U.S. patent application number 11/518826 was filed with the patent office on 2007-01-18 for surgical site marker delivery system.
Invention is credited to Michael Hoffa, Joseph L. Mark, Zachary R. Nicoson, Brian Zimmer.
Application Number | 20070016017 11/518826 |
Document ID | / |
Family ID | 37662502 |
Filed Date | 2007-01-18 |
United States Patent
Application |
20070016017 |
Kind Code |
A1 |
Mark; Joseph L. ; et
al. |
January 18, 2007 |
Surgical site marker delivery system
Abstract
A site marker delivery system is provided that may be used in
combination with a tissue cutting device for marking a biopsy site.
The system includes a tube attached to a hub. A push-rod is
slidably disposed within the lumen of the tube. The push-rod is
advanced forward through the lumen of the tube causing a marker
seated within the tube to be deployed at a biopsy site.
Inventors: |
Mark; Joseph L.;
(Indianapolis, IN) ; Hoffa; Michael; (Brownsburg,
IN) ; Zimmer; Brian; (Indianapolis, IN) ;
Nicoson; Zachary R.; (Indianapolis, IN) |
Correspondence
Address: |
RADER, FISHMAN & GRAUER PLLC
39533 WOODWARD AVENUE
SUITE 140
BLOOMFIELD HILLS
MI
48304-0610
US
|
Family ID: |
37662502 |
Appl. No.: |
11/518826 |
Filed: |
September 11, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11238295 |
Sep 28, 2005 |
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11518826 |
Sep 11, 2006 |
|
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60618868 |
Oct 14, 2004 |
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Current U.S.
Class: |
600/431 ;
600/564 |
Current CPC
Class: |
A61B 2090/3908 20160201;
A61B 17/3468 20130101; A61B 90/39 20160201; A61B 2017/00477
20130101; A61B 2090/3987 20160201 |
Class at
Publication: |
600/431 ;
600/564 |
International
Class: |
A61B 6/00 20060101
A61B006/00; A61B 10/00 20060101 A61B010/00 |
Claims
1-31. (canceled)
32. A marker delivery system, comprising: a cannula having
proximate and distal ends, wherein both of said proximal and distal
ends are open, said cannula defining a lumen extending between said
proximal and distal ends; wherein said cannula further includes at
least one holding tab connected to an internal surface of said
lumen of said cannula, adjacent to said distal end of said cannula,
said holding tab serving to frictionally engage at least a portion
of a marker to said cannula; and a push rod dimensioned to slidably
pass through said lumen of said cannula, entering in said distal
end, said push rod being operable to advance said marker past said
holding tab of said lumen out of said lumen and into a body
cavity.
33. The marker delivery system of claim 32, further including a
deployment plunger connected to a push rod.
34. The marker delivery system of claim 33, wherein said deployment
plunger includes a push plate having opposing surfaces and at least
one retaining arm extending away from said one of said opposing
faces, said retaining arm being operable to engage a complementary
retaining rim disposed on said proximal end of said cannula to lock
said push rod in place.
35. The marker delivery system of claim 33, wherein said deployment
plunger is integrally connected to said push rod.
36. The marker delivery system of claim 32, wherein said cannula
includes a pair of holding tabs arranged in an opposing manner,
said pair of holding tabs cooperating to frictionally retain at
least a portion of a marker to said cannula.
37. The marker delivery system of claim 32, wherein said holding
tab is constructed of a flexible material.
38. The marker delivery system of claim 32, wherein the marker is
at least partially retained within said cannula.
39. The marker delivery system of claim 32 further including a
handle connected to a portion of said cannula.
40. The marker delivery system of claim 39, wherein said handle is
integrally connected to said cannula.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 60/618,868 filed Oct. 14, 2004 which is hereby
incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] The invention generally relates to a biopsy site marker
delivery system that may be used with a biopsy tissue cutting
device. More particularly, the invention relates to a biopsy site
marker delivery system for non-surgically implanting a site marker
at a biopsy.
BACKGROUND OF THE INVENTION
[0003] In the field of breast cancer, stereotactically guided and
percutaneous biopsy procedures have increased in frequency as well
as in accuracy as modem imaging techniques allow the physician to
locate lesions with ever increasing precision. However, for a given
biopsy procedure, a subsequent examination of the biopsy site is
very often desirable.
[0004] For example, in those cases where the lesion is found to be
benign, a follow-up examination of the biopsy site may be conducted
at a later time. Where the lesion is found to be malignant, the
physician may want to place additional site markers to help guide
the surgeon to the malignancy.
[0005] A number of procedures and devices for marking and locating
particular tissue locations are known in the prior art. For
example, location wire guides are well known for locating lesions,
particularly in the breast. One such known device includes a
tubular introducer needle and an attached wire guide, which has at
its distal end, a helical coil configuration for locking into
position about the targeted lesion. The needle is introduced into
the breast and guided to the lesion site using an imaging system of
a known type, for example, X-Ray, ultrasound or magnetic resonance
imaging (MRI), at which time the helical coil at the distant end is
deployed about the lesion. Then, the needle may be removed from the
wire guide, which remains locked in position distally about the
lesion for guiding a surgeon down the wire to the lesion site
during subsequent surgery. While such a location system is
effective, it is obviously intended and designed to be only
temporary, and is removed once the surgery or other procedure has
been completed.
[0006] It is also known to employ biocompatible dyes or stains to
mark breast lesions. First, a syringe containing the colorant is
guided to the detection lesion, using an imaging system. Later,
during the extraction procedure, the surgeon harvests a tissue
sample from the stained tissue. However, while such staining
techniques can be effective, it is difficult to precisely localize
the stain. Also, the stains are difficult to detect
fluoroscopically and may not always be permanent.
[0007] Additionally, it is known to implant markers directly into a
patient's body using an invasive surgical technique. This enables a
practitioner to later return to the site of the graft by
identifying the rings, for evaluation purposes.
[0008] Each of the above systems and methods for marking a biopsy
site has disadvantages associated with effectiveness, accuracy, and
invasive surgical techniques. Accordingly, what is needed is a site
marker delivery system for delivering a marker to a biopsy site,
and deploying the marker at the site effectively, accurately, and
without the need for additional invasive surgical procedures.
SUMMARY OF THE INVENTION
[0009] In one embodiment of the present invention, the marker
delivery system further includes a hub having a proximal end, a
distal end and a channel extending between these ends. A tube
having a lumen, a proximal end and a distal end, is attachable to
the hub proximate the distal end thereof. The tube includes an
aperture in communication with the lumen. The aperture is formed
through a portion of a side wall of the tube proximate the distal
end thereof.
[0010] A push-rod is dimensioned to be slidably passed through the
channel of the hub and the lumen of the tube to the distal end
thereof. The push-rod is operative to advance a marker seated in
the lumen of the tube and out of the lumen through the aperture
formed in the side wall of the tube.
[0011] A tube guide may be provided that is selectively attachable
to a non-working end of a tissue cutting device to facilitate the
proper alignment of the tube with a channel of the tissue cutting
device. The tube guide includes proximal and distal ends and is
formed with a channel extending between these ends.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a perspective view of an embodiment of a site
marker delivery system according to the invention.
[0013] FIG. 1A is an enlarged view of a distal end of the site
marker delivery system of FIG. 1 in area A after deployment of a
site marker.
[0014] FIG. 1B is an enlarged view of a distal end of the site
marker delivery system of FIG. 1 in area A before deployment of a
site marker.
[0015] FIG. 2 is an exploded view of the embodiment of the site
marker delivery system of FIG. 1.
[0016] FIG. 3A is an enlarged view of the hub and deployment
trigger of the embodiment of the site marker delivery system of
FIG. 1 in a first position.
[0017] FIG. 3B is an enlarged view of the hub and deployment
trigger of the embodiment of the site marker delivery system of
FIG. 1 in a second position.
[0018] FIG. 4A is a perspective view of a tissue cutting device
that may be used with the embodiment of the site marker delivery
system of FIG. 1.
[0019] FIG. 4B is a cross-section of the tissue cutting device of
FIG. 4A illustrating the channel formed along the longitudinal
access of the tissue cutting device.
[0020] FIG. 5 is a fragmentary view of the tissue cutting device of
FIG. 4A and the tube guide of the embodiment of FIG. 1.
[0021] FIG. 5A is an enlarged view of the tube guide of the site
marker delivery system of FIG. 1.
[0022] FIG. 6 is a side view of the site marker delivery system of
FIG. 1A in a first position prior to deployment of the site
marker.
[0023] FIG. 7 is a side view of the site marker delivery system of
FIG. 1 attached to the tissue cutting device in a second position
after the site marker has been deployed.
[0024] FIG. 8 is a flow diagram of a method of using the site
marker delivery system of FIG. 1 to mark a biopsy site.
[0025] FIG. 9 is an alternative embodiment of a site marker
delivery system.
DETAILED DESCRIPTION OF THE INVENTION
[0026] An embodiment of a site marker delivery system 10 that may
be used in combination with a tissue cutting device for
efficiently, accurately and sanitarily depositing a marker at a
biopsy site, is disclosed. The marker delivery system 10 includes
advantages over conventional delivery devices which are sometimes
difficult to use, often result in inaccurate placement of the
marker within the biopsy cavity, and allow for relatively large
volumes of biological fluids to spill out from the biopsy device
onto other equipment, medical professionals, the surrounding work
area and floor.
[0027] The site marker delivery system 10 is formed of medical
grade materials, for example, stainless steel, plastic and rubber.
The site marker delivery system 10 includes universal features that
allows the system to be used with a number of tissue cutting
devices of different sizes, particularly with regard to an inner
diameter of an inner cannula and the length of the cutting element
of a particular tissue cutting device. The system 10 is adaptable
for use in conventional biopsy procedures which may be performed
manually and stereo-tactically. Other advantages provided by the
site marker delivery system 10 over conventional marker delivery
devices will become apparent from reading the following.
a. Hub
[0028] FIG. 1 illustrates an embodiment of a site marker delivery
system 10 according to the invention. The marker delivery system 10
includes a hub 12 having a proximal end 14 and a distal end 16. The
hub 12 is formed with a channel 15 (as best seen in FIGS. 3A-3B)
that extends between the proximal 14 and distal 16 ends.
[0029] In one embodiment, the hub 12 includes a tactile indicator
40 adjacent the proximal end 14 that is indicative of the
circumferential orientation of an aperture 24 of a tube 18 to be
described hereinafter. The tactile indicator 40 may include a
marking 64 that allows the indicator 40 to be visible in low light
conditions as an additional means of indicating the orientation of
the aperture 24 of the tube 18.
b. Tube
[0030] A tube 18 having a lumen (not shown) is provided having a
proximal end 20 and distal end 22. The tube 18 is fixedly
attachable to the hub 12 adjacent the distal end 16 of the hub 12.
As mentioned above, the tube 18 includes an aperture 24 that is in
communication with the lumen. The aperture 24 is formed through a
portion of a side-wall of the tube 18 proximate the distal end 22.
In one embodiment, the tube 18 is dimensioned to slidably pass
through a channel C of a tissue cutting device (See FIG. 4B).
[0031] The tube 18 is preferably formed of a substantially rigid
medical grade material such as stainless steel, plastic or other
materials suitable. A marker (M) may be seated within the tube 18.
It is preferred that the marker M is seated adjacent a proximal end
of the aperture 24 (See FIG. 6). To retain marker M within tube 18
at least one retention tab 41 may be provided. Prior to deployment,
retention tab 41 is depressed inwardly from an outer surface of
tube 18 so as to form a lip to prevent a marker M from prematurely
deploying out of aperture 24 (See FIG. 1B). Once ejection of the
marker M is facilitated (to be explained in further detail below),
the marker M is pushed against retention tab 41, overcoming the
spring force in retention tab 41 such that retention tab 41 is
forced upwardly (See FIG. 1A) to allow passage of marker M through
to aperture 24.
[0032] In one embodiment, the tube may further include an inclined
wall 42 formed proximate a distal end 43 of the aperture 24 (See
FIG. 1A). The inclined wall 42 operates as a ramp that assists in
facilitating the ejection of the marker M out of the aperture 24
(to be explained in further detail below).
c. Tube Guide
[0033] A tube guide 26 may be provided. The tube guide 26 is
selectively attachable to a non-working end of a tissue cutting
device. The tube guide 26 includes a proximal end 28 and a distal
end 30. The tube guide 26 is formed with a channel 32 that extends
between the proximal 28 and distal 30 ends (See FIG. 5).
[0034] Preferably, the tube guide 26 includes at least one
attachment pin 36 disposed on an exterior wall thereof. The
attachment pin 36 is constructed for engaging a complimentary
mounting groove 38 formed on the non-working end of the tissue
cutting device so as to key the tube guide to the tissue cutting
device. After the tube guide 26 is keyed to the tissue cutting
device, the channel 32 of the tube guide 26 is longitudinally
aligned with the channel C of the tissue cutting device.
Accordingly, tube guide 26 operates to maintain the orientation
between the marker delivery system 10 and the tissue cutting
device.
[0035] As best illustrated in FIG. 6, the proximal end 28 of the
tube guide 26 is formed as a funnel shaped wall 45. The funnel
shaped wall 45 operates to direct the tube 18 into the channel 32
of the tube guide 26 such that the tube 18 can be advanced through
the channel C of the tissue cutting device. In this fashion, the
tube 26 can be directed into the channel 32 of the tube guide
without having to visibly guide the tube 18 into the channel 32,
unlike conventional marker delivery devices that required that the
apparatus holding the markers be visibly guided into a channel C of
a tissue cutting device.
[0036] As shown in FIG. SA, the tube guide 26 preferably includes a
first fluid sealing ring 46 disposed on its exterior wall adjacent
the distal end 30 and a second fluid sealing ring 48 disposed
within the channel 32 adjacent the distal end 30. The first and
second fluid sealing rings 46, 48 operate to prevent bodily fluids
from spilling out through the tissue cutting device or the site
marker delivery system when the biopsy site is being marked. This
helps maintain a safe, clean, and sanitary environment for medical
personnel and patients.
[0037] The tube guide 26 may also include an air venting aperture
50 that has an inner diameter less than an inner diameter of the
channel 32 of the tube guide 26. The disparate diameters insures
that the tube 18 cannot be erroneously fitted into the air venting
aperture 50 causing it to be out of alignment with the channel C of
the tissue cutting device.
d. Push-Rod
[0038] A push-rod 34 is dimensioned to slidably pass through the
channel 15 of the hub 12 and the lumen of the tube 18 to the distal
end 22 of the tube 18. The push-rod 34 is operable to advance the
marker M seated in the lumen of the tube 18 out of the lumen
through the aperture 24. In one embodiment, the push-rod 34 has an
outer diameter that is substantially contiguous with the lumen of
the tube 18. In this fashion, the push-rod 34 operates to close or
block the aperture 24 such that after the marker M has been
deployed it can not fall back into the aperture 24.
e. Deployment Trigger
[0039] The site marker delivery system 10 preferably also includes
a deployment trigger 44 that is selectively attachable to the
proximal end 14 of the hub 12. As seen in FIG. 2, the push rod 34
is attachable to a first surface 54 of the deployment trigger 44
such that the deployment trigger 44 is operable to advance the push
rod 24 toward the distal end 22 of the tube 18 when the deployment
trigger 44 is being attached to the proximal end 14 of the hub
12.
[0040] Preferably, the deployment trigger 44 is formed as a push
plate having opposing surfaces and at least one retaining arm 52
extending from the first surface 54. The at least one retaining arm
52 operates to engage a complimentary retaining rim 56 (best seen
in FIG. 3A) disposed adjacent the proximal end 14 of the hub 12.
The engagement of the at least one retaining arm 52 and the
retaining rim 56 operates to lock the push rod 34 in place after
the marker has been advanced out through the aperture 24 of the
tube 18. The engagement procedure provides a tactile and audible
indication to the user of the site marker delivery system 10 that
the marker has been deployed. The tactile indication is force
feedback from snapping the at least one retaining arm 52 onto the
retaining rim 56. The audible indication is provided by the user
actually hearing a "snapping" sound when the deployment trigger 44
is engaged with the hub 12.
[0041] As best illustrated in FIG. 3A, the deployment trigger 44
also includes a spring 58 disposed between the proximal end 14 of
the hub 12 and the deployment trigger 44. The spring 58
concentrically surrounds a proximal end of the push rod 34 wherein
a first end 60 of the spring 58 frictionally engages a central
portion of the deployment trigger 44 and a second end 62 of the
spring 58 frictionally engages the proximal end 14 of the hub 12.
The spring 58 is adapted to maintain the longitudinal alignment
between the deployment trigger 44 and the proximal end 14 of the
hub 12. This allows for the push-rod 34 to be substantially
stabilized when being axially advanced toward the distal end 22 the
tube 18.
f. Method of Using the Marker Delivery System
[0042] FIG. 8 illustrates a method of using the site marker
delivery system 10 in combination with a tissue cutting device for
the purpose of marking a biopsy site. The method begins at 100 with
attaching the tube guide 26 to the non-working end of the tissue
cutting device. This step ensures that the channel 32 of the tube
guide 26 is in alignment with the channel C of the tissue cutting
device.
[0043] At 110, the method continues by sliding the tube 18 through
the channel 32 of the tube guide 26 and the channel C of the tissue
cutting device toward the distal end of the tissue cutting
device.
[0044] At 120, the user of the site marker delivery system 10
receives a tactile indication from contacting the distal end of the
tissue cutting device with the distal end 22 of the tube 18. This
indicates that the marker delivery system 10 is in position for
deployment of the site marker.
[0045] At 130, the method continues by aligning the aperture 24 of
the tube 18 with an aperture formed proximate the distal end of the
tissue cutting device. The tactile indicator 40 assists the user in
orientating the aperture 24 with the aperture in the tissue cutting
device. The method advances to 140.
[0046] At 140, the biopsy site is marked by depositing a marker
seated in the lumen of the tube 18 at the biopsy site. This is
accomplished by advancing the push-rod 34 through the channel 15 of
the hub 12 and the lumen of the tube 18 toward the distal end 22 of
the tube 18 until the marker M is discharged from the lumen and out
through the aperture 24. If a retention tab 41 is provided, this
step may also pushing retention tab 41 upwardly such that marker M
may be advanced to the aperture 24 by push-rod 34.
[0047] At 150, the push-rod is locked in place after the marker M
has been discharged from the lumen through the aperture 24 by
engaging the deployment trigger 44 onto the proximal end 14 of the
hub 12. In this fashion, the push rod 34 operates to prevent the
marker from falling back into the aperture 24 during removal of the
side marker delivery system 10 and the tissue cutting device from
the biopsy site.
[0048] Referring now to FIG. 9, an alternative embodiment of an end
deployment site marker delivery system 200 is shown. End deployment
site marker delivery system 200 includes a cannula 202, a push rod
204, and a handle 206. Cannula 202 is hollow and defines an inner
lumen having a proximal end 208 and a distal end 210. Both proximal
and distal ends 208 and 210 are open. In one embodiment, proximal
end 208 further includes at least one retaining rim 212 (to be
explained in further detail below).
[0049] In one embodiment, positioned slightly in board of distal
end 210 is at least one holding tab 214. Holding tab 214 is formed
on an internal surface of cannula 202 and is sized so as to
frictionally engage a portion of a site marker 216 (to be explained
in further detail below). In one embodiment holding tab 214 is
constructed of a suitable material having a predetermined degree of
flexibility such that a predetermined amount of force may flex the
holding tab out of engagement with site marker 216.
[0050] Push rod 204 is connected to a deployment plunger 218 at its
proximal end. Push rod 204 further includes a distal end 220 that
is selectively contactable with site marker 216. Push rod 204 is
dimensioned to slidaby pass through the lumen of cannula 202 to the
distal end 210 of cannula 202. However, push rod 204 further may be
dimensioned so as to be substantially contiguous with the lumen of
cannula 202 to block or close open distal end 210 such that after
marker 216 has been deployed, it cannot reenter cannula 202.
[0051] Deployment plunger 218 is formed as a push plate having
opposing surfaces 222, 224 and at least one retaining arm 226
extending from one of the opposing surfaces 222. Retaining arm 226
operates to engage retaining rim 212 of cannula 202 in a
complementary fashion. Engagement of retaining arm 226 and
retaining rim 212 operates to lock push rod 204 in place after
marker 216 has been advanced out though distal end 210. The
engagement of retaining arm 226 and 212 provides a tactile (force
feedback from snapping retaining arm 226 onto retaining rim 212)
and audible (the "snapping" sound generated when retaining arm 226
engages retaining rim 212) indication to the user of site marker
delivery system 200 that marker 216 has been deployed.
[0052] Handle 206 is connected to cannula 202. In one embodiment,
handle 206 is integrally formed with cannula 202. Handle 206
provides a convenient gripping portion for grasping cannula 202 to
maintain the position of cannula 202 while activating the
deployment plunger 218.
[0053] Marker 216 is positioned within open distal end 210 of
cannula. In one embodiment, marker 216 includes a head portion 228
and a body portion 230, where head portion 228 is sized to be at
least slightly larger than the outside diameter of cannula 202 such
that head portion 228 remains outside of the lumen of cannula 202.
While head portion 228 is configured as a "cap" in FIG. 9, it is
understood that other geometries may be employed for head portion
228 such as a blunt end or a trocar tip. Further, it is also
understood that marker 216 need not be provided with a head portion
228 at all.
[0054] Body portion 230 is sized to at least partially slidably
pass into distal end 210 of cannula 202. However, body portion 230
is also sized such that it frictionally engages holding tab 214.
Holding tab 214 retains marker 216 to cannula 202 until it is
deployed via push rod 204.
[0055] When deployment plunger 218 is activated, push rod 204 moves
through cannula 202 until distal end 220 of push rod 204 comes into
contact with an end 232 of body portion 230. Push rod 204 then over
comes the frictional force of holding tab 214 and pushes marker 216
out through distal end 210 of cannula 202 into the body cavity.
When deployment plunger 218 has reached distal end 210 of cannula
202, retaining arm 226 engages retaining rim 212 thereby indicating
deployment of marker 216.
[0056] The foregoing embodiments of the site marker delivery system
is disclosed for illustrative purposes. Many adaptations and
modifications will become apparent to one of ordinary skill in the
art upon reading the above descriptions. The scope of the invention
should be determined with reference to the appended claims, along
with the full scope of equivalence to which such claims are
entitled.
* * * * *