 |
Description  |
|
|
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a device and method for the
detection of breast tumors in women comprising cooling the tissues of the
breast and then scanning the temperature patterns with thermographic
techniques. More particularly, the invention relates to a breast cooling
device for enchancing the detection of breast cancer comprising
liquid-perfused cooling patches, means for pumping liquid through the
patches and means for controlling the temperature of the cooling liquid.
2. Description of the Prior Art
In the past, a limited number of devices and methods have been described
for measuring or sensing the temperature of various tissues, such as the
skin temperature, in order to determine the presence of cancerous tissue.
It is well established that the temperature of the skin in the vicinity of
a tumor, such as a cancerous tumor, is significantly higher than the
temperature of normal skin tissue located in the same or similar body
area. The higher temperature is due largely to a greater perfusion of warm
blood in the area of the tumor compared to perfusion in the non-tumorous
area.
One such type of prior art device comprises an item of clothing to be worn
over the skin, the item including a suitable distribution of packages
comprising liquid crystals responsive to changes in skin temperature. In
this type of prior art device, the package for the liquid crystals may be
in the form of a circular or elongated laminar package. Or, the liquid
crystals can be incorporated in cavities within a plastic sheet or rod. In
one embodiment, the liquid crystals are encapsulated and the capsules
incorporated in the textile fibers which are used for making body garments
such as brassieres. The liquid crystals in each cavity or capsule may be
selected to be operative in different temperature ranges, such as between
95.degree. to 97.degree. F., 97.degree. to 99.degree. F., etc. Temperature
gradients on the skin of a person are made visible by placing liquid
crystals, whether in the form of packages, fibers of encapsulated liquid
crystals, or garments made of such fibers, on or near any desired area of
a person's body. An example of the above described use of liquid crystals
is found in U.S. Pat. No. 3,830,224.
Yet another use of liquid crystals for sensing the temperature of the skin
of a person is described in U.S. Pat. No. 3,847,139 where liquid crystals
are coated onto the inside surface of a conformable textile brassiere to
provide a visible indication of the skin temperature. In this embodiment,
the liquid crystals, either in free solution or as a dispersion of
encapsulated liquid crystals, are sprayed onto the inner surface of the
textile garment.
Yet another device and method for diagnostic thermography is shown in U.S.
Pat. No. 3,335,716. In this prior art invention, the body is coated with a
phosphor which luminesces when excited with ultraviolet light. The degree
of luminescence is inversely proportional to the temperature of the
underlying tissue. The temperature gradient of the body is monitored with
a television camera and displayed on a picture tube.
Another type of device for measuring the temperature of small areas of skin
tissue is shown in U.S. Pat. No. 3,877,463. In this embodiment, the
perfusion rate of superficial skin tissue is used as an aid in diagnosing
the presence or absence of tumors. The determination is carried out by
cooling a small area of normal tissue and of suspected malignant tissue
through a thermal resistance of known value and measuring the temperature
difference between the two readings. The cooling device is manufactured in
the shape of a small cylinder (about 1 inch diameter) and comprises a flat
heat collecting disc, heat sink means, cooling means, and thermocouple
sensing means.
SUMMARY OF THE INVENTION
A primary object of the invention is to provide a device and method for
enhancing the detection of malignant tissue in the breast of a woman.
Another object of the present invention is to provide a device for the
early detection of breast cancer in women which comprises a compliant body
conforming garment in the nature of a brassiere designed to cover the
upper torso and breasts of a patient with a pair of liquid-perfused
cooling patches or panels for evenly and uniformly cooling this region of
the body prior to obtaining an infrared scan of the cooled region. Each
liquid-perfused cooling panel is conformably attached to the interior
surface of each cup of the brassiere.
A major object of the present invention is to provide a convenient,
comfortable and inexpensive device for cooling the skin tissue of the
breast and thoracic regions of a patient to a uniform temperature prior to
scanning the temperature patterns with thermographic techniques.
The preferred embodiment of the present invention comprises a
brassiere-like garment made of body conforming material including a pair
of body compliant liquid-perfused cooling panels lying adjacent and held
within the inner contour of each cup with suitable attaching means such as
snaps, sewing, etc., a pump connected by flexible tubing to the
liquid-perfused cooling panels, a solenoid valve for controlling the flow
of cooling liquid between the pump and the refrigerator-heat exchanger and
heaters, a refrigerator-heat exchanger for cooling the cooling fluid, a
heater for heating the cooling fluid, a cooling fluid reservoir tank, a
temperature sensor located in the reservoir tank for sensing the cooling
fluid temperature and a temperature readout and controller circuit for
controlling the solenoid valve and heater circuit.
An important advantage of the present invention over prior art is that it
provides uniform cooling and temperature control of the entire breast area
simultaneously.
Another advantage of the present invention is that it provides means for
adjusting the temperature of the entire breast area to precise
pre-determined levels.
These and other objects and advantages will become apparent from a reading
of the following detailed description of the preferred embodiments which
are illustrated in the figures in the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front perspective view of the body conforming garment portion
of the present device.
FIG. 2 is a perspective view of the back of the body conforming garment
showing the liquid-perfused cooling panels or patches disposed within the
cups of the garment.
FIG. 3 is a plan view of the liquid-perfused panel constructed in
accordance with the invention.
FIG. 4 is a schematic diagram illustrating the cooling, pumping and
temperature control systems constructed according to the present invention
.
DETAILED DESCRIPTION OF THE INVENTION
Referring now to FIG. 1 of the drawing, there is shown illustrated
generally at 16 the body conforming garment made in accordance with the
present invention. Garment 16 is designed to cover the upper torso and
breasts of a person and is usually referred to as a brassiere. Garment 16
comprises cup portions 11 for positioning over the breasts and support
means represented by shoulder straps 10 for supporting garment 16 in its
proper position in relation to the breasts. Shoulder straps 10 include a
buckle for adjusting the length of the straps. Straps 10 extend from the
upper portion of cups 11 and over the shoulders to the back portion 12 of
garment 16. The tops and sides of cups 11 are reinforced with straps 13.
In order to maximize conformation of cups 11 over the person's breasts an
extra panel of stretchable elastic material 14 is included over the
sternum between reinforcing straps 13.
Referring to FIG. 2, there is illustrated the body contacting side of the
breast cooling means of the invention. As can be seen from the
illustration, the preferred cooling means is in the form of a garment
generally known as a brassiere comprising a pair of liquid-perfused
cooling panels attached by suitable means, such as by sewing, shown at 26,
to the inner surface of the brassiere. Each liquid-perfused cooling panel
includes a multiplicity of individual sections 20 which are in the shape
of Mercator projections which conform generally to the contour of the
breast when fitted and coupled with the interior of the brassiere. Each
cooling panel is connected to cooling liquid inlet line 24 and to cooling
liquid outlet line 25 through a connecting Y coupler 26. Connecting
channels or manifolds 21 form a continuous flow path through each cooling
panel and permit perfusion of cooling fluid throughout each section 20 of
the cooling panel while at the same time allow sufficient flexibility of
the cooling panel for a biconcave fit into the brassiere cups. The
brassiere is designed to permit complete coverage of the breast area and
allows for freedom of cup movement for conformation to breast shape.
Backstraps 22 are fastened together by suitable means to hold and conform
the brassiere to the torso. Preferably, backstraps 22 are provided with
releasable fastening means such as Velcro material. For that purpose,
Velcro material is attached to opposing sides of backstraps 22 and pressed
together to make the connection.
FIG. 3 illustrates the design and planar configuration of the
liquid-perfused cooling panel of the invention. This view shows the
cooling panel before folding and fitting into each cup of the brassiere.
In the preferred embodiment of FIG. 3, the cooling panel includes six
sections, all of which are connected by a free flow manifold 21. A method
for making the preferred cooling panels of this invention is disclosed in
U.S. Pat. No. 3,830,676 and in U.S. patent application Ser. No. 553,030,
filed Feb. 25, 1975 and entitled "Liquid Cooled Helmet." In general, these
cooling panels are made of two superposed sheets of flexible waterproof
material such as rubber, polyurethane, fabric coated with elastomeric
material and sealing the sheets such as by vulcanizing or heat-sealing at
the edges and along spaced apart lines 31 to form the desired pattern and
liquid cooling passageways 30. Inlet tube 32 and outlet tube 33 are
connected to the outlet cooling line 25 and the inlet cooling line 24,
respectively, of FIG. 2. The design of the preferred cooling panel of FIG.
3 is such that it is readily attached to the brassiere simply by folding
and fitting a panel in each cup of the brassiere and sewing the outer
edges of the panels to the brassiere.
Referring to FIG. 4, there is shown a schematic illustration of the
pumping, cooling and temperature control means for use with the liquid
cooled brassiere of the invention. The pumping system comprises pumping
means 40 which, preferably, is a water pump, having sufficient capacity to
produce flow rates of 0.5 gallons/minute with a pressure head in excess of
20 psig. A suitable commercially available pump, for example, is the Model
12-64-303, 117 volt, manufactured by Micropump Company. The cooling fluid
from pump 40 flows under a pressure of 10 psig. to 30 psig. to solenoid
valve 41 and there the flow is routed either through bypass line 43 or
through refrigeration unit 42. If the temperature of the cooling fluid is
above a desired temperature, solenoid valve 41 will direct the stream of
cooling fluid through refrigeration unit 42; if the temperature is below
the desired temperature the solenoid valve 41 will direct the flow through
bypass line 43. Heating means 44 receives the cooling fluid from either
bypass line 43 or refrigeration unit 42. After being heated to the proper
temperature by heating means 44, the cooling fluid flows to reservoir 47,
then into inlet line 24 of the brassiere, as shown in FIG. 2. Restrictor
valve 45 placed prior to the pump 40 inlet assures that the desired
pressure is maintained in the cooling line to the brassiere. Refrigeration
unit 42 preferably will have over 1000 BTU/hr. cooling capacity. A typical
unit, for example, is Model HRC-4 manufactured by Haws Refrigeration
Company. Heating means 44 preferably has a heating capacity of 400-500
BTU/hr. A heater commercially available from Briskeat Company is suitable
for the purposes of the invention.
Since the temperature of the cooling fluid must be controlled within narrow
limits, the temperature control system is extremely important. The thermal
control system comprises temperature sensing means 46, which may be a
thermocouple, temperature readout 48 and temperature controller 49.
Temperature is controlled by an analog temperature controller such as the
Love Controls Corporation Model 48-837. Temperature control is within .+-.
0.5.degree. C. using this device.
Sensor 46 is situated in reservoir 47 and senses any change in the
temperature of the cooling fluid. A change in the temperature generates a
signal in sensor 46 which is sensed by temperature readout 48 and
temperature controller 49. In turn, controller 49 controls the on-off
status of heating means 44 and the action of solenoid valve 41. If the
temperature of the cooling fluid is below the desired temperature,
solenoid valve 41 directs the flow of cooling fluid through bypass line
43.
The liquid-cooled brassiere and its associated pumping-thermal control
system is preferably used in the following manner: The patient dons the
brassiere and adjusts the support straps for maximum skin tissue coverage,
comfort and fit. Brassiere purfusant tubing, inlet tube 24 and outlet tube
25 in FIG. 2, is connected to the pumping-thermal control system and the
system energized to start the flow of water, the preferred cooling fluid,
within the system. The desired cooling fluid or brassiere panel
temperature is then set on the temperature controller and the ensuing
combination of chilling-cooling sequences brings the perfusant water
temperature to the desired low skin temperature. Generally, it is
desirable to lower the skin temperature to 15.degree. C. in order to
ensure complete local vasoconstriction.
After the patient's breasts have been uniformly cooled to the desired
temperature, the liquid-cooled brassiere is removed and an infrared
thermographic scan is begun. For this purpose a Spectroscan 2000 infrared
scanner can be used.
Thermographic scan techniques are well known and will not be described
further herein. Sequential thermographic photographs or video tapes will
show not only skin discontinuities in skin temperature overlying malignant
tumor areas (warmer), but will also depict time transient recovery
responses. Diseased areas not large enough or close enough to the skin
surface to appear in the normal infrared scan may appear as alterations in
transients of recovery temperature.
* * * * *
|
|
 |
|
 |
Description |
|
