U.S. patent application number 11/239838 was filed with the patent office on 2006-02-09 for surgical biopsy device.
This patent application is currently assigned to Rex Medical. Invention is credited to Stephan A. Defonzo, Peter W.J. Hinchliffe, James P. JR. McGuckin.
Application Number | 20060030847 11/239838 |
Document ID | / |
Family ID | 25293486 |
Filed Date | 2006-02-09 |
United States Patent
Application |
20060030847 |
Kind Code |
A1 |
McGuckin; James P. JR. ; et
al. |
February 9, 2006 |
Surgical biopsy device
Abstract
A surgical biopsy apparatus for cutting tissue comprising a
housing having a longitudinal axis, first and second members
movable from a retracted position to an extended position with
respect to the housing, a third member slidably positioned and
extendable with respect to the first member, a fourth member
slidably positioned and extendable with respect to the second
member, and an electrocautery cutting wire slidable with respect to
the third and fourth members to surround a region of tissue
positioned between the third and fourth members to cut the
tissue.
Inventors: |
McGuckin; James P. JR.;
(Radnor, PA) ; Hinchliffe; Peter W.J.; (Dowington,
PA) ; Defonzo; Stephan A.; (Wayne, PA) |
Correspondence
Address: |
Rex Medical
1011 High Ridge Road
Stamford
CT
06905
US
|
Assignee: |
Rex Medical
|
Family ID: |
25293486 |
Appl. No.: |
11/239838 |
Filed: |
September 30, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10642009 |
Aug 15, 2003 |
6960172 |
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11239838 |
Sep 30, 2005 |
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09844729 |
Apr 27, 2001 |
6626903 |
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10642009 |
Aug 15, 2003 |
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09122185 |
Jul 23, 1998 |
6280450 |
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09844729 |
Apr 27, 2001 |
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60053664 |
Jul 24, 1997 |
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Current U.S.
Class: |
606/47 ;
600/564 |
Current CPC
Class: |
A61B 10/0266 20130101;
A61B 2017/32004 20130101; A61B 17/320725 20130101; A61B 18/14
20130101; A61B 17/320016 20130101; A61B 17/32056 20130101; A61B
90/40 20160201; A61B 2018/2238 20130101; A61B 2018/1407 20130101;
A61B 10/02 20130101; A61B 17/221 20130101; A61B 2017/2212 20130101;
A61B 2017/2215 20130101; A61B 18/1482 20130101; A61B 90/39
20160201; A61B 2017/00287 20130101; A61B 10/0041 20130101; A61B
17/0218 20130101; A61B 2017/00796 20130101; A61B 2017/008
20130101 |
Class at
Publication: |
606/047 ;
600/564 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 10/00 20060101 A61B010/00 |
Claims
1. A surgical biopsy apparatus for cutting tissue comprising: a
housing having a longitudinal axis; first and second members
movable from a retracted position to an extended position with
respect to the housing; third and fourth members, the third member
slidably positioned with respect to the first member and extendable
with respect to the first member and the fourth member slidably
positioned with respect to the second member and extendable with
respect to the second member; and an electrocautery cutting wire
movable with respect to the third and fourth members to surround a
region of tissue positioned between the third and fourth members to
cut the tissue.
2-34. (canceled)
Description
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 09/122,185, filed Jul. 23, 1998 which claims
priority from U.S. provisional application No. 60/053,664, filed
Jul. 24, 1997. The contents of both these applications are
incorporated herein by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] This application relate al device for removing tissue and
more particularly relates to a surgical tissue biopsy device
insertable through a small incision in the body.
[0004] 2. Background of Related Art
[0005] Over 150,000 women in the United States alone are diagnosed
each year with breast cancer. A biopsy of breast tissue is
indicated when a breast abnormality is found, allowing removal of
the tissue and testing to determine whether the abnormality is
malignant and further surgery is necessary. Early diagnosis and
removal of cancerous tissue is critical for successful treatment as
early detection greatly increases the chances of survival.
[0006] Numerous devices are currently available for performing
breast biopsies. These devices function to dissect a portion of the
breast tissue and remove it from the body for pathology to
determine whether the tissue is malignant.
[0007] The most invasive procedure is referred to as open
excisional biopsy. In this procedure, large tissue samples are
surgically removed, requiring long recovery times, risking
disfigurement of the breast, increased scarring and increased
morbidity.
[0008] In an attempt to overcome the disadvantages of open surgery,
more minimally invasive instruments have been developed. One
minimally invasive approach utilizes a percutaneous instrument
referred to as a fine needle biopsy instrument. In this instrument,
a needle and syringe are inserted directly through the breast into
the target tissue, e.g. the lump, to remove a cell sample for
pathology. One disadvantage of this technique is that numerous cell
samples are required to be taken from the tissue to obtain a
sufficient mass for testing, thereby requiring numerous needle
sticks and increasing the time required for the procedure. Another
disadvantage is that careful locational tracking of the tissue
cells removed is required for accurate analysis. Also, with these
devices there is a greater potential for false negatives due to the
small sized specimens being removed without removal of sufficient
surrounding areas of healthy tissue for comparison.
[0009] Another type of minimally invasive device is referred to as
core needle biopsy. This device has a spring actuated cutter and
obtains a larger specimen than the fine needle biopsy instruments.
The specimen is suctioned into a side window in the needle and then
back through the proximal end of the needle. Although larger than
fine needle biopsy instruments, these needles are still relatively
small, e.g. 2 mm in diameter. Since typically removal of between
five and twenty tissue cores of 2 mm in diameter and 20 mm in
length is required for accurate pathology, five to twenty needle
sticks into the patient of this 2 mm diameter needle is required.
These devices also have the disadvantage that the spring force
cutting action may displace malignant cells into the adjacent
normal tissue. Also, the amount of false negatives can be high
because of inadequate removal of surrounding healthy tissue. Like
fine needle biopsy, success and accuracy of the procedure is skill
dependent because the device must be maneuvered to various
positions and these different positions accurately tracked.
[0010] Another disadvantage common to both fine needle and core
needle biopsy devices is that the entire lesion cannot be removed.
Therefore, if the tests show the lesion is malignant, another
surgery must be scheduled and performed to remove the entire lesion
and surrounding tissue. Besides the additional cost and surgeon
time, this can have an adverse psychological affect on the patient
who must await the second surgical procedure.
[0011] Some percutaneous devices, such as the Mammotome marketed by
Ethicon, Inc., attempted to overcome some of these disadvantages of
percutaneous devices by enabling multiple specimens to be removed
with a single needle stick. The specimens are removed from the
proximal end of the needle by a vacuum. Although overcoming some
disadvantages such as reducing the number of needle sticks, the
Mammotome still fails to overcome many of the other drawbacks since
careful tracking is required, success is skill dependent, and a
second surgery is necessary if the lesion is malignant, with the
attendant expenses and trauma.
[0012] In an attempt to avoid a second procedure, the ABBI
instrument marketed by United States Surgical Corporation provided
a larger needle so that the entire specimen and tissue margins
could be removed. The extra tissue excised is achieved by a larger
diameter cannula. The cannula removes breast tissue from the skin
surface entry point to the interior region of the breast where the
lesion is located. The advantage of this instrument is that if
pathology indicates the tumor is malignant, then an additional
surgical procedure is not necessary since the tumor and margins
were removed by the large cannula. However, a major disadvantage of
this instrument is that if pathology indicates the lesion is
benign, then a large tissue mass would have been unnecessarily
removed, resulting in more pain, a larger scar, and possible
disfigurement of the breast. Thus, ironically, the instrument is
more beneficial if the tumor is malignant, and disadvantageous if
the tumor is benign. In either case, the instrument has the further
disadvantages of causing additional bleeding because of the large
incision and requiring closure of a larger incision, thereby
increasing scarring, lengthening patient recovery time, and adding
to the cost, time and complexity of the procedure.
[0013] It would therefore be advantageous to provide a surgical
breast biopsy device which can access the targeted lesion through a
small incision but be able to remove the entire lesion and margin,
thereby avoiding the necessity for a second surgery. Such device
would advantageously reduce the risk of cancer seeding, provide
more consistent testing, reduce surgery time, reduce bleeding, and
minimize disfigurement of the patient's breast.
SUMMARY
[0014] The present invention overcomes the foregoing deficiencies
and disadvantages of the prior art. The present invention provides
a surgical biopsy apparatus for cutting tissue comprising a housing
having a longitudinal axis, first and second members movable from a
retracted position to an extended position with respect to the
housing, a third member slidably positioned and extendable with
respect to the first member, a fourth member slidably positioned
and extendable with respect to the second member, and an
electrocautery cutting wire movable with respect to the third and
fourth members to surround a region of tissue positioned between
the third and fourth members to cut the tissue.
[0015] The apparatus preferably further includes a tissue retrieval
bag movable with respect to the third and fourth members and
movable from a retracted position within the housing to an extended
position distally of the housing to surround a region of tissue
positioned between the third and fourth members to remove the cut
tissue.
[0016] The apparatus preferably further comprises a first carrier
slidably positioned over the first and third member, wherein the
first carrier supports and advances the electrocautery wire and a
suture for closing the tissue retrieval bag
[0017] Preferably the first and second members move radially
outwardly away from the longitudinal axis of the housing and the
third and fourth members initially move radially outwardly away
from the longitudinal axis followed by movement inwardly towards
the longitudinal axis. The third member is preferably telescopingly
received within a first channel in the first member and the fourth
member is preferably telescopingly received within a second channel
in the second member.
[0018] The present invention also provides a surgical biopsy
apparatus for cutting a tissue mass comprising a housing, a
plurality of first members extendable with respect to the housing
and movable in a first direction at a first angle to the
longitudinal axis of the housing, a plurality of second members
movable with respect to the first members in a second direction
different than the first direction and at an angle to the first
angle, and a cutting wire movable longitudinally with respect to
the first and second members to cut the tissue mass.
[0019] The apparatus preferably includes a tissue retrieval bag
movable longitudinally with respect to the first and second members
to remove the tissue mass cut by the cutting wire. Preferably, a
loop of the cutting wire and a mouth of the tissue retrieval bag
are enlarged by the plurality of first and second members.
[0020] The apparatus may include a marker supported within the
housing and insertable into the tissue mass, the marker composed of
shape memory material and the first and second members surrounding
the marker. The first and second members may also be composed of
shape memory material.
[0021] The present invention also provides a surgical biopsy
apparatus comprising a housing, a plurality of members advanceable
with respect to the housing to provide a boundary for an area of
tissue to be removed, a cutting wire loop advanceable with respect
to the plurality of members to cut the area of tissue and/or a
tissue retrieval bag advanceable with respect to the plurality of
members to remove the area of tissue. Preferably, the cutting wire
loop and/or a mouth of the tissue retrieval bag is moved to a
larger diameter as it is advanced with respect to the members.
Preferably at least one carrier is provided which is advanceable
over one of the plurality of members to advance the cutting wire
and the tissue retrieval bag toward the target tissue.
[0022] The apparatus may also include an ultrasonic transducer at a
distal end of the housing to enhance ultrasound imaging during the
biopsy procedure.
[0023] The present application also provides a method for removing
a tissue mass for biopsy comprising inserting a cannula to a
position proximal of the target tissue mass, advancing a plurality
of tissue penetrating members from the cannula to an angular
position to create a boundary area around the tissue mass, and
advancing an electrocautery cutting wire with respect to the tissue
penetrating members to surround the tissue mass defined within the
boundary area.
[0024] The method may further comprise the step of advancing a
tissue containment bag with respect to the tissue penetrating
members to encapsulate the cut tissue mass for removal, wherein the
cutting wire and tissue containment bag are advanced substantially
simultaneously.
[0025] A method for performing breast biopsy is also provided
comprising inserting into breast tissue a housing having a diameter
smaller than a diameter of the tissue to be biopsied, advancing
penetrating members through the breast tissue to create a tissue
boundary area having a transverse cross-sectional length greater
than the diameter of the housing, and advancing a cutting wire so a
loop of the cutting wire moves to a diameter greater than the
diameter of the housing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Preferred embodiment(s) of the present disclosure are
described herein with reference to the drawings wherein:
[0027] FIG. 1A is a perspective view of the biopsy apparatus of the
present invention in the initial position;
[0028] FIG. 1B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 1A showing the outer (female)
rails in the retracted position;
[0029] FIG. 2A is a perspective view of the apparatus of FIG. 1
showing the outer and inner (male) rails in the fully deployed
(advanced) position;
[0030] FIG. 2B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 2A;
[0031] FIG. 3A is a perspective view of the apparatus of FIG. 1
showing the outer rails in the fully deployed position;
[0032] FIG. 3B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 3A;
[0033] FIG. 4A is a perspective view of the apparatus of FIG. 1
showing the outer rails in the fully deployed position and the
inner rails slightly advanced from within the outer rails;
[0034] FIG. 4B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 4A;
[0035] FIG. 5A is a perspective view of the apparatus of FIG. 1
showing the outer rails in the fully deployed position and the
inner rails partially advanced from within the outer rails;
[0036] FIG. 5B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 5A;
[0037] FIG. 6A is a perspective view of the apparatus of FIG. 1
showing the outer rails in the fully deployed position and the
inner rails further advanced to an intermediate position;
[0038] FIG. 6B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 6A;
[0039] FIG. 7A is a perspective view of the apparatus of FIG. 1
showing the outer rails in the fully deployed position, the inner
rails in the fully deployed (advanced) position, and the carriers
initially advanced over the outer rails; (the cutting wire, suture,
and bag being removed for clarity);
[0040] FIG. 7B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 7A;
[0041] FIG. 8A is a perspective view of the apparatus of FIG. 1
showing the outer rails in the fully deployed position, the inner
rails in the fully deployed position, and the carriers partially
advanced over the inner rails past an intermediate position;
[0042] FIG. 8B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 8A;
[0043] FIG. 9A is a perspective view of the apparatus of FIG. 1
showing the outer rails in the fully deployed position, the inner
rails in the fully deployed position, and the carriers extended
over the inner rails to the fully deployed (advanced) position;
[0044] FIG. 9B is an enlarged perspective view of the distal end
portion of the apparatus of FIG. 9A;
[0045] FIG. 10 is a longitudinal sectional view illustrating the
interaction of the deployment rings, rails and carriers when the
apparatus is in the initial position;
[0046] FIG. 11 is an enlarged view of a portion of the apparatus of
FIG. 10 showing the proximal deployment rings for advancing the
rails;
[0047] FIG. 12 is an enlarged view of a portion of the apparatus of
FIG. 10 showing the distal deployment ring for advancing the
carriers;
[0048] FIG. 13 is a longitudinal sectional view illustrating the
interaction of the deployment rings, rails and carriers when the
apparatus is in the fully deployed position;
[0049] FIG. 14 is an enlarged view of a portion of the apparatus of
FIG. 13 showing the interaction of the deployment rings, rails and
carriers;
[0050] FIG. 15 is an enlarged perspective view of the distal end of
the apparatus of FIG. 13;
[0051] FIG. 16 is a further enlarged view of the distalmost portion
of the apparatus of FIG. 15 illustrating the carriers fully
advanced over the inner rails;
[0052] FIG. 17A is an enlarged transverse cross-sectional view
showing engagement of the lock with the pin and carriers;
[0053] FIG. 17B is a further enlarged view of a portion of the
apparatus shown in FIG. 17A;
[0054] FIG. 18A is an enlarged longitudinal sectional view showing
the interaction of the pin, lock and rails in the deployed position
of the apparatus;
[0055] FIG. 18B is an enlarged sectional view, cut in the
longitudinal and transverse planes showing the interaction of the
pin, lock and catheter in the deployed position of the
apparatus;
[0056] FIG. 19 is an enlarged view of the apparatus of FIG. 1
showing a first embodiment of the carriers for supporting the
cutting wire and suture;
[0057] FIG. 20 is an enlarged view of two of the carriers of FIG.
19 shown supporting the cutting wire and suture;
[0058] FIGS. 21A and 21B are enlarged front and rear views,
respectively, of the carriers of FIG. 19 showing the cutting wire
and suture extending through the respective openings;
[0059] FIG. 22 is an enlarged view of an alternate embodiment of
the carrier having hooks to retain the cutting wire;
[0060] FIG. 23 is a perspective view of an alternate embodiment of
the apparatus of the present invention having a wire loop tissue
marker, wherein the apparatus is shown with the marker deployed,
the outer rails fully deployed, and the inner rails in the
retracted position;
[0061] FIG. 24 is an enlarged view of the distal end of the
apparatus of FIG. 23 showing the outer rails in the fully deployed
position, the inner rails in the fully deployed position, and
initial advancement of the carriers to advance the cutting wire,
suture and tissue containment bag;
[0062] FIG. 25 is a top perspective view of the apparatus having an
alternative mechanism for advancing the rails and carriers;
[0063] FIG. 26 is a bottom perspective view of the apparatus of
FIG. 25;
[0064] FIGS. 27-34 are perspective views illustrating the method of
using the apparatus of the present invention for excising breast
tissue, wherein:
[0065] FIG. 27 illustrates the apparatus of the present invention
approaching the breast to access the lesion;
[0066] FIG. 28 illustrates the cannula of the apparatus inserted
through an incision in the breast in line with the lesion;
[0067] FIG. 29 illustrates the cannula inserted through an incision
in the breast and the outer rails deployed proximally of the
lesion;
[0068] FIG. 30 illustrates the inner rails deployed to an
intermediate position and partially encircling the lesion;
[0069] FIG. 31 illustrates the inner rails fully deployed to
encircle the lesion;
[0070] FIG. 32 illustrates partial deployment of the carriers to
advance the cutting wire, suture and tissue retrieval bag;
[0071] FIG. 33 illustrates the carriers fully deployed with the
tissue retrieval bag encircling the excised tissue,
[0072] FIG. 34 illustrates the apparatus with the tissue
encapsulated in the retrieval bag withdrawn from the breast;
[0073] FIG. 35 is a perspective view of the apparatus inserted in a
different orientation through an opening in a breast compression
plate; and
[0074] FIG. 36 is a perspective view of an alternate embodiment of
the apparatus of the present invention having a transducer for
imaging.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0075] Referring now in detail to the drawings where like reference
numerals identify similar or like components throughout the several
views, the surgical apparatus for removing tissue is designated
generally by reference numeral 10 in FIG. 1. The apparatus 10 of
the present invention is particularly designed for removing breast
tissue, however use of the apparatus for removal, i.e. biopsy, of
other body tissue is contemplated.
[0076] Referring to FIGS. 1A and 2A, apparatus 10 has a housing or
cannula 12, a series of deployment rings 20, 30, 40, and a handle
portion 14. The ring 20 deploys outer (female) or first rails 50
and ring 30 deploys inner (male) or second rails 60. As shown,
outer rails (or outer tissue penetrating members) 50 and second
rails (or inner tissue penetrating members) 60 are deployed from an
initial position retracted within lumen 18 of cannula 12 as shown
in FIGS. 1A and 1B to a deployed position where outer rails 60
encircle the tissue to be biopsied. The tissue is then severed and
removed in the manner described below. As will be appreciated, the
apparatus 10 enables removal of a lesion through a relatively
smaller incision since the cannula 12 determines the size of the
entry incision to the target site, and the rails 60 deploy radially
outwardly defining an area having a diameter larger than the
diameter of the cannula, thereby allowing a larger area/volume of
tissue to be removed.
[0077] Cannula or housing 12 can be composed of two separate
cannulas: a proximal cannula 13 extending from conically shaped
handle portion 14 and a reduced diameter cannula 16 extending
distally from proximal cannula 13 and beginning at plastic
interface 13a. Alternatively, cannula 12 can be composed of a
single cannula having a larger diameter proximal portion (like
cannula 13) and a smaller diameter distal portion (like cannula
16). A portion of cannula 16 or of the reduced diameter cannula
portion is configured for insertion into the patient's body.
[0078] Cannula 13 preferably has a diameter D1 of about 13 mm and
cannula 16 preferably has a diameter D2 of about 10 mm. Clearly
other diameters are contemplated which can preferably range from
about 30 mm to about 7 mm. Elongated slots 17a and 17b accommodate
the respective pins of deployment rings 20, 30 and 40 in the manner
described below. A pair of identical slots is formed on the
opposite side of cannula 13 to accommodate the second pins of the
deployment rings 20, 30 and 40.
[0079] As noted above, in the initial position, the outer rails 50
are fully retracted and housed within channel 18 of reduced
diameter cannula 16 as shown in FIGS. 1A and 1B. Outer rails 50
have a central lumen 52 for telescopingly receiving inner rails 60.
Thus, inner rails 60 are likewise retracted within cannula 16 in
the initial position of the apparatus 10.
[0080] In this initial position shown in the sectional views of
FIGS. 10-12, first and second proximal deployment rings 20 and 30
are in the proximalmost position adjacent handle portion 14 and
distal deployment ring 40 is in its proximalmost position. A pair
of pins 22, preferably spaced 180.degree. apart, extends through
respective apertures 24 in ring 20 to engage ring-like slug 25.
Slug 25 has a pair of radial openings 21 to frictionally receive
metal locks 23, and locks 23 have openings 26 to receive pins 22.
In this manner, ring 20 is operatively attached to slug 25. The
other radial openings 21, which although do not receive pins 22,
have locks 23 seated therein.
[0081] Slug 25 also has a series of axial openings 28,
corresponding in number to the number of outer rails 50, e.g. six.
Outer rails 50 extend through these axial openings 28 in slug 25
and are affixed to locks 23. That is, locks 23 have a pair of
spaced apart legs or tabs 29 (see also FIG. 18A) which frictionally
engage notches at the proximal end of outer rails 50. In this
manner, rails 50 are connected to slug 25 by frictional engagement
with lock 23. Thus, when pins 22 (and ring 20) are slid forward in
slot 17a, slug 25 and operatively connected outer rails 50 are
advanced.
[0082] In a similar manner, ring 30 has a pair of pins 32 extending
through respective apertures 34 to engage ring-like slug 35 and
ring 40 has a pair of pins 42 extending through apertures 44 to
engage ring-like slug 45. Slugs 35 and 45, like slug 25,
frictionally receive locks 33, 43 within radial openings 36, 46,
and have a series of axial openings 38, 48, to receive the inner
rails 60 and carriers 70, respectively. The number of openings 38,
48 corresponds to the respective number of rails 60 and carriers
70. Locks 33 and 43 have openings 31, 41 to receive and secure the
pins 32, 42. In this manner, rings 30 and 40 are operatively
connected to slugs 35 and 45. Locks 33 and 43 also have tabs 39, 49
to receive the respective notches in the proximal portion of the
rails 60 and carriers 70. Thus, rings 30, 40 are operatively
connected to rails 60 and carriers 70, respectively, for deployment
thereof. (Engagement of lock 43 with the notches 73 of carriers 70
is best seen in FIGS. 17B and 18B).
[0083] To deploy the outer rails 50, proximal deployment ring 20 is
slid distally to advance slug 25, carrying the rails 50 distally to
advance from channel 18 of cannula 16 to the deployed position as
shown in FIGS. 3A and 3B. (The pins in these Figures as well as
FIGS. 4-9 have been removed for convenience). Edge 19 of slot 17a
functions as a positive stop to limit travel of proximal ring 20.
As can be appreciated, in this position; rails 50 extend radially
outwardly with respect to a longitudinal axis L of cannula 16. In
this position, rails 50 can direct inner rails 60 upwardly and
outwardly with respect to the reduced diameter cannula 16.
[0084] The outer rails 50 can have blunt tips as shown, or
alternatively, to reduce the penetrating forces, can have more
sharpened tips or beveled edges (described below) to facilitate
cutting through tissue as they are advanced. Also, although six
outer rails 50 are shown, a fewer or larger number of rails could
be provided. Outer rails 50 are preferably composed of shape memory
material with their memorized shape of that shown in FIG. 3B.
[0085] Once the outer rails 50 have been deployed, proximalmost
deployment ring 30 is linearly advanced to advance the inner rails
60 from within lumen 52 of outer rails 50. As shown in FIGS. 4-5,
as ring 34 is slid distally within elongated slot 17a of channel
12, slug 34 moves the inner rails 60 first radially outwardly with
respect to the longitudinal axis L of cannula 16 at a similar angle
to the angle of rails 50, and then in a direction somewhat parallel
to the longitudinal axis L to begin encircling the target tissue
(FIGS. 6A and 6B). Further advancement of ring 34 moves the inner
rails 60 inwardly toward longitudinal axis (as extrapolated) with
their tips 64 coming together as shown in FIGS. 2A and 2B.
Deployment ring 20 can act as a stop for advancement of deployment
ring 30. Alternatively, other means and mechanisms could be
provided to provide a positive stop for advancement of the rings.
In this fully advanced position, the rails 60 fully encapsulate,
e.g., encircle the target tissue, defining a somewhat spherical
tissue target region which can be of substantially circular or
substantially elliptical transverse cross section. This target
region has a diameter, defined by the distance D3 between the
opposing inner rails 60, greater than diameter D2 of the distal
cannula 16 and diameter D1 of proximal cannula 13, thus enabling a
larger region of tissue to be removed than the diameter of the
incision. In a preferred embodiment, the distance D3 is preferably
slightly greater than about 3 cm, thereby allowing a 3 cm tissue
region to be removed. It is also contemplated that other distances
between the inner rails can be utilized.
[0086] As with the outer rails 50, inner rails 60 can have blunt
tips as shown, or alternatively, to reduce the penetrating forces,
can have sharper pointed tips or beveled edges to cut through
tissue as they are advanced. FIGS. 30 and 32, discussed below, show
by way of example beveled penetrating tips. Also, although six
rails are shown, a fewer or larger number of rails could be
provided. Inner rails 60 are preferably made of shape memory
material which have a memorized shape of that shown in FIG. 2B.
[0087] As noted above, outer and inner rails 50, 60 are preferably
made of shape memory metal material, such as Nitinol, a nickel
titanium alloy. To facilitate passage of the outer rails 50 through
the housing, e.g.; cannula 16, and facilitate passage of inner
rails 60 through outer rails 50 into the tissue, cold saline is
injected through or around the rails in their retracted position
within cannula 16. This shape memory material characteristically
exhibits rigidity in the austenitic state and more flexibility in
the martensitic state. The cold saline maintains the temperature
dependent rails 50, 60 in a relatively softer condition as they are
in the martensitic state within the cannula. This facilitates the
exit of outer rails 50 from cannula 16 and the exit of inner rails
60 from outer rails 50 as frictional contact between the tips of
outer rails 50 and the inner surface of cannula 16 and frictional
contact between the tips of inner rails 60 and the inner walls of
outer rails 50 would otherwise occur if the rails were maintained
in a rigid, i.e. austenitic, condition.
[0088] After deployment of the outer rails 50, they are exposed to
the warmer body temperature. This change in temperature causes the
rails 50 to transition to their austenitic state to facilitate
passage through the tissue. Similarly, after deployment of inner
rails 60 from outer rails 50, they are exposed to the warmer body
temperature, thereby causing rails 60 to transition to their
austenitic state to facilitate passage through tissue. A stopcock
could be provided to ensure constant infusion of cold saline during
advancement of the rails.
[0089] Once the inner rails 60 have been fully deployed, the
carriers or catheters 70 are deployed to advance cutting wire 86
and suture 82 which is attached to tissue containment bag 84. (The
cutting wire 86, suture 82 and bag 84 are not shown in FIGS. 7-9
for clarity). More specifically, as shown in FIGS. 7A and 7B,
movement of distal ring 40 in a distal direction, advances carriers
70 from channel 18 of cannula 16 as pins 42 extending through
distal ring 40 slide within slot 17b to advance slug 44.
[0090] One embodiment of the carriers 70 for retaining and
advancing the wire 86 and suture 82 is shown in FIGS. 19-21. Each
carrier 70 has a pair of cutting wire openings 74a, 74b and a pair
of suture openings 72a, 72b positioned slightly proximally of
openings 72a, 72b so that during advancement of carriers 70, suture
82 will trail cutting wire 86. One of the carriers 70 has a
longitudinal slot 71 (see FIG. 18B) to enable the cutting wire 86
and suture 82 to extend proximally for attachment to a tension
spring described in more detail below. For ease of manufacturing,
each of the catheters 70 has a longitudinal slot so identical
catheters can be made, however, optionally only one of the
catheters 70 needs to be provided with the slot since the free end
of the wire 86 and suture 82 can use a single passage proximally
through the cannulas 13 and 16.
[0091] Suture 82, as shown, is threaded through adjacent carriers
70 as it extends through opening 72a and exits opening 72b in one
carrier 70, then extends through opening 72a and out opening 72b in
an adjacent carrier 70, and continues through openings 72a, 72b of
adjacent carriers 70 until it extends through all the carriers 70.
One end of the suture 82 is looped (reference numeral 83) around
tissue containment bag 84 and attached thereto so that tensioning
of the suture 82 cinches the open end of bag 84 to close the bag
around the tissue severed by cutting wire 86. The free end of
suture 82 extends rearwardly through (e.g. through slot 71) or
adjacent one of the carriers 70, and extends proximally within with
one end affixed to the cannula or handle. To enable tensioning of
the suture 82, preferably a constant force spring (not shown) is
mounted at one end within cannula 12 or handle 14. The free end of
suture 82 is mounted to the other end of the spring so that
advancement of the suture 82 by the carriers 70 unravels the spring
and applies tension thereto, thereby applying tension to suture 82
to close the mouth of the tissue containment bag 84 as it is fully
advanced.
[0092] The cutting wire 86 is threaded through openings 74a, 74b in
adjacent carriers 70 in a similar manner as suture 82. That is,
wire 86 extends into a carrier 70 through opening 74a and exits the
carrier 70 through opening 74b where it can enter opening 74a in
adjacent carrier 80. The wire is formed into a loop 85 as shown,
with the free end extending proximally through one of the carriers
70, e.g. through longitudinal slot 71, terminating within cannula
12. A constant force spring (not shown) is mounted at one end
within cannula 12 or handle 14 and at another end to the proximal
end of cutting wire 86. A connection wire (not shown) electrically
connects cutting wire 86 to an RF frequency source for applying RF
energy to the cutting wire 86. As cutting wire 86 is advanced, it
is held in tension by the spring.
[0093] An opening 87 in carrier 70 has an internal diameter
dimensioned to receive an outer rail 50 and an inner rail 60. In
this manner, carriers 70, when advanced, can ride over rails 50, 60
to advance the cutting wire 86, suture 82 and bag 84. Cutting wire
86 is preferably mounted to a radiofrequency energy source so RF
energy is applied as wire 86 is advanced distally with respect to
the rails 60 to progressively cut and cauterize the tissue.
[0094] Distal movement of ring 40 advances carriers 70 as they
initially ride over the outer rails 50 as shown in FIGS. 7A and 7B,
with opening 87 fitting over the outer surface of rails 50. Further
distal movement of ring 40 advance carriers 70 over inner rails 60
(FIGS. 8A and 8B) until they reach their final deployed position of
FIGS. 9A and 9B. In this position, distal ring 40 is at the
distalmost end of slot 17b, with the edge 15 (see FIG. 1A) of the
slots 17b acting as a positive stop for pins 42 to limit forward
travel of the ring 40 and slug 45, and consequently limit travel of
the carriers 70. In this final position of the apparatus shown in
FIGS. 9A and 9B, also shown in the enlarged views of FIGS. 15 and
16, the inner rails 60 and outer rails 50 are fully contained
within channel 72 of carrier 70. In this position, the cutting wire
and the suture (with attached tissue containment bag) have traveled
fully over the rails 50, 60 to the distal tips 64 of inner rails
60.
[0095] Note that as the carrier 70 is initially advanced over the
rails, the diameter of the loop 85 of cutting wire 86 is enlarged
since in this region outer rails 50 and inner rails 60 extend
radially outwardly away from the longitudinal axis of the cannula
16. As the carrier 70 is further advanced to intermediate region 63
of inner rail 60, i.e. the region where the distance between
opposing rails 60 peak and just before they begin their inward
orientation towards the longitudinal axis of cannula 16, the loop
85 will widen to its largest diameter, substantially equal to the
diameter D3 between opposing rails. This largest diameter of loop
85 defines the largest diameter of the tissue region being cut. As
the wire 86 continues to advance past intermediate portion 63 of
rails 60, the diameter of the loop 85 reduces as the inner rails 60
extend inwardly towards the longitudinal axis L of cannula 16 and
the distance between opposing inner rails 60 decreases. The spring
attached at the proximal end applies constant tension to the wire
86 to reduce its loop size.
[0096] The suture loop 83 of suture 82, which slightly trails wire
86, is expanded and reduced in a similar manner as wire loop 85 as
the carriers 70 advance over the rails 50, 60. That is, suture loop
83 increases in diameter, to thereby widen the opening 88 in tissue
containment bag 84, as carriers 70 advance to the intermediate
region 63 of inner rails 60. After advance past the intermediate
region 63, the suture loop 83 decreases in diameter to reduce the
opening 88 in bag 84 as the spring at the proximal end of suture 82
applies constant tension to reduce the loop size. Thus, initial
widening of suture loop 83 opens the mouth of bag 84 to receive the
tissue mass severed by the cutting wire 86, and reduction of the
loop 83 as the suture 84 is pulled proximally by the tension of the
aforedescribed spring closes the mouth of the bag 84 to entrap the
severed tissue. The severed tissue can then be removed, fully
enclosed in the bag, to prevent any undesired leakage. The opening,
i.e. expansion, of the cutting wire 86 and the bag 84 is also
described below in conjunction with the method of FIGS. 27-34.
[0097] Note that carriers 70 can have blunt tips as shown, or
alternatively, to reduce the penetrating forces, can have pointed
tips or beveled edges to cut through tissue as they are advanced.
The number of carriers 70 can also vary, but preferably will be the
same number as the number of outer and inner rails utilized. The
carriers with the openings for the suture and wire can be integral
with the elongated hollow member that rides over the rails or,
alternatively, can be a separate component attached to the
elongated members. For example, in FIG. 21B, the carrier 70
includes elongated carrier pusher 77 which can be integral with or
attached thereto.
[0098] It is also contemplated, that instead of being retained
inside cannula 12, e.g. cannula 16, prior to deployment, the tissue
retrieval bag could alternatively be mounted outside the cannula,
e.g. outside cannula 16. This would reduce the overall size
requirements of the cannula since the additional room for the
folded bag within the cannula would not be required.
[0099] FIG. 22 illustrates an alternative embodiment of a carrier
for retaining the cutting wire, suture and tissue retrieval bag.
The bag and suture are mounted in a similar fashion as in the
embodiment of FIG. 21. However, instead of openings through the
carrier 70, for the cutting wire, the carriers 70' each have an
eyelet 75 to retain the wire. The eyelets 75 are formed at the end
of rods 76 which extending through longitudinal slot 71. The free
end of the wire 86 would extend through one of the longitudinal
slots 71 in carrier 70 to a proximally positioned spring. This
embodiment allows the entire region of the wire to be exposed to
tissue. The suture is not shown for clarity but would extend
through openings in the carrier in the identical manner as FIG.
21.
[0100] In an alternate embodiment of FIGS. 23 and 24, a
localization marker 110 can be utilized to identify the region and
provide sonographic or x-ray visualization of the center of the
tissue site. More specifically, apparatus 100 (only the distal
portion is shown) contains a marker 110 having a wire i11 forming a
wire loop 115, which is preferably made of shape memory material
such as Nitinol. In the retracted position, support tube 114 is
contained within the cannula 112 and loop 115 is contained within
support tube 114 in a substantially straightened configuration
substantially aligned with the longitudinal axis of the support
tube 114 and the straight portions of wire 111. To mark the tissue
site, support tube 114 is advanced from cannula 112, and then wire
111 is advanced from channel 117 of support tube 114 so that wire
loop 115 extends distally therefrom. Once advanced from support
tube 114, wire loop 115 returns to its memorized looped
configuration of FIG. 23. A sharpened tip 119 facilitates
insertion. Also, cold saline is injected into tube 114 as described
above, thereby decreasing the frictional contact with the inner
wall of tube 114 to facilitate advancement of the wire.
[0101] Wire loop 115 provides an indication via imaging or other
visualization techniques of the target tissue, and more
particularly a verification of the center of the target tissue. The
rails 160 can then be advanced to encircle the wire marker 110 as
shown in FIG. 24.
[0102] In all other respects, the apparatus 100 of FIGS. 23 and 24
is identical to apparatus 10 of FIGS. 1-22, as it includes outer
rails 150, inner rails 160, carriers 170, a suture 182 attached to
tissue containment bag 184, and a RF wire 186. The rails 150, 160
and carriers 170 are advanced in the same manner as in apparatus 10
and therefore are not described again.
[0103] It is also contemplated that the wire marker can be used as
confirmation of the position of the deployed inner and outer rails
50 and 60. A lockout can be provided that would allow deployment of
rails 50 and 60 only after the wire marker is advanced, thereby
aiding the positioning of the rails with respect to the lesion.
[0104] Methods of utilizing the apparatus of the present invention
for excising a lesion from the breast will now be described. It
should be appreciated that the apparatus can be deployed either
manually as in FIGS. 27-34, or machine actuated as in FIG. 35.
[0105] Turning first to the method illustrated in FIGS. 27-34, in
this method, the breast is not compressed and the apparatus,
designated generally by reference numeral 200, is deployed manually
to access the target lesion and remove the lesion. Apparatus 200 is
identical to apparatus 10 of FIGS. 1-21 except for the way the
cutting wire is mounted to the carrier and the provision of beveled
tips on the outer rails. The cutting wire is mounted to the
apparatus via eyelets in the manner shown in FIG. 22. Consequently,
the apparatus 200 has been labeled with reference numerals in the
"200" series to correspond to the double digit reference numerals
of apparatus 10. Mounting pins have also been removed for
convenience.
[0106] Gripping handle portion 214, apparatus 200 is inserted
through incision "i" in the breast to access tissue lesion "t". In
this position, deployment rings 220, 230 and 240 are in their
proximalmost positions in respective slots 217a, 217b with the
outer (female) rails 250, inner (male) rails 260, and carriers
(catheters) 270 retracted within reduced diameter cannula 16.
[0107] The cannula is then advanced through the incision "i" as
shown in FIG. 28, in alignment with the lesion "t", with the rails
250, 260 and carriers 270 in the retracted position. Next, the
outer rails 250 are advanced to the position of FIG. 29, still
spaced proximally of lesion "t". Outer rails have a sharpened edge
251 to facilitate passage through tissue. The edge could
alternately be beveled to facilitate passage.
[0108] Inner rails 260 are then advanced from within outer rails
250 to encircle the lesion "t" as shown in FIGS. 30 and 31. Note
that inner rails have beveled tips 261 forming sharpened edges to
facilitate passage through tissue. As appreciated, both outer rails
250 and inner rails 260 return to their memorized shape,
corresponding to their positions in FIG. 31, as they exit from the
cool saline within cannula 212 and are exposed to the warmer body
temperature. Since the rails extend radially outwardly after
insertion of the cannula, the diameter of the tissue region to be
excised (which is preferably substantially circular in cross
section) exceeds the diameter of the cannula. Stated another way,
the size of the excised tissue region can be increased without
requiring a corresponding increase in the size (outer diameter) of
the cannula. The region encapsulated is substantially spherical in
shape and is much larger than the lesion.
[0109] Next, as shown in FIGS. 32 and 33, carriers 270 are advanced
to advance cutting wire 286 and suture 282 extending around the
mouth of tissue containment bag 284. As cutting wire 286 is
advanced by carrier 270 with respect to the outer rails 260, RF
energy is applied to the wire 286 to cut and cauterize the tissue
surround the lesion "t". As can be appreciated, the cutting wire
286 is progressively opened to a larger diameter as it is advanced
to the intermediate region of the rails 260, substantially
corresponding to the diameter of the sphere defined by the inner
rails 260. This diameter is substantially larger than the diameter
of the lesion "t" to be removed. Thus, not only is the entire
lesion "t" removed, but also a safety margin of tissue, e.g., about
1 centimeter radially in all directions from the lesion, is
excised. If the safety margin is about 1 centimeter radially, the
area of tissue removed will be about 3 centimeters.
[0110] Trailing cutting wire 286 is suture 282 and tissue
containment bag 284. Thus, suture 282 looped around the mouth of
bag 284 progressively increases in diameter, thereby increasing the
opening in the mouth of bag 284 as it is advanced to the
intermediate region of outer rails 250. Thus, as lesion "t" is
excised, it enters the mouth of bag 284 and is captured therein. As
the bag 284 completes its travel, i.e. the carrier 270 is advanced
to the distal tips 261 of inner rails 260, the mouth of the bag 284
is automatically closed by the tension of suture 282 around the
mouth of bag 284 due to the proximally applied force of the spring
attached to the free end of the suture as described above. Thus the
excised tissue is fully captured within bag 284. The lesion and
area of surrounding tissue are withdrawn substantially intact for
accurate pathology. Moreover, since sufficient margins have been
removed, even if the tumor is malignant, a second surgery is not
necessary. FIG. 34 illustrates apparatus 200 withdrawn from the
breast with the tissue encapsulated within tissue containment bag
284. The rails 250 and 260 are elastically deformable to enable
compression of the specimen as the apparatus is withdrawn through
the relatively small incision.
[0111] FIG. 35 illustrates the use of the apparatus with machine
controlled deployment. In the method of FIG. 35, the breast is
compressed between compression plates P1 and P2 to facilitate
imaging as well as access to the lesion "t." Apparatus 300 is
advanced in the orientation shown, by table mounted controls (not
shown), through aperture A in compression plate P2. That is,
apparatus 300 would be positioned on a table, and advanced in a
horizontal direction toward lesion "t". The inner and outer rails
and carriers are then advanced by preset machine actuated controls
which engage the deployment rings via pins (not shown) to excise
and remove the lesion. This is achieved by mounting pins to the
apertures 324, 334 and 344 in deployment rings 320, 330 and 340.
The pins (not shown) will then be advanced by the table mounted
actuators to advance the rings and connected slugs to deploy the
rails and carriers in the manner described above.
[0112] The apparatus 400 of FIGS. 25 and 26 illustrates an example
of machine controlled actuation similar to apparatus 300 of FIG.
35. This apparatus differs only in that it has sliders which
optionally allow for manual advancement if desired. That is,
instead of automated actuation, the surgeon can advance sliders
423, 433 and 443, which have internal pins connected to the slugs
in the same manner as described above.
[0113] For machine actuation of apparatus 400, pins 422, 432 and
442 would be placed within slots in the machine, either in the
orientation of FIG. 25 or the orientation of FIG. 26, depending on
the orientation of the table mounted controls. The machine would be
preset for controlled advancement of the pins, which would advance
the rails and carriers in the same manner as pins 22, 32 and 42 of
apparatus 10 described above. Optionally, an adapter can be mounted
to the table which in turn mounts the apparatus.
[0114] In any of the foregoing embodiments of the biopsy apparatus
of the present invention, the cannula can include a lumen for
injection of drugs or agents to treat or destroy the target and/or
surrounding tissue or to inhibit cell proliferation. The lumen can
be a separate tube in the cannula, formed integral with the cannula
or be the same lumen which contains the rails. Types of materials
which can be injected include, for example, chemotherapeutic
agents, cryogenic material, ablation fluid, heating fluid, etc.
These materials can be delivered to the target region either
before, after or during specimen removal.
[0115] Imaging
[0116] FIG. 36 illustrates an embodiment of the apparatus which
utilizes ultrasound to help guide and visualize the apparatus
during insertion and use. Apparatus 500 is identical to apparatus
200 in all respects, except for the provision of ultrasonic
transducer 501 (shown in phantom), and is therefore provided with
corresponding reference numerals in the "500" series, Transducer
501 is positioned at the distal end of the apparatus 500, and is
wired to a conventional power supply S. The wire extends inside
cannula 512 and exits the proximal end of handle portion 514 as
shown. Monitor screen M is wired to power supply S to enable
viewing via ultrasound of the surgical site.
[0117] Currently, as is known, low ultrasound frequency provides
increased ability to see a greater distance but at the expense of
resolution. Conversely, high frequency provides greater (clearer)
resolution but with a decreased ability to see distances. Thus,
typically, since the ultrasound probe is placed outside the breast
tissue, at a distance from the lesion, it must be used at a low
frequency to ensure the lesion can be viewed. However, resolution
suffers and difficulty in detecting the boundaries of the lesion
could occur. Lower resolution also decreases the chances of
detecting calcium which is often an indicator of the presence of
abnormal growths, i.e. tumors. For this reason, the breast tissue
is often compressed between compression plates to shorten the
distance from the probe outside to the breast to the lesion.
However, compression of the breast adds an additional step to the
procedure and could distort the image and result in inaccurate
lesion removal, especially if the lesion site is marked in a
non-compressed condition of the breast.
[0118] In the apparatus 500, by placing the transducer at the end
of the apparatus, the distance from the lesion is greatly reduced.
This allows a higher frequency to be used which provides greater
resolution and an increased ability to detect calcium. Also, by
placement of the distal end of the instrument, the surgeon can view
the lesion in an orientation aligned with the cannula, also
facilitating vision.
[0119] It should be understood that the use of a transducer at the
tip of the instrument can be used in other biopsy devices.
[0120] While the above description contains many specifics, those
specifics should not be construed as limitations on the scope of
the disclosure, but merely as exemplifications of preferred
embodiments thereof. For example, the inner and outer rails can be
reversed so that the set of rails which extends to encapsulate the
lesion is positioned outside instead of inside, the initially
deployed set of rails. Also, the cutting wire could be positioned
outside rather than inside the rails. Additionally, although
described for use for breast biopsy, the apparatus can be used to
excise tissue in other areas of the body and in other surgical
procedures. Those skilled in the art will envision many other
possible variations that are within the scope and spirit of the
disclosure as defined by the claims appended hereto.
* * * * *