U.S. patent application number 11/964244 was filed with the patent office on 2008-05-01 for device for biopsy of tumors.
This patent application is currently assigned to Sanarus Medical Inc.. Invention is credited to Daren L. Stewart, Shigeru Tanaka, Kevin H. Van Bladel.
Application Number | 20080103411 11/964244 |
Document ID | / |
Family ID | 27104576 |
Filed Date | 2008-05-01 |
United States Patent
Application |
20080103411 |
Kind Code |
A1 |
Van Bladel; Kevin H. ; et
al. |
May 1, 2008 |
Device for Biopsy of Tumors
Abstract
A device and method of use for securing and coring of tumors
within the body during a biopsy of the tumor, specifically breast
tumors. An adhesion probe for securing the tumor is described. The
probe secures the tumor by piercing the tumor and providing a
coolant to the distal tip to cool the tip. The cooled tip adheres
to the tumor. A coring instrument adapted for cutting a core sample
of the tumor is described. The instrument is provided with a
cannula that can cut a core sample of the tumor. The instrument is
adapted for use with the probe with the probe fitting within the
cannula. The instrument can be used in conjunction with the probe
to secure and core a sample of the tumor for biopsy.
Inventors: |
Van Bladel; Kevin H.;
(Pleasanton, CA) ; Tanaka; Shigeru; (Halfmoon Bay,
CA) ; Stewart; Daren L.; (Pleasanton, CA) |
Correspondence
Address: |
CROCKETT & CROCKETT
24012 CALLE DE LA PLATA
SUITE 400
LAGUNA HILLS
CA
92653
US
|
Assignee: |
Sanarus Medical Inc.
|
Family ID: |
27104576 |
Appl. No.: |
11/964244 |
Filed: |
December 26, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
10421498 |
Apr 22, 2003 |
6990087 |
|
|
11964244 |
Dec 26, 2007 |
|
|
|
09847931 |
May 3, 2001 |
6551255 |
|
|
10421498 |
Apr 22, 2003 |
|
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09690321 |
Oct 16, 2000 |
6540694 |
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09847931 |
May 3, 2001 |
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Current U.S.
Class: |
600/564 |
Current CPC
Class: |
H04L 41/147 20130101;
A61B 2010/0208 20130101; A61B 2018/0293 20130101; A61B 10/0266
20130101; H04L 47/14 20130101; A61B 18/02 20130101; A61B 2018/0262
20130101; H04L 47/11 20130101 |
Class at
Publication: |
600/564 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A biopsy device for securing and coring a mass within the breast
of a human patient during a biopsy of said mass, said biopsy device
comprising: an adhesion probe comprising: a rigid tube adapted for
insertion into the body of the patient, said rigid tube having a
proximal end, a distal end, a proximal segment having a first outer
diameter, a distal segment having a second outer diameter, the
first outer diameter being larger than the second outer diameter;
said distal segment adapted to be adhered to the mass within the
breast; a cannula, having a proximal end and a distal end, adapted
for use with the adhesion probe, and said cannula comprising: a
tube having a lumen extending from the proximal end to the distal
end, said lumen having an internal diameter approximately matching
the first outer diameter of the proximal segment of the adhesion
probe; said cannula adapted for insertion into the body of the
patient over the adhesion probe; and said cannula being slidable
over the adhesion probe.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 10/421,498, filed Apr. 23, 2002, now U.S. Pat. No. 7,311,672,
which is a continuation application of U.S. application Ser. No.
09/847,931, filed May 3, 2001, now U.S. Pat. No. 6,551,255, which
is a continuation-in-part application of U.S. application Ser. No.
09/690,321, filed Oct. 16, 2000, now U.S. Pat. No. 6,540,694.
FIELD OF THE INVENTIONS
[0002] The devices and method described below relate to the
diagnosis and treatment of breast lesions, and more generally, to
the diagnosis and treatment of tumors and lesions throughout the
body.
BACKGROUND OF THE INVENTIONS
[0003] Biopsy is an important procedure used for the diagnosis of
patients with cancerous tumors, pre-malignant conditions, and other
diseases and disorders. Typically, in the case of cancer, when the
physician establishes by means of procedures such as palpation,
mammography or x-ray, or ultrasound imaging that suspicious
circumstances exist, a biopsy is performed. The biopsy will help
determine whether the cells are cancerous, the type of cancer, and
what treatment should be used to treat the cancer. Biopsy may be
done by an open or percutaneous technique. Open biopsy, which is an
invasive surgical procedure using a scalpel and involving direct
vision of the target area, removes the entire mass (excisional
biopsy) or a part of the mass (incisional biopsy). Percutaneous
biopsy, on the other hand, is usually done with a needle-like
instrument through a relatively small incision, blindly or with the
aid of an imaging device, and may be either a fine needle
aspiration (FNA) or a core biopsy. In FNA biopsy, individual cells
or clusters of cells are obtained for cytologic examination and may
be prepared such as in a Papanicolaou smear. In core biopsy, as the
term suggests, a core or fragment of tissue is obtained for
histologic examination which may be done via a frozen section or
paraffin section. One important area where biopsies are performed
is the diagnosis of breast tumors.
[0004] Traditionally, the biopsy technique for breast tumors
involves placing a biopsy device multiple times into the breast and
taking several samples of tissue from a mass or tumor which is
suspected of being cancerous. Several samples are required to be
sure that some tissue from the suspect mass has been captured, and
enough tissue has been sampled to ensure that, if disperse cancer
cells exist in the suspect mass some of those cancer cells will be
captured in the samples. Each time the device is placed the
physician must locate and direct the device with ultrasound imaging
into the correct position near the suspect mass. Some breast tumors
and lesions are very well defined, hard spherical masses which grow
within the soft, compliant breast tissue. It is difficult to force
a needle into these lesions because they are resistant to puncture
and fairly mobile. Forcing the biopsy needle into the lesion is
like trying to spear an apple floating in water.
[0005] Vacuum assisted biopsy system proposed by Biopsys involves
sucking a breast lesion into a cannula and shearing off the
captured edge of the lesion to obtain a biopsy sample. The device
uses a vacuum to collect tissue into the side of an open tubular
device, and then uses a rotating corer to cut the tissue collected.
The rotating corer is slidable within the tubular section and can
be pulled back to remove the tissue collected in the rotating
corer. An additional stylet inside the rotating corer can be used
to push the tissue out of the corer. The device can be rotated on
its axis to remove a sample, 360 degrees around the central
placement of the device. Typically, physicians sample six to eight
cores. One advantage of this device is that the physician does not
have to remove the device for additional biopsy samples. However,
the tumor itself must be re-engaged after every coring operation,
which entails substantial effort in relocation and confirmation
that the target suspect mass has been engaged by the side aperture.
Tumors may be too tough to yield to the suction and deform as
necessary to enter the side opening of the cannula. Doctors also
currently use the device to take a circular sequence of cores by
rotating the device about its long axis or by sideways movement of
the suction head to take a line of cores.
[0006] After biopsy and analysis, the tumor must be treated with a
separate device, as Biopsys teaches that their coring device should
not be used for resection. Indeed, the device is not designed to
perform resection with assurance that complete resection of a
suspect mass has been accomplished. Mechanical cutting and
disruption of the tissue structure and cancer cell dispersion (that
is, tearing of the tissue around the cancer and movement of the
cancer cells amongst normal tissue) will result in unintentional
delivery of cancer cells into healthy tissue adjacent the
lesion.
SUMMARY
[0007] The devices and methods described below provide for
diagnosis of tumors within the breast. The devices include a probe
with structures that permit the surgeon to secure a suspect mass or
tumor within the breast during the biopsy procedure. The probe is
provided with a rigid tube and a sharp distal tip. To secure the
tumor to the probe, the surgeon pierces the tumor with the distal
rod. Gas tubing extending within the rigid tube directs coolant to
the distal tip to cool the tip, the tumor then adhering to the
cooled probe.
[0008] The devices also include a coring apparatus with structures
that permit the surgeon to core a sample of the tumor during the
biopsy procedure. The coring apparatus is provided with a cannula
that advances through a tumor to core a sample of the tumor. The
coring apparatus is adapted for use with the probe. The probe is
inserted into the cannula with the distal tip of the probe
extending beyond the distal tip of the cannula. The surgeon can
insert the devices into the body until the probe pierces the tumor.
Coolant is directed to the distal tip of the probe to lightly cool
the distal tip and the tumor. The lightly cooled distal tip adheres
to the tumor cells. Once secured to the probe, the surgeon can core
a sample of the tumor with the coring apparatus. After coring is
complete, the surgeon can retract the device with the core sample.
This method of biopsy prevents destruction of the tumor cells and
reduces the dispersion of tumor cells to healthy cell areas.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 illustrates the adhesion probe for securing a breast
tumor during a biopsy or ablation procedure.
[0010] FIG. 2 is a cross section of the adhesion probe of FIG.
1.
[0011] FIG. 3 illustrates the adhesion probe within a coring
cannula.
[0012] FIG. 4 illustrates the biopsy instrument adapted for use
with the adhesion probe of FIGS. 1 and 2.
[0013] FIGS. 5 and 6 illustrate the biopsy instrument adapted with
the adhesion probe of FIGS. 1 and 2.
[0014] FIG. 7 illustrates a method of breast tumor biopsy using the
device of FIGS. 5 and 6.
[0015] FIG. 8 illustrates a method of breast tumor biopsy using the
device of FIGS. 5 and 6.
[0016] FIG. 9 illustrates a method of breast tumor biopsy using the
device of FIGS. 5 and 6.
[0017] FIG. 10 illustrates a method of breast tumor biopsy using
the device of FIGS. 5 and 6.
[0018] FIG. 11 illustrates the adhesion probe withdrawn from the
biopsy instrument.
[0019] FIG. 12 illustrates the holding tray for holding the
adhesion probe.
[0020] FIG. 13 illustrates a biopsy gun adapted for use with the
adhesion probe of FIG. 1.
[0021] FIGS. 14 and 15 are cross sections of the biopsy gun of FIG.
13.
[0022] FIG. 16 illustrates a method of breast tumor biopsy using
the device of FIG. 13.
[0023] FIG. 17 illustrates a method of breast tumor biopsy using
the device of FIG. 13.
[0024] FIG. 18 illustrates a method of breast tumor biopsy using
the device of FIG. 13.
[0025] FIG. 19 illustrates a method of breast tumor biopsy using
the device of FIG. 13.
[0026] FIG. 20 is a cross section of a biopsy gun provided with a
gas turbine motor and adapted for use with the adhesion probe of
FIG. 1.
[0027] FIG. 21 is a cross section of a biopsy gun provided with a
gas turbine motor and adapted for use with the adhesion probe of
FIG. 1.
[0028] FIGS. 22 and 23 illustrate an embodiment of the adhesion
probe which uses a coolant supplied in small bottles.
[0029] FIGS. 24 and 25 show a cross-sectional view of a
pneumatically operated biopsy instrument, with the adhesion probe
of FIG. 1 in place within the biopsy instrument.
[0030] FIG. 26 is a schematic diagram of the pneumatic system for
operating the biopsy instrument of FIGS. 24 and 25.
DETAILED DESCRIPTION OF THE INVENTIONS
[0031] FIG. 1 illustrates an adhesion probe 1 for securing a breast
tumor during a biopsy or resection procedure. This probe uses
Joule-Thomson cooling or liquid nitrogen to create a lightly cooled
region at the distal tip. This lightly cooled region adheres to a
suspect lesion or tumor. The adhesion probe 1 comprises a long,
slender yet rigid tube 2. A short rigid penetrating segment 3
extends distally from the distal end of the rigid tube, and a
suitable handle 4 is mounted on the proximal end of the tube. The
handle includes a quick release mechanism which is operable through
quick release actuator 5.
[0032] FIG. 2 illustrates the adhesion probe 1 in cross section,
showing the rigid tube 2, the distal penetrating segment 3 and the
handle 4. A coolant inlet tube 10 passes through the handle and the
rigid tube, extending to the distal end of the rigid tube, and
terminating just proximal of the distal tip of the penetrating
segment. The inlet tube has an orifice 11 at the distal end of the
inlet tube, which may be merely a straight cut termination of the
tube or a small nozzle of smaller internal diameter than the
immediately upstream portion of the inlet tube. The rigid tube has
a proximal segment 12 having an outer diameter of about (0.065)
inches, an internal diameter of about (0.047) inches, and a length
of about (10) inches. The penetrating segment 3 comprises a first
segment 13 and a sharp distal tip 14. The first segment has an
outer diameter of about (0.043) inches, an inner diameter of about
(0.033) inches, and a length of about (1) inch. As can be seen from
the cross section, the sharp distal tip is solid and adapted for
piercing through a tumor. The length of the penetrating segment is
chosen to be approximately the same size as the target tissue mass
to be sampled, or the size of the desired core sample. This
penetrating segment is forced into a lesion or tumor.
[0033] Between the proximal segment of the rigid tube and the first
segment of the penetrating segment is a tapered segment 15 of the
rigid tube of about (0.05) inches long where the inner and outer
diameters of the rigid tube tapers from the diameters of the
proximal segment to the diameters of the first segment. An annular
cavity or lumen 16 is created by the outer surface of the inlet
tube and the inner surface of the rigid tube. The gas and/or liquid
exiting the orifice of the inlet tube counterflows along the
annular cavity and is exhausted from the probe to a suitable point
far removed from the probe. If gas such as Argon is chosen, the gas
undergoes a Joule Thompson expansion as the gas is directed out
through the orifice. As the gas and/or liquid are directed to the
penetrating segment and out through the orifice, the surface area
about the penetrating segment is cooled. Cooling with argon gas
supplied to the probe with the dimensions described above at a
pressure of about 1200-2000 psi will provide cooling to a
temperature range of about 0.degree. C. to -10.degree. C. With gas
supplied at 3000 psi, the adhesion probe will attain a low
temperature of about -60.degree. C. in water. The gas or liquid
used for cooling may include gaseous argon, nitrogen, carbon
dioxide, air, liquid nitrogen, freon, CFC's. perfluorocarbons, or
any other suitable coolant. Gas may be provided through a
cryosurgical system such as Endocare's Cryocare.RTM. cryosurgical
systems.
[0034] FIG. 3 illustrates the rudimentary relationship between the
coring cannula 20 and the adhesion probe 1. The cannula is a
slender yet rigid tube having a proximal opening 21 and a distal
opening 22, and a lumen 23 extending through the cannula from the
proximal end of the cannula to the distal end. The cannula is
slidably disposed around the adhesion probe, and may be
longitudinally translated relative to the adhesion probe. The
cannula is adapted for insertion through a small incision in the
skin, and may be inserted along with the adhesion probe or over the
adhesion probe. As described in the following figures, the cannula
may be forced distally over the penetrating segment to core any
tissue which is secured to the penetrating segment from any
surrounding body tissue.
[0035] FIG. 4 illustrates a spring-loaded biopsy instrument 24
adapted for use with the adhesion probe 1 and the cannula 20. The
biopsy instrument comprises a housing 25. The housing comprises a
grip 26, sized for a human hand, and a receptacle 27 distal to the
grip. At the proximal end of the housing, a fitting 28 with an
inlet 29 communicates with the lumen of the cannula. The cannula
extends from within the housing at the inlet and out through the
distal end of the housing.
[0036] The biopsy instrument 24 includes a coring mechanism. The
coring mechanism comprises a cannula translating mechanism housed
within the receptacle 27. A block 32 is slidably mounted on rails
33 attached to or integrally formed to the housing 25. A trigger
button 34 capable of coupling with the block is preferably
positioned about the grip 26 for ease of operation of the button by
the same hand holding the grip. A spring 35 is interposed between
the block and the trigger button. The spring exerts a distally
urging force to the block. At the distal end of the receptacle is a
stopper 36 attached to or integrally formed into the housing. The
cannula 20 is fixedly fitted through the block and urged distally
forward by the spring. The distally urging force of the spring
forces the block and therefore the cannula to distally translate.
The spring may have a spring constant between 5 to 15 lbs. per
inch, and is preferably between 7 and 11 lbs. per inch.
[0037] FIGS. 5 and 6 show the adhesion probe 1 in place within the
lumen 23 of the cannula 20. The adhesion probe can be inserted into
and through the lumen from the proximal opening 21 of the cannula.
To secure the probe to the biopsy instrument 24, the handle 4 of
the probe is fitted to the fitting 28. The gas and/or liquid source
is connected to the handle via the feed line.
[0038] The cannula translating mechanism has a locked position and
an unlocked position. FIG. 5 illustrates the translating mechanism
in the locked position. In the locked position, the spring 35 is
compressed and the block 32 is coupled to the trigger button 34.
The penetrating segment 3 of the adhesion probe is exposed,
extending distally from the cannula 20. FIG. 6 illustrates the
translating mechanism in the unlocked position, with the cannula
translated distally over the penetrating segment. To move the
translating mechanism from the locked position to the unlocked
position, the trigger button is depressed. As the button is
depressed, the block uncouples from the button and the urging force
from the compressed spring urges the block and the cannula distally
forward. (Any suitable latching mechanism may be used to releasably
secure the block in the proximal position and release the block as
desired by the operator of the device.) As the block is urged
distally forward, the block and the cannula translate along the
rails 33 until the block engages the stopper 36. As the cannula
translates distally over the penetrating segment of the adhesion
probe, any tissue stuck to the penetrating segment is cored from
the surrounding lesion, and may be removed with the device.
[0039] FIGS. 7 through 10 illustrate the device in use. At the
start of the biopsy procedure, the patient is prepared and the
breast is appropriately prepped and draped. The site is prepared
using local anesthesia and optionally, intravenous sedation. The
patient is positioned on the operating table in the supine
position, with the patient on her back. (If the procedure is
accomplished under stereotactic guidance, the patient may be prone
on a stereotactic table, exposing the breast below the table.) The
breast is imaged, if not previously imaged, to determine the
location of the tumors. A small incision of about (4) mm is made in
the breast to allow the adhesion probe 1 and cannula 20 to be
easily inserted into the skin. The adhesion probe is inserted into
the biopsy instrument 24 so that it is positioned within the
cannula, the penetrating tip 3 extending distally from the distal
end of the cannula 20. The cannula translating mechanism is set in
the locked position, leaving the penetrating segment outside the
cannula. The distal end of the device, including the penetrating
segment of the adhesion probe and the distal end of the cannula, is
inserted into the breast through the incision. The distal end of
the device is maneuvered to the target lesion within the breast
under stereotactic or ultrasound guidance.
[0040] The coring procedure is illustrated in FIGS. 7 through 10.
FIG. 7 shows the adhesion probe 1 and the cannula 20 being inserted
through the incision made in the skin overlying the tumor. The
adhesion probe has been inserted into the cannula so that it is
coaxially disposed within the cannula, and its distal penetrating
segment protrudes from the distal end of the cannula. The handle
has been secured to the proximal end of the instrument 24, so that
the adhesion probe and biopsy instrument are latched together via
the quick release mechanism. The adhesion probe and biopsy
instrument can thus be manipulated as a single piece. The patient's
breast 39 and skin 40 are shown schematically. The tumor, lesion or
other suspect mass 41 is located within the breast, surrounded by
soft tissue and fatty tissue. An ultrasound scanner or other
imaging device is used to obtain an image of the breast, including
the tumor and any device inserted into the breast, and the surgeon
uses the display from the imaging device to assist in guidance of
the probe and the cannula to the tumor.
[0041] FIG. 8 illustrates the adhesion probe 1 and the cannula 20
being inserted into the breast 39 until the probe penetrates the
tumor 41. The surgeon pushes the probe and the cannula into the
breast until the penetrating segment 3 of the adhesion probe
pierces through the tumor and until the tapered segment 15 of the
rigid tube 2 is proximate to the tumor.
[0042] FIG. 9 illustrates the adhesion probe 1 being activated to
secure the tumor 41. To secure the tumor to the probe during the
biopsy procedure, the surface area about the penetrating segment 3
is cooled. Either gas or liquid is directed from the source to the
penetrating segment. If the surgeon uses gas, as the gas is
directed out through the orifice 11 of the coolant inlet tube 10,
the gas undergoes a Joule-Thomson effect to freeze the surface area
about the penetrating segment. The gas source can be a high
compression tank or a whippet. The surface area is frozen to a
temperature range of about 0.degree. C. to -60.degree. C. At this
temperature range, the cooled surface area does not ablate the
tumor cells to hinder tumor cell analysis. Only a relatively small
amount of gas or liquid is needed to cool the surface area to this
temperature range. The gas or liquid exiting the orifice and
counterflowing along the annular cavity 16 is exhausted from the
probe. The cooled surface area freezes a thin layer of tumor cells
in contact about the cooled surface area, and the tumor is secured
to the probe. The cooled annular volume of body tissue is
illustrated in FIG. 9 as item 42.
[0043] FIG. 10 illustrates activation of the cannula translating
mechanism to cut a core sample of the frozen tumor 41. Once the
tumor is secured to the probe 1, the biopsy instrument 24 is
activated to core a sample of the frozen tumor. To begin coring the
tumor, the translating mechanism is operated via the trigger button
34 (see FIG. 5). The trigger button is depressed and the cannula 20
advances distally towards the frozen tumor. As the cannula contacts
the tumor and advances towards the sharp distal tip, the cannula
cuts a sample 43 of the frozen tumor. The resulting core sample is
a layer of frozen or partially frozen tumor tissue about the
penetrating segment 3. Because the tumor is frozen, dispersion and
seeding of the tumor cells to healthy areas of the breast is
minimized compared to normal biopsy methods.
[0044] Once a sample of the breast tumor 41 is cored, the adhesion
probe 1 with the secured core sample remains within the cannula 20.
To remove the core sample from the breast 39, the biopsy instrument
24 and the adhesion probe are retracted from the breast, with the
core sample still protected within the cannula during retraction.
Once the biopsy instrument and probe are retracted outside the
breast, the adhesion probe with the core sample 43 is withdrawn
from the biopsy instrument out from the inlet 29, or out the
proximal opening 21 of the cannula, as shown in FIG. 11. The sample
is still secured to the penetrating segment of the adhesion probe
1. The sample thaws in a short time, and can be moved to a holding
tray shown in FIG. 12. The holding tray 44 has a wall 45 which has
one or more slots 46. For at least a portion of the slot height,
the width of the slots approximates the outer diameter of the
penetrating segment of the adhesion probe, so that the adhesion
probe may be slipped down into the groove and pulled out
horizontally, allowing the sample to be cleanly scraped off of the
penetrating segment. The adhesion probe and holding tray may be
provided as disposables in a kit sold for each procedure performed
by a physician.
[0045] Another method of using the system facilitates multiple
sampling during a single placement of the biopsy instrument 24.
After placement of the biopsy instrument and adhesion probe 1,
adhesion of the adhesion probe to the tumor 41 and translation of
the cannula 20 over the penetrating segment 3, the adhesion probe
may be pulled proximally out of the cannula while leaving the
cannula and biopsy instrument in place in the breast 39. The tissue
which adheres to the adhesion probe is then removed. Leaving the
cannula in the advanced position within the patient's breast, the
adhesion probe may then be re-inserted into the cannula (in the
same space or biopsy track). The cannula is then pulled back,
exposing the penetrating segment within the tumor (and within the
initial cored space). While light pressure is applied around the
breast, the adhesion probe is cooled, freezing an additional
cylindrical volume of tissue surrounding the probe. The cannula may
then be advanced to core out the frozen volume of tissue.
Successive cylindrical core samples are thereby obtained. In our
own studies, this procedure yielded seventeen successive
cylindrical core samples.
[0046] FIG. 13 shows a biopsy gun 50 for use with the adhesion
probe of FIG. 1. The biopsy gun comprises a housing 51, the cannula
20, and a trigger 52 for driving the cannula distally. At the
proximal end of the housing, a snap fitting 53 with an inlet 54
communicates with the lumen of the cannula. The cannula extends
from within the housing at the inlet and out through the distal end
of the housing. The cannula is adapted for insertion through a
small incision in the skin.
[0047] FIGS. 14 and 15 illustrate the biopsy gun in cross section.
As shown in the cross sections, the biopsy gun 50 includes a coring
mechanism that includes a cannula rotating mechanism and a cannula
translating mechanism. The cannula rotating mechanism comprises a
motor 57, a pinion gear 58, and a drive gear 59. The drive gear has
a bore sized to fit the cannula 20. The cannula is rotationally
fixed into the drive gear through the bore, so that rotation of the
drive gear results in corresponding rotation of the cannula. The
pinion gear is rotatably coupled to the motor at one end and its
gear teeth mesh with the drive gear. When the motor is activated,
the motor causes the pinion gear to rotate. The rotation of the
pinion gear is translated to the drive gear to rotate the drive
gear and thereby rotate the cannula. The rotating mechanism may be
used during coring to assist in cutting a core sample from
surrounding tissue.
[0048] The cannula translating mechanism comprises the trigger 52,
trigger upper extension 61, a pivotable arm 62 with a first end 63
connected to the trigger and a second end 64 connected to a
carriage 65. The carriage is slidably mounted in a track 66 via a
rail 67 that fits into the track. The track is fixedly attached to
the housing 51, or formed integrally into the housing, and is
preferably duplicated on both sides of the housing. The rail is
slidably mounted onto the track with the arm pivotably attached to
the carriage at the proximal end of the carriage. The trigger is
pivotably mounted to the housing about a pivot pin 68 and attached
to the first end of the arm. The carriage is attached to the second
end of the arm. The cannula 20 is loosely fitted through the
carriage. The bearings 69 are fixed to the cannula on either side
of the carriage, and allow the cannula to be rotatable within the
carriage but longitudinally locked to the carriage, so that any
longitudinal (proximal or distal) movement of the carriage causes
corresponding longitudinal movement of the cannula.
[0049] The cannula translating mechanism has a proximal position
and a distal position. FIG. 14 illustrates the translating
mechanism in the proximal position, where the cannula will not be
engaged with the tumor. In the proximal position, the carriage 65
is positioned at the proximal end of the track 66 and the
penetrating segment 3 of the adhesion probe 1 is exposed, extending
distally from the cannula. FIG. 15 illustrates the translating
mechanism in the distal position, with the cannula translated
distally over the penetrating segment of the adhesion probe, where
it will engage and core a tumor secured to the penetrating segment.
To move the translating mechanism to the distal position, the
trigger 52 is depressed. As the trigger is depressed, the trigger
rotates about the pivot pin 68 to advance the arm 62 and the rail
67 to the distal end of the track, thereby also advancing the
carriage to the distal end of the track. As the carriage advances
from the proximal end to the distal end of the track, the cannula
20 advances from the proximal end of the gun 50 to the distal end
of the gun. Any tissue stuck to the tip of the adhesion probe when
the cannula is advanced is cored from the surrounding lesion, and
may be removed with the device.
[0050] FIG. 15 also shows the adhesion probe 1 in place within the
lumen 23 of the cannula 20. The adhesion probe can be inserted into
and through the lumen from the proximal opening 21 of the cannula.
To secure the adhesion probe to the gun 50, the handle 4 of the
adhesion probe is snap fitted to the snap fitting 53. The gas
and/or liquid source is connected to the handle via the feed
line.
[0051] FIGS. 16 through 19 illustrate the device in use. FIG. 16
shows the adhesion probe 1 and the cannula 20 being inserted
through the incision made in the skin overlying the tumor. The
patient's breast 78 and skin 79 are shown schematically. The tumor,
lesion or other suspect mass 80 is located within the breast,
surrounded by soft tissue and fatty tissue. An ultrasound scanner
or other imaging device is used to obtain an image of the breast,
including the tumor and any device inserted into the breast, and
the surgeon uses the display from the imaging device to assist in
guidance of the probe and the cannula to the tumor.
[0052] FIG. 17 illustrates the adhesion probe 1 and the cannula 20
being inserted into the breast until the probe penetrates the tumor
80. The surgeon pushes the probe and the cannula into the breast
until the penetrating segment 3 of the adhesion probe 1 pierces
through the tumor and until the tapered segment 15 of the rigid
tube 2 is proximate to the tumor.
[0053] FIG. 18 illustrates the adhesion probe 1 being activated to
secure the tumor 80. To secure the tumor to the probe during the
biopsy procedure, the surface area about the penetrating segment 3
is cooled. Either gas or liquid is directed from the source to the
penetrating segment. If the surgeon uses gas, as the gas is
directed out through the orifice 11 of the coolant inlet tube, the
gas undergoes a Joule-Thomson effect to freeze the surface area
about the penetrating segment. The cooled annular volume of body
tissue is illustrated in FIG. 18 as item 81. The gas source can be
a high compression tank or a whippet. The surface area is frozen to
a temperature range of about 0.degree. C. to -60.degree. C. At this
temperature range, the cooled surface area does not ablate the
tumor cells to hinder tumor cell analysis. Only a relatively small
amount of gas or liquid is needed to cool the surface area to this
temperature range. The gas or liquid exiting the orifice and
counterflowing along the annular cavity 16 is exhausted from the
probe. The cooled surface area freezes a thin layer of tumor cells
in contact about the cooled surface area, and the tumor is secured
to the probe.
[0054] FIG. 19 illustrates activation of the coring mechanisms to
cut a core sample of the frozen tumor 80. Once the tumor is secured
to the probe, the biopsy gun is activated to core a sample of the
frozen tumor. The rotating mechanism of the gun may be activated
while the translating mechanism is still in the proximal position.
To begin coring the tumor, the translating mechanism is operated
via the trigger. The trigger is depressed and the cannula advances
distally towards the frozen tumor. As the cannula contacts the
tumor and advances towards the sharp distal tip, the rotating
cannula cuts a sample of the frozen tumor. The resulting core
sample is a layer of frozen or partially frozen tumor tissue about
the penetrating segment 3. Because the tumor is frozen, dispersion
and seeding of the tumor cells to healthy areas of the breast is
minimized compared to normal biopsy methods.
[0055] Once a sample of the breast tumor is cored, the coring
mechanism is deactivated with the cannula remaining in the distal
position. The adhesion probe 1 with the secured core sample remains
within the cannula. To remove the core sample from the breast, the
biopsy gun and the adhesion probe are retracted from the breast,
with the core sample still protected within the cannula during
retraction. Once the gun and probe are retracted outside the
breast, the adhesion probe with the core sample 43 is withdrawn
from the gun out from the inlet 10, or out the distal end of the
cannula, as shown in FIG. 11. The sample is still secured to the
distal segment of the adhesion probe 1, and can be removed as
previously illustrated in FIG. 12.
[0056] FIG. 20 illustrates an alternative coring mechanism, showing
a gas turbine 83 in place of the motor of the previous figures.
This turbine is powered by the exhaust gas from the adhesion probe,
thereby eliminating the need for an electric motor. A flexible tube
84 is connected to the exhaust pathway of the adhesion probe or gas
supply line through a coupling 85, and is also coupled to the
turbine, directing exhaust gas into the turbine. A suitable turbine
gas control valve 86 may be used to control gas supply to the
turbine. The cannula 20 is rotatably coupled to the gas turbine
using the same type of pinion gear and drive gear arrangement as is
used for the electric motor. FIG. 21 illustrates another embodiment
of the turbine driven coring mechanism, in which the turbine is
mounted directly on the cannula, in the place of the carriage of
the previous embodiments, and is slidably mounted within the
housing. The tubing 87 is flexible, allowing distal and proximal
translation of the turbine during operation. The turbine driven
devices of FIGS. 20 and 21 may be used in the same manner as the
biopsy instruments and guns of FIGS. 4 and 13.
[0057] The adhesion probe and methods of use described above have
been developed for use with a cryosurgical system, which controls a
relatively high volume coolant source, and can also be used to
operate cryoprobes to cryoablate lesions, tumors and other target
masses in the breast. The adhesion probe and biopsy apparatus
(biopsy instrument and biopsy gun) are conveniently combined with
such pre-existing cryosurgical system to take advantage of cooling
sources already in place in an operating room. The adhesion probes
and biopsy devices of FIGS. 22 and 23, however, are designed for
stand-alone use, so that a physician does not need a cryosurgical
system on site in order to take advantage of the method of
cryo-adhesion. FIG. 22 illustrates a self-contained adhesion probe.
The self-contained adhesion probe includes the rigid tube 2 with
the penetrating segment 3. Inside the rigid tube, coolant inlet
tube 10 with an orifice 11 extends to the first segment 13 of the
penetrating segment. At the proximal end of the rigid tube, screw
threads or other releasable fittings are provided to permit
releasable attachment to the gas source. The rigid tube is fitted
with a sharp distal tip 14. Exhaust gas is vented through vent 88
on the proximal segment of the rigid tube. The gas source is
provided in the form of a canister 89 of compressed gas. Carbon
dioxide (CO.sub.2) is a suitable gas, and is readily available in
the form of cylinders (whippet chargers, bulbs or capsules). Liquid
freon and other refrigerants are also a suitable coolants which can
be obtained in small canisters or spray cans. The canister is
releasably mounted into a bracket or holder 90. The holder has a
fitting 91 for receiving the proximal end of the rigid rod and
providing secure releasable attachment. The holder as a second
fitting 92 which matches the fittings on the proximal end of the
biopsy apparatuses. The output 93 of the canister is directed to
the inlet 94 of the coolant inlet tube 10 through the pass-through
port in the holder.
[0058] As illustrated in FIG. 23, the rigid tube may be removed
from the gas source and holder to provide a simple needle
configuration. This assembly can be used in much the same was as
the embodiments using a gas hose (FIGS. 7-10 and 16-19), but may
also be used in an "over-the-wire" method. In this method, the
rigid rod is manipulated to penetrate the patient's breast and
force the penetrating segment into the lesion. The biopsy apparatus
is then threaded over the rigid tube, leaving the proximal end of
the rigid tube extending slightly from the proximal end of the
biopsy apparatus. The coolant holder is then threaded or otherwise
secured onto the proximal end of the rigid tube, and the proximal
releasable fitting is fitted into the receiving fitting on the
holder. The cooling and coring steps are then accomplished as
described above. This method permits easier manipulation of the
adhesion probe into the tumor, and also eliminates reliance on
large cryosurgical systems.
[0059] FIG. 24 illustrates a pneumatically operated biopsy
instrument 100 adapted for use with the adhesion probe 1 of FIG. 1.
The biopsy instrument comprises a housing 101 sized and shaped to
form a convenient handle, and also to house the components of the
instrument. The various tubes used in the instrument are fitted
through an inlet 102 at the proximal end 103 of the housing. The
biopsy instrument further comprises the cannula 20 which extends
from within the housing and out through the distal end 104 of the
housing. As in the previous embodiments, the cannula is slidably
fitted over the adhesion probe. The adhesion probe itself passes
entirely through the housing in this embodiment.
[0060] As shown in FIG. 24, the biopsy instrument includes a coring
mechanism which serves as both a translating mechanism and a
rotating mechanism for the cannula. The combined translating/coring
mechanism performs the rotating operation as it performs the
longitudinal translation of the cannula that is required for
coring. The cannula translating mechanism is comprised of a
pneumatic or hydraulic actuator 105 which includes a cylinder or
piston chamber 106, a proximal closure head 107 and a distal
closure head 108, a piston 109, a fluid supply port 110 in the
proximal closure head, and an actuator rod 111 which is threaded
form of a lead screw or jack screw. The cylinder can be formed from
the inner surface of the housing, or the housing may be integrally
formed with the cylinder. The piston is disposed within the piston
cylinder chamber, such that the piston, although tightly fitting
within the cylinder chamber, is capable of translating
longitudinally along the cylinder. It may also be rotatable
relative to the cylinder. Operating fluid is supplied to (and drawn
from) the actuator through actuator supply tube 112. The supply
tube extends from the operating fluid source (not shown), through
the inlet 102 of the housing, and to the cylinder fluid supply
port, such that the distal end of the tube communicates with the
cylinder. The supply tube and the adhesion probe pass through the
inlet in side-by-side relationship.
[0061] The piston is attached to the cannula 20, and is
longitudinally fixed to the cannula. The piston may be rotatably
fixed to the cannula, but the cannula may also be longitudinally
fixed to the piston while remaining freely rotatable relative to
the piston. The piston has a bore with a diameter chosen to closely
match the outer diameter of the cannula, so that the cannula is
held tightly by piston within the bore. The cannula is
longitudinally fixed into the bore of the piston, such that the
translation of the piston distally and proximally through the
cylinder is translated to the cannula. The cannula extends from the
proximal end of the housing, through the piston bore, through the
actuator rod 111, and out through the distal closure head.
(Alternatively, the cannula can terminate proximally within the
cylinder, so long as it is fixed to the piston chamber.) In the
embodiment shown, the adhesion probe and cannula are coaxially
disposed within the piston, actuator rod and cylinder.
[0062] The cannula rotating mechanism is comprised of a lead screw
111 (which also serves as the actuator rod) and a lead screw nut
113. The lead screw nut is disposed at the distal end of the piston
cylinder 106, within the distal closure head (it may be formed
integrally with the distal closure head). The lead screw is formed
of a tube, with screw threads on the outside of the tube and a
lumen passing through the tube. The proximal end of the lead screw
is longitudinally fixed to the piston 109, such that the lumen of
the lead screw communicates with the bore of the piston. (The
cannula passes through the lumen of the lead screw.) The lead screw
nut is adapted to receive the lead screw. The lead screw is screwed
into and through the lead screw nut, such that the lead screw
extends from within the piston cylinder 106 out through the lead
screw nut to the exterior of the cylinder. The cannula 20 passes
through the lumen of the lead screw and is rotationally fixed into
the lead screw, either directly or indirectly. When the piston is
translated, the lead screw translates under operation of the piston
and rotates via translation through the lead screw nut. The lead
screw can have a pitch of (1) inch per revolution, such that for
every inch of translation, the lead screw rotates one revolution.
Because the cannula is rotationally fixed to the cannula, the
rotation of the lead screw is translated to the cannula.
[0063] The cannula translating mechanism has a retracted/proximal
position and an extended/distal position. FIG. 24 illustrates the
translating mechanism in the retracted position, where the cannula
20 will not be engaged with the tumor. In the retracted position,
the piston is positioned at the proximal end of the cylinder and
the penetrating segment of the adhesion probe 1 is exposed,
extending distally from the cannula. FIG. 25 illustrates the
translating mechanism in the extended position, with the cannula
translated distally over the penetrating segment 3 of the adhesion
probe, where it will engage and core a tumor secured to the
penetrating segment. To move the translating mechanism from the
retracted position to the extended position, a gas is supplied to
the cylinder via the gas/vacuum tube 112. Based upon the
configuration of the piston and cylinder, it is preferred that the
gas pressure range be about 60 psi to 120 psi. However, other gas
pressure ranges can be used depending on other piston-cylinder
configurations. When there is sufficient gas pressure within the
cylinder, the piston translates distally to the distal end of the
cylinder. Under operation of the piston, the lead screw 111 and the
cannula are translated distally. The cannula translates distally
over the penetrating segment of the adhesion probe. As the cannula
translates, the cannula rotates under operation of the lead screw
and lead screw nut assembly. Any tissue stuck to the tip of the
adhesion probe when the cannula is translated and rotated is cored
from the surrounding lesion, and may be removed with the
instrument, as described in the earlier figures. To move the
translating mechanism back to the retracted position, a vacuum is
provided to the cylinder via the gas/vacuum tube. Based upon the
configuration of the piston and cylinder, the degree of vacuum
necessary to draw the piston proximally may vary. Under the vacuum
force, the piston translates proximally to the proximal end of the
cylinder. Under operation of the cylinder, the lead screw and the
cannula translate proximally, and rotate during translation as the
lead screw is draw back through the lead screw nut. The single feed
actuator described in these figures can be replaced with an
equivalent dual feed actuator, where high pressure operating fluid
is supplied to both sides of the piston to move the piston distally
and proximally. However, the arrangement shown simplifies the
construction of the cylinder minimizes then number of components
that must be housed within the housing.
[0064] FIG. 26 is a schematic diagram of the pneumatic system for
operating the biopsy instrument of FIGS. 24 and 25. The cooling gas
is supplied from a tank 120 of cooling gas, such as argon or
nitrogen stored at high pressure, through a high pressure supply
line 121. External pressure regulator 122 regulates pressure in the
line to desired pressure for high pressure supply to the manifold
of valves shown through pressure fitting 123. The supply line
inside the manifold is provided an internal pressure regulator 124
which regulates pressure in the line to desired pressure for high
pressure supply to the adhesion probe (1000-3000 psi). A manifold
supply valve 125 and an adhesion probe supply valve 126 are
operable to control flow of high pressure gas to the adhesion
probe. From the high pressure valve 126, the downstream portion of
the high pressure supply line 121, designated as item 121d,
connected to the adhesion probe through high pressure fitting 127.
Control of the pneumatic cylinder it accomplished with lower
pressure gas from tap line 128 through pneumatic gas pressure
regulator 129, which is set to provide gas in the range of about
60-120 psi, though the pressure range may be varied depending on
the system composition. The low pressure regulator supplies gas to
a first three-way valve 130, which in turn selectively supplies low
pressure gas to the second three way valve 131 or the operating
fluid inlet 132 of jet Venturi pump 133 (also referred to as an
ejector pump or an induction pump). The second three way valve
selectively connects the actuator supply line 134 (which is
connected to actuator supply tube 112 through pressure fitting 135)
to operating gas provided from the first three way valve, or
connects the actuator supply tube 112 to the vacuum inlet 136 of
the jet Venturi pump. To supply low pressure gas to the actuator
and force the coring cannula distally, the operator or control
system operates the three way valves to connect the low pressure
gas supply to actuator supply line 134, selectively operating the
first three way valve to supply high pressure gas to the second
three way valve, and operating the second three way valve to supply
the high pressure gas to the actuator supply line. To apply a
vacuum to the actuator and force the coring cannula to retract
proximally, the operator or control system operates the first three
way valve to supply low pressure gas to the operating fluid inlet
of the jet Venturi pump and operates the second three way valve to
connect the actuator supply line to the vacuum inlet of the Venturi
pump. The control of the system may be accomplished with direct
operator control of the various valves, or it may be accomplished
through a computer system. For the jet Venturi pump, the JSM90
model vacuum pump supplied by Vaccon Co., Inc. provides suitable
vacuum pressure to operate the actuator.
[0065] Various embodiments of coring means, translating means, and
rotating means can be used in place of the spring operated
translating means of FIGS. 4 through 6 or the translating means and
rotating means of FIGS. 13 through 15 and FIGS. 24 and 25. The
cannula can be fitted with a slide bolt, for example, which can
then be manually pushed distally in the holders to advance the
cannula. The cannula may merely be forced over the adhesion probe
by hand, without the assistance of the coring mechanisms. The
adhesion probe has been described in embodiments which use coolants
to cool the probe and target tissue and thereby make the probe
adhere to the target tissue. Alternatively, heating elements such
as RF heating elements, resistive heating elements, ultrasound
heating elements and the like may be used to heat the probe and
target tissue and thereby make the probe adhere to the target
tissue. In such embodiments, the heating should be limited to that
necessary for light necrosis of the target tissue that does not
penetrate deeply into the target tissue, or to a small longitudinal
segment of the tissue, so that a viable biopsy core may be
obtained. However, if the entire tumor or lesion is to be removed
with the aid of the adhesion probe, heating need not be so
limited.
[0066] The devices and methods illustrated above have been
illustrated in relation to the treatment of tumors and lesions
within the breast. However, they may be used to treat tumors and
lesions throughout the body wherever the tumors which are difficult
to secure and locate are encountered. Thus the devices and methods
may be used for tumors and lesions of the uterine tube (such as
uterine fibroids), kidney, liver, prostate or brain.
[0067] Thus, while the preferred embodiments of the devices and
methods have been described in reference to the environment in
which they were developed, they are merely illustrative of the
principles of the inventions. Other embodiments and configurations
may be devised without departing from the spirit of the inventions
and the scope of the appended claims.
* * * * *