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BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to tissue sampling. More specifically, it
relates to an apparatus and method for removing a sample of breast tissue
for histo pathological examination. Even more specifically, it relates to
an apparatus and method wherein a guiding spool is aligned over compressed
breast tissue of a suspicious nature, the alignment is verified by the
positioning of markings on the spool with those of the mammography
apparatus, with the taking of an X-ray through the central aperture of the
radiopaque spool to determine that the micro-calcification or lesion is
located beneath, and with the advancement of a tube-like punch through the
breast to remove the suspicious tissue for examination.
More generally, the invention relates to any type of alignment and sampling
device wherein energy, which could be of various frequencies, is used to
locate an anomalous area not immediately accessible, and where a bore or
punch guide having an aperture therein that is transparent to the
specified frequency is aligned over the anomalous area to confirm the
accurate alignment and direct the punch to remove the area in question.
2. Description of the Prior Art
One of the most common forms of cancer is that of the female breast. Women
are urged to examine themselves regularly for suspicious lumps or areas
within the breast, and it is also recommended that a regular schedule of
mammographic examination be maintained, especially above a certain age. In
the case of non-palpable lesions or microcalcifications that are uncovered
through these mammographies, it is necessary to obtain a sample of the
suspicious tissue for histo pathological examination. This is done by
various methods including surgical biopsy procedures and aspiration of the
sample through needles. Both these methods have their drawbacks, however,
in that the surgical procedure can entail a large initial incision,
leaving a scar that can cause apprehension to the patient, and in the
needle aspiration, that the microcalcification or lesion is still present
in the breast, and that subsequent mammographies will reveal it, causing
confusion, and the possibility of an unneeded, redundant second procedure.
The present invention seeks to address these problems by providing a
method and apparatus that substantially entirely removes the area in
question while leaving a minimal amount of scarring. It secondly overcomes
a disadvantage in the surgical procedures that require a guide wire
placement in the breast and the subsequent moving of the patient to an
operating theater for the actual excision of the tissue where, firstly,
the guide wire can be dislodged from the correct position while the
patient is transported and, secondly, the cost involved of providing and
staffing the two separate locations or rooms in the medical facility. The
present invention allows the practitioner to perform the procedure in one
location, with the invasiveness thereof being kept to a minimum. In a
search at the U.S. Patent and Trademark Office, a number of patents were
uncovered that are deemed relevant to the instant invention:
In U.S. Pat. No. 5,197,482 issued on Mar. 30, 1993 to William R. Rank et
al. there is disclosed a helical tipped lesion localization needle device
and method. This constitutes a helically wound coil attached at both ends
of a shaft, and is designed to be inserted into the body through a
cannula. The helical construction allows the device to be rotated to
advance the marker into the lesion for subsequent surgical procedures. In
contrast to the present invention, the guide spool fastened to the outer
portion of the patient is absent, as is the tubular hollow cutting punch
of the present invention.
Next is U.S. Pat. No. 5,209,232 issued on May 11, 1993 to Simha Levene.
This discloses a system of biopsy needle positioning wherein the position
of the needle holder as it progresses into the patient's breast is
monitored by a CPU such that images are provided to constantly update the
progress of the biopsy needle towards the lesion. This is clearly
different from the present invention in that no cutting punch is taught,
the Levene patent being a positioning system for a needle prior to a
surgical excision procedure.
In U.S. Pat. No. 5,056,523 issued on Oct. 15, 1991 to John E. Hotchkiss et
al. there is disclosed a breast lesion localizer. This involves a first
and second radiolucent platform that are in a movable, parallel, and
spaced apart relationship to one another. The uppermost of these platforms
contains an insert with a plurality of probe passages. Radiopaque scales
are provided coplanar to the probe positioning guide to allow the operator
to judge the depth of the lesion relative to the platforms and, thus, the
probe guides. The probe can thus be inserted proximate the suspicious
tissue and the tissue aspirated. Unlike the instant invention, there is no
teaching of the guide spool, the aperture therein, nor of the tubular
cutting member for the excision of the tissue.
U.S. Pat. No. 5,213,100 issued on May 25, 1993 to Herbert Summ discloses a
mammography apparatus with a stereotactic biopsy unit. In this device, the
holders for the biopsy needle extend parallel to the plane of exposure and
have at their ends releasable closures that allow the patient to be moved
away from the unit after the placement of the needles without disturbing
the placement of the indicating needles. As in the patents discussed
above, there is not seen the guide spool with its radiopaque aperture for
alignment with the suspect tissue, nor is there seen the cutting punch of
the present invention.
Lastly, U.S. Pat. No. 5,078,142 issued on Jan. 7, 1992 to Bernard W. Siczek
et al. discloses a mammographic needle biopsy system. In this invention,
the patient lies on a table which includes a breast aperture through which
the breast pendulantly protrudes. A compression paddle presses the breast
against an X-ray film holder and a needle holder that is adjustable
through azimuth, elevation, and insertion depth is controlled through a
computer to place the aspirating needle at the suspect area. Unlike the
instant invention, there is no complete excision of the suspect area, nor
is the guide spool required for the present invention taught.
None of the above inventions and patents, taken either singly or in
combination, is seen to describe the instant invention as claimed.
SUMMARY OF THE INVENTION
Briefly, the present invention is an apparatus and method for obtaining
samples of suspicious breast tissue. The breast is placed between two
plates, which compress, and therefore stabilize the tissue. The upper
compression plate has an aperture therein that allows for the placement of
a guide spool having a flesh adhering surface thereon onto the compressed
breast itself. Markings on the spool allow for accurate placement using
the cross hairs, or laser pointer, of the mammographic unit. For
additional placement verification, the guide spool is radiopaque and,
thus, an X-ray taken directly down through the aperture will aid in
ascertaining if the spool is properly placed. A tubular punch is advanced
and rotated, cutting through the tissue, which is recovered in the tube.
Alternatively, a localizing needle can be placed with its tip proximate
the calcification, a guide wire mandrel having the same diameter as the
guide spool aperture placed over it, the guide spool placed and aligned,
the mandrel removed, and the tubular punch is inserted and advanced as
above, removing the tissue in question, along with the localizing needle.
Accordingly, it is a principal object of the invention to provide an
improved breast biopsy apparatus and method of use that will overcome the
disadvantages of the prior art in a simple and effective manner.
It is another object of the invention to provide a breast biopsy apparatus
that allows the sample of breast tissue to be taken at one location,
without the intermediate step of moving the patient from the mammography
apparatus to an operating room.
It is a further object of the invention to provide a breast biopsy
apparatus and method that completely excises the tissue in question so as
to eliminate the possibility of a redundant and wasteful procedure if the
lesion or microcalcification is detected in a subsequent mammography.
Still another object of the invention is to provide a breast biopsy
apparatus and method that allows for a guide spool for the cutting tube or
punch to be placed by providing markings on the spool for alignment with
the cross hairs, or laser pointer, on the mammography equipment.
Still yet another object of the invention is to provide a breast biopsy
apparatus and method that includes an aperture in the radiopaque guide
spool for both guiding the cutting tube or punch and also aids in
alignment by allowing an X-ray to be taken "down" through the aperture
such that, if the lesion or suspicious area is seen therein, confirms that
the spool is accurately placed.
It is yet another object of the invention to provide a breast biopsy
apparatus and method that removes the lesion or calcified area with less
invasiveness than current surgical biopsy procedures.
It is yet still another object of the invention to provide a method which
recovers adequate tissue for histo pathologic diagnosis.
Finally, it is a general goal of the invention to provide 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 objects of the present invention will become readily
apparent upon further review of the following specification and drawings.
The present invention meets or exceeds all the above objects and goals.
Upon further study of the specification and appended claims, further
objects and advantages of this invention will become apparent to those
skilled in the art.
Finally, it is a general goal of the invention to provide improved elements
and arrangements thereof in an apparatus for the purposes described which
is inexpensive, dependable and fully effective in accomplishing its
intended purposes.
BRIEF DESCRIPTION OF THE DRAWINGS
Various other objects, 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 partial perspective view of the present invention showing the
guide spool in place on the breast through the opening in the upper
compression plate.
FIG. 2 is a perspective view of the guide spool, showing its lower surface
with the tacky adhesive for facilitating firm contact with the patient's
breast.
FIG. 3 is a partially cutaway side view of the guide spool and the cutting
tube or punch.
FIG. 4 is an expanded partial cutaway view of the indicated area in FIG. 3
showing the beveled cutting edge of the punch.
FIG. 5 is a cutaway side view of the localizer needle mandrel used in the
alternative embodiment of the invention.
FIG. 6 is a perspective view of the guide spool in place on the patient's
breast, with the cutting tube or punch being advanced into the guide spool
aperture.
FIG. 7 is a partially cutaway side view showing the cutting punch advancing
into the breast tissue and approaching the calcified area.
FIGS. 8A-8G and FIGS. 8I-8K is a cutaway side view showing various steps in
the alternative embodiment of the invention, wherein a localizing needle
is placed to assist in the guiding of the cutting punch.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIGS. 1 and 6, the present invention is indicated generally at
10. The breast B of the patient P is placed between two compression plates
12, 14. These plates are in a spaced apart relationship to one another and
are adjustable such that breast B can be compressed; that is the tissue
thereof can be held such that it will not move inadvertently while the
biopsy procedure is being carried out. The top plate 12 has an access
opening 16 located proximate its center. This access opening is
dimensioned such that the guide spool 20, which will be discussed more
fully below, can be placed therein, in contact with the surface of the
breast B. The compression plates 12, 14 are known in the mammographic art,
and apart from the aperture 16 in the top plate 12, would be similar to
the known art devices, being preferably made from a radiolucent material
so as not to interfere with the mammographic procedure.
Prior to the usage of the instant invention, it is to be assumed that a
suspicious area has been found in the breast B of the patient P. The
microcalcified areas or lesions that the present invention concerns itself
with are primarily non-palpable. Thus the location of the lesion in the
breast B is known before the present invention is called into use.
The discussion now turns to the guide spool 20. The spool 20, in the
preferred embodiment described herein has an asymptotic shape: i.e. a bell
shape (best seen in FIG. 2), and includes an outer wall 22, a bottom
surface 24, and a top surface 26. Extending completely from the top
surface 26 to the bottom 24 is a guide aperture 28. The bottom surface 24
is covered with a tacky adhesive 29. This adhesive serves to prevent the
spool 20 from moving during the procedure. The spool 20 also includes
guide markings M, as seen in FIG. 6. These guide markings M allow the user
to align the spool 20 on to the surface of the breast by corresponding to
the alignment crosshairs on the mammographic device. The markings M are
located on the top surface 26 of the spool 20, and also proximate the
bottom surface 24 on the outer wall. The spool 20 is preferably made from
a radiopaque material, since guide aperture 28 also serves as a
supplementary alignment means in that if, after the guide spool 20 is in
place, the user were to expose an X-ray from directly above the guide
spool 20 in the direction indicated by arrow A1 in FIG. 1, the presence of
the calcified area in the developed plate would indicate that the spool 20
will guide cutting tube or punch 30 correctly, as will be hereinafter
described.
Turning now to FIGS. 3, 4, and 5, the construction and disposition of the
cutting tube or punch 30 will be discussed. The tube 30 has an open end 32
that is surrounded by a beveled cutting edge 34 (best seen in FIG. 4). At
the distal end of the tube from the cutting edge 34 is a handle 36. The
cutting tube 30 thus includes an inner wall 38 and an outer wall 40. The
cutting portion of the tube 30 would preferably be made of a surgical
grade of stainless steel or some other biologically neutral substance that
has the ability to be sterilized after use, if the user should so desire.
For the operation of the present invention, the breast B is compressed
between compression plates 12, 14, as can be seen in FIG. 1. Using either
the, laser light pointer, cross hairs on the mammographic system and the
corresponding markings M on the guide spool 20, the "bore sighting"
technique through the guide aperture 28 of the guide spool 20 discussed
above, or a combination of all, the guide spool 20 is placed such that the
guide aperture lies directly in a line with the calcified area in the
breast tissue B. The cutting tube 30 is then placed within the guide spool
aperture 28 and is advanced while being rotated, as indicated by
directional arrows A2 and A3 in FIG. 6, to cut into the breast tissue and
excise the portion desired for examination. In FIG. 7 there is shown an
example of the cutting tube 30 advancing towards a calcified area 100 in
the breast tissue B. It is contemplated that the cutting tube 30 could be
advanced completely through the breast tissue, until it comes into contact
with compression plate 12, and then removed. The size of the cutting tube
30 would be from to 1 centimeter in diameter though other dimensions, of
course, could be used, depending on the size of the lesion and the
experience, guided by wisdom, of the practitioner.
The discussion now is directed to FIGS. 8A-8G and 8I-8K where, in an
alternative embodiment of the invention, a guide wire W is initially
placed within the breast tissue to mark the calcified area 100. A guide
wire mandrel 50 is placed over the wire W, as seen in FIG. 8B, and moved
in the direction indicated by the arrow A4 until it comes into contact
with the breast B. The mandrel 50 is dimensioned identically to that of
the cutting tube 30 so that it fits smoothly into the guide aperture 28 of
the spool 20. Thus, the spool 20 can be placed over the guide wire mandrel
50, by inserting mandrel 50 into the aperture 28. As seen in FIGS. 8C and
8D, the spool 20 is brought into contact with the breast B and the tacky
adhesive surface 29 on the bottom 24 of the spool 20 adheres to the breast
B. The guide aperture 28 is now aligned with the calcified area 100 and
the mandrel 50 can be removed from the aperture 28. Cutting tube or punch
30 is now placed in the guide aperture 28 and is advanced through the
breast B, as can be seen in FIGS. 8E, 8F, 8G, and 8K, with 8K showing the
cutting tube extending completely through the tissue and touching the
compression plate 14. FIGS. 8I and 8J show the removal of tissue sample
within the cutting tube 30, along with the guide wire W. Following
hereinafter is a list of the elements designated by reference numbers in
the above specification:
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biopsy apparatus 10
upper compression plate 12
lower compression plate 14
breast B
top plate access opening 16
guide spool 20
patient P
spool outer wall 22
spool bottom surface 24
spool top surface 26
spool guide aperture 28
tacky adhesive 29
spool guide markings M
directional arrow A1
directional arrow A2
directional arrow A3
directional arrow A4
cutting tube or punch 30
open end 32
beveled cutting edge 34
central aperture for alignment
35
with guide wire or laser light pointer
handle 36
inner wall 38
outer wall 40
calcified area or lesion 100
guide wire W
guide wire mandrel 50
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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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