U.S. patent number 3,786,801 [Application Number 05/184,501] was granted by the patent office on 1974-01-22 for method and apparatus for aiding in the detection of breast cancer.
This patent grant is currently assigned to Diagnostic, Inc.. Invention is credited to Otto W. Sartorius.
United States Patent |
3,786,801 |
Sartorius |
* January 22, 1974 |
METHOD AND APPARATUS FOR AIDING IN THE DETECTION OF BREAST
CANCER
Abstract
A method for detection of cancer of the breast is provided which
comprises drawing a partial vacuum around the area of the breast
immediately peripherally surrounding the breast nipple to restrain
sphincter contraction of the duct openings in the nipple area,
then, while maintaining this first mentioned partial vacuum,
intermittently applying a zone of reduced pressure to the nipple
itself for the extraction of secretion therefrom in sufficient
quantity for the cytological examination of epithelial cells found
therein for abnormalities. An apparatus is also provided for
practicing the method.
Inventors: |
Sartorius; Otto W. (Santa
Barbara, CA) |
Assignee: |
Diagnostic, Inc. (St. Paul,
MN)
|
[*] Notice: |
The portion of the term of this patent
subsequent to September 28, 1988 has been disclaimed. |
Family
ID: |
26880186 |
Appl.
No.: |
05/184,501 |
Filed: |
September 28, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
801613 |
Feb 24, 1969 |
3608540 |
|
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Current U.S.
Class: |
600/573; 604/176;
604/540; 604/74 |
Current CPC
Class: |
A61B
10/0041 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2F,2R,2B,273,280,281,282,299-302,304 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Sell; Donald M.
Parent Case Text
This application is a continuation-in-part of application Ser. No.
801,613 filed Feb. 24, 1969, now U.S. Pat. No. 3,608,540.
Claims
That which is claimed is:
1. A method for withdrawing breast secretion for the detection of
cellular abnormality within the breast of a mammalian female
comprising (1) contacting the breast with a cup having a bottom and
outer and inner continuous sidewalls spaced from one another
dividing the cup into peripheral and central recesses opening into
the mouth of the cup, the mouth of the cup being pressed against
the breast with the nipple of the breast being received in the
central recess and the portion of the breast immediately
surrounding the nipple being contacted by the edges of said
sidewalls and closing the mouth of the cup, (2) reducing the
pressure in the peripheral recess of the cup to thereby firmly seat
and hold the cup against the breast and, (3) while maintaining the
reduced pressure in said peripheral recess intermittently reducing
the pressure in the central recess to cause natural secretion from
the breast to bead on said nipple, then (4) releasing the cup from
the breast and removing said beads of natural secretion to enable
examination of cells contained therewithin for detection of breast
abnormalities.
2. A device adapted for self-retention on the breast of a mammalian
female to facilitate the withdrawal of natural secretions
therefrom, said device comprising a cup being generally circular in
cross section and having a closed bottom with continuous
concentrically spaced outer and inner sidewalls rising therefrom
with the upper edges thereof terminated at and forming the mouth of
the cup, said concentrically spaced sidewalls dividing said cup
into a peripheral recess and a central recess opening into the
mouth of the cup, said inner sidewall sealingly separating said
central recess and said peripheral recess from one another, said
central recess being of a size to snugly receive the nipple of a
breast therewithin and said peripheral recess presenting a
ring-shaped opening of a size to closely surround the portion of
the breast immediately surrounding the nipple area, said cup having
a pair of port means therein opening independently into each of
said recesses, each of said port means including means for the
attachment of suction means thereto so that when the device is
placed in position against the breast with the nipple of the breast
seated in said central recess the recesses of the cup may be
individually depressurized.
Description
INTRODUCTION
The present invention relates to a method and apparatus for aiding
in the detection of breast cancer in females. More particularly,
this invention provides a unique application of suction for
obtaining epithelial cells from the lining of the breast ducts and
an apparatus for practicing this method.
BACKGROUND OF THE INVENTION
Breast cancer ranks as the number one malignancy in the human
female and accounts for approximately one-fourth of all cancers in
women. Studies have shown a definite correlation between the size
of the original cancer or lesion at the time of diagnosis and the
mortality rates for cancers of the breast. The smaller the size of
the lesion, the more likely the recovery of the patient.
At the present time, early diagnosis of possible breast cancer is
usually conducted by touch, and/or mammograms (breast X-rays) to
determine the presence of suspicious breast lesions. Upon detection
of lesions the differential diagnosis between benign lesions and
malignant lesions in the female breast is generally confirmed by
biopsy done under general anesthesia in a hospital. Only about one
in four lesions is found to be malignant and the prognosis for
cancer of the breast has improved very little over the last several
decades. The diagnostic procedure, being cumbersome, costly and
time-consuming, is done only when circumstances, such as discovery
of an unusual lump in the breast, arouse sufficient suspicion on
the part of the physician to warrant the pain and inconvenience of
a biopsy to the patient.
Natural secretions from the breast are an uncommon symptom of
breast cancer, and even if cancer is present may or may not contain
cancer cells. Thus, even though it has been known that breast
cancer begins in the lumna of the ductal system of the breast, no
effective way has heretofore been presented for obtaining
satisfactory cell material from the lining of the ducts themselves
for proper study.
THE INVENTION
This invention represents a substantial improvement over that
described in my previous application in that the present invention
provides a greatly simplified method for obtaining cells from the
breast ducts for examination and a correspondingly less complex
apparatus for its practice. This improved method in its simplicity
closely resembles the routine "Pap" smear test procedure for the
early detection of vaginal cancer.
The method described in my previous application enables the
extraction of breast secretions having a sufficient quantity of
epithelial cells therein for cytological examination from a high
percentage of women. However, practice of the method requires a
combination of suction and irrigation of the breast with an
irrigating liquid. Thus, the epithelial cells of the breast
secretion are carried in the irrigating liquid, causing a
consequent high degree of preparation of the extracted secretion
for cytological examination, and great care and skill in the
resulting examination of the extracted secretion; the method also
requires the use of relatively elaborate apparatus in its
practice.
The present invention provides a breast secretion extraction
procedure involving the use of a novel combination of suction
pressures to the breast to induce mammary secretions having
sufficient cellular material for accurate diagnosis by cytoligical
examination in a high percentage of women, e.g. 70 percent or
more.
The method of this invention for the early diagnosis of breast
cancer requires no irrigating liquid and thus minimizes the
consequent possibility of contamination and misinterpretation of
cytological findings inherent therein. This new method comprises
(1) the application of a constant peripheral zone of reduced
pressure, i.e., a suction pressure, to the area of the breast
surrounding the nipple and in very close proximity thereto, and (2)
the intermittent application of a zone of reduced pressure to the
breast nipple itself to extract breast secretion from the nipple
while maintaining the constant suction in the peripheral zone, (3)
removal of beads of breast secretion from from the nipple, and (4)
cytological examination of epithelial cells dispersed therein.
Because of its innate simplicity, the absence of any foreign fluid
mixed with the breast secretion, and the ease of examination of
extracted secretion, this procedure is remarkably similar in its
practice to the vaginal Pap smear test procedure.
The method of this invention enables a quick, simple and painless
method for obtaining breast ductal secretions having a sufficiently
representative quantity of ductal cells to enable reasonably
accurate early diagnosis for the presence of breast cancer. The
application of suction to the area of the breast immediately
peripherally surrounding the nipple apparently inhibits, or
restrains, any sphincter contraction otherwise present at the duct
system openings into the nipple. The intermittent suction applied
to the nipple area while maintaining the peripheral area under a
constant reduced pressure causes beads of secretion to quickly form
on the nipple, which beads may be readily removed for examination
simply by wiping the nipple with albumen coated slides, followed by
rapid fixation of the slides for cytological examination under
suitable magnification. To cleanse the nipple and soften
inspissated material which may be present at the mouths of the duct
openings into the nipple before practicing the method, the
application of a hot towel to the breast nipple and subsequent
sterile cleansing of the nipple by the use of alcohol, Zephiran, 2%
acetic acid or acetone is recommended.
The device or apparatus I have invented for practicing my new
method comprises a cup having a continuous outer sidewall and a
continuous inner sidewall spaced therefrom defining a continuous
peripheral recess and a central recess, both opening into the mouth
of the cup and being otherwise sealingly separated from one
another. The cup is adapted so that as it is pressed against the
breast the peripheral recess closely surrounds the nipple area of
the breast and the central recess receives the nipple therein. The
cup has a pair of openings in the bottom thereof for creating
suction in the recesses. One of the openings communicates with the
peripheral recess to seal the cup against the breast and the other
communicates with the central recess to withdraw breast secretion
from the nipple of the breast received therewithin.
The practice of the method and the construction of the presently
preferred form of apparatus for practicing the method are described
in more detail with reference to the accompanying drawing
wherein:
FIG. 1 is a perspective view of a form of apparatus for the
practice of the invention;
FIG. 2 is a cross-sectional view of the device of FIG. 1 taken
substantially along section line 2--2;
FIG. 3 is a bottom view of the device of FIG. 1; and
FIG. 4 is a side view of the device of FIG. 1 in its functional
position on the breast.
Referring first to FIG. 1, a form of device or apparatus for
practicing the method of this invention is illustrated, being
designated in its entirety by the numeral 100. This device
comprises a cup having a continuous outer cylindrical sidewall 102
and a continuous inner cylindrical sidewall 104 concentrically
spaced therefrom. The sidewalls rise from a flat, circular bottom
wall 106 and divide the cup 100 into outer and inner recesses 108
and 110, respectively. The device can be of any suitable non-porous
material but is preferably of a tough, rigid, transparent plastic
inert to body fluids, such as polypropylene or polymethyl
methacrylate, or other suitable tough synthetic plastic polymer.
Ports 112 and 114 open through the bottom wall 106 of the cup
respectively into outer and inner recesses 108 and 110. Tubular
nipples 116 and 118, depending from the bottom 106 of the breast
cup 100, provide means for the attachment of the mouth of a syringe
thereto for evacuation of the recesses. As these devices are
inexpensive enough to be discarded after use, any suitable port
guide arrangement can be used, e.g., each port may simply be sealed
with a rubbery sealing membrane which is puncturable by a hollow
syringe needle.
After inspissated material at the mouth of the nipple has been
loosened, where necessary, and the nipple and nipple area have been
cleaned as noted hereinbefore, the device is applied to the breast
126. Rims 120 and 122, respectively, of the outer and inner
sidewalls of the cup 100 seat firmly against the flesh of the
breast surrounding the nipple, the outer or peripheral recess 108
closely surrounding, but excluding, the nipple 128 of the breast
and the inner or central recess 110 snugly received the nipple 128
therewithin. Following placement of the device, evacuation of the
outer recess 108 is carried out. This may be accomplished by
application of a conventional 10 c.c. syringe 124 to port extension
118 and withdrawal of the syringe plunger to the 5 or 6 c.c. mark
whereupon clamp 132 may be tightened on the flexible tubing 130
interconnecting the syringe tip and the port extension to maintain
a constant partial vacuum in the outer recess of the cup. Upon
creation of reduced pressure by this means in the outer recess, the
device is self-retained against the breast and sphincter
contraction at the end of the duct system opening into the nipple
is restrained. The extraction or withdrawal of breast secretion may
begin.
To extract the breast secretion, the inner recess of the cup within
which the nipple of the breast snugly rests is subjected to an
intermittent partial suction, i.e. reduced pressure or partial
vacuum, as through use of a 10 c.c. syringe applied to port
extension 116 by means of another piece of flexible interconnecting
tubing 130 and the syringe plunger alternately withdrawn to the 5
or 6 c.c. mark and then pressed forward to first subject the nipple
to suction pressure and then release the nipple from suction
pressure and thus "milk" breast secretion from the nipple. The
secretion thus obtained forms as beads on the nipple and may then
be subjected to examination by known techniques for the
pathological examination of cellular material contained therein,
e.g. by serial smearing on albumen coated slides followed by
fixation for microscopic examination, or other cytological
examination procedure.
While the invention has been described with reference to human
mammography and the early detection of cancer, the invention is
applicable to the examination of any mammal and to the detection of
other cellular disturbances in the breast ductal system.
* * * * *