U.S. patent application number 13/483235 was filed with the patent office on 2013-12-05 for control for biopsy device.
This patent application is currently assigned to Devicor Medical Products, Inc.. The applicant listed for this patent is Patrick A. Mescher. Invention is credited to Patrick A. Mescher.
Application Number | 20130324882 13/483235 |
Document ID | / |
Family ID | 49671094 |
Filed Date | 2013-12-05 |
United States Patent
Application |
20130324882 |
Kind Code |
A1 |
Mescher; Patrick A. |
December 5, 2013 |
CONTROL FOR BIOPSY DEVICE
Abstract
An exemplary biopsy system includes a biopsy device having a
probe. The probe includes a distally extending needle and a cutter
movable relative to the needle. The probe also includes a tissue
sample holder detachably coupled to the proximal end of the probe.
The biopsy system has a cycle where the biopsy system provides
vacuum to the biopsy device, retracts the cutter to a proximal
position, advances the cutter to a distal position, and transports
a sample to the tissue sample holder. The biopsy system is capable
of adjusting the duration of its cycle during operation of the
biopsy device.
Inventors: |
Mescher; Patrick A.;
(Bellbrook, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Mescher; Patrick A. |
Bellbrook |
OH |
US |
|
|
Assignee: |
Devicor Medical Products,
Inc.
Cincinnati
OH
|
Family ID: |
49671094 |
Appl. No.: |
13/483235 |
Filed: |
May 30, 2012 |
Current U.S.
Class: |
600/566 |
Current CPC
Class: |
A61B 2010/0225 20130101;
A61B 10/0283 20130101; A61B 2010/0208 20130101; A61B 10/0275
20130101; A61B 10/0096 20130101 |
Class at
Publication: |
600/566 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A biopsy system comprising a biopsy device, wherein the biopsy
device comprises a probe, wherein the probe comprises: (a) a
needle, wherein the needle extends distally from the probe, (b) a
cutter, wherein the cutter is movable relative to the needle, and
(c) a tissue sample holder, wherein the tissue sample holder is
detachably coupled to a proximal end of the probe; wherein the
biopsy system is operable in a cycle to provide vacuum to the
biopsy device, retract the cutter to a proximal position, advance
the cutter to a distal position, and transport a sample to the
tissue sample holder; and wherein the biopsy system is configured
to adjust the duration of the cycle of the biopsy system during the
cycle of the biopsy system.
2. The biopsy system of claim 1, wherein the biopsy system is
operable to measure the amount of vacuum provided to the biopsy
device.
3. The biopsy system of claim 2, wherein the biopsy system is
operable to selectively categorize the measured vacuum
pressure.
4. The biopsy system of claim 3, wherein the biopsy system is
operable to selectively categorize the measured vacuum pressure as
relatively low, relatively nominal, or relatively high.
5. The biopsy system of claim 3, wherein the cutter is configured
to dwell at the proximal position, wherein the biopsy system is
operable to adjust the duration of time the cutter is configured to
dwell at the proximal position during the cycle of the biopsy
system based on the selected category of the measured vacuum
pressure.
6. The biopsy system of claim 5, wherein the biopsy system is
operable to increase the duration of time the cutter is configured
to dwell at the proximal position when the measured vacuum pressure
is selectively categorized as relatively low, or wherein the biopsy
system is operable to decrease the duration of time the cutter is
configured to dwell at the proximal position when the measured
vacuum pressure is selectively categorized as relatively high.
7. The biopsy system of claim 3, wherein the biopsy system is
operable to adjust the speed of the translation of the cutter from
the proximal position to the distal position during the cycle of
the biopsy system based on the selected category of the vacuum
pressure.
8. The biopsy system of claim 7, wherein the biopsy system is
operable to decrease the speed of the translation of the cutter
from the proximal position to the distal position when the measured
vacuum pressure is selectively categorized as relatively low, or
wherein the biopsy system is operable to increase the speed of the
translation of the cutter from the proximal position to the distal
position when the measured vacuum pressure is selectively
categorized as relatively high.
9. The biopsy system of claim 3, wherein the cutter is operable to
oscillate proximally and distally after advancing to the distal
position, wherein the biopsy system is operable to adjust the
amount of cutter oscillations during the cycle of the biopsy system
based on the selected category of the vacuum pressure.
10. The biopsy system of claim 9, wherein the biopsy system is
operable to increase the amount of cutter oscillations when the
measured vacuum pressure is selectively categorized as relatively
low, or wherein the biopsy system is operable to decrease the
amount of cutter oscillations when the measured vacuum pressure is
selectively categorized as relatively high.
11. The biopsy system of claim 9, wherein the biopsy system is
operable to bypass the amount of cutter oscillations when the
measured vacuum pressure is selectively categorized as relatively
high.
12. The biopsy system of claim 3, wherein the biopsy system is
operable to adjust the duration of time to transport the sample to
the tissue sample holder during the cycle of the biopsy system
based on the selected category of the vacuum pressure.
13. The biopsy system of claim 12, wherein the biopsy system is
operable to increase the duration of time to transport the sample
to the tissue sample holder when the measured vacuum pressure is
selectively categorized as relatively low, or wherein the biopsy
system is operable to decrease the duration of time to transport
the sample to the tissue sample holder when the measured vacuum
pressure is selectively categorized as relatively high.
14. The biopsy system of claim 1, wherein the biopsy system is
operable to increase the amount of vacuum provided to the biopsy
device after the cutter translates from the proximal position to
the distal position.
15. The biopsy system of claim 14, wherein the biopsy system is
operable to adjust the amount of vacuum provided to the biopsy
device to a maximum amount of vacuum after the cutter translates
from the proximal position to the distal position.
16. The biopsy device of claim 15, wherein the biopsy system
further comprises an interface configured to selectively increase
or decrease vacuum provided to the biopsy device, wherein the
biopsy system is operable to override the selected increase or
decrease in vacuum by the interface when the amount of vacuum is
adjusted to the maximum amount of vacuum.
17. A method for operating a biopsy system, wherein the biopsy
system comprises a biopsy device, wherein the biopsy device
comprises a probe having a needle distally extending from the
probe, a cutter movable relative to the needle, and a tissue sample
holder detachably coupled to the proximal end of the probe, wherein
the biopsy system is operable to provide vacuum to the biopsy
device, the method comprising: (a) applying a selected amount of
vacuum to the biopsy device; (b) retracting the cutter to a
proximal position; (c) dwelling the cutter at the proximal
position; (d) advancing the cutter to a distal position; and (e)
applying maximum vacuum to the biopsy device to override the
selected amount of vacuum.
18. A method for operating a biopsy system, wherein the biopsy
system comprises a biopsy device, wherein the biopsy device
comprises a probe having a needle distally extending from the
probe, a cutter movable relative to the needle, and a tissue sample
holder detachably coupled to the proximal end of the probe, wherein
the biopsy system is operable to provide vacuum to the biopsy
device, the method comprising: (a) applying a selected amount of
vacuum to the biopsy device; (b) retracting the cutter to a
proximal position; (c) measuring the amount of vacuum applied to
the biopsy device; (d) categorizing the measured amount of vacuum
applied to the biopsy device; (e) dwelling the cutter at the
proximal position for an amount of time determined based on the
categorized amount of vacuum; and (f) advancing the cutter to a
distal position at a speed determined based on the categorized
amount of vacuum.
19. The method of claim 18, wherein the cutter is configured to
oscillate proximally and distally after advancing to the distal
position, wherein the amount of cutter oscillations is determined
based on the categorized amount of vacuum.
20. The method of claim 18 further comprising applying a maximum
amount of vacuum after the cutter is advanced to the distal
position.
Description
BACKGROUND
[0001] Biopsy samples have been obtained in a variety of ways in
various medical procedures using a variety of devices. Biopsy
devices may be used under stereotactic guidance, ultrasound
guidance, MRI guidance, PEM guidance, BSGI guidance, or otherwise.
For instance, some biopsy devices may be fully operable by a user
using a single hand, and with a single insertion, to capture one or
more biopsy samples from a patient. In addition, some biopsy
devices may be tethered to a vacuum module and/or control module,
such as for communication of fluids (e.g., pressurized air, saline,
atmospheric air, vacuum, etc.), for communication of power, and/or
for communication of commands and the like. Other biopsy devices
may be fully or at least partially operable without being tethered
or otherwise connected with another device.
[0002] Merely exemplary biopsy devices are disclosed in U.S. Pat.
No. 5,526,822, entitled "Method and Apparatus for Automated Biopsy
and Collection of Soft Tissue," issued Jun. 18, 1996; U.S. Pat. No.
6,086,544, entitled "Control Apparatus for an Automated Surgical
Biopsy Device," issued Jul. 11, 2000; U.S. Pat. No. 6,626,849,
entitled "MRI Compatible Surgical Biopsy Device," issued Sep. 11,
2003; U.S. Pat. No. 7,442,171, entitled "Remote Thumbwheel for a
Surgical Biopsy Device," issued Oct. 8, 2008; U.S. Pat. No.
7,854,706, entitled "Clutch and Valving System for Tetherless
Biopsy Device," issued Dec. 1, 2010; U.S. Pat. No. 7,938,786,
entitled "Vacuum Timing Algorithm for Biopsy Device," issued May
10, 2011; U.S. Pat. Pub. No. 2006/0074345, entitled "Biopsy
Apparatus and Method," published Apr. 6, 2006; U.S. Pat. Pub. No.
2008/0214955, entitled "Presentation of Biopsy Sample by Biopsy
Device," published Sep. 4, 2008; U.S. Pat. Pub. No. 2008/0221480,
entitled "Biopsy Sample Storage," published Sep. 11, 2008; U.S.
Pat. Pub. No. 2009/0131821, entitled "Graphical User Interface For
Biopsy System Control Module," published May 21, 2009; U.S. Pat.
Pub. No. 2009/0131820, entitled "Icon-Based User Interface On
Biopsy System Control Module," published May 21, 2009; U.S. Pat.
Pub. No. 2010/0152610, entitled "Hand Actuated Tetherless Biopsy
Device with Pistol Grip," published Jun. 17, 2010; U.S. Pat. Pub.
No. 2010/0160819, entitled "Biopsy Device with Central Thumbwheel,"
published Jun. 24, 2010; U.S. Pat. Pub. No. 2010/0317997, entitled
"Tetherless Biopsy Device with Reusable Portion," published Dec.
16, 2010; U.S. Non-Provisional patent application Ser. No.
12/953,715, entitled "Handheld Biopsy Device with Needle Firing,"
filed Nov. 24, 2010; U.S. Non-Provisional patent application Ser.
No. 13/086,567, entitled "Biopsy Device with Motorized Needle
Firing," filed Apr. 14, 2011; U.S. Non-Provisional patent
application Ser. No. 13/150,950, entitled "Needle Assembly and
Blade Assembly for Biopsy Device," filed Jun. 1, 2011; U.S.
Non-Provisional patent application Ser. No. 13/205,189, entitled
"Access Chamber and Markers for Biopsy Device," filed Aug. 8, 2011;
U.S. Non-Provisional patent application Ser. No. 13/218,656,
entitled "Biopsy Device Tissue Sample Holder with Bulk Chamber and
Pathology Chamber," filed Aug. 26, 2011; and U.S. Provisional
Patent App. No. 61/566,793, entitled "Biopsy Device With Slide-In
Probe," filed Dec. 5, 2011. The disclosure of each of the
above-cited U.S. Patents, U.S. Patent Application Publications, and
U.S. Non-Provisional Patent Applications is incorporated by
reference herein.
[0003] While several systems and methods have been made and used
for obtaining a biopsy sample, it is believed that no one prior to
the inventor has made or used the invention described in the
appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] While the specification concludes with claims which
particularly point out and distinctly claim this technology, it is
believed this technology will be better understood from the
following description of certain examples taken in conjunction with
the accompanying drawings, in which like reference numerals
identify the same elements and in which:
[0005] FIG. 1 depicts a schematic view of an exemplary biopsy
system;
[0006] FIG. 2 depicts a perspective view of an exemplary biopsy
device;
[0007] FIG. 3 depicts a perspective view of the biopsy device of
FIG. 2 showing an exemplary probe decoupled from an exemplary
holster;
[0008] FIG. 4 depicts a rear perspective view of the holster of
FIG. 3;
[0009] FIG. 5 depicts a rear perspective view of the holster of
FIG. 4 with a top housing cover omitted;
[0010] FIG. 6 depicts an exploded perspective view of the holster
of FIG. 5;
[0011] FIG. 7 depicts a perspective view of the probe of FIG.
3;
[0012] FIG. 8 depicts a top plan view of the probe of FIG. 7 with a
top probe cover omitted;
[0013] FIG. 9 depicts an exploded perspective view of the probe of
FIG. 8;
[0014] FIG. 10 depicts a perspective view of an exemplary tissue
sample holder;
[0015] FIG. 11 depicts a front view of an exemplary user interface
for the biopsy device of FIG. 2;
[0016] FIG. 12 depicts a flowchart of an exemplary control for the
biopsy device of FIG. 2;
[0017] FIG. 13 depicts a flowchart of another exemplary control for
the biopsy device of FIG. 2;
[0018] FIG. 14 depicts a flowchart of another exemplary control for
the biopsy device of FIG. 2; and
[0019] FIG. 15 depicts a flowchart of another exemplary control for
the biopsy device of FIG. 2.
[0020] The drawings are not intended to be limiting in any way, and
it is contemplated that various embodiments of the technology may
be carried out in a variety of other ways, including those not
necessarily depicted in the drawings. The accompanying drawings
incorporated in and forming a part of the specification illustrate
several aspects of the present technology, and together with the
description serve to explain the principles of the technology; it
being understood, however, that this technology is not limited to
the precise arrangements shown.
DETAILED DESCRIPTION
[0021] The following description of certain examples of the
technology should not be used to limit its scope. Other examples,
features, aspects, embodiments, and advantages of the technology
will become apparent to those skilled in the art from the following
description, which is by way of illustration, one of the best modes
contemplated for carrying out the technology. As will be realized,
the technology described herein is capable of other different and
obvious aspects, all without departing from the technology.
Accordingly, the drawings and descriptions should be regarded as
illustrative in nature and not restrictive.
[0022] I. Overview of Exemplary Biopsy System
[0023] FIG. 1 depicts an exemplary biopsy system (10) comprising a
biopsy device (100), a plurality of conduits (400) and a control
module (500). Biopsy device (100) comprises a holster (202) and a
probe (102). A needle (110) extends distally from probe (102) and
is inserted into a patient's tissue to obtain tissue samples as
will be described in greater detail below. These tissue samples are
deposited into a tissue sample holder (302) that is coupled to a
proximal end of probe (102), as will also be describe in further
detail below. Of course needle (110) and tissue sample holder (302)
may be coupled to probe (102) at a range of locations. For
instance, needle (110) may extend from the top of probe (102), from
a side of probe (102), from the bottom of probe (102), or, may be
omitted from probe (102) entirely. Tissue sample holder (302) may
be coupled to the top of probe (102), to a side of probe (102), to
the bottom of probe (102), or, may be omitted from probe (102)
entirely. Probe (102) of the present example is separable from
holster (202), though this is merely optional. It should also be
understood that the use of the term "holster" herein should not be
read as necessarily requiring any portion of probe (102) to be
inserted into any portion of holster (202). While an notched upper
control unit (220) of the holster (202) and a latch (190) of probe
(102) are used to cooperatively removably secure probe (102) to
holster (202), as shown in FIGS. 2-4 and 7 and described in greater
detail below, it should be understood that a variety of other types
of structures, components, features, etc. (e.g., bayonet mounts,
prongs, clamps, clips, snap fittings, etc.) may be used to provide
removable coupling of probe (102) and holster (202). Furthermore,
in some biopsy devices (100), probe (102) and holster (202) may be
of unitary or integral construction, such that the two components
cannot be separated. By way of example only, in versions where
probe (102) and holster (202) are provided as separable components,
probe (102) may be provided as a disposable component, while
holster (202) may be provided as a reusable component. Still other
suitable structural and functional relationships between probe
(102) and holster (202) will be apparent to those of ordinary skill
in the art in view of the teachings herein.
[0024] Biopsy system (10) shown in FIG. 1 further includes a
control module (500) that is fluidly coupled to biopsy device (100)
via one or more conduits (400). In the present example, control
module (500) comprises a vacuum source (510) operable to provide a
vacuum to biopsy device (100). Control module (500) further
comprises a user interface (526) that allows a user adjust the
level of vacuum provided to biopsy device (100). It may be
desirable for a user to adjust the level of vacuum depending on the
characteristics (hardness, thickness, etc.) of the tissue to be
sampled by biopsy device (100). User interface (526) will be
discussed in more detail below. By way of example only, vacuum
source (510) is contained within control module (500) and is
fluidly coupled to probe (102) via a first conduit (402), such as
flexible tubing. Of course, in addition or in the alternative,
vacuum source (510) may be incorporated into probe (102),
incorporated into holster (202), and/or be a separate component
altogether. One merely exemplary biopsy device (100) having a
vacuum source (510) incorporated therein is disclosed in U.S.
Non-provisional patent application Ser. No. 12/953,715, entitled
"Handheld Biopsy Device with Needle Firing," filed Nov. 24, 2010,
the disclosure of which is incorporated by reference herein. As
shown in FIG. 1, vacuum source (510) is in fluid communication with
probe (102) and, as will be described in greater detail below, with
needle (110). Thus, vacuum source (510) may be activated to draw
tissue into a lateral aperture (112) of needle (110), described in
more detail below. Vacuum source (510) is also in fluid
communication with tissue sample holder (302) and a cutter (120).
Vacuum source (510) of control module (500) may thus also be
activated to draw severed tissue samples through a cutter lumen
(136) of cutter (120) and into tissue sample holder (302). Of
course other suitable configurations and uses for vacuum source
(510) will be apparent to those of ordinary skill in the art in
view of the teachings herein. It should also be understood that
vacuum source (510) may simply be omitted, if desired.
[0025] In some versions, vacuum source (510) is provided in
accordance with the teachings of U.S. Pat. Pub. No. 2008/0214955,
entitled "Presentation of Biopsy Sample by Biopsy Device,"
published Sep. 4, 2008, the disclosure of which is incorporated by
reference herein. As yet another merely illustrative example,
vacuum source (510) may be provided in accordance with the
teachings of U.S. Pat. Pub. No. 2011/0208086, entitled "Biopsy
Device with Auxiliary Vacuum Source," published Aug. 25, 2011, the
disclosure of which is incorporated by reference herein. Still
other suitable ways in which vacuum source (510) may be provided
will be apparent to those of ordinary skill in the art in view of
the teachings herein.
[0026] A. Exemplary Control Module and Conduits
[0027] Control module (500) of the present example is further
fluidly coupled to biopsy device (100) by a second conduit (404)
and a third conduit (406), such as flexible tubing, though one or
both may be omitted. Third conduit (406) is in fluid communication
with a saline bag (410) via control module (500). Saline bag (410)
comprises saline fluid, though it should be understood that other
fluids, gels, solids suspended in fluid, and/or other fluid-like
materials may be used as will be apparent to one of ordinary skill
in the art in view of the teachings herein. Of course it should be
understood that saline bag (410) may be directly coupled to third
conduit (406) and/or to biopsy device (100). Furthermore, in some
versions, third conduit (406) is not coupled to control module
(500), but may instead include a luer lock end (not shown) to which
syringes (not shown) or other items may be coupled to deliver
fluids, medicaments, and/or other items. Second conduit (404) is
also fluidly coupled to control module (500) and provides filtered
atmospheric air to the biopsy device (100) via a filter (not shown)
in control module (500). As with third conduit (406), in some
versions second conduit (404) is not coupled to control module
(500), but and instead includes a luer lock end (not shown) or a
filter (not shown). In the present example, second conduit (404)
and third conduit (406) are joined together by a connector (408)
prior to coupling to probe (102). Connector (408) may comprise a
valve to seal either second or third conduit (404, 406) while the
other conduit (404, 406) is in fluid communication with probe
(102). Of course in other versions, connector (408) may comprise a
Y-shaped connector to permit both second conduit (404) and third
conduit (406) to be coupled to probe (102).
[0028] In some versions, conduits (400) may be coupled to a
retraction system (520) of control module (500) such that first,
second, and/or third conduit (402, 402, 406) may be retracted into
control module (500) when not in use. By way of example only,
retraction system (520) may comprise one or more spring-loaded
spools (522) each sized to coil first, second, and/or third conduit
(402, 404, 406) about spools (522). Spools (522) may be coupled to
a ratchet assembly (not shown) such that when a user pulls on
conduits (402, 404, 406), the ratchet assembly prevents
spring-loaded spools from retracting conduits (402, 404, 406). A
retraction button (524) is mounted to a casing of control module
(500) and is operable to release the ratchet assembly to retract
conduits (402, 404, 406). In addition, or in the alternative,
spools (522) may be coupled to hand cranks (not shown) to manually
retract conduits (402, 404, 406) about spools (522). In some
versions, retraction button (524) is operated from biopsy device
(100), for example, by a button (228) on notched upper control unit
(220), such that a user can retract conduits (402, 404, 406) while
using the device. By way of example only, a button (not shown) on
biopsy device (100) may activate a solenoid to release the ratchet
assembly. Accordingly, the user can reduce the amount of potential
tangling and/or any excess conduit (402, 404, 406) around where the
user is using biopsy device (100). In addition, or in the
alternative, such remote retraction may be selectively braked or
controlled (either by a brake or a motor) to slowly retract the
conduit (402, 404, 406). Such slowed retraction may prevent conduit
(402, 404, 406) from rapidly retracting and pulling biopsy device
(100) out of the user's hands.
[0029] While conduits (402, 404, 406) are shown as separate
conduits, it should be understood that conduits (402, 404, 406) may
be combined into a single tube subdivided into any number of
suitable conduits. In some versions, conduits (402, 404, 406) may
be longitudinally fused together to form a rectangular unitary
three conduit tube. Of course still further configurations for
conduits (402, 404, 406) will be apparent to one of ordinary skill
in the art in view of the teachings herein. In some versions
conduits (402, 404, 406) may not retract, or only part of conduits
(402, 404, 406) may retract. In such a configuration, conduits
(402, 404, 406) may be separable from a connector (not shown)
operable to couple to one or more receptacles (not shown) on
control module (500). Accordingly, after conduits (402, 404, 406)
are used in a procedure, conduits (402, 404, 406) may be detached
from the connector and disposed of. New conduits (402, 404, 406)
may be coupled to the connector for the next procedure. In one
merely exemplary configuration, a reusable conduit portion may be
coupled to a disposable conduit portion. The reusable conduit
portion of this example may be coupled to the retraction system
(520). Accordingly, the reusable conduit portion may have a
predetermined size, such as five feet, and one or more disposable
conduits may be coupled to the reusable conduit portion to provide
various lengths of conduit for a procedure. When the procedure is
finished, the disposable conduit portions are disposed of and the
reusable conduit portion is retracted into control module (500) for
storage. In addition, or in the alternative, retraction system
(520) and conduits (402, 404, 406) may be constructed as a
selectively insertable device that may be inserted or removed from
control module (500). By way of example only, such a selectively
insertable retraction system (520) may be configured similarly to
the vacuum canisters described in U.S. Pat. No. 7,938,786, entitled
"Vacuum Timing Algorithm for Biopsy Device," issued May 10, 2011
the disclosure of which is incorporated by reference herein.
Accordingly, in some versions the entire retraction system (520)
may be disposable or, in some versions, reclaimable to be
resterilized for reuse.
[0030] In the present example, a power cord (420) extends from
vacuum control unit (500) to electrically couple and power biopsy
device (100). Power cord (420) may be configured to supply DC or AC
power to biopsy device (100). In addition, or in the alternative,
power cord (420) may also be operable to transmit data between
control module (500) and biopsy device (100). Power cord (420)
includes an end connector (not shown) configured to selectively
couple to an end connector (298) of cable (290), shown in FIGS.
2-6. Accordingly, power cord (420) of control module (500) may be
separable from holster (202) such that each may be stored
separately, though this is merely optional. Power cord (420) of the
present example is also coupled to a spring-loaded spool (522) that
may be retracted by retraction system (520) described above. It
should be understood that spool (522) to which power cord (420) is
coupled may be a separate spool from the spools for conduits (402,
404, 406). In addition, the retraction system (520) for spool (522)
to which power cord (420) is coupled may be a separate retraction
system as well. For instance, control module (500) may have a
removable retraction system (520) for conduits (402, 404, 406) that
may be removed and disposed of while a permanent retraction system
(520) is provided for power cord (420). Of course, some versions of
biopsy device (100) may be internally powered such that power cord
(420) may be omitted. In some versions, spools (522) may comprise a
single spool having multiple discrete spools such that conduits
(402, 404, 406) and power cord (420) are retracted and extended at
the same time and rate. In some versions, power cord (420) may be
incorporated into the singular tube conduit described above such
that a single cord, having three subdivisions for fluid flow and
one subdivision to transmit power, extends from vacuum control unit
(500). Still further configurations for power cord (420), control
module (500), and/or retraction systems (520) will be apparent to
one of ordinary skill in the art in view of the teachings
herein.
[0031] B. Exemplary Biopsy Device Overview
[0032] Biopsy device (100) of the present example is configured to
be held by a user against a patient and guided by an ultrasound
imaging device. Of course, biopsy device (100) may instead be used
under stereotactic guidance, MRI guidance, PEM guidance, BSGI
guidance, or otherwise. It should also be understood that biopsy
device (100) may be sized and configured such that biopsy device
(100) may be operated by a single hand of a user. In particular, a
user may grasp biopsy device (100), insert needle (110) into a
patient's breast, and collect one or a plurality of tissue samples
from within the patient's breast, all with just using a single
hand. Alternatively, a user may grasp biopsy device (100) with more
than one hand and/or with any desired assistance. In some settings,
the user may capture a plurality of tissue samples with just a
single insertion of needle (110) into the patient's breast. Such
tissue samples may be pneumatically deposited in tissue sample
holder (302), and later retrieved from tissue sample holder (302)
for analysis. While examples described herein often refer to the
acquisition of biopsy samples from a patient's breast, it should be
understood that biopsy device (100) may be used in a variety of
other procedures for a variety of other purposes and in a variety
of other parts of a patient's anatomy (e.g., prostate, thyroid,
etc.). Various exemplary components, features, configurations, and
operabilities of biopsy device (100) will be described in greater
detail below; while other suitable components, features,
configurations, and operabilities will be apparent to those of
ordinary skill in the art in view of the teachings herein.
[0033] Biopsy device (100) of the present example comprises a
separable probe (102) and holster (202) as shown in FIGS. 2-6. In
the present example, probe (102) is configured to initially slide
onto holster (202) laterally until a distal probe portion (120)
enters and abuts a portion of notched upper control unit (220),
then probe (102) is slid distally to secure probe (102) to holster
(202). Once slide distally, latch (190) of probe (102) engages a
latch member (238) of holster (202) to securely couple probe (102)
to holster (202). Tissue may then be severed and transported
proximally into tissue sample holder (302). Biopsy device (100) and
tissue sample holder (302) may be further constructed in accordance
with at least some of the teachings of U.S. Pat. No. 7,938,786,
entitled "Vacuum Timing Algorithm for Biopsy Device," issued May
10, 2011; U.S. Pat. Pub. No. 2008/0221480, entitled "Biopsy Sample
Storage," published Sep. 11, 2008; U.S. Pat. Pub. No. 2010/0317997,
entitled "Tetherless Biopsy Device with Reusable Portion,"
published Dec. 16, 2010; U.S. Non-Provisional patent application
Ser. No. 12/953,715, entitled "Handheld Biopsy Device with Needle
Firing," filed Nov. 24, 2010; U.S. Non-Provisional patent
application Ser. No. 13/086,567, entitled "Biopsy Device with
Motorized Needle Firing," filed Apr. 14, 2011; and/or U.S.
Non-Provisional patent application Ser. No. 13/205,189, entitled
"Access Chamber and Markers for Biopsy Device," filed Aug. 8, 2011,
the disclosures of which are incorporated by reference herein. Of
course still further configurations for biopsy system (10) will be
apparent to one of ordinary skill in the art in view of the
teachings herein.
[0034] II. Exemplary Holster
[0035] Holster (202) comprises a top housing cover (210), a housing
base (260), and a cable (290). Cable (290) comprises a plurality of
wires (292), shown in FIG. 6, to provide power and/or control
signals to various components contained within housing base (260).
Cable (290) further includes an end connector (298) operable to
selectively couple holster (202) to a connector of power cord
(420), described above, or, in some versions, end connector (298)
may be directly coupleable to control module (500). Housing base
(260) comprises a biocompatible rigid plastic material, such as
polycarbonate, that is molded to include a distal upwardly bending
arcuate portion (262), shown in FIGS. 2-3, such that housing base
(260) may be positioned closer to a patient's body during use. By
way of example only, arcuate portion (262) is sized to permit a
portion of a patient's anatomy, such as a breast or other part of
the patient's thorax, to at least partially occupy the curved
cavity formed by arcuate portion (262) such that biopsy device
(100) may be readily positioned at various orientations near to the
patient's body. By way of example only, the configuration of
arcuate portion (262) may permit greater access to a patient's
breast than might otherwise be provided by a generally rectangular
or cylindrical shaped biopsy device. Arcuate portion (262) extends
proximally for approximately one-fifth the length of holster (202),
though this is merely optional. In some versions, arcuate portion
(262) may extend proximally for approximately half, less than half,
or more than half of the longitudinal length of holster (202). In
addition, or in the alternative, arcuate portion (262) may comprise
a padded portion (not shown), such as a gauze pad, to reduce the
"mechanical" feel of arcuate portion (262) in the event that
arcuate portion (262) comes into contact with the patient's skin.
Still further arrangements for arcuate portion (262) will be
apparent to one of ordinary skill in the art in view of the
teachings herein.
[0036] Referring now to FIGS. 3-4, top housing cover (210) also is
formed of a biocompatible rigid plastic material, such as
polycarbonate, and includes a notched upper control unit (220), a
gear slot (230), a mid rail (240), a front rail (242), a latch
member (238), and a gear aperture (250). As best seen in FIG. 3,
holster gear (272) is exposed through gear aperture (250) and is
configured to mesh with probe gear (170) of probe (102) when probe
(102) is coupled to holster (202). Accordingly, rotation of holster
gear (272) rotates probe gear (170) to drive a cutter actuation
assembly (150) in probe (102), described in greater detail below.
Gear slot (230) is a recessed portion of top housing cover (210)
configured to penult probe gear (170) to travel along gear slot
(230) as probe (102) is slide onto holster (202). Gear slot (230)
comprises a lateral portion (232) and a longitudinal portion (234).
Accordingly, when probe (102) is coupled to holster (202), probe
gear (170) first enters lateral portion (232) and travels along
lateral slot (232) until probe (102) is substantially
longitudinally aligned with holster (202). Once probe (102) is
longitudinally aligned with holster (202), probe (102) is pushed
forward by the user, causing probe gear (170) to travel within
longitudinal portion (234) of gear slot (230) until probe gear
(170) meshes with holster gear (272). Of course gear slot (230) is
merely optional and may be omitted. In addition, or in the
alternative, a similar gear slot (not shown) may be formed on a
bottom portion of probe (102).
[0037] As probe (102) is slid distally, a mid slot (108) of probe
(102) slides onto mid rail (240) of top cover (210) and a front
slot (128) slides onto front rail (242). The combination of mid
slot (108), mid rail (240), front slot (128), and front rail (242)
provide additional alignment for coupling probe (102) to holster
(202). In addition, rails (240, 242) may also be sized such that
rails (240, 242) resist lateral displacement of probe (102)
relative to holster (202) once probe (102) is coupled to holster
(202). Of course still further configuration for rails (240, 242)
and slots (108, 128) will be apparent to one of ordinary skill in
the art in view of the teachings herein.
[0038] Notched upper control unit (220) initially extends upwardly
and then inwardly from a first surface of top cover (210), thereby
forming an inverted L-shaped component having an overhang (222). In
the example shown, notched upper control unit (220) comprises an
upwardly extending portion (224) coupled to an overhang (222),
thereby forming an upper boundary to secure probe (102) against
holster (202). Accordingly, overhang (222) retains probe (102)
against holster (202) even if biopsy device (100) is inverted or
positioned in any other orientation. In addition, while notched
upper control unit (220) increases the height of holster (202), it
will be appreciated by one of ordinary skill in the art in view of
the teachings herein that the width of holster (202) is narrowed by
providing upper control unit (220). Accordingly, this narrowed
width may permit a user to grasp holster (202) and/or the assembly
biopsy device (100) in a similar manner to holding a pencil or
other narrow-bodied object.
[0039] Notched upper control unit (220) further includes a control
panel (226) having a plurality of buttons (228) thereon. In the
present example, buttons (228) comprise a rocker button (228a), a
first button (228b), and a second button (228c). In the present
example, second button (228c) is operable to selectively activate
biopsy device (100) to take a biopsy sample of tissue. First button
(228b) is operable to selectively apply a vacuum from control
module (500) to one or more portions of biopsy device (100), such
as to cutter lumen (136). Rocker button (228a) is operable to
selectively advance or retract cutter (152), thereby opening or
closing lateral aperture (118). Buttons (228a, 228b, 228c) may of
course have other uses, as will be apparent to one of ordinary
skill in the art in view of the teachings herein. Moreover,
additional buttons (228) may be provided to provide additional
functionality. For instance, as noted above, one such additional
button (228) may include a button to trigger retraction of conduits
(402, 404, 406) and/or power cord (420) into vacuum control unit
(500). In addition, or in the alternative, indicators (not shown)
may be included on notched upper control unit (220) to provide
visual feedback to the user. In yet a further configuration,
notched upper control unit (220) may comprise a touch panel, such
as a resistive touch screen, capacitive touch screen, piezoelectric
touch screen, acoustic pulse recognition, and/or any other type of
touch screen as will be apparent to one of ordinary skill in the
art in view of the teachings herein.
[0040] As noted previously, latch member (238) engages latch (190)
to selectively couple probe (102) to holster (202). In the present
example, latch member (238) snaps into a gap (192), shown best in
FIG. 8, of probe (102) and is secured via latch (190) when probe
(102) is slid onto holster (202). When probe (102) is to be
decoupled, latch (190) is depressed inwardly by a user to permit
latch member (238) to clear latch (190) and exit gap (192). The
user can then decouple probe (102) from holster (202).
[0041] Top cover (210) further includes a proximal end (212) having
a sample holder cog (214) and a peg (216) extending proximally
therefrom. Sample holder cog (214) is operable to rotate a
rotatable manifold (310) of tissue sample holder (302) to rotate a
plurality of tissue sample chambers into alignment with a cutter
lumen (136), as will be discussed in more detail below. Peg (216)
is operable to decouple a parking pawl (not shown) when probe (102)
is coupled to holster (202). Sample holder cog (214) and peg (216)
may be further constructed and/or configured in accordance with at
least some of the teachings of U.S. Pat. No. 7,938,786, entitled
"Vacuum Timing Algorithm for Biopsy Device," issued May 10, 2011
and/or U.S. Non-Provisional patent application Ser. No. 13/205,189,
entitled "Access Chamber and Markers for Biopsy Device," filed Aug.
8, 2011, the disclosures of which are incorporated by reference
herein.
[0042] Still further configurations for top cover (210) of holster
(202) will be apparent to one of ordinary skill in the art in view
of the teachings herein.
[0043] FIGS. 5-6 depict holster (202) with top cover (210) removed,
showing the components (270, 280, 288) contained within housing
base (260). In the present example, holster (202) includes a cutter
drive motor (270), a sample holder motor (280), and a controller
(288). In the present example, cutter drive motor (270) is coupled
to holster gear (272), a top portion of which extends out of top
cover (210) through gear aperture (250). Cutter drive motor (270)
is operable to engage and drive cutter actuation assembly (150)
within probe (102), as will be discussed in greater detail below.
In the present example, cutter drive motor (270) is mounted with
one or more rubber bushings (274) and/or rubber gaskets (276) to
isolate vibrations from cutter drive motor (270). Sample holder
motor (280) is coupled to sample holder cog (214) and includes an
encoder assembly (282) operable to transmit the rotational position
of sample holder cog (214) to controller (288). Controller (288) of
the present example is electrically coupled to cutter drive motor
(270), sample holder motor (280), encoder assembly (282), control
panel (226) and control module (500). Controller (288) is operable
to output control signals to cutter drive motor (270) and/or sample
holder motor (280) in response to one or more control or input
signals from encoder assembly (282), control panel (226) and
control module (500). Controller (288) may be further constructed
or configured in accordance with at least some of the teachings of
U.S. Pat. No. 7,938,786, entitled "Vacuum Timing Algorithm for
Biopsy Device," issued May 10, 2011; U.S. Pat. Pub. No.
2010/0317997, entitled "Tetherless Biopsy Device with Reusable
Portion," published Dec. 16, 2010; U.S. Non-Provisional patent
application Ser. No. 12/953,715, entitled "Handheld Biopsy Device
with Needle Firing," filed Nov. 24, 2010; and/or U.S.
Non-Provisional patent application Ser. No. 13/086,567, entitled
"Biopsy Device with Motorized Needle Firing," filed Apr. 14, 2011,
the disclosures of which are incorporated by reference herein.
[0044] Still further constructions and/or configurations for
holster (202) will be apparent to one of ordinary skill in the art
in view of the teachings herein.
[0045] III. Exemplary Probe
[0046] FIGS. 2-3 and 7-9 depict an exemplary probe (102) configured
to couple to holster (202) described above. Probe (102) of the
present example comprises a probe body (104), a needle (110)
extending distally from probe body (104), and a tissue sample
holder (302) detachably coupled to a proximal end of probe (102).
Probe body (104) of the present example comprises a biocompatible
rigid plastic material, such as polycarbonate, divided into a
chassis portion and a top probe cover, though this is merely
optional. Indeed, in some versions, probe body (104) may be of
unitary construction. As shown in FIGS. 3 and 7, probe body (104)
includes a main portion (106) and a distal probe portion (120).
Main portion (106) includes a mid slot (108) configured to slide
onto mid rail (240) of top cover (210), as described above. Latch
(190) of the present example is integrally formed as part of main
portion (106), though this is merely optional and latch (190) may
comprise a separate component mechanically coupled to main portion
(106). As best shown in FIG. 8, latch (190) is molded such that a
gap (192) receives latching member (238) of holster (202) when
probe (102) is coupled to holster (202). A first indicator (194) is
also included on main body (106) to indicate to the user the first
step, sliding probe (102) laterally, to couple probe (102) to
holster (202). Of course still other configurations and/or
constructions for main portion (106) and/or latch (190) will be
apparent to one of ordinary skill in the art in view of the
teachings herein.
[0047] Distal probe portion (120) of the present example extends
from main portion (106) and includes a top surface (122), a lateral
surface (124), an outer surface (126), and a front slot (128). Top
surface (122) and lateral surface (124) of the present example are
formed substantially perpendicular to each other and are sized such
that distal probe portion (120) nests beneath overhang (222) and
adjacent to upwardly extending portion (224). Accordingly, as seen
in FIG. 2, lateral surface (124) abuts upwardly extending portion
(224) and top surface (122) is enclosed by overhang (222). In the
present example, top surface (122) includes a second indicator
(123) that instructs the user of the second step, sliding the probe
longitudinally, to assemble probe (102) with holster (202). Outer
surface (126) of the present example is shaped to provide a smooth
transition from distal probe portion (120) to notched upper control
unit (220) when probe (102) is coupled to holster (202), though
this is merely optional.
[0048] Needle (110) is secured within probe body (104) by manifold
(140), shown in FIG. 8, and extends distally therefrom. Needle
(110) terminates with blade assembly (350) coupled to distal end
(130) of needle (110). In the present example, needle (110)
comprises an ovular two-piece needle having an ovular tube (112)
with a notch (114) formed at a distal end of ovular tube (112) and
an inset (116). Notch (114) is sized to receive inset (116) such
that inset (116) and ovular tube (112) are flush at distal end
(130) and form a two tiered needle having a longitudinal lumen
(132) and a lateral lumen (134). In the present example, inset
(116) comprises a cylindrical tube having a plurality of openings
(119) formed in a sidewall of inset (116). As will be apparent to
one of ordinary skill in the art in view of the teachings herein,
openings (119) allow fluid communication between lateral lumen
(134) and longitudinal lumen (132). Needle (110) may be further
constructed in accordance with at least some of the teachings of
U.S. Non-Provisional patent application Ser. No. 13/150,950,
entitled "Needle Assembly and Blade Assembly for Biopsy Device,"
filed Jun. 1, 2011 and/or in any other configuration as will be
apparent to one of ordinary skill in the art in view of the
teachings herein.
[0049] Manifold (140) of the present example receives needle (110)
into an ovular aperture formed in manifold (140) to fixedly secure
needle (110) into distal probe portion (120). While the present
example depicts manifold (140) anchoring needle (110) within distal
probe portion (120), it should be understood that manifold (140)
may be anchored anywhere within probe (102). Manifold (140) further
includes a plurality of hex tabs (142) and square tabs (144) to
fixedly secure manifold (140) within distal probe portion (120).
Hex tabs (142) include a hexagonal protrusion (not shown) extending
from hex tabs (142) and configured to insert into complementary hex
shaped recesses formed in distal probe portion (120) while the
portion from which the hexagonal protrusions extend rests atop the
framework within distal probe portion (120). Square tabs (144)
insert into square recesses formed in distal probe portion (120).
Accordingly, hex tabs (142) and square tabs (144) cooperatively
secure manifold (140) within distal probe portion (120). It should
be understood from the present example that manifold (140)
substantially secures needle (110) to probe body (104) such that
longer needles may be used with biopsy device (100) due to the
anchoring provided by manifold (140). Of course it should be
understood that manifold (140), hex tabs (142), and square tabs
(144) are merely optional. By way of example only, tabs other than
hex tabs (142) and/or square tabs (144) may be used, or, in some
versions, manifold (140) may be integrally formed with distal probe
portion (120) such that tabs (142, 144) may be omitted entirely.
Still further configurations for manifold (140) will be apparent to
one of ordinary skill in the art in view of the teachings
herein.
[0050] In the example shown in FIGS. 8-9, a fluid junction member
(146) is coupled to a proximal end of manifold (140) to fluidly
couple lateral lumen (134) with one or more of conduits (400)
described above. Fluid junction (146) is substantially sealed at a
proximal end by distal sealing cylinder (156) of cutter overmold
(154), as will be described below. Cutter (152) is inserted into
inset (116) such that longitudinal lumen (132) is substantially
fluidly coupled and sealed with cutter (152) and cutter lumen
(136). Accordingly, the portion of ovular tube (112) extending
proximally from inset (116) fluidly couples lateral lumen (134) to
manifold (140) and fluid junction member (146). As seen in FIGS.
8-9, fluid junction (146) includes a Y-joint that couples fluid
junction (146) to an inlet tube (196) that is subsequently coupled
to one or more conduits (400), described above. By way of example
only, inlet tube (196) may be selectively fluidly coupled to a
vacuum source, a saline source, and/or an atmospheric source to
selectively supply vacuum, saline, and/or atmospheric air through
lateral lumen (134). Such selective supply of vacuum, saline,
and/or atmospheric air may be controlled by control module (500)
and/or through other valving assemblies, as will be apparent to one
of ordinary skill in the art in view of the teachings herein. Of
course other valving assemblies and/or vacuum systems may be
provided in such as those disclosed in U.S. Pat. No. 7,854,706,
entitled "Clutch and Valving System for Tetherless Biopsy Device,"
issued Dec. 1, 2010; U.S. Pat. No. 7,938,786, entitled "Vacuum
Timing Algorithm for Biopsy Device," issued May 10, 2011; and/or
otherwise.
[0051] As noted above, cutter (152) is inserted into inset (116) to
fluidly couple cutter lumen (136) with longitudinal lumen (132). A
proximal end (168) of cutter (152) is also fluidly coupled to
connector tube (182) of tissue sample holder seal (180), as will be
described below, thereby providing a fluid passageway for tissue to
travel from longitudinal lumen (132) into tissue sample holder
(302). In the present example, cutter (152) comprises an elongate
tubular member having a honed distal end operable to sever tissue
as cutter (152) is advanced distally within inset (116).
Accordingly, when tissue is prolapsed into lateral aperture (118)
(such as by providing a vacuum through lateral lumen (134)) cutter
(152) may be advanced by cutter actuation assembly (150) to sever
the tissue. A vacuum may then be applied through tissue sample
holder (302) to draw the tissue proximally through cutter lumen
(136) and into a sample holder of a tissue sample tray (306) (shown
in FIGS. 2 and 7). Thus, tissue may be harvested from a location
proximate to lateral aperture (118) and deposited within tissue
sample holder (302). Of course tissue may be deposited at other
locations, as will be apparent to one of ordinary skill in the art
in view of the teachings herein.
[0052] Cutter (152) of the present example includes a cutter
overmold (154) that is operable to rotate and translate cutter
(152) within needle (110). In the present example, cutter overmold
(154) is formed of plastic molded about cutter (152) to fixedly
secure cutter overmold (154) to cutter (152), though any other
suitable materials may be used, and cutter overmold (154) may be
secured relative to cutter (152) using any other suitable
structures or techniques (e.g., set screws, etc.). Cutter overmold
(154) comprises a distal sealing cylinder (156), a proximal hex end
(158) and threading (159) interposed therebetween. As noted above,
distal sealing cylinder (156) is inserted into fluid junction (146)
to fluidly seal the proximal end of fluid junction (146). In some
versions, an o-ring (not shown) or other gasket (not shown) may be
disposed about distal sealing cylinder (156) to assist in fluidly
sealing the proximal end of fluid junction (146). Of course other
configurations for distal sealing cylinder (156) and/or components
to seal the proximal end of fluid junction (146) will be apparent
to one of ordinary skill in the art in view of the teachings
herein.
[0053] Threading (159) of cutter overmold (154) is configured to
engage and thread into internal threading (166) of nut member
(160). In the present example, nut member (160) is fixedly secured
relative to probe (102) such that rotation of cutter (152) engages
threading (159) and internal threading (166) to longitudinally
advance or retract cutter (152) relative to needle (110) and probe
(102). For instance, as shown in FIGS. 8-9, nut member (160)
comprises a distal square end (162) and a proximal square end (164)
each of which anchors nut member (160) to probe (102) such that nut
member (160) does not rotate or translate relative to probe (102).
Of course it should be understood that in some versions nut member
(160) may be integrally formed or affixed to probe (102). By way of
example only, threading (159, 166) may be configured to have a
pitch that provides approximately 40-50 threads per inch. Such a
thread pitch may provide a ratio of cutter (152) rotation to cutter
(152) translation that is ideal for severing tissue. Alternatively,
any other thread pitch may be used. Still further configurations of
nut member (160) will be apparent to one of ordinary skill in the
art in view of the teachings herein.
[0054] Cutter overmold (154) also includes a proximal hex end (158)
configured to insert into and engage with hex recess (172) formed
through probe gear (170). Accordingly, when probe gear (170) is
rotated, the proximal hex end (158) is rotated. This rotation
causes threading (159) to engage internal threading (166) of nut
member (160), thereby actuating cutter (152) proximally or distally
depending upon the rotation direction of probe gear (170). As noted
above, probe gear (170) extends out of the bottom of probe (102)
and is configured to mesh with holster gear (272). When probe (102)
is coupled to holster (202), cutter drive motor (270), described
above, is operable to drive cutter (152) to actuate proximally or
distally as threading (159) threads within nut member (160). Hex
end (158) is further configured such that cutter (152) and cutter
overmold (154) may translate longitudinally relative to probe gear
(170) while probe gear (170) is still operable to rotate cutter
(152) and cutter overmold (154). Accordingly, probe gear (170)
remains engaged with holster gear (272) while cutter (152) and
cutter overmold (154) actuate longitudinally. Of course it should
be understood that proximal hex end (158) and hex recess (172) are
merely optional and may comprise any other complementary components
that mesh to transfer rotational movement, including stars, teethed
gears, squares, triangles, etc.
[0055] Tissue sample holder (302), shown in FIG. 10, is coupled to
a proximal end of probe (102) and is fluidly coupled to cutter
(152) such that tissue samples are transported proximally through
cutter lumen (136) and into a sample holder (not shown) of tissue
sample trays (306). Tissue sample holder (302) may be constructed
in accordance with at least some of the teachings of U.S. Pat. No.
7,938,786, entitled "Vacuum Timing Algorithm for Biopsy Device,"
issued May 10, 2011; U.S. Pat. Pub. No. 2008/0221480, entitled
"Biopsy Sample Storage," published Sep. 11, 2008; U.S.
Non-Provisional patent application Ser. No. 13/205,189, entitled
"Access Chamber and Markers for Biopsy Device," filed Aug. 8, 2011;
U.S. Non-Provisional patent application Ser. No. 13/218,656,
entitled "Biopsy Device Tissue Sample Holder with Bulk Chamber and
Pathology Chamber," filed Aug. 26, 2011; and/or otherwise.
[0056] Tissue sample holder (302) of the present example comprises
a cover (304) containing a rotatable manifold (310) with a
plurality of tissue sample trays (306) inserted into rotatable
manifold (310). Rotatable manifold (310) comprises a plurality of
longitudinal chambers extending therethrough and annularly disposed
about rotatable manifold (310). Accordingly, each chamber can be
selectively aligned with cutter (152) and connector tube (182),
described below, such that tissue samples can be transported from
lateral aperture (118) into each chamber. Each chamber comprises an
upper longitudinal tray portion and a lower fluid portion that is
parallel and offset from the upper tray portion. Merely exemplary
chambers are shown and described in U.S. Pat. Pub. No.
2008/0221480, entitled "Biopsy Sample Storage," published Sep. 11,
2008; U.S. Non-Provisional patent application Ser. No. 13/205,189,
entitled "Access Chamber and Markers for Biopsy Device," filed Aug.
8, 2011, the disclosure of which is incorporated by reference
herein. The tray portion is configured to receive a sample holder
(308) of tissue sample trays (306) such that sample holder (308) is
configured to receive a severed tissue sample therein. Each sample
holder (308) of tissue sample trays (306) comprises a floor, a pair
of sidewalls, and a proximal wall forming a cavity that is
configured to receive a tissue sample therein. The floor,
sidewalls, and/or proximal wall include a plurality of holes (not
shown) such that fluid may be communicated from within each sample
holder (308) to the lower portion of the corresponding chamber
formed in the rotatable manifold. When a vacuum is applied to the
lower fluid portion, the vacuum is transmitted through sample
holder (308), through connector tube (182), into cutter (152) and
to lateral aperture (118). Accordingly, when the vacuum is applied,
a severed tissue sample is transported proximally by the vacuum
into a corresponding sample holder (308). Of course other
configurations for tissue sample holder (302) will be apparent to
one of ordinary skill in the art in view of the teachings herein.
In some versions, tissue sample trays (306) and/or sample holders
(308) comprise a high-contrast color compared to the color of the
tissue samples, for instance, green, red, blue, etc., such that a
user may visually detect the presence of a tissue sample within
tissue sample trays (306). In the example shown, a dedicated
passage does not receive a sample holder (308); instead, a plug
(310) is provided to selectively seal a dedicated passage.
[0057] Referring back to FIG. 9, tissue sample holder (302) is
coupled to cutter (152) by a tissue sample holder seal (180). Seal
(180) comprises a proximal wall (184) formed as a cylindrical disk
that is configured to seal a distal end of tissue sample holder
(302) to a proximal end of probe (102). By way of example only,
proximal wall (184) may comprise a resilient silicon rubber disk
against which tissue sample holder (302) may be compressed to form
a fluid-tight seal. In some versions, proximal wall (184) may
include an annular recess (not shown) sized to receive and form an
interference or compression fit with a rim of tissue sample holder
(302) to further seal tissue sample holder (302) to seal (180).
Tissue sample holder seal (180) of the present example also
includes a connector tube (182) that extends distally into probe
(102) to fluidly couple to proximal end (168) of cutter (152).
Connector tube (182) is integrally formed with a proximal wall
(184) and includes an internal passageway (183) into which proximal
end (168) of cutter (152) is inserted. In the example shown,
connector tube (182) has a sufficient longitudinal length such that
cutter (152) can actuate via cutter actuation assembly (150)
proximally and/or distally within connector tube (182) without
decoupling from connector tube (182). In the present example,
connector tube (182) is configured to fluidly seal with proximal
end (168) of cutter (152). By way of example only, connector tube
(182) may be sized to form an interference fit with proximal end
(168) of cutter (152). In addition, or in the alternative,
connector tube (182) may include one or more interior seals (not
shown), such as wiper seals, dome seals, domed-wiper seals, etc. to
fluidly couple connector tube (182) to proximal end (168) of cutter
(152).
[0058] Seal (180) also includes an aperture (186) formed through
seal (180) to fluidly couple to an outlet tube (198). In the
present example, aperture (186) is parallel to and offset from
connector tube (182). Aperture (186) is configured to align with a
lower portion of a corresponding chamber of rotatable manifold
(310), described above. Outlet tube (198) is inserted into aperture
(186) at a first end and is coupled to one or more conduits (400)
at a second end to fluidly couple aperture (186) to the one or more
conduits (400). For instance, outlet tube (198) may be coupled to a
vacuum source such that a vacuum is provided through rotatable
manifold (310), cutter (152), and to lateral aperture (118). In
addition, or in the alternative, outlet tube (198) may be coupled
to a saline source to provide saline through cutter (152) to flush
the system. Further still, outlet tube (198) may be coupled to a
medicine delivery system to provide medicine out of lateral
aperture (118) (e.g., anti-inflammatory medicines, pain medicines,
etc.).
[0059] A central opening (187) also extends through seal (180) and
is configured to permit sample holder gear (188) to extend
therethrough. In some versions, central opening (187) may include
seals (not shown), such as wiper seals, dome seals, domed-wiper
seals, etc. to fluidly seal sample holder gear (188) and seal
(180). In the present example, sample holder gear (188) is
configured to engage a portion of rotatable manifold (310), such as
a T-shaped axle, to rotate rotatable manifold (310) when sample
holder gear (188) is rotated. As noted above, sample holder motor
(280), shown in FIG. 5-6, is operable to engage and rotate
rotatable manifold (310) via the meshing of sample holder cog (214)
and sample holder gear (188) when probe (102) is coupled to holster
(202). Still other constructions for tissue sample holder seal
(180) and/or sample holder gear (188) will be apparent to one of
ordinary skill in the art in view of the teachings herein.
[0060] IV. Exemplary Operation Modes
[0061] As discussed above, user interface (526) on control module
(500) allows a user to adjust several operational modes to
selectively control operation of biopsy device (100). Exemplary
operation modes and interfaces will be described below in further
detail, while others will be apparent to those of ordinary skill in
the art in view of the teachings herein. Additional exemplary
operational modes and interfaces are disclosed in U.S. Pat. Pub.
No. 2009/0131821, entitled "Graphical User Interface For Biopsy
System Control Module," published May 21, 2009 and U.S. Pat. Pub.
No. 2009/0131820, entitled "Icon-Based User Interface On Biopsy
System Control Module," published May 21, 2009, the disclosures of
which are incorporated by reference herein.
[0062] FIG. 11 depicts user interface (526) comprising selection
bars (527, 528, 529). Each selection bar (527, 528, 529) comprises
an operation mode that a user may selectively control by using
icons (530, 534, 536, 540, 542, 546). A user may touch the screen
of user interface (526) on the selected icon to adjust and/or
select an operational mode. Other suitable methods of adjusting
and/or selecting operational modes, such as providing a button or a
switch on user interface (526) or remotely, will be apparent to one
with ordinary skill in the art in view of the teachings herein.
Indicators (532, 538, 544) on selection bars (527, 528, 529)
display the current or selected operation mode of biopsy device
(100).
[0063] Cutter selection bar (527) allows a user to select various
sequences for cutter (120). Cutter (120) is initially in a distal
position to close lateral aperture (112). Cutter (120) is then
retracted proximally to open at least a portion of aperture (112)
to allow to tissue to prolapse into aperture (112). After tissue
enters aperture (112), cutter (120) advances to the distal
position. As cutter (120) advances distally, cutter (120) severs
the tissue prolapsed into aperture (112) and closes aperture (112).
Operation of cutter (120) may be varied by a user. Cutter selection
bar (527) comprises an aperture icon (530), speed icon (534), and
aperture indicator (532). A user may use aperture icon (530) to
adjust the size of aperture (112) with cutter (120) in a manner
such that aperture (112) will not open further than a preselected
size. It may be desirable to not allow cutter (120) to fully
retract proximally in order to acquire tissue samples of a
relatively shorter length, to acquire tissue samples that are
relatively close to the surface of a patient's skin, or for other
purposes. A user may adjust this effective needle aperture (112) by
activating aperture icon (530). Each time the user activates
aperture icon (530), biopsy system (10) will make a corresponding
adjustment to the effective needle aperture (112), such as through
control module (500). Such adjustments may be incremental, such as
to provide an aperture (112) that is 50%, 75%, or 100% open, though
other increments may be used. In addition, each time the user
activates aperture icon (530), the cutter portion of aperture icon
(530) moves relative to the needle portion of aperture icon (530).
Arrows are shown above the cutter portion of aperture icon (530) to
emphasize the maximum proximal position of cutter (120) selected by
the user. A text representation (e.g., "Sm" for small aperture
(112), "Lg" for large aperture (112), etc.) may be included to
further indicate the effective aperture (112) size selected by the
user.
[0064] It may also be desirable to vary the speed of cutter (120).
A user may use speed icon (534) to adjust the translational speed
of cutter (120) in a manner such that cutter may retract proximally
and advance distally at a preselected speed. A user may adjust
cutter (120) speed by activating speed icon (534). Each time the
user activates speed icon (534), biopsy system (10) will make a
corresponding adjustment to cutter (120) speed, such as through
control module (500) (e.g. higher or lower). Such adjustments may
be incremental. Each time a user activates speed icon (534), the
arrow in speed icon (534) may move relative to the hash marks to
indicate the relative cutter (120) speed. Cutter (120) may also
dwell at the proximal position to allow a sufficient amount of
tissue to prolapse into aperture (112). The amount of time cutter
(120) dwells at the proximal position may be adjusted based on the
selected cutter (120) speed. As cutter (120) speed is increased,
cutter (120) dwell time may be reduced. As cutter (120) speed is
decreased, cutter (120) dwell time may be increased. Cutter (120)
dwell time may be adjusted simultaneously with cutter (120) speed
when a user activates speed icon (534) or cutter (120) dwell time
may be adjusted separately from cutter (120) speed using a
different icon, button, switch, etc. as will be apparent to one
with ordinary skill in the art based on the teachings herein.
[0065] Aperture indicator (532) may also be provided on user
interface (526) screen. As shown in FIG. 11, aperture indicator
(532) includes a display of a needle (110) end with a brightly lit
cutter (120). Aperture indicator (532) may indicate the current
position of cutter (120) within needle (110). As shown in FIG. 11,
aperture indicator (532) shows cutter (120) in a fully distal
position to close aperture (112). As cutter (120) is retracted
proximally, aperture indicator (532) may display cutter (120)
retracting proximally on user interface (526). This allows a user
to view the actual cutter (120) position and cutter (120) speed to
ensure that the selected settings adjusted by aperture icon (530)
and speed icon (534) have been properly applied.
[0066] Manifold selection bar (528) allows a user to select various
sequences for tissue sample holder (302). Manifold (310) of tissue
sample holder (302) may be configured to rotate after a tissue
sample is acquired, to present the tissue sample to the user for
viewing before the user acquires the next tissue sample. As merely
an illustrative example, a tissue sample may be drawn into a
chamber in manifold (310) that is in the twelve o'clock position
when the tissue sample is initially acquired. Manifold (310) is
then rotated until the tissue sample is at the three o'clock
position, thereby permitting a user to easily view the tissue
sample from the side of biopsy device (100). Such rotation may
occur substantially immediately after tissue sample is drawn to
manifold (310), or biopsy system (10) may wait to see if any user
inputs occur within a certain time period (e.g., 2 seconds) after
the tissue sample has been acquired, then rotate the tissue sample
to the three o'clock position only if no user inputs have occurred
within that time period. The rotational position of manifold (310)
may be maintained such that tissue sample is kept at the three
o'clock position until some other user input is provided. A user
may provide input indicating a desire to obtain another tissue
sample, biopsy system (10) may rotate manifold (310) to align the
next available chamber (e.g., a chamber that is immediately
adjacent to the chamber in which the most recently acquired tissue
sample resides). As an alternative to waiting for user input,
tissue sample may be kept in the three o'clock position for a
certain time (e.g., 5 seconds), with manifold (310) being
automatically rotated to align the next available chamber with
cutter (120), regardless of whether a user has provided an
input.
[0067] Manifold selection bar (528) comprises a manifold icon
(536), an advance icon (540), and a manifold indicator (538). A
user may use manifold icon (536) to adjust the rotation of manifold
(310) to view the acquired tissue sample such that manifold (310)
rotates to a predetermined position. It may be desirable to rotate
manifold (310) to various positions to view the tissue sample
depending on the user orientation of biopsy device (100) or where
the user is positioned relative to biopsy device (100). A user may
adjust the rotation of manifold (310) to view the sample by
activating manifold icon (536). Each time the user activates
manifold icon (536), biopsy system (10) will make a corresponding
adjustment to the rotation of manifold (310), such as through
control module (500). Such adjustments may be incremental, such as
to provide a rotation that is at 90 degree increments, though other
increments may be used. In addition, each time the user activates
manifold icon (536), an arrow in manifold icon (536) may light up
to indicate the corresponding 90 degree increment that the user has
selected to position manifold (310) in the tissue viewing
position.
[0068] It may also be desirable to select a predetermined chamber
in manifold (310) in which to transport the acquired tissue sample.
A user may use advance icon (540) to rotate manifold (310)
incrementally to the immediately adjacent chamber. Each time the
user activates advance icon (540), biopsy system (10) will make a
corresponding adjustment to the rotation of manifold (310), such as
through control module (500). Such adjustments may be incremental
to correspond to each chamber in manifold (310), though other
increments may be used. Manifold (310) may advance more than one
chamber at time, such as in 90 degree or 180 degree increments.
Advance icon (540) comprises a display of the chambers in manifold
(310) with a dot to illustrate the initial chamber selected to
receive a tissue sample. Each time the user activates advance icon
(540), the dot may rotate either clockwise or counterclockwise to
indicate the corresponding chamber of manifold (310) that the user
has selected to receive a tissue sample.
[0069] As shown in FIG. 11, manifold selection bar (528) comprises
manifold indicator (538). Manifold indicator (538) comprises a
display of the chambers of manifold (310). A shaded region covers
the currently selected chamber of manifold (310) to receive a
tissue sample. As manifold (310) is rotated, other chambers will
rotate on manifold indicator (538) under the shaded region. Each
chamber of manifold (310) may be numbered on manifold (310) to
easily identify a specific chamber. Accordingly, a text
representation of the number of the selected chamber of manifold
(310) to receive the tissue sample may be indicated on manifold
indicator (538) in the center of manifold indicator (538).
[0070] Vacuum selection bar (529) comprises level icon (542), clear
icon (546), and level indicator (544). Once needle (110) is
inserted into a patient with cutter (120) in the distal position,
vacuum may be applied to lateral lumen (134) and/or longitudinal
lumen (132). With the vacuum applied as described above, cutter
(120) is retracted proximally to open aperture (112), which results
in tissue prolapsing into aperture (112) under the influence of the
above-described vacuum. Cutter (120) may dwell in a retracted
position for a certain period of time to ensure sufficient prolapse
of tissue. Cutter (120) may then advance distally such that cutter
(120) closes aperture (112), the prolapsed tissue is severed and at
least initially contained within cutter lumen (136). With vacuum
applied and communicated through cutter lumen (136), severed tissue
sample may be drawn proximally through cutter lumen (136) and into
the selected chamber of manifold (310).
[0071] It may be desirable to adjust the vacuum level applied to
biopsy device (100) depending on the characteristics (hardness,
thickness, etc.) of the tissue to be sampled. A user may adjust the
vacuum level by activating level icon (542). Each time the user
activates level icon (542), biopsy system (10) will make a
corresponding adjustment to the amount of vacuum applied to biopsy
device (100), such as through control module (500). Such
adjustments may be incremental, such as to provide a selected
amount of increase or decrease to the amount of vacuum, though
other increments may be used. Level icon (542) may include a set of
ascending bars, to indicate the vacuum level of biopsy system (10).
To adjust the vacuum level of biopsy system (10), the user may
activate level icon (542). Each time the user activates level icon
(542), the vacuum level of biopsy system (10) may increase
incrementally. Such incremental increase may be indicated by
illuminating an additional bar in the set of ascending bars of
level icon (542). The number of bars that are illuminated in level
icon (542) may be indicative of the vacuum level of biopsy system
(10). If the user activates level icon (542) when all of the bars
are illuminated (e.g., which may indicate that the vacuum level is
at its highest), the level of vacuum may be significantly decreased
to the lowest level, such that only the first bar in the set of
bars is illuminated. Thus, a user may cycle through various
incremental vacuum levels by repeatedly activating level icon
(542).
[0072] At some point during use of biopsy device (100), biopsy
device (100) may exhibit signs of being jammed with tissue or other
debris. Such signs will be apparent to one with ordinary skill in
the art in view of the teachings herein. During such times, or
otherwise, it may be desirable to initiate a sequence that may
clear such tissue or debris in order to improve performance of
biopsy device (100). Clear icon (546) may be activated to initiate
such sequence. When a user activates the clear icon (546) a maximum
amount of vacuum may be applied to biopsy device (100) for a
certain period of time. Other suitable clearing methods (e.g.,
translating cutter back and forth, flushing saline, etc.) will be
apparent to one with ordinary skill in the art based on the
teachings herein.
[0073] As shown in FIG. 11, vacuum selection bar (529) comprises
level indicator (544). Level indicator (544) comprises a set of
bars in ascending heights to indicate the actual vacuum level
applied to biopsy device (100). As vacuum is applied to biopsy
device (100), a corresponding bar may be illuminated to indicate
the level of vacuum applied to biopsy device (100). Each ascending
bar indicates a level of vacuum such that illumination of a higher
bar corresponds to a higher level of vacuum, while illumination of
a lower bar corresponds to a lower level of vacuum. Accordingly, as
actual vacuum is applied to biopsy device (100), the set of bars on
level indicator (544) may illuminate to depict the level of vacuum
applied to biopsy device (100) to the user. Other suitable methods
of indication will be apparent to one with ordinary skill in the
art in view of the teachings herein.
[0074] IV. Exemplary Control
[0075] An exemplary control to operate biopsy system (10) is shown
in FIG. 12. Step (700) comprises applying a vacuum to biopsy device
(100). Control module (500) may be activated to fluidly apply
vacuum to lateral lumen (134) and/or longitudinal lumen (132) at
the vacuum level preselected by level icon (542). In step (710),
cutter (120) is retracted to a proximal position to open at least a
portion of lateral aperture (112). Cutter (120) is retracted to the
preselected proximal position by aperture icon (530) at the
preselected speed by speed icon (534). Cutter (120) may be
retracted while vacuum is being generated to biopsy device (100) or
cutter (120) may be retracted after vacuum has been generated to a
desired level to biopsy device (100). Once lateral aperture (112)
is open to the predetermined position, tissue may be prolapsed into
lateral aperture (112). Cutter (120) may dwell at a proximal
position, as shown in step (720), to allow a sufficient amount of
tissue to be prolapsed into lateral aperture (112). Step (730)
comprises advancing cutter (120) distally to close lateral aperture
(112) at the preselected speed by speed icon (534). As cutter (120)
advances distally, the prolapsed tissue in lateral aperture (112)
is severed by cutter (120) within needle (110). Cutter (120) may
optionally dither by oscillating proximally and distally to ensure
that tissue is fully severed within needle (110), as shown in step
(740). With vacuum applied to biopsy device (100) at the
preselected level by level icon (542), the severed tissue may then
be transported through cutter lumen (136) from lateral aperture
(112) to tissue sample holder (302) in step (750). The tissue
sample is deposited into the preselected chamber of manifold (310)
by advance icon (540).
[0076] Cycle time is measured by the amount of time required to
take a tissue sample. The cycle begins when vacuum is activated in
step (700) and ends when the tissue sample is deposited in tissue
sample holder (302) after step (750). The size of the tissue sample
may depend on the amount of cycle time to take a tissue sample. A
longer cycle time may allow for a larger tissue sample, while a
shorter cycle time may result in a smaller tissue sample. The size
of the tissue sample may depend on cycle time due to such factors
as the translational and/or rotational speed of cutter (120), the
dwell time of cutter (120), the amount of dithers cutter (120)
performs, the amount of vacuum pressure applied to biopsy device
(100), the amount of time to transport tissue from lateral aperture
(112) to tissue sample holder (302), etc. Other suitable factors
will be apparent to one with ordinary skill in the art in view of
the teachings herein. It may be desirable to optimize the cycle
time and/or the tissue sample size by adjusting such cycle time
factors as discussed below.
[0077] FIG. 13 depicts an exemplary control for vacuum regulation
to biopsy device (100). The control shown in FIG. 13 is similar to
the control shown in FIG. 12, except that the control of FIG. 13
has an additional step (832). Step (832) comprises applying maximum
vacuum regulation to biopsy device (100) after advancing cutter
(120) distally. As discussed above, a user may vary vacuum
regulation to biopsy device (100) by user interface (526) on
control module (500) to selectively increase or decrease vacuum
pressure. If a user has adjusted the vacuum pressure to biopsy
device (100) below the available maximum amount of vacuum pressure,
the amount of time required to transport the severed tissue sample
from lateral aperture (112) to tissue sample holder (302) may
increase because of the lower amount of vacuum pressure applied to
biopsy device (100), thus increasing the cycle time. Step (832)
overrides the vacuum pressure adjustment made by a user with user
interface (526) to apply maximum vacuum pressure to biopsy device
(100) after cutter (120) has advanced distally. By waiting to apply
maximum vacuum pressure after cutter (120) advances distally, a
user may still selectively adjust vacuum pressure to biopsy device
(100) by user interface (526) to prolapse tissue at selected levels
into lateral aperture (112). Step (832) may also be performed after
cutter (120) dithers, as shown in step (840) if a dither step is
performed.
[0078] The available maximum vacuum pressure may be determined by
comparing the ambient pressure with the maximum pressure that may
be generated with control module (500). Ambient pressure may be
measured with a pressure sensor in control module (500), on biopsy
device (100), or at other suitable sensor locations on biopsy
system (10) as will be apparent to one with ordinary skill in the
art based on the teachings herein. Maximum pressure generated by
control module (500) may be determined by fully activating vacuum
source (510) until the vacuum levels to a substantially steady
pressure. Pressure generated by control module (500) may also be
measured by a pressure sensor in control module (500), on biopsy
device (100), or at other suitable locations on biopsy system (10)
as will be apparent to one with ordinary skill in the art. The
pressure may be substantially steady when the pressure
substantially remains within a predetermined range for a
predetermined amount of time. Once the pressure generated by
control module (500) reaches a substantially steady maximum
pressure, the difference between the maximum pressure and ambient
pressure may be determined for the maximum vacuum pressure
available to biopsy device (100). The maximum vacuum pressure may
vary depending on ambient pressure, etc. A minimum amount of vacuum
pressure may be determined by the minimum amount of vacuum pressure
required to transport a tissue sample through cutter lumen (136) to
tissue sample holder (302). The control may disable biopsy device
(100) from use if the determined maximum vacuum pressure is below
the minimum amount of vacuum pressure required to transport tissue
to tissue sample holder (302).
[0079] Another exemplary control for vacuum regulation to biopsy
device (100) is shown in FIG. 14. The control shown in FIG. 14 is
similar to the control shown in FIG. 12, except that the control of
FIG. 14 measures actual vacuum pressure as depicted in step (912).
Actual vacuum pressure may be measured with a pressure sensor in
control module (500), on biopsy device (100), or at other suitable
sensor locations on biopsy system (10) as will be apparent to one
with ordinary skill in the art based on the teachings herein.
Various elements of biopsy device (100) (such as cutter (120)
rotational and/or translational speed, dwell time of cutter (120),
amount of dithers of cutter (120), amount of time to transport
tissue to tissue sample holder (302), etc.) may then be adjusted
based on the measured vacuum pressure.
[0080] Once vacuum pressure is measured in step (912), the level of
vacuum pressure may be categorized. As shown in FIG. 14, vacuum
pressure may be categorized into three levels such as relatively
low, relatively medium, and relatively high. Other suitable number
of level categories and type of categories will be apparent to one
with ordinary skill in the art based on the teachings herein. Based
on the category, biopsy system (10) may be adjusted from the
nominal user preselected settings. If the vacuum level is
categorized as relatively low, step (920) may be followed to dwell
cutter (120) for an increased amount of time above the nominal
amount of time. Next, cutter (120) may be advanced distally at a
decreased speed below the nominal speed as in step (930). Step
(940) comprises dithering cutter (120) an increased amount of
cycles above the nominal amount of cycles. At relatively low vacuum
pressure, the amount of time to transport tissue from lateral
aperture (112) to tissue sample holder (302) may be increased above
a nominal transport time as depicted in step (950). Dwelling cutter
(120) for an increased amount of time, advancing cutter (120) at a
decreased speed, dithering cutter (120) an increased amount of
times, and allowing an increased amount of tissue transport time
allows tissue to be sufficiently prolapsed into lateral aperture
(112) and transported to tissue holder (302) with a sufficient
tissue sample size with a relatively low vacuum pressure. It should
be noted that any one of steps (920, 930, 940, 950) may be applied
individually or in combination to optimize the desired tissue
sample size and cycle time at a relatively low vacuum pressure.
[0081] After step (912), if vacuum pressure is at a relatively
nominal level, the nominal or preselected settings may be used.
Cutter (120) may dwell at a proximal position for a nominal amount
of time as shown in step (922). Cutter (120) may then advance
distally at a nominal speed, step (932), and dither for a nominal
amount of cycles, step (942). Tissue may be transported to tissue
sample holder (302) in a nominal amount of time. It should be noted
that any one of steps (922, 932, 942, 952) may be applied
individually or in combination to optimize the desired tissue
sample size and cycle time at a relatively medium vacuum
pressure.
[0082] If vacuum pressure is categorized as relatively high, step
(924) may be applied, which comprises dwelling cutter (120) at a
proximal position for a decreased amount of time, or a decreased
amount of time below the nominal cutter (120) dwell time. Step
(934) comprises advancing cutter (120) distally at an increased
speed above the nominal advancement speed. The amount of cutter
(120) dither cycles may be decreased below nominal, as shown in
step (944). The amount of cutter (120) dither cycles may also be
bypassed as will be apparent to one with ordinary skill in the art
based on the teachings herein. Tissue may be transported from
lateral aperture (112) to tissue sample holder (302) in a decreased
amount of time below nominal, as in step (954). Dwelling cutter
(120) for a decreased amount of time, advancing cutter (120) at an
increased speed, decreasing cutter (120) dither cycles, and
decreasing the amount of tissue transport time allows tissue to be
sufficiently prolapsed into lateral aperture (112) and transported
to tissue sample holder (302) with a sufficient tissue sample size
at a relatively high vacuum pressure and a lower cycle time. It
should be noted that any one of steps (924, 934, 944, 954) may be
applied individually or in combination to optimize the desired
tissue sample size and cycle time at a relatively high vacuum
pressure.
[0083] Vacuum pressure may be measured after step (910), or
selectively after each step shown in FIG. 14. If vacuum pressure
levels vary between steps, vacuum pressure may be recategorized
after any step in FIG. 14 to adjust control of biopsy device (100)
after each step or a selected number of steps. As an illustrative
example, if vacuum pressure is measured in step (912) and
categorized as relatively high, step (924) may be applied to dwell
cutter (120) for an increased amount of time. If vacuum pressure is
measured again after step (924), it may be recategorized as
relatively medium and step (932) may be applied to advance cutter
(120) at a nominal speed. Vacuum pressure may be measured and/or
recategorized after any selected step. Other suitable variations
will be apparent to one with ordinary skill in the art in view of
the teachings herein.
[0084] Another exemplary control for biopsy device (100) is
depicted in FIG. 15. The exemplary control shown in FIG. 15 is
similar to the exemplary control of FIG. 14, except that maximum
vacuum regulation is applied after closing lateral aperture (112).
Similarly to the control of FIG. 14, the control of FIG. 15
measures vacuum pressure in step (1012) and categorizes the level
of vacuum pressure into three categories, such as relatively low,
relatively medium, and relatively high. Other suitable number of
level categories and type of categories will be apparent to one
with ordinary skill in the art based on the teachings herein. As
described above, if vacuum pressure is relatively low, cutter (120)
may dwell at a proximal position for an increased amount of time
(step 1020) and/or cutter (120) may be advanced distally at a
decreased speed (step 1030). If vacuum pressure is relatively
medium, cutter (120) may dwell for a nominal amount of time (step
1022) and/or cutter (120) may be advanced proximally at a nominal
speed (step 1032). If vacuum pressure is relatively high, cutter
(120) may dwell at a proximal position for a decreased amount of
time (step 1024) and/or cutter (120) may be advanced distally at an
increased speed (step 1034). Any one of steps (1020, 1022, 1024,
1030, 1032, 1034) may be applied individually or in combination to
optimize the desired tissue sample size and cycle time.
[0085] Vacuum pressure may be measured after step (1010), or
selectively after each step shown in FIG. 15. If vacuum pressure
levels vary between steps, vacuum pressure may be recategorized
after any step in FIG. 14 to adjust control of biopsy device (100)
after each step or a selected number of steps. As an illustrative
example, if vacuum pressure is measured in step (1012) and
categorized as relatively high, step (1024) may be applied to dwell
cutter (120) for an increased amount of time. If vacuum pressure is
measured again after step (1024), it may be recategorized as
relatively medium and step (1032) may be applied to advance cutter
(120) at a nominal speed. Vacuum pressure may be measured and/or
recategorized after any selected step. Other suitable variations
will be apparent to one with ordinary skill in the art in view of
the teachings herein.
[0086] Once cutter (120) is advanced to a distal position to close
lateral aperture (112) and sever tissue, maximum vacuum regulation
may be applied to biopsy device (100) (step (1040). As discussed
above, a user may vary vacuum regulation to biopsy device (100) by
adjusting user interface (526) on control module (500) to
selectively increase or decrease vacuum pressure. If a user has
adjusted the vacuum pressure to biopsy device (100) below the
available maximum amount of vacuum pressure, the amount of time
required to transport the severed tissue sample from lateral
aperture (112) to tissue sample holder (302) may increase because
of the lower amount of vacuum pressure applied to biopsy device
(100), thus increasing the cycle time. Step (1040) overrides the
vacuum pressure adjustment made by a user with user interface (526)
to apply maximum vacuum pressure to biopsy device (100) after
cutter (120) has advanced distally. With maximum vacuum pressure
applied to biopsy device (100), cutter (120) dither may be
decreased or bypassed (step 1044) and/or a minimum amount of time
to transport tissue from lateral aperture (112) to tissue sample
holder (302) may be applied (step 1050). Steps (1044) and (1050)
may decrease cycle time while still allowing a desired tissue
sample size. By waiting to apply maximum vacuum pressure after
cutter (120) advances distally, a user may still selectively adjust
vacuum pressure to biopsy device (100) by user interface (526) to
prolapse tissue at selected levels into lateral aperture (112). Any
one of steps (1044, 1050) may be applied individually or in
combination to optimize the desired tissue sample size and cycle
time.
[0087] 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.
[0088] Embodiments of the present invention have application in
conventional endoscopic and open surgical instrumentation as well
as application in robotic-assisted surgery.
[0089] By way of example only, embodiments described herein may be
processed before surgery. First, a new or used instrument may be
obtained and if necessary cleaned. The instrument may then be
sterilized. In one sterilization technique, the instrument is
placed in a closed and sealed container, such as a plastic or TYVEK
bag. The container and instrument may then be placed in a field of
radiation that can penetrate the container, such as gamma
radiation, x-rays, or high-energy electrons. The radiation may kill
bacteria on the instrument and in the container. The sterilized
instrument may then be stored in the sterile container. The sealed
container may keep the instrument sterile until it is opened in a
medical facility. A device may also be sterilized using any other
technique known in the art, including but not limited to beta or
gamma radiation, ethylene oxide, or steam.
[0090] Embodiments of the devices disclosed herein can be
reconditioned for reuse after at least one use. Reconditioning may
include any combination of the steps of disassembly of the device,
followed by cleaning or replacement of particular pieces, and
subsequent reassembly. In particular, embodiments of the devices
disclosed herein may be disassembled, and any number of the
particular pieces or parts of the devices may be selectively
replaced or removed in any combination. Upon cleaning and/or
replacement of particular parts, embodiments of the devices may be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning of a
device may utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
[0091] Having shown and described various embodiments of the
present invention, further adaptations of the methods and systems
described herein may be accomplished by appropriate modifications
by one of ordinary skill in the art without departing from the
scope of the present invention. Several of such potential
modifications have been mentioned, and others will be apparent to
those skilled in the art. For instance, the examples, embodiments,
geometrics, materials, dimensions, ratios, steps, and the like
discussed above are illustrative and are not required. Accordingly,
the scope of the present invention should be considered in terms of
the following claims and is understood not to be limited to the
details of structure and operation shown and described in the
specification and drawings.
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