U.S. patent application number 15/674139 was filed with the patent office on 2017-12-28 for biopsy device with integral vacuum assist and tissue sample and fluid capturing canister.
The applicant listed for this patent is Devicor Medical Products, Inc.. Invention is credited to John A. Hibner.
Application Number | 20170367687 15/674139 |
Document ID | / |
Family ID | 35423317 |
Filed Date | 2017-12-28 |
United States Patent
Application |
20170367687 |
Kind Code |
A1 |
Hibner; John A. |
December 28, 2017 |
BIOPSY DEVICE WITH INTEGRAL VACUUM ASSIST AND TISSUE SAMPLE AND
FLUID CAPTURING CANISTER
Abstract
A biopsy device includes a body, a probe cannula, a cutter, a
vacuum source, a tissue sample holder, and a flexible tube. The
probe cannula extends distally from the body and defines an
internal passage with a side aperture. The cutter is translatable
relative to the probe cannula to sever a tissue sample received in
the probe cannula. The vacuum source is in communication with the
cutter. The tissue sample holder includes a vacuum port on the
exterior surface to communicate with the vacuum source and a
removable portion to hold solid tissue samples. The removable
portion is selectively removable from the tissue sample holder and
includes a straining member to separate fluids from solids. The
flexible tube couples the tissue sample holder with the body such
that the tissue sample holder is flexibly spaced away from the
body.
Inventors: |
Hibner; John A.; (Mason,
OH) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Devicor Medical Products, Inc. |
Cincinnati |
OH |
US |
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Family ID: |
35423317 |
Appl. No.: |
15/674139 |
Filed: |
August 10, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15266500 |
Sep 15, 2016 |
9757100 |
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15674139 |
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14993645 |
Jan 12, 2016 |
9468425 |
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15266500 |
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14188744 |
Feb 25, 2014 |
9265485 |
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14993645 |
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12775780 |
May 7, 2010 |
8956306 |
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14188744 |
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11753952 |
May 25, 2007 |
7758515 |
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12775780 |
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10953834 |
Sep 29, 2004 |
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11753952 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2010/0225 20130101;
A61B 2010/0208 20130101; A61B 10/0283 20130101; A61B 10/0275
20130101 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1.-20. (canceled)
21. A biopsy device comprising: (a) a probe cannula defining an
internal passage and having a side aperture; (b) a cutter
translatable relative to the probe cannula to sever a tissue sample
received in the probe cannula; (c) a vacuum source in communication
with the cutter; (d) a container; (e) a tissue sample holder
located in the container, wherein the tissue sample holder is
configured to capture solid tissue samples and hold the solid
tissue samples therein while allowing fluid to escape the tissue
sample holder; (e) a flexible tube configured to communicate solid
tissue samples from the cutter to the tissue sample holder; and (f)
a dynamic seal coupling the flexible tube to the cutter such that
the cutter is configured to rotate and translate relative to the
flexible tube.
22. The biopsy device of claim 21, further comprising an elbow
adapted to receive the solid tissue samples in a first direction
and direct the received solid tissue samples in a second direction
lateral to the first direction.
23. The biopsy device of claim 22, wherein the tissue sample holder
includes a straining member, wherein the straining member is
positioned laterally relative to the second direction.
24. The biopsy device of claim 21, wherein the tissue sample holder
includes a straining member, wherein the straining member defines a
horizontal plane.
25. The biopsy device of claim 24, further comprising a second
flexible tube, wherein the second flexible tube passes through the
horizontal plane defined by the straining member and terminates at
an end within the container.
26. The biopsy device of claim 24, further comprising a vacuum
lumen communicating to a distal end of the probe cannula and a
second flexible tube between the container and the vacuum lumen,
wherein the second flexible tube is configured to communicate
vacuum with the vacuum lumen.
27. The biopsy device of claim 26, wherein the second flexible tube
is positioned above the plane defined by the straining member and
terminates at a free end within the tissue sample holder.
28. The biopsy device of claim 27, further comprising a switching
assembly responsive to the cutter, wherein the switching assembly
is operatively configured to expose the vacuum lumen to the vacuum
source in response to the cutter being retracted to prolapse tissue
into the side aperture, wherein the switching assembly is
configured to be responsive to the cutter being distally positioned
to expose the vacuum lumen to an increased pressure to effect
retraction of severed tissue to the container via the conduit.
29. The biopsy device of claim 21, wherein the container defines a
fluid reservoir, wherein at least a portion of the fluid reservoir
is defined by the tissue sample holder.
30. The biopsy device of claim 29, wherein the tissue sample holder
includes a removable portion, wherein the removable portion of the
tissue sample holder includes a basket, wherein the removable
portion includes a straining member, wherein a vacuum port is
positioned above the straining member.
31. The biopsy device of claim 21, wherein the dynamic seal is
physically attached to a distal portion of the cutter.
32. The biopsy device of claim 21, further comprising a motor
assembly operatively configured to translate the cutter to sever a
tissue sample.
33. A biopsy system comprising: (a) a biopsy device including: (i)
a body, (ii) a probe cannula defining an internal passage and
having a side aperture, and (iii) a cutter translatable relative to
the probe cannula to sever a tissue sample received in the probe
cannula; (b) a sample collection assembly including: (i) an outer
container, (ii) a lid couplable to the outer container, and (ii) a
tissue sample holder disposed within the outer container such that
the tissue sample holder is configured to separate solid tissue
samples from fluid as vacuum is communicated through the outer
container, thereby holding tissue samples severed by the cutter;
and (c) a first tube extending from the outer container to the
biopsy device such that the first tube is configured to communicate
tissue samples from the biopsy device to the tissue sample holder,
wherein at least a portion of the first tube includes an elbow
portion configured to direct tissue samples toward the tissue
sample holder.
34. The biopsy system of claim 33, wherein the tissue sample holder
includes a floor defining a plurality of openings, the openings
configured to strain solid tissue samples from fluid.
35. The biopsy system of claim 33, wherein the first tube
terminates at a proximal end located above at least a portion of
the tissue sample holder.
36. The biopsy system of claim 33, further comprising a vacuum
conduit, wherein the tissue sample holder includes a strainer,
wherein the strainer defines a straining plane, wherein the vacuum
conduit includes a proximal end that is disposed below the
straining plane such that the vacuum conduit is configured to draw
fluid through the strainer of the tissue sample holder.
37. A biopsy system comprising: (a) a biopsy device including: (i)
a first body, (ii) a second body selectively attachable to the
first body, (ii) an elongate needle extending from the second body
and defining an internal passage and a side aperture, and (iii) a
cutter translatable and rotatable relative to the side aperture of
the elongate needle to sever a tissue sample received in the side
aperture; (b) a sample collection assembly including: (i) an outer
container, (ii) a lid couplable to the outer container, and (ii) a
tissue sample holder disposed within the outer container such that
the tissue sample holder is configured to separate solid tissue
samples from fluid as vacuum is communicated through the outer
container, thereby holding tissue samples severed by the cutter,
wherein the tissue sample holder includes a removable portion the
configured for removal from the outer container and for insertion
into a formalin container to store tissue samples; and (c) a first
tube extending from the outer container to the biopsy device such
that the first tube is configured to communicate tissue samples
from the biopsy device to the tissue sample holder, wherein at
least a portion of the first tube includes an elbow portion
configured to direct tissue samples toward the tissue sample
holder.
38. The biopsy system of claim 37, a second tube communicating
between the outer container of the sample collection assembly and a
vacuum source, wherein the second tube is configured to supply
vacuum to the first tube to transport tissue samples through the
first tube to the tissue sample holder.
39. The biopsy system of claim 38, wherein the cutter and the first
tube each define an inner surface coated with a hydrolubricous
material configured to aid in transport of tissue samples.
40. The biopsy system of claim 37, wherein the first body is
configured to be reused one or more times after a biopsy procedure,
while the second body is configured for use in only a single biopsy
procedure.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of co-pending and
commonly-owned U.S. patent application Ser. No. 12/775,780,
entitled "BIOPSY DEVICE WITH INTEGRAL VACUUM ASSIST AND TISSUE
SAMPLE AND FLUID CAPTURING CANISTER" to Hibner, filed on May 7,
2010, published as U.S. Patent Publication No. 2010/0228146, which
is a continuation of U.S. Pat. No. 7,758,515, "BIOPSY DEVICE WITH
INTEGRAL VACUUM ASSIST AND TISSUE SAMPLE AND FLUID CAPTURING
CANISTER" to Hibner, et al. filed on May 25, 2007, which is a
continuation in part of U.S. patent application Ser. No.
10/953,834, "BIOPSY APPARATUS AND METHOD" to Hibner et al., filed
29 Sep. 2004 (U.S. Pat. Publ. No. 2006/0074345), and the
disclosures of which are hereby incorporated by reference in their
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates in general to biopsy devices,
and more particularly to biopsy devices having a cutter for
severing tissue, and even more particularly to biopsy devices for
multiple sampling with a probe remaining inserted
BACKGROUND OF THE INVENTION
[0003] When a suspicious tissue mass is discovered in a patient's
breast through examination, ultrasound, MRI, X-ray imaging or the
like, it is often necessary to perform a biopsy procedure to remove
one or more samples of that tissue in order to determine whether
the mass contains cancerous cells. A biopsy may be performed using
an open or percutaneous method.
[0004] An open biopsy is performed by making a large incision in
the breast and removing either the entire mass, called an
excisional biopsy, or a substantial portion of it, known as an
incisional biopsy. An open biopsy is a surgical procedure that is
usually done as an outpatient procedure in a hospital or a surgical
center, involving both high cost and a high level of trauma to the
patient. Open biopsy carries a relatively higher risk of infection
and bleeding than does percutaneous biopsy, and the disfigurement
that sometimes results from an open biopsy may make it difficult to
read future mammograms. Further, the aesthetic considerations of
the patient make open biopsy even less appealing due to the risk of
disfigurement. Given that a high percentage of biopsies show that
the suspicious tissue mass is not cancerous, the downsides of the
open biopsy procedure render this method inappropriate in many
cases.
[0005] Percutaneous biopsy, to the contrary, is much less invasive
than open biopsy. Percutaneous biopsy may be performed using fine
needle aspiration (FNA) or core needle biopsy. In FNA, a very thin
needle is used to withdraw fluid and cells from the suspicious
tissue mass. This method has an advantage in that it is very
low-pain, so low-pain that local anesthetic is not always used
because the application of it may be more painful than the FNA
itself. However, a shortcoming of FNA is that only a small number
of cells are obtained through the procedure, rendering it
relatively less useful in analyzing the suspicious tissue and
making an assessment of the progression of the cancer less simple
if the sample is found to be malignant.
[0006] During a core needle biopsy, a small tissue sample is
removed allowing for a pathological assessment of the tissue,
including an assessment of the progression of any cancerous cells
that are found. The following patent documents disclose various
core biopsy devices and are incorporated herein by reference in
their entirety: U.S. Pat. No. 6,273,862 issued Aug. 14, 2001; U.S.
Pat. No. 6,231,522 issued May 15, 2001; U.S. Pat. No. 6,228,055
issued May 8, 2001; U.S. Pat. No. 6,120,462 issued Sep. 19, 2000;
U.S. Pat. No. 6,086,544 issued Jul. 11, 2000; U.S. Pat. No.
6,077,230 issued Jun. 20, 2000; U.S. Pat. No. 6,017,316 issued Jan.
25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28, 1999; U.S. Pat.
No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No. 5,964,716 issued
Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27, 1999; U.S.
Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No. 5,769,086
issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22, 1997;
U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US Patent
Application 2003/0199753 published Oct. 23, 2003 to Hibner et
al.
[0007] At present, a biopsy instrument marketed under the trade
name MAMMOTOME is commercially available from ETHICON ENDO-SURGERY,
INC. for use in obtaining breast biopsy samples. This device
generally retrieves multiple core biopsy samples from one insertion
into breast tissue with vacuum assistance. In particular, a cutter
tube is extended into a probe to cut tissue prolapsed into a side
aperture under vacuum assistance and then the cutter tube is fully
retracted between cuts to extract the sample, deposited upon an
externally exposed surface accessible by a grasping instrument.
[0008] With a long probe, the rate of sample taking is limited not
only by the time required to rotate or reposition the probe but
also by the time needed to translate the cutter. As an alternative
to this "long stroke" biopsy device, a "short stroke" biopsy device
is described in the following commonly assigned patent
applications: U.S. patent application Ser. No. 10/676,944, "Biopsy
Instrument with Internal Specimen Collection Mechanism" filed Sep.
30, 2003 in the name of Hibner et al. The cutter is cycled across
the side aperture, reducing the sample time. Several alternative
specimen collection mechanisms are described that draw samples
through the cutter tube, all of which allow for taking multiple
samples without removing the probe from the breast.
[0009] In particular, in the cross referenced U.S. patent
application Ser. No. 10/953,834, "BIOPSY APPARATUS AND METHOD",
these tissue samples are drawn by vacuum proximally through the
cutter tube into a serial tissue stacking assembly that preserves
the order of sample taking can be visually observed through a
transparent lumen, and can serve as a transport container for
samples taken during a pathology examination.
[0010] Some clinicians prefer to capture a plurality of biopsy
samples in a small canister attached to a proximal end of the
biopsy instrument, such as described in U.S. Pat. No. 6,638,235 to
Miller and U.S. Pat. Appl. Publ. No. 2006/0260994 to Mark. Vacuum
draws these samples into the canister while allowing fluids to pass
through tubing back to a fluid capturing receptacle. Periodically,
the canister is disengaged from the biopsy instrument for removing
each sample and sending to pathology professionals for
assessment.
[0011] While these known tissue storage approaches have a number of
advantages, bodily tissues and fluids present a biological hazard
to medical personnel that must be controlled while not interfering
with the efficiency of the biopsy procedure.
SUMMARY OF THE INVENTION
[0012] The present invention addresses these and other problems of
the prior art by providing a biopsy device that has a probe cannula
that is inserted into tissue to obtain a core biopsy sample by
translating a cutter with the probe cannula. A pneumatic pressure
differential is used to draw a severed tissue sample proximally
from the probe cannula into a biopsy sample and fluid capturing
canister sized to complete a full biopsy and therapy procedure and
to provide a convenient method of transporting the same to a
pathology professional for sample assessment. Contact with the
biopsy samples and extracted bodily fluids is avoided in that the
container need not be opened in a biopsy suite. In addition, the
overall volume of single patient use disposable items is reduced by
combining the fluid collection and sample collection containers
into a single reservoir, thereby reducing the volume of product
inventory and biohazard waste materials.
[0013] These and other objects and advantages of the present
invention shall be made apparent from the accompanying drawings and
the description thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] While the specification concludes with claims particularly
pointing out and distinctly claiming the present invention, it is
believed the same will be better understood by reference to the
following description, taken in conjunction with the accompanying
drawings in which:
[0015] FIG. 1 is an isometric view of a self-contained biopsy
system including a biopsy device with cover omitted in fluid
communication with the biopsy sample and fluid capturing
canister.
[0016] FIG. 2 an isometric view of the biopsy device of FIG. 1 with
the cover and lower handle tray omitted and a reusable handpiece
disengaged from a disposable probe assembly.
[0017] FIG. 3 an exploded view from below, left of the disposable
probe assembly of FIG. 2.
[0018] FIG. 4 is an isometric view from left, aft of the disposable
probe assembly of FIG. 2 cut away to expose a pneumatic sequencing
spool valve.
[0019] FIG. 5 is an exploded view of the biopsy sample and fluid
capturing canister of FIG. 1.
[0020] FIG. 6 is a vertical cross section bisecting the biopsy
sample and fluid capturing canister of FIG. 1.
[0021] FIG. 7 is a vertical cross section bisecting an alternative
biopsy sample and fluid capturing canister for the biopsy system of
FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0022] Turning to the Drawings, wherein like numerals denote like
components throughout the several views, in FIG. 1, a biopsy device
10 includes a reusable handpiece 12 and a disposable probe assembly
14. A self-contained biopsy system 16 is formed by attaching a
replaceable biopsy sample and fluid capturing canister 18. The
canister 18 is generally sized to accommodate comfortably a volume
of fluid that would be extracted, including saline flushing during
a biopsy procedure with sufficient internal volume as well to hold
biopsy tissue samples 19 (FIG. 6). As such, biohazards associated
with bodily tissue and fluids are mitigated in that all such
materials are readily transported from a biopsy suite for pathology
assessment without the necessity of on-site access.
[0023] Tissue is drawn by vacuum assistance generated by vacuum
pump 20 integral to the reusable handpiece 12 into a side aperture
22 of a probe cannula 24 of the disposable probe assembly 14. The
pneumatic vacuum assistance is achieved via a cutter tube 26
(exposed in the side aperture 22) that translates within a cutter
lumen 28 of the probe cannula 24 and via an underslung lateral
lumen 30 that distally communicates to the cutter lumen 28 through
holes or apertures (not shown) just proximal to a piercing tip 32
of the probe cannula 24. A DC motor 34 in the reusable handpiece 12
powers rotation and translation of the cutter tube 26 to effect the
severing.
[0024] The disposable probe assembly 14 responds to the position of
the cutter tube 26 by sequencing pneumatic communication between
the biopsy probe device 10 and the replaceable canister 18 via a
vacuum supply line 36, a needle vacuum line 38, and a sample
retraction line 40. The vacuum supply line 36 receives vacuum
pressure at its distal end from the vacuum pump 20 and proximally
passes through and proximally is engaged over a hose nib 42 formed
onto the canister lid 44 of the canister 18. The needle vacuum line
38 distally communicates to a pneumatic sequencing spool valve 46
in the disposable probe assembly 14 and is frictionally held within
a first protruding cylindrical hose receptacle 48 formed onto a
canister lid 44 of the canister 18. The sample retraction line 40
distally communicates to the disposable probe assembly 14 and
proximally passes through and is frictionally held within a second
protruding cylindrical hose receptacle 50.
[0025] The reusable handpiece 12 includes a pneumatic manifold 52
having an upper right port 54 connected to the vacuum supply line
36 and an upper left port 56 open to atmosphere. It should be
appreciated that the manifold 52 serves as a mounting for the
vacuum pump 20 that generates the pressure differential between the
ports 54, 56.
[0026] With particular reference to FIGS. 1-2, insertion of the
probe cannula 24 into tissue is integrally supported by the
piercing tip 32 attached at the distal end as well as a
longitudinal jack hammer motion to the probe cannula 24 selected by
positioning a slide button 58 distally and depressing a forward
motor button 60. In response, the DC motor 34 drives a transmission
section 61 grounded to a top cover 64 (depicted in phantom in FIG.
1) of the reusable handpiece 12 to longitudinally reciprocate an
internal carriage frame assembly 62 that is engaged for movement
with the probe cannula 24. With the slide button 58 proximally
positioned, depression of the forward motor button 60 causes the DC
motor 34 to advance and rotate the cutter tube 26, depicted in FIG.
1 as having been fully distally translated, closing the side
aperture 20. Depression of a reverse motor button 68 causes the
cutter tube 26 to retract. Depression of a mode button 70 may cause
other functions to be performed. An additional feature contemplated
but not depicted includes using the mode button 70 to selectively
communicate a saline supply to the lateral lumen 30 to flush the
probe cannula 24. It should be appreciated that the biopsy device
10 includes a minimum of "tethers" that would impede use, pose a
tripping hazard, prevent use in an austere clinical setting, or
extend set-up time.
[0027] Alternatively, instead of "hard-walled" lateral lumen 30
separated from the cutter lumen 28 along its length, applications
consistent with the present invention may have a cylindrical probe
cannula (not depicted) wherein the cutter tube 26 is positioned
off-center to translate across a side aperture. A "soft-walled"
lateral lumen may then be defined as a space between an outer
diameter of the cutter tube and an inner diameter of the
cylindrical probe cannula.
[0028] In FIGS. 1-4, the disposable probe assembly 14 has a bottom
cover 78 with a distal probe mount cover 80 that assists in
supporting the probe cannula 24 while allowing the longitudinal
jack hammer motion. A plurality of locking tabs 82 with locking
edges 84 extend upwardly through pass-through slots (not shown)
formed in the periphery of a lower handle tray 86 (FIG. 1) attached
to the cover 64 of the reusable handpiece 12 to resiliently extend
outwardly into engaging contact with the slots facilitating
replacement of the disposable probe assembly 14. Relieved areas 88
are formed behind each locking tab 82 in a top extension member 89
that surrounds a probe support body 90. The combination covers a
cavity defined by the bottom cover 78, which allows depression of
the locking tabs 82 to unlock the disposable probe assembly 14 to
install another identical or similar assembly.
[0029] A proximal end of the cutter tube 26 receives a cutter gear
92 having distal and proximal reduced diameter bearing surfaces 94,
96 on each longitudinal side of a rotation spur gear section 98,
which engage the reusable handpiece 12 for rotation and for
longitudinal translation through a distally open longitudinal
aperture 100 (FIG. 3) formed in the bottom cover 78.
[0030] In FIGS. 2-4, the disposable probe assembly 14 has movable
components that respond to the actuating motions of the reusable
handpiece 12. The probe support body 90 includes a distal probe
mount 106 that is received within the distal probe mount cover 80
of the bottom cover 78. Proximal to and underlying a longitudinal
axis of the disposable probe assembly 14 defined by a probe guide
hole 108 passing through the distal probe mount 106, a vertically
open longitudinal slot 110 is formed into a necked portion 112 of
the probe support body 90.
[0031] With particular reference to FIGS. 3-4, at a proximal end of
the longitudinal trough 110, a distally open, longitudinally
aligned valve bore 114 is formed in a proximal block portion 116 of
the probe support body 90. Central and proximal ports 118, 120
communicate with the valve bore 114 laterally from a left side of
the proximal block portion 116 and a distal port 122 communicates
laterally from a right side of the proximal block portion 116. A
right distal ninety-degree fitting 124 communicates between the
distal port 122 and an intake filter 128.
[0032] A valve control rod 130 has a prismatic distal actuating
portion 132 extending distally out of the valve bore 114
constrained for only longitudinally movement within the
longitudinal slot 110. The valve control rod 130 also has a valve
spool portion 134 that longitudinally translates within the valve
bore 114 to selectively position between a first position and a
second position. A proximal O-ring 136 near a proximal end of the
valve spool portion 134 and a distal O-ring 138 are spaced such
that the first position entails the O-rings 136, 138 bracketing the
central and distal ports 118, 122 (i.e., distal position of the
valve control rod 130) and the second position entails the O-rings
136, 138 bracketing the proximal and central ports 120, 118,
respectively (i.e., proximal position of the valve control rod
130).
[0033] A distal vacuum conduit 140 has one end attached to a center
ninety-degree fitting 142 attached to the central port 118 and the
other end attached to a probe union ninety-degree fitting 144 that
communicates with the lateral lumen 30. The needle vacuum line 38
has its distal end attached to a proximal ninety degree fitting 146
attached to the proximal port 120.
[0034] A front actuation finger 148 (FIG. 2) of a front carriage
150 is received within an upwardly open socket 152 formed on a left
side of a vacuum control shuttle 154 having a lateral concave
recessed band 156 shaped to encompass with a clearance a lower
portion of the rotation spur gear section 98 of the cutter gear 92.
The vacuum control shuttle 154 is laterally sized to bridge the
longitudinal slot 110 with a downwardly projecting vacuum actuator
lug 157 (FIG. 3) attached to an underside of the shuttle 154 that
is received within a vertically open elongate delay slot 158 of the
distal actuating end 132 of the vacuum control rod 130. Thus, the
rather long cutter travel is translated into a smaller valve
movement as the shuttle reaches either full proximal or full distal
travel.
[0035] A sample retraction line 40 is proximally held by a tube
guide 162 extending inwardly from proximal end of the top extension
member 89 of the disposable probe assembly 14. A distal end of the
longitudinally aligned sample retraction line 40 is received
through a rear dynamic seal 164 attached to a proximal end of the
cutter gear 92, and into the cutter tube 26.
[0036] The reusable handpiece 12 of the biopsy device 10 is
substantially as described in greater detail in four commonly-owned
and co-pending U.S. patent applications (1) Ser. No. 11/198,558,
"Biopsy Device With Replaceable Probe And Incorporating Vibration
Insertion Assist And Static Vacuum Source Sample Stacking
Retrieval" to Hibner et al., filed 8 Aug. 2005, published as US
2007-0032741 A1; (2) Ser. No. 11/736,117, "Tissue Sample Revolver
Drum Biopsy Device" to Hibner et al., filed 17 Apr. 2007; (3) Ser.
No. 11/753,665, "Tissue Sample Serial Capturing Biopsy Device" to
Hibner, filed 25 May 2007; and (4) Ser. No. 11/465,143 "Vacuum
Syringe Assisted Biopsy Device" to Hibner, filed 17 Aug. 2006,
published as US 2007-0032743 A1, the disclosures of all of which
are hereby incorporated by reference in their entirety. An aft
carriage is omitted from the illustrative version for clarity as
not being necessary, although a common reusable handpiece may
include a second carriage for mounting to other types of disposable
probe assemblies as described in the cross referenced
applications.
[0037] In FIGS. 5-6, the biopsy sample and fluid capturing canister
18 has a tapered cylindrical fluid container 170 whose upper
band-shaped lip seals 172 to and is encompassed by a downward
circumferential lip 174 of the canister lid 44. A sample collector
basket 176 has tapered cylindrical sides 178 shaped to come to rest
at approximately a midpoint of the interior of the fluid container
170. Near the top of the tapered cylindrical sides 178 of the
sample collector basket 176, a perforated disk 180 is horizontally
attached to serve as support to a filter disk 182 adhered to an
undersurface. The combination acts in a similar fashion to a drip
coffee filter basket. About approximately a third of the upper
circumference of the cylindrical sides 178 of the sample collector
basket 176, a raised side wall portion 184 culminates in a
horizontal and inwardly projecting annular ring portion 186 that
serves as a handle for drawing the sample collector basket 176 out
of the fluid container 170.
[0038] The center of the perforated disk 180 of the sample
collector basket 176 includes a first hose receptacle 188
registered for the needle vacuum line 38 to pass on downward into a
fluid collection reservoir 190 formed within the fluid container
170 below the perforated disk 180 of the sample collector basket
176. The center of the perforated disk 180 of the sample collector
basket 176 also includes a second hose receptacle 192 registered
for the sample retraction line 40 to pass on downward into the
fluid collection reservoir 190. It should be appreciated that caps
or a closed lid (not shown) may be used to seal the biopsy sample
and fluid capturing canister 18 after the lines 36, 38, 40 are
removed.
[0039] With reference to FIGS. 4 and 6, in use, the cutter 26 is
initially distally positioned as the probe cannula 24 is inserted
into tissue. The vacuum motor 20 operates providing a low pressure
within the fluid collection reservoir 190 inside of the replaceable
canister 18 via vacuum supply line 36. A hydrophobic filter 198
prevents fluids from reaching the vacuum motor 20. The low pressure
communicates to the cutter tube 26 via the sample retraction line
40. After the probe cannula 24 is inserted into tissue beside a
suspicious lesion, the cutter tube 26 is retracted. The spool valve
46 is in the first position, with the vacuum lumen 30 vented to
atmosphere via central port 118 and distal port 122. The retraction
of the cutter gear 92 causes the shuttle 154 to retract
correspondingly with its downward lug 152 moving within the delay
slot 158 of the distal actuating portion 132 of the valve control
rod 130. Once the carriage 150 of the reusable handpiece 12 reaches
full proximal travel, the lug 157 contacts the proximal end of the
delay slot 158 and changes the pneumatic sequencing spool valve 46
from the first position to the second position. Thus, the vacuum
lumen 30 is also exposed to vacuum via central and proximal ports
118, 120 of the spool valve 46 that communicates via the needle
vacuum line 38 to the replaceable container 18, exposing the
suspicious lesion to the vacuum assistance from both lines 38, 40
to prolapse tissue into the side aperture 20. The spool valve 46
stays in this configuration as the cutter tube 26 is advanced
distally while rotating to sever the tissue sample 19. As the
shuttle 154 approaches its distal-most position, the lug 157
contacts the distal end of the delay slot 158 of the distal
actuating portion 132 of the valve control rod 130, changing to the
first position wherein the vacuum lumen 30 is vented to atmosphere
and the tissue sample 19 is retracted into the replaceable
container 18 by vacuum pressure via the sample retraction line
40.
[0040] Once tissue samples 19 are collected in the replaceable
container 18, the replaceable container 18 is removed from the
biopsy device 10 and transported to a pathology professional for
sample assessment.
[0041] Alternately, the bodily fluids are drained from the
container and replaced with tissue preparation fluid (e.g.
Formalin) prior to being sent off for pathological assessment. The
bodily fluids are removed from the replaceable canister 18 by
removing the canister lid 44, needle vacuum line 38, and the sample
retraction line 40 from the replaceable canister assembly 18. While
supporting the tapered cylindrical fluid container 170 and the
annular ring portion 186 located on sample collector basket 176,
the fluids are poured from the tapered cylindrical fluid container
170 with the tissue samples 19 remaining in the tapered cylindrical
fluid container 170. The sample collector basket 176 and attached
filter disk 182 are then removed form the tapered cylindrical fluid
container 170 and tissue preparation fluid (e.g. Formalin) is
poured into the tapered cylindrical fluid container 170. A canister
lid (not shown) without hose receptacles or nibs is attached to the
tapered cylindrical fluid container 170 prior to transporting to a
pathology professional for sample assessment. Alternately, after
the fluids are poured from the tapered cylindrical fluid container
170, the sample collector basket 176, and attached filter disk 182
are removed from the tapered cylindrical fluid container 170. The
tissue samples 19 are transferred from the tapered cylindrical
fluid container 170 into a container (not shown) containing tissue
preparation fluid (e.g. formalin) prior to transportation to a
pathology professional for sample assessment.
[0042] Another alternate embodiment of a biopsy sample and fluid
capturing canister 18' is depicted in FIG. 7 as including a fully
enclosed sample collector basket 192 with a lower perforated disk
194 and filter 196 to fully contain the tissue samples 19 as they
exit sample retraction line 40. The lower perforated disk 194 and
filter 196 act to separate the tissue samples 19 from bodily
fluids. Once tissue samples 19 are collected in the replaceable
container 18, the fully enclosed sample collector basket 192 can be
removed form the replaceable container 18 and placed directly into
a container (not shown) containing tissue preparation fluid (e.g.
Formalin) prior to transportation to a pathology professional for
sample assessment.
[0043] It should be appreciated that any patent, publication, or
other disclosure material, in whole or in part, that is said to be
incorporated by reference herein is incorporated herein only to the
extent that the incorporated material does not conflict with
existing definitions, statements, or other disclosure material set
forth in this disclosure. As such, and to the extent necessary, the
disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference. Any
material, or portion thereof, that is said to be incorporated by
reference herein, but which conflicts with existing definitions,
statements, or other disclosure material set forth herein, will
only be incorporated to the extent that no conflict arises between
that incorporated material and the existing disclosure
material.
[0044] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art, given the benefit of the present disclosure,
that such embodiments are provided by way of example only. Numerous
variations, changes, and substitutions will now occur to those
skilled in the art without departing from the spirit and scope of
the appended claims.
[0045] For example, as a means to further reduce the size and
weight of the overall biopsy device 10, the DC motor 34 employed to
rotate and translate the cutter tube 26 can also drive the vacuum
pump 20 via appropriate gearing.
[0046] For another example, although the integral vacuum pump
advantageously makes the biopsy device 10 more self-sufficient in
austere clinical situations, applications consistent with aspects
of the invention may employ a separate vacuum source.
[0047] As another example, while a DC motor integral to the
reusable handpiece has certain advantages in the illustrative
version, applications consistent with aspects of the invention may
utilize a motor comprising materials compatible with use in a
strong magnetic environment (e.g., magnetic resonance imaging) or
remotely placed (e.g., via a drive cable).
[0048] As another example, while a pneumatically closed system
between the replaceable container 18 and the biopsy device 10
provides various advantages, applications consistent with aspects
of the invention may provide separate vacuum source connections to
the biopsy device and to the replaceable container 18.
* * * * *