Note: Descriptions are shown in the official language in which they were submitted.
CA 02513439 1996-10-16
1
TISSUE TAGGING DEVICE
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This application is a division of copending
Canadian Application Serial No. 2,188,088, filed October 16,
1996.
1. Technical Field
The present disclosure relates generally to
surgical instruments. More specifically, the present
disclosure relates to a tagging device for identifying a
particular location within a mass of body tissue.
2. Background of Related Art
Tagging or marking of locations within body
tissue, such as non-palpable lesions discovered within the
body, and devices such as needles and wires for marking
these lesions, are well known in the art. The devices
generally comprise a hypodermic needle or cannula which is
inserted into the body and positioned adjacent to or in
contact with the lesion. The wire marker, which extends
beyond the distal end of the cannula, is anchored into or
adjacent the lesion so that the lesion is marked for
subsequent surgical procedure such as excision or biopsy.
After marking the lesion with the wire marker, the cannula
may be removed from the body, leaving the wire in place and
extending from the body.
In procedures involving marking the location of
suspect tissue within the breast, the breast is typically
compressed during a mammographic tagging procedure so that
after the needle is in place and compression discontinued,
it is possible that the needle marker may dislodge or
migrate to
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a different position than the position set during the
tagging procedure. Various tissue marking needle systems
have been proposed to aid in locating non-palpable lesions
within the breast and to prevent inadvertent dislodgment
and/or migration of the needle. One such system includes a
cannula needle and a wire guide made of a shape memory
characteristic material which assumes a J-hook
configuration. An example of such a device may be found in
U.S. Patent No. 5,011,973 issued April 30, 1991 to Gatturna.
The needle is inserted into the breast and advanced to
identify the location of the breast lesion. The wire is
advanced inwardly allowing the J-hooked end to engage body
tissue to immobilize the needle. However, devices utilizing
such J-hook systems have been unable to solve the problem of
preventing migration of the marker. The needle and the hook
device can be displaced if pressure is applied to the breast
during transport of the patient or during surgery. Also, if
the strength or resiliency of the wire is less than that
required to penetrate the lesion, the hook may not reform,
allowing the marker to migrate.
Another example of a tissue-marking needle system,
commonly referred to as a needle and hook-wire system, may
be found in U.S. Patent No. 5,158,084 issued October' 27,
1992 to Ghiatas. The tissue-marking needle system includes
a stainless steel wire having a hooked-end. Similar to the
J-hook system, the needle is inserted into the breast to
locate the lesion and the wire is slid through the needle to
engage the body tissue to anchor the wire at the breast
lesion. However, compression of the
CA 02513439 1996-10-16
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breast during mammographic filming of the breast lesion may
result in migration or displacement of the needle. Although
the hook prevents outward movement of the wire, it does not
prevent inward advancement of the wire.
Accordingly, a need exists for an improved tissue
tagging device which overcomes the above-noted
disadvantages, is easy to use and provides more reliability
when marking suspect tissue.
SUNR~iARY
In accordance with the present disclosure, a
tagging device for identifying the location of lesions
within body tissue is provided.
In accordance with one embodiment of the present
invention there is provided a tagging device comprising:
(a) a first handle; (b) a second handle movable relative to
the first handle; (c) a first elongated member fixedly
attached to the first handle; (d) a second elongated member
fixedly attached to the second handle; and (e) an anchor,
the first and second elongated members being fixedly
attached to the anchor in a spaced manner.
Provision of a pair of elongated members
facilitates deployment of the anchor in the target tissue
and further permits relocation and/or removal of the anchor,
if desired, through reversal of the movements associated
with deployment of the anchor. Introduction of the anchor
to the target tissue may be accomplished using structures
disclosed herein or through other introductory mechanisms,
as are known or would be apparent to those of ordinary
skill.
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BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a tagging device;
FIG. 2 is an enlarged view of the distal end of
the embodiment shown in the indicated area of detail of FIG.
1;
FIG. 3 is a perspective view with parts separated
of the embodiment shown in FIG. 2;
FIG. 4 is a plan view of the embodiment of FIG. 1;
FIG. 5 is a cross-sectional view taken along
section line 5-5 of FIG. 1;
FIG. 6 is an enlarged view of the distal end of
the tagging device shown in the indicated area of detail of
FIG. 5;
FIG. 7 is an enlarged view of the body of the
tagging device shown in the indicated area of detail of FIG.
5;
FIG. 8 is a longitudinal cross-sectional view
which illustrates initial plunger advancement of the
embodiment of the tagging device shown in FIG. 1;
FIG. 9 is a longitudinal cross-sectional view
which illustrates full distal advancement of the embodiment
r
of the tagging device shown in FIG. 1;
FIG. 10 is a perspective view which illustrates
the embodiment of the tagging device shown in FIG. 1
inserted into body tissue in a retracted position of the
plunger;
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FIG. 11 is a perspective view which illustrates the
embodiment of the tagging device shown in FIG. 1 inserted
into body tissue in an advanced position of the plunger;
FIG. 12 is a perspective view which illustrates the
5 embodiment of the tagging device shown in FIG. 1 anchored in
position with the hollow needle removed from within the body
tissue;
FIG. 13 is a perspective view which illustrates the
embodiment of the tagging device shown in FIG. 1 in which the
anchoring assembly is detached from the device and secured in
position within the body tissue;
FTG. 14 is a perspective view of another embodiment
of the tagging device;
FIG. 15 is a perspective view with parts separated
of the tagging device of FIG. 14;
FIG. 16 is a perspective view of the anchor
assembly of the tagging device of FIG. 14;
FIG. 17 is a top view of the tagging device of FIG.
14;
FIG. 18 is a longitudinal cross-sectional view
taken along section line 8-8 of FIG. 17;
FIG. 19 is an enlarged view of the distal end of
the embodiment of the tagging device shown in the indicated
area of detail of FIG: 18;
FIG. 20 is an enlarged view of the proximal end of
the body of the embodiment of the tagging device shown in the
indicated area of detail of FIG. 18;
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FIG. 21 is a partial side cross-sectional view
which illustrates the distal end of the tagging device of
FIG. 14 in a retracted plunger position;
FIG. 22 is a partial side cross-sectional view of
the distal end of the tagging device of FIG. 14 which
illustrates initial plunger advancement;
FIG. 23 is a partial side cross-sectional view
which illustrates final plunger advancement of the
embodiment of the tagging device of FIG. 14;
FIG. 24 is a partial side cross-sectional view
which illustrates the anchor assembly of the tagging device
shown in FIG. 14 in the fully advanced position;
FIG. 25 is a side view of an embodiment of tissue
marking assembly of the present invention;
FIG. 26 is a side view, partially in section, of
the tissue marking assembly of FIG. 25;
FIG. 27 is a side view similar to FIG. 25 with the
anchor in a second position; and
FIG. 28 is a side view, partially in section, of
the tissue marking assembly of FIG. 25, with the anchor in
the second position.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Preferred embodiments of the presently disclosed
tagging device will now be described in detail with
reference to the drawings, in which like reference numerals
designate
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identical or corresponding elements in each of the several
views.
One embodiment of the presently disclosed tagging
device will now be described with reference to FIGS. .1-13. In
FIGS. 1 and 2, tagging device l0 generally includes a~body 20
formed of first and second body halves 22, 24, an elongated
tube 26 extending distally from the body 20, an anchoring
assembly 12 supported on the elongated tube 26, and an
actuator assembly 34 operably associated with the anchor
assembly 12.
Referring to FIG. 3, (also shown in FIGS. 8 and 9)
the body 20 defines a stepped throughbore 50 having a first
diameter portion 52 and a second smaller diameter portion 54.
The first diameter portion 52 opens onto a rear face of the
body 22, 24. The second diameter portion 54 is connected to
the proximal end of the first diameter portion 52, and opens
onto a distal face of the body 20. The body 20 is flared
outwardly at its distal end, and includes a pair of sidewalls
25, 27 having spaced vertical ridges 29 formed thereon. The
flared distal end and the spaced vertical ridges 29
facilitate grasping and actuation of the device.
The actuator assembly 34 includes an actuator knob
40, an actuator piston 42, and an actuator plunger 38. The
actuator piston 42 is configured to be slidably positioned
within the first diameter portion 52 of the throughbore 50. A
proximal end of the piston 42 extends from the throughbore 50
and is connected to the actuator knob 40. The actuator
CA 02513439 1996-10-16
plunger 38 has a proximal end 39 fastened to the distal end
of the piston 42, and a distally extending body portion.
The distally extending body portion passes through the
second diameter portion 54 of the throughbore 50 into the
elongated tube 26. y
Referring to FIGS. 4-7, the proximal end of the
elongated tube 26 is secured within the smaller diameter
portion 54 of the throughbore 50. The distally extending
body portion of the plunger 38 extends from within the
throughbore 50 into the elongated tube 26 and can be
reciprocated therein by pressing on the actuator knob 40. To
prevent inadvertent proximal movement of the actuator
assembly 34 and possible disengagement from the body 20, the
actuator piston 42 has a resilient latch member 58
cantilevered thereto positioned to be engaged in an opening
5G formed in the body 24. The latch member 58 includes a
free end 60 that projects into the opening 5G when the
actuator assembly 34 is in a retracted position. Proximal
movement of the actuator 34 beyond the fully retracted
position is prevented by engagement between the free end 60
of the latch member 58 and an inner surface G2 of the opening
56. Distal movement of the actuator piston 42 causes a
sidewall of the latch member 58 to engage another wall of
opening 56 to bias the latch member 58 from within the
opening 56 and permit distal movement of the actuator
assembly 34.
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Referring temporarily back to FIG. 3, the first
diameter portion 52 of the throughbore 50 has a planar wall
59. The actuator piston 42 also includes a planar wall G1
configured to slidably engage the planar wall 59 of the
throughbore 50 to prevent relative rotation therebetween.
Referring again to FIGS. 4 to 7, anchoring assembly
12 includes an anchor 14, an elongated member 16, for
example, wire and a guide member 18. The anchor 14 is
configured to be positioned in the distal end of the
elongated tube 26, and includes an intermediate opening G4 to
facilitate attachment to one end of the elongated member 1G.
The proximal end of the elongated member 16 is fastened to
the guide member 18 which is formed with a cylindrical
longitudinal throughbore 45 configured to permit the guide
member 18 to be slidably received about the elongated tube
2G. A slot 32 is formed in the distal end of the elongated
needle 26 to permit the elongated member 1G to communicate
directly with the anchor 14. The proximal end of the
elongated tube 26 includes a section G3 of increased
diameter. The guide member 18 is slidably positioned about
the section G3 of increased diameter to increase the
frictional fit between the two members.
The distal end of the plunger 38 includes an angled
surface 44 that engages the proximal end of the anchor 14
when the plunger is moved distally, and is positioned to
pivot the distal end of the anchor 14 about the proximal end
of the anchor 14.
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In use, as shown in FIGS. 8-13, elongated tube 2G
is positioned to locate a breast lesion, as shown in FIG. 10,
by inserting the tagging device 10 as indicated by arrow "A".
The location is preferably confirmed using known techniques
such as mammographics, stereotactics or X-ray. As shown in
FIGS. 8-9 and 11, the tagging device 10 is actuated by
grasping the body 20 and pressing down on the actuator knob
40 to move the actuator piston 42 and plunger 38 distally, as
indicated by Arrows "B" in FTGS. 8, 9 and 11, into engagement
with the anchor 14. As the anchor 14 is pushed distally,
elongated member 1G also travels distally. The guide member
18 is thus pulled distally by elongated member 1G. However,
guide member 18 is positioned on increased diameter portion
63 of the elongated tube 26, and its movement therealong is
retarded by friction. Thus, anchor 14 traverses an arcuate
path in the direction of Arrow "C" in FIGS. 8, 9 and 11 as
plunger 38 moves distally. The anchor 14 is pushed
completely from the distal end of the elongated tube 26 and
will continue to pivot about the distal tip of the angled
surface 44. At this point, the anchor 14 will have been
rotated approximately ninety degrees and will be anchored in
position marking the lesion site.
As illustrated in FIGS. 12 and 13, the guide member
18 can be removed as indicated by Arrow ~~D~~ in FTG. 12 from
the elongated tube 2G after the anchor 14 has been ejected.
The guide member 18 can be slid from the elongated tube 2G
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easily because the diameter of the elongated tube 2G is not
increased towards the distal end of the tube 26.
A further embodiment of the presently disclosed
tagging device will now be described with reference to FIGS.
14 to 24. In FIGS. 14 and 15, tagging device 100 includes a
body 120 having first and second body halves 122, 124
defining a stepped throughbore having a first diameter
portion 152 and a second diameter portion 154. The
throughbore is configured to slidably receive a piston
142 and a plunger 138 of an actuation assembly 134. An
elongated tube 12G is fastened within the stepped throughbore
150 and extends distally from the body 122, 124. The proximal
end of the actuator assembly 134 includes an actuator knob
140 which can be pressed to move the plunger 138 distally
within the tube 126. All of the above features have been
discussed with reference to the first embodiment and will not
be discussed in detail herein.
Referring to FIGS. 16 to 20, an anchor assembly
includes an arcuate anchor 114 and an elongated member 11G
fastened to a central portion of the anchor 114 at an
attachment point 117. The anchor 114 slopes upwardly from
the attachment point 117 in the proximal and distal
directions along its longitudinal axis. The anchor 114 is
formed with a distal end having a tapered surface with an
edge 119 and a proximal end having a tail 121 which extends
along a curved surface 127 to a position substantially
perpendicular to the upwardly sloping proximal end of the
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anchor 114. The anchor 114 is positioned in the distal end
of the tube 126 and the elongated member 116 extends from the
attachment point 117 of anchor 114 proximally within the tube
126.
As shown in FIGS. 19 and 20, the plunger 138 is
formed from a tube which has a proximal end 129 fastened to
the actuator piston 142 via a pin 125 and a distal end 131
positioned to engage the tail 121 of the anchor 114. The
anchor 114 is configured to be slidably positioned within the
distal end of the tube 126. The tapered surface 119, the
curved surface 127 and the attachment point 117 of the anchor
fractionally engage inner surfaces of the tube 126 to retain
the anchor 114 within the tube 126. The distal ends of the
tube 126 and the tubular plunger 138 comprise hollow slots
132 and 133, respectively. Each slot 132, 133 is dimensioned
to allow passage of the wire 116 but prevent passage of the
anchor 114.
In use, as shown in FIGS. 21 to 24, tube 126 is
positioned to locate a breast lesion by inserting the tagging
device 100 into body tissue 160 adjacent suspect tissue. The
location is preferably confirmed using known techniques such
as mammographics, stereotactics or X-ray. The tagging device
100 is actuated by pressing down on the actuator knob 140 to
move the actuator piston 142 and plunger 138 distally into
engagement with the tail 121 of the anchor 114. Because of
the angle of the tail 121 with respect to the plunger 138,
the anchor 114 is pivoted, as indicated by Arrow "F" in FIGS.
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21 to 23, until the curved surface 127 of the anchor 114 is
positioned within the distal end of the plunger 138.
At this point, the anchor 114 will have been
rotated to a position substantially perpendicular to the
elongated member 116 marking the lesion site. Since the
anchor 114 is no longer frictionally held within the tube
126, the tube 126 can be easily separated from the elongated
member 116 as shown in FIG. 24 leaving the end of the
elongated member 116 extending from the body.
Turning to the alternative embodiment of FIGS. 25-
28, tissue marking assembly 200 includes first handle 202,
second handle 204, first elongated member 206, second
elongated member 208 and anchor 210. The materials of
construction of the various components of tissue marking
assembly.200 are preferably as described herein for the other
embodiments. First elongated member 206 is fixedly attached
to first handle 202, while second elongated member 208 is
fixedly attached to second handle 204. Both first and second
elongated members 206, 208 are.fixedly attached to anchor 210
in a spaced relation, as shown. Referring to the partial
sectional views of FIGS 26 and 28, both first and second
handles 202, 204 include an internal passage (passages 212
and 214, respectively) which are sized to receive an
appropriate structure, e.g., a needle, for introducing the
anchor to the target tissue. Thus, internal passages 212,
214 are in axial alignment to facilitate passage of the
introducing structure therethrough.
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First handle 202 is movable with respect to second
handle 204, thereby allowing the user to remotely rotate
anchor 210 thorough at least 90~. The degree to which anchor
21o may be remotely rotated may be modified by increasing the
degree to which first and second handles 202, 204 are
relatively movable. First handle 202 includes an outwardly
directed flange 216 which is sized to engage inwardly
directed stop 218 on second handle 204, as shown in FIG. 28.
Abutment of flange 216 with stop 218 limits the relative
movement of first handle 202 relative to second handle 204.
In a preferred embodiment, travel of first handle 202
relative to second handle 204 from the position shown in
FIGS. 25 and 26 to the position shown in.FIGS. 27 and 28
effects a 90g rotation of anchor 210.
Second handle 204 preferably includes finger grips
220 on a distal face thereof, and first handle 202 preferably
defines a finger loop 222. Finger grips 220 and finger loop
222 facilitate movement of first handle 202 relative to
second handle 204 to effect rotation of anchor 210.
As shown in FIGS. 25 and 26, first handle 202 is in
its distal-most position relative to second handle 204.
Thus, the operative length of first elongated member 206,
which is the length of first elongated member 20G from the
finger grips of second handle 204 to anchor 210, is, roughly
equal to the corresponding operative length of second
elongated member 208. Accordingly, anchor 210 is oriented
transverse to the longitudinal axis of elongated members 206,
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208. As shown in FIGS 27 and 28, however, first handle 202
is in its proximal-most position relative to second handle
204. In this position, the operative length of first
elongated member 206 is substantially less than the operative
5 length of second elongated member 208, thereby effecting
rotation of anchor 210 into substantial alignment with the
longitudinal axis of elongated members 206, 208.
In use, first and second handles 202, 204 may be
repeatedly moved between the relative positions of FIGS. 25,
10 26 and FIGS. 27, 28, as desired, so as to move anchor 210
between its transverse and longitudinal orientations. In
this way, anchor 210 may be introduced (longitudinal
orientation), deployed in target tissue (transverse
orientation), undeployed (longitudinal orientation) and
15 removed, if desired, or redeployed in the same or a different
location (transverse orientation). The ability to deploy and
redeploy anchor 210 provides the user with increased
flexibility and advantageously improves the user's ability to
position anchor 210 in the appropriate tissue.
It will be understood that various modifications
may be made to the embodiments disclosed herein. For
example, the elongated member need not be made from wire but
rather could be made from another strand, fiber, or filament
of natural or manufactured material. Therefore, the above
description should not be construed as limiting, but merely
as exemplifications of preferred embodiments. Those skilled
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in the art will envision other modifications within the scope
and spirit of the claims appended hereto.
