U.S. patent application number 11/740847 was filed with the patent office on 2007-08-30 for devices and methods for performing procedures on a breast.
This patent application is currently assigned to RUBICOR MEDICAL, INC.. Invention is credited to Sean C. Daniel, James W. VETTER.
Application Number | 20070203427 11/740847 |
Document ID | / |
Family ID | 37889279 |
Filed Date | 2007-08-30 |
United States Patent
Application |
20070203427 |
Kind Code |
A1 |
VETTER; James W. ; et
al. |
August 30, 2007 |
DEVICES AND METHODS FOR PERFORMING PROCEDURES ON A BREAST
Abstract
A method may include steps of providing a tissue cutting device
having a shaft and a cutting element. The cutting element may be
movable from a collapsed position to an expanded position. The
tissue cutting device may be introduced into the patient's breast
through a first incision with the cutting element in the collapsed
position. The cutting element may then be expanded. The cutting
element may then be moved through breast tissue to cut around the
tissue to be removed, and the breast tissue may be removed through
a second incision that is different from the first incision.
Inventors: |
VETTER; James W.; (Portola
Valley, CA) ; Daniel; Sean C.; (Palo Alto,
CA) |
Correspondence
Address: |
YOUNG LAW FIRM, P.C.;ALAN W. YOUNG
4370 ALPINE ROAD
SUITE 106
PORTOLA VALLEY
CA
94028
US
|
Assignee: |
RUBICOR MEDICAL, INC.
Redwood City
CA
|
Family ID: |
37889279 |
Appl. No.: |
11/740847 |
Filed: |
April 26, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10923511 |
Aug 20, 2004 |
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|
11740847 |
Apr 26, 2007 |
|
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|
10732670 |
Dec 9, 2003 |
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10923511 |
Aug 20, 2004 |
|
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|
10272448 |
Oct 16, 2002 |
6936014 |
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10923511 |
Aug 20, 2004 |
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10796328 |
Mar 8, 2004 |
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|
10923511 |
Aug 20, 2004 |
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09417520 |
Oct 13, 1999 |
6423081 |
|
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10796328 |
Mar 8, 2004 |
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09146743 |
Sep 3, 1998 |
6022362 |
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09417520 |
Oct 13, 1999 |
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Current U.S.
Class: |
600/564 |
Current CPC
Class: |
A61B 10/04 20130101;
A61B 18/1482 20130101; A61B 17/3439 20130101; A61B 17/32056
20130101; A61B 2017/22034 20130101; A61B 2218/002 20130101; A61B
2090/3782 20160201; A61B 10/0041 20130101; A61B 10/02 20130101;
A61B 2017/00734 20130101; A61B 2018/00011 20130101; A61B 17/320725
20130101; A61B 18/148 20130101; A61B 90/39 20160201; A61B 18/14
20130101; A61B 2017/306 20130101; A61B 2017/22047 20130101; A61B
2218/008 20130101; A61B 17/320016 20130101; A61B 2090/3908
20160201; A61B 10/0283 20130101; A61B 2018/1407 20130101; A61B
2018/1475 20130101; A61B 2217/005 20130101; A61B 2017/3488
20130101; A61B 2218/007 20130101; A61M 1/0023 20130101; A61B
10/0266 20130101; A61B 17/3476 20130101; A61B 2017/008
20130101 |
Class at
Publication: |
600/564 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A method of removing breast tissue, comprising the steps of:
providing a tissue cutting device having a shaft and a cutting
element, the cutting element being movable from a collapsed
position to an expanded position; introducing the tissue cutting
device into the patient's breast through a first incision with the
cutting element in the collapsed position; expanding the cutting
element; moving the cutting element through breast tissue to cut
around the tissue to be removed; and removing the breast tissue
through a second incision different from the first incision.
2. The method of claim 1, wherein: the providing step is carried
out with the tissue removing device having a tissue collection
element; and the removing step being carried out with the tissue
being carried in the tissue collection element.
3. The method of claim 1, wherein: the providing step is carried
out with the cutting element being an RF cutting element, the RF
cutting element bowing outward when moving from the first position
to the second position.
4. The method of claim 1, further comprising the step of: the
forming step is carried out with the second incision being at least
partially formed by the tissue cutting device.
5. The method of claim 1, further comprising the step of: forming
at least part of the second incision with the cutting element.
6. The method of claim 5, wherein: the forming step is carried out
with the second incision being formed by the tip of the tissue
cutting device piercing through the skin at the second incision so
that the tissue cutting device is penetrates the first and second
incisions.
7. The method of claim 5, wherein: the forming step is carried out
with the second incision being created by the cutting element of
the tissue cutting device.
8. The method of claim 1, further comprising the step of:
encapsulating the tissue to be removed in a tissue collection
element; and the removing step is carried out with the tissue
contained in the tissue collection element.
9. The method of claim 8, further comprising the step of: releasing
the tissue collection element; and the removing step being carried
out with the tissue contained within the tissue collection element
when removed through the second incision.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of application Ser. No.
10/923,511, filed Aug. 20, 2004, which is a continuation-in-part of
application Ser. No. 10/732,670, filed Dec. 9, 2003, and a
continuation-in-part of application Ser. No. 10/272,448, filed Oct.
16, 2002, now U.S. Pat. No. 6,936,014, issued Aug. 30, 2005, and a
continuation-in-part of application Ser. No. 10/796,328, filed Mar.
8, 2004, which is a continuation of application Ser. No.
09/417,520, filed Oct. 13, 1999, now U.S. Pat. No. 6,423,081,
issued Jul. 23, 2002, which is a divisional of application Ser. No.
09/146,743, filed Sep. 3, 1998, now U.S. Pat. No. 6,022,362, issued
Feb. 8, 2000, all applications and patents of which are hereby
incorporated herein by reference in their entireties and from which
priority is hereby claimed under 35 U.S.C. .sctn.119(e) and
.sctn.120.
BACKGROUND OF THE INVENTION
[0002] 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 used to
detect small, nonpalpable lesions which may appear opaque densities
relative to normal breast parenchyma and fat or as clusters of
microcalcifications. 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.
[0003] Under general or local anesthesia, the surgeon may then
perform a needle-localized breast biopsy. In this procedure, 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
then be excised in toto with a small margin or rim of normal breast
tissue on all sides. Obtaining good margins of normal tissue using
conventional techniques 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.
[0004] 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.
[0005] 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
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 using fine needle aspiration, core needle biopsy,
vacuum-assisted core needle biopsy or other suitable method. 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. Core needle biopsy uses a larger size needle,
usually 14 gauge to sample the lesion. Tissue architecture and
histology are preserved with this method. 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. 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.
[0006] 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.
[0007] 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.
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.
SUMMARY OF THE INVENTION
[0008] According to an embodiment thereof, the present invention is
a method of removing breast tissue. The method may include steps of
providing a tissue cutting device having a shaft and a cutting
element, the cutting element being movable from a collapsed
position to an expanded position; introducing the tissue cutting
device into the patient's breast through a first incision with the
cutting element in the collapsed position; expanding the cutting
element; moving the cutting element through breast tissue to cut
around the tissue to be removed; and removing the breast tissue
through a second incision different from the first incision.
[0009] The providing step may be carried out with the tissue
removing device having a tissue collection element; and the
removing step may be carried out with the tissue being carried in
the tissue collection element. The providing step may be carried
out with the cutting element being an RF cutting element, the RF
cutting element bowing outward when moving from the first position
to the second position. The method may be carried out with the
forming step being carried out with the second incision being at
least partially formed by the tissue cutting device. The method may
also include a step of forming at least part of the second incision
with the cutting element. The forming step may be carried out with
the second incision being formed by the tip of the tissue cutting
device piercing through the skin at the second incision so that the
tissue cutting device is penetrates the first and second incisions.
The forming step may be carried out with the second incision being
created by the cutting element of the tissue cutting device. The
method may also include a step of encapsulating the tissue to be
removed in a tissue collection element. The removing step may be
carried out with the tissue contained in the tissue collection
element. The method may also include a step of releasing the tissue
collection element; and the removing step may be carried out with
the tissue contained within the tissue collection element when
removed through the second incision.
[0010] These and other aspects of the present invention will become
apparent from the following drawings and description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 shows a needle made in accordance with the present
invention.
[0012] FIG. 2 shows a tissue removing device.
[0013] FIG. 3 shows the needle introduced into a breast.
[0014] FIG. 4 shows a first anchor deployed within the breast.
[0015] FIG. 5 shows a second anchor deployed within the breast.
[0016] FIG. 6 shows a stiffener removed to provide a flexible
proximal end.
[0017] FIG. 7 shows the flexible, proximal portion taped to the
breast.
[0018] FIG. 8 shows a tissue removing device advanced over the
needle and a cutting element deployed.
[0019] FIG. 9 is a perspective view of a combination introducer and
suction sleeve, according to another embodiment of the present
invention.
[0020] FIG. 10 is a side cross-sectional view of the combination
introducer and suction sleeve of FIG. 9.
[0021] FIG. 11 is a perspective view of the combination introducer
and suction sleeve of FIG. 9, with a trocar inserted therein.
[0022] FIG. 12 is a side cross-sectional view of the combination
introducer and suction sleeve of FIG. 9, illustrating exemplary
structure with which the suction sleeve may attach to the
interventional device.
[0023] FIG. 13 is a perspective cross-sectional view of the
combination introducer and suction sleeve, attached to an exemplary
interventional device
[0024] FIG. 14 is a perspective view of another embodiment of a
suction sleeve according to the present invention, coupled to an
exemplary interventional device.
[0025] FIG. 15 shows another guide element used to introduce a
cutting device into the tissue.
[0026] FIG. 16 shows a piercing element removed from a lumen in the
guide member.
[0027] FIG. 17 shows a cutting device introduced into the guide
element.
[0028] FIG. 18 shows guide member retracted and anchored to the
tissue with needles and an adhesive tape.
[0029] FIG. 19 shows a perspective view of another guide member
having a window through which the cutting element extends when
cutting the tissue.
[0030] FIG. 20 shows a tube which is cut to form a lip.
[0031] FIG. 21 is a cross-sectional view of FIG. 21 along line
I-I.
[0032] FIG. 22 shows the tube of FIG. 21 covered with a shrink
tube.
[0033] FIG. 23 is a cross-sectional view of FIG. 23 along line
II-II with the addition of a cutting element shown in an expanded
or bowed configuration.
[0034] FIG. 24 is a cross-sectional view of FIG. 23 along line
III-III.
[0035] FIG. 25 shows another device for cutting or incising
tissue.
[0036] FIG. 26 shows a removable core.
[0037] FIG. 27 is a cross-sectional view of the device of FIG. 26
along line A-A.
[0038] FIG. 28 shows the removable core positioned within a
sheath.
[0039] FIG. 29 shows the cutting or incising device positioned
within the sheath.
[0040] FIG. 30 shows the cutting device positioned so that the
cutting element will sweep around the tissue area being
removed.
[0041] FIG. 31 shows a tissue removal device introduced through
another incision.
[0042] FIG. 32 shows the tissue removal device attached to the
tissue.
[0043] FIG. 33-35 show use of the tissue cutting device to create a
path for removing the tissue.
[0044] FIG. 36 shows the cutting device used to penetrate the
tissue to create a tissue removal incision.
[0045] FIG. 37 shows the tissue contained within a tissue
collection element having a tether which is coupled to the tissue
cutter.
[0046] FIG. 38 shows the tissue cutter removed with the tether
extending from the excised tissue.
[0047] FIG. 39 shows a side view of a tissue cutting device
adjacent a tissue area to be removed.
[0048] FIG. 40 shows the cutting element beginning to sweep around
the tissue area.
[0049] FIG. 41 shows the cutting element partially retracted to
trap tissue between the cutting element and the shaft of the
device.
[0050] FIG. 42 shows the tissue cutting device marking the
tissue.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0051] Referring to FIGS. 1-8, a needle 2 may be used to guide
another medical device, such as a tissue cutting device 6, when
performing a procedure on the breast. Any suitable tissue cutting
device may be used such as the devices disclosed in U.S. Pat. Nos.
6,440,147 and 6,022,362 which are also hereby incorporated by
reference. The tissue cutting device 6 has a cutting element 8
capable of assuming positions between collapsed and bowed
positions. The tissue cutting device 6 is pivoted or rotated so
that the cutting element 8 sweeps through and cuts the tissue along
an arc. A tissue collection element 10 may also be provided which
collects the tissue being cut. The needle 2 may also include a
stiffener 4 which is used in the manner described in application
Ser. No. 10/272,448, filed Oct. 16, 2002.
[0052] The needle 2 may also have one or more indicators 14 to mark
an angular position relative to the longitudinal axis 16 of the
needle 2. The indicator 14 extends radially outward from the needle
at a angle selected by the user. The indicator 14 may also simply
be a longitudinal stripe 18 or other marking on the shaft which
indicates a particular angular orientation on the needle 2. The
indicator 14 may provide information to the user regarding various
parameters depending upon the procedure being performed. For
example, when using the device 6 described above, the angular
position, or positions, provides the user with the angular extent
of the tissue to be removed.
[0053] The indicators 14 may be coupled to one more anchors 20
which are deployed to anchor the needle 2. The anchor 20 is
preferably curved, such as J- or C-shaped, and extends radially to
lie within the same angular orientation as the indicator 14. An
advantage of coupling the indicator 14 to the anchor 20 is that
anchor 20 itself provides information regarding the relative
orientation or the needle 2, anchor 20 and tissue area of interest.
Thus, the anchor 20 itself may be one of the indicators 14.
Although the anchor 20 and indicator 14 are preferably aligned at
the same angular orientation, they may also be offset to account
for the geometry of other devices used with the needle 2. As can be
appreciated, of course, the indicators 14 may also be independent
of any anchoring elements. For example, the needle 2 may be placed
in the breast and the indicators 14 could then be moved to selected
angular position(s). The needle 2 may also have depth markers 22
along the body. The anchor 20 is preferably a stainless steel wire
having a sharpened tip to pierce through the tissue. The
orientation of the anchor 20 is partially guided by the geometry of
the arc-shaped lumens (not shown) receiving the anchors 20.
[0054] Use of the device is now described in connection with a
tissue removal procedure with reference to FIGS. 1-8. Of course,
other procedures may be performed without departing from the scope
of the invention. The needle 2 is introduced into the area of
interest under suitable guidance such as ultrasound visualization.
Once the needle 2 has been introduced in a desired or known
orientation relative to the tissue area of interest, the entire
needle 2 is rotated so that the first indicator 14 and marker 18
are aligned with a first angular position relative to the tissue
area of interest. The first anchor 20 is then deployed into the
tissue with the anchor 20 deployed at the selected angular
orientation. The second indicator 14 is then rotated to a second
selected angular orientation with respect to the area of interest.
The second orientation is determined by visualizing the area of
interest relative to the needle 2 and/or first anchor 20 to
determine the appropriate location for the second anchor 20. The
second anchor 20 is then deployed by advancing the anchor into the
tissue. As can be appreciated, the needle 2 and anchors 20
themselves provide visual landmarks for locating the area of
interest. The markings on the needle 2 and the indicators 14 also
help to guide use of the tissue cutting device 6 as described
herein.
[0055] The stiffener 4 is then removed to provide the flexible
proximal portion. The flexible proximal portion may be taped to the
patient to prevent inadvertent contact as shown in FIG. 7. When
performing the procedure, the flexible condition may be maintained
to provide the benefit described above such as the ability to pull
from varying angles as compared to a conventional rigid needle. The
tissue removal device 6 may then be coupled to the needle 2 as
shown in FIG. 8 and then advanced while being guided by the needle
2. The needle 2 may be introduced to a predetermined depth where
the longitudinal stop 38 guides the depth of introduction of the
tissue removal device. Of course, the needle 2 may be introduced
deeper into the tissue with the user using the depth markings 40 on
the needle 2 and/or tissue removal device 6 to determine the
appropriate introduction depth for the tissue removal device 6. The
cutting element 8 is then deployed to the bowed position and the
cutting element 8 is swept through tissue to cut around the tissue
area of interest. The tissue is then collected by the collection
element 10 for removal. The device 6 is then withdrawn and anchors
30, which are described in more detail in application Ser. No.
10/272,448, filed Oct. 16, 2002, are retracted to permit withdrawal
of the needle 2 as well.
[0056] FIG. 9 is a perspective view of a combination introducer and
suction sleeve 902. The sleeve 92 may be used in the same manner as
the guide members described herein and such uses is expressly
incorporated here. FIG. 10 is a side cross-sectional view thereof.
Considering now FIGS. 9 and 10 collectively, the first external
surface 904 of the combination introducer and suction sleeve 902
may have a generally tapered or funnel shape, in that it defines a
relatively narrow diameter distal end and a relatively wider
proximal end. Such a generally funnel or tapered shape eases the
introduction of the device 802 within tissue. The combination
introducer and suction sleeve 902 has a suction port 908 that opens
to an internal lumen 916 defined by the internal surface 918. The
combination introducer and suction sleeve 902 also includes a
second external surface 912 that defines a tapered appearance.
Defined within the first and/or second external surfaces 904, 912
are a plurality of openings 906 that open to the internal lumen
916. In FIGS. 9-11, only the first external surface 904 defines
such openings 906, although the openings are not limited to this
surface. The suction port 908 is configured to couple with a vacuum
line, as shown at 116. The combination introducer and suction
sleeve 902 may further include structures to couple to one or more
devices. Such coupling structure(s) may include, for example, a
snap or interference fitting 914 and/or one or more O-rings, such
as shown at 910.
[0057] FIG. 11 is a perspective view of the combination introducer
and suction sleeve of FIG. 9, with a trocar 1102 inserted therein.
According to an embodiment of the present invention, the trocar
1102 may be inserted into the combination introducer and suction
sleeve 902 and the assembly may be packaged as a (preferably single
use) unit. According to another embodiment of the present
invention, a physician may utilize the assembly as follows:
[0058] An incision into tissue is made with a blade;
[0059] The physician then inserts the assembly including the trocar
1102 into the tissue and pushes the combination introducer and
suction sleeve 902 into the tissue through the incision into
position under or near the lesion or targeted site within the
tissue. The pointed and/or sharp distal tip 1104 of the trocar 1102
and the tapered profile of the combination introducer and suction
sleeve 902 aid the assembly's advancement within the tissue;
[0060] The trocar 1102 may then be removed from the combination
introducer and suction sleeve 902 and a desired (excisional RF, for
example) device may then be inserted therethrough, with the shaft
thereof disposed within and protruding from the internal lumen
916;
[0061] The combination introducer and suction sleeve 902 may then
be pulled back until it contacts, snaps and/or otherwise locks onto
the device, as shown at FIGS. 12 and 13. In FIGS. 12 and 13, only
the handle 102 of the device is shown, and the shaft 104 thereof is
omitted for clarity of illustration. Examples of a tissue cutting
device coupled to the combination introducer and suction sleeve 902
coupled thereto is shown in FIG. 14;
[0062] A vacuum line, such as shown at 116, may then be attached to
the suction port 908;
[0063] If needed, the device with the combination introducer and
suction sleeve 902 attached thereto may then be repositioned at,
near, under or within the target lesion, as desired. This
repositioning may be carried out under ultrasound guidance, for
example. The openings 906 may aid with the ultrasound
visualization. The combination may include other features and/or
markings to increase the visibility thereof under various imaging
modalities, and
[0064] The physician may then continue with the intended procedure
as per the instructions for use of the device utilized.
[0065] Alternatively, the trocar 1102 may be removed from the
combination introducer and suction sleeve 902 and the desired RF
device introduced and locked therein. The distal tip of the desired
RF device protruding from the distal end of the combination
introducer and suction sleeve 902 may then be used to reach the
intended biopsy site.
[0066] Alternately still, a stopcock may be attached to the suction
port 908 instead of the suction line 116 and one or more beneficial
agents (e.g., antibiotics, fibrin, lidocaine) may be delivered to a
target site through the openings 906.
[0067] The present combination vacuum sleeve and suction sleeve 902
may aid in positioning a biopsy or other interventional device
where it is needed. For example, interventional devices that
include a rather bulky or high-drag distal end may be readily
positioned at the intended site by means of the introducer
functionality of the combination 902. While the combination 902 is
advantageous before the biopsy or other interventional procedure is
started by easing the positioning of the biopsy instrument at or
near the target site, it is also useful during the procedure
itself, as it is effective in evacuating hot gasses and fluids from
the biopsy cavity, thereby decreasing collateral tissue thermal
damage. The same combination may then also be used to treat the
cavity post-procedure by, for example, providing a ready-made
pathway for the introduction of beneficial agents, compositions
and/or cavity treatment devices to the cavity or lesion site.
[0068] Referring now to FIGS. 15-18, another system 200 and method
are shown wherein the same or similar reference numbers refer to
the same or similar structure. As mentioned above, a guide member
202 may be used to guide a cutting device 204. The guide member 202
may be any of the suitable guide members described herein including
the needle 2 of FIGS. 1-8 or the introducer 902 of FIGS. 9-14. The
cutting device 204 may be any of the cutting devices described
herein or another suitable device such as those described in U.S.
Pat. No. 7,044,956, issued May 16, 2006, which is hereby
incorporated herein by reference in its entirety. The cutting
device 204 has a cutting element 205 which bows outwardly when
expanded.
[0069] The guide member 202 has a tubular body 206 and a removable
penetrating element 208 having a sharp tip 210 for piercing tissue
during introduction. The guide member 202 also has a port 212
coupled to a vacuum source 214 for removing hot gasses generated
during cutting. The penetrating element 208 has a shaft 216
extending through a lumen 217 in the guide member 202. The guide
member 202 may include one or more anchors 218 which holds the
guide member 202 at the desired position. The anchor 218 may simply
be an adhesive strip 220 which the user peels away from the body
and adheres to the skin. The anchor 218 may also be another
suitable anchor such as one or more needles 221 which are advanced
into the tissue. The anchors 218 help to resist movement of the
guide member 202 so that the guide member 220 may be used to guide
longitudinal and even rotational positioning of the cutting device
204 as explained herein. Referring to FIG. 19, the anchor 218 may
also be a balloon 221 which is inflated to anchor the guide
member.
[0070] After the guide member 202 has been introduced to the
desired depth, the penetrating element 208 is then removed and the
tissue cutting device 204 is introduced and advanced into the guide
member 220 (FIG. 17). The guide member 202 may include a stop 222
which prevents further advancement of the tissue cutting device 202
so that the device 204 remains in the same longitudinal position.
The guide member 202 may also include one or more angular
indicators 224 which may be the anchors 218. Referring to FIG. 19,
another guide member 202A is shown which has a window 226 oriented
in the desired direction of cutting. The window 226 guides the user
by limiting and/or defining the cutting motion to help guide the
cutting procedure. The use and structural features of the guide
member 220, indicators 224, anchors 118 and stop 222 may be the
same or similar to those described in connection with FIGS.
1-8.
[0071] Referring again to FIG. 14, the cutting element 108
preferably has an ultrasound marker 232 at an anticipated apex of
the cutting element 108 when the cutting element 108 is expanded to
help position the device. The apex 232 does not necessarily
correspond with the geometric middle of the cutting element 108
when the cutting element 108 is collapsed since only one end of the
cutting element 108 may be moved to bow the cutting element 108
outward. For example, the proximal end of the cutting element 108
may be advanced distally to bow the cutting element 108 outward in
which case the first marker 232 would appear to be closer to the
proximal end when the cutting element 108 is collapsed. The cutting
device 204 may also include a second marker 234 and a third marker
236 which correspond to the ends of the cutting element 108 when
the cutting element 108 is collapsed. Referring again to FIG. 17,
the guide member 20 may have a first marker 229, corresponding to
an anticipated apex 229 of the cutting element 108, and a second
marker 228 and a third marker 230 corresponding to the ends 228,
230 of the cutting element 108 when collapsed. In this manner, the
guide member 202 may help properly position the cutting device. Of
course, any of the guide members or tissue cutting devices
described herein, such as the needle 2, may also have the
ultrasound markers positioned in this manner. The cutting element
and the guide may be marked in any suitable manner. For example,
the cutting element or guide may include a hollow area which would
enhance the ultrasound signature. When placing a marker on the
cutting element, the marker may be designed to be easily visible
when the cutting element 205 is powered at a level lower than the
power level used during cutting. For example, the cutting element
205 may be designed to become more visible when an RF generator is
switched to coagulation mode which has lower power than the cutting
mode used when cutting tissue.
[0072] Referring now to FIGS. 20-24, the tissue cutting device 204
may have a shaft 240 with an asymmetrical cross-sectional shape
adjacent to the cutting element 205 to aid parting off the tissue
when completing the cutting operation. The shaft 240 is thicker in
the direction in which the cutting element 205 expands as compared
to the direction opposite cutter expansion. Stated another way, the
shaft 240 may be thicker on a leading side 242, which leads the
cutting element when rotated in the direction of arrow 245, than on
an opposing or trailing side 244. The shaft 240 may also be thicker
on the leading side in a direction substantially perpendicular to
expansion of the cutting element 205A (shown mounted to shaft 240
in the dotted-line position). Cutting element 205A is mounted to
the shaft 240 in an orientation about 90 degrees from the
orientation of the cutting element 205. Of course, the cutting
element 205A may be mounted to the shaft 240 in other orientations
relative to the thicker part of the shaft such as any position
between element 205 and element 205A. Stated still another way, the
cutting element 205 may be oriented and mounted on the shaft 240 in
any manner which provides a thicker side within the first 90
degrees of the leading side compared to the shaft thickness in the
90 degrees trailing the cutting element 205. In the various
suggested configurations described, the thicker part of the shaft
240 is preferably at least 1.25 times, 1.50 times, or even 1.75
times thicker than the thinner part of the shaft 240.
[0073] The shaft 240 may be formed in any suitable manner.
Referring to FIGS. 20-24, for example, a metallic tube 248 is cut
to form a lip 250 which is bent outwardly to provide the thicker
shaft section. The tube 248 is then covered with a shrink tube 252
and heated to bond the shrink tube 252 to the tube 248. The shrink
tube 252 covers the opening in the tube created by formation of the
lip 252. The shrink tube 252 also forms a beveled surface 254 which
covers an opening 253 in the tube 248 created by the lip 250.
[0074] Use of the system 200 is now described with reference again
to FIGS. 15-19. The guide member 202 is introduced into the tissue
to an appropriate depth relative to the tissue to be removed. As
explained above, the guide member 202 may be used to help define
and/or guide aspects of the cutting motion such as the depth of
insertion and/or one or more angular positions indicating the
angular extent of the targeted tissue. For example, the ultrasound
marker 229 may be used to position the guide member 202 so that the
anticipated apex of the cutting element 205 is positioned
appropriately. When the guide member 202A of FIG. 19 is used, the
cutting window 226 is positioned in the desired angular orientation
which positions the tissue to be removed within the window 226. The
window 226 may have an opening a bit larger than the anticipated
requirement so that the window 226 guides, but not necessarily
overly limits, the angular and longitudinal position of the cutting
device 204.
[0075] Once the guide member 202, 202A has been positioned properly
relative to the desired cutting operation the tissue penetrating
element 208 may be removed and the cutting device 204 is introduced
into the guide member 202. The guide member 202 is then retracted a
predetermined amount so that the guide member 202 is properly
positioned to remove hot gases generated during RF cutting as
described above. When using the guide member 202A having the
cutting window 226, the guide member does not, of course, need to
be retracted.
[0076] The cutting device 204 is then used to cut around the tissue
to be removed. The tissue may be removed in a tissue collection
element 10 (see FIG. 2). Alternatively, vacuum means may also be
used to remove the tissue as now described and further described in
application Ser. No. 10/796,328, filed Mar. 8, 2004. The cutting
device 204 may be any suitable cutting device such as those
described in U.S. Pat. No. 7,044,956, issued May 16, 2006.
[0077] Referring now to FIGS. 25-29, another system is shown which
uses a sheath 495 to receive one or more devices such as a core
400, which may be used for imaging, and an excisional device 100
which is used to cut the tissue. The core 400 has an active element
440 configured to perform intra-tissue imaging and of relaying
information back to a display device (shown in FIG. 30) 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.
[0078] To accommodate the removable transducer core 400, the
excisional device 100 of FIG. 25 includes 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, a 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.
[0079] FIG. 26 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 and may be used alone or
in addition to surface ultrasound to localize the lesion with a
great degree of precision.
[0080] FIG. 27 shows a cross section of the embodiment of the
excisional device 100 of FIG. 25, taken along line AA'. As shown in
FIG. 27, the cutting tool 125 is exposed through the transducer
window 120. The window 120 may, as shown in FIG. 27, 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 FIGS. 25 or 27. 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.
[0081] FIG. 28 shows the removable core 400 inserted within the
expandable sheath 495. The expandable sheath 495 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. 28, 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.
[0082] FIG. 29 shows another embodiment of a soft tissue excisional
device assembly 600 according to the present invention. In the
configuration shown in FIG. 29, 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. 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. The tissue collection
device 260 is not shown, for clarity but may be used in any manner
described herein or in the applications or patents incorporated
herein without departing from the scope of the invention.
[0083] In FIG. 29, the excisional device 100 is shown inserted
within the expandable sheath 495. Indeed, the excisional device
100, in FIG. 29, 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 element or tool 125 and the
transducer window 410 extends therethrough. The meshwork 500, in
FIG. 30, 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 526 (a turn knob 526 shown in
FIG. 29) to be manually accessible to the surgeon.
[0084] 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 550 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
or any suitable RF power source found in most operating rooms),
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. Any other
suitable cutting or excisional device may be used in connection
with the present invention such as those described in U.S. Pat. No.
7,044,956, issued May 16, 2006.
[0085] The vacuum means may be associated with the cutting tool 125
(FIG. 25) or the cutting device 204 (FIG. 17) or may be a separate
removal device 300 as shown in FIG. 30. As will be further
described, the tissue may also be removed through the same incision
or a separate incision from the incision through which the cutting
device 204 extends. Referring still to FIG. 31, the tissue removal
device 300 may have one or more suction ports 302 at a distal end
308. The suction port 302 is coupled to a lumen 304 which in turn
is coupled to a vacuum source 306. The suction port 302 can be
flared outwardly to enhance suction adherence and to help retract
tissue away from the tissue being removed as shown in FIG. 32. The
end 308 may have longitudinal slots (not shown) covered by an
elastic cover 309 which permits the end 308 to flare outwardly in a
manner similar to expandable trocars and cannulae as is known in
the art. The end 308 may be actuated with a thumb switch 310 or
other suitable actuator. Of course, the tissue removal device 300
may also directly grasp or pierce the tissue with piercing elements
311, such as needles 313, rather than relying on suction adherence.
For example, the tissue removal device 300 may advance needles 312
into the tissue to anchor and grasp the tissue.
[0086] The tissue removal device 300 may be introduced through the
same incision as the tissue cutting device 204 or may be introduced
through a different incision. For example, the user may choose to
introduce the cutting device 204 based primarily on the desired
orientation of the cutting device 200 relative to the tissue area
being removed. The user may then choose the removal incision based
on other factors such as proximity to the skin or for cosmetic
considerations. Referring to FIGS. 33-35, the removal incision may
be partially or completely created with the tissue cutting device
204. For example, the cutting element 205 may be expanded and
energized when the shaft is being withdrawn and/or advanced so that
the cutting element 205 creates a tissue channel. This procedure
may be repeated to create the desired channel such as an X- or
Y-shaped channel. The cutting element 205 may have a movable
insulating sheath 260 which covers a portion of the cutting element
205, such as the distal portion of the element 205, to prevent
inadvertent cutting of the tissue being removed when creating the
tissue channel. Use of a movable insulating sleeve 260 is described
in U.S. Pat. No. 7,198,626, issued Apr. 3, 2007, which is hereby
incorporated herein by reference in its entirety.
[0087] Referring to FIG. 36, the cutting element 205 may also be
used to create a separate incision for removal of the tissue by
cutting a channel directly from the area in which the tissue has
been cut and extending outwardly from the severed portion. The
cutting element 205 is positioned so that further extension and
bowing of the cutting element 205 will essentially create a path
outwardly from the severed portion of the tissue. This procedure
may be performed after severing the tissue in this area so that the
cutting element 205 can be initially positioned without RF power.
The ultrasound markers described herein, and in particular the
marker near the apex of the cutting element 205 when expanded and
bowed, are particularly useful in properly positioning the cutting
element 205 at this time. The cutting element 205 may then be
powered with RF to partially or completely create the tissue
channel. This procedure may be desirable when the cutting procedure
causes the cutting element 205 to pass near the skin. The cutting
device 204 may also include a movable insulating sleeve 261 which
covers part of the cutting element 205, such as portions on the
ends of the cutting element 205, during this part of the procedure
to reduce the excess lateral cutting during creation of the tissue
channel.
[0088] When removing the tissue, the tissue may be contained within
a tissue collection element 320 released by the cutting device 204
when the tissue is severed or which is deployed by itself after
excision of the tissue. The tissue collection element 320 may
simply trail the cutting element 205 similar to the patents and
applications incorporated by reference herein in which the tissue
collection element remains coupled to the device.
[0089] FIG. 37 shows the collection element 320 containing the
tissue with a tether 322 extending from the tissue collection
element 320 and being withdrawn as the cutting device 204 is
removed. The tether 322 may be used to guide advancement and
engagement of the tissue removal device 300. For example, the
tissue collection element 320 may have a connector 324 which
engages the removal device 300 with a suitable mechanical, magnetic
or suction connection. The connector 324 may be positioned at the
end of the tether 322 so that engagement with the connector 324 is
easily guided by the tether 322.
[0090] Referring still to FIG. 37, the tether 322 may be
particularly useful when removing the tissue through a separate
incision since the tether 322 can be easily retrieved using a
conventional suture snare or the like. The tether 322 may also be
used without the tissue collection element 320 by simply attaching
the tether 320 to the tissue with a needle, screw 321 (see FIG. 37)
or other suitable attachment feature. The tether 320 may be
delivered by the cutting device 204 or may be part of another
device such as the tissue removal devices described herein.
[0091] Referring to FIGS. 39-41, still another aspect of the
present invention is shown. The tissue cutting device 204 is shown
and all features and aspects of the tissue cutting devices
described herein are incorporated here. The tissue cutting device
204 is shown sweeping around the tissue to be removed. The cutting
element 205 is then partially retracted so that only a small piece
of tissue connects the tissue to be removed from the surrounding
tissue as shown in FIG. 41. The tissue cutting device 205 may then
be used to manipulate the tissue to assist or prepare the tissue
for removal. The tissue cutting device 204 may be designed to lock
the cutting element 205 in the partially opened position of FIG. 41
to trap the tissue between the cutting element 205 and the shaft
240 so that the cutting device 204 may be used to manipulate the
tissue. For example, the tissue may be manipulated while the tissue
is being encapsulated in a tissue collection element or when the
tissue is being engaged by any of the tissue removal devices
described herein such as the device 300. When it is desired to
remove the tissue, the cutting element 205 is collapsed further to
complete the cut.
[0092] The tissue cutting device 204 may also mark the tissue
sample and/or the tissue surrounding the tissue sample as shown in
FIG. 42. Marking the tissue may assist in identifying the tissue
for removal or to mark the tissue remaining in the body for
subsequent therapy or treatment. The tissue may be marked in any
suitable manner such as those described in application Ser. No.
10/871,790, filed Jun. 17, 2004, which is hereby incorporated
herein by reference in its entirety. For example, the tissue
cutting device 204 may have one or more dye injection ports 330 to
mark the tissue. Of course, the cutting device may also leave
behind a marker, such as a spiral spring or coil as described
above, to mark the tissue rather than marking the tissue with a dye
or the like. It is understood that marking the tissue being removed
and/or marking the tissue remaining in the body may be used in
connection with any of the other features and aspects of the
present invention including use with any of the tissue cutting or
removal devices described herein.
[0093] The present invention has been described in connection with
the preferred embodiments, however, it is understood that many
alternatives are possible without departing from the scope of the
invention.
* * * * *