U.S. patent number RE30,446 [Application Number 06/021,112] was granted by the patent office on 1980-12-16 for apparatus for detecting temperature variations over selected regions of living tissue, and method thereof.
This patent grant is currently assigned to E-Z-Em Company, Inc.. Invention is credited to Franklin M. Greene, Phillip H. Meyers.
United States Patent |
RE30,446 |
Meyers , et al. |
December 16, 1980 |
Apparatus for detecting temperature variations over selected
regions of living tissue, and method thereof
Abstract
An apparatus for detecting temperature variations over selected
regions of living tissue. The invention relates to the apparatus
and to the method of detecting said temperature variations for aid
in the early detection of malignant tissue in the breasts. The
invention provides for the use of liquid crystals encapsulated
between elastic flexible sheets which represent a composite film.
The crystals are responsive to changes in temperature of said
tissue to display a color pattern on said film representative of
said temperature variations. The film conforms to the contour of
the tissue to which it is applied, without materially deforming
said tissue, by evacuating air from between said film and said
tissue. The color pattern produced on said film is observed and is
recorded photographically to obtain a thermogram of said
temperature variations. The contoured film and the tissue are fan
cooled for a relatively short period of time to produce a more
sensitive color pattern on said film representative of said
temperature variations.
Inventors: |
Meyers; Phillip H. (New
Orleans, LA), Greene; Franklin M. (Flushing, NY) |
Assignee: |
E-Z-Em Company, Inc. (Westbury,
NY)
|
Family
ID: |
21802405 |
Appl.
No.: |
06/021,112 |
Filed: |
March 16, 1979 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
Reissue of: |
779264 |
Mar 18, 1977 |
04135497 |
Jan 23, 1979 |
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Current U.S.
Class: |
600/549;
374/162 |
Current CPC
Class: |
A61B
5/015 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61B 010/00 () |
Field of
Search: |
;128/280,282,379,399-401,736 ;73/356 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"The Chameleon Chemical", Life Magazine..
|
Primary Examiner: Howell; Kyle L.
Assistant Examiner: Jaworski; Francis J.
Attorney, Agent or Firm: McAulay, Fields, Fisher, Goldstein
& Nissen
Claims
We claim:
1. A method of detecting temperature variations over selected
regions of the breasts of a woman within a predetermined range of
temperatures, and which method utilizes .[.liquid crystals enclosed
between.]. .Iadd.an .Iaddend.elastic flexible .[.sheets which
represent a composite.]. film, .Iadd.having temperature responsive
liquid crystals.Iaddend., and which crystals are responsive to
changes in skin temperatures of said breasts to display a color
pattern on said film representative of said temperature variations,
said method comprising:
(a) wrapping said film around the breasts to be examined,
(b) securing said film in position around said breasts;
(c) positioning a first end of a tubular member and a spacer
adjacent said first end in a region spaced from the edges of said
film and between said breasts, said spacer providing communication
between said first end of said tubular member and the region under
said film;
(d) connecting the opposite end of said tubular member to a vacuum
source;
(e) evacuating air from between said film and said breasts;
(f) causing said film to stretch and conform to the contour of said
breasts without materially deforming said breasts; and
(g) observing the color pattern produced on said film
representative of the temperature variations over said breasts.
2. The method of claim 1 wherein said spacer is a porous
material.
3. The method as recited in claim 1, further comprising the step of
forming an opening in said film, said tubular member being
sealingly positioned in said opening and providing fluid
communication between the woman's skin and the vacuum source.
4. The method of claim 3 wherein said spaer is a porous
material.
5. The method as recited in claim 1, further comprising the step of
cooling said contoured film and said breasts for a relatively short
period of time to remove the color pattern on said film, and then
re-observing a more sensitive color pattern produced on said film
representative of said temperature variations.
6. The method as recited in claim 1, further comprising the step of
recording the color pattern produced on said film to obtain a
thermogram of said temperature variations.
7. A method of detecting temperature variations of the breasts of a
woman within a predetermined range of temperatures, and which
method utilizes .[.liquid crystals enclosed between.]. .Iadd.an
.Iaddend.elastic flexible .[.sheets which represent a composite.].
film .Iadd.having temperature responsive liquid crystals.Iaddend.,
and which crystals are responsive to changes in skin temperatures
of said breasts to display a color pattern on said film
representative of said temperature variations, said method
comprising:
(a) wrapping said film around the woman and in contact with the
breasts to be examined;
(b) securing said film in position around said breasts;
(c) positioning one port of said tubular member in a region spaced
from the edges of said film and adjacent to the sternum of the
woman's chest;
(d) connecting the opposite port of said tubular member to a vacuum
source;
(e) applying a porous spacer between said one port of said tubular
member and the woman's skin;
(f) evacuating air from between said film and said breasts;
(g) causing said film to stretch and conform to the contour of said
breasts without materially deforming said breasts;
(h) cooling said contoured film and said breasts for a relatively
short period of time; and
(i) observing the color pattern produced on said film
representative of the temperature variations over selected regions
of said breasts.
8. The method as recited in claim 7, further comprising the step of
recording the color pattern produced on said film to obtain a
thermogram of said temperature variations.
9. An apparatus for detecting temperature variations of the breasts
of a woman within a predetermined range of temperatures, said
apparatus comprising:
(a) .[.a plurality of.]. .Iadd.an .Iaddend.elastic flexible
.[.sheets superimposed on each other to represent a composite.].
film having liquid crystals .[.enclosed therebetween.]., said
crystals being responsive to changes in skin temperature of said
breasts to display a color pattern on said film representative of
said temperature variations;
(b) securing means for securing said film in position when said
film is wrapped around the breasts to be examined; and
(c) a tubular member, a first end of said tubular member being
located in a region spaced from the edges of said film and adapted
to be positioned between said breasts, the second end of said
tubular member adapted to be connected to a vacuum source for
evacuating air from between said film and said breasts;
(d) said .[.sheets.]. .Iadd.film .Iaddend.having sufficient
flexibility and elasticity to .[.cause.]. .Iadd.permit
.Iaddend.said film to stretch and conform to the contour of said
breasts without materially deforming said breasts when a vacuum is
drawn; and
(e) a spacer located at said first end of said tubular member to
prevent collapse of said flexible film around said first end of
said tubular member, said spacer providing communication between
said first end of said tubular member and the region under said
film; whereby a color pattern is produced on said film
representative of the temperature variations over regions of said
breasts.
10. The apparatus of claim 9 wherein said spacer is a porous
material.
11. The apparatus as recited in claim 9, wherein said film has a
through-opening therein, said tubular member being sealingly
positioned in said opening to provide fluid communication through
said tubular member between the woman's skin and the vacuum
source.
12. The apparatus of claim 11 wherein said spacer is a porous
material.
13. The apparatus as recited in claim 9, wherein said film is sized
to wrap around the chest of the woman, said securing means
comprising first and second elastic chest encircling straps, said
first strap being wrapped longitudinally along said film adjacent
its upper edge and said second strap being wrapped longitudinally
along said film adjacent its lower edge, and interengaging members
respectively affixed to the opposite ends of each of said first and
second straps for fastening said straps around the torso of the
woman being examined.
14. An apparatus for detecting temperature variations of the
breasts of a woman within a predetermined range of temperatures,
said apparatus comprising:
(a) .[.a plurality of.]. .Iadd.an .Iaddend.elastic flexible
.[.sheets superimposed on each other to represent a composite.].
film having liquid crystals .[.enclosed therebetween.]., said
crystals being responsive to changes in skin temperature of said
breasts to display a color pattern on said film representative of
said temperature variations;
(b) securing means for securing said film in position when said
film is wrapped around the chest of the woman to be examined and in
contact with the breasts to be examined,
(c) said securing means comprising first and second elastic chest
encircling straps, said first strap being wrapped longitudinally
around said film adjacent its upper edge and said second strap
being wrapped longitudinally around said film adjacent its lower
edge, and interengaging members respectively affixed to the
opposite ends of each of said first and second straps for fastening
said straps around the torso of the woman being examined;
(d) vacuum means for evacuating air between said film and said
breasts; said vacuum means comprising .[.a vacuum source,.]. a
valve assembly having a tubular member connected to said film and a
vacuum source, one end of said tubular member being located in a
region spaced from the edges of said film and adapted to be
positioned adjacent to the sternum of the woman's chest, the
opposite end of said tubular member being connected to said vacuum
source;
(e) said .[.sheets.]. .Iadd.film .Iaddend.having sufficient
flexibility and elasticity to .[.cause.]. .Iadd.permit
.Iaddend.said film to stretch and conform to the contour of said
breasts without materially deforming said breasts when a vacuum is
drawn; and
(f) a porous spacer positioned adjacent said one end of said
tubular member to prevent collapse of said flexible film around
said one end of said tubular member;
whereby a color pattern is produced on said film representative of
the temperature variations over selected regions of said
breasts.
15. The apparatus as recited in claim 14, wherein said film has a
through-opening therein, said tubular member being sealingly
positioned in said opening and providing fluid communication
between the woman's skin and the vacuum source.
16. The apparatus as recited in claim 14, wherein said film
securing means further comprises first and second elastic shoulder
straps each extending over a separate one of the shoulders of the
woman, and interengaging members respectively affixed to the
opposite ends of each of said first and second shoulder straps for
fastening said shoulder straps around said first chest encircling
strap.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to an apparatus for detecting
temperature variations over selected regions of a living tissue,
and to a method of detecting said temperature variations. The
technique utilizes an encapsulated liquid crystal film that
conforms to the contour of the tissue by evacuating air from
between said film and said tissue. The crystals are responsive to
changes in temperature of said tissue to display a color pattern on
said film representative of said temperature variations.
2. Description of the Prior Art
Thermography, in its broadest sense, is a technique for detecting
and measuring variations in the heat emitted by various regions of
the body and transforming them into visible signals that can be
recorded photographically. The technique is lately experiencing
increased interest as a potentially significant aid in diagnosing
abnormal or diseased underlying conditions, particularly those
involving cancer of the breast.
At present, progress in the treatment of cancer of the female
breast lies mainly in the area of early detection, with the
diagnosis made and treatment instituted at an early stage of the
disease. Although frequent physical examinations are recommended by
the medical community, it is recognized that malignant tumors
detected by this technique are often of such size as to indicate
that the malignancy has already spread to other areas of the body.
In order to provide earlier detection of the disease, much emphasis
has also been placed on radiographic mammography. However, since
this technique involves X-ray examinations, there is the danger of
exposing the patient to excessive radiation. Mammography further
requires the use of sophisticated equipment that is extremely
costly, and the assistance of technically skilled personnel.
In recent years, significant scientific progress has been made in
the use of thermography as an added instrument of diagnosis. All
methods of thermographic examination are based on the fact that
malignant neoplasms are surrounded by an extraordinarily large
number of blood vessels. This serves to explain localized rises in
temperature, stemming from the increased blood flow and metabolic
activity, which are transmitted to the overlying skin surface. All
work using thermography has been directed toward diagnosis by means
of the differences in temperature of points or areas on the skin.
For example, the skin temperature of the breast on the side with a
tumor is found to be more than 1.degree. C. higher than that on the
healthy side. Advanced carcinomas were warmer still, and it is
possible to deduce the serverity of the condition from the raised
temperature.
Initial work with this technique was in the area of electronic
infra-red thermography (EIT). This is a method of remote sensing of
the infra-red radiation emitted by the surface of the breast. The
scientific community was not entirely satisfied with this technique
because of its limited reliability and the difficulty of
interpreting the results. In this regard, the early equipment did
not provide reliably informative thermograms in recording the small
temperature differential between the tumor side and the healthy
side of the breast. Furthermore, the slight temperature variations
might well be caused by other conditions unrelated to the tumor.
For example, the effects of the menstrual cycle, of hormonal
contraceptives and of pregnancy have been found to cause minor
day-to-day temperature changes which must be taken into
consideration when reading the thermogram. Thus, it became accepted
practice in the medical community that EIT, on its own, gave too
many false-positive diagnoses, and that only a concurrent
mammographic examination would allow greater certainty in
diagnosing the condition as benign or malignant. The equipment
required in practicing EIT was also extremely costly and often
required the assistance of skilled personnel.
Continued research brought forth the development of liquid crystal
thermography to obtain a multi-colored recording of the body region
under examination. The liquid crystalline state is a particular
form of matter lying midway between the solid crystal and a normal
(iostropic) liquid. The use of liquid crystals in thermography
evolved when it was determined that certain cholesterine esters
with the properties of liquid crystals had the ability to react to
variations in temperature by changing color. It soon became
apparent that such cholesteric liquid crystals (CLC) might be used
in science and technology as a temperature indicator.
The initial procedures practiced in the use of liquid crystals were
extremely complicated and burdensome for the patient. In view of
the fact that the temperature indicators had to be on a black
background in order to show their color reaction with sufficient
clarity, the patient's skin first had to be painted with a black
undercoat, onto which the liquid crystals were then applied with a
brush. The color reactions that ensued were visible only by
daylight and were recorded by a camera on color film. Apart from
the impracticality of this procedure for mass screening or routine
examinations, it also has the disadvantage that the liquid crystals
can be used only once. An additional problem with this technique is
that it does not reproduce accurately the local vascular features.
Moreover, the brushing technique is time-consuming and
uncomfortable for the patient. Furthermore, heat diffusion causes
unsharpness of detail in the images obtained thereby preventing a
reliable diagnostic interpretation.
The technology further evolved to the point where the liquid
crystals are not encapsulated in plates. The encapsulated liquid
crystals (ELC), which form the basis of plate thermography, offers
the advantage of changing the liquids into pseudo-solids, and
improves the handling and processing of the liquid crystals. The
plate registers temperature differences by means of the color
reactions produced by the encapsulated cholesterine-type fluid
crystals. As temperature rises, the reactions run through the color
scale from red to green to blue, and the individual shades are able
to indicate temperature differences of 1/10th of a degree
centrigrade. The color reactions take place a few seconds after the
plate has been placed against the subject to be examined. The
reaction is also reversible with equal rapidity in that the colors
disappear quickly when the plate is removed from the subject to be
examined.
Although the plate records zones of differing temperature with a
relatively sharp outline, the use of plate thermography is still
pretty well confined to clinical research facilities and/or use
thereof in the doctor's office. The equipment is not suitable for
use directly by the patient in her home, and is not sufficiently
portable for use outside of the doctor's office.
Furthermore, because the plate is fairly rigid, it is not possible
to shape it to the contour of the breast being examined. Thus, in
examining the female breast, it is normal to diagrammatically
divide the breast into four quadrants and then apply the plate
separately to each one of the quadrants. A lateral view can also be
obtained by having the patient turn sideways and applying the plate
while the arm is raised. Color photographs can be taken of the
color pattern produced on the plate. It will be readily appreciated
that, due to the curvature of the breast, it is not possible to
examine the breast with the use of only one plate. In this regard,
it is important not to materially deform the tissue which is in
contact with the plate since this would serve to distort the
thermogram and thereby prevent a reliable diagnostic
interpretation.
It thus became apparent that greater utility in the field of liquid
crystal thermography would be possible if the plates were rendered
flexible. The technology soon evolved to the use of such flexible
plates in the form of thin plastic sheets superimposed on each
other to form a composite film having the liquid crystals
encapsulated therebetween. The construction may be deemed as
representing micro-encapsulated liquid crystals sandwiched between
two polyester sheets or substrates. The film is capable of being
manufactured so as to be responsive to selective temperatures
within a particular range of temperatures. This is a function of
the crystals selected for use in the film. In other words, the
crystals are selected so that they are operative in a temperature
range that encompasses foreseen variations of body temperature in
the region of the body under examination. The method of
manufacturing such films is readily disclosed in the prior art as
evidenced by U.S. Pat. Nos. 3,619,254 and 3,969,264.
Today, thermography using liquid crystals is receiving additional
interest in diagnosing changes in venous and arterial blood
vessels, bone and thyroid gland diseases, dermatological
examinations, and in other clinical and physiological
investigations.
In some applications, the initial thermographic test is then
followed by another with the skin pre-cooled with cool air from a
hand blower. The objective in this technique is to exclude the
pronounced degree of heat formation and vascular visualization from
physiological causes that is an almost regular feature of the
sexually mature woman and of one receiving hormone medication. The
thermographic images that result from this could well mask a
pathological vascular picture. However, the areas of heat or
vascular features stemming from pathological causes will reappear
more rapidly than normal vascularization after cooling of the
breast, or else will not disappear in the first place.
The use of liquid crystal thermography as an aid in detecting
changes in the temperature of the skin, and particularly in
detecting breast cancer, is noted in U.S. Pat. Nos. 3,830,224 and
3,847,139. In each of these patents, the liquid crystals are
incorporated into the body of a garment, such as a brassiere, which
is intended to conform essentially to the contour of the breasts.
While the devices respectively disclosed in these patents produce a
meaningful thermogram over certain regions of the breast, they have
not proven satisfactory as an aid in diagnosing the condition of
the entire breast. In this regard, it is important that the
crystals be in contact with the entire region to be examined. The
disclosed brassiers do not satisfy this requirement. In some
instances, depending on the size and shape of the woman's breasts,
some of the portions of the brassiere do not come in contact with
the breasts at all while other portions contact the breasts to such
an extent as to deform the breasts thereby producing a distorted
thermogram. Furthermore, the brassieres have the tendency to hide
or mark the sides of the breasts to prevent a reliable diagnostic
examination. The present invention eliminates the objections and
disadvantages present in using the aforesaid brassiere garments by
providing an improved apparatus, and method of using the same,
which causes the film to effectively conform to the contour of the
entire breast without materially deforming said breast.
SUMMARY OF THE INVENTION
The invention provides for use of liquid crystals encapsulated
between elastic flexible sheets which represent a composite film.
The crystals are responsive to changes in temperature of the tissue
against which the film is brought in contact with to display a
color pattern on said film representative of said temperature
variations. The film conforms to the contour of the tissue to which
it is applied, without materially deforming said tissue, by
evacuating air from between said film and said tissue. The color
pattern produced on said film is observed and is recorded
photographically to obtain a thermogram of said temperature
variations. The contoured film and the tissue may also be fan
cooled for a relatively short period of time to produce a more
sensitive color pattern on said film representative of said
temperature variations.
Accordingly, an object of the present invention is to provide an
apparatus for detecting temperature variations over selected
regions of living tissue within a predetermined range of
temperatures.
Another object of the present invention is to provide an apparatus
for aid in the early detection of malignant tissue in the breasts
of a woman.
A further object of the present invention is to provide a method of
detecting temperature variations over selected regions of a woman's
breast, within a predetermined range of temperatures, by causing
encapsulated liquid crystal film to conform to the contour of the
breast without materially deforming said breasts to produce a color
pattern on said film representative of said temperature
variations.
Another object and feature of the present invention is to provide
an apparatus for detecting temperature variations over selected
regions of living tissue, which apparatus is relatively inexpensive
and which may be used without the need of highly trained
personnel.
A further object, feature and advantage of the present invention is
to provide a device for aid in the early detection of malignant
tissue in the breasts which is portable so as to encourage its use
by doctors outside their offices and by women in their own
homes.
The above and other objects, features and advantages of the present
invention will become more apparent from a full consideration of
the following detailed description when taken in conjunction with
the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the improved apparatus constructed
in accordance with the present invention, and illustrating the
apparatus secured to the woman and in contact with the breasts to
be examined;
FIG. 2 is an exploded view of some of the component parts of the
improved apparatus comprising the encapsulated liquid crystal film,
the straps for securing the film to the woman, and the valve
assembly which serves to connect the film to a vacuum source;
FIG. 3 is a cross-sectional view taken along line 3--3 of FIG. 1;
and
FIG. 4 is a block diagram of the steps used in practicing the
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to the drawings, particularly FIGS. 1, 2 and 3, numeral
10 represents an apparatus for detecting temperature variations
over selected regions of a living tissue, which apparatus is
constructed in accordance with the present invention. Apparatus 10
includes a device, represented generally by numeral 12, which
changes color when brought in contact with the tissue to be
examined. More specifically, device 12 comprises a plurality of
elastic flexible sheets 14 and 16 superimposed on each other to
represent a composite film 18 having liquid crystals 20
encapsulated therebetween. The crystals 20 are responsive to
changes in temperature of the tissue being examined, within a
predetermined range of temperatures, to display a color pattern 22
on said film 18 representative of said temperature variations.
Since the construction of the encapsulated liquid crystal film 18
(ELC) is well-known in the art, a more detailed description of the
same is not deemed necessary. In this regard, attention is directed
to the patents heretofore referred to in the description of the
prior art for a more detailed description of the method of
manufacturing such films.
Film 18 is provided with an upper edge 24 and a lower edge 26
extending longitudinally the length of the film. Film 18 is further
provided with a through-opening 28 located between said upper and
lower edges 24 and 26, respectively. The film is sized to wrap
around the tissue being examined. For example, in the preferred use
of the invention, it is intended that film 18 be wrapped around the
breasts of a woman. In order to accommodate such use of the film,
it is recommended that it have a dimensional figuration of 36
inches (92.3 cm) in length by 12 inches (30.7 cm) in width. It
should be understood, however, that the overall dimensions of film
18 will be a function of the tissue being examined. In this regard,
while the disclosed apparatus is used for detecting temperature
variations over selected regions of the breasts of a woman, it will
be appreciated that the apparatus may readily be used in making
other clinical and physiological investigations, such as in
diagnosing temperature changes in other venous and arterial blood
vessels.
A valve assembly, represented generally by numeral 30, is provided
having a tubular member 32 and an associated valve control 34. The
valve control is located between the ends 36 and 38 of tube 32.
Tube end 36 is suitably dimensioned to be received within film
opening 28 to permit fluid communication between the opposite sides
of film 18. In actual assembly, the tube end 36 passes through the
opening 28 and projects outwardly from sheet 16 in the direction of
the tissue to be examined. Tube 32 is sealingly connected to film
18 by lock nut fasteners 40 and 42, respectively engaging tube 32
from opposite sides of film 18 adjacent the tube end 36. The
opposite end 38 of tube 26 is adapted to be connected to a vacuum
source as hereinafter described.
FIG. 1 illustrates the film 18 secured to the patient and in
contact with the breasts to be examined. The film is positioned
with the longitudinally extending edges 24, 26 wrapped around the
chest of the patient. It is important that the film completely
encircle the tissue to be examined for reasons that will
hereinafter become apparent. Film 18 is secured in place by means
of a pair of elastic straps 44 and 46, respectively encircling the
woman's chest. In this regard, chest strap 44 is wrapped
longitudinally around film 18 adjacent its upper edge 24 and chest
strap 46 is wrapped longitudinally around said film adjacent its
lower edge 26. Interengaging fastening members, represented by
numeral 48, are respectively affixed to the opposite ends of each
of said straps 44, 46 for fastening said straps around film 18 in a
stretched condition. In the preferred embodiment, the interengaging
members 48 may take the form of Velcro fasteners or the like.
Film 18 may be further secured in place by means of a pair of
elastic shoulder straps 50 and 52 respectively extending over a
separate one of the woman's shoulders. Here again, interengaging
fastening members 48 are respectively affixed to the opposite ends
of each of said shoulder straps 50, 52 for fastening said shoulder
straps around the chest encircling strap 44 in a stretched
condition. The arrangement is such that film 18 is firmly secured
to the patient with the straps 44, 46 and 50, 52 serving as a
harness to engage and locate the upper and lower edges 24, 26 of
film 18 firmly, yet comfortably, against the patient's skin. In
other words, film 18 is secured in place with the upper and lower
edges thereof in sealing contact with the regions of the chest
spaced above and below the breasts to be examined. It is important
that the said straps be spaced from the valve assembly 30 and from
the regions of the breasts being examined to prevent deforming of
said breasts during the examining procedure.
In order to insure that film 18 uniformly contacts all regions of
the tissue being examined, the invention provides for evacuating
air between film 18 and the breasts to cause said film to conform
to the contour of the breasts without materially deforming said
breasts. This is achieved by connecting the end 38 of tube 32 to a
vacuum source represented by numeral 54. In order to efficiently
perform the evacuating technique, a porous member 56, such as
cotton or the like, is positioned between tube end 36 and the
patient's skin 58, as shown in FIG. 3. The use of such porous
member serves two important functions. Firstly, it prevents the
skin from being sucked against tube end 36 by reason of the vacuum
produced which might otherwise cause some discomfort to the
patient. Secondly it prevents the highly flexible film 18 from
being collapsed against the skin in the region immediately
circumscribing the opening 28. If the film were to collapse in this
region, a pocket would be created which would effectively seal off
the region surrounding the tube end 36 and prevent further
evacuation from taking place. The cotton thus serves as a spacer or
buffer to permit air to be evacuated from the space between film 18
and the patient's skin.
It has been found that the evacuation technique effectively takes
place by locating tube end 36 spaced from and adjacent to the
sternum of the woman's chest. The cotton member 56 is positioned in
place by inserting it from the upper edge 24 of film 18 prior to
the fastening of strap 44 in its stretched condition.
At such time as the air is being evacuated, it is a simple matter
to prevent additional pockets from being formed between film 18 and
the patient's skin by merely lifting edges 24, 26 at the location
adjacent the pocket to complete the evacuating techniques. This
also serves to remove any wrinkles that appear on film 18 during
the evacuating step. The result obtained will be to cause the ELC
film to simultaneously conform to the contour of both breasts,
without materially deforming said breast, and to permit a
diagnostic examination of both breasts at the same time. All
portions of the breasts are contacted by the film to permit a quick
reliable diagnostic examination.
As previously referred to in the description of the prior art, a
color pattern 22 is produced on film 18 representative of
temperature variations over selected regions of the breasts. The
color pattern may be observed by the doctor or by the patient
standing in front of a mirror in her home. A permanent record of
such color pattern may be obtained by photographically recording
the pattern produced on said film to obtain a thermogram of said
temperature variations. Referring to FIG. 1, the photographic
record is obtained by means of camera 60 and synchronized
electronic flash 62 having polarized filters.
In some applications, the initial thermographic test is followed by
another test with the contoured film 18 and the breasts subjected
to a cooling operation for a relatively short period of time. The
cooling step is effected by a hand held cooling fan or blower as
represented by number 64 in FIG. 1. The cooling-down technique may
be used whenever low temperature detail is required in a specific
area.
FIG. 4 is a block diagram of the steps used in practicing the
invention. These steps comprise the sequence of applying the film
to the surface of the tissue to be examined; securing the film to
the tissue; evacuating air from between the film and the tissue to
be examined; causing the film to conform to the contour of the
tissue; cooling the tissue and the film; and observing and
recording the temperature variations.
In practicing the inventive technique, a short period of time
should be permitted to lapse after the patient undresses to permit
her breasts to equalize to room temperature. It is recommended that
the room temperature be between 20.degree. C. and 22.degree. C.,
with all drafts being eliminated. There is no need to use
air-conditioned or temperature-controlled examination rooms to
practice the invention. The ELC film having the proper temperature
range is then applied in contact with the breasts. The film is
available in temperature ranges from 29.degree. C. to 37.degree.
C., and film having other specific temperature ranges can be made
available for higher or lower temperature applications. If the
colors that appear are in the blue-green range, the temperature
characteristic of the film is too low and a film having the next
higher range should be selected. If the colors that appear are tan
or brown, a film having the next lower range should be
selected.
Once the correct film is selected, the patient places a marker on
her nipples. This will enable the technician and/or the patient to
know at all times where the areolar area is located. The ELC film
is then wrapped around the patient and secured with the
harness-like straps. The porous cotton or gauze is placed next to
the sternum in the space located between the end of the tubular
member and the patient's skin. The other end of the tubular member
is connected to the vacuum source which is simply and conveniently
a hand operated pump. The vacuum pump is then operated and if any
wrinkles appear on the film during the evacuating step, the upper
and lower edges of the film are lifted and re-adjusted to eliminate
any pockets. At such time as the observation is completed, a
photographic record may be obtained by taking one or more views of
the thermo pattern produced on the film to obtain a thermograph of
the temperature variations over the regions of the tissue being
examined. It has been found that a highly satisfactory photographic
record is obtained by the use of a flash system that is
synchronized to the CU-5 Polaroid camera.
If the cooling-down step is required, the contoured film and both
breasts are cooled by means of the fan or blower which is operated
for approximately one minute. This serves to remove the color
pattern initially produced on the film. It is recommended that a
period of 30 seconds be permitted to lapse after the cooling source
is removed. The doctor or patient may then re-observe the more
sensitive color pattern produced on the film representative of said
temperature variations.
The improved technique thus employs the use of ELC film which is
readily and effectively contoured to the breasts with uniform
contact by means of evacuating the air from between the film and
the tissue to be examined. The technique produces a reliable full
color thermo pattern of both breasts simultaneously, which pattern
is recorded in full color by means of a high intensity, color
balanced, polarized light system.
While a preferred embodiment of the invention has been shown and
described in detail, it will be readily understood and appreciated
that numerous omissions, changes and additions may be made without
departing from the spirit and scope of the present invention.
* * * * *