U.S. patent application number 11/045006 was filed with the patent office on 2005-08-18 for excisional biopsy devices and methods.
Invention is credited to Chernomorsky, Ary S., Lee, Roberta, Vetter, James W..
Application Number | 20050182339 11/045006 |
Document ID | / |
Family ID | 24259393 |
Filed Date | 2005-08-18 |
United States Patent
Application |
20050182339 |
Kind Code |
A1 |
Lee, Roberta ; et
al. |
August 18, 2005 |
Excisional biopsy devices and methods
Abstract
An excisional biopsy system includes a tubular member that has a
proximal end and a distal end in which one or more windows are
defined. A first removable probe has a proximal portion that
includes a cutting tool extender and a distal portion that includes
a cutting tool. The first removable probe may be configured to fit
at least partially within the tubular member to enable the cutting
tool to selectively bow out of and to retract within one of the
windows when the cutting tool extender is activated. A second
removable probe has a proximal section that includes a tissue
collection device extender and a distal section that includes a
tissue collection device. The second removable probe may also be
configured to fit at least partially within the tubular member to
enable the tissue collection device to extend out of and to retract
within one of the windows when the tissue collection device
extender is activated. A third removable probe may also be
provided. The third removable probe may also be configured to fit
at least partially within the tubular member and may include an
imaging device, such as an ultrasound transducer, mounted therein.
By selectively activating the cutting tool and the tissue
collection device while rotating the excisional device, a tissue
specimen may be cut from the surrounding tissue and collected for
later analysis.
Inventors: |
Lee, Roberta; (Redwood City,
CA) ; Vetter, James W.; (Portola Valley, CA) ;
Chernomorsky, Ary S.; (Millbrae, CA) |
Correspondence
Address: |
YOUNG LAW FIRM
A PROFESSIONAL CORPORATION
4370 ALPINE ROAD SUITE 106
PORTOLA VALLEY
CA
94028
|
Family ID: |
24259393 |
Appl. No.: |
11/045006 |
Filed: |
January 26, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11045006 |
Jan 26, 2005 |
|
|
|
10066353 |
Jan 31, 2002 |
|
|
|
6863676 |
|
|
|
|
10066353 |
Jan 31, 2002 |
|
|
|
09565611 |
May 4, 2000 |
|
|
|
6440147 |
|
|
|
|
09565611 |
May 4, 2000 |
|
|
|
09417520 |
Oct 13, 1999 |
|
|
|
6423081 |
|
|
|
|
09417520 |
Oct 13, 1999 |
|
|
|
09146743 |
Sep 3, 1998 |
|
|
|
6022362 |
|
|
|
|
Current U.S.
Class: |
600/564 ;
600/567; 606/167 |
Current CPC
Class: |
A61B 10/04 20130101;
A61B 2218/002 20130101; A61B 10/0041 20130101; A61B 2018/1475
20130101; A61B 2018/00333 20130101; A61B 2018/1407 20130101; A61B
10/02 20130101; A61B 10/0266 20130101; A61B 2090/3782 20160201;
A61B 2018/00011 20130101; A61B 18/1482 20130101; A61B 2090/3784
20160201; A61B 17/320725 20130101 |
Class at
Publication: |
600/564 ;
606/167; 600/567 |
International
Class: |
A61B 017/32; A61B
010/00 |
Claims
1-77. (canceled)
78. A device configured to remove a specimen of breast tissue that
is cut from surrounding breast tissue, comprising: a shaft, and a
tissue collection element coupled to the shaft, the tissue
collection element including a thin flexible membrane, the tissue
collection device being movable from a retracted position to an
expanded position, the thin flexible membrane being configured to
encapsulate the cut specimen while maintaining the cut specimen
intact and isolating the captured specimen from contact with the
surrounding breast tissue.
79. The device of claim 78, wherein the tissue collection element
includes a flexible element to which the thin flexible membrane is
attached and wherein the flexible element is configured to
selectively bow away from and retract toward the shaft.
80. The device of claim 78, wherein the thin flexible membrane
forms a bag.
81. The device of claim 80, wherein the bag is configured to
selectively open to capture the cut specimen and close to
encapsulate the cut specimen as the tissue collection element bows
away from and retracts toward the shaft, respectively.
82. The device of claim 78, wherein the tissue collection element
is configured to expand to a size at least equal to the size of the
cut specimen.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of U.S.
patent application Ser. No. 09/417,520, which is a divisional
patent application of U.S. patent application Ser. No. 09/146,743,
now U.S. Pat. No. 6,022,362.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention pertains to the field of soft tissue
excisional biopsy devices and methods. In particular, the present
invention relates to the field of devices and methods for excising
suspicious lesions from soft tissue, such as breast tissue.
[0004] 2. Description of the Related Art
[0005] Breast cancer is a major threat and concern to women. Early
detection and treatment of suspicious or cancerous lesions in the
breast has been shown to improve long-term survival of the patient.
The trend is, therefore, to encourage women not only to perform
monthly self-breast examination and obtain a yearly breast
examination by a qualified physician, but also to undergo annual
screening mammography commencing at age 40. Mammography is the only
screening modality available today that can detect small,
nonpalpable lesions. These nonpalpable lesions may appear as opaque
densities relative to normal breast parenchyma and fat or as
clusters of microcalcifications.
[0006] The conventional method for diagnosing, localizing and
excising nonpalpable lesions detected by mammography generally
involves a time-consuming, multi-step process. First, the patient
goes to the radiology department where the radiologist finds and
localizes the lesion either using mammography or ultrasound
guidance. Once localized, a radio-opaque wire is inserted into the
breast. The distal end of the wire may include a small hook or
loop. Ideally, this is placed adjacent to the suspicious area to be
biopsied. The patient is then transported to the operating room.
Under general or local anesthesia, the surgeon performs a procedure
called a needle-localized breast biopsy. In the needle-localized
breast biopsy, the surgeon, guided by the wire previously placed in
the patient's breast, excises a mass of tissue around the distal
end of the wire. The specimen is sent to the radiology department
where a specimen radiograph is taken to confirm that the suspicious
lesion is contained within the excised specimen. Meanwhile, the
surgeon, patient, anesthesiologist and operating room staff, wait
in the operating room for confirmation of that fact from the
radiologist before the operation is completed. The suspicious
lesion should ideally be excised in toto with a small margin or rim
of normal breast tissue on all sides. Obtaining good margins of
normal tissue is extremely dependent upon the skill and experience
of the surgeon, and often an excessively large amount of normal
breast tissue is removed to ensure that the lesion is located
within the specimen. This increases the risk of post-operative
complications, including bleeding and permanent breast deformity.
As 80% of breast biopsies today are benign, many women
unnecessarily suffer from permanent scarring and deformity from
such benign breast biopsies.
[0007] More recently, less invasive techniques have been developed
to sample or biopsy the suspicious lesions to obtain a histological
diagnosis. The simplest of the newer techniques is to attempt
visualization of the lesion by external ultrasound. If seen by
external ultrasound, the lesion can be biopsied while being
continuously visualized. This technique allows the physician to see
the biopsy needle as it actually enters the lesion, thus ensuring
that the correct area is sampled. Current sampling systems for use
with external ultrasound guidance include a fine needle aspirate,
core needle biopsy or vacuum-assisted biopsy devices.
[0008] Another conventional technique localizes the suspicious
lesion using stereotactic digital mammography. The patient is
placed prone on a special table that includes a hole to allow the
designated breast to dangle therethrough. The breast is compressed
between two mammography plates, which stabilizes the breast to be
biopsied and allows the digital mammograms to be taken. At least
two images are taken 30 degrees apart to obtain stereotactic views.
The x, y and z coordinates targeting the lesion are calculated by a
computer. The physician then aligns a special mechanical stage
mounted under the table that places the biopsy device into the
breast to obtain the sample or samples. There are believed to be
three methods available to biopsy lesions using a stereotactic
table: (1) fine needle aspiration, (2) core needle biopsy and (3)
vacuum-assisted core needle biopsy.
[0009] Fine needle aspiration uses a small gauge needle, usually 20
to 25 gauge, to aspirate a small sample of cells from the lesion or
suspicious area. The sample is smeared onto slides that are stained
and examined by a cytopathologist. In this technique, individual
cells in the smears are examined, and tissue architecture or
histology is generally not preserved. Fine needle aspiration is
also very dependent upon the skill and experience of the operator
and can result in a high non-diagnostic rate (up to about 83%), due
to inadequate sample collection or preparation.
[0010] Core needle biopsy uses a larger size needle, usually 14
gauge to sample the lesion. Tissue architecture and histology are
preserved with this method. A side-cutting device, consisting of an
inner trough with an outer cutting cannula is attached to a
spring-loaded device for a rapid semi-automated firing action.
After the lesion is localized, local anaesthetic is instilled and a
small incision is made in the skin with a scalpel. The device
enters the breast and the needle tip is guided into the breast up
to the targeted lesion. The device is fired. First, the inner
cannula containing the trough rapidly penetrates the lesion.
Immediately following this, the outer cutting cannula rapidly
advances over the inner cannula cutting a sample of tissue off in
the trough. The whole device is then removed and the sample
retrieved. Multiple penetrations of the core needle through the
breast and into the lesion are required to obtain an adequate
sampling of the lesion. Over 10 samples have been recommended by
some.
[0011] The vacuum-assisted breast biopsy system is a larger
semi-automated side-cutting device. It is usually 11 gauge in
diameter and is more sophisticated than the core needle biopsy
device. Multiple large samples can, be obtained from the lesion
without having to reinsert the needle each time. A vacuum is added
to suck the tissue into the trough. The rapid firing action of the
spring-loaded core needle device is replaced with an oscillating
outer cannula that cuts the breast tissue off in the trough. The
physician controls the speed at which the outer cannula advances
over the trough and can rotate the alignment of the trough in a
clockwise fashion to obtain multiple samples.
[0012] If a fine needle aspirate, needle core biopsy or
vacuum-assisted biopsy shows malignancy or a specific benign
diagnosis of atypical hyperplasia, then the patient needs to
undergo another procedure, the traditional needle-localized breast
biopsy, to fully excise the area with an adequate margin of normal
breast tissue. Sometimes the vacuum-assisted device removes the
whole targeted lesion. If this occurs, a small titanium clip should
be placed in the biopsy field. This clip marks the area if a
needle-localized breast biopsy is subsequently required for the
previously mentioned reasons.
[0013] Another method of biopsying the suspicious lesion utilizes a
large end-cutting core device measuring 0.5 cm to 2.0 cm in
diameter. This also uses the stereotactic table for stabilization
and localization. After the lesion coordinates are calculated and
local anesthesia instilled, an incision large enough is permit
entry of the bore is made at the entry site with a scalpel. The
breast tissue is cored down to and past the lesion. Once the
specimen is retrieved, the patient is turned onto her back and the
surgeon cauterizes bleeding vessels under direct vision. The
incision, measuring 0.5 to larger than 2.0 cm is sutured
closed.
[0014] The stereotactic table requires awkward positioning of the
patient and may be extremely uncomfortable. The woman must lie
prone during the entire procedure, which may be impossible for some
patients. In addition, the lesion to be biopsied must be in the
center working area of the mammography plates. This may be
extremely difficult and uncomfortable for the patient if the lesion
is very posterior near the chest wall or high towards the
axilla.
[0015] The woman is subjected to increased radiation exposure as
multiple radiographs are required throughout the course of the
procedure to: (1) confirm that the lesion is within the working
area of the mammography plates, (2) obtain the stereotactic
coordinates (at least two views), (3) verify the positioning of the
biopsy needle prior to obtaining tissue, and (4) verify that the
lesion was indeed sampled. If any difficulty is encountered during
the procedure, additional radiographic exposures are required to
verify correction of the problem.
[0016] Using the core needle biopsy or vacuum-assisted device,
bleeding is controlled only by manual pressure. Bleeding is
generally not an issue with fine needle aspiration, but is a
legitimate complication of the former two methods. Ecchymoses,
breast edema and hematomas can occur. This causes increased
post-procedural pain and delays healing. Rarely, the patient may
require an emergency operation to control and evacuate a tense
hematoma.
[0017] Another major concern is the possibility of tumor
dissemination. The core needle biopsy and vacuum-assisted devices
both cut into the tumor and carve out multiple samples for
examination. While cutting into the tumor, cancerous cells may be
dislodged. Cutting across blood vessels at the same time may allow
the freed cancerous cells access to the blood stream, thus possibly
seeding the tumor beyond its original locus. The long-term
consequences of tumor seeding with the risk of bloodborne
metastases are unknown at this time, as the techniques are
relatively new. However, documented instances of cancerous cells
seeding locally into needle tracks exist. There are numerous
reports of metastases growing in needle tracks from previous
biopsies of a cancerous mass. Most of these are from lung or liver
cancers. However, at least one case of mucinous carcinoma of the
breast growing in a needle track has been reported. The long-term
consequences of neoplasm seeding into needle tracks are currently
unknown, again because the techniques are relatively new. Some
recommend excision of the entire needle track, including the skin
entry site, during the definitive surgical procedure for a
diagnosed cancer, whether it is a lumpectomy or a mastectomy.
Others assume that with a lumpectomy, the post-operative radiation
therapy will destroy any displaced cancer cells in the needle
track. With the trend towards treating very small cancers only by
excision and without a post-excision course of radiation therapy,
the risk of cancer cells metastasizing and growing in needle tracks
is very real.
[0018] The large core cutting device (0.5 cm to 2.0 cm) generally
eliminates the risk of needle track seeding as it is designed to
excise the lesion intact. A stereotactic table is required with the
same inherent awkwardness for the patient, as discussed above.
Bleeding is controlled, albeit manually, requiring that the patient
wait until the end of the procedure to be turned over. Compression
is used to stabilize the breast and localize the lesions. The
breast, however, may be torqued and distorted between the
compression plates such that when the plates are removed after the
biopsy, the large core track left behind may not be straight, but
actually tortuous. This can result in permanent breast
deformity.
[0019] The location of the insertion site into the breast is
dictated by the positioning of the breast in the machine and not by
the physician. The entry site is usually away from the
nipple-areolar complex and is usually located on the more exposed
areas of the breast. For the fine needle aspirate, core biopsy and
vacuum-assisted devices, the incision is usually very small and the
scar almost unappreciable. However, in the case of the large core
biopsy device (0.5 to 2.0 cm), a large incision is needed. Such a
large incision often results in a non-aesthetically placed
scat.
[0020] The newer conventional minimally invasive breast biopsy
devices have improved in some ways the ability to diagnose
mammographically detected nonpalpable lesions. These devices give
the patient a choice as to how she wants the diagnosis to be made.
Moreover, these devices are substantially less expensive than the
older traditional needle-localized breast biopsy. They are not,
however, the final solution. Due to the above-discussed problems
and risks associated with compression, needle-track seeding, blood
borne metastases, bleeding, radiation exposure and awkwardness of
the stereotactic table, more refined devices and methods are needed
to resolve these issues. Also, the conventional biopsy devices do
not consider margins in their excisions and if cancer is diagnosed,
the patient must undergo a needle-localized breast lumpectomy to
ensure that adequate margins are removed around the cancer. Devices
and methods, therefore, must address the problem of obtaining
adequate margins so that a second procedure is not required.
Margins, moreover, cannot be assessed while the breast is being
compressed.
SUMMARY OF THE INVENTION
[0021] It is, therefore, an object of the present invention to
provide devices and methods to efficiently and safely excise
suspicious lesions from the breast. It is also an object of the
present invention to provide devices and methods that remove the
entire lesion intact with the minimum amount of normal tissue
surrounding the lesion needed to provide adequate margins. It is a
further object of the present invention to provide devices and
methods that provide hemostasis in the breast to minimize
complications of ecchymosis, hematoma formation, and breast edema.
It is another object of the present invention to provide methods
and devices to provide intra-tissue ultrasonic guidance to provide
real time, in situ monitoring of the procedure. A still further
object is to provide devices and methods that allow the physician
to minimize the size of the incision through which the procedure is
performed and to leave an aesthetically acceptable scar on the
breast.
[0022] In accordance with the above-described objects and those
that will be mentioned and will become apparent below, an
embodiment of an excisional biopsy system according to the present
invention comprises a tubular member including a proximal end and a
distal end, the tubular member defining a first window near the
distal end, and a first removable probe that includes a proximal
portion including cutting tool extending means, a distal portion
and a cutting tool near the distal portion, the first removable
probe being configured to fit at least partially within the tubular
member to enable the cutting tool to selectively bow out of and to
retract within the first window when the cutting tool extending
means are activated.
[0023] The first removable probe may further include a window slide
and the proximal end may further include a window slide extending
means, the window slide being configured to selectively cover a
portion of the first window when the window slide extending means
are activated. The cutting tool may include one of a thin ribbon
sharpened on a leading edge thereof and a wire. The cutting tool
may include an RF cutting tool and the first removable probe may be
adapted to be connected to an RF power source. The cutting tool may
include a monopolar or a bipolar RF cutting tool. The tubular
member may include a first internal guide that is configured to
enable the first removable probe to slide within the tubular
member. The first removable probe may include a second internal
guide, the second internal guide enabling the cutting tool to slide
within the first removable probe when the cutting tool extending
means are activated. The first removable probe may include a third
internal guide, the third internal guide enabling the window slide
to slide within the first removable probe when the window slide
extending means are activated. The biopsy system may further
include a second removable probe comprising a proximal section
including a tissue collection device extending means and a distal
section including a tissue collection device, the second removable
probe being configured to fit at least partially within the tubular
member to enable the tissue collection device to extend out of and
to retract within the first window when the tissue collection
device extending means are activated. Alternatively, the tubular
member may define a second window near the distal end thereof, and
the biopsy system may further include a second removable probe
comprising a proximal section including a tissue collection device
extending means and a distal section including a tissue collection
device, the second removable probe being configured to fit at least
partially within the tubular member to enable the tissue collection
device to selectively extend out of and to retract within the
second window when the tissue collection device extending means are
activated.
[0024] The tissue collection device may include a thin ribbon or a
wire, as well as a thin flexible sheet of material attached to the
thin ribbon or wire, the thin flexible sheet at least partially
encapsulating a tissue specimen as the thin ribbon or wire is
extended and the tubular member rotated. The thin flexible sheet of
material may include a bag attached to the ribbon or wire so as to
open and close when the ribbon or wire is extended and retracted,
respectively. The tissue collection device may include a thin
ribbon or a wire, and a thin flexible sheet of material may be
attached to the thin ribbon or wire, the thin flexible sheet at
least partially encapsulating a tissue specimen as the thin ribbon
or wire is extended and the tubular member rotated. The thin
flexible sheet of material may include a bag attached to the thin
ribbon or wire so as to open and close when the thin ribbon or wire
is extended and retracted, respectively. The tubular member may
include a first internal guide that is configured to enable one of
the first and the second removable probe to slide within the
tubular member until the cutting tool and/or the tissue collection
device faces out of the first window. Similarly, the tubular member
may include a second internal guide that is configured to enable
the second removable probe to slide within the tubular member until
the tissue collection device faces out of the second window. The
distal portion of the first removable probe may further include a
tissue collection device near a trailing edge of the cutting tool,
the tissue collection device being configured to selectively extend
out of and retract into the first window. The proximal portion of
the first removable probe may include a tissue collection device
extending means, the tissue collection device extending means being
adapted to enable the tissue collection device to extend out of and
to retract within the first window independently of the cutting
tool. The tissue collection device may be coupled to the cutting
tool and the cutting tool extending means may also be configured to
selectively extend the tissue collection device out of the first
window and retract the tissue collection device into the first
window as the cutting tool is extended and retracted, respectively.
The first removable probe may include an insulator between the
tissue collection device and the cutting tool. The insulator may
include an air gap and/or an insulating material attached to and
separating the cutting tool from the tissue collection device. The
first removable probe may define one or more internal lumens that
terminate near the distal portion as an opening formed in a surface
of the first removable probe, the opening being adapted to deliver
a pharmaceutical agent and/or to provide suction.
[0025] A third removable probe may be provided, the third removable
probe being configured to fit at least partially within the tubular
member and including an imaging device mounted therein. The imaging
device may include an ultrasound sensor, such as a linear array of
ultrasound transducers, for example. The ultrasound sensor may be
disposed near a distal tip of the third removable probe and away
from the cutting tool, so that the ultrasound sensor sweeps a plane
ahead of the cutting tool as the tubular member rotates. The
ultrasound sensor may be tuned within the range from about 7.5 MHz
to about 20 MHz. The ultrasound sensor may be disposed within the
tubular member at an angle .alpha. relative to the cutting tool,
the angle .alpha. being no smaller than that necessary to
effectively control the operation of the cutting tool in response
to information gathered from the ultrasound transducer as the
tubular member rotates. For example, the angle .alpha. may be less
than about 90 degrees.
[0026] The tubular member, first removable probe, the second
removable probe and/or the third removable may be configured for a
single use and may be disposable.
[0027] The present invention is also a soft tissue treatment
method, comprising the steps of inserting a generally tubular
member into the soft tissue, the tubular member defining a first
window in a surface thereof, the tubular member being configured to
accept a removable probe inserted therein; inserting a first
removable probe into the tubular member, the first removable probe
including a cutting tool that is adapted to face out of the first
window; selectively activating the cutting tool to cut a tissue
specimen while rotating the tubular member within the tissue;
removing the first removable probe from the tubular member while
the tubular member stays in place; inserting a second removable
probe into the tubular member, the second removable probe including
a tissue collection device that is adapted to face out of the first
window, and selectively activating the tissue collection device to
encapsulate the tissue specimen rotating the tubular member.
[0028] The first removable probe may be inserted into the tubular
member before the tubular member is inserted into the soft tissue.
The method may further include the steps of inserting a third
removable probe into the tubular member, the third removable probe
including an imaging device therein that is configured to face out
of the first window, and rotating the tubular member while
activating the imaging device to image the soft tissue at least one
of before and after the tissue collection device is activated. The
tubular member may define a second window in the surface thereof
and the method may further include the steps of inserting a third
removable probe into the tubular member, the third removable probe
including an imaging device therein that is configured to face out
of the second window, and rotating the tubular member while
activating the imaging device to image the soft tissue at least one
of before, during and after the tissue collection device is
activated.
[0029] Steps may be carried out to display information received
from the imaging device on a display device and to vary the
operation of the cutting tool and/or the tissue collection device
during the first and/or second activating steps based upon the
displayed information from the imaging device. The cutting tool may
include an electrosurgical blade and the method may further include
the step of varying a power applied to the electrosurgical blade
based upon information received from the imaging device or feedback
to the RF generator. A step of stabilizing the soft tissue in an
uncompressed state prior to the first inserting step may also be
carried out.
[0030] The tubular member and/or the first removable probe may
define an internal lumen and a plurality of through holes in fluid
communication with the internal lumen, and the method may further
comprise one or more of the following steps: delivering a
pharmaceutical agent to the tissue via the plurality of through
holes, and suctioning smoke and/or fluids from the soft tissue via
the plurality of through holes.
[0031] The present invention may also be viewed as a soft tissue
treatment method, comprising the steps of inserting a generally
tubular member into the soft tissue, the tubular member defining a
first window in a surface thereof, the tubular member being
configured to accept a removable probe inserted therein; inserting
a first removable probe into the tubular member, the first
removable probe including a cutting tool and a tissue collection
device that are adapted to face out of the first window;
selectively activating the cutting tool to cut a tissue specimen
while rotating the tubular member within the soft tissue, and
selectively activating the tissue collection device to encapsulate
the tissue specimen while rotating the tubular member.
[0032] The first removable probe may be inserted into the tubular
member before the tubular member is inserted into the soft tissue.
The tubular member may define a second window in the surface
thereof and the method may further include the steps of inserting a
second removable probe into the tubular member, the second
removable probe including an imaging device therein that is
configured to face out of the second window, and rotating the
tubular member while activating the imaging device to image the
soft tissue at least one of before, during and after at least one
of the cutting tool and the tissue collection device are activated.
The method may also include the steps of displaying information
received from the imaging device on a display device; and varying
an operation of at least one of the cutting tool and the tissue
collection device during at least one the first and second rotating
steps based upon the displayed information from the imaging
device.
[0033] The first and second activating steps may be carried out
simultaneously and the cutting tool and the tissue collection
device may be coupled to one another. Alternatively, the first and
second activating steps may be carried out simultaneously or
consecutively and the cutting tool and the tissue collection device
may be activated independently of one another.
[0034] According to another embodiment thereof, the present
invention is also an excisional biopsy system for soft tissue,
comprising a tubular member defining a first, a second and a third
window near a distal tip thereof; a first removable probe
comprising a proximal portion that includes cutting tool extending
means, a distal portion and a cutting tool near the distal portion,
the first removable probe being configured to fit at least
partially within the tubular member to enable the cutting tool to
selectively bow out of and to retract within the first window when
the cutting tool extending means are activated; a second removable
probe comprising a proximal section including a tissue collection
device extending means and a distal section including a tissue
collection device, the second removable probe being configured to
fit at least partially within the tubular member to enable the
tissue collection device to extend out of and to retract within the
second window when the tissue collection device extending means are
activated, and a third removable probe, the third removable probe
being configured to fit at least partially within the tubular
member and including an imaging device mounted therein that is
configured to face out of the third window.
[0035] The present invention may also be viewed as an excisional
biopsy system for soft tissue, comprising a tubular member defining
a first and a second window near a distal tip thereof; a first
removable probe comprising a proximal portion and a distal portion,
the proximal portion including a tool extending means, the distal
portion including a cutting tool and a tissue collection tool, the
first removable probe being configured to fit at least partially
within the tubular member to enable the cutting and tissue
collection tools to selectively extend out of and to retract within
the first window when the tool extending means are activated, and a
second removable probe, the third removable probe being configured
to fit at least partially within the tubular member and including
an imaging device mounted therein that is configured to face out of
the second window.
[0036] The cutting and tissue collection tools may be mechanically
coupled to one another. The cutting and tissue collection tools may
also be independently activated and the tool extending means may
include a cutting tool extending means operative to extend and to
retract the cutting tool out of and into the first window and a
tissue collection extending means operative to extend and to
retract the tissue collection tool into and out of the first
window.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] For a further understanding of the objects and advantages of
the present invention, reference should be made to the following
detailed description, taken in conjunction with the accompanying
figures, in which:
[0038] FIG. 1A shows an embodiment of the excisional device
according to the present invention with the cutting tool in its
flat, retracted configuration.
[0039] FIG. 1B shows the excisional device of FIG. 1A with its
cutting tool in an extended, bowed configuration.
[0040] FIG. 1C shows another view of the excisional device of FIG.
1A.
[0041] FIG. 2A depicts the distal region of another embodiment of
the excisional device according to the present invention, showing
the excisional device together with the external tissue collection
attached thereto in the open configuration.
[0042] FIG. 2B shows the excisional device of FIG. 2A together with
the external tissue collection attached thereto in the closed
configuration.
[0043] FIG. 2C shows an embodiment of the proximal region of the
excisional device according to the present invention.
[0044] FIG. 3A depicts the operation of an embodiment of the
excisional device and method according to the present
invention.
[0045] FIG. 3B further shows the operation of an embodiment of the
excisional device and method according to the present
invention.
[0046] FIG. 3C further depicts the operation of an embodiment of
the excisional device and method according to the present
invention.
[0047] FIG. 4 shows a detailed view of a cutting tool suitable for
use with the excisional device according to the present
invention.
[0048] FIG. 5 shows a cross section of the cutting tool, taken
along line AA' in FIG. 4.
[0049] FIG. 6 shows a detailed view of another cutting tool
suitable for use with the excisional device according to the
present invention.
[0050] FIG. 7 shows a cross section of the cutting tool, taken
along line BB' in FIG. 6.
[0051] FIG. 8 shows another embodiment of a cutting tool suitable
for use with the excisional biopsy device according to the present
invention.
[0052] FIG. 9 is a cross-sectional schematic of the tubular member
110, to illustrate the relative placements of the cutter window 120
and of the transducer 270 about the circumference of the tubular
member 110. Unnecessary details have been omitted for clarity.
[0053] FIG. 10 shows an excisional device according to another
embodiment of the present invention, in which the tubular member of
the excisional device includes an internal lumen through which a
removable transducer core may be inserted.
[0054] FIG. 11 shows an embodiment of a removable transducer core
according to the present invention.
[0055] FIG. 12 shows a cross section of the embodiment of the
excisional device of FIG. 10, taken along line AA'.
[0056] FIG. 13 shows the removable transducer core of FIG. 11
inserted within an expandable sheath, according to a further
embodiment of the present invention.
[0057] FIG. 14 shows another embodiment of a soft tissue excisional
device assembly according to the present invention, in which a
removable transducer core is inserted and secured within the
excisional device so that the active element faces out of the
transducer window.
[0058] FIG. 15 shows another embodiment of a cutting tool (and
method of making same) that is suitable for use within the
excisional device according to the present invention.
[0059] FIG. 16 shows a view of the completed cutting tool of FIG.
15.
[0060] FIG. 17 shows an embodiment of the method of excisional
biopsy method according to the present invention.
[0061] FIG. 18 is a top view of a removable cutting probe,
according to an embodiment of the present invention.
[0062] FIG. 19 is a side view of the removable cutting probe of
FIG. 18, showing the adjustable window slide in a first position,
according to an embodiment of the present invention.
[0063] FIG. 20 is a side view of the removable cutting probe of
FIG. 18, showing the adjustable window slide in a second position,
according to an embodiment of the present invention.
[0064] FIG. 21 is a top view of a removable tissue collection
probe, according to an embodiment of the present invention.
[0065] FIG. 22 is a detail view of a removable tissue collection
probe of FIG. 21.
[0066] FIG. 23 is a side view of the removable tissue collection
probe of FIG. 21, showing the tissue collection device thereof in
an extended (bowed) configuration.
[0067] FIG. 24A is a top view of a removable cutting and tissue
collection combination probe, according to an embodiment of the
present invention.
[0068] FIG. 24B is a partial cross-sectional view of the removable
cutting and tissue collection combination probe of FIG. 24A, taken
along lines AA'.
[0069] FIG. 25 is a top view of a removable cutting and tissue
collection combination probe, according to another embodiment of
the present invention.
[0070] FIG. 26 is a side view of a removable cutting and tissue
collection combination probe, according to a still further
embodiment of the present invention, wherein the cutting device and
tissue collection devices are shown in their extended
configuration.
[0071] FIG. 27A is a partial cross-section of a tissue collection
probe, taken at the level of the tissue collection device thereof,
wherein the tissue collection device is in its initial,
non-extended configuration.
[0072] FIG. 27B is a partial cross-section of a tissue collection
probe of FIG. 27A, wherein the tissue collection device is in its
extended configuration.
[0073] FIG. 27C is a partial cross-section of a tissue collection
probe of FIG. 27B, wherein the tissue collection device has
returned to its non-extended configuration after capturing the
target tissue.
[0074] FIG. 28 is a flowchart of a soft tissue treatment method,
according to another embodiment of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0075] FIGS. 1A, 1B and 1C show an embodiment of the distal region
105 of the excisional biopsy device 100 according to the present
invention. Considering FIGS. 1A, 1B and 1C collectively, the distal
region 105 of the excisional biopsy device 100 includes a generally
tubular member 110 having a generally tapered distal tip 115. The
distal tip 115 is configured to penetrate soft tissue, such as
breast tissue, lung tissue, liver tissue and the like. Preferably,
therefore, the distal tip 115 and the distal region 105 of the
excisional biopsy device 100 present a smooth, and relatively
atraumatic profile to the soft tissue in which it is designed to
penetrate. Alternatively, the tip 115 may be sharply pointed and/or
may include an energy source (not shown) to facilitate cutting
through the tissue. The tubular member 110 may be formed of rigid
and hard plastic, or may be made of stainless steel, for example.
Preferably, the tubular member 100 is used once and disposed of,
for both safety and functional reasons.
[0076] A cutter window 120 is disposed within the tubular member
110. The cutter window 120 may be, for example, a shallow trench
formed in the tubular member 110. As best seen in FIG. 1C, the
cutter window 120 may be a shallow and substantially rectangular
trench in the tubular member 110, or may be, for example, a thin,
shallow I-shaped trench. The excisional biopsy device 125 includes
a work element, such as a cutting tool 125. The distal end of the
cutting tool 125 is attached to the tubular member 110 near its
distal tip 115. For example, the distal end of the cutting tool 125
may be attached to the distal-most point 121 of the cutter window
120. The cutting tool 125, however, may alternatively be attached
to other points within the distal region 105. The distal portion of
the cutting tool 125 is exposed through the cutter window 120. The
remaining portion of the cutting tool 125 is disposed within an
internal guide or lumen 130 of the generally tubular member 110.
The internal guide 130 constrains the movement of the cutting tool
125 and allows the cutting tool 125 to freely slide therein,
parallel to the longitudinal axis of the tubular member 110. With
particular reference now to FIG. 2C, the proximal portion 225 of
the cutting tool 125 emerges from the internal lumen 130 near the
proximal end 215 of the tubular member 110. The proximal end of the
cutting tool 125 may, for example, include a push or turn knob 226.
The push or turn knob 226 allows the operator of the excisional
biopsy device 100 to selectively push the cutting tool 125 in the
distal direction (away from the physician and toward the distal tip
115) or retract the cutting tool 125 in the proximal direction
(toward the physician and away from the distal tip 115). To assist
in controlling the movement of the cutting tool 125, the cutting
tool is preferably biased in the proximal direction, as symbolized
by the arrow 227 in FIG. 2C. This biasing may be effectuated by
means of a spring 228 attached at or near the proximal end 215 of
the tubular member 110 and to the proximal portion 225 of the
cutting tool 125. In this manner, the default configuration of the
cutting tool 125 is the retracted position, wherein the cutting
tool 125 lies substantially flat within the cutter window 120 of
the tubular member 110.
[0077] The cutting tool 125, when pushed in the distal direction by
the physician applying pressure in the distal direction on the push
or turn knob 226 or equivalent structure, slides within the
internal guide 130 of the tubular member 110. As the distal end of
the cutting tool 125 is attached near the distal end of the tubular
member 110 or to the distal-most point 121 of the cutter window
120, the portion thereof exposed through the cutter window 120
tends to bow outwardly, extending out of the cutter window 120, as
shown in FIG. 1B. The extension out of the cutter window 120 and
the degree of bowing may be controlled by the physician, by
appropriate action on the push or turn knob 226. Thus, the possible
range of extension and bowing is potentially infinite, being
limited only by the physician's ability to control the cutting tool
125 by finely pushing and retracting the push or turn knob 226. The
degree of extension, as well as the shape of the bowed portion of
the cutting tool, therefore, may be controlled by selectively
sliding the cutting tool within the internal guide 130 of the
tubular member 110.
[0078] The shape of the bowed portion and the ease with which the
distal portion of the cutting tool 125 bows outwardly may be varied
by varying the physical characteristics of the cutting tool 125.
Preferably, the cutting tool is formed of a resilient, readily
deformable material that, when unstressed, returns to its original
unbiased configuration. For example, a nickel titanium alloy may be
used for the cutting tool 125, to allow the cutting tool 125 to
exhibit shape-memory characteristics. The shape of the cutting tool
125 in its bowed and extended configuration (FIG. 2) may be further
controlled by varying, for example, the thickness of the cutting
tool over the portion thereof exposed through the cutter window
120. A locally thicker portion of the cutting tool 125 will not
bend as readily as a locally relatively thinner portion thereof.
Judiciously varying the thickness, for example, of the cutting tool
125, therefore, allows the curvature of the bowed portion thereof
to be controlled.
[0079] As shown in FIGS. 1A, 1B, and with reference to FIG. 1C,
pushing on the push or turn knob 226 (or any such functionally
equivalent structure) causes the cutting tool 125 to bow outwardly
and extend out from the cutter window 120 of the tubular member
110, as shown in FIG. 1B. Similarly, retracting the push or turn
knob 226 (or any such functionally equivalent structure) causes the
cutting tool 125 to flatten out within the cutter window 120 and to
assume a configuration (shown in FIG. 1A) that may be substantially
flush with the outer surface of the tubular member 110. In this
configuration, the tubular member 110 may easily penetrate soft
tissue, such as breast, lung, liver or other soft body tissue.
[0080] In operation, the surgeon makes an incision into the
patient's skin, such as the surface of the breast. The excisional
biopsy device 100 then may be directly introduced into the breast
tissue, or an expandable sheath (shown at reference numeral 495 in
FIG. 13) may be introduced into the incision and thereafter
expanded as the excisional biopsy device 100 is introduced therein.
In any event, the excisional biopsy device is introduced into the
breast tissue itself and positioned, for example, adjacent to the
lesion in the breast or adjacent the target site from which the
excision is to take place. During the introduction of the
excisional biopsy device 100 into the soft tissue, the cutting tool
125 is in its retracted configuration wherein the portion thereof
exposed through the cutter window 120 is substantially flat. The
excisional device 100, in this configuration, therefore, exhibits a
smooth and tapered profile to the surrounding tissue. Once the
device 100 has been determined to have been properly positioned
within the soft tissue, the device is rotated about its
longitudinal axis. The rotation may be carried out manually, or the
rotation of the device may be carried out by a motorized unit
disposed within the proximal region of the device 100. As the
device 100 rotates, the surgeon causes the cutting tool 125 to bow
outwardly and to extend from the cutter window 120. Preferably, the
degree of bowing and outward extension is at least sufficient to
include the lesion (such as the targeted microcalcification within
the breast) within the space between the cutter window 120 and the
cutting tool 125. The cutting tool 125 cuts the tissue as the
device 100 is rotated, thereby severing the lesion from its
surrounding breast tissue mass. By completing at least one
revolution within the breast tissue, the cutting tool 125 sweeps a
volume of revolution of breast tissue and severs that volume from
the main tissue mass. Such volume of revolution includes at least
the targeted lesion. Preferably, the volume of revolution severed
from the main tissue mass not only includes the targeted lesion,
but also includes a margin of healthy tissue surrounding the
lesion. The degree of extension and bowing of the cutting tool 125
may be varied within a given revolution of the excisional biopsy
device 100. In this manner, it is possible to exert fine control
over the amount of tissue cut away from the main tissue mass, as
well as fine control over the shape of the severed mass.
[0081] After the lesion and preferably a margin of healthy tissue
around the lesion have been severed, the severed tissue may be
removed from the main tissue mass. This removal of the severed
tissue may be effectuated by any number of means, including the
retraction of the excisional biopsy device 100 from the main tissue
mass. Alternately, severed tissue extraction may be carried out by
means of the structure and method to be described below.
[0082] The cutting tool 125 may, as shown in FIG. 1C, be configured
as a thin ribbon. The thin ribbon 125 shown in FIG. 1C is
preferably sharpened on its leading edge to facilitate cutting
through tissue and sometimes fibrous and calcified masses. The
leading edge of the cutting tool 125 is that edge thereof that
first comes into contact with the tissue to be severed as the
device 100 is rotated. Such a sharpened leading edge is shown in
FIG. 4 at reference numeral 127. The width of such a ribbon cutting
tool 125 is preferably smaller than the width of the cutter window
120 into which it recedes when the cutting tool 125 is retracted in
the proximal direction.
[0083] Another embodiment of the cutting tool 125 is shown in FIG.
8. To decrease the forward resistance of the cutting tool 125 as it
slowly cuts through tissue, the leading edge of the portion thereof
exposed through the cutter window 120 may be serrated, including a
plurality of teeth 127. In turn, the leading edge of the plurality
of teeth 127 may include a sharpened edge. In this manner, as the
excisional device 100 rotates, only the forward-most tips of the
teeth 127 will initially come into contact with the tissue to be
cut, thus reducing the tissue surface upon which the force of the
rotating cutting blade 125 is applied. Thus, the cutting blade 125
of FIG. 8 is believed to be highly effective in cutting through
even relatively dense or fibrous tissue while minimizing the torque
to be applied to the excisional biopsy device 100 as it is caused
to rotate within the main soft tissue mass.
[0084] Referring to FIG. 4 and also to FIG. 5, the cutting tool 125
may further comprise an interior lumen 128 running an entire length
or a portion of the length of the cutting tool 125. The cutting
tool 125 may further include a plurality of through holes 126 in
the distal portion of the cutting tool 125 exposed through the
cutter window 120. The plurality of through holes 126 are in fluid
communication with the internal lumen 128. In use, the internal
lumen 128 may be connected, in the proximal portion of the
excisional biopsy device 100, to a fluid reservoir. The fluid
reservoir, which may be internal or external to the proximal
section of the device 100, supplies the distal portion of the
cutting tool 125 with, for example, anaesthetic (such as, for
example, lidocaine) and/or antibiotic fluid. In this manner, such
anaesthetic and/or antibiotic fluid (or other fluid) may be
delivered precisely to the tissue surrounding the cutting tool 125
as it rotates. A precisely dosed anaesthetic, for example, may be
delivered to the very site where it is most needed. As such
anaesthetic is delivered only where it is needed, the effect
thereof is near instantaneous, and the patient feels little or no
pain as the excisional biopsy device 100 according to the present
invention is rotated within her breast, or other soft tissue. FIG.
5 shows a cross-section of the cutting tool 125 of FIG. 4, taken
along line AA' in FIG. 4.
[0085] Care should be exercised in selecting the configuration and
materials for the cutting tool 125 shown in FIGS. 4 and 5. Indeed,
the configuration and materials selected should allow the cutting
tool 125 to bow and extend out of the cutter window 120 of the
device 100 without, however, pinching or substantially disrupting
the flow of fluid delivered via the internal lumen 128 of the
cutting tool 125, if the cutting tool 125 is provided with such.
For example, the cutting tool 125 may be made of a shape-memory
metal, such as nickel-titanium and/or the proximal portion of the
cutting tool 125 may be formed relatively thicker than other
portions thereof.
[0086] Another embodiment of the cutting tool 125 is shown in FIGS.
15 and 16. As shown therein, the cutting tool 125 may be formed by
a thin sheet of steel or shape memory alloy. The sheet may include
a plurality of through holes 126 to allow the anaesthetic or other
fluid to be instilled therethrough. A small tube 540 may be
disposed on the sheet, aligned with the through holes 126. The
sheet may be folded in the direction indicated by the arrows 530,
thus securing the tube 540 between the two folded sides of the
sheet. The edges 550 of the sheet may be sealed together to render
them fluid tight. For example, the sides 550 of the sheet may be
welded together or secured by other means known to those of skill
in the metal working arts. The edges 560 between the through holes
126 may be sharpened, to allow the cutting tool 125 to efficiently
cut through soft tissue. As shown in FIG. 16, the tube 540 may
deliver anaesthetic or other fluid to the cutting tool 125, which
delivers minute amounts thereof precisely where it is needed: where
the cutting edges 560 of the cutting tool 125, thereby affording
the patient immediate relief and minimizing the amount of
anaesthetic that need be delivered. The proximal end of the tube
540 may be in fluid communication with an anaesthetic reservoir
(not shown) and/or an anaesthetic pump (also not shown).
[0087] Alternatively, the cutting tool 125 may include a thin wire,
such as shown at 125 in FIGS. 6 and 7. In this case, an external
radio frequency (hereafter, RF) power source 240 (shown at 240 in
FIG. 2C) supplies the cutting tool 125 with RF energy via two
bipolar electrodes (not shown) attached to the cutting tool 125 of
FIG. 6. Other energy sources may also be used within the context of
the present invention, RF power being discussed herein for
illustrative purposes only. The RF power delivered by the RF power
source 240 allows the cutting tool 125 of FIG. 6 to become an
electrosurgical cutting and/or an electrocoagulating tool by
selectively varying the power applied to the cutting tool 125.
Suitable generators for such an electrosurgical cutting device 125
are known to those of skill in this art. An example of such a
suitable generator is described in U.S. Pat. No. 4,903,696 issued
Feb. 27, 1990 and assigned to Everest Medical Corporation, Brooklyn
Center, Minn., the disclosure of which is incorporated herewith in
its entirety. As with the cutting tool 125 shown in FIGS. 4 and 5,
the cutting tool 125 of FIGS. 6 and 7 includes an internal lumen
128 and a plurality of through holes 126 to allow anaesthetic or
other fluid to be delivered to the surrounding tissue as the
cutting tool 125 cuts through the soft tissue as the device 100 is
rotated.
[0088] As alluded to above, the excisional biopsy device 100
according to the present invention cuts out a (not necessarily
symmetrical) volume of revolution as it cuts through the soft
tissue upon rotation of the generally tubular member 110. This
severed mass of tissue may be stabilized using an extendable tissue
anchoring device, which anchoring device also assists in the
retrieval of the severed tissue sample from the breast. The
anchoring device may, for example, include a suction device or
other substantially rigid anchor member to anchor the tissue
sample. Alternatively, the severed tissue sample may be collected
in a tissue collection device, as shown at reference numeral 260 in
FIGS. 2A and 2B. The tissue collection device 260 is attached
externally to the tubular member 110, and preferably also to the
trailing edge of the cutting tool 125. The tissue collection device
260 is preferably formed of a thin and flexible plastic membrane
shaped like a bag. The opening of the bag-shaped collection device
260 is preferably co-extensive with the opening 120 and is
preferably attached to the tubular member 110 and to the trailing
edge of the cutting tool 125. In this manner, the opening or
"mouth" of the bag-shaped collection device 260 opens and closes
along with the bowing and retraction, respectively, of the cutting
tool 125. Indeed, the "mouth" of the bag-shaped collection device
260 is opened when the cutting tool 125 is bowed and extended out
of the cutter window 120 and substantially closed when the same is
retracted within the cutter window 120, as the two edges (one
attached to the tubular member 110 just adjacent to the edge of the
cutter window 120 and the other attached to the trailing edge of
the cutting tool 125) of the collection device are then pressed
together.
[0089] Therefore, when the excisional device 100 is inserted into
soft tissue and rotated, the cutting tool 125 may be caused to bow
and to extend outwardly from the cutter window 120 and caused to
cut tissue coming into contact therewith. As the device 100 rotates
and cuts, the tissue between the cutting tool 125 and the tubular
member 110 tends to advance toward and into the collection device.
As the cutting tool 125 is in it's bowed and extended state, the
"mouth" or opening of the bag-shaped collection device 260 is also
correspondingly open, allowing the severed tissue to collect
therein. As the revolution of the tubular member 100 is completed,
the cutting tool 125 may be retracted and caused to assume a
configuration wherein it is disposed within the recessed cutter
window 120, substantially flush with the outer surface of the
tubular member 110, as shown in FIG. 2B. In this configuration, the
collection device 260 is closed, thereby securing the excised
tissue sample therein. The device 100 may then be safely retracted
from the main tissue mass, such as the breast. As the excised
sample is physically isolated from the remaining tissue mass, the
probability of seeding the surrounding tissue with potentially
abnormal cells is markedly decreased. This probability is also
further decreased, as the excisional device 100 according to the
present invention allows the surgeon to obtain adequate margins of
healthy tissue surrounding the target lesion by choosing the degree
of bowing and extension of the cutting tool 125. In this manner,
the integrity of the lesion itself is not violated, thereby
maintaining tissue architecture intact.
[0090] As the collection device 260 is preferably formed of a thin
and flexible membrane, it is able to lay substantially flat against
the outer surface of the tubular member 110 or slightly recessed
within the cutter window 120 during insertion thereof into the soft
tissue. The collection device 260, therefore, offers little
additional drag and resistance to the device 100 as it is inserted
into the incision made in the patient's skin during or prior to the
procedure. Suitable materials for the tissue collection device 260
include plastics and nylon, for example. Any strong adhesive may be
utilized to secure the tissue collection device 260 to the tubular
member 110 and to the cutting tool 125. Other means of securing the
collection device 260 may also be employed without, however,
departing from the scope of the present invention. Likewise, the
tissue collection device 260 may be formed of a material other than
specifically enumerated herein while remaining within the spirit of
the present invention. Preferably, the shape and size of the tissue
collection device 260 are such as to minimize drag on the
excisional biopsy device 100 as it is inserted and rotated into the
tissue. For example, the tissue collection device 260 preferably
should be only as large as necessary to contain the excised tissue
sample.
[0091] The excisional biopsy device 100 according to the present
invention is preferably accurately positioned adjacent to the
lesion within the breast or other organ. Toward that end, the
present invention allows the surgeon to gain near real time or real
time information as to the internal structure of the soft tissue
during the procedure itself. Referring now back to FIGS. 1 and 2C,
the present invention may include a transducer 270 mounted within
the distal portion of the tubular member 110. This transducer 270
is preferably adapted to image tissue about to be cut by the
cutting tool 125 as the excisional biopsy device 100 is rotated
within the soft tissue. Indeed, the transducer 270 preferably
generates information relative to the tissue about to be cut--that
is, tissue that that has not yet been brought into contact with the
cutting tool 125 as the tubular member 110 rotates about its
longitudinal axis. In this manner, as the rotational speed of the
excisional biopsy device 100 is preferably quite slow (the rotation
may be manually carried out or may be caused by a slow moving
motorized unit attached to the tubular member 110), the surgeon may
evaluate the information generated by the transducer 270 and may,
based upon this information, vary the degree of bowing and
extension of the cutting tool 125. For example, when the device 100
is positioned adjacent to the lesion of interest and rotated, the
transducer 270 will detect the presence and location of the lesion
before the lesion comes into contact with the cutting tool 125.
After the lesion has been detected by the transducer 270, the
surgeon may push on the push or turn knob 226 or other structure
that causes the cutting tool to bow and extend from the cutter
window 120. The lesion (and preferably an adequate margin of
healthy tissue) will then be severed from the main mass, and
optionally collected, for example, in the tissue collection device
260. When the transducer 270 indicates that the rotation of the
tubular member has brought the cutting tool 125 past the lesion,
the cutting tool 125 may be retracted within the cutter window 120.
The cutting, it can be seen, may be specifically tailored to the
size and shape of the lesion within the main tissue mass in near
real time or in real time, thereby allowing the surgeon to excise
all of the tissue required and only the tissue that is necessary to
achieve the intended results.
[0092] Preferably, the transducer 270 is an ultrasound sensor
mounted substantially flush with the external surface of the
tubular member 110. The ultrasound sensor 270 is preferably
electrically connected, via a communication channel such as
electrical conductors, to at least one data processing and display
device, shown at reference 250 in FIG. 2C. The data processing and
display device(s) 250 allows the surgeon to see, in near real time
or in real time, the internal structure of the tissue about to be
cut by the cutting tool 125. This allows the surgeon not only to
see a graphical representation of the internal structure of the
tissue during the procedure itself, but also allows the surgeon to
assure himself or herself that the entire lesion or group of
lesions has been properly excised by, for example, rotating the
tubular device within the tissue while the cuffing tool is
retracted within the cutter window 120 while the transducer 270 is
energized. Viewed from another aspect, therefore, the present
invention is an intra-tissue ultrasound imaging device that may,
but need not include a cutting tool, such as referenced by numeral
125 in the figures.
[0093] In operation, the (e.g., ultrasound) transducer sweeps a
plane (graphically shown at 280 in FIG. 3A) within the tissue ahead
of the work element, such as cutting tool 125. In selecting the
operational characteristics of the ultrasound transducer 270, the
surgeon must balance the required resolution (i.e., the smallest
feature that must be discernable) with the degree of penetration of
the ultrasound waves within the tissue and the intensity of the
ultrasonic waves generated. In general, higher frequencies allow
better resolution. However, high frequencies do not penetrate the
tissue as far as do lower frequency ultrasound waves. Preferably,
the ultrasound transducer 270 is tuned within the range from about
5 MHz to about 20 MHz. More preferably, the ultrasound transducer
270 is tuned within the range of about 7.5 MHz to about 20 MHz. For
example, in the case wherein the excisional biopsy device 100
according to the present invention is used within the female
breast, the ultrasound transducer may be tuned within the range of
about 10 MHz to about 13 MHz.
[0094] To effectively image the internal tissue structure prior to
cutting it with, for example, the cutting tool 125, the transducer
270 must be positioned within the tubular member 110 away from the
cutting tool 125. With reference to FIG. 9, the transducer 270 may
be disposed within the tubular member at an angle .alpha. relative
to the cutting tool 125. The angle .alpha. is preferably no smaller
than that necessary to effectively control the operation of the
work element (such as cutting element 125) in response to
information gathered from the transducer 125 as the tubular member
110 rotates. This angle .alpha., therefore, is dependent at least
upon the rotational speed imposed upon the tubular member 110 and
upon the time necessary for the surgeon to assimilate the
information generated by the transducer and to effectively control
the cutting tool 125 in response to such information. Preferably,
the angle .alpha. is less than about 180 degrees.
[0095] When used in conjunction with an intra-tissue ultrasound
transducer, such as shown at 270, the excisional biopsy device 100
according to the present invention may include a variety of work
elements in place of or in addition to the cutting tool 125. Such
work elements include, for example, an abrasive device, a
reciprocating cutting device, an electrosurgical device or a
vibrating device.
[0096] In the case of lesions within the breast, it is useful to
stabilize the breast prior to imaging and performing invasive
procedures. Such stabilization is conventionally performed by
compression plates that squeeze the breast and compress the tissue
therein. Such compression is necessary to allow x-ray radiation, as
used in mammography, to produce a useful image. Although such
compression is not needed or believed to be desirable according to
the present invention, stabilization of the breast remains
necessary. For this purpose, the breast stabilization devices
described in commonly assigned U.S. patent application Ser. No.
09/158,215 entitled "Breast Stabilization Devices And Methods"
filed on Sep. 22, 1998, and Ser. No. 09/200,661 entitled "Breast
Stabilization Devices And Imaging And Interventional Methods Using
Same" filed on Nov. 25, 1998, the disclosures of each being
incorporated herein in their entirety, may be useful.
[0097] Reference is now made to FIGS. 3A, 3B and 3C, which
illustrate an embodiment of the excisional biopsy method according
to the present invention. Although FIGS. 3A-3C illustrate an
embodiment of the present invention within the context of breast
surgery, it is to be understood that the present inventive method
is equally applicable to other soft tissue masses, such as, for
example, lung, thyroid or liver tissue, with only minor
modifications that will become apparent to skilled practitioners in
this art.
[0098] Turning first to FIG. 3A, a small incision 331 is made in
the breast 310, preferably in the peri-areolar region. Preferably,
the breast is stabilized, using, for example, the breast
stabilizing devices disclosed in U.S. patent application Ser. No.
09/158,215 or 09/200,661 referred to above. The portion of the
device 100 that remains outside of the soft tissue may include
attachment means (not shown) for clamping the device to a rim
structure, for example, to allow stable operation and precise
guidance thereof. The small incision is preferably made on the
border of the areola 330 surrounding the nipple 320, as this
provides a better cosmetic scar than on the skin on the side of the
breast 310. Depending on the size of the lesion and the size of the
excisional biopsy device 100 to be inserted therein, an expandable
sheath (an example of which is shown at reference numeral 495 in
FIG. 13) may be inserted into the breast tissue. In any event, the
excisional biopsy device 100 is inserted into the breast tissue and
positioned adjacent the lesion 300, which may be, for example, a
microcalcification or other abnormal lesion. Once in position, the
device 100 is rotated, for example, in the direction indicated in
FIG. 3A. The portion of the excisional biopsy device 100 that
remains outside the soft tissue may have a greater diameter than
the portion thereof that is designed to penetrate the soft tissue.
This aids in manual rotation of the device 100. In the
configuration depicted in FIG. 3A, the cutting tool 125 is
retracted within the cutter window 120 and the tissue collection
device 260, if present, is substantially flat against the external
surface of the tubular member 110. The device 110 is rotated about
its longitudinal axis and the transducer 270 is energized, the
information therefrom being transmitted to, for example, the
display device 250 shown in FIG. 2C. When the lesion 300 comes into
view, the surgeon then gauges the size, shape and location thereof
and controls the bowing and extension of the work element, such as
cutting tool 125 based on the information received from the
transducer 270 and displayed upon the display 250. FIG. 3B depicts
the situation wherein the lesion 300 has been imaged and the
surgeon has extended the cutting tool 125 to sever the lesion 300
from the surrounding breast tissue. The severed tissue may be
received and collected in a tissue collection device 260, as the
device 100 rotates. Anaesthetic and/or antibiotic (or other) fluids
may be delivered directly to the affected tissue by through holes
126 (best seen in FIGS. 2A, 2B and FIGS. 4-7), greatly decreasing
pain during the procedure.
[0099] After the lesion and any desired margin of healthy tissue is
severed from the main breast tissue mass, the cutting tool 125 is
retracted within the cutter window 120. This closes the tissue
collection device 260, if present, and allows the entire device 100
to be retracted from the breast in the direction of arrow 350, as
shown in FIG. 3C. If the tissue collection device 260 is present,
the lesion 300 will be isolated from surrounding tissue by the
membrane of the tissue collection device 260, thus minimizing any
possibility of seeding potentially abnormal cells to surrounding
breast tissue. Moreover, the tissue architecture of the retrieved
lesion 300 is substantially preserved, thereby allowing accurate
histopathology to be performed upon the entire mass excised from
the breast. Indeed, any compression such tissue may undergo is
believed to be solely due to the retraction of the device back
through the entrance track of the device 100 in the uncompressed
breast tissue. Thereafter, when the excisional device 100 is
removed from the breast 310, the push or turn knob 226 may be acted
upon to extend and bow the cutting tool 125, thereby allowing the
excised lesion to be retrieved from the tissue collection device
260 for examination. If the tissue collection device is not
present, conventional suction means may be employed to extract the
severed lesion from the surrounding breast tissue. Bleeding is
controlled by suitably varying the RF or other power source applied
to the electrosurgical cutting tool 125, if present, to stem the
bleeding by cauterizing the tissue coagulating the blood.
[0100] After the procedure, a small cavity remains in the breast
where the lesion had previously been. However, since no compression
of the breast was carried out, no expansion of the tissue occurs
after the procedure, unlike conventional techniques. Therefore, the
cavity and the entrance and exit path of the device remain as small
as possible, leading to fewer complications, less tissue trauma and
improved aesthetics.
[0101] According to another embodiment of the present invention,
shown in FIGS. 10, 11 and 12, the transducer 270 is replaced by a
removable transducer core 400. The removable transducer core 400
includes an active element 440 configured to perform intra-tissue
imaging and of relaying information back to a display device (shown
in FIG. 14) via a communication channel, such as shown at reference
numeral 460. The communication channel 460 may be wireless or may
include, for example, optical fibers and/or electrical conductors.
The active element 440 may draw power from an internal battery (not
shown) or from a power source, such as shown at reference numeral
480. The active element 440 may include an ultrasound transducer.
Other types of transducers may be used instead of or in addition to
an ultrasound transducer. The removable transducer core 400
preferably includes a generally tubular shaft 430. A proximal
section 450 is included near the proximal portion of the transducer
core 400.
[0102] To accommodate the removable transducer core 400, the
excisional device 100 of FIG. 10 defines an internal lumen 420
through which the removable transducer core 400 may be inserted.
Preferably, the excisional device 100 is used once and disposed of,
for safety and functional reasons. The removable transducer core
400, however, may either be disposable or re-usable for a limited
number of uses. To allow the active element 440 of the transducer
core 400 to image the lesion to be excised and the surrounding
tissue, the generally tubular member 110 of the excisional device
100 includes a transducer window 410. When the removable transducer
core 400 is inserted within the internal lumen 420, the proximal
section 450 of the core 400 preferably snaps into a locked
configuration with the proximal end of the excisional device 100.
When in its locked configuration, the active element 440 of the
transducer core 400 is aligned with and faces the transducer window
410, to allow the active element 440 to image the lesion and the
surrounding tissue therethrough. To facilitate insertion of the
tubular member 110 in the patient's soft tissue the distal-most tip
thereof may include an (mono or bipolar) RF electrosurgical element
or wire, as indicated at reference numeral 116, which may be
energized by an RF source, as shown at 240 in FIGS. 2C and 14.
[0103] FIG. 11 shows an embodiment of the removable core 400
according to the present invention. As the removable core 400 may
advantageously be used independently of the excisional device 100,
the removable core 400 includes a distal tapered tip 470, to allow
it to easily penetrate soft tissue. Moreover, its thin profile
allows the surgeon to insert the removable core 400 within soft
tissue without, however, unduly damaging the tissue or making a
large incision. The removable core 400 allows the surgeon to
precisely localize the lesion to be excised from within the tissue
itself. For example, the active element 440 of the removable core
400 may include an ultrasound transducer having similar
characteristics as the sensor 270, and may be used alone or in
addition to surface ultrasound to localize the lesion with a great
degree of precision.
[0104] FIG. 12 shows a cross section of the embodiment of the
excisional device 100 of FIG. 10, taken along line AA'. As shown in
FIG. 12, the cutting tool 125 is exposed through the cutter window
120. The window 120 may, as shown in FIG. 12, include support
guides 122 to support and guide the cutting tool 125 as it is
outwardly extended and bowed. The tissue collection device 260, for
clarity, is not shown in either FIG. 10 or 12. However, to
accommodate the bulk of the excised tissue sample collected in the
tissue collection device 260 after the cutting and collecting
operation described herein, the tubular member 110 may include a
recessed section 131. The recessed section provides space for the
collected (e.g., bagged) tissue sample in the tissue collection
device 260 when the excisional device is removed from the soft
tissue mass. In this manner, the collected tissue sample within the
tissue collection device 260 does not protrude from the generally
smooth outer surface of the excisional device 100 upon retraction
of the latter from the soft tissue mass from which the tissue
sample is excised. The internal lumen 420 allows the removable core
400 to slide therein and to properly position the active element
440 facing the transducer window 410.
[0105] FIG. 13 shows the removable core 400 inserted within an
expandable sheath 495. The expandable sheath includes a proximal
base section 510. Attached to the proximal base section 510 is a
generally cylindrical expandable meshwork 500 of, for example,
plastic or nylon fibers. The meshwork 500 may be somewhat tapered
at its distal end 520, to provide a smooth transition between the
expandable meshwork 500 and the removable core device 400. The
proximal section 450 of the core 400 may snap-fit to the proximal
base section 510 of the expandable sheath 495, so as to be securely
and removably attached thereto. As shown in FIG. 13, the expandable
meshwork 500 expands just enough to accommodate the removable core
400 inserted therein. In practice, the expandable sheath 495 and
removable core 400 assembly may be inserted within the soft tissue
together, to allow the surgeon to image the lesion prior to
inserting the somewhat greater diameter excisional device 100
therein. Thereafter, the surgeon may retract the removable core 400
from the expandable sheath 495, leaving the expandable sheath 495
in place within the soft tissue, such as the breast.
[0106] FIG. 14 shows another embodiment of a soft tissue excisional
device assembly 600 according to the present invention. In the
configuration shown in FIG. 14, the removable core 400 is inserted
and secured within the excisional device 100 so that the active
element 440 faces out of the transducer window 410. As in FIG. 10,
the tissue collection device 260 is not shown, for clarity. In FIG.
14, the excisional device 100 is shown inserted within the
expandable sheath 495. Indeed, the excisional device 100, in FIG.
14, is shown inserted within and past the distal end 520 of the
meshwork 500, so the distal portion of the excisional device 100
including the cutting tool 125 and the transducer window 410
extends therethrough. The meshwork 500, in FIG. 14, has expanded to
accommodate the diameter of the excisional device 100. The proximal
portion of the excisional device 100 may extend from the proximal
base section of the expandable sheath 495. This allows the push or
turn knob 226 (a turn knob 226 shown in FIG. 14) to be manually
accessible to the surgeon. A number of peripheral devices may be
connected to the assembly 600. Examples of such include a core
power source 480, which may be, for example, an electrical source
for an ultrasound transducer, one or more data processing and
display devices 250 on which the internal structure of the tissue
imaged by the active element 440 of the core 400 may be displayed,
suction means 490, a cutting tool power source (a variable RF
energy source, for example), and/or other devices 590. The suction
device 490 may provide a suction force to the window 120 through an
internal lumen to facilitate cutting of the tissue by the cutting
tool 125.
[0107] The excisional device assembly 600 may be rotated in toto,
or the excisional device 100 may be rotated independently of the
expandable sheath 495, depending upon the degree of friction
between the two. Preferably, the excisional device 100 is removable
from the expanded sheath 495 shown in FIG. 14, while leaving the
expanded sheath 495 in place within the soft tissue. In this
manner, after retraction of the excisional device 100 from the
sheath 495, the sheath 495 remains in place within the soft tissue
to allow other instruments to be inserted therethrough. For
example, the removable core 400 may, after the excisional procedure
proper, be re-inserted through the expanded sheath 495 to the
excision site. Thereafter, the surgeon may cause the active element
440 of the removable core 400 to become energized, to image the
excision site to insure that the complete lesion has been removed
from the soft tissue mass. To do this, the surgeon may rotate the
removable core 400 within the expanded sheath 495 while observing
the display or displays for signs of the lesion. If none is found,
it is probable that the entire lesion has been successfully removed
and the surgeon may then retract the core 400 from the sheath 495
and the sheath from the tissue mass and repair the incision made
prior to inserting the assembly therein. Alternatively, the surgeon
may choose to remove both the expanded sheath 495 and the core 400
simultaneously.
[0108] FIG. 17 shows an embodiment of the method of excisional
biopsy method according to the present invention. In FIG. 17, it is
assumed that the soft tissue from which the lesion is to be excised
is breast tissue and that the active element 440 of the removable
core 400 is an ultrasound transducer. Other combinations are
possible, and the present invention should not be limited to
applications related to breast tissue and ultrasound. The removable
core 400 and the active element 440, in FIG. 17, are together
abbreviated as "US CORE", a shorthand expression for the phrase
"ultrasound core" and the word "assembly" is abbreviated to
"Ass'y". Moreover, it is to be understood that the steps shown in
FIG. 17 constitute but a broad outline of one possible embodiment
of the present inventive method. Therefore, other additional steps
may be inserted between the steps shown in FIG. 17, or other steps
may be substituted for some of the displayed steps without,
however, departing from the scope of the present invention.
[0109] The method starts at step S0. In step S1, the lesion within
the breast is grossly targeted, using, for example, standard or
stereotactic surface ultrasound. In step S1, a rough estimate of
the location of the lesion within the breast is obtained. The
surgeon, after having located the general location of the lesion,
may mark the location thereof on the ultrasound display or displays
and/or on the corresponding surface of the breast, with an "X", for
example. The breast is stabilized in step S2. Preferably, the
breast is stabilized in an uncompressed or slightly expanded state,
in the manner disclosed in the commonly assigned and co-pending
U.S. patent application Ser. No. 09/158,215 or 09/200,661
previously discussed and incorporated by reference herein. The
woman's other breast is preferably placed within a counterpart
breast stabilizing device, which helps to immobilize the woman
during the procedure. One of the ultrasound ports of the breast
stabilizing device is aligned with the lesion, for example, by
aligning one of its ultrasound ports with the marked location on
the breast. Suction is then applied to the breast stabilizing
device, in the manner described in the above-referenced application
and a correctly oriented surface ultrasound device is secured to
the ultrasound port of the stabilizing device. Other means of
stabilizing the breast may also be used without, however, departing
form the present invention.
[0110] In step S3, an entry site on the breast is chosen.
Preferably, the peri-areolar region is chosen as the incision site,
as scars within the peri-areolar region are less visible than scars
in more exposed regions of the breast and for other anatomical
reasons. The incision site is then anaesthetized, both on the skin
surface and subcutaneously. Also in step S3, a small incision is
made at the chosen incision site. Preferably, the incision is large
enough to accommodate the expandable sheath 495 with the removable
core 400 inserted therein. In step S4, the expandable sheath 495,
together with the removable core inserted therethrough, is inserted
into the incision made in step S3. Under surface ultrasound
guidance, for example, the sheath 495/core 400 assembly is
navigated adjacent to the lesion. If the sheath 495/core 400
assembly can be properly positioned adjacent to the target lesion,
the method according to the present invention proceeds to step S5.
If the sheath 495/core 400 assembly cannot be properly positioned
adjacent to the target lesion, all or a portion of the
above-detailed steps are repeated until proper positioning of the
sheath 495/core 400 assembly is achieved, adjacent to the target
lesion.
[0111] Assuming now that step S4 has been completed to the
surgeon's satisfaction, the core 400 is removed from the expandable
sheath 495 and the expandable sheath 495 is left in place within
the breast, as shown in step S5. In step S6, the removable core 400
is inserted within the internal lumen 420 of the tubular member of
the excisional device 100 and locked securely in place, so that the
active element 440 (in this case, an ultrasound transducer) is
aligned with and faces out of the transducer window 410 of the
device 100. Again leaving the expandable sheath 495 in place within
the breast, the excisional device 100 (with the core 400 secured
therein) is advanced through the expandable sheath 495. The sheath
495 then expands within the breast tissue to accommodate the
somewhat larger diameter of the excisional device 100. The
excisional device 100 is advanced past the tapered distal end 520
of the sheath 495, so the assembly including the sheath 495, the
excisional device 100 and the removable core 400 is positioned
adjacent to the target lesion within the breast tissue, as shown in
step S7.
[0112] In step S8, the correct position adjacent the target lesion
and the correct rotational orientation of the aforementioned
assembly (FIG. 14) are confirmed, using surface ultrasound and/or
the core ultrasound 400. The active element 440 of the core 400 is
particularly well suited for this task, as the excisional device
100 may be rotated within the tissue, and positioned so the cutting
tool 125 is properly positioned to allow it to rotate, extend and
bow outwardly in such a manner as to precisely sever the lesion
from the surrounding tissue with an adequate margin of healthy
tissue. Indeed, the ultrasound transducer 440, as it rotates along
with the excisional device 100, images the lesion before the
cutting tool 125 cuts it, thereby allowing the surgeon to optimally
deploy the cutting tool based upon his or her observation of the
imaged tissue on a display or displays. In step 9, the surgeon may
activate an anaesthetic infusion, the anaesthetic being delivered
by the cutting tool 125 via the plurality of through holes 126,
best seen in FIGS. 4 and 6. Step S9 may be skipped if the cutting
tool 125 does not provide for through holes 126 or if the surgeon
does not deem it necessary to anaesthetize the tissue during the
rotation of the cutting tool 125. For example, the tissue may have
been previously anaesthetized. While rotating at least the
excisional device 100 (with the removable core 400 secured
therein), the cutting tool 125 is extended using, for example the
push or turn knob 226 shown in FIGS. 2C and 14, thereby causing the
cutting tool 125 to extend from the window 410 and to bow
outwardly, as shown in step S10. Depending on the amount of
friction between the excisional device 100 and the expandable
sheath 495 (which may be freely chosen depending upon the choice of
material for the meshwork 500 and the configuration of the mesh),
the sheath 495 may rotated along with the excisional device 100.
The degree of extension and bowing may be finely controlled by the
surgeon as the excisional device 100 is rotated, either manually or
by a motorized unit (not shown) coupled thereto. As the cutting
tool is rotated, the severed tissue sample is preferably collected
(e.g., bagged) in a tissue collection device 260 (FIGS. 2A and 2B),
as shown at step S111. The blood vessels may be coagulated as the
cutting tools rotates and cuts the tissue, or afterwards. In step
S12, after the excisional device 100 has completed at least one
revolution within the breast and has cut a volume of revolution
therein, including at least the target lesion and preferably a
margin of healthy tissue surrounding the lesion, the excisional
biopsy device 100 and removable core 400 assembly are retracted
through the sheath 495, leaving the sheath 495 once again in place
within the breast. Preferably, the tissue collection device 260 and
the tissue sample it encloses lie within the recessed section 131
of the generally tubular member 110. In this manner, the filled
collection device 260 does not protrude or protrude too much from
the surface of the tubular member 110, thereby allowing the
retrieved tissue sample to be readily retracted with the excisional
device 100 through the sheath 495.
[0113] After retraction of the excisional device 100, the core 400
may be retracted from the device 100 and re-inserted through the
sheath 495 left in place within the breast. The core 400 is then
advanced adjacent to the excision site, and rotated to allow the
surgeon to image the excision site to insure that the entire lesion
has indeed been removed, as shown in step S13. Some or all of the
above steps may be repeated should the imaging of the excision site
by the core 400 within the sheath 495 reveal that a portion of the
target lesion was not excised. Assuming that the entire target
lesion has been removed, the incision is repaired by, for example,
suturing the peri-areolar incision site. The method ends at step
S16.
[0114] The removable transducer core 400 of FIG. 11 is not the only
removable probe that may be fitted to and within the tubular member
110 of the excisional device 100 (see FIG. 10, for example).
Indeed, FIG. 18 shows a top view of a removable cutting probe 700,
according to an embodiment of the present invention. The removable
probe 700 includes a proximal portion 702 and a distal portion 704.
The proximal portion 702 may include cutting tool extending means
718 and the distal portion 704 may include a cutting tool 706, such
as a wire or ribbon cutting tools described above. The cutting tool
706 may be sharpened on its leading edge. The first removable probe
700 is preferably configured to fit at least partially within the
tubular member 110 to enable the cutting tool 706 to selectively
bow out of and to retract within a first window 710 when the
cutting tool extending means 718 are activated. The first window
710 is defined within the surface of the removable probe 700.
According to an embodiment of the present invention, the removable
cutting probe 700 may be inserted within the internal lumen 420 (or
guided within guides internal to the tubular member 110) of the
tubular member 110 in such a manner that the window 710 defined
within the probe 700 faces the window 410 (FIG. 10) defined within
the surface of the tubular member 110. Alternatively, the tubular
member 110 may define one or more additional windows similar to
that shown at 410 in FIG. 10. In this case, the removable probe 700
(and those to be described relative to FIGS. 21-27C) may be
inserted within the tubular member 110 such that the window 710
faces one of these additional windows (hereinafter collectively
referenced by numeral 410) and/or the window 410 in FIGS. 10 and
12.
[0115] According to an embodiment of the present invention, the
cutting tool 706 may include an RF cutting tool. In this case, the
RF cutting tool and the removable cutting probe 700 may be
connected to an RF power source, such as shown at 240 in FIGS. 2C,
14 and 18. The RF cutting tool, for example, may be either a
monopolar or a bipolar RF cutting tool, as disclosed above.
[0116] The removable cutting probe 700 may also include an internal
guide 712 (or may define an internal lumen) to enable the cutting
tool 706 to slide within the removable cutting probe 700 when
cutting tool extending means 718 are activated. The cutting tools
extending means 718 are shown as a thumb-activated dial in FIGS.
18-20. However, any other means of advancing and retracting the
cutting tool 706 may also advantageously be used within the context
of the present invention. According to a still further embodiment,
the distal portion 704 of the removable cutting probe 700 may
further include a window slide 708 disposed within the window 710
and the proximal end 702 may further include window slide extending
means 716. The window slide 708 is coupled to the window slide
extending means 716 and is guided within the removable cutting
probe 700 by an internal guide or lumen 714 along the length of the
probe 700. According to the present invention, the window slide 708
is configured to selectively cover a portion of the window 710 when
the window slide extending means 716 are activated. The window
slide extending means 716 are shown in FIGS. 18-20 as
thumb-activated dials. However, any means of extending the window
slide 708 within the window 710 to selectively cover a portion
thereof may readily be implemented within the removable cutting
probe 700, as those of skill will recognize. Functionally, the
window slide 708 covers a portion of the window 710 to selectively
vary the width of the window 710 through which the cutting tool 706
is allowed to extend or bow.
[0117] The operation of the removable cutting probe 700 is
graphically shown in FIGS. 19 and 20. FIG. 19 is a side view of the
removable cutting probe of FIG. 18, showing the adjustable window
slide 708 in a first position, according to an embodiment of the
present invention, whereas FIG. 20 is a side view of the removable
cutting probe of FIG. 18, showing the adjustable window slide 708
in a second position. As shown in FIG. 19, the window slide 708 is
less engaged within the window 710 and it is in FIG. 20.
Consequently, the cutting tool 706 in FIG. 19 is able to extend
over a wider portion of the window 710 than it is able to when the
window slide 708 is in the relatively more engaged position shown
in FIG. 20. For example, the window slide 708 may be further
engaged within the window 710 (FIG. 20) when the physician wants to
cut a smaller tissue specimen than would otherwise be cut when the
probe 700 is in the configuration illustrated in FIG. 19.
[0118] FIG. 21 is a top view of a removable tissue collection probe
800, according to an embodiment of the present invention. As shown
therein, the removable tissue collection probe 800 includes a
proximal section 802 and a distal section 804. The proximal section
802 may include a tissue collection device extending means 814 and
the distal section 804 may include a tissue collection device 808,
810. Similar to the removable cutting probe 700 of FIGS. 18-20, the
removable tissue collection probe 800 may be configured to fit at
least partially within the tubular member 110 to enable the tissue
collection device 808, 810 to extend out of and to retract within
the window 410 (or other window defined within the surface of the
tubular member 110) when the tissue collection device extending
means 814 are activated. Similar to the activating means 716, 718
of FIGS. 18-20, the tissue collection device extending means 814
may be configured as a thumb-dial or a wheel or as any other
suitable means for extending the tissue collection device 808, 810,
such as a lever, for example. As shown in the top view of FIG. 21
and in the detail top view of FIG. 22, the tissue collection device
808, 810 may include a ribbon or wire 808 that may be configured to
extend or bow out of and retract back within the window 806 in the
probe 800. Attached to the wire or ribbon 808 is a thin flexible
sheet of non-porous or porous material 810, such as polyethylene or
polyethylene teraphthalate (PET), for example. A non-porous
material is preferable to isolate the tissue specimen from the
surrounding tissue. Such isolation is used to prevent possible
cancer cells from seeding along the insertion track of the probe
and/or the excisional device 100. A non-porous flexible material
810 prevents fluid and cell leakage therefrom and insures isolation
of the cut tissue specimen. The thin flexible sheet of material 810
may be dispensed from a roll 814 of such material, the free end of
the sheet 810 being attached to the ribbon or wire 808. In this
manner, the roll 814 may dispense the material 810 as the ribbon or
wire 808 is extended or bowed out of the window 806 (and out of a
corresponding (facing) window in the tubular member 110) and
completely or partially encompass or encapsulate the tissue
specimen (see reference numeral 1008 in FIGS. 27A-27C) as the
tubular member 110 and contained probe 800 are rotated within the
patient's soft tissue. Alternatively, the tissue collection device
808, 810 may be configured as shown and described relative to FIGS.
2A and 2B, for example. When the tissue collection device extending
means 814 are activated, the ribbon or wire 808 slides along the
internal lumen or guide 812 defined in the probe 800 and causes the
ribbon or wire 808 to bow and extend out of the window 806 defined
in the probe 800, thereby deploying the flexible material 810 and
encapsulating the tissue specimen. These embodiments allow the
tissue specimen to be removed in one piece for best histological
analysis by a pathologist. FIGS. 27A through 27C show still another
tissue collection device configuration, as will be described
below.
[0119] FIG. 23 shows a side view of the removable tissue collection
probe 800 of FIG. 21, showing the tissue collection device 808, 810
in an extended configuration. As shown therein, the tissue
collection device extending means 814 has been (manually, for
example) activated to cause the bowing of the tissue collection
device 808, 810 out of the window 806 defined within the tissue
collection probe 800. This bowing, or extension, of the wire or
ribbon 808 causes the thin sheet of material 810 to be unrolled or
otherwise deployed. As the tubular member 110 of the excisional
device 100 is rotated, the tissue collection probe contained
therein is also rotated, in the direction shown by arrow 816, for
example. The tissue collection device extending means 814 may be
activated extended (bowed) so as to cause the ribbon or wire 808 to
follow substantially the same path within the tissue, as did the
cutting tool 706. This eases the collection process, as the ribbon
or wire 808 merely follows the path of the incision previously made
by the cutting tool 706 or 125. As the excisional device is
rotated, the tissue specimen (i.e., lesion) is captured within the
sheet of material or bag 810, whereupon it may readily be extracted
from the patient for pathological examination.
[0120] FIG. 24A is a top view of a removable cutting and tissue
collection combination probe 900, according to an embodiment of the
present invention, whereas FIG. 24B is a partial cross-sectional
view of the removable cutting and tissue collection combination
probe 900 of FIG. 24A, taken along lines AA'. As shown in FIG. 24A,
the combination cutting and tissue collection removable probe 900
includes a proximal end 902 and a distal end 904. In the embodiment
of FIG. 24A, the proximal end 902 may include cutting tool
extending means 908 and tissue collection device extending means
906. The extending means 906, 908 may be configured as thumb dials
or as any devices that are operative to extend the tissue
collection device 918 and/or the cutting tool 914, such as a lever,
for example. As shown in FIG. 24B, the wires and/or ribbons that
constitute the cutting tool 914 and part of the tissue collection
device 918 extend from the extending means 906, 908 along the
length of the probe 900. The cutting tool 914 and the wire or
ribbon of the tissue collection device 918 may be guided within the
probe 900 by guides 912 and 910, respectively. Alternatively, the
cutting tool 914 and the wire or ribbon of the tissue collection
device 918 may be guided within the probe 900 by one or more
internal lumens defined therein, in a manner similar as described
relative to internal lumen 420 of tubular member 110, shown in FIG.
10. As the cutting tool 914 may be energized by RF energy, the
cutting tool 914 may be separated from the tissue collection device
918 by an air gap 920 (for example) of sufficient width to prevent
arcing therebetween.
[0121] FIG. 25 is a top view of a removable cutting and tissue
collection combination probe 925, according to another embodiment
of the present invention. The embodiment of FIG. 25 differs from
that shown in FIG. 24A in that the cutting tool 914 is separated
from the tissue collection device 918 not by an air gap, but by an
insulating material 922, such as a flexible plastic insulator. In
the case wherein the cutting tool 914 includes an RF cutting
device, the cutting tool 914 is electrically coupled to an RF power
source, such as shown at 240. The configuration of the proximal end
902 of the probe shown in FIG. 25 also differs from that shown in
FIG. 24A, in that a single extending means 926 is configured to
activate both the cutting tool 914 and the tissue collection device
918, as the cutting tool 914 and the tissue collection device 918
are mechanically coupled to one another. The assembly including the
mechanically coupled cutting tool 914 and tissue collection device
918 is coupled to the extending means 926 along the length of the
probe, and is guided there along by an internal guide or lumen
924.
[0122] FIG. 26 is a side view of a removable cutting and tissue
collection combination probe 950, according to a still further
embodiment of the present invention, wherein the cutting tool 930
and the tissue collection device 932, 934 are shown in their
extended (bowed) configurations. As shown, the probe 950 includes a
proximal portion 902 and a distal portion 904. In the embodiment of
FIG. 26, the proximal portion 902 includes a cutting tool extending
means 926 that is configured to activate the cutting tool 930 and a
tissue collection device extending means 944 that is configured to
activate and extend the tissue collection device 932, 934. The
tissue collection device 932, 934 may include a ribbon or wire 932
that is adapted to bow (extend) out of and to retract back within a
first window 942 defined within the probe 950. A thin and flexible
sheet of material 934 is attached to the trailing edge of the wire
or ribbon 932 to encapsulate or otherwise capture the cut tissue
specimen upon activation of the tissue collection device 932, 934
and rotation of the tubular member 110 and probe 950, in the
direction indicated by arrow 928, for example. Similarly, the
cutting tool 930 (including an RF cutting tool, for example) is
configured to extend out of and retract back into a second window
936. Both of the first and second windows 942, 936, when the probe
950 is inserted into the tubular member 110, are aligned with
corresponding windows defined within the tubular member 110. One
such window is shown in FIG. 10 at reference numeral 410.
[0123] The combination probe 950 of FIG. 26 may also include a
plurality of through holes in fluid communication with an internal
lumen 940 defined within the internal wall of the probe 950. In
turn, the internal lumen 940 is in fluid communication with a port
942, which may be disposed at the proximal end of the probe 950.
The through holes 938 may be utilized for the delivery of a fluid
to the patient during the excisional procedure, such as antibiotic
agents, analgesic agents or most any pharmaceutical agent. Such
agents may be administered to the patient from the port 942.
Alternatively, the port 942 may be coupled to suction and the
through holes 938 may be utilized to suction out the excisional
site of smoke, blood or other bodily fluids during or after the
excisional procedure. Alternatively still, more than one port 942
may be provided in the proximal portion 902 and more than one lumen
940 may be defined along the length of the probe 950. The
additional lumen may be in fluid communication with selected
through holes 938. By this structure, both delivery of a
pharmaceutical agent and suctioning may be provided within a single
probe 950.
[0124] Although the probes shown in FIGS. 18-26 have been described
as removable probes adapted to fit at least partially within the
excisional device 110, it should be noted that they need not be
utilized therewith, and may be utilized independently thereof. For
example, the cutting probe of FIGS. 18-20 may be inserted and
operated within soft tissue by themselves, without being inserted
in the excisional device 110 of FIG. 10. Likewise, the tissue
collection probe 800 may be utilized without the excisional device
110. For example, the cutting probe 700 of FIGS. 18-20 may be
utilized to cut the tissue specimen from the surrounding soft
tissue, whereupon the tissue collection probe 800 of FIGS. 21-23
may be inserted after removal of the cutting probe 700. Moreover,
the features of each of the probes of FIGS. 18-27C may be combined
to best suit the application envisaged. The present invention,
therefore, is not to be limited by the specific embodiments
illustrated in FIGS. 18-27C, as various other combinations of the
disclosed features are possible, as those of skill will readily
recognize.
[0125] FIG. 27A-27C are partial cross-sections of a tissue
collection probe 1000, taken at the level of the tissue collection
device 1018 thereof, as the probe 1000 captures and encapsulates a
tissue specimen (lesion) 1008 within the patient's soft tissue,
such as the breast. Turning first to FIG. 27A, the tissue
collection device 1018 includes a thin sheet of flexible material
1002, which is folded on itself. One end of the thin flexible sheet
of material 1002 is coupled at 1006 to the ribbon 1004, while the
other end thereof is attached to the body of the probe 1000. The
ribbon 1004 is configured to selectively extend out of and retract
back into a window, such as shown at 806 in FIG. 23, for example. A
tissue specimen (lesion) 1008 is to be excised from the soft tissue
1018. To do so, the excisional device 110 (and thus the probe 1000
fitted therein) is rotated in the direction of the arrow 1010,
while the ribbon 1004 is extended (bowed) in the direction of arrow
1012, shown in FIG. 27B. As the ribbon 1004 is extended, it unfolds
and deploys the thin sheet of flexible material 1002, to at least
partially encapsulate the tissue specimen 1008. As shown in FIG.
27C, the ribbon 1004 of the tissue collection device 1018 may then
be retracted in the direction of arrow 1016 after the rotation 1014
(FIG. 27B) of the excisional device 110 causes the tissue specimen
1008 to be fully encompassed or encapsulated by the thin sheet of
flexible material 1002. The excisional device 110 may then be
removed from the patient, along with the collected tissue specimen
1008. To aid in the visualization of the tissue collection device
1018 during the excisional procedure, the ribbon 1004 thereof may
include or be coated with a radiopaque material or may include a
material readily visible by surface or intra-tissue ultrasound.
[0126] FIG. 28 is a flowchart of a soft tissue treatment method,
according to another embodiment of the present invention. As shown
in step S281, the cutting probe, such as shown at 700 in FIGS.
18-20, is inserted into the excisional device 100. The excisional
device 100 and cutting probe assembly 700 is then inserted into the
patient's soft tissue, at the site of interest. The cutting tool
710 of the probe assembly 700 is extended (bowed) to cut the tissue
specimen of interest from the surrounding tissue and the excisional
device 100 is then rotated, as shown at step S282. Step S283 calls
for the removal of the cutting probe 700 from the excisional device
100, leaving the excisional device 100 in place within the patient.
A tissue collection probe, such as shown at 800 in FIGS. 21-23, may
then be inserted within the excisional device 100 (if not already
inserted therein), as shown at S284. The tissue collection device
808-810 may be extended (bowed) out from the excisional device 100
and the assembly including the excisional device 100 and tissue
collection probe 800 may then be rotated (in a direction opposite
from the direction of rotation during the cutting step S282, for
example). As noted in step S285, this extends the collection device
808-810 along the same path as traveled by the cutting tool 710 of
the cutting probe 700 in step S282 and causes the tissue collection
device 808-810 to at least partially encompass (encapsulate) the
tissue specimen, as shown, for example in FIG. 27C. The assembly
including the excisional device 100 and tissue collection device
800 and the encapsulated tissue specimen may then be retracted from
the patient, as shown at S286, and the specimen forwarded for
histological analysis.
[0127] Alternatively, the combination cutting and tissue collection
probe 900 may be inserted in the excisional device, instead of
consecutively inserted the cutting probe 700 and tissue collection
probe 800 therein. In this case, the tissue collection device 918
or 932, 934 may be activated simultaneously with or after the
deployment of the cutting tool 914. Moreover, to better control the
deployment of the cutting tool of FIGS. 18-20 or 24A-26 and/or the
tissue collection device of FIGS. 21-23, 24A-26 or 27A-27C, an
intra-tissue ultrasound sensor such as described relative to FIGS.
1-17 may be used, to sweep a plane ahead of the cutting tool and/or
tissue collection device as the tubular member 110 of the
excisional device 100 rotates.
[0128] While the foregoing detailed description has described
several embodiments of this invention, it is to be understood that
the above description is illustrative only and not limiting of the
disclosed invention. For example, the method of the present
invention may also be carried out without the use of the tubular
member 110, by inserting the probes disclosed herein relative to
FIGS. 18-27C directly in the patient's soft tissue, as the present
cutting and tissue collection probes have utility independent of
the excisional device 100. A number of other modifications will no
doubt occur to persons of skill in this art. For example, the shape
and placement of the cutting device and tissue collection extending
means (814, 906, 908, 926, 944) may differ from that illustrated
and described herein, for ergonomical or other concerns. All such
modifications, however, should be deemed to fall within the scope
of the present invention. Thus, the invention is to be limited only
by the claims as set forth below.
* * * * *