Note: Descriptions are shown in the official language in which they were submitted.
WO 93/11827 PCI'/US91/09255
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APPARATUS AND METHOD FOR LOCATING A BREAST MASS
Field of the Invention - -
The present invention relates to a medical
instrument for locating a mass in body tissue so that
the mass may be accessed or removed by the most direct
or most appropriate incision from the epidermal layer
to the mass.
Backaround of the Invention
Locating masses or tumors in human tissue is
necessary for a biopsy of the suspicious mass and
subsequent removal. Sometimes it is possible to locate
a mass merely by touching the skin above and around the
- suspicious area. However, often the mass is too small
to be noticed by hand or is located in fatty tissue
that interferes with deter~ining the precise location
of the mass. A specific e,ample o~ the latter case is
the location of small breast masses or calcifications.
~ Typically, the precise location of the~e
types of masses can only be determined by x-ray analy-
20 8iS, using specialized instrumentation prior to asurgical operation to locate the mass t~ be removed.
Typically, a very thin needle is inserted into the
breast down to the mass under x-ray control (mammogra-
phy). Once it is determined by x-ray control that the
tip of the needle is located at the mass site, the
patient is transported to an operating room, where the
surgeon creates an incision in the breast by following
along the path of the inserted needle with a scalpel
until reaching the mass. This method often involves a
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very long incision and increases the risk of post-
operative infection.
An alternate method of creating an in~ision
to gain access to or remove a breast mass is to study
x-rays of the breast mass taken from various angles.
Based upon experience and notional extrapolation of the
views from different angles of the breast massJ an
incision is made in an attempt to cut along the most
direct path to the mass.
Several devices exist for localizing masses
in human tissue. See, for example, U.S. Patent Nos.
4,682,606 to DeCaprio, 3,890,970 to Gullen, and
3,598,119 to White.
The DeCaprio patent discloses a surgical
needle which is inserted into a located mass and
encircled by a cork screw device. The cork screw
device is twisted around the mass until the tip of the
worm of the screw is just beyond the furthest side of
the mass. Thereafter, the handle of the cork screw
device is withdrawn and a guiding extension rod is
replaced to direct the surgeon to the depth of the mass
in the patient's tissue. Then, a cutting instrument is
inserted over the extension rod for removing the mass
from the tissue.
The Gullen patent discloses a surgical
cannula for delivery of paracervical anaesthesia. The
cannula includes a catheter having a closed distal end
with a perforated membrane. The distal end is firm and
sharp enough to be inserted into body tissue to a
predetermined depth, as limited by a stop member. A
thin membranous ballooning portion is provided
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proximate the distal end of the catheter for expansion
upon application of a fluid pressure within the
catheter to lock the cannula in place in the
tissue. The device is left in the tissue of the
patient by the ballooning portion to provide periodic
supply of fluid anaesthesia during a surgical
procedure.
Similar to the patent to Gullen, the White
patent discloses a medical instrument for use in
~0 gynecological procedures to allow the administration of
a paracervical block, continuo~sly or intermittently,
with only a single placement. The device comprises an
elongated hollow tube having an open distal end and
receiving a needle for guiding the device into tissue.
An inflatable bladder is provided near the distal end
of the hollow tube for retaining the device in the
tissue and minimizing trauma associated with the
procedure.
The prior art devices discussed above provide
a procedure for retaining a catheter type instrument in
the tissue of a patient, but fail to provide a
procedure for precisely identifying a mass within the
tissue. Moreover, the prior art devices are of an
insufficient size to accurately locate a mass within
breast tissue prior to surgery.
Summary of the Invention
It is a primary object of the present
invention to provide a device for accurately locating a
mass within breast tissue prior to a surgical procedure
for taking a biopsy of, or removing the mass.
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According to one embodiment of the present
invention, a catheter has proximal and distal open ends
for receiving a hollow needle insertable into the
catheter. An inflatable balloon is provided at-the
distalmost end of the catheter for expansion around the
catheter at the distal end of the catheter. ~ source
of sterile fluid (such as air or saline solution) îs
connected to the catheter adjacent the proximal end of
the catheter, and has a separate port connection to the
catheter.
Preferably, the inflatable balloon is formed
as an outer layer or sheath extending along the length
of the catheter. The distalmost end of the outer layer
forming the inflatable balloon has a smaller thickness
than the remainder of the outer layer. As such, upon
the supply of fluid, the distal end of the outer layer
expands, while the remaining portion of the outer layer
remains flush with the periphery of the catheter.
With the balloon deflated and flush with the
periphery of the catheter, a hollow needle is inserted
to extend beyond the distal end of the catheter, and
the device is inserted into the tissue to a po~ition
adjacent the mass to be located. Typically, this is
performed under the control of x-ray (mammography) to
precisely locate the mass. Once the mass is located
and the combined catheter and needle is moved adjacent
to the mass, local anesthetic is applied through the
needle to the tissue area surrounding the mass, and the
balloon is then inflated to identify the location of
the mass. The needle can then be withdrawn. The
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inflated balloon is felt by the surgeon to determine
the location of the mass.
In another embodiment of the present ~ -
invention, a needle is inserted adjacent the mass,
typically during the x-ray mammography while the breast
is under compression and then an anesthetizing agent is
introduced. A catheter having a balloon member at the
distalmost end is then inserted in the needle until the
balloon is just inside the tip of the needle. Then the
needle is withdrawn, typically while the breast is
still under compression. The proximal end of the
catheter is preferably connected to a removable valve
(such as a check valve) and the balloon is inflated to
enable the surgeon to determine the location of the
mass.
The above and other objects of the present
invention will become more apparent when reference is
made to the following description, taken in conjunction
with the accompanying drawings.
Brief_Descri~tion of the Drawinqs
Fig. 1 is a perspective view of the mass
localization device of the present invention;
Fig. 2 is a cross sectional vieiw taken
through line 2-2 of Fig. 1 and illustrating the
inflatable balloon of the localization device in both
inflated and deflated states;
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Fig. 3 is a partial sectional view of the
mass localization device of Fig. 1, and illustrating
the inflatable balloon in its inflated state;
Figs. 4 and S are exaggerated enlarged cross
sectional views illustrating initial and final steps in
employing the mass localization device of the present
invention for locating a mass in breast tissue~
Fig 6 is a cross sectional view of a
modified form of the mass localization device of Fig.
2; and,
Fig. 7 is a cross sectional view of another
mass localization device according to the present
invention.
Descri~tion of the Preferred Embodiments
Figs. 1-3 illustrate the mass localization
device of the present invention, generally shown at 10.
The localization device 10 includes a rubber
catheter 12 having a proximal open end 14 and distal
open end 16. The catheter 12 includes an inner wall 18
and an outer wall 20. The inner wall 18 and the outer
wall 20 are connected together at proximal end 14 and
distal end 16. Between the proximal end 14 and the
distal end 16 is a gap 22 located between the inner
wall 18 and-the outer wall 20.
The inner wall 18 has a substantially uniform
cross section along its entire length. The outer wall
20 includes a thickened ring 24 near the distal end 16
of the catheter, which separates the outer wall 20 into
a proximal portion 26 and a distal portion 28. The
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proximal portion 26 has a greater thickness than the
distal portion 28, which is more flexible for reasons
described hereinafter.
A No. 25 gauge hollow needle 30 or the
S smallest gauge needle which is appropriate under the
circumstances as will be apparent to one skilled in the
art upon reading the present specification is provided
having a hub 32 located at the proximal end of the
needle 30, and a sharp open distal end 34. The needle
30 has a length slightly greater than the catheter 12.
The catheter 12 has a length of S, 10, 15, or 20 cm,
depending on the size of the breast being operated on.
The hollow needle 30 is insertable through the proximal
end 14 of the catheter 12 so that the sharp distal end
34 extends siight~y beyond the distal end 16 of the
catheter 12.
The distal portion 28 of the outer wall 20 of
catheter 12 forms an inflatable balloon at the distal
end 16 of the catheter. A source of fluid, preferably
a source of sterile air 33 or a source of a sterile
saline solution or another liquid which preferably
provides no side effects in case of a rupture of the
balloon such as methylene blue, is communicated to the
balloon 28 ~ia a port 36 provided by a port extension
38 which attaches, or preferably is formed as part of
the outer wall 20 of catheter 12. Upon supply of fluid
through port 36, the balloon 28 expands to the position
illustrated in Fig. 3, and illustrated in Fig. 2 in
phantom at 28'. A preferred diameter of the balloon 28
is 2 to 5 cm. The thickened ring 24 allows only the
balloon 28 to expand, rather than both the balloon 28
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and the proximal portion 26 of the outer wall 20. When
no supply of fluid is connected to port 36, for
expanding the balloon 28, the balloon 28 maintai~s a
flush relationship with the periphery of the catheter
12 as illustrated in Fig. 1 and 2.
In use, the mass localization device 10 is
inserted into body tissue under x-ray control to be
adjacent to a mass in the tissue. Once the distal end
of the device 10 is located proximate to the mass,
local anaesthesia is supplied through needle 30 to the
area adjacent the mass. The balloon 28 is then
expanded to identify the location of the mass, and the
needle 30 is removed. Thereafter, a surgeon can feel
the location of the inflated balloon and form an
incision from a point on the skin located closest to
the balloon so as to make as small an incision as
possible to gain access to the mass.
Figs. 4 and 5 illustrate a localization
technique for non-palpable breast masses employing the
localization device 10 of the present invention.
Initially, the needle 30 is inserted through the
catheter 12 so that the distal end of the needle
extends slightly beyond the distal end 16 of the
catheter 12. Under x-ray control, the localization
device 10 is inserted into the breast tissue 40 and
maneuvered towards a mass 42 as illustrated in Fig. 4.
The device 10 is carefully moved towards the mass 42 so
that the distal end 16 of the catheter 12 is proximate
the mass 42 as illustrated in Fig. 5. At this point,
local anesthetic is injected through the needle 30 to
the suspicious area. Thereafter, the supply of fluid
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33 is connected to the port 36 for inflating the
balloon 28 to the position shown in Fig. S. Now, the
mass 42 is palpable since a surgeon can feel the mass
42 through the skin by feeling for the inflated balloon
28. The needle 30 is then withdrawn from the catheter
12 and the patient is prepared for a surgical biopsy or
other procedure with the catheter left in place. As a
result, the surgeon forms an incision which accurately
provides for the most direct access (or the most
appropriate access) to the mass so that the surgeon can
take a biopsy of the suspicious area.
With reference now to Fig. 6, a valve 50 is
preferably provided at one end of the port extension
38. The valve 50 is preferably a suitable,
conventional check valve which enables the catheter 20
to be supplied with fluid such as by inserting a needle
of a syringe into the check valve and pushing the
plunger into the syringe. Upon withdrawal of the
needle of the syringe from the check valve 50, the
pressurized f~uid would remain in the catheter to
maintain the balloon 28 in an inflated condition. The
syringe may then be reinserted into the check valve 50
to provide additional fluid under pressure or to remove
fluid under pressure. The fluid under pressure would
be removed by withdrawing the plunger while the needle
of the syringe is inserted in the check valve. In this
way, the check valve and the syringe permit the balloon
at the end of the catheter to be inflated, maintained
in an inflated condition, and deflated as desired.
In addition, the catheter 20 is covered by a
sheath 52 which is prefera~ly made of latex~ The
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sheath 52 covers the catheter from the distal end 16 of
the catheter to the port extension 38. In this way,
the sheath facilitates insertion of the catheter into
the body tissue and prevents or minimizes any crimping
of the inflatable balloon. If desired, after proper
insertion of the catheter has been achieved, the sheath
may be torn apart adjacent the extension port and
withdrawn from the catheter. As the sheath is
progressively pulled rearwardly and torn, the sheath is
gradually removed from the catheter completely.
Alternatively, the sheath may be torn apart and
withdrawn only enough to uncover the balloon at the
distal portion of the catheter. The sheath is
preferably of a suitable, conventional form and may be
provided with a weakened portion, such as a perforation
running along the length of the sheath, to facilitate
the tearing of the sheath.
With reference now to Fig. 7, another
embodiment of a mass localization device according to
the present invention includes a needle 60. The needle
60 preferably has a length which is appropriate for the
distance that the needle is to be inserted into the
breast or other body tissue. Typically, needles of
various lengths will be available for use in connection
2S with the present invention with the needles having a
length of about 5 centimeters to about 25 centimeters.
The needle 60 has a sharp point to facilitate
insertion of the needle into the breast or body tissue.
The needle 60 also has an internal diameter which is
sufficient to pass a catheter 64 having a balloon 66
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which may be inflated so as to have a diameter of about
2 to 5 centimeters or more.
The needle 60 may be connected to a syrInge
(not shown) by a suitable, conventional hub 61. For
example, the hub 61 may be threaded so as to threadably
connect with a corresponding portion of the syringe.
When the needle 60 is connected to a syringe, an
anesthetizing agent or another fluid may be in~ected
through the needle as desired. The syringe is
removable from the needle as described more fully below
to facilitate the insertion of the catheter 64 through
the needle.
With the ~yringe removed (and after the
needle has been inserted into the breast tissue with
the tip of the needle at the llass to be localized), the
catheter is inserted into the needle until the balloon
66 which is provided at the distal end 68 of the
catheter 64 is just within the tip of the needle 60. A
mark 70 is provided on the catheter at a location which
indicates that the balloon 66 is just within the tip of
the needle. Preferably, the mark is located at the
rearwardmost end of the hub 61 when the balloon is just
within the tip of the needle 60.
If the catheter is sufficiently rigid, the
catheter may be inserted into the needle without the
use of a stylette. However~ if the catheter is not
sufficiently rigid, insertion of the catheter into the
needle may be facilitated by providing a stylette 72
inside the catheter. The stylette 72 has a blunt tip
so as not to perforate the balloon 66.
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When a stylette is used, the stylette 72 and
the catheter 64 are inserted into the needle 60 as a
unit. After the catheter is properly inserted into the
needle, the needle i5 removed by withdrawing the needle
over the catheter 64. In order to permit the needle to
be withdrawn, the catheter should have a length which
is slightly more than twice as long as the needle and
the hub 61. If a stylette was used, the ~tylette is
then removed by withdrawing the stylette from the
catheter. If desired, the stylette may be removed
prior to withdrawing the needle from the catheter.
After the needle and stylette have been
withdrawn from the catheter, the catheter is supplied
with a pressurized fluid to inflate the balloon as
described above in connection with Figs. 1-5.
Preferably, a valve, especially a check valve as
described above, is provided between the end of the
catheter and the supply of pressurized fluid so as to
enable the balloon to be readily inflated, maintained -
in an inflated condition and then deflated as desired.
If the valve would obstruct the removal of
the needle from the catheter, the valve should be
releasably connected to the catheter. In this way, the
valve may be disconnected from the catheter until after
the needle has been removed and the balloon is ready to
be inflated.
The valve may be releasably connected to the
catheter by a coupling ?6 which is received by the
proximal end of the catheter. The coupling 76 includes
a portion which may be tapered or provided with a
series of ridges so as to be frictionally retained
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within the catheter after insertion. Upon the use of
sufficient force, however, the valve may be removed
from the catheter by pulling the couplin~ 76 out of the
proximal end of the catheter.
The valve may be supplied with fluid under
pressure as described above in connection with Fig. 6.
In this way, a syringe may be inserted into the valve
and the plunger depressed to inflate the balloon. Upon
withdrawal of the syringe from the valve, the balloon
will remain inflated to anchor the catheter in the body
tissue where desired.
In use, the needle of the mass localization
device according to Fig. 7 is inserted into the breast
or other tissue preferably while the breast is
undergoing x-ray mammography and is under compression.
The needle is inserted until the tip of the needle is
at the mass to be localized. Then an anesthetizing
agent is injected into the body tissue such as by a
syringe which is releasably connected to the needle.
The syringe is then disconnected from the needle and a
catheter is inserted into the needle. Incertion of the
catheter may be facilitated by the use of a stylette
which is provided inside the catheter. When the
catheter has been positioned with the balloon (at the
end of the catheter) just within the tip of the needle,
the needle is withdrawn and then the stylette is
withdrawn. The catheter is then supplied with a
sterile fluid to inflate the balloon as desired.
While the localization of breast masses has
been specifically described, it is envisioned that the
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present invention can be employed for localizing masses
in various other tissue environments.
The above description is intended by way of.
example only, and is not intended to limit the present
invention in any way except as set forth in the
following claims.
