Note: Descriptions are shown in the official language in which they were submitted.
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ELECTRONIC ALLERGO-SENSITIVITY TEST DEVICE
BACKGROUND OF THE INVENTION
1. FIELD OF THE INVENTION
The present invention relates to allergen testing.
More specifically, it relates to a device for allergen
testing that includes a pair of sensing electrodes, an
allergen delivery electrode connected to an allergen sample
tray, a microprocessor for amplifying and comparing the
signals from the two sensing electrodes, an A/D converter
for turning the amplified data to a digital information
stream, and an interface including software to display and
store the gathered information on a conventional personal
computer (PC).
2. DESCRIPTION OF THE PRIOR ART
Presently, allergy testing commonly takes the form of
introducing allergens to a portion of the patients' dermis
and then measuring the size and color of the induced weal.
This often involves breaking the surface of the skin to
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introduce the substance and has a number of drawbacks. It
is painful, for one, and the patient can have a severe
reaction if they are extremely sensitive to one of the
introduced substances. Additionally, the procedure causes
some discomfort. Another prior art method of testing
involves introducing the potential allergen and then
measuring the temperature response, by means of electrodes
or the other sensing means, of the skin proximate the area
where the substance was introduced. This allows for smaller
amounts of the allergen to be used, but in many cases it
still involves the breaking of the skin. The present
invention attempts to improve on these prior art methods and
devices by using galvanometric skin response to determine
the sensitivity of the patient to various substances. As
will be seen, the simplicity and effectiveness of my
invention is not rivaled in the prior art.
There have been a number of U.S. Patents issued that
relate to this art that were uncovered during a search, and
they are hereinafter discussed:
U.S. Patent No. 4,702,259, issued on October 27, 1987
to Marc rerreira et al., dieclos~s a d~vico for moasuring
and indicating changes in the electrical resistance of a
living body. The device includes an analog portion, a
digital portion and a stable source of power for both
portions. The analog portion includes a bridge network
which includes a potentiometer, which turns together with
the potentiometer provided in the digital portion, and
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digital processing circuitry. Digital displays determine
and display a count indicative of the position of the
potentiometer and the total amount of rotation of said
potentiometer. In addition, a computer may be interfaced
with the device to record or play back the changes in the
resistance of the living body. Unlike the present
invention, there is nowhere in the document a teaching or
disclosure that discusses using the apparatus as a testing
device for allergen response, nor is there any type of
delivery system for stimuli disclosed.
U.S. Patent No. 4,805,621 issued to Roland Heinze et
al. on February 21, 1989 discloses an apparatus for
measuring the impedance of body tissue with a signal source
connected to the tissue to be measured which supplies an
electrical signal to the tissue, a unit for acquiring an
impedance signal from the body tissue dependent on the
electrical signal, and a evaluation stage for the impedance
signal. The evaluation stage filters out low frequency
signal components corresponding to the conductance of the
tissue, and has a signal output to which the signal
components which were filtered out are supplied. In this
device, an electrical signal is impressed on the tissue of
the patient through a pair of electrodes and the voltage
drop is measured. This is unlike the present invention,
which measures the galvanometric skin response in the
presence of allergenic substances and displays the same.
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Next in this discussion is U.S. Patent No. 4,809,707
issued to Thomas L. Kraft et al. on March 7, 1989. Kraft et
al. show an electrode for performing a plurality of allergy
tests on a patient undergoing tests. The allergy electrode
consists of a plurality of individual testing electrodes and
a single common electrode. Each of the testing electrodes
includes allergen delivery apparatus and a temperature
sensor. The allergen is contained in a removable allergen
impregnated pad. If a dry allergen is used, it may be
hydrolized with a drop of distilled water prior to
application. A small electric charge charges a charge plate
on one side of the allergen pad and a common ring on the
electrodes is grounded in a circuit with the charging plate,
thereby causing electric field to transfer the allergen
through the pores of the skin. The area surrounding the
allergen delivery area is sensed for temperature by a thin
film temperature sensor and a rigid temperature conducted
base. A thermistor or other temperature to voltage
transducer converts the sensed temperature to an electric
voltage which is applied through appropriate differential
amplifiers and multiplexer to an analog to digital
converter. The digital data is then stored by a
microprocessor in random access memory. An output device
can be connected to receive the stored data and the time at
which it was stored so as to manifest to the physician the
change in temperature of the tested area with respect to
time. This discloses an electrode for non-invasive allergy
testing. Included are plurality of testing electrodes and a
common electrode. Each of the testing electrodes have
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therein an allergen impregnated pad, a charge plate, a
common ring grounded in the circuit with the charge plate,
and a thin film temperature sensor or the like. A smal l
charge is placed on the charge plate, which causes the
allergen to transfer through the pores of the skin, while
the thin film sensors monitor temperature in the proximate
area. The common electrode monitors the temperature in a
distant area. Processing and storage means are disclosed to
allow the physician to review the results of the test.
Lastly, U.S. Patent No. 4,819,657 issued on April 11,
1989, also to Thomas L. Kraft et al. discloses a automatic
allergy detection system. The system includes an electrode
capable of testing up to eight different allergies and an
associated electronic unit. The electrode includes
apparatus to transcutaneously deliver an allergen to the
patient without puncturing the patient's skin. The
electrode also includes a temperature sensor for sensing the
skin temperature in the area surrounding the deliver of the
allergen. Electronic apparatus is provided for processing
the sensed temperature and storing data related thereto for
subsequent print out to an output device. The allergy
testing system is controlled so that periodic temperature
readings are made at thirty second intervals over
approximately a fifteen minute testing span. The data can
be printed out in a graphic format to allow the physician to
easily and quickly make more accurate diagnosis. In this
device there are disclosed electrodes similar to those
discussed in Kraft et al. ('707). However, more detail is
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gone into concerning the processing and data storage portion
of the device. Neither of the two Kraft et al. patents
discusses the use of galvanometric skin response as a method
of ascertaining a patients sensitivity to a specific
substance.
None of the above inventions and patents, taken either
singly or in combination, is seen to describe the instant
invention as claimed.
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SUMMARY OF THE INVENTION
The present invention is a device for testing a
patient's sensitivity to a plurality of potential allergens
by using the galvanometric skin response of the patient's
body to determine the same. A pair of electrodes are
attached at separate locations of the body and are connected
to a signal amplification unit and A/D converter, which is
in turn connected to the bus of a personal computer. An
allergen sampling tray is also connected to the computer bus
and also a third electrode adapted to deliver the allergen
samples in sequence transcutaneously. The skin response
changes according to severity of the allergen reaction, and
the signal amplification means and A/D converter allow these
changes to be viewed graphically in a real time mode on the
computer screen and also to be stored within the computer
and to be printed out to allow the physician and the patient
a hard copy of the test data.
Accordingly, the invention provides a new and
improved galvanic skin response allergen testing device
which overcomes or at least lessens the disadvantages
of the prior art in a simple but effective manner. The
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invention provides an allergen testing device using
galvanometric skin response that allows the patient
to be tested without the discomfort of prior art
devices and in particular, without the use of painful
massive injections. The invention provides an allergen
testing device using galvanometric skin response that
is interfaced with a personal computer to allow the
testing physician to view the real time responses of
the patient on the computer screen during exposures to
different substances. The invention provides an allergen
testing device using galvanometric skin response wherein
a series of allergens is delivered transcutaneously by
an electrode. The invention provides an allergen testing
device using galvanometric skin response that allows for
the storage of the test data in storage memory of a
personal computer and printout of the same data for
reference by the physician and patient. The invention
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also provides improved elements and arrangements thereof
in an apparatus for the purposes described which is
inexpensive, dependable and fully effective in accomplishing
its intended purposes.
These and other advantages of the present invention will
become readily apparent upon further review of the following
specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Various other features and attendant
advantages of the present invention will become more fully
appreciated as the same becomes better understood when
considered in conjunction with the accompanying drawings, in
which like reference characters designate the same or
similar parts throughout the several views, and wherein:
Fig. 1 is a diagrammatic view of a patient attached to
the inventive device.
Fig. 2 is an example of the display generated by the
contemplated software on a personal computer screen or,
alternatively, in a printout for hard copy reference.
Fig. 3 is a block diagram showing the electronic signal
processor used in the instant invention.
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention is an allergen tester that
utilizes the galvanometric response of the.skin to ascertain
the severity of a patient's reaction to various substances.
It has been observed through clinical observation that the
human body loses energy when exposed to substances that
induce an allergic or otherwise detrimental reaction. This
energy loss is very rapid and can be measured in microvolts.
Thus, the present invention is a system that seeks to use
this phenomenon to allow the physician to see, graphically,
and in real time, the degree of a patients sensitivity to a
given substance at the time of testing.
Referring to Fig. 1 there is seen a patient P, a first
electrode 10, a second electrode 12, signal amplification
and interface box 20, allergen sample tray 30, allergen
delivery electrode 32, signal interface wire 22, allergen
storage tray interface wire 34,~and a personal computer 40.
The personal computer 40 would be any of the now ubiquitous
devices on the market, but preferably would be one of the
type employing a high speed processor for quick operation.
The two electrodes 10, 12 are placed on the patient P's
body in any convenient location. In the figure shown here,
the electrode 10 is placed on the patient P's head or neck
region and the electrode 12 is placed on the hip region.
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The unit would first be activated and a galvanometric
baseline would be established. It should be noted that
though no power means are shown, both the allergen sample
tray 30 and the signal amplification and interface box 20
could be powered by standard household or commercial AC
current through a variety of well known means, or, by virtue
of the fact that the entire system would not draw much
power, they could be operated off the switchable power
supply already present in the computer. In any case, the
means to power the units would be available and obvious to a
skilled person. The allergen delivery electrode 32 is now
affixed to the patient P. A method of delivering allergens
transcutaneously is disclosed in U. S. Patent No. 4,809,707,
discussed above.
As the allergen is delivered, the response from the
electrodes 10, 12 is monitored. If the patient P has no
reaction to the substance the line on the monitor will
resemble a flat horizontal line such as that at indicated at
100 in Fig. 2. It should be mentioned here that the means
of turning the sequential microvolt 0 changes in the
electrodes 10, 12 as measured over time (indicated by the
arrow Al in Fig. 2) into the Cartesian type display shown in
Fig. 2 are well known, and it is not deemed necessary to
discuss the techniques in the present document. ~ The details
of the amplification and interface box are shown in Fig. 3
and it would be obvious to a skilled artisan how to
construct such a device. Returning to Fig. 2, if the
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patient reacted to the substance, the graph would drop as
the skin response changed, as is seen at the portion of the
graph marked 110 in figure~2. The recovery slope 120 in~the
same figure shows the energetic flexibility or "bounce back"
of the patient from the substance. The greater the drop in
the graph, the more severe the reaction. Thus, it is
contemplated that, through the allergen storage tray 30 and
the allergen storage tray interface wire 34, a variety of
different substances could be delivered in sequence through
the allergen delivery electrode 32 by computer controlled
signals that would switch to different storage sites 36, 36'
within the allergen storage tray 30 for the delivery of the
substance to the delivery electrode 32. This would quickly
and easily give the physician the ability to ascertain the
substances that the patient needed to avoid or be given
immunotherapy for exposure thereto. Plots or printouts (not
shown) could be generated for reference by the software
contemplated in the invention. Additionally, records could
be kept in the long term memory storage (not shown) of the
computer 40 to provide comparisons over the course of
treatment.
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The following is a list of the elements discussed in
the above specification:
patient P
first electrode 10
second electrode 12
signal amplification and interface 20
allergen sample tray 30
allergen delivery electrode 32
signal interface wire 22
allergen storage interface wire 34
personal computer 40
flat horizontal graph line 100
reaction drop on graph 110
recovery slope on graph 120
first allergen storage site 36
second (separate) allergen storage site 36'
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From the foregoing description, one skilled in the art
can easily ascertain the essential characteristics of this
invention and, without departing from the spirit and scope
thereof, can make various changes and modifications of the
invention to adapt it to various usages and conditions. For
example, the artisan could easily determine various other
methods of administering miniscule amounts of allergy
producing agents for the purpose of monitoring galvanic
response recovery rates.
It is to be understood that the present invention is
not limited to the sole embodiment described above, but
encompasses any and all embodiments within the scope of the
following claims:
It is to be understood that the present invention is
not limited to the sole embodiment described above, but
encompasses any and all embodiments within the scope of the
following claims.
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