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BACKGROUND OF THE INVENTION
The present invention relates to a novel breast localization needle which
may be readily inserted and anchored within the body tissue to identify to
the surgeon the location of nonpalpable lesions.
During the past thirty years, there has not been a substantial increase in
the rate of survival in the treatment of breast cancer using a surgical
radiation therapy or chemotherapeutic treatment of the breast lesions,
with the five year survival rate still being approximately 50%. However,
if very small lesions, less than one centimeter in size, are detected
early and appropriately surgically removed, the rate of survival is
between 92 to 97%. The use of mammography, or X-ray examination, of the
breast has been able to detect small lesions or tumors in asymptomatic
females. Although, these lesions can be identified by X-ray examination,
their surgical removal is often times difficult because they are small in
size and they are difficult to precisely locate, especially in large
breasts, and in the case where the lesions are located deep within the
tissue mass.
To aid the surgeon in locating the nonpalpable lesions within the breast,
Kopans has suggested and disclosed a technique (Radiology, March, 1980,
Vol 128, p. 781) wherein a hypodermic needle is initially placed into the
breast to locate the breast lesion. After the needle is positioned in the
breast, the location is optimally confirmed by using two mammographic or
X-ray positions. During these mammographic filmings the breast is
compressed to confirm the positioning of the needle at or adjacent to the
breast lesion. When the needle is properly placed, a stainless steel wire
having a hairpin hooked-end portion is slid through the needle wherein the
hooked hairpin-end portion exits from the needle to engage the body tissue
to retain the needle adjacent to or at the breast lesion. Upon the exit of
the hooked portion to engage the breast tissue, an additional set of
mammograms is taken to verify the position of the hook, wire and needle
with respect to the breast lesion. If the position is correct, the
introducing needle is withdrawn over the wire and the wire is anchored to
the tissue and the patient is taken to surgery. The wire permits the
surgeon to know where the lesion lies within the breast tissue.
However, the Kopans' needle and wire-hook arrangement possesses several
disadvantages because during mammographic filming of the breast lesion and
location of the needle within the breast, the breast is compressed which
can cause the needle to move or be displaced with respect to the breast
lesion. Additionally, after the hairpin hook wire has been inserted
through the needle and expanded to anchor the Kopan's needle/hook-wire
apparatus in place, a second set of mammograms is required to verify the
positioning of the needle within the breast tissue. If the position is
incorrect, the hooked wire cannot be easily removed and forceful removal
results in considerable damage to the tissue as well as the fact that the
ultimate removal of the hook-wire from the breast causes undesirable
tearing and damage to the breast tissue.
More recently, Homer has disclosed a needle/wire device and technique
(Radiology, October, 1985, Vol. 157, pp. 259-260) which includes a
curved-end wire which is made of tough pseudo-elastic alloy which
possesses a memory. A needle containing a wire having a J-shaped hook on
the end is inserted into the breast and advanced to identify the location
of the breast lesion. The wire is then advanced inwardly such that the
curved hooked end engages the body tissue to immobilize the needle during
mammography imaging to insure that the needle is correctly positioned at
or adjacent the breast lesion. Although such a curved J-shaped retractable
wire within a stylus eliminates the need for multiple X-rays, the needle
and hook device can be relatively easily displaced if traction or pressure
is applied to the breast during transport of the patient or during
surgery. Thus, actual migration of the hook-wire device in the breast
tissue occurs during surgery and movement of the patient to surgery.
SUMMARY OF THE INVENTION
One object of the present invention is a novel breast localization needle
which may be readily positioned and locked within the body tissue to
precisely locate and pinpoint breast lesions for subsequent surgical
removal or biopsy.
Another object of the present invention is a novel breast localization
needle which includes one or more barbs which may be extended outwardly
from the side walls of the needle to lock and anchor the needle within the
body tissue to precisely locate breast lesions for subsequent surgical
removal.
Still another object of the present invention is a novel breast
localization needle which includes a helical screw needle tip on the
distal end which may be readily positioned and locked within the body
tissue to precisely locate breast lesions for subsequent surgical removal.
Still another object of the present invention is a novel breast
localization needle which includes a flexible outer cannula portion which
permits the positioning of the breast localization needle to locate deep
breast lesions for subsequent surgical removal.
Still another object of the present invention is a pair of interlocking
handle members which are engageable with respect to the outer cannella
member and inner stylus member to assist in the insertion of the breast
localization needle into the body tissue to locate breast lesions for
subsequent surgical removal.
Still another object of the present invention is a remote incisional
cannula accessory which is insertible over the breast localization needle
to permit the surgeon to make a incision for removal of the breast lesion
remote from the point of insertion of the breast localization needle into
the body tissue.
Still a further object of the present invention is a novel nonpalpable
lesion locator which may be inserted into a body tissue to pinpoint and
locate the nonpalpable lesion.
A further object of the present invention is to provide a novel method for
surgically removing lesions when the incision is made remote from the
point of entry where the localization needle enters the body tissue.
With these and further objects of the present invention, the nature of
which will become more apparent, the invention will be more fully
understood by reference to the drawings, the accompanying detailed
description and the appended claims.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of the breast localization needle in accordance with
one embodiment of the present invention showing the displacement of the
needle during insertion into the body tissue;
FIG. 2 is a side view of the embodiment shown in FIG. 1 showing the inner
stylus retracted in the barb position within the body tissue to lock the
breast localization needle in place;
FIG. 3 is a side view showing a further embodiment of the breast
localization needle wherein the inner stylus includes a projection thereon
which cooperates with a slot in the outer needle section to facilitate
insertion and retraction of the position barb within the body tissue.;
FIG. 4 is a further embodiment of the breast localization needle having
more than one barb cooperating with openings in the side wall of the
needle during insertion of the needle into the body tissue;
FIG. 5 is a side elevation view of the embodiment shown in FIG. 4 showing
the barbs exposed and locking the breast localization needle in place
within the body tissue;
FIG. 6 is a sectional view taken along the lines 6--6 in FIG. 1;
FIG. 6A is a side elevational view of a further embodiment of an inner
stylus for the breast localization needle in accordance with the present
invention;
FIG. 6B is a side elevational view of a further embodiment of an inner
stylus for the breast localization needle in accordance with the present
invention;
FIG. 7 is a side elevational view of a further embodiment of a breast
localization needle in accordance with the present invention;
FIG. 8 is a side view of the inner stylus the used in inserting the
localization needle of the embodiment of the present invention as shown in
FIG. 7;
FIG. 9 is a side view of the embodiment of the present invention as shown
in FIG. 7 with the inner stylus removed from the localization needle;
FIG. 10 is a further embodiment of the present invention showing a needle
screw mounted to the end of the needle for anchoring and drawing the
needle within the body tissue to locate a lesion therein;
FIG. 11 is a side view of a further embodiment of a breast localization
needle wherein the needle possesses a screw thread on the end thereof for
drawing the needle into the body tissue and for anchoring the needle
within the tissue;
FIG. 12 is a side view of the embodiment shown in FIG. 11 showing the inner
stylus retracted with the barb extending outwardly through the side wall
thereof when the inner stylus is retracted after insertion of the needle
into the body tissue;
FIG. 13 is a further embodiment of a lesion localization needle with the
outer needle portion having a screw thread mounted to the distal end of
the needle to facilitate insertion and anchoring of the needle within the
body tissue;
FIG. 14 is a side view of a further embodiment of the present invention
illustrating the placement of a sheath cannula having a helical screw
distal end being directed to a lesion over a fine guide needle used to
locate the lesion.
FIG. 14A is a sectional view taken along lines 14A--14A of FIG. 14.
FIG. 14B is a view similar to FIG. 14 illustrating the removal of the fine
guide needle from the body tissue and the anchoring of the sheath cannula
of the nonpalpable lesion.
FIGS. 15-15A are side views showing the positioning of handle and locking
members about the outer and inner stylus members of the breast
localization needle in accordance with the present invention;
FIGS. 16-16B are side views illustrating the locking members engaging the
outer and inner cannula when the inner stylus has been retracted to expose
the barb and anchor the needle within the body tissue;
FIG. 17 is a rear elevation view of the outer collar member of the proximal
handle portion which engages the inner stylus member in accordance with
the present invention;
FIG. 17A is a cross-sectional view taken along the lines 17A--17A of FIG.
17;
FIG. 18 is a front elevation view of the inner collar member of the
proximal handle portion which is engageable with the inner needle stylus
member of the localization needle in accordance with the present
invention;
FIG. 19 is a cross-sectional view taken along the lines 19--19 of FIG. 18;
FIG. 20 is a cross-sectional view of the outer collar member of the distal
handle portion which is engageable with the outer needle member of the
localization needle in accordance with the present invention;
FIG. 21 is a cross-sectional view of the inner collar member of the distal
handle portion which is engageable with the outer annular member of the
localization needle in accordance with the present invention;
FIG. 22 is a side view of a cylindrical hollow cannula which is positioned
about the breast localization needle for guide and insertion therearound
into the body which permits the surgeon to position a guide wire at the
location of a lesion in the body tissue;
FIG. 23 is a cross-sectional view taken along lines 23--23 of FIG. 22;
FIG. 24 is a perspective view showing the insertion of the breast
localization needle within the body tissue and the partial insertion of
the hollow outer cannula as shown in FIG. 22 thereabout;
FIG. 25 is a perspective view illustrating the full insertion of the outer
hollow cannula about the localization needle and the insertion of a guide
needle portion of the hollow outer cannula through the skin adjacent to
the localization needle entry point with the guide needle being laterally
displaced along the interior of the body tissue to exit a point remote
from the entry point of the localization needle;
FIG. 26 is a perspective view showing the advancement of a tube member over
the guide wire to identify a surgical path for the surgeon to surgically
remove the lesion within the body tissue;
FIG. 27 illustrates a clamping device engageable with the localization
needle to retain the same within the body tissue during surgery; and
FIGS. 28-31 illustrate a cutting and crimping device in accordance with the
present invention which is engageable with the breast localization needle,
and illustrate the crimping and compressing components of the breast
localization needle together to permit the use of long localization
needles and shortening the same prior to transport of the patient from the
radiology area to the operating room.
DETAILED DESCRIPTION
Referring now to the drawings where like numerals have been used throughout
the several views to designate the name or similar parts, in FIGS. 1 and 2
a breast localization needle assembly 10 is illustrated which includes an
outer tubular needle or cannula member 12 having a distal end 13 and a
proximal end 14. The needle or cannula member 12 may be comprised of a
rigid material composed of either steel, polymer or a combination thereof
and may be of a variable length as required. Although the needle assembly
10 has been specifically identified as a breast localization assembly, the
needle assembly of the present invention has application in locating
cancerous nonpalpable lesions within the human or animal body, be it a
brain tumor, or any medical procedure which requires the pinpointing of a
lesion, foreign body or normal structure within the body or organ of the
body. The outer tubular needle cannula member 12 may include a single or
multiple side holes or openings 15 in the sidewall which are of
predetermined and variable distances from the distal end 13 of the cannula
member 12. The needle assembly 10 further includes an inner stylus needle
or annular member 17 which may be slidably advanced within the outer
tubular cannula member 12 as desired. The inner cannula member 17 includes
a distal end 18 and a proximal end 19, with a hub 20 mounted on the
proximal end 19 of the inner cannula member 17. The hub includes a
projection 21 thereon which cooperates with a recessed depression 14a of
the proximal end 14 of the cannula member 12 to prevent rotation of the
inner stylus or cannula member 17 with respect to the outer cannula member
12 during insertion of the needle assembly 10 into the body tissue.
As shown in FIGS. 1, 2 and 6, the inner stylus or cannula member 17
includes a cutaway portion or groove 23 therein adjacent to the distal end
18. The distal end 18 is, preferably, tubular and circular in shape and is
adapted to receive a wire member 25 having a pointed end 26 which extends
beyond the distal end 18. The forward end portion 25a of wire member 25 is
secured to the distal end 18 by soldering, welding or by adhesion and the
wire portion 25 includes a free end defining a proximal barb or hook
member 27 which is adapted to be received in the cutaway or groove portion
23 of the inner stylus member 17. The rearward wall 23a of the groove 23
slopes upwardly towards the opening 15, defining a guide surface for the
free, barb end 27 of the wire 25. The end 27a of the barb member is
positioned within the opening 15 in the sidewall of the outer tubular
needle member 12. As shown in FIGS. 1 and 6, the needle assembly 10 is so
assembled that the pointed end 26 of the wire member 25 extends beyond the
distal end 13 of the outer needle member 12 during insertion of the
assembly into the tissue of the body, the position as shown in FIGS. 1 and
6.
When it is believed that the needle assembly 10 has been positioned
adjacent to or at the lesion within the body or breast tissue, the hub 20
which is attached to the proximal end 19 of the inner cannula member 17 is
pulled outwardly away from the proximal end 14 of the outer cannula member
12, which movement causes the barb member 27 to move outwardly through
opening 15 in the sidewall of the outer cannula member 12, the position as
shown in FIG. 2.
The needle assembly 10 is advanced into the target area of a human or
animal body, either for simply making the location or removing any
substance, fluid, tissue, tumor, blood or foreign body, be it the breast,
liver, ductal structure, brain, lung or other organs where it is desirable
to take a biopsy, a sample structure or to surgically remove an unwanted
mass or lesion from the body. The desired position is obtained by
advancing the needle assembly into the target area using the forward
pressure on the hub 20 on the inner cannula member to advance the needle
assembly into the target. After the needle has been properly positioned
using either X-ray, ultrasound, or other filming means, the hub and inner
cannula 17 is retracted and moved outwardly thereby deploying the barb
member 27 through opening 15 in the sidewall of the outer cannula member
to lock and firmly hold the needle in position within the body tissue.
When the needle assembly 10 has been inserted into the breast, the
movement of the barb member 27 into the body tissue anchors and firmly
retains the needle assembly within the breast or body tissue. The location
of the opening 15 in the outer cannula member 12 is predeterminedly from
the distal end 13, as desired. That is the opening 15 may be located on
the outer cannula at a position where it is desired that the needle
assembly be anchored to the body tissue. Preferably this position is
adjacent the distal end, but it could be located at any position
intermediate the distal and proximal ends provided proper anchoring of the
assembly occurs with respect to the body tissue.
If after deployment of the barb 27, it is determined by X-ray, ultrasound
or filming means, that the needle assembly has not located a lesion, the
barb 27 can be retracted by advancing the inner cannula 17 into the outer
cannula 12. The needle assembly 10 can then be repositioned to locate the
lesion, the inner cannula 17 being moved outwardly of the outer cannula to
again deploy the barb when the lesion is located. Additionally, the hub
projection 21 during the insertion mode is adapted to rest and be received
by the recessed depression 14a in the outer cannula member. This indexes
the inner stylus cannula member with respect to the outer cannula member
12 and prevents rotation of the inner cannula member 17 with respect to
the outer cannula 12 which could cause dislocation of the barb member 27
from the aperture 15 in the outer cannula member 12. As is well known in
the art, the length of the outer cannula member 12 can vary depending upon
the depth of the lesion that is to be localized and identified for
subsequent surgical operation. Additionally, as shown in FIG. 3, the outer
cannula member may have an elongated slot 16 positioned therein which
cooperates with a projection 17a on the inner cannula member 17. Thus, the
projection 17a, as shown in FIG. 3, is in its forward position within slot
16 during insertion of the assembly into the body tissue. The slot 16
confines the movement of the projection 17a on the inner cannula member 17
such that when the hub 20 is retracted outwardly and the barb member is
exposed, as shown in FIG. 2, the projection will engage a stop surface 16a
defined by the outer proximal end of the elongated slot 16. Thus, the slot
16 and the projection 17a on the inner cannula member 17 cooperate to
confine the forward and rearward travel of the inner cannula member 17 to
maintain the barb member 27 within the opening 15 in the sidewall of the
needle assembly 10 as desired. Alternatively, the outer cannula 17 may
have a projection 16b shown by dashed line in FIG. 3, depending from the
inner surface thereof into a slot or channel 17b having end walls 17c and
17d, shown by dashed lines in FIG. 3, and cooperating therewith to limit
travel of the inner needle 17 in movement between its extended portion,
where projection 16b engages end 17d, and its retracted position where
projection 16b engages end 17c.
FIGS. 4 and 5 illustrate a further embodiment of the breast localization
needle assembly 10 which comprises a plurality of openings 15 in the
sidewall of the outer needle or cannula member 12. As illustrated in these
drawings, the inner cannula member 17 has more than one barb member 27
mounted to the inner cannula member 17 each of which cooperates and moves
outwardly through an associated opening 15 in the sidewall in the needle
assembly 10. The operation of the needle assembly 10 is identical with the
operation as described for the assembly as shown in FIGS. 1 through 3.
FIGS. 6A and 6B illustrate further embodiments of the inner stylus 17 of
the needle assembly 10. In FIG. 6A, a groove or channel 23 is formed in
the upper surface of a conventional needle 17 near its distal end 18,
rearward of the top of the needle 17. A short wire segment or member 25 is
located in the groove 23 with its forward end 25a secured therein and its
other end free, defining rearwardly projecting barb member 27.
In FIG. 6B, the distal end 18 of the inner stylus 17 has a groove or
channel 23 formed therein which receives a wire segment 25. The forward
end 25a of the wire segment is secured to the stylus 17 within the groove
23 and its other end being free defining rearwardly projecting barb member
27. A pointed tip member 26 is secured to the forward end of the stylus 17
in a recess 17b formed in the forward end of the stylus.
FIGS. 7-9 illustrate a further embodiment of the present invention wherein
the needle assembly 10 is comprised of a shortened outer tubular needle or
cannula member 12 which is fixedly attached, preferably to a tubular
spring helix 30 or any flexible tube at the proximal end 14 of the outer
cannula member 12. The tubular helix 30 is impregnated or coated with a
polymeric material, in a manner similar to the procedure described in U.S.
Pat. No. 4,004,765. Thus, the spring helix 30 is joined at the proximal
end 14 of the outer cannula member 12 with the resultant spring helix
cannula portion thereof being flexible to prevent the possibility of
inadvertent displacement of the needle assembly 10 deeper into a breast,
lung or other vital organ with locating a lesion therein because of
compression of the target during film imaging. The needle assembly 10
includes an elongated inner stylus or cannula member 17 having a hub 20
positioned on the end thereof with the inner cannula member 17 being
tubular in shape and defining a passageway 31 therethrough. The inner
cannula member 17 is further comprised of a forward portion 33 having a
distal end 18 thereon with a tapered pointed end 26 extending forwardly
therefrom. Rearwardly of the distal end 18 is a barb member 27 which is
adapted to be received within the forward portion which cooperates with an
opening 15 in the outer cannula member 12 in much the same manner as
described above with respect to figures 1 through 5. The forward portion
of the inner cannula member 17 is attached to a flexible wire or
monofilament welded or bonded to the end of the forward portion of the
inner cannula member 17. The wire or monofilament 34 extends through
passageway 31 in the tubular inner cannula member 17 as shown in FIG. 7.
The inner stylus or cannula member 17 has a distal end 18a (FIG. 8) which
matingly cooperates and engages the recessed annular shoulder 19a on the
proximal end 19 of the forward portion 33. Such a cooperation assures
registration of the cannula member 17 and the forward portion 33 during
insertion into the body tissue when cannula member 17 is utilized to
stiffen the needle assembly 10, as shown in FIG. 7.
When the needle assembly is advanced as a single unit into the target area,
once the target has been entered, the wire or monofilament 34 is retracted
deploying the barb member 27 through opening 15 in the outer cannula
member 12, as shown in FIG. 9. Once the target and the barb has been
deployed, the inner cannula member 17 is removed from within the outer
cannula member 12 and spring helix 30, thus creating a flexible
localization needle assembly 10, as shown in FIG. 9. If by chance the
needle assembly 10 requires relocation, the inner cannula member 17 is
advanced over the wire or monofilament 34 to engage distal end 18a with
the recessed annular shoulder to stiffen the needle assembly and to
thereby retract the barb member 27 and reposition the needle as desired.
FIG. 10 illustrates a further modification of the needle assembly 10 which
is comprised of an outer tubular cannula member 12 attached to a spring
helix 30 or flexible tube which has been coated by a procedure disclosed
by U.S. Pat. No. 4,004,765. However, the outer cannula member 12 does not
have an opening 15 in the side thereof and the forward portion 33 of the
inner cannula member includes only a sharp projection 33a extending beyond
the distal end 18 of the forward portion of the inner cannula member 17.
Attached to the distal end 13 of the outer cannula member 12 is a helical
screw needle 35 which is tapered to a fine point which provides a
screw-type configuration which will lock the needle assembly 10 into the
body tissue or any other target by clockwise rotation of the assembly.
After X-ray or other filming confirms the correct position of the needle
assembly 10, the inner stylus or cannula member 17 is withdrawn (not shown
in FIG. 10) and the helical screw member 35 performs the function of
anchoring the needle assembly within the target area.
Although it is not shown in FIG. 10, it is within the scope of the present
invention that the mounting of the helical screw needle 35 upon the distal
end 13 of the outer tubular cannula member 12 can be used with the inner
stylus cannula member 17, as shown in FIG. 8, without the use of a wire
member or pointed end attached to the inner cannula member 17 and the
proximal end thereof. In such an embodiment it is proposed that a very
thin polymer catheter coating or cover 37 may be used to cover the outside
surface of the helical screw assembly 35 to facilitate insertion of the
needle assembly into the body tissue. After insertion of such an assembly
into the body tissue, rotation of the needle assembly 10 facilitates
engagement of the helical screw needle with the body tissue to properly
anchor the needle assembly in the body tissue.
FIGS. 11 and 12 further illustrate another embodiment of the present
invention which is similar to the embodiment disclosed in FIGS. 1 and 2
but wherein a helical screw needle member 35 is securely fastened to the
distal end 13 of the outer tubular cannula member 12. In this embodiment
of the localization needle assembly 10, the outer tubular cannula member
12 is comprised of a rigid material composed of either steel, polymer, or
a combination thereof and which may be of variable length, as required.
The outer tubular cannula member 12 may include single or multiple side
holes or openings 15 which are predeterminely located from the distal end
13 of the outer cannula member 12. The assembly 10 includes also an inner
cannula member 17 which is slidably advanced within the outer cannula
member 12. The inner cannula member 17 includes a distal end 18 and a
proximal end 19 with a hub 20 mounted on the proximal end 19 of the inner
cannula member 17. The hub includes a projection 21 which cooperates with
a recessed depression 14a in the proximal end 14 of the outer cannula
member 12 to prevent rotation of the inner cannula member 17 with respect
to the outer cannula member 12 during insertion of the needle assembly
into the body tissue. In the same manner as shown in FIGS. 1, 2 and 6, the
inner cannula member 17 includes a cutaway portion or groove 23 which is
adapted to receive a wire member 25 having a pointed end 26 which extends
upon the distal end 18 of the inner cannula member 17. The wire member 25
includes a hook portion 27 which is adapted to be received in the groove
of the inner stylus member and is positioned within the opening 15 of the
sidewall of the outer needle member 12 when the assembly is inserted
within the body. As shown in FIG. 11, the pointed end 26 of the wire
member 25 extends beyond the distal end 13 of the helical screw needle 35
which is attached top the distal end 13 of the outer cannula member 12 and
is tapered to a fine point which permits a screw-type configuration which
aids in locking the needle assembly 10 to the body tissue or other target
as previously described. In FIG. 12, the inner member 17 has been
retracted thereby positioning the barb member 27 into the body tissue
adjacent to the assembly 10.
FIG. 13 illustrates a localization needle assembly 10 which does not
include the structure wherein the inner stylus or cannula member 12
includes a cutaway portion with a wire member 25 mounted therein which
includes a barb portion which extends through an opening in the sidewall
of the outer cannula member 12. Instead, the embodiment of FIG. 13
includes a tubular outer cannula member 12 having a distal end 13 and a
proximal end 14. Mounted to the distal end 13 is a helical screw needle 35
and the outer cannula member 13 is adapted to slidably receive an inner
cannula member 17. The inner cannula member 17 may have a distal end
portion 18 which includes either a pointed end 26 or it can itself be a
very fine needle having a point thereon. Thus, in the fully inserted
position, as shown in FIG. 13, the needle assembly 10 is screwed or turned
into the body tissue to locate the lesion for subsequent surgical removal.
Again, the helical screw needle may include a polymer catheter cover 37,
as previously shown in FIG. 10, to facilitate insertion of the needle
assembly 10 into the body tissue.
A further embodiment of the localization needle assembly 10 is shown in
FIGS. 14 and 14A wherein the inner cannula member 17 is a very small
diameter guide needle of approximately 22 gauge, which extends the length
thereof. The guide needle is used to probe the particular body tissue to
identify the lesion or to probe the particular organ into which the needle
assembly is to be inserted. After the inner cannula member 17 locates the
particular lesion or area of the organ to be localized, an outer cannula
member 12, of approximately 18-20 gauge, is slidably advanced over the
inner cannula member or needle 17. The outer cannula member includes at
its distal end 13 a helical screw needle 35 thereon, which has an opening
38 in the end so that it may be encircled and advanced over the inner
cannula or needle member 17. When the outer cannula member 12 is
positioned adjacent the target area, with rotation of the outer cannula
member 12, cannula member 12 helical screw needle is advanced into the
organ or breast tissue area, anchoring the needle assembly therein. Such a
needle assembly is very advantageous when the lesion is very deep within
the body or the organ is difficult to penetrate and hold and retain the
needle assembly within the body for subsequent surgical removal or biopsy.
When the helical screw needle anchors the needle assembly to organ or
breast tissue area, the guide needle is withdrawn, as shown in FIG. 14B.
This design works particularly well for gaining access to difficult
scarred target areas.
FIGS. 15-15A illustrate a handle and locking means which may be utilized in
conjunction with the localization needle assembly 10 to position the
needle assembly within the body tissue to pinpoint the lesion or body
organ to be localized. The handle and locking means 40 is comprised of an
outer proximal handle portion 42 and a distal handle portion 48. The
proximal handle portion 42 is comprised of an outer collar member 43 and
an inner collar member 44. The distal handle portion 48 is composed of an
outer collar member 56 and an inner collar member 60. An alignment marking
54 for the handle and locking means 40 includes segments 54a-54d for the
four collar members 43, 44, 56 and 60, respectively. Each of the collar
members 43 and 44 of the proximal handle portion 42 has an off-center bore
45 extending therethrough. The dimension of the off-center bore 45 in the
outer and inner collar members 43 and 44 is sized to be slidably
engageable with the outer surface of the inner stylus or cannula member 17
of the various embodiments of the present invention. The outer collar
member 43, as shown in FIGS. 17 and 17A has a female recess 46 and
cooperating flange 47 which is adapted to receive a complementary
projection 49 on the inner collar member 44 which has an annular flange 51
partially therearound to enable the outer and inner collar members 43 and
44 to be matingly engaged together when the outer alignment markings 54a
and 54b on the outer surfaces of the collar members 43 and 44 are aligned,
as shown in FIG. 15, the proximal handle portion 42 may be slidably
engaged onto the inner cannula member 17. Rotation of collar members 43
and 44 of the proximal handle portion 42 in opposite directions causes the
off-center bore 45 within each of these collar members to lock to and
firmly retain the inner cannula member 17 in a fixed position.
Similarly, distal handle portion 48 of the handle and locking means 40
includes an outer collar member 56 and an inner collar member 60 which may
be locked together to engage the outer cannula member 12 in the same
manner that the collar members 43 and 44 of the proximal handle portion 42
are engageable with and lock to the inner cannula member 17. As shown in
FIGS. 16-16B, and FIGS. 20 and 21, the outer collar member 56 and the
inner collar member 60 each include an off-center bore 45 therethrough
with the inner collar member 60 including a recess 62 therein and an
annular flange 63 which are adapted to receive a projection 64 and annular
flange 65 on the outer collar member 56. When the collar members 56 and 60
are matingly engaged together, the off-center bore 45, which is larger
than bore 45 slidably receives the outer cannula member 12 therein, when
aligned to the position as shown in FIG. 15 with alignment markings 54c
and 54d aligned. When the collar members 56 and 60 are rotated in opposite
directions until the alignment markings 54c and 54d are as shown in FIG.
15A, the off-center bore 45 extending through the assembled collar members
56 and 60 cause the distal handle portion 48 to firmly lock to the outer
cannula member 12, the position as shown in FIG. 15A. It is within the
scope of the present invention that either the distal handle portion 48 or
the proximal handle portion may be used alone to engage and lock to an
elongated tube, wire or a cannula member to permit the tube, wire or
cannula member to be maneuvered by the user as desired.
For the purpose of locking the two handle portions 42 and 48 together, the
inner collar member 44 of the proximal handle portion 42 has an annular
projection 66 which is recessed in friction fit relation in a
complementary shaped recess 67 formed in the outer collar member 56 of the
distal handle portion 48 when the two handle portions are assembled
together on the needle assembly 10 as shown in FIGS. 15 and 15A. When the
alignment markings 54 are all aligned as shown in FIG. 15, the two handle
portions 42 and 48 are movable as a unit along the length of the needle
assembly 10. When the collar members of the two handle portions 42 and 48
are adjusted to the portions shown in FIG. 15A, the proximal handle
portion 42 is locked to the inner stylus 17, the distal handle portion 48
is locked to the outer needle and the two handle portions are frictionally
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