U.S. patent application number 15/408999 was filed with the patent office on 2017-05-04 for apparatus for the percutaneous marking of a lesion.
This patent application is currently assigned to Bard Peripheral Vascular, Inc. and Bard Shannon Limited. The applicant listed for this patent is Bard Peripheral Vascular, Inc. and Bard Shannon Limited. Invention is credited to Richard M. Chesbrough, Richard E. Davis, Steven E. Field, Ryan L. Goosen, Jeffery W. Zerfas.
Application Number | 20170119492 15/408999 |
Document ID | / |
Family ID | 24386199 |
Filed Date | 2017-05-04 |
United States Patent
Application |
20170119492 |
Kind Code |
A1 |
Chesbrough; Richard M. ; et
al. |
May 4, 2017 |
APPARATUS FOR THE PERCUTANEOUS MARKING OF A LESION
Abstract
A method for safely operating a marking apparatus includes:
providing a handle, a cannula that extends from the handle, a
stylet slidably received within a lumen of the cannula for movement
between a ready position and an extended position, and a plunger
coupled to the stylet; providing a safety that comprises a channel
provided on one of the handle and the plunger and a catch provided
on the other of the handle and the plunger; defining a safety-on
position wherein the catch and the channel are rotationally
misaligned; defining a safety-off position wherein the catch and
the channel are rotationally aligned; and rotating the catch with
respect to the channel to move the safety from the safety-on
position to the safety-off position to permit movement of the
plunger and the stylet from the ready position to the extended
position to expel the imaging marker from the cannula.
Inventors: |
Chesbrough; Richard M.;
(Bloomfield Hills, MI) ; Field; Steven E.; (Grand
Rapids, MI) ; Goosen; Ryan L.; (Caledonia, MI)
; Zerfas; Jeffery W.; (Kalamazoo, MI) ; Davis;
Richard E.; (Belding, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bard Peripheral Vascular, Inc. and Bard Shannon Limited |
Tempe |
AZ |
US |
|
|
Assignee: |
Bard Peripheral Vascular, Inc. and
Bard Shannon Limited
|
Family ID: |
24386199 |
Appl. No.: |
15/408999 |
Filed: |
January 18, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14072436 |
Nov 5, 2013 |
9579159 |
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15408999 |
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13248279 |
Sep 29, 2011 |
8579931 |
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14072436 |
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12335118 |
Dec 15, 2008 |
8052708 |
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13248279 |
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10421517 |
Apr 23, 2003 |
7569065 |
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12335118 |
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09596160 |
Jun 16, 2000 |
6575991 |
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10421517 |
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60139580 |
Jun 17, 1999 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/3987 20160201;
A61B 2090/3925 20160201; A61B 90/39 20160201; A61M 5/007 20130101;
A61B 2090/3995 20160201; A61B 2090/3908 20160201; A61B 2090/3966
20160201; A61B 17/3468 20130101; A61B 8/481 20130101 |
International
Class: |
A61B 90/00 20060101
A61B090/00; A61B 17/34 20060101 A61B017/34; A61B 8/08 20060101
A61B008/08 |
Claims
1-99. (canceled)
100. A method for safely operating a marking apparatus in a
percutaneous imaging marker placement procedure, comprising:
providing a handle, a cannula that extends from the handle, a
stylet slidably received within a lumen of the cannula for movement
between a ready position and an extended position, an imaging
marker disposed completely within a marker recess formed by the
cannula and the stylet, and an actuator having a plunger connected
to the stylet to move the stylet from the ready position to the
extended position to expel the imaging marker from the cannula;
providing a safety that comprises a channel provided on one of the
handle and the plunger and a catch provided on the other of the
handle and the plunger, the catch being rotatable relative to the
channel; defining a safety-on position wherein the catch and the
channel are rotationally misaligned so as to prevent movement of
the plunger and stylet from the ready position to the extended
position; defining a safety-off position wherein the catch and the
channel are rotationally aligned so as to permit movement of the
plunger and stylet from the ready position to the extended
position; and rotating the catch with respect to the channel to
move the safety from the safety-on position to the safety-off
position to permit movement of the plunger and stylet from the
ready position to the extended position to expel the imaging marker
from the cannula.
101. The method of claim 100, wherein with the safety in the
safety-off position, the method further comprising manually moving
the plunger in a distal direction to move the stylet from the ready
position to the extended position so as to eject the imaging marker
from the cannula.
102. The method of claim 101, comprising manually controlling a
rate at which the plunger is moved so as to control a rate at which
the imaging marker is ejected from the cannula.
103. The method of claim 101, comprising manually positioning a tip
of the cannula as the imaging marker is being ejected.
104. The method of claim 101, comprising locking the stylet in the
extended position.
105. The method of claim 104, wherein the catch is part of the
plunger, and the act of locking is effected by engaging the catch
of the plunger with a detent of the handle.
106. The method of claim 100, comprising providing the handle with
a grip portion having an enlarged diameter portion against which a
user's fingers can bear during an insertion of the cannula into a
patient.
107. The method of claim 100, wherein the safety is positioned in
the safety-on position, such that the catch and the channel are
rotationally misaligned, before packaging or use, such that the
plunger cannot be depressed or advanced within the handle.
108. A method of operating a marking apparatus for the percutaneous
placement of an imaging marker at a location in a patient,
comprising: providing a handle defining a hollow interior;
providing a cannula mounted to the handle and configured to extend
from the handle, the cannula being configured to define a lumen
open to the hollow interior of the handle, a distal end of the
cannula forming an insertion tip with an axial opening at the
insertion tip; providing a stylet having a proximal end with a
proximal tip and a distal end, slidably received within the lumen
for movement between a ready position and an extended position,
where, in the ready position, the distal end of the stylet is
spaced inwardly from the insertion tip to define a marker recess
between the distal end of the stylet and the axial opening, and in
the extended position the distal end of the stylet extends at least
into the marker recess; providing an imaging marker disposed
completely within the marker recess to be expelled through the
axial opening by movement of the stylet from the ready position to
the extended position, wherein the imaging marker has no lead long
enough to extend from the interior of the tissue mass to the
exterior of the tissue mass when the imaging marker has been placed
in the tissue mass; providing an actuator having a plunger
connected to the proximal end of the stylet, and configured to
effect the relative movement of the cannula and the stylet to move
the stylet from the ready position to the extended position; and
operating a safety to selectively prohibit the sliding of the
stylet, wherein the safety comprises a channel provided on one of
the handle and the plunger and a catch provided on the other of the
handle and the plunger such that when the catch and channel are
aligned, the stylet can slide from the ready position to the
extended position, and when the catch and the channel are
misaligned, the stylet cannot slide from the ready position to the
extended position.
109. The method of claim 108, wherein with the safety positioned
such that the catch is aligned with the channel, the method further
comprising manually moving the stylet from the ready position to
the extended position so as to eject the imaging marker from the
cannula.
110. The method of claim 109, comprising manually controlling a
rate at which the plunger is moved so as to control a rate at which
the imaging marker is ejected from the cannula.
111. The method of claim 109, comprising manually positioning a tip
of the cannula as the imaging marker is being ejected.
112. The method of claim 109, comprising locking the stylet in the
extended position.
113. The method of claim 108, wherein the catch is part of the
plunger, and the act of locking is effected by engaging the catch
of the plunger with a detent of the handle.
114. The method of claim 108, comprising providing the handle with
a grip portion having an enlarged diameter portion against which a
user's fingers can bear during an insertion of the cannula into the
patient.
115. The method of claim 108, wherein before packaging or use of
the marking apparatus, the safety is operated such that the catch
and the channel are misaligned so that the plunger cannot be
depressed or advanced within the handle.
116. The method of claim 108, wherein at least a portion of the
stylet remains within the hollow interior of the handle as the
stylet is slid between the ready position to the extended
position.
117. The method of claim 108, further comprising fixing the stylet
in the extended position to prevent a retraction of the stylet from
the extended position.
118. The method of claim 117, wherein the act of fixing is achieved
by providing a detent on one of the plunger and the handle and the
catch on the other of the plunger and the handle, the catch being
receivable within the detent as the stylet is moved from the ready
position to the extended position.
119. A method for safely operating a marking apparatus, comprising:
providing a handle, a cannula that extends from the handle, a
stylet slidably received within a lumen of the cannula for movement
between a ready position and an extended position, and a plunger
coupled to the stylet; providing a safety that comprises a channel
provided on one of the handle and the plunger and a catch provided
on the other of the handle and the plunger; defining a safety-on
position wherein the catch and the channel are rotationally
misaligned; defining a safety-off position wherein the catch and
the channel are rotationally aligned; and rotating the catch with
respect to the channel to move the safety from the safety-on
position to the safety-off position to permit movement of the
plunger and the stylet from the ready position to the extended
position to expel the imaging marker from the cannula.
Description
RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/421,517, filed Apr. 23, 2003, which is a
divisional of U.S. patent application Ser. No. 09/596,610, filed
Jun. 16, 2000, which claims the priority of U.S. Provisional Patent
Application Ser. No. 60/139,580, filed Jun. 17, 1999.
BACKGROUND OF THE INVENTION
[0002] Field of the Invention
[0003] This invention relates generally to an apparatus for the
percutaneous positioning of a radiopaque marker for identifying the
location of a lesion in a stereotactic biopsy procedure. More
particularly, the invention relates to an introducer having a
hollow cannula in combination with a movable stylet and a
radiopaque marker disposed within the cannula and ejected from it
by movement of the stylet.
[0004] Related Art
[0005] Tissue biopsies are commonly performed on many areas and
organs of the body where it is desirable to ascertain whether or
not the biopsied tissue is cancerous. Often, a lesion or other
tissue to be biopsied is identified through use of an imaging
technique such as a computerized axial tomography (CAT) scan,
ultrasonography, and mammography.
[0006] One problem commonly encountered, especially in breast
biopsies, is that the lesion is so small that the biopsy reduces
its size to the extent that it is no longer visible by the imaging
method employed. In such circumstances, it is desirable to place a
radiopaque marker at the site of the biopsy to enable the medical
practitioner subsequently to locate the lesion quickly and
accurately in the event complete removal of the affected tissue is
indicated. This problem is currently met by placing a radiopaque
marker at the biopsy area by means of a cannula or similar device
housing the marker.
[0007] More particularly, one of the markers heretofore in use is a
staple-type clip. The clip is introduced through a large-diameter
cannula, specifically one of 11 gauge.
[0008] Some practitioners employ an embolization coil as a marker.
This requires them to find a cannula or hollow needle of a size to
receive the coil and some means to force the coil through the
needle, all the while trying to keep these components together and
sterile.
[0009] Prior devices for marking a biopsy area have several other
disadvantages. A significant disadvantage is that the marker is not
always completely ejected from the cannula or can be drawn back
into or toward the cannula by the vacuum created upon the
withdrawal of the cannula, which results in the marker being moved
from the intended site, leading to inaccurate identification of the
location of the biopsy area. A second major disadvantage is that
current markers have a tendency to migrate within the tissue, also
causing error in determining the biopsy location.
SUMMARY OF THE INVENTION
[0010] The present invention provides a biopsy marking apparatus
for the percutaneous placement of a marker at a biopsy site in a
tissue mass to facilitate subsequent determination of the location
of the biopsy site. The biopsy marking apparatus comprises an
introducer having a handle to be grasped by a user, a cannula, a
stylet, and a radiopaque marker. The cannula has a proximal end
mounted to the handle and a distal end defining an insertion tip.
The stylet is slidably received within the cannula for movement
between a ready position in which a distal end of the stylet is
spaced inwardly from the cannula tip to form a marker recess
between the distal end of the stylet and the cannula tip, and an
extended position in which the distal end of the stylet extends at
least to the cannula tip to effectively fill the marker recess.
[0011] A plunger is movably mounted to the handle and operably
engages the stylet, the plunger being movable between a first
position and a second position for moving the stylet between the
ready position and the extended position.
[0012] A latch is provided for fixing the stylet in the extended
position to prevent retraction of the stylet from that
position.
[0013] A radiopaque marker is disposed within the marker recess,
whereby, when the plunger is moved between the first and second
positions, the stylet is moved from the ready to the extended
position to eject the radiopaque marker from the marker recess, and
the latch fixes the stylet in the extended position to prevent the
return of the marker to the marker recess.
[0014] The latch preferably comprises a detent on either the
plunger or the handle and a catch on the other, the catch being
receivable within the detent as the plunger is moved from the first
to the second position.
[0015] In another aspect, the invention also provides a radiopaque
marker having a marker body and an anchor extending away from the
body for fixing the location of the radiopaque marker in a tissue
mass by the tissue mass prolapsing about the anchor. Preferably,
the body has an interior hollow portion forming an air trap to
enhance the ultrasound characteristic of the radiopaque marker.
[0016] Other features and advantages of the invention will be
apparent from the ensuing description in conjunction with the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] In the drawings:
[0018] FIG. 1 is a plan view of an introducer used to place a
radiopaque marker at a biopsy location in accordance with the
invention;
[0019] FIG. 2 is an enlarged sectional view of the area II of FIG.
1, illustrating the position of a radiopaque marker within the
introducer prior to ejection;
[0020] FIG. 3 is an enlarged sectional view of the area III of FIG.
1, illustrating the arrangement of a handle, a plunger, and a
stylet of the introducer;
[0021] FIG. 4 is a sectional view taken along line 4-4 of FIG. 1
and illustrating the introducer in a ready condition;
[0022] FIG. 5 is a sectional view taken along line 4-4 of FIG. 1
and illustrating the introducer in a discharged condition;
[0023] FIG. 6 is an enlarged view of a first embodiment of a
radiopaque marker according to the invention;
[0024] FIG. 7 is an enlarged view of a second embodiment of a
radiopaque marker according to the invention;
[0025] FIG. 8 is an enlarged view of a third embodiment of a
radiopaque marker according to the invention;
[0026] FIG. 9 is an enlarged view of a fourth embodiment of a
radiopaque marker according to the invention;
[0027] FIG. 10 is a partially broken away perspective view, greatly
enlarged, of a fifth embodiment of a radiopaque marker according to
the invention;
[0028] FIG. 11 is a plan view of the radiopaque marker of FIG.
10;
[0029] FIG. 12 is a greatly enlarged view of a sixth embodiment of
a radiopaque marker according to the invention;
[0030] FIG. 13 is a greatly enlarged view of a seventh embodiment
of a radiopaque marker according to the invention;
[0031] FIG. 14 is a greatly enlarged view of an eighth embodiment
of a radiopaque marker according to the invention; and
[0032] FIG. 15 is a greatly enlarged view of a ninth embodiment of
a radiopaque marker according to the invention.
DETAILED DESCRIPTION
[0033] FIGS. 1 to 4 illustrate a biopsy marking apparatus 10
according to the invention, which is capable of the percutaneous
placement of a radiopaque marker at the location of a tissue
biopsy. The biopsy marking apparatus 10 comprises an introducer 12
and a radiopaque marker 14 (FIG. 2) contained within the introducer
12. The introducer 12 includes a handle 16 having a hollow interior
18. The handle 16 comprises a grip portion 20 from which extends a
tapered nose portion 22. The grip portion 20 defines a rear opening
24 that provides access to the hollow interior 18. A pair of
detents 26 are formed in the grip portion 20 near the rear opening
24. Channels 28 are formed on the interior surface of the grip
portion 20 and extend from the rear opening 24 to the detents
26.
[0034] The nose portion 22 comprises a guide passage 30 extending
from the tip of the nose portion 22 to the hollow interior 18 of
the handle 16. The guide passage 30 decreases in diameter inwardly
from the tip of the nose portion to form a cannula seat 32.
Alternatively, the diameter of the guide passage 30 may be
substantially equal to or slightly smaller than the outer diameter
of a cannula 34, which in any case is press-fit within the cannula
seat 32. As is customary, the cannula is formed with a hollow
interior 36 and a sharpened tip 38.
[0035] A stylet 40 comprising a shaft 42 and a base 44 is received
within the hollow interior 18 of the handle 16 in a manner such
that the shaft 42 extends through the guide passage 30 and into the
cannula interior 36 and the stylet base lies within the hollow
interior 18.
[0036] A plunger 50 comprises a cylindrical body 52 from which
extend a pair of catches 54 at diametrically opposed positions. The
cylindrical body 52 is sized so that it is slidably received within
the rear opening 24 of the handle 16, where it is so oriented with
respect to the handle that the catches 54 are aligned with the
guide channels 28.
[0037] It will be recognized that the foregoing construction
provides a biopsy marking apparatus which may be preassembled as a
unit and prepackaged, all under sterile conditions, thereby
affording the practitioner substantially greater convenience and
reliability. Such a construction also permits use of a narrower
cannula, which may be of 14 gauge or smaller.
[0038] In operation, the introducer 12 begins in the ready
condition shown in FIG. 4. In this condition, the stylet shaft is
received within the cannula but does not extend to the cannula tip
38, thereby forming a marker recess 46 within the cannula 34, the
radiopaque marker 14 is disposed within the marker recess 46, and
the plunger 50 is in a position relative to the handle 20 in which
the catches are outside the handle; that is, they are not received
within the detents 26. However, the plunger 50 is so oriented with
respect to the handle that the catches 54 are aligned with the
guide channels 28.
[0039] With the introducer in the ready condition, the cannula is
positioned so that its tip is at or near the location of a tissue
mass where a biopsy has been taken. Preferably, the cannula tip is
positioned by using imaging systems. The cannula tip 38 can be
designed for enhanced visibility using common imaging systems, such
as CAT scan, ultrasonography and mammography. Suitable cannula tips
are disclosed in U.S. Pat. No. 5,490,521, issued Feb. 13, 1996 to
R. E. Davis and G. L. McLellan, which is incorporated by reference.
Ultrasound enhancement technology is also disclosed in U.S. Pat.
No. 4,401,124, issued Aug. 30, 1983 to J. F. Guess, D. R. Dietz,
and C. F. Hottinger; and U.S. Pat. No. 4,582,061, issued Apr. 15,
1986 to F. J. Fry.
[0040] Once the cannula is positioned at the desired location, the
plunger 50 is moved from its first or ready condition as
illustrated in FIGS. 1 to 4 to a second or discharged condition in
which the catches 54 are received within the detents 26 to lock the
plunger 50 in the discharged condition and the stylet shaft extends
beyond the cannula tip 38. The catches 50 and detents combine to
function as a latch for locking the plunger in the discharged
condition. As the plunger 50 is moved from the ready condition to
the discharged condition, the plunger 50 drives the stylet base 44
forward to advance the stylet shaft 42 within the cannula interior
36. As the stylet shaft 42 is advanced, the radiopaque marker 14 is
ejected from the marker recess 46 through the cannula tip 38 and
into the tissue at the biopsy location.
[0041] It is preferred that the stylet shaft 42 be sized in a
manner such that when the plunger 50 is in the discharged condition
the stylet shaft 42 extends beyond the cannula tip 38 to ensure the
complete ejection of the radiopaque marker 14 from the marker
recess 46. The extension of the stylet shaft 42 beyond the cannula
tip 38 also prevents the radiopaque marker 14 from being drawn back
into the marker recess upon the removal of the introducer 12 from
the tissue mass, which can occur as the tissue mass collapses and
is drawn towards and into the cannula by the resilient nature of
the tissue mass and the creation of a vacuum by the cannula as it
is withdrawn from the tissue.
[0042] The rate at which the plunger 50 is moved from the ready
condition to the discharged condition is preferably manually
controlled by the user to control the rate at which the marker 14
is ejected into the tissue mass. Manual control of the ejection
rate of the radiopaque marker provides the user with the ability to
adjust the position of the cannula tip as the marker is being
ejected and thereby permits additional control of the final
location of the marker within the tissue mass. In other words,
"on-the-fly" adjustment of the cannula tip during positioning of
the marker 14 enables a more accurate placement of the marker.
[0043] The biopsy marking apparatus 12 may be placed in a safety
condition (not shown) before packaging or use by rotationally
orienting the plunger 50 with respect to the handle 16 so that the
catches 54 are out of alignment with the guide channels 28, whereby
the plunger cannot be depressed or advanced within the handle. It
will be apparent that the marking apparatus can be placed in the
ready condition previously described simply by rotating the plunger
relative to the handle until the catches 54 are aligned with the
guide channels 28.
[0044] It will also be apparent that the biopsy marking apparatus
10 may incorporate or be fitted with any one of several known
trigger devices, some of them spring-loaded, for advancement of the
plunger 50. Such a trigger device is disclosed, for example, in
U.S. Pat. No. 5,125,413, issued Jun. 30, 1992 to G. W. Baran.
[0045] It should be noted that as a variation of the foregoing
procedure the cannula employed during the biopsy procedure might be
left in place with its tip remaining at the site of the lesion. The
introducer 12 of the present invention would then be directed to
the site through the biopsy cannula or, alternatively, the marker
14 of the present invention would be introduced to the biopsy
cannula and ejected from its tip into the tissue mass by fitting
the biopsy cannula to the introducer 12 in place of the cannula
34.
[0046] The radiopaque marker 14 used in combination with the
introducer 12 to mark the location of the tissue biopsy should not
only be readily visible using contemporary imaging techniques but
it should not migrate within the tissue from the position in which
it is initially placed. FIGS. 6 to 15 disclose various embodiments
of radiopaque markers 14 that are highly visible using contemporary
imaging techniques and are resistant to migration in the
tissue.
[0047] FIG. 6 illustrates a first embodiment 60 of a radiopaque
marker comprising a coil spring 62 from which extend radiopaque
fibers 64. The coil spring 62 is preferably made from platinum or
any other material not rejected by the body. The coil spring 62 is
wound to effectively form a hollow interior comprising one or more
air pockets, which are highly visible using contemporary ultrasound
imaging techniques. The radiopaque fibers 64 are preferably made
from Dacron, which is also highly visible using current imaging
techniques.
[0048] The radiopaque marker 60 is highly visible using any of the
commonly employed contemporary imagining techniques because of the
combination of reflective surfaces formed by the coils, the hollow
interior and the air pockets of the coil spring 62, as well as the
radiopaque fibers 64.
[0049] The coil spring 62 is pre-shaped prior to being loaded into
the marker recess 46 so that it tends to form a circular shape as
shown in FIG. 6 after it is ejected from the marker recess 46. The
circular shape tends to resist migration within the tissue.
[0050] FIG. 7 illustrates a second embodiment 70 of a radiopaque
marker having a star-burst configuration comprising a core 72 with
multiple fingers 74 extending from the core.
[0051] FIG. 8 illustrates a third embodiment 80 of a radiopaque
marker that is similar to the star-burst marker 70 in that it
comprises a core 82 from which extend three fingers 84. Each of the
fingers includes radiopaque fibers 86, which are preferably made
from Dacron or a similar material.
[0052] FIG. 9 illustrates a fourth embodiment 90 of a radiopaque
marker having a generally Y-shaped configuration comprising an arm
92 from which extend diverging fingers 94. The arm and fingers 92,
94 are preferably made from a suitable resilient metal such that
the fingers can be compressed towards each other and the entire
radiopaque marker 90 stored within the marker recess 46 of the
cannula. Upon ejection of the marker 90 from the marker recess 46
into the tissue mass, the fingers 94 will spring outwardly to
provide the marker 90 with an effectively greater cross-sectional
area.
[0053] In addition to providing the marker 90 with an effectively
greater cross-sectional area, the tips of the fingers 94, together
with the free end of the arm 92, effectively form points of contact
with the surrounding tissue mass that help to anchor the marker 90
in its release condition to prevent migration through the tissue
mass.
[0054] FIG. 10 illustrates a fifth embodiment 100 of a radiopaque
marker having a wire-form body in a horseshoe-like configuration
comprising a rounded bight portion 102 from which extend inwardly
tapering legs 104, each of which terminate in curved tips 106. The
entire marker 100 preferably has a circular cross section defining
a hollow interior 108. The hollow interior provides for the
trapping of air within the marker 100 to improve the ultrasound
characteristics of the marker 100.
[0055] The curved bight portion 102 and legs 104 preferably lie in
a common plane. However, the tips 106 extend away from the legs 104
and out of the common plane so that the tips 106 will better
function as anchors for the tissue that prolapses about the tips
106 once the marker 100 is ejected from the marker recess 46 and
the introducer 12 is withdrawn from the tissue mass.
[0056] FIG. 12 illustrates a sixth embodiment 110 of a radiopaque
marker that is similar to the horseshoe-like fifth embodiment
marker 100 in that it comprises a bight portion 112 from which
extend legs 114, which terminate in tips 116. The legs 114 of the
marker 110 are crossed relative to each other, unlike the legs of
the marker 100, providing the marker 110 with an effectively larger
cross- sectional diameter. The tips 116 are oriented at
approximately 90.degree. relative to the legs 114 to form anchors.
The marker 110 also has a hollow interior 118 for enhanced
radiopaque characteristics.
[0057] Though, as illustrated in FIG. 12, the tips 116 of the
marker 110 are oriented at approximately 90.degree. with respect to
the legs 114, it is within the scope of the invention for the tips
116 to extend at substantially any angle with respect to the legs
114. The tips 116 also need not extend away from the legs in the
same direction. For example, the tips 116 could extend in opposite
directions from the legs 114.
[0058] FIG. 13 illustrates a seventh embodiment 120 of a radiopaque
marker having a generally helical configuration comprising multiple
coils 122 of continuously decreasing radius. The helical marker 120
is preferably made from a radiopaque material and has a hollow
interior 124 to enhance its radiopaque characteristics. The
decreasing radius of the coils 122 provides the marker 120 with
multiple anchor points created by the change in the effective
cross-sectional diameter along the axis of the helix. In other
words, since the effective cross-sectional diameter of each coil is
different from the next and each coil is effectively spaced from
adjacent coils at the same diametric location on the helix, the
tissue surrounding the marker 120 can prolapse between the spaced
coils and each coil effectively provides an anchor point against
the tissue to hold the marker 120 in position and prevent its
migration through the tissue mass.
[0059] FIG. 14 illustrates an eighth embodiment 130 of a radiopaque
marker comprising a cylindrical body 132 in which are formed a
series of axially spaced circumferential grooves 134. The spaced
grooves 134 form a series of ridges 136 therebetween on the outer
surface of the cylindrical body 132. The cylindrical body 132
preferably includes a hollow interior 138.
[0060] The alternating and spaced ridges 136 and grooves 134
provide the marker 130 with a repeating diameter change along the
longitudinal axis of the cylindrical body 132. As with the helical
marker 120, the grooves 134 between the ridges 136 provide an area
in which the tissue surrounding the marker 130 can prolapse thereby
enveloping the ridges 136, which function as anchors for preventing
the migration of the marker 130 in the tissue mass.
[0061] FIG. 15 illustrates a ninth embodiment 140 of a radiopaque
marker comprising a cylindrical body 142 having an axial series of
circumferential grooves 144 whose intersections with adjacent
grooves form ridges 146. The cylindrical body 142 preferably
includes a hollow interior 148. An anchor 150 extends from the
cylindrical body 142. The anchor 150 comprises a plate 152
connected to the cylindrical body 142 by a wire 154.
[0062] The grooves 144 and ridges 146 of the maker 140 provide
anchors in the same manner as the grooves 134 and ridges 136 of the
marker 130. The anchor 150 further enhances the non-migrating
characteristics of the marker 140 by permitting a large portion of
the surrounding tissue mass to prolapse between the plate 150 and
the cylindrical body 142.
[0063] The fifth through the ninth embodiments all preferably have
a wire-form body. The various wire-form body shapes can be formed
by stamping the shape from metal stock or the bending of a
wire.
[0064] It should be noted that virtually all of the embodiments of
the radiopaque marker described as being hollow can be made without
a hollow interior. Similarly, those without a hollow interior can
be made with a hollow interior. The hollow interior improves the
ultrasound characteristics of the particular marker beyond the
inherent radiopaque and ultrasound characteristics attributable to
the marker shape and material. In practice, the use of the hollow
interior is limited more by manufacturing and cost considerations
rather than by performance.
[0065] Also, the shape of each marker can be altered to improve or
enhance its non-migrating characteristics by adding an express
anchor such as that disclosed in connection with the marker 140 or
by modifying the marker to provide more anchor points as may be
compatible with the basic configuration of the marker.
[0066] The combination of the enhanced radiopaque characteristics
of the markers and the enhanced non-migrating features result in
markers that are superior in use for identifying biopsy location
after completion of the biopsy. The ability to accurately locate
the biopsy site greatly reduces the amount of tissue that must be
removed in a subsequent surgical procedure if the biopsy is
cancerous. Additionally, the marker further enhances the ability to
use percutaneous methods for removing the entire lesion, reducing
the trauma associated with more radical surgical techniques.
[0067] The radiopaque markers described and illustrated herein are
smaller than the staple-type clip and embolization coil used
heretofore, thereby permitting a cannula of 14 gauge or less.
[0068] While the invention has been specifically described in
connection with certain specific embodiments thereof, it is to be
understood that this is by way of illustration and not of
limitation, and the scope of the appended claims should be
construed as broadly as the prior art will permit.
TABLE-US-00001 PARTS LIST 10 biopsy marking apparatus 12 introducer
14 radiopaque marker 16 handle 18 hollow interior 20 grip portion
22 nose portion 24 rear opening 26 detents 28 guide channels 30
guide passage 32 cannula seat 34 cannula 36 cannula interior 38
cannula pointed tip 40 stylet 42 stylet shaft 44 stylet base 46
marker recess 48 50 plunger 52 cylindrical body 54 catch 56 58 60
radiopaque marker 62 coil spring 64 radiopaque fibers 66 68 70
second embodiment radiopaque marker 72 core 74 markers 76 78 80
third embodiment radiopaque maker 82 core 84 fingers 86 88 90
fourth embodiment radiopaque marker 92 arm 94 fingers 96 98 100
fifth embodiment radiopaque marker 102 curved bight portion 104
legs 106 tips 108 110 sixth embodiment radiopaque marker 112 curved
bight portion 114 legs 116 tips 118 hollow interior 120 seventh
embodiment radiopaque marker 122 coil 124 126 128 130 eighth
embodiment radiopaque marker 132 cylindrical body 134 grooves 136
ridges 138 hollow interior 140 ninth embodiment radiopaque marker
142 cylindrical body 144 grooves 146 ridges 148 hollow interior 150
anchor 152 plate
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