAD. However such a long TTF cannot be easily
tolerated.
[0449] Skin microcirculation is divided into nutritional
circulation and thermoregulatory circulation. It is well known that
the thermoregulatory circulation that accounts for the majority of
fingertip skin circulation is tightly controlled by autonomic
nervous system. The thermoregulatory control mechanism is effected
through arteriovenous shunts that bypass pre-capillary part of the
side to the post-capillary of venous side. These networks of small
arterioles are highly innervated and in cases of sympathetic
stimuli such as mental stress and cold exposure, their contraction
increase distal resistance and results in rerouting blood flow to
AV shunts. This phenomenon explains cold fingers in fingertips
during adrenergic stress. The side effect of this phenomenon on
digital thermal monitoring of vascular reactivity (DTM) can be
significant. However, such a "noise" effect is not limited to
digital thermography. Indeed, studies have shown that BAUS is
similarly affected by such sympathetic conditions. To minimize the
effects of these conditions on endothelia function measurement, the
International Task Force for Brachial Artery Reactivity has
proposed certain guidelines for subject preparation and BAUS
measurement to standardize the technique. Similar considerations
can be exercised for DTM. However, the fact that this technique is
much more simplified and can be repeated easily (potentially at the
comfort home and ambulatory monitoring), makes it possible to have
a more accurate assessment of endothelial function in those with
hyperadrenergic conditions.
[0450] Importantly, significant temperature changes in control arms
were found in some individuals that may reflect the neuroregulatory
response to the cuff inflation and deflation. A consistent pattern
in the temperature changes of the contralateral finger was not
found, although most TR and some TF responses were negative in the
contralateral finger. This contralateral vasomotion is believed to
show the neurogenic factors involved in the arm-cuff based vascular
reactivity test and provides, for the first time, the ability to
provide characterization of this influence in different
individuals.
[0451] Physiologic stimuli such as local pain, pressure, and
ischemia are known to create systemic effects mostly mediated by
autonomic (sympathic and parasympathic) nervous system. DTM
provides a mechanism to correlate primary and secondary autonomic
disorders shown by heart rate variability, and orthostatic hypo and
hyper-tension in coronary heart disease and a host of other
disorders, with the thermal behavior of contralateral finger.
[0452] Blood pressure measurement, which can be subject to high
variability and White Coat effect, has evolved over time into
ambulatory monitoring including use outside of the hospital.
Similarly, measurement of brachial vasoreactivity, including as
measured by DTM, may show marked variations including diurnal,
postprandial, positional, exercise and stress related variability.
Solutions to control for variability issues include multiple
measurements and standardized settings for measurement. A
requirement for multiple measurements cannot be met by BAUS, which
is a very complicated, cumbersome and expensive measurement. In
contrast, DTM has great potential to provide an endothelial
function measurement device capable of ambulatory monitoring. Such
a device, including combined with blood pressure monitoring device,
can provide an excellent tool for screening and monitoring of
vascular function at minimum cost. In addition, skin temperature
monitoring with vascular challenge can measure endothelial function
in multiple vascular beds (e.g. wrist, arm, thigh, calf) to make a
more comprehensive assessment of total body vascular health.
Skin Temperature and Vascular, Metabolic and Neuroregulatory
Function
[0453] In one embodiment of the invention, changes in skin
temperature before, during, and after an ischemia challenge are
measured and related to the underlying vascular, metabolic, and
neuroregulatory functions of the tissues. In one embodiment,
repeated measurement of the temperature response as well as testing
temperature responses in multiple vascular beds including the arm,
forearm, wrist, and both legs provides a more comprehensive
assessment. For example, the aforementioned AV shunts in digital
capillaries can affect distal microvessel resistance and therefore
the flow measurement or response to ischemic challenge can vary
depending on the opening of these AV shunts as a consequence of
sympathetic drive. One way to measure the AV shunt effect is to
simultaneously measure temperature at the distal finger tips as
well as proximal to the finger tip such as on the wrist or forearm.
By comparing temperature changes in these two locations, one can
create a differential signature plot that indicates the activity of
the sympathetic nervous system and/or AV shunting.
[0454] In one embodiment, measurements on the contralateral hand to
that receiving a vascular challenge are used to establish a
vascular, metabolic, and neuroregulatory profile for the patient.
The present inventors have surprisingly found that, rather than
being considered as "noise" to be discounted or controlled, in
certain embodiments of the present invention, measurement of skin
temperature on the contralateral hand is utilized to provide
important insights into the vascular reactivity profile of the
individual. In contrast to the test hand to which a vascular
challenge is applied, for example by occlusion of the brachial
artery feeding the test hand, the contralateral hand is also
monitored by a fingertip temperature measurement on the
corresponding digit of the contralateral hand but without vascular
challenge to the vasculature feeding the contralateral hand. Since
85% of skin circulation is thermoregulatory and tightly controlled
by the sympathetic system, changes in the contralateral finger
temperature can be quite diagnostic. In some individuals the
temperature of contralateral fingers goes up in the inflation phase
while in other individuals the temperature of the contralateral
finger declines in the deflation phase. In some patients, the
contralateral finger temperature goes up in the inflation phase and
declines in the deflation phase. The contralateral finger response
reflects both the activity of the sympathetic nervous system but
also the ability of both the nervous system and the vasculature to
work together to respond appropriately to vascular challenge.
[0455] In certain embodiments, DTM is combined with other
modalities for assessing neurovascular regulation including the
cold pressor test, and the tilt test. In one method of measuring
vascular reactivity and endothelial function, DTM is employed
together with the cold pressor test in any other place in the body
that does not affect the thermal measurement. In preferred
embodiments, the contralateral hand or foot is exposed to cold such
as by emersion in cold water for 1-5 minutes, ordinarily sufficient
to stimulate a significant vascular response. In normal subjects,
the reaction is vasodilation of vessels which would result in
increased fingertip temperature in the hand not exposed to the cold
challenge but in patients with cardiovascular risk factors, this
effect is hampered and the dilation may be replaced with
constriction. In alternative or additional embodiments, DTM is
employed together with a tilt test, which tests the effect of the
body's position in temperature changes at the fingertip. It is
expected that those with high sympathetic response or increased
vasoreactivity will show different temperature changes compared to
normal subjects. In certain subjects with extreme vasoreactivity, a
significant drop in finger temperature may be manifest as a
consequence of the tilt test.
[0456] This technology and multiple embodiments of the device
disclosed herein for thermal monitoring can be used for numerous,
physiologic measurement as well as health and disease monitoring
applications. Such applications include monitoring of fingertip
skin temperature in response to hyperemia for Obesity Management
(predicting regaining weight). Obese people may have lower basal
metabolic rate that can create different temperature response
during the test. For example, lower heat production can be seen as
higher TF. Higher burning rate can be seen as lower TF (given other
factors constant) which is associated with lack of blood supply and
oxygen.
[0457] It is well known that tissue temperature is a direct result
of blood perfusion, but other parameters also contribute. These
parameters can be classified as: [0458] 1) Anthropometric factors,
such as tissue composition, skin thickness, fat content, surface
area, tissue volume, body mass index, age and gender, among others.
[0459] 2) Environmental factors, ambient temperature, the presence
of air currents, unequal radiation, air humidity and posture.
[0460] 3) Hemodynamic factors, due to the presence of large
proximal conduit arteries and small vessels and capillaries, which
respond differently to occlusion and reperfusion, and have
different contributions to tissue temperature. [0461] 4)
Physiological factors, i.e. body temperature, skin temperature,
tissue metabolism, response of conduit vessel diameter to hypoxia
and ischemia, microvasculature response, and the activation of
arteriovenous anastomoses. Different embodiments of this invention
characterize and quantify the effect of different factors that
affect the baseline temperature and temperature response observed
after brachial artery occlusion.
[0462] In one embodiment, monitoring of fingertip skin temperature
in response to hyperemia (DTM) is used to screen for
hypersympathetic patients. The microvessel resistant component of
the DTM measurement can be extreme in certain subjects and analysis
of DTM results will identify these subjects. Hypersympathetic
subjects can be distinguished based on their vasospastic response
and sever drop in temperature and reduced TR response.
[0463] In one embodiment, DTM is used for screening for smooth
muscle cell dysfunction (SMC). The variables of slope versus
rebound level are analyzed to discriminate between endothelial
dysfunction, which is a hallmark of atherosclerosis, and medial
dysfunction, which is a hallmark of hypertension.
[0464] In one embodiment, Blood Pressure monitoring (BP) is
combined with DTM. The combination of BP and DTM is particularly
suitable for the management of hypertension. DTM and BP measurement
are facilitated by an integrated device that provides monitoring of
blood pressure in conjunction with a pressure cuff used to provide
vascular occlusion as part of a DTM measurement. In one embodiment
the BP aspect of the combined device relies on conventional
oscillometric measurement of blood pressure. In an alternate
embodiment, blood pressure measurement is implemented by measuring
radial artery waveforms to calculate systolic, diastolic and mean
pressures. Using different ischemia challenge protocols, one can
distinguish between different stages of hypertensive vascular
disease. Subjects in later stages of the disease whose vasodilatory
capacity is severely reduced may show lower TR. Longer duration of
ischemia may distinguish this group with the earlier stages of
hypertension where the vasodilatory capacity is relatively high. In
another embodiment, DTM and/or combinations of DTM and glucose
monitoring is employed for management of diabetes. As with
hypertension, using different ischemia challenge protocols, one can
distinguish between different stages of diabetic vascular disease.
However, in diabetic patients a reduced vasodilatory reservoir of
the vascular system may be expected. In both cases, DTM can provide
useful information about the status of the disease and repeated
measurements can provide insights into trends.
Using Vascular Reactivity as Indicator of Cardiovascular Health
[0465] Having determined that Digital Thermal Monitoring (DTM)
during reactive hyperemia provides a novel non-invasive,
non-imaging method having the potential to aid in the assessment of
peripheral vascular function and to predict clinically unapparent
coronary heart disease (CHD), DTM was compared in a cohort of
individuals against history of CHD and against Framingham 10-year
Risk Score or Estimation (FRS). A sensitive screening test for
early atherosclerotic vascular disease should correlate with the
magnitude of Framingham Risk Estimates, and should predict CHD vs.
absence of CHD. However, Framingham risk estimates are not intended
to predict presence of CHD but risk of future CHD events based on
population studies. The Framingham Heart Study risk algorithm
encompasses only coronary heart disease, not other heart and
vascular diseases and was based on a study population that was
almost all Caucasian. Wilson PWF, et al. "Prediction of coronary
heart disease using risk factor categories" Circulation 97 (1998)
1837-1847. In addition, the Framingham Risk Score is heavily
weighted by age and sex and thus has low predictive value for
individuals under 55 and for women. Nonetheless, a more than 20%
10-year estimated risk is regarded as CHD-equivalent. It is noted
that new guidelines consider diabetes as a CHD equivalent. An
incremental predictive value over FRS for CHD would suggest a
complementary or alternative clinical utility and provided an
impetus for the study.
[0466] Methods and Study Conditions: 133 subjects (51% male,
average age 54, including 19 with known CAD) completed a medical
questionnaire and underwent DTM during reactive hyperemia using 2
minute cuff occlusion.
[0467] In order to optimize accurate measurement of vascular
response to the test, at least 12 hr prior to the test all
vasoactive medications are withdrawn. Similarly other non-drug
vasoactive compounds such as caffeine, alcohol, exposure to cold
weather, urinary urgency or full bladder, physical or mental
exercise, and all other factors that may temporarily affect
vascular function were controlled. TABLE-US-00001 Study population
133 CVD (y/n) (19/114) Sex (m/f) (67/66) Age (yrs) 54 .+-. 10 Body
Mass Index (BMI) 25.6 .+-. 4.56 Hypertension 33 Hyperlipidemia 24
Diabetes 14 Active Smoker 7 Family History of Heart Attack 59
[0468] A VENDYS vascular reactivity experimental procedure was
conducted as follows: TABLE-US-00002 Step 1) Attach the thermistor
to the distal palmar pad of the middle finger of the hand, and tape
it. 2) Allow the initial temperature before the occlusion is
started to stabilize for at least 2 minutes. 3) Then start the
occlusion of the blood by placing the blood pressure cuff on the
arm at about 200 mm of Hg. 4) Note the temperature continuously
right from the stabilization of the temperature. Keep the occlusion
for about 5 minutes. 5) Then suddenly release the occlusion after 5
minutes and keep on monitoring the increase in the temperature of
the finger for about another 3 minutes. 6) Plot the readings of the
temperature against the time and do the further analysis from the
curve obtained. 7) The results were compared with other markers of
cardiovascular health including the presence of known existing
cardiovascular disease and the Framingham Risk Score.
[0469] The Framingham Risk Score (FRS) is a coronary prediction
algorithm that seeks to provide an estimate of total CHD risk (risk
of developing one of the following: angina pectoris, myocardial
infarction, or coronary disease death) over the course of 10 years.
Separate score sheets are used for men and women and the factors
used to estimate risk include age, total blood cholesterol, HDL
cholesterol, blood pressure, cigarette smoking, and diabetes
mellitus. Relative risk for CHD is estimated by comparison to low
risk Framingham participants of the same age, optimal blood
pressure, total cholesterol 160-199 mg/dL, HDL cholesterol 45 mg/dL
for men or 55 mg/dL for women, non-smoker and no diabetes. In the
present study, to exclude any bias from the influence of diabetes,
comparisons between VENDYS parameters and Framingham risk estimates
were conducted with diabetes counted as a risk factor for CHD, and
separately with diabetes considered as a Coronary Heart Disease
(CHD)-equivalent condition.
[0470] For the present study, sitting blood pressure was recorded
in the left arm before DTM testing, using an Omron HEM 705 CP
semi-automated sphygmomanometer (Omron Healthcare, Inc.,
Bannockburn, Ill., USA). Digital thermal measurement (DTM) was
carried using a VENDYS 5000BC.TM. DTM system (Endothelix, Inc.,
Houston, Tex., USA). The device comprises a computer-based
thermometry system (0.01.degree. F. thermal resolution) designed
and implemented as disclosed herein and including two fingertip
thermocouple probes, coupled to a PC. The experimental protocol and
data collection are controlled by software implementing the steps
of FIG. 5. The probes are designed to minimize the area of
skin-probe contact, pressure on fingertip, and drift in the
baseline temperature. A standard sphygmomanometer cuff and
compressor permits controlled occlusion-hyperemia.
[0471] Subjects fasted overnight and refrained from smoking,
alcohol or caffeine ingestion and use of any vasoactive medications
on the day of the testing. Subjects remained seated, with the
forearms supported at knee level. VENDYS.TM. DTM probes
(Endothelix, Inc., Houston, Tex., USA) were affixed to the index
finger of each hand. After a period of stabilization of basal skin
temperature, the right upper arm cuff was rapidly inflated to 200
mmHg for 2 minutes, and then rapidly deflated to invoke reactive
hyperemia distally. Temperature was measured in both fingers
throughout the protocol, until approximately three minutes after
cuff deflation. DTM was performed according to an automated
operator-independent protocol.
[0472] Whole blood was analyzed for Total Cholesterol,
LDL-Cholesterol, Triglycerides and HDL-Cholesterol by
Cardiocheck.
[0473] The following primary parameters were calculated:
TABLE-US-00003 Measures reflecting the ischemic stimulus/thermal
debt TS Starting fingertip temperature Tmin (=Nadir (N)) Lowest
temperature observed after cuff inflation TF (Temperature Fall) =
TS - Tmin TTF Time from cuff release to TF Parameters reflecting
thermal recovery/vascular reactivity Tmax Highest temperature
observed after cuff deflation TR Tmax - TS; temperature
recovery/rebound NP (Nadir-to-Peak) = Tmax - Tmin TTR Time from
cuff release to TR Slope NP/(TTR - TTF) AUC Area under
temperature-time curve at various time points Additional DTM
parameters of thermal debt and recovery referenced to start
temperature (TS) TF % (TF/TS) .times. 100 TR % (TR/TS) .times. 100
Tmax % (Tmax/TS) .times. 100 NP % (NP/TS) .times. 100 Slope % NP
%/TTR
[0474] Normalizing VENDYS Indices--"Relative" Values (percentage
change): Because fingertip start temperature varies between
individuals, and the DTM technology is based on monitoring changes
in temperature, all absolute values were transformed to relative
values. For example: Relative TR (TR %)=(TR/TS).times.100.
[0475] Results: The variables of temperature fall from baseline
(T.sub.F), time to temperature fall (T.sub.TF), repayment slope
S.sub.R (1810), time to temperature rebound (T.sub.TR), rebound
temperature over baseline (T.sub.R) and the nadir to peak
temperature (T.sub.NP) as generally depicted in FIG. 13 were
analyzed for the study participants. The results were subject to
statistical analysis. As shown below, the variables of T.sub.R,
T.sub.NP and S.sub.R showed the difference between the CVD patients
and of the patients not having evidence of CVD was highly
significant. DTM discriminated between CHD and non-CHD subjects
more than FRE, particularly in women and in those .ltoreq.55 yrs.
In Receiver Operating Characteristic (ROC) analysis, with CHD as
the response variable, Area Under the Curve (AUC) for FRE, TR %,
and slope % were 0.60, 0.71, and 0.73, respectively (p<0.01).
TABLE-US-00004 CVD = Yes (N = 19) CVD = No (N = 114) T-test
Variable Mean .+-. STD Mean .+-. STD (p-value) T.sub.F (c) 1.19
.+-. 0.63 1.20 .+-. 0.53 0.996 T.sub.R (c) 0.34 .+-. 0.38 0.89 .+-.
0.92 0.0003 T.sub.NP (c) 1.53 .+-. 0.51 2.08 .+-. 0.90 0.0005
S.sub.R (c/min) 0.62 .+-. 0.36 0.93 .+-. 0.45 0.006 T.sub.TF (min)
2.83 .+-. 1.52 2.30 .+-. 0.3 0.218 T.sub.TR (min) 2.95 .+-. 1.45
2.47 .+-. 0.92 0.196
[0476] DTM parameters, corrected for starting skin temperature
(TS), (post-occlusion temperature recovery, TR %, nadir-to-peak
temperature gain (NP %) and slope of recovery %) were lower in
subjects reporting CHD (2 tailed p values 0.006 or less). As
depicted in FIGS. 47 a and b, DTM discriminated between CHD and
non-CHD subjects more than FRS, particularly in women and in those
.ltoreq.55 yrs. In univariate Receiver Operating Characteristic
Curve (ROC) analysis, with CHD as the response variable was
conducted. ROC Curves plot the true positive rate against the false
positive rate for the different possible cut points of a diagnostic
test. ROC analysis shows the tradeoff between sensitivity and
specificity (any increase in sensitivity will be accompanied by a
decrease in specificity). The closer the curve follows the
left-hand border and then the top border of the ROC space, the more
accurate the test. FIG. 45 depicts ROC curve analysis comparing NP,
TR and Slope values obtained by DTM testing with that of Framington
Risk Scoring for the study population.
[0477] The accuracy of a given test depends on how well the test
separates the group being tested into those with and without the
disease in question. One measure of accuracy is determined by an
Area Under ROC curve (AUC) analysis. A value of 0.90-1=excellent
(A); 0.80-0.90=good (B); 0.70-0.80=fair (C); 0.60-0.70=poor (D) and
0.50-0.60=fair (F). AUC analysis for FRS, TR %, NP %, slope % and
Tmax % gave values of 0.60, 0.71, 0.69, 0.73, and 0.71
respectively. Combining TR % with FRS increased the AUC to 0.794.
Thus, DTM complemented FRS in distinguishing between cohorts with
and without self-reported CHD and represents a new biomarker for
inapparent CHD, particularly in women and in younger
individuals.
[0478] As the data shows in FIG. 46b, the TR and NP DTM values
easily discriminated healthy individuals from CHD patients. In
contrast, in this study FRS only marginally discriminated CHD from
non-CHD as the data shows in FIG. 46a. Importantly, and as shown in
FIG. 48, unlike FRS, DTM is able to identify CHD in females and
young (<55 yrs) populations.
[0479] Furthermore, as shown in FIG. 47b, the TR value of DTM
showed highly significant differences from non-diabetics with a P
of 0.0055.
[0480] Indeed and as depicted in the data analysis of FIG. 47a, TR
values obtained by DTM from this cohort revealed a graded
relationship between Framingham risk, this trend having a P=0.0029.
In sum, DTM was shown to be better than blood pressure and lipid
profile in correlating with heart disease. If not better than FRS
in detection of CHD, DTM provides a complement FRS. Also, DTM can
be used to differentiate a very high risk group (with
CCS>90.sup.th percentile) from those with CCS=0 and or those
with CCS=0 & no risk factors. Importantly, in contrast to FRS
which is solely a population based risk predictor, DTM provides
information on individuals. A combination of FRS and DTM provides
more information than each alone, and provides a favorable
combination.
Correlation with Coronary Angiography
[0481] Endothelial dysfunction (ED) precedes and predicts coronary
heart disease. The present inventors hypothesized that impaired
vascular reactivity (a surrogate of endothelial dysfunction)
detected by a digital thermal monitoring (DTM) device, which
measures temperature changes at the fingertip during a reactive
hyperemia test, can predict angiographically significant coronary
artery disease (CAD).
[0482] Methods: 153 patients were studied: 118 undergoing coronary
angiography and 35 noncardiac age-matched controls. A DTM device
(VENDYS.TM.) was used to measure vascular reactivity and
endothelial function during a 2-minute suprasystolic cuff inflation
and subsequent 3-minute cuff deflation procedure. Coronary
angiography defined significant CAD as >1 major vessel with
>50% stenosis.
[0483] Results: AS depicted in FIG. 49a, of 118 who underwent
coronary angiography, 99 had significant CAD and 19 had <50%
stenosis. After adjustment for traditional risk factors of coronary
heart disease, temperature rebound (TR) measured by VENDYS.TM.
independently detected patients with significant CAD (P=0.007). See
Figure.
[0484] Conclusions: DTM, a non-invasive, non-imaging, inexpensive,
bedside test, significantly correlated with invasive coronary
angiography for the detection of coronary artery disease. Further
studies are needed to evaluate the clinical utility of this novel
method to improve existing risk stratification.
Normalization of Values:
[0485] In one embodiment, the value of T.sub.R is normalized using
thermodynamic equations for calculating heat flow based on the
following parameters in reference to FIG. 21: baseline temperature
1802, fall temperature change TF, ambient room temperature, core
temperature, tissue heat capacity, tissue metabolism rate, tissue
heat conduction, the mass of the testing volume, the location the
method is conducted, blood flow rate, the position of the subject
10 during the method, and a variety of other physical and/or
physiological factors that may effect the value of T.sub.R. In an
experimental embodiment of the method 500 described above with
respect to FIG. 8, an ambient temperature of 22 degrees C. was
measured. A first subject was tested and found to have a baseline
temperature of 35 degrees C., a TF of 2 degrees C. and a T.sub.R of
0.5 degrees. A subject like first subject has a baseline
temperature which is significantly greater than the ambient
temperature, and it is expected that such a subject will experience
a higher than normal T.sub.F and a lower than normal T.sub.R.
Furthermore, a subject having a baseline temperature which is
significantly greater than the subject's core temperature is
expected to experience a higher than normal T.sub.F and a lower
than normal T.sub.R. A second subject was tested and found to have
a baseline temperature of 25 degrees C., a T.sub.F of 1 degrees C.
and a T.sub.R of 3 degrees. A subject like second subject has a
baseline temperature which is close to the ambient temperature, and
it is expected that such a subject will experience a lower than
normal T.sub.F and a higher than normal T.sub.R. Furthermore, a
subject having a baseline temperature which is close to the
subject's core temperature is expected to experience a lower than
normal T.sub.F and a higher than normal T.sub.R.
[0486] In addition to differences between individuals, it has been
observed that in a given individual, if tested on different
occasions, may have "intra-individual" variability in measurements
of vascular reactivity. This is similar to blood pressure
variability where is well recognized that measurement of brachial
vasoreactivity may show marked variations including diurnal,
postprandial, and positional variability. In addition, other
variables including for example, ambient temperature and recent
exercise or anxiety may influence results. For example, a subject
having a baseline temperature which is significantly greater than
the room temperature, as depicted in FIG. 49b, is expected to
experience a higher than normal T.sub.F and a lower than normal
T.sub.R. On another occasion the same subject will be found to have
a low baseline temperature such as for example 25 degrees C., a
T.sub.F of 1 degree C. and a T.sub.R of 3 degrees. In this second
instance the subject has a baseline temperature which is close to
the ambient temperature, and it is expected that the subject will
experience a lower than normal T.sub.F and a higher than normal
T.sub.R. Certain of these variables can be controlled by multiple
measurements and standardized settings for measurement.
[0487] However, even though vascular reactivity graphs obtained by
measuring the temperature of a finger before, during and after
vasostimulation by cuff occlusion may appear grossly different as
can be seen in FIG. 23 and 24, the overall pattern of the response,
i.e. the slope of the repayment curve (S.sub.R) and whether or not
the rebound temperature exceeds baseline, will be characteristic of
the individual's vascular reactivity and health. In one embodiment
of the invention, individual variability is normalized
mathematically.
Multiple Measurements
[0488] Similar to blood pressure measurements, endothelial function
and vascular reactivity are highly variable physiologic parameters.
Multiple measurements and averaging of such variables are expected
to provide a more accurate assessment. For example, as shown in
table . . . three measurements in an individual can help categorize
vascular reactivity in three groups, reactive, moderately reactive,
and poorly reactive. TABLE-US-00005 Based on 3 Moderately Poorly
measurements Reactive >90.sup.th % Reactive Reactive <10th %
Reactive +++ ++ + ++ + (ReTest) + + + Moderately Reactive +++ + ++
++ + (ReTest) + + + Poorly Reactive +++ + ++ + ++ (ReTest) + +
+
Thermodoppler:
[0489] Methods and apparatus for comprehensive assessment of
vascular function are provided by combining temperature changes
with changes in peak systolic Doppler velocity measurement by
Doppler ultrasonography. This combination of thermography and
Doppler ultrasonography is herein termed "thermodoppler." For
example, and with an apparatus such as that as depicted in FIG. 31,
shown in place in FIG. 32c, the radial artery can be placed under
continuous Doppler measurement together with fingertip or palm
thermal monitoring before and after cuff occlusion test. In one
embodiment, the probe is bidirectional Doppler probe 1902 which is
be placed over the radial artery and held in place by any number of
attachments known in the art, including adhesives or, for example,
a wrist band 1904. Doppler data as seen in FIG. 32d is obtained by
continuous monitoring of peak systolic Doppler velocity decreases
after occlusion from its maximum immediately after release of the
cuff (cuff deflation) and declining over time to base velocity
before occlusion. This response inversely correlates with distal
vascular resistance. Immediately after releasing the cuff,
resistance is minimum. Upon perfusion the resistance increases back
to baseline resistance. The speed of return to baseline resistance,
the area 2011 under the produced curve as well as the slope, can be
used to study the function of the resistant vasculature. Decreased
vasodilative capacity (micovessels resume resistance quickly) after
occlusion is indicative of inability of the vasculature to remain
dilated and maintain high blood perfusion.
[0490] The Doppler pulse velocity curve can be used as a
non-invasive correlate of metabolic and biochemical factors
affecting the distal microvascular resistance (e.g. lactate
concentration, pH, calcium ion, etc. In summation, the curve can be
calibrated to study, non-invasively, factors affecting vascular
health.
Comprehensive Measures of Vascular Health, Including Both
Macrovascular and Microvascular Analysis
[0491] In one embodiment of the present invention, methods and
apparatus for determining and comparing the microvascular and the
macrovascular response of an individual are provided. As depicted
figuratively in FIG. 51b, a comprehensive assessment of vascular
health includes at three components: functional status of the
individual, risk factor assessment based on epidemiologic studies,
and structural studies of the individual. The present invention
contributes new non-invasive methods and apparatus for functional
assessment as well as important combinations of the functional
assessment with risk factor and structural analysis.
[0492] Functional assessment in accordance with an embodiment of
the invention includes three compartments: the microvasculature,
the macrovasculature and the neurovasculature. The macrovasculature
is composed of large and relatively large conduit vessels, such as
for example in the arms, the brachial and radial arteries. The
microvasculature is made up of resistance vessels, the arterioles
and capillaries. The microvasulature is strongly influenced by the
neurovascular system. As shown in FIG. 51a, in accordance with an
embodiment of the invention, an individual's baseline functional
status is determined by measuring blood pressure, which is
influenced by both the microvasculature and the
neurovasculature.
[0493] Digital thermal monitoring has been determined by the
present inventors to provide a powerful measure of neuroreactivity.
It has been surprisingly found that when a vascular challenge is
applied to a target body such as an arm, the corresponding
contralateral remote body reacts as instructed by the
neurovasculature. Thus, if blood is occluded from a right arm
(target body), a normal neurovasulature senses the need for greater
perfusion and directs increased blood flow in the contralateral
left arm (remote body). If the individual has a healthy
microvasculature, the neurovascular instruction to increase blood
flow is effective to induce vasodilation in the contralateral
microvasculature and an increase blood flow. This increase in blood
flow can be detected by instrumentalities including for example
with a thermocouple, thermister, resistance temperature detector,
heat flux detector, liquid crystal sensor, thermopile, or an
infrared sensor. Increased blood flow in the contralateral remote
body part can also be detected by skin color, nail capilloroscopy,
fingertip plethysmography, oxygen saturation change, laser Doppler,
near-infrared spectroscopy measurement, and peripheral arterial
tonometry.
[0494] In accordance with an embodiment of the invention, baseline
functional status of the macrovasculature is determined using Pulse
Wave Velocity (PWV) and/or Pulse Wave Flow (PWF) analysis.
[0495] As shown in FIG. 51a, functional assessment of reactive
capacity for the individual is determined using Pulse Wave Velocity
(PWV) and/or Pulse Wave Flow (PWF) analysis for the
macrovasculature after challenge, such as with a chemical or
physical vasostimulant. The functional capacity of the
microvasculature is determined using Doppler Flow Velocity (DFV)
and/or Digital Thermal Monitoring (DTM) subsequent to vascular
challenge.
Infrared Imaging
[0496] In one embodiment of the invention, infrared imaging is used
for thermographic assessment of endothelial dysfunction.
Temperatures before, during, and after vasostimulation, such as may
be provided by cuff occlusion, are measured by infrared camera.
Infrared (IR) thermography is employed to study vascular health
before, during, and after a direct vascular stimulant such as
nitrate or cuff occlusion. For example, infrared imaging of both
hands or feet during cuff occlusion test (before cuff occlusion,
during and post occlusion) using infrared thermography results in a
comprehensive vascular and neurovascular assessment of vascular
response in both hands or feet. FIG. 52 depicts the results of IR
thermography of two hands of the same individual where the brachial
artery is occluded by an inflated blood pressure cuff on the
individual's right arm. In this application, quantitative
measurements of temperature changes are generated by numerical
analysis of each depth of color in the image. The technique
typically utilizes a color map of the thermal image as shown in
FIG. 52.
[0497] In one embodiment, IR thermography is used to assess the
condition of a diabetic foot including an assessment of vascular
function and reactivity in diabetic patients who are at risk
developing foot ulcers or "diabetic foot" as a consequence of
vascular disturbances and severely compromised perfusion or
ischemia of the foot. Heterogeneity in skin perfusion and vascular
health can be seen. The technique can also be used to indicate
development of diabetic neuropathy.
[0498] Baseline imaging of the feet of a diabetic patient is
performed. Imaging is performed after administration of
nitrite/nitrate compound e.g. nitrotriglyceride (NTG). Point IR
measurement of temperature such as aural thermography can be used
for assessment of total body vascular response to vascular
stimulant such as nitrate. In such cases a higher temperature
response indicates a better vascular function.
[0499] In one embodiment, a method and apparatus is provided for
using a combination of infrared thermography, digital temperature
measurements of vascular reactivity and Doppler ultrasonography
simultaneously.
Miniature DTM Device with Finger Occlusion Cuff:
[0500] One embodiment of a miniature DTM device (MDTMD) is shown in
FIG. 53A. Another embodiment is shown in FIG. 53B. The MDTMD is
placed on a finger such as the index finger, and is dimensioned
such that the device does not interfere with normal functioning.
The embodiment of the device depicted in FIGS. 53A and 53B consists
of three sub-units: (a) an occluding band placed close to the base
of the finger. The band consists of two rings, one stationary that
has a display unit mounted on it, and the other which can be
twisted so as to deploy the inflation. Both are connected with a
thick band that enables the tightening mechanism and ensures a snug
and comfortable cushioning. Sub-unit (b) is a temperature sensing
band placed closer to the finger tips, and sub-unit (c) is a data
acquisition and transmission system (DATS), mounted on the
occluding band. This system also contains a display unit that shows
the pressure and temperature reading along with a sensor. In one
embodiment, a remote telemedic computer system receives, analyzes
and presents the data to medical staff almost instantaneously. In
other embodiments, optional additional measuring devices may
include an oximeter, which records the instantaneous heart rate of
the soldier, and a plethysmographic device to read the blood
pressure.
[0501] Device functionality is briefly described below, elaborating
on the physical operating principles. Upon activation, the
occluding band first compresses the artery in the finger, causing
ischemia (i.e. interruption in the flow of blood to the finger
tips). After a pre-set or programmable occlusion time, the finger
tips--having been deprived of normal blood circulation--attain a
reduced surface temperature closer to ambient. Following this
period of constriction, the occluding band can be manually loosened
by pressing a button on the occluding band, thereby immediately
restoring blood flow. The subsequent time-variations of the
finger-tip temperature are measured by the sensor.
[0502] Referring again to FIG. 53A depicting an embodiment of a
Miniaturized DTM Device. Depiction A is a top view of the MDTM
device that shows the display unit. B shows the side view, note the
thin plastic ring close to the finger tip that mounts the skin
temperature sensor. In an alternative embodiment, the temperature
sensor is disposed in a stretch tube-shape (sleeve) over the
finger, for example from the base of the finger to near the tip or
last inter phalangeal crease. This embodiment may be preferred
where the fingertip is needed for sensory controlled functions of
the finger.
[0503] Depiction C of FIG. 53, shows the cable connecting the skin
temperature sensor and the occluding band, while D shows a close up
view of the MDTMD. Depiction E is an end-on view. A strap connects
the two rings that lock themselves when the top ring is twisted.
The strap is also to ensure a snug and comfortable fit. In F, a
button on the stationary ring is to deploy the deflation process
ensuring that two rings come back to their original position. G
depicts another projection illustrating the MDTMD. The device is
dimensioned not to interfere with normal subject prehensile or
ambulatory function, and will work by triggering reactive hyperemia
followed by temperature measurement using micro-transducers.
DTM Parameters
[0504] The graph presented in FIG. 54 illustrates different
parameters that can be calculated from a temperature fall and
rebound curve determined by temperature measurements in conjunction
with a reactive hyperemia test. This includes the delta of
temperature and AUC between different time points.
[0505] It is understood that variations may be made in the
foregoing without departing from the scope of the disclosed
embodiments. Furthermore, the elements and teachings of the various
illustrative embodiments may be combined in whole or in part some
or all of the illustrated embodiments. Although illustrative
embodiments have been shown and described, a wide range of
modification, change and substitution is contemplated in the
foregoing disclosure and in some instances, some features of the
embodiments may be employed without a corresponding use of other
features. Accordingly, it is appropriate that the appended claims
be construed broadly and in a manner consistent with the scope of
the embodiments disclosed herein.
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