U.S. patent application number 14/446398 was filed with the patent office on 2014-11-13 for mri compatible biopsy device with detachable probe.
The applicant listed for this patent is Devicor Medical Products, Inc.. Invention is credited to Thomas Edward Albrecht, David Denis Beck, John Anthony Hibner, Richard F. Schwemberger.
Application Number | 20140336529 14/446398 |
Document ID | / |
Family ID | 28794031 |
Filed Date | 2014-11-13 |
United States Patent
Application |
20140336529 |
Kind Code |
A1 |
Hibner; John Anthony ; et
al. |
November 13, 2014 |
MRI COMPATIBLE BIOPSY DEVICE WITH DETACHABLE PROBE
Abstract
A biopsy device comprises a probe assembly and an obturator. The
probe assembly comprises a cannula having a closed distal end
configured to penetrate tissue, an open proximal end, a first lumen
in fluid communication with the open proximal end, and a side
aperture located proximal to the closed distal end. The side
aperture is in fluid communication with the first lumen. The
obturator is removably insertable in the first lumen through the
open proximal end. The obturator is configured to substantially
block the side aperture when the obturator is inserted in the first
lumen. The probe assembly may be inserted in a patient's tissue
(e.g., breast) with the obturator disposed in the cannula to block
the side aperture. The obturator may then be removed, and a cutter
may be advanced through the cannula to sever tissue protruding
through the side aperture.
Inventors: |
Hibner; John Anthony;
(Mason, OH) ; Albrecht; Thomas Edward;
(Cincinnati, OH) ; Schwemberger; Richard F.;
(Cincinnati, OH) ; Beck; David Denis; (Cincinnati,
OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Devicor Medical Products, Inc. |
Cincinnati |
OH |
US |
|
|
Family ID: |
28794031 |
Appl. No.: |
14/446398 |
Filed: |
July 30, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12887781 |
Sep 22, 2010 |
8808198 |
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14446398 |
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10170535 |
Jun 12, 2002 |
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12887781 |
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60374635 |
Apr 23, 2002 |
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Current U.S.
Class: |
600/566 ;
600/567 |
Current CPC
Class: |
A61B 2010/0208 20130101;
A61B 10/0233 20130101; A61B 2017/347 20130101; A61B 2017/0046
20130101; A61B 2017/00911 20130101; A61B 10/0275 20130101; A61B
17/3403 20130101; A61B 5/0555 20130101; A61B 10/0283 20130101; A61B
2090/374 20160201 |
Class at
Publication: |
600/566 ;
600/567 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1.-20. (canceled)
21. A biopsy device, comprising: (a) a probe assembly comprising an
elongated cannula, wherein the cannula is insertable into tissue,
the cannula comprising: (i) a distal end, (ii) an open proximal
end, (iii) a lumen in fluid communication with the open proximal
end, (iv) a side aperture located proximal to the closed distal
end, wherein the side aperture is in fluid communication with the
lumen, and (v) a thumbwheel, wherein the thumbwheel is aligned with
the open proximal end, wherein the thumbwheel is operable to rotate
the cannula; (b) an obturator, wherein the obturator is removably
insertable in the lumen through the open proximal end, wherein the
obturator is configured to substantially block the side aperture
when the obturator is inserted in the lumen, wherein the obturator
is configured to close the open proximal end of the cannula when
the obturator is inserted in the lumen, wherein the obturator is
operable to be inserted in the lumen when the cannula is inserted
into tissue, wherein the obturator is operable to be removed from
the lumen after the cannula is inserted into tissue and while the
cannula remains inserted into tissue; and (c) a handpiece, wherein
a distal end of the handpiece is configured to be removably coupled
with a proximal end of the probe assembly, wherein the handpiece is
configured to couple to the proximal end of the probe assembly when
the obturator is removed from the lumen.
22. The biopsy device of claim 21, wherein the cannula further
comprises a second lumen in fluid communication with the first
lumen, wherein the second lumen is further in fluid communication
with the open proximal end.
23. The biopsy device of claim 22, wherein a distal portion of the
obturator includes through holes.
24. The biopsy device of claim 22, wherein the cannula further
comprises an inner longitudinal wall extending proximally from the
closed distal end of the cannula, wherein the longitudinal wall
separates at least part of the first lumen from at least part of
the second lumen.
25. The biopsy device of claim 24, wherein the first lumen has a
length, wherein the longitudinal wall has a length, wherein the
length of the longitudinal wall is less than the length of the
first lumen.
26. The biopsy device of claim 21, wherein the obturator is further
configured to substantially seal the first lumen when the obturator
is inserted in the first lumen.
27. The biopsy device of claim 21, wherein the handpiece comprises
a locking device configured to selectively lock the handpiece to
the probe assembly, wherein the locking device is further
configured to prevent the handpiece from unlocking from the probe
assembly when the cutter is disposed in the cannula.
28. The biopsy device of claim 21, wherein the handpiece further
comprises a cutter, wherein the cutter is operable to translate
within the first lumen when the body is attached to the probe
assembly, wherein the cutter is configured to fully retract within
the handpiece.
29. The biopsy device of claim 28, further comprising a vacuum
extraction system operable to selectively withdraw a piece of
tissue severed by the cutter through the cannula.
30. The biopsy device of claim 21, wherein the distal end of the
cannula is closed.
31. The biopsy device of claim 30, wherein the closed distal end of
the cannula comprises a sharp tip.
32. A biopsy device, comprising: (a) a probe assembly comprising an
elongated cannula, the cannula comprising: (i) a distal end, (ii)
an open proximal end comprising a thumbwheel fixedly secured to the
open proximal end, (iii) a lumen in fluid communication with the
open proximal end, and (iv) a side aperture located proximal to the
distal end, wherein the side aperture is in fluid communication
with the lumen; (b) an obturator, wherein the obturator is
removably insertable in the lumen through the open proximal end,
wherein the obturator is configured to block the side aperture when
the obturator is inserted in the lumen, wherein the obturator is
configured to seal lumen when the obturator is inserted in the
lumen; and (c) a handpiece, wherein a distal end of the handpiece
is configured to be removably coupled with a proximal end of the
probe assembly when the obturator is removed, wherein the handpiece
comprises a cutter, wherein the cutter is moveable relative to the
handpiece.
33. A method of performing a biopsy, the method comprising: (a)
inserting an insertion assembly in a patient's tissue, wherein the
insertion assembly is configured to penetrate the patient's tissue,
the insertion assembly comprising: (i) a cannula having a side
aperture formed in a sidewall of the cannula, and (ii) an obturator
slidably disposed in the cannula, wherein the obturator is
positioned to block the side aperture; (b) withdrawing the
obturator from the cannula to unblock the side aperture, wherein
the obturator is withdrawn from the cannula while the cannula
remains inserted in the patient's tissue, such that tissue
protrudes through the side aperture in response to the act of
withdrawing the obturator from the cannula; (c) advancing a cutter
distally through the cannula to sever tissue protruding through the
side aperture of the cannula; and (d) communicating the severed
tissue proximally through the cannula.
34. The method of claim 33, wherein the act of inserting an
insertion assembly in a patient's tissue comprises inserting the
insertion assembly in a patient's breast.
35. The method of claim 33, further comprising coupling a handpiece
with the cannula, wherein the act of coupling a handpiece with the
cannula is performed between the act of withdrawing the obturator
from the cannula and the act of advancing a cutter distally through
the cannula, wherein the cutter is advanced by the handpiece.
Description
PRIORITY
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/170,535, entitled "MRI Compatible Biopsy
Device with Detachable Probe," filed Jun. 12, 2002, published as
U.S. Pub. No. 2003/0199753 on Oct. 23, 2003, the disclosure of
which is incorporated by reference herein, and which claims the
benefit of U.S. Provisional Patent Application Ser. No. 60/374,635,
entitled "MRI Compatible Biopsy Device with Detachable Probe,"
filed Apr. 23, 2002.
[0002] Subject matter in the present application is related to that
in co-pending and commonly-owned U.S. patent application Ser. No.
10/171,330, entitled "Localization Mechanism for an MRI Compatible
Biopsy Device," filed Jun. 12, 2002, published as U.S. Pub. No.
2003/0199785 on Oct. 23, 2003, the disclosure of which is
incorporated by reference herein.
FIELD OF THE INVENTION
[0003] The present invention relates, in general to devices for
tissue sampling and, more particularly, to an improved device for
core biopsy probes stereotopically positioned by coordinates
derived from magnetic resonance imaging (MRI) scans for acquiring
subcutaneous biopsies and for removing lesions.
BACKGROUND OF THE INVENTION
[0004] The diagnosis and treatment of patients with cancerous
tumors, pre-malignant conditions, and other disorders has long been
an area of intense investigation. Non-invasive methods for
examining tissue are palpation, Thermography, PET, SPECT, Nuclear
imaging, X-ray, MRI, CT. and ultrasound imaging. When the physician
suspects that tissue may contain cancerous cells, a biopsy may be
done either in an open procedure or in a percutaneous procedure.
For an open procedure, a scalpel is used by the surgeon to create a
large incision in the tissue in order to provide direct viewing and
access to the tissue mass of interest. Removal of the entire mass
(excisional biopsy) or a part of the mass (incisional biopsy) is
done. For a percutaneous biopsy, a needle-like instrument is used
through a very small incision to access the tissue mass of interest
and to obtain a tissue sample for a later examination and analysis.
The advantages of the percutaneous method as compared to the open
method are significant: less recovery time for the patient, less
pain, less surgical time, lower cost, less risk of injury to
adjacent bodily tissues such as nerves, and less disfigurement of
the patient's anatomy. Use of the percutaneous method in
combination with artificial imaging devices such as X-ray and
ultrasound has resulted in highly reliable diagnoses and
treatments.
[0005] Generally there are two ways to percutaneously obtain a
portion of tissue from within the body, by aspiration or by core
sampling. Aspiration of the tissue through a fine needle requires
the tissue to be fragmented into small enough pieces to be
withdrawn in a fluid medium. The method is less intrusive than
other known sampling techniques, but one can only examine cells in
the liquid (cytology) and not the cells and structure (pathology).
In core sampling, a core or fragment of tissue is obtained for
histologic examination, genetic tests, which may be done via a
frozen or paraffin section. The type of biopsy used depends mainly
on various factors present in the patient, and no single procedure
is ideal for all cases. However, core biopsies seem to be more
widely used by physicians.
[0006] Recently, core biopsy devices have been combined with
imaging technology to better target the lesion. A number of these
devices have been commercialized. One such commercially available
product is marketed under the trademark name MAMMOTOME.TM., Ethicon
Endo-Surgery, Inc. An embodiment of such a device is described in
U.S. Pat. No. 5,526,822 issued to Burbank, et al., on Jun. 18,
1996, and is hereby incorporated herein by reference.
[0007] As seen from that reference, the instrument is a type of
image-guided, percutaneous, coring, breast biopsy instrument. It is
vacuum-assisted, and some of the steps for retrieving the tissue
samples have been automated. The physician uses this device to
capture "actively" (using the vacuum) the tissue prior to severing
it from the body. This allows the sampling tissues of varying
hardness. The device can also be used to collect multiple samples
in numerous positions about its longitudinal axis, and without
removing the device from the body. These features allow for
substantial sampling of large lesions and complete removal of small
ones.
[0008] U.S. patent application Ser. No. 08/825,899 filed on Apr. 2,
1997, which is hereby incorporated herein by reference, described
other features and potential improvements to the device including a
molded tissue cassette housing permitting the handling and viewing
of multiple tissue samples without physical contact by the
instrument operator. Another described therein is the
interconnection of the housing to the piercing needle using a
thumbwheel, to permit the needle to rotate relative to the housing,
the preventing the vacuum tube from wrapping about the housing.
During use, the thumbwheel is rotated so that the device rotates
within the lesion, and samples can be taken at different points
within the lesion.
[0009] In actual clinical use for breast biopsy the instrument
(probe and driver assembly) is mounted to the three
axis-positioning head of an x-ray imaging machine. The three
axis-positioning heads is located in the area between the x-ray
source and the image plate. The x-ray machines are outfitted with a
computerized system which requires two x-ray images of the breast
be taken with the x-ray source at two different positions in order
for the computer to calculate x, y and z axis location of the
suspect abnormality. In order to take the stereo x-ray images the
x-ray source must be conveniently movable. The x-ray source
therefore is typically mounted to an arm which, at the end opposite
the x-ray source, is pivotally mounted to the frame of the machine
in the region of the image plate.
[0010] Recently, there has been a need for a hand held core
sampling biopsy device. This need has been fulfilled by
Ethicon-Endo Surgery in U.S. Pat. No. 6,086,544 issued on Jul. 11,
2000, which is hereby incorporated herein by reference. This
aforementioned patent discloses a hand held MAMMOTOME.TM. that may
be held approximately parallel to the chest wall of the patient for
obtaining tissue portions close to the chest wall than may be
obtained when using an instrument that may be obtained when using
an instrument that is mounted is manipulated by the operator's hand
rather than by an electromechanical arm. Thus, the operator may
steer the tip of the handpiece on the MAMMOTOME.TM. with great
freedom towards the tissue mass of interest. The surgeon has
tactile feedback while doing so and can thus ascertain to a
significant, degree, the density and hardness of the tissue being
encountered. In addition, a hand held MAMMOTOME.TM. is desirable
because the handpiece on the MAMMOTOME.TM. may be held
approximately parallel to the chest wall of the patient for
obtaining tissue portions closer to the chest wall than may be
obtained when using an instrument that is mounted to an
electromechanical arm.
[0011] Recently, there has been a desire to use the above described
biopsy devices with MRI imaging devices instead of x-ray imaging
devices. However, existing medical biopsy sampling devices use
small, multi-lumen probes extensively fabricated mostly if not
entirely from metal. However, the ability to provide accurate
minimally invasive diagnosis of suspicious breast lesions hinges on
the size of the sample obtained and accuracy in placement of the
sampling device.
[0012] The metallic nature of these probes has many drawbacks.
Typically these metal probes are electrically conductive and often
magnetically weak, which interferes with their use under MRI
guidance. The electrically conductive and magnetically weak nature
of metal probes often work to create field distortions, called
artifacts, on the image. The image of the lesion will show the
metal probe, and this is problematic because the image of the probe
can obscure the image of the lesion.
[0013] The small sample size of conventional biopsy needles also
presents a significant limitation due to the increase in the
duration of the procedure. Due to the tendency for contrast agent
to "wash out" of suspicious lesions, and the progressive increase
in enhancement of surrounding non-malignant breast parenchyma,
suspicious lesions may become indistinguishable to the breast
parenchyma within a few minutes. This limits the number of samples
that can be retrieved using conventional spring-loaded core biopsy
needles under direct imaging guidance.
[0014] A further problem not infrequently encountered during core
needle biopsy is the development of a hematoma at the biopsy site
during the procedure. An accumulating hematoma can be problematic
during MRI-guided biopsy because residual contrast agent
circulating in the hematoma can mimic enhancement in a suspicious
lesion. In addition, the accumulation of air at the biopsy site can
cause susceptibility artifacts that can potentially interfere with
the fat-suppression MRI techniques at the biopsy site cavity.
[0015] These limitations of conventional biopsy needles have led
several authors to conclude that lesions should be at least 1 cm in
diameter before imaging could confirm that the MRI-guided biopsy
device was definitely within (as opposed to adjacent to) the
suspicious target. However, the demand for minimally invasive
MRI-guided core biopsy is greatest for small lesions because they
are more common, more difficult to characterize on MRI grounds
alone, and have the best prognosis if they are found to be
malignant.
[0016] Therefore, there has been a desire to have generally
non-metallic (especially non-ferromagnetic) biopsy probe of the
type described above to eliminate artifacts. These needs have been
filled by commonly-owned U.S. patent application Ser. No.
10/021,680, entitled "MRI Compatible Surgical Biopsy Device," filed
Dec. 12, 2001, now U.S. Pat. No. 6,626,849, issued Sep. 30, 2003,
the disclosure of which is hereby incorporated by reference in its
entirety. The lack of undesirable artifacts for the disclosed
hand-held biopsy device allows the accurate placement of the probe.
Moreover, disclosed vacuum assist allows visualization of the
lesion entering a bowl of the probe to confirm accurate placement,
as well as avoiding problems associated with a hematoma or an air
cavity. Moreover, the volume and ability to rapidly rotate the open
cutting bowl of the probe allows for multiple samples in succession
without removal of the probe. Thereby, the duration of the
procedure is reduced.
[0017] However, elimination of the artifact created by the metal
probe entirely is also problematic because physicians rely
extensively on some type of artifact to notify them as to where the
tip of the probe is relative to the lesion. These needs have been
filled by commonly-owned U.S. patent application Ser. No.
10/021,407, entitled "MRI Compatible Surgical Biopsy Device Having
a Tip Which Leaves an Artifact," filed Dec. 12, 2001, now U.S. Pat.
No. 7,192,404, issued Mar. 20, 2007, the disclosure of which is
hereby incorporated by reference in their entirety. Having a target
in the cutter at the distal end of the probe helps avoid advancing
the probe through the chest cavity as well as accurately placing
the bowl of the probe adjacent to the suspicious tissue for drawing
into the cutting bowl.
[0018] While the aforementioned hand-held MRI compatible biopsy
devices provide many advantages, opportunities exist for
improvements and additional clinical functionality. For instance,
the hand-held biopsy device presents a long, external handle that
is inappropriate for closed magnet MRI machines. Furthermore, while
the hand-held biopsy device allows great freedom in lateral and
angular orientation, in some instances it is preferable to
specifically position the biopsy probe. The MRI machine may provide
very accurate stereotactic placement information that is only
partially utilized in inserting the probe. In particular, the
hand-held biopsy device is inserted through an opening in a
compression plate, so some two-dimensional alignment is provided.
However, the angle and depth of insertion the probe tends to vary,
especially without continual reimaging of the probe during
insertion, which is particularly inappropriate for closed MRI
magnets.
[0019] Furthermore, the vacuum assist reduces occurrence of a
hematoma and draws in tissue to increase the sample size without
repositioning the probe; however, current clinical procedures often
require additional invasive procedures to the biopsy site to
administer anesthesia or to perform additional diagnostic or
treatment procedures.
[0020] Consequently, a significant need exists for an MRI-guided
biopsy device for increased positioning accuracy, especially one
suitable for both open and closed MRI machines and which supports
additional diagnostic and therapeutic treatments to the biopsy site
without requiring additional invasive procedures.
BRIEF SUMMARY OF THE INVENTION
[0021] The invention overcomes the above-noted and other
deficiencies of the prior art by providing a detachable probe
assembly that is physically located with respect to Magnetic
Resonance Imaging (MRI) stereotopic guidance so that a biopsy site
location is accurately and rapidly acquired and maintained. Being
separately fixable to a localization mechanism used with a breast
coil allows for use of core biopsy procedures in closed MRI
machines without repeated insertions of the biopsy probe. Even if
used with an open MRI machine, the detachable nature avoids having
to hold in place for an extended period of time by hand a biopsy
handle, which provides a cutter to the biopsy probe.
[0022] In one aspect of the invention, the detachable biopsy probe
includes a dual lumen elongated tubular needle. In addition to a
cutter lumen that has a cutter or sample opening laterally placed
near the distal end, a vacuum chamber lumen is in fluid
communication with the sample opening to vacuum assist the taking
of a biopsy sample. The probe assembly includes an engagement
member that is readily spatially fixed. The engagement member
provides access to the vacuum chamber lumen for fluid or gas
transfer and provides access to the cutter lumen by the biopsy
handle and by other diagnostic and therapeutic tools.
[0023] In another aspect of the invention, a biopsy tool is
provided with a detachable probe assembly with a needle having at
least one lumen for taking biopsies. An engagement member at the
proximal end of the needle allows attachment to a mounting device
that positions the needle. The biopsy tool also includes a biopsy
handle that readily engages and disengages to the detachable probe
so that diagnostic scans can be performed even within the narrow
confines of some scanning machines.
[0024] In yet another aspect of the invention, a core biopsy system
is disclosed with the biopsy tool mechanically powered remotely via
a power cord from a control module. A localization mechanism is
used in conjunction with a breast coil to position the detachable
probe assembly and to guide the probe assembly when inserted into a
patient's breast to be MRI imaged. Accurate positioning of the
probe assembly is enhanced by alignment guides that may be
referenced to stereotactic coordinates provided by the MRI scan,
aiding in the accurate insertion of the probe the designated biopsy
site.
[0025] These and other objects and advantages of the present
invention shall be made apparent from the accompanying drawings and
the description thereof.
BRIEF DESCRIPTION OF THE FIGURES
[0026] FIG. 1 is plan view of the biopsy instrument, mounting
fixture, an Magnetic Resonance Imaging (MRI) breast coil fixture,
and patient support table in working relationship outside the
confines of an MRI machine.
[0027] FIG. 2 is a plan view of the biopsy instrument, localization
fixture, partially cut away MRI breast coil fixture, patient
support table, and in working relationship and configured for
insertion into a MRI machine.
[0028] FIG. 3 is a plan view of the localization fixture, partially
cut away MRI breast coil fixture, patient support table, and a
detached probe assembly of the biopsy instrument mounted to the
localization fixture, in working relationship and configured for
insertion into the MRI machine.
[0029] FIG. 4 is an isometric view of the biopsy instrument
disassembled into a biopsy instrument handle, probe housing, and
probe.
[0030] FIG. 4A is a frontal isometric detail view of an alternative
needle tip of a biopsy instrument.
[0031] FIG. 5 is an exploded isometric view of the biopsy
instrument handle.
[0032] FIG. 6 is an exploded isometric view of the probe of the
biopsy instrument of FIG. 4.
[0033] FIG. 7 is a transverse cross section of the probe of the
biopsy instrument of FIG. 4 along lines 7-7.
[0034] FIG. 8 is an enlarged isometric view of the interface
between the handle and probe housing illustrating the visual
confirmation elements that indicate the position of the distal end
of the cutter.
[0035] FIG. 9 is a fragmentary plan view in partial section of the
distal portion of the handle and probe housing and assembly,
illustrating the disconnect feature with the cutter retracted.
[0036] FIG. 10 is a fragmentary plan view in partial section of the
distal portion of the handle and probe housing and assembly,
illustrating the tolerance take-out feature and the disabled
disconnect feature when the cutter is advanced.
[0037] FIG. 11 is an isometric view of the biopsy instrument with
the handle portion disconnected from a tower/bracket localization
fixture and probe assembly.
[0038] FIG. 12 is an isometric view of the biopsy instrument
mounted to the tower/bracket localization fixture of FIG. 11.
[0039] FIG. 13 is an exploded isometric view of the tower/bracket
localization version of the localization fixture and probe assembly
of the biopsy instrument.
[0040] FIG. 14 is a side elevation view of the biopsy instrument in
partial section to illustrate a tower/bracket support for
stabilizing the handle and probe assembly of the biopsy
instrument.
[0041] FIG. 15 is a side elevation view of the dual tower support
version of the localization fixture positioning a detachable probe
assembly with its dual lumens closed by a vacuum conduit and an
obturator stylet.
[0042] FIG. 16 is an isometric view of the biopsy instrument
mounted to a dual tower localization fixture.
[0043] FIG. 17 is an isometric view of the slide plate of a
localization fixture guiding a scissors support in a lowered
position for vertically orienting a biopsy instrument.
[0044] FIG. 18 is an isometric view of the slide plate of a
localization fixture guiding the scissors support in a raised
position for vertically orienting a biopsy instrument.
[0045] FIG. 19 is a sequence of clinical operations for using the
detachable MRI-guided biopsy instrument of FIG. 1 in both open and
closed MRI machines.
[0046] FIG. 20 is an isometric view of a tip protector mounted onto
a needle tip of the detachable probe assembly of FIG. 11.
[0047] FIG. 21 is an isometric detail view of the trip protector of
FIG. 20.
DETAILED DESCRIPTION OF THE INVENTION
[0048] FIG. 1 depicts a core biopsy instrument system 10 that is
vacuum assisted, detachable, and compatible with use in a Magnetic
Resonance Imaging (MRI) machine, such as the depicted closed MRI
machine 12. In the illustrative embodiment, the core biopsy
instrument system 10 includes an MRI-compatible biopsy tool 14 that
is selectably attached to a localization mechanism or fixture 16 to
accurately and rapidly perform core biopsies of breast tissue with
a minimum of insertions of a biopsy probe. A control module (not
shown) senses encoder position signal and switch signals from the
biopsy tool 14 and provides mechanical and vacuum power to the
biopsy tool 14 via power cord 18.
[0049] With reference to FIGS. 1-2, a patient 20 is lying prone
upon a patient support table 22, depicted in FIG. 1 as removed from
a magnet bore 24 of the MRI machine 12. The patient's chest rests
upon a top surface 26 of a chest support 28, the top surface 24
having openings 30, 32 for allowing the patient's breasts to hang
downward for imaging and treatment. With particular reference to
FIG. 2, the right opening 30 is depicted with the localizer fixture
16 laterally positioned to cooperate with a medial compression
plate (not shown) to longitudinally fix and compress the patient's
right breast. Antenna elements (not shown) are placed about the
opening 30 to detect radio frequency (RF) signals emanated by
breast tissue induced by a strong magnetic field from the MRI bore
24. The chest support 28 and antennas are generally termed a breast
coil 34.
[0050] The biopsy tool 14 includes a biopsy handle 36 that is
attachable to a probe assembly 38. The localization fixture 16
accurately positions the probe assembly 38 for stereotactic
mammography biopsy procedures for a specific biopsy site location
for a distal tip 40 of the probe assembly 38. This location is
identified by an X-axis coordinate that is horizontal and
longitudinal with respect to the patient (depicted as right to left
in FIGS. 1-2). A Z-axis is defined as the vertical height, with the
X and Z axis orthogonally defined on a lateral compression plate 42
of the localization fixture 16, the lateral compression plate 42
cooperating with the medial compression plate (not shown) to fix
and compress the patient's breast. This location is also defined in
terms of depth of insertion, or Y-axis, which is depicted as up and
down in the FIGS. 1-2. A probe assembly mounting device 44 connects
to a probe housing 46 of the biopsy tool 14.
[0051] The mounting device 44 includes alignment positioning guides
(described in more detail below) to orient the probe housing 46,
and hence the probe assembly 38, to the desired X-Y-Z coordinate.
For instance, a depth slide 48 allows mounting of the probe
assembly 38 with the distal tip 40 extends outside of the opening
30 and lateral compression plate 42. Thereafter, the probe assembly
38 is guided along the Y-axis by the depth slide 48 while
maintaining the selected X-Z-axes coordinates. In addition, the
mounting device 44 advantageously supports the biopsy handle 36
when attached to the probe assembly 38 as depicted in FIG. 2 to
maintain the angle of insertion of the probe assembly 38. The probe
housing 46 provides access to the interior of the probe assembly 38
via a vacuum lumen access conduit 50 for draining fluids, inserting
fluids such as anesthetics.
[0052] FIG. 3 depicts the core biopsy instrument system 10 with the
biopsy handle 36 removed and the depth slide 48 moved inward to
allow insertion of the patient support table 22 into the narrow
confines of the MRI magnet bore 24. Moreover, the surgeon may take
full advantage of the stereotactic coordinates provided by the MRI
machine 12, even if using a closed magnetic bore 24. In particular,
the stereotactic derived coordinates may be used even if not
actively imaging the probe assembly 38 during insertion. The
localization fixture 16 enables the surgeon to manually insert the
probe assembly 38 with an indication of current depth. The surgeon
is given tactile feedback while doing so and can thus ascertain to
a significant degree the density and hardness of tissue being
encountered. Alternately, a mechanism to provide mechanical
advantage to the pedestal may enable a controlled and deliberate
insertion of the probe into the tissue. In addition, a means to
prevent the pedestal and probe assembly from moving proximally once
inserted to the proper location within the tissue would aid in
maintaining the proper position of the probe within the tissue.
With the probe assembly 38 maintained in the correct location after
insertion, the probe assembly 38 provides access for other
diagnostic and therapeutic tools and fluid treatments.
[0053] Alternatively or in addition, a Y-axis adjustment mechanism
may be incorporated into the localization fixture 16 to provide
mechanical advantage, thereby achieving a controlled and deliberate
insertion of the probe assembly 38. Moreover, the Y-axis adjustment
mechanism may incorporate a frictional, ratcheting or locking
feature to prevent inadvertent movement of the probe assembly 38
after placement at the desired biopsy location. Examples of such
Y-axis adjustment include but are not limited to a thumb wheel in
geared communication between the probe assembly mounting device 150
and the localizer support frame 126.
[0054] FIG. 4 depicts the biopsy tool 14 with the biopsy handle 36
depicted as readily attached to the probe housing 46, which in turn
is readily attached to the probe assembly 38. The probe assembly 38
includes a male cylindrical mating portion 52 presenting a central
cutter opening 54 on a proximal end that is aligned with the
longitudinal length of a cutter lumen 56 of an elongated needle 58.
The cutter lumen 56 communicates with a sample port 60 laterally
presented near a needle tip 62 at the distal end of the needle 58.
The needle tip 62 is for penetrating the soft tissue of a surgical
patient. The needle tip 60 is sharpened and is preferably made from
an MRI compatible resin such as ULTEM or VECTRA. In the
illustrative embodiment, the needle tip 60 is a three-sided
pyramidal shaped point, although the needle tip 62 configuration
may also have other shapes and/or inserts. For example, a sharpened
blade inserted into the tip would reduce the probe insertion force
into tissue. The blade could be made of titanium, stainless steel,
nitinol, aluminum, Elgiloy, etc. In addition, as in the
aforementioned application Ser. No. ______, entitled "AN MRI
COMPATIBLE BIOPSY DEVICE HAVING A TIP WHICH LEAVES AN ARTIFACT",
the illustrative embodiment advantageously includes a material that
leaves a small, but not troublesome artifact on an MRI scan.
[0055] FIG. 4A depicts a needle tip 62' having a conical shape with
a distally presented X-shaped slot 63 for receiving a pointed,
sharpened blade 65 that reduces the probe insertion force into
tissue. The blade 65 could be made of titanium, stainless steel,
nitinol, aluminum, Elgiloy, ceramic, etc. It will be appreciated
that other shapes of sharpened blade 65 may be used, such as a
single pointed surface in a distally presented single slot rather
than two perpedicularly crossed, pointed surfaces as depicted.
[0056] It will be appreciated that a cutter element or an obturator
stylet is advanced inside the cutter lumen 56 to block the sample
port 60 during insertion. Once the needle 58 is positioned, the
sample port 60 is exposed to allow tissue to enter. In particular,
a vacuum may be presented to a "sample bowl" inside the cutter
lumen 56 near the sample port 60 by applying vacuum power through a
vacuum chamber lumen 64 that communicates along the longitudinal
length of the needle 58 to the male cylindrical mating portion 52.
In particular, a series of small holes allow gas and fluid to enter
the vacuum chamber lumen 64 from the sample port 60 but prevent
tissue samples from entering.
[0057] Annular rings 66 about the cylindrical mating portion 52
grip and seal to an interior of a female cylindrical mating portion
68 on the probe housing 46. Between annular rings, a proximal
vacuum port (not shown in FIG. 4) communicates with a vacuum
passage (not shown) in the probe housing 46. The engagement between
the mating portions 52, 68 advantageously allows rotation of the
needle 58 with a thumb wheel 70 annularly presented near the
proximal end of the needle 58. The radial opening presented by the
annual rings 66 maintains communication between the vacuum passage
in the probe housing 46 and the vacuum chamber lumen 64 regardless
of radial orientation of the needle 58. Thereby, the sample port 60
may be presented to tissue at any and all radial positions about
the distal end of the needle 58. With the assistance of vacuum, a
large volume of tissue may be selectably drawn into the sample bowl
for biopsy sampling.
[0058] The probe housing 46 includes laterally presented attachment
prongs 72 for mounting to the localization fixture 16. In addition,
the probe housing 46 presents a proximally directed cuboidal
engagement member 74 with longitudinally aligned vertical and
horizontal grooves 76 for flanges 78 from the biopsy handle 36. The
probe housing 46 also receives hooked locking tabs 80, 82 on the
distal engaging end of the biopsy handle 36 for selective locking
and unlocking under the influence of a pair of opposing depression
grips 84, 86 attached to respective tabs 80, 82. The biopsy handle
36 includes a sample window 88 for extracting any tissue sample
withdrawn from the cutter lumen 52 under the influence of a vacuum
passing through the cutter, as described in more detail below.
[0059] FIG. 5 depicts a disassembled biopsy handle 36 that contains
the means for translating and rotating a cutter 90 within the
cutter lumen 56. It will be appreciated that two rotating
mechanical power sources are presented to the proximal end of the
biopsy handle 36 through the power cord 18 to provide the
independent translation and rotation motions. These two rotating
mechanical power sources enter through a cord opening 92 defined
between a removable shell 94 and a bottom shell 96, the two held
together by screws. Alternately, one rotating mechanical power
source could drive both translation and rotation elements. Via
standard gearing means, the single power source could be
appropriately connected to both of the drive elements. The
removable shell 94 is removed when assembling a power cord 18 to
the handle 36. A lower gear housing 98 is supported upon the bottom
shell 96 and cooperates with a top shell 100 to constrain movement
of an elongate drive screw 102, an elongate axial screw 104 and
cutter carriage 106. In particular, both screws 102, 104 are
allowed to rotate, positioned parallel to one another and the
longitudinal axis of the cutter lumen 56. Each screw 102, 104 is
driven by a respective power source from the power cord 18. The
drive screw 102 passes through the carriage 106 and interacts with
corresponding ridges therein to impart a longitudinal translation
corresponding to the direction and rate of rotation of the drive
screw 102.
[0060] In some applications, a single rotary power source may be
used as an alternative to two independent rotating mechanical power
sources. A transmission mechanism at the biopsy handle 36 may
convert the single rotary power source into the two motions,
translation and rotation. As yet another alternative, the single
rotary power source may directly supply both a translation and
rotary motion. Such a translating and rotating power cable would be
coupled to the cutter 90 to directly control its movement.
[0061] The cutter 90 is an elongate tube with a sharpened distal
end for cutting tissue presented within the distal end of the
cutter lumen 56. The proximal end of the cutter 90 includes a
cutter gear 108 that is exposed through a gear window 110 of the
carriage 106 to mesh with the axial screw 104 for axial rotation of
the cutter 90. A tissue remover 111 is a tube that is fixedly
aligned with the longitudinal axis to enter the proximal end of the
cutter 90. The tissue remover 111 extends up to the sample window
88 and has a vacuum selectably applied to it by the control module.
Thus, when the cutter 90 is retracted, vacuum from the tissue
remover 111 draws the sample to the distal end of the cutter 90 for
retraction to the sample window 88, whereupon the sample encounter
the tissue remover 111 and is dislodged for exiting the biopsy tool
14.
[0062] The carriage 106 includes distally projected guides 112, 114
that advantageously take-out slack between biopsy handle 36 and the
probe housing 46, as well as providing indicia to the surgeon as to
the depth of translation of the cutter 90. Taking out slack between
the assembled parts of the handle 36 and housing 46 advantageously
minimizes the deadzone length of the distal end of the needle 58.
The cutter 90 should completely translate past the sample port 60
in order to reliably cut a sample. To ensure a full cut, the cutter
90 should translate the maximum distance expected for the assembly.
If variation exists in manufacturing tolerances between the
engagement components, then a further distance has to be included
in the cutter lumen 56 distal to the sample port 60 to accommodate
the over-travel. Thereby, the needle tip 62 must be advanced
farther than desirable in some instances, preventing placement of
the sample port 60 near critical body tissues. At or near full
travel, the guides 112, 114 contact the probe housing 46, causing
movement of the housing 46 to its maximum, distal position. Thus,
critical dimensioning to minimize tolerance build-up is
simplified.
[0063] FIG. 5 also depicts a brace 116 and brace arm 118 that are
employed in one version of the localization fixture 16 to support
the weight and maintain the alignment of the handle 36. Thereby,
flexure of the assembly is avoided that may place a load on the
probe assembly 38, and thus unwanted movement of the needle 58 from
the desired biopsy site location.
[0064] FIGS. 6-7 depict the needle 58 of FIG. 4 and described more
fully in the aforementioned U.S. patent application Ser. No.
10/021,680, entitled "MRI Compatible Surgical Biopsy Device," now
U.S. Pat. No. 6,626,849. In particular, elongated needle 58 is
formed from a left body member 120 and a right body member 121 on
either side of the longitudinal axis. The edges of the halves 120
and 121 are gated for easy part filling, and the edges are stepped
with ridges that allow the two halves 120 and 121 to attach
together with ease. The two halves 120, 121 are adhesively attached
to one another. A cutter tube liner 122 is inserted between the two
halves 120, 121 to provide a smooth surface for the cutter 90,
especially by preventing adhesive from entering the cutter lumen 56
during assembly; as well as, aid in pneumatically sealing the
cutter lumen from the vacuum lumen.
[0065] FIG. 8 shows an enlarged view of the engagement of the
handle 36 to the probe housing 46, with the advanced cutter 90
evident through the window 88. In addition, the guides 112, 114 are
advanced almost into contact with the probe housing 46, indicating
that the distal end of the cutter 90 is approaching its furthest
translation. The guides 112, 114 contact the probe housing 90 when
at or near this extreme to take-out any tolerance. Indicia on the
side of the guides 112, 114 may be referenced by the surgeon to
determine the position of the cutter. Also shown in more detail is
hooked locking tabs 80, 82 entering the probe housing 46, the thumb
wheel 70 used to rotate the needle 80, and the vacuum lumen access
conduit 50 used to evacuate or otherwise access the vacuum lumen
64.
[0066] FIGS. 8-10 show that each grip 84, 86 includes a respective
inwardly projecting member 124, 125 that contact the guides 112,
114 when the cutter 90 is distally advanced, thereby preventing
removal of the handle 36. In FIG. 9, the cutter 90 is retracted,
allowed the depression of the grips 84, 86, unlocking the hooked
locking tabs 80, 82 from the probe housing 46. In FIG. 10, cutter
carriage 106 is advanced, the guides 112, 114 are contacting the
probe housing 46, thereby removing any longitudinal gap between the
hooked locking tabs 80, 86 and the probe housing 46.
[0067] FIGS. 11-14 depicts a localization fixture 16 that includes
means for accurately positioning the probe assembly 38 and
supporting the biopsy handle 36. In particular, a localizer support
frame 126 is formed from the compression plate 42 in a hinged,
orthogonal relation to a horizontal slide plate 128, both laterally
attached to one another by gussets 130, 132. Rods 134, 136
horizontally pass through the compression plate to adjustably
attach to the medial compression plate (not shown) for compressing
the patient's breast. Apertures, depicted as parallel rows of slots
138, in the compression plate 42 are provided to obtain access to a
desired biopsy site location while providing enough remaining
structure in the compression plate 42 for adequate contact with the
patient's breast. Alternately, the apertures may be a series of
holes aligned both horizontally and vertically or simply one large
opening. Alternatively, the apertures may be a series of holes
aligned both vertically and vertically, parallel columns of slots,
or a large opening of other shapes. As yet a further alternative,
portions of the compression plate 42 may be permeable to allow an
aperture to be formed as needed.
[0068] The desired biopsy site location is stereotopically
determined during an MRI scan with reference to a fiducial marker
140 that presents a small artifact. The fiducial marker 140 is
contained within a fiducial marker holder 142 that may be placed at
a convenient location on the compression plate 42, accurately
placed with reference to indents spaced along the slots 138.
Alternatively, the fiducial marker may be embedded or affixed to
the compression plate 42.
[0069] The localizer support frame 126 defines and provides the
guide for positioning the probe assembly 38. The X-Y-Z axes are
defined with regard to the slots 138 and compression plate 42. In
particular, the vertical dimension, or Z-axis, and horizontal
dimension, or X-axis, are defined by the surface of the compression
plate 42. The depth dimension, or Y-axis, is defined as distance
away from the plane of the compression plate 42. The horizontal
slide plate 128 includes laterally aligned front and back rails
144, 146 for setting the X-axis coordinate. Horizontal indicia 148
along the front rail 144 give the surgeon an accurate measurement
of the position of a probe assembly mounting device 150.
[0070] A first version of the mounting device 150 is depicted that
uses a single vertical pedestal 152 to position and support the
probe assembly 38. In addition, the biopsy handle 36 is supported
by the brace 116 connected to the proximal underside of the handle
36 to a handle support rod 156 that is slid through a rod hole 158
to the corresponding side of the vertical pedestal 152. The
appropriate height for the brace 116 is determined by selecting one
of a range of slots arrayed along the underside of the handle,
thereby pivoting the brace 116 about the brace arm 118 whose first
end slidably pivots within a slot 162 in the middle of the brace
154 and second end attaches to the distal end of the handle 36.
[0071] With the handle 36 detached from the probe assembly 38 as
depicted in FIG. 11, an obturator stylet 164 is slide into the
cutter lumen 56 to close the cutter port 88. The stylet 164 may
have radially oriented through holes near its distal end to
maintain fluid communication between the tissue and the vacuum
lumen. Alternately, the stylet 164 may be partially withdrawn,
allowing the cutter port 88 to be in fluid communication with the
conduit 50.
[0072] A slide 166 includes a grooved underside to horizontally
slide on rails 144, 146 of the slide plate 128. The slide 166 also
includes a central channel 168 oriented in the Y-axis depth
dimension to guide the pedestal 152 as it slides in the Y-axis
direction. Sufficient range of motion in depth is achieved with a
pivoting depth slide 170, aligned and pivotally attached to the
slide 166. With the pivoting depth slide 170 in its lowest,
horizontal position, the pedestal 152 may be slid outward
sufficiently for the probe assembly 38 to be out of the compression
plate 42. With the pedestal 152 distally slid onto the slide 166,
the pivoting depth slide 170 may be pivoted upward or otherwise
removed to allow the patient to be transferred into the magnet 24.
Depth indicia 172 along the central channel 168 give the surgeon an
indication of the insertion depth of the probe assembly 38.
[0073] A vertical slide 174 slides on the pedestal 152 for vertical
positioning along the Z-axis, with a measurement provided by
vertical indicia 176 on the pedestal 152. Holes 178 on each lateral
side of the vertical slide 174 allow mounting of the probe housing
46 on either side by insertion of attachment probes 72.
[0074] FIGS. 15-16 depict a second version of the mounting device
150 that uses a second vertical pedestal 180 in lieu of a brace
assembly to support the handle 36. The probe housing 46 is also
depicted as attached to the opposite side of the first vertical
pedestal 152. A second vertical slide 181 of the second vertical
slide 180 advantages contacts the first vertical slide 174, as
shown in FIG. 16, so that setting the vertical height for both is
accomplished in one step. Each vertical slide 174, 181 moves in a
ratchet fashion against its respective vertical pedestal 152, 180,
and thus remains in position after being separated from one another
as shown in FIG. 15. Moreover, the close nesting of the two
vertical pedestals 174, 180 enhances the ability to minimize the
proximal displacement of the localization fixture 16 when used
within the close confines of a closed MRI magnetic bore 24. It will
be further appreciated that the second vertical slide 181 includes
a shaped area that engages the underside of the handle 36 in such a
way as to correctly align the handle 36 at the same X-axis
horizontal dimension as the probe assembly 38.
[0075] FIGS. 17-18 depict a third version of the mounting device
150 wherein the slide 166 and pedestal 152 are replaced with a
scissors table assembly 182 that includes a first slide 184 for
horizontal movement on the slide plate 128. A depth slide 186 is
nested within a top channel 188 of the first slide 182. With
particular reference to FIG. 18, a pair of scissors braces 190 are
extended when drawn together with a screw 192, thereby elevating
the depth slide 186 with respect to the first slide 184. It will be
appreciated that the third version of the mounting device 150
advantageously provides a level support for both the detachable
probe assembly 38 as well as the biopsy handle 36 without having to
perform two vertical adjustments. This version also allows a single
means to attach the probe to the pedestal, as well as not having to
perform two separate attachments for each of the handle 36 and
probe assembly 38.
[0076] FIG. 19 depicts a sequence of operations, or method 200, for
performing an MRI-guided breast core biopsy that accurately and
quickly performs a core biopsy even in a closed MRI. Moreover, the
method takes full advantage of the stereotopic location information
rendered from the MRI scan to position an MRI compatible core
biopsy probe without the necessity of continuous imaging of the
distal tip of the biopsy probe.
[0077] Prior to performing a clinical breast biopsy, the equipment
is initialized to ensure proper function. Thus, in block 202, the
probe that comprises a needle, thumb wheel and housing is assembled
with the handle. The assembled biopsy tool is connected via a power
cord to a control module and the system is powered up, initiating
power up logic in the control module (block 204). Parameters for
rotation speed and translation distances are loaded. If the control
module determines that the system has not been powered up recently,
such as 60 minutes, then initialization logic is performed. Thus,
translational drivetrain initialization is performed (block 206);
rotational drivetrain initialization is performed (block 208); and
vacuum system initialization is performed (block 210). If
initialization is not required, then blocks 206-210 are
bypassed.
[0078] Then, the patient's breast is immobilized in the
localization mechanism (block 212) and the patient is moved into
the MRI magnet bore (block 214). An MRI scan is performed to
stereotopically locate suspicious tissue with reference to a
movable fiduciary marker on the localization mechanism (block 216).
For a closed MRI magnet bore, the patient is then removed (block
218), which is not necessary for an open bore. Anesthesia is
administered prior to the minimally invasive vacuum assisted core
biopsy procedure (block 220). Using the X-Y-Z positioning
capabilities of the localization mechanism, the positioning guides
on the localization mechanism are positioned for insertion to the
predetermined biopsy site (block 222).
[0079] Optionally, insertion may be enhanced by use of an insertion
tool installed through the probe assembly 38 (block 224). For
instance, an ultrasonic cutting tip, extender, and outer tube
assembly may be inserted through the probe assembly 38 through a
slot in the needle tip 62, or exiting from the sample port 60 to be
snapped onto the needle tip 62. This could be accomplished with a
housing on the ultrasonic device that is configured to snap onto
the needle 58, similarly to how a trocar obturator snaps onto the
trocar cannula. Then, the ultrasonic tip is energized prior to
insertion into the patient.
[0080] The probe assembly is mounted on the localization mechanism
(block 226) at the designated X-Z coordinate and with the mounting
device withdrawn along the depth axis. The cutter lumen is sealed
with an obturator stylet (block 228), if not otherwise sealed by a
tool in block 224. The vacuum lumen may be similarly sealed (e.g.
stopcock attached to vacuum lumen access conduit 50) or be used to
aspirate fluid and tissue during insertion. Then the probe is
advanced along the Y-axis, guided by the localization mechanism to
avoid misalignment (block 230). Once in place, if an insertion
enhancement tool was installed in block 224, then this tool is
withdrawn through the cutter lumen of the probe assembly (block
232).
[0081] With the probe in place, various fluid transfers may
advantageously take place through the probe assembly (block 234).
For example, vacuum may be applied through the vacuum lumen with
the sample port exposed to drain any hematoma or air bubble formed
at the biopsy site. Treatment fluids may be inserted directly to
the biopsy site, such as anesthesia or MRI contrast agent. If the
patient is to be scanned in a closed magnet bore, then the patient
is moved back into the bore for scanning (block 236). In addition,
vacuum may optionally be applied to the biopsy site to draw in
suspicious tissue into the bowl of the sample port for confirmation
prior to cutting the sample (block 238). Then, the MRI scan is
performed to confirm placement of tissue in the bowl of the probe
assembly, and adjustment of the probe assembly placement and
re-scans are performed as required (block 240).
[0082] Sample mode is selected through the control module to
perform the sequence of steps to translate and rotate the cutter
according to predetermined settings, with vacuum assist to draw in
the sample and to retract the sample along with the cutter to the
sample window (block 244). If more samples at this biopsy site are
required for diagnostic or for treatment purposes (block 246), then
the thumb wheel is rotated to reorient the sample port to another
angle (block 248), and sample mode is performed again by returning
to block 244.
[0083] After the core biopsy is performed, the probe assembly
provides an excellent opportunity for other minimally invasive
diagnostic procedures and treatments without the necessity for
another insertion. If the biopsy handle is installed, such as in an
open MRI magnet bore, the handle is removed so that the detachable
probe assembly may be accessed (block 250). Examples of tools that
may be inserted through the probe assembly include: (1) gamma
detectors; (2) energized tunneling tips to reduce tunneling forces;
(3) inserts to aid in reconstruction of removed tissue (e.g., one
or two sided shaver inserts); (4) spectroscopy imaging devices; (5)
general tissue characterization sensors {e.g., (a) mammography; (b)
ultrasound, sonography, contrast agents, power Doppler; (c) PET and
FDG ([Flourine-18]-2-deoxy-2-fluoro-glucose); (d) MRI or NMR,
breast coil; (e) mechanical impedance or elastic modulus; (f)
electrical impedance; (g) optical spectroscopy, raman spectroscopy,
phase, polarization, wavelength/frequency, reflectance; (h)
laser-induced fluorescence or auto-fluorescence; (i) radiation
emission/detection, radioactive seed implantation; (j) flow
cytometry; (k) genomics, PCR (polymerase chain reaction)--brca1,
brca2; (l) proteomics, protein pathway}; (6) tissue marker sensing
device; (7) inserts or devices for MRI enhancement; (8) biochips
on-a-stick; (9) endoscope; (10) diagnostic pharmaceutical agents
delivery devices; (11) therapeutic anti-cancer pharmaceutical
agents delivery devices; (12) radiation therapy delivery devices,
radiation seeds; (13) anti-seeding agents for therapeutic biopsies
to block the release of growth factors and/or cytokines (e.g.,
chlorpheniramine (CPA) is a protein that has been found to reduce
proliferation of seeded cancer sells by 75% in cell cultures.);
(14) fluorescent tagged antibodies, and a couple fiber optics to
stimulate fluorescence from a laser source and to detect
fluorescence signals for detecting remaining cancer cells; (15)
positive pressure source to supply fluid to the cavity to aid with
ultrasound visualization or to inflate the cavity to under the
shape or to reduce bleeding; (16) biological tagging delivery
devices (e.g., (a) functional imaging of cellular proliferation,
neovacularity, mitochondrial density, glucose metabolism; (b)
immunohistochemistry of estrogen receptor, her2neu; (c) genomics,
PCR (polymerase chain reaction)--brca1, brca2; (d) proteomics,
protein pathway); and (17) marking clips.
[0084] Then, a tissue marker is inserted through the probe assembly
so that subsequent ultrasonic, X-ray, or MRI scans will identify
the location of the previous biopsy (block 252) and the probe is
removed (block 254).
[0085] FIGS. 20-21 depict a tip protector 260 that advantageously
protects the needle tip 62 of the probe assembly 38 prior to
insertion into tissue and simplifies localization of the probe
assembly 38 in some instances. Furthermore, the tip protector 260
does not interfere with pre-clinical setup procedures (e.g.,
testing for vacuum leaks). In particular, the tip protector 260
includes an attachment member 262 with clips onto the needle 58
without obstructing the sample port 60. A distal portion of the tip
protector completely encompasses the needle tip 62 with a
protection member, depicted as a hemispheric disk 264, that may be
placed in contact with a patient's breast without discomfort. In
addition, in some applications the hemispheric disk 264 may be
comprised of or include an MRI artifact producing material, such as
those described above. Since the hemispheric disk 264 is MRI
scanned outside of the patient's breast, a stronger artifact may be
presented to aid in quickly locating the artifact without obscuring
the suspected lesion.
[0086] With a novel fiducial marker integrated into the tip
protector 260, there is potentially one less step in the
localization process for operators that prefer to position fiducial
marker at the closest insertion point to a suspected lesion prior
to insertion. Procedurally, with the tip protector 260 in place,
the operator would attach the probe assembly 38 onto the pedestal
152 and move the probe assembly 38 up against the breast tissue in
the vicinity of where they believe the suspicious tissue to be,
based on an earlier diagnostic image. Next, when the distance from
this fiducial marker to the lesion is calculated, the "delta"
distances are based on where the probe is currently positioned.
There is a fixed offset along the Y axis to account for the
distance from the fiducial to the middle of the bowl. The
attachment member 262 accurately locates the hemispheric disk 264
so that this Y-axis offset is predictable. This would be more
intuitive because the delta positions are from where the probe is
currently located.
[0087] While the present invention has been illustrated by
description of several embodiments and while the illustrative
embodiments have been described in considerable detail, it is not
the intention of the applicant to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications may readily appear to those skilled in the art.
For example, although the detachable probe assembly provided
numerous benefits, it will be appreciated aspects of the present
invention may be directed to a single piece biopsy tool. For
example, access to the cutter lumen for diagnostic and therapeutic
tools may be incorporated through the cutter or similar
openings.
[0088] For another example, although a localization mechanism 16 is
depicted that laterally compresses a downward hanging patient's
breast, aspects of the present invention are applicable to other
orientations of localization and imaging.
[0089] As an additional example, although MRI is discussed herein
as the imaging modality for stereotopically guiding the core
biopsy, aspects of the present invention apply to other imaging
modalities.
[0090] As yet a further example, although a Cartesian X-Y-Z
positioning approach is disclosed herein, it will be appreciated
that a polar or spherical positioning approach may be implemented
in whole or in part so that the detachable probe assembly enters at
a predefined angle.
[0091] As yet an additional example, although a prone breast
compression device is depicted, application of the present
invention may be used in medical compression devices oriented in
other manners, to include standing, lying on one side, or supine.
In addition, aspects of the present invention may be applicable to
positioning a biopsy probe through a medial compression plate, or a
top and bottom compression plate pair, instead of a lateral
compression plate. Furthermore, aspects of the present invention
are applicable to other diagnostic imaging modalities currently
used or that become available in the future. In addition, aspects
of the present invention would have application to diagnostic
guided biopsy procedures on other portions of the body, as well as
to positioning a probe for utilizing other diagnostic and treatment
devices in a minimally invasive manner.
[0092] As yet a further example, an elongate needle may be formed
without a structural, longitudinal barrier between the vacuum
chamber lumen and the cutter lumen. Instead, the advancing cutter
90 may define a cutter lumen having a circular cross section within
a noncircular cross section (e.g., oval) of the internal cavity of
the elongate needle. Moreover, a noncircular liner may be used to
prevent adhesive entering the undifferentiated internal cavity.
* * * * *