U.S. patent application number 13/737175 was filed with the patent office on 2013-05-16 for biopsy device with auxiliary vacuum source.
This patent application is currently assigned to Devicor Medical Products, Inc.. The applicant listed for this patent is Devicor Medical Products, Inc.. Invention is credited to Kory A. Gunnerson, John A. Hibner, Trevor W.V. Speeg.
Application Number | 20130123663 13/737175 |
Document ID | / |
Family ID | 44477104 |
Filed Date | 2013-05-16 |
United States Patent
Application |
20130123663 |
Kind Code |
A1 |
Hibner; John A. ; et
al. |
May 16, 2013 |
BIOPSY DEVICE WITH AUXILIARY VACUUM SOURCE
Abstract
A biopsy device includes a body, a needle, a hollow cutter, a
vacuum pump, and a tissue sample holder. The needle extends
distally from the body. The hollow cutter is movable relative to
the needle to sever a tissue sample. The vacuum pump is carried by
the body. The tissue sample holder is supported on the body and
disposed proximally of the needle and receives tissue samples
severed by the cutter. The tissue sample holder is in fluid
communication with the vacuum pump and an external source of
vacuum.
Inventors: |
Hibner; John A.; (Mason,
OH) ; Speeg; Trevor W.V.; (Williamsburg, OH) ;
Gunnerson; Kory A.; (West Lafayette, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Devicor Medical Products, Inc.; |
Cincinnati |
OH |
US |
|
|
Assignee: |
Devicor Medical Products,
Inc.
Cincinnati
OH
|
Family ID: |
44477104 |
Appl. No.: |
13/737175 |
Filed: |
January 9, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12709695 |
Feb 22, 2010 |
8376957 |
|
|
13737175 |
|
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Current U.S.
Class: |
600/566 |
Current CPC
Class: |
A61B 10/0283 20130101;
A61B 2010/0208 20130101; A61B 10/0275 20130101 |
Class at
Publication: |
600/566 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A biopsy device comprising: a body; a needle extending distally
from the body; a hollow cutter movable relative to the needle to
sever a tissue sample; a vacuum pump carried by the body; and a
tissue sample holder supported on the body and disposed proximally
of the needle and configured to receive tissue samples severed by
the cutter; wherein the tissue sample holder is configured for
fluid communication with the vacuum pump, and wherein the tissue
sample holder is also configured for fluid communication with an
external source of vacuum.
2. The biopsy device of claim 1 wherein the tissue sample holder
comprises a tissue receiving member removable from the biopsy
device.
3. The biopsy device of claim 1 wherein the tissue sample holder
comprises an outer portion and a tissue sample receiving tray
disposed within the outer portion and removable from the outer
portion.
4. The biopsy device of claim 1 wherein the tissue sample holder
comprises an outer cup, a cap disposed on a proximal end of the
outer cup, and a collection tray disposed at least partially within
the outer cup.
5. The biopsy device of claim 5 wherein the outer cup is in fluid
communication with the external source of vacuum.
6. The biopsy device of claim 1 wherein the vacuum pump carried by
the body is operable to communicate vacuum to the cutter via the
tissue sample holder.
7. The biopsy device of claim 1 wherein the tissue sample holder is
configured to convey vacuum from an external source of vacuum to
the cutter.
8. A biopsy device comprising: a body; a needle extending distally
from the body; a hollow cutter movable relative to the needle to
sever a tissue sample; a vacuum pump disposed within the body; and
a tissue sample holder disposed on a proximal portion of the body
and configured to receive tissue samples severed by the cutter;
wherein the tissue sample holder comprises a collection tray, a
port in communication with the vacuum pump disposed within the
body, and a port configured for providing communication with an
external source of vacuum.
9. The biopsy device of claim 8 wherein the external source of
vacuum is in fluid communication with the cutter.
10. The biopsy device of claim 8 further comprising a fluid
canister in communication with the biopsy device.
11. The biopsy device of claim 10 wherein the external source of
vacuum is coupled with the fluid canister.
12. The biopsy device of claim 11 wherein the fluid canister
comprises a first port coupling the external source of vacuum with
the fluid canister and a second port coupling the biopsy device
with the fluid canister.
13. The biopsy device of claim 12 further comprising a first
flexible conduit coupling the fluid canister with the external
source of vacuum and a second flexible conduit coupling the fluid
canister with the biopsy device.
14. The biopsy device of claim 11 wherein the vacuum pump, the
fluid canister, and the external source of vacuum are all in fluid
communication with the tissue sample holder.
15. The biopsy device of claim 11 wherein the fluid canister
comprises a hydrophobic filter, wherein the hydrophobic filter is
configured to substantially isolate the external vacuum source from
liquids communicated to the fluid canister while permitting the
external vacuum source to induce a vacuum.
16. A biopsy device comprising: a reusable portion comprising a
battery, at least one motor powered by the battery, and a vacuum
pump; a disposable portion releasably attachable to the reusable
portion, the disposable portion comprising a needle adapted for
insertion into tissue and a hollow cutter for severing a tissue
sample; and a tissue sample holder for receiving tissue samples
severed by the cutter; wherein the tissue sample holder is adapted
for fluid communication with the vacuum pump upon attachment of the
disposable portion to the reusable portion, and wherein the tissue
sample holder is configured to receive vacuum from at least one
external vacuum source.
17. The biopsy device of claim 16 wherein the biopsy device is
operable to suction severed tissue samples through the hollow
cutter to the tissue sample holder.
18. The biopsy device of claim 16 wherein the motor is operable to
simultaneously drive both the cutter and the vacuum pump.
19. The biopsy device of claim 16 wherein the cutter is configured
to simultaneously rotate and translate within needle.
20. The biopsy device of claim 16 wherein the external vacuum
source is configured to activate simultaneously with the vacuum
pump.
Description
PRIORITY
[0001] This application is a continuation of U.S. application Ser.
No. 12/709,695, filed Feb. 22, 2010, entitled "Biopsy Device with
Auxiliary Vacuum Source," published as U.S. Pub. No. 2011/0208086,
the disclosure of which is incorporated by reference herein.
BACKGROUND
[0002] 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.
[0003] 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. Pub. No. 2003/0109803,
entitled "MRI Compatible Surgical Biopsy Device," published Jun.
12, 2003; U.S. Pub. No. 2006/0074345, entitled "Biopsy Apparatus
and Method," published Apr. 6, 2006; U.S. Pub. No. 2007/0118048,
entitled "Remote Thumbwheel for a Surgical Biopsy Device,"
published May 24, 2007; U.S. Pub. No. 2008/0214955, entitled
"Presentation of Biopsy Sample by Biopsy Device," published Sep. 4,
2008; U.S. Pub. No. 2009/0171242, entitled "Clutch and Valving
System for Tetherless Biopsy Device," published Jul. 2, 2009; U.S.
Non-Provisional patent application Ser. No. 12/335,578, entitled
"Hand Actuated Tetherless Biopsy Device with Pistol Grip," filed
Dec. 16, 2008; U.S. Non-Provisional patent application Ser. No.
12/337,942, entitled "Biopsy Device with Central Thumbwheel," filed
Dec. 18, 2008; and U.S. Non-Provisional patent application Ser. No.
12/483,305, entitled "Tetherless Biopsy Device with Reusable
Portion," filed Jun. 12, 2009. 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.
[0004] While several systems and methods have been made and used
for obtaining a biopsy sample, it is believed that no one prior to
the inventors has made or used the invention described in the
appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] While the specification concludes with claims which
particularly point out and distinctly claim the invention, it is
believed the present invention 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:
[0006] FIG. 1 depicts a perspective view of an exemplary biopsy
system including a biopsy device, fluid canister, and auxiliary
vacuum source;
[0007] FIG. 2 depicts a perspective view of the biopsy device of
the biopsy system of FIG. 1, with a probe portion separated from a
holster portion;
[0008] FIG. 3 depicts a side cross-sectional view of the biopsy
device of FIG. 2, with the probe portion separated from the holster
portion;
[0009] FIG. 4 depicts an exploded view of the biopsy device
components of FIG. 3, with portions shown in cross-section, and
with a battery and a circuit board removed;
[0010] FIG. 5 depicts a side cross-sectional view of the biopsy
device of FIG. 2;
[0011] FIG. 6 depicts an exploded view of cutter and needle
components of the biopsy device of FIG. 2, with portions shown in
cross-section.
[0012] FIG. 7 depicts a side cross-sectional view of the fluid
canister of the biopsy system of FIG. 1.
[0013] The drawings are not intended to be limiting in any way, and
it is contemplated that various embodiments of the invention 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 invention, and together with the
description serve to explain the principles of the invention; it
being understood, however, that this invention is not limited to
the precise arrangements shown.
DETAILED DESCRIPTION
[0014] The following description of certain examples of the
invention should not be used to limit the scope of the present
invention. Other examples, features, aspects, embodiments, and
advantages of the invention 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 invention. As will be realized, the invention is capable of
other different and obvious aspects, all without departing from the
invention. Accordingly, the drawings and descriptions should be
regarded as illustrative in nature and not restrictive.
[0015] Overview
[0016] As shown in FIG. 1, an exemplary biopsy system (1000)
comprises a biopsy device (10), a fluid canister (300), and an
auxiliary vacuum source (400). Fluid canister (300) and an
auxiliary vacuum source (400) will be described in greater detail
below. As shown in FIGS. 1-3, biopsy device (10) of the present
example comprises a needle (20), a body (30), and a tissue sample
holder (40). In particular, needle (20) extends distally from the
distal portion of body (30), while tissue sample holder (40)
extends proximally from the proximal portion of body (30). Body
(30) is sized and configured such that biopsy device (10) may be
operated by a single hand of a user. In particular, and as
described in greater detail below, a user may grasp body (30) with
a single hand, insert needle (20) 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 body (30) 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
(20) in the patient's breast. Such tissue samples may be
pneumatically deposited in tissue sample holder (40), as described
in greater detail below, then retrieved from tissue sample holder
(40) for analysis.
[0017] Body (30) of the present example comprises a probe (12) and
a holster (14). As shown in FIGS. 2-3, and as described in greater
detail below, probe (12) is separable from holster (14). In
particular, probe (12) and holster (14) may be removably coupled
using bayonet mounts (not shown) or any other suitable structures
or features. Use of the term "holster" herein should not be read as
requiring any portion of probe (12) to be inserted into any portion
of holster (14). Indeed, in some variations of biopsy device (10),
probe (12) may simply sit on holster (14). In some other
variations, a portion of holster (14) may be inserted into probe
(12). Furthermore, in some biopsy devices (10), probe (12) and
holster (14) may be of unitary or integral construction, such that
the two components cannot be separated. By way of example only, in
versions where probe (12) and holster (14) are provided as
separable components, probe (12) may be provided as a disposable
component, while holster (14) may be provided as a reusable
component. Still other suitable structural and functional
relationships between probe (12) and holster (14) will be apparent
to those of ordinary skill in the art in view of the teachings
herein.
[0018] Some variations of biopsy device (10) may include one or
more sensors (not shown), in probe (12) and/or in holster (14),
that is/are configured to detect when probe (12) is coupled with
holster (14). Such sensors or other features may further be
configured to permit only certain types of probes (12) and holsters
(14) to be coupled together. In addition or in the alternative,
such sensors may be configured to disable one or more functions of
probes (12) and/or holsters (14) until a suitable probe (12) and
holster (14) are coupled together. Of course, such sensors and
features may be varied or omitted as desired.
[0019] While examples described herein refer to the acquisition of
biopsy samples from a patient's breast, it should be understood
that biopsy device (10) 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.
[0020] Exemplary Needle
[0021] As shown in FIGS. 1-6, needle (20) of the present example
comprises a cannula (21) with a tissue piercing tip (22), a lateral
aperture (24), a first lumen (26), and a second lumen (28). Tissue
piercing tip (22) is configured to pierce and penetrate tissue,
without requiring a high amount of force, and without requiring an
opening to be pre-formed in the tissue prior to insertion of tip
(22). A cutter (50) is disposed in first lumen (26), and is
operable to rotate and translate within first lumen (26) as will be
described in greater detail below. Lateral aperture (24) is located
proximal to tip (22), is in fluid communication with first lumen
(26), and is configured to receive tissue when needle (20) is
inserted in a breast and when a cutter (50) is retracted as will
also be described in greater detail below. A plurality of openings
(27) may provide fluid communication between first and second
lumens (26, 28). A plurality of external openings (not shown) may
also be formed in needle (20), and may be in fluid communication
with second lumen (28). Examples of such external openings are
disclosed in U.S. Pub. No. 2007/0032742, entitled "Biopsy Device
with Vacuum Assisted Bleeding Control," published Feb. 8, 2007, the
disclosure of which is incorporated by reference herein. Of course,
as with other components described herein, such external openings
are merely optional.
[0022] Needle (20) of the present example further comprises a hub
(200), as shown in FIGS. 3-6. Hub (200) may be formed of plastic
that is overmolded about needle (20) or otherwise secured to needle
(20), such that hub (200) is unitarily secured to needle (20).
Alternatively, hub (200) may be formed of any other suitable
material through any suitable process and may have any other
suitable relationship with needle (20).
[0023] Hub (200) of the present example comprises a sleeve portion
(204). Sleeve portion (204) extends integrally into probe portion
(12) of body (30). As shown in FIGS. 3-5, sleeve portion (204)
defines a hollow interior (206), which is in fluid communication
with second lumen (28) of needle (20). Sleeve portion (204) also
defines a plurality of openings (208), which are radially spaced
about the perimeter of sleeve portion (204) at a common
longitudinal position, and which are in fluid communication with
hollow interior (206). Openings (208) are exposed to ambient air,
such that openings (208) provide a vent in the present example.
Openings (208) are selectively fluidly coupled with second lumen
(28) of needle (20) in this example, as will be described in
greater detail below. In particular, openings (208) are selectively
coupled with second lumen (28) during use of biopsy device (10), to
selectively provide venting to second lumen (28). A pair of o-rings
(210) are positioned about a shuttle valve slider (152), to
substantially seal second lumen (28) relative to openings (208)
when second lumen (28) is not to be vented, depending on the
longitudinal position of slider (152) as will be described in
greater detail below. A seal (212) is also provided at the proximal
end of sleeve (204), at the interface of cutter (50) and sleeve
(204). Seal (212) is configured to substantially seal the interface
of cutter (50) and sleeve (204), even as cutter (50) rotates and
translates relative to sleeve (204). In particular, seal (212)
sealingly engages a smooth portion (254) of a sleeve (250) that is
unitarily secured to cutter (50). Sleeve (250) further comprises a
hex portion (252).
[0024] Other suitable, features, components, and configurations for
needle (20) and hub (200) will be apparent to those of ordinary
skill in the art in view of the teachings herein. For instance,
needle (20) and/or hub (200) may be configured in accordance with
any of the teachings in U.S. Non-Provisional patent application
Ser. No. 12/483,305, entitled "Tetherless Biopsy Device with
Reusable Portion," filed Jun. 12, 2009, the disclosure of which is
incorporated by reference herein. Still other ways in which needle
(20) and/or hub (200) may be formed, including alternative
techniques, materials, features, components, configurations,
functionalities, and operabilities, will be apparent to those of
ordinary skill in the art in view of the teachings herein.
[0025] Exemplary Body
[0026] As noted above, body (30) of the present example comprises a
probe portion (12) and a holster portion (14). In the present
example, a battery (not shown), a first circuit board (35), a
second circuit board (not shown), a motor (36), and a vacuum pump
(38) are provided within probe portion (12). The battery may
comprise a rechargeable battery, a non-rechargeable battery, or any
other type of battery. In other versions, biopsy device (10) is
powered by some other source, such as a conventional AC power
source or piece of capital equipment, such that the battery is
merely optional. The battery is coupled with motor (36) via first
circuit board (35), second circuit board (not shown) and a trigger
button (not shown) in the present example. The battery may be
similar to the battery disclosed in U.S. Non-Provisional patent
application Ser. No. 12/483,305, entitled "Tetherless Biopsy Device
with Reusable Portion," filed Jun. 12, 2009, the disclosure of
which is incorporated by reference herein.
[0027] As shown in FIGS. 3-5, motor (36) of the present example is
in mechanical communication with vacuum pump (38) and a cutter
actuation mechanism (60). In particular, motor (36) is operable to
simultaneously activate vacuum pump (38) and cutter actuation
mechanism (60) when motor (36) is activated. Alternatively, vacuum
pump (38) and cutter rotation mechanism (60) may be activated in
any other suitable fashion. By way of example only, vacuum pump
(38) and/or cutter rotation mechanism (60) may be activated
manually and/or by separate motors and/or in any other suitable
fashion. Motor (36) of the present example comprises a conventional
DC motor. However, it should be understood that motor (36) may
alternatively comprise a pneumatic motor (e.g., with impeller,
etc.), a pneumatic linear actuator, an electromechanical linear
actuator, or a variety of other types of movement-inducing devices.
Various suitable ways in which other types of movement-inducing
devices may be incorporated into biopsy device (10) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0028] As shown in FIGS. 3-5, a drive shaft (62) extends from motor
(36), and is rotationally driven by motor (36). A pair of bearings
(70) and a drive gear (72) are positioned about drive shaft (62).
Bearings (70) support drive shaft (62), while drive gear (72)
rotates unitarily with drive shaft (62). In particular, motor (36)
may be selectively activated to rotate drive shaft (62) and drive
gear (72) in either rotational direction. Drive gear (72) meshes
with a second gear (74), which is unitarily secured to a second
shaft (64). Second shaft (64) also includes associated bearings
(70) and a third gear (76). Second shaft (64) and gears (74, 76)
rotate unitarily, such that motor (36) is operable to rotatingly
drive second shaft (64) and gears (74, 76) via drive shaft (62) and
drive gear (72).
[0029] Vacuum pump (38) of the present example comprises a
conventional diaphragm pump. In particular, a second shaft (64),
which is rotationally driven by motor (36) as described above, is
coupled with an eccentric disk (not shown--e.g., a device for
converting circular motion into rectilinear motion, comprising a
disk fixed off-center to second shaft (64)), which is configured to
cause a rod (not shown--e.g., the rod may be coupled with or
otherwise driven by the eccentric disk) of vacuum pump (38) to
reciprocate as motor (36) and shafts (62, 64) rotate. This rod of
vacuum pump (38) drives a diaphragm (not shown) of vacuum pump (38)
as the rod reciprocates, causing vacuum pump (38) to induce a
vacuum. It should be understood that vacuum pump (38) of the
present example operates in the same way regardless of which
direction motor (36) rotates. Of course, any other suitable type of
vacuum pump may be used. Vacuum pump (38) of the present example is
operable to induce a vacuum in tissue sample holder (40) when
vacuum pump (38) is activated, as will be described in greater
detail below. Cutter actuation mechanism (60) is operable to rotate
and translate cutter (50) when cutter rotation mechanism (60) is
activated, as will also be described in greater detail below. In
particular, cutter actuation mechanism (60) is operable to cause
cutter (50) to rotate within first lumen (26) and concomitantly
cause cutter (50) to translate within first lumen (26), such as to
sever a biopsy sample from tissue protruding through lateral
aperture (24).
[0030] Other suitable, features, components, and configurations for
body (30) and its associated components will be apparent to those
of ordinary skill in the art in view of the teachings herein. For
instance, body (30) and/or one or more components of body (30) may
be configured in accordance with any of the teachings in U.S.
Non-Provisional patent application Ser. No. 12/483,305, entitled
"Tetherless Biopsy Device with Reusable Portion," filed Jun. 12,
2009, the disclosure of which is incorporated by reference herein.
Still other ways in which body (30) and/or its associated
components may be formed, including alternative techniques,
materials, features, components, configurations, functionalities,
and operabilities, will be apparent to those of ordinary skill in
the art in view of the teachings herein.
[0031] Exemplary Valve Mechanism
[0032] As shown in FIGS. 3-6, biopsy device (10) also includes a
valve mechanism (150) in the present example. Valve mechanism (150)
may be similar to the valve mechanism disclosed in U.S.
Non-Provisional patent application Ser. No. 12/483,305, entitled
"Tetherless Biopsy Device with Reusable Portion," filed Jun. 12,
2009, the disclosure of which is incorporated by reference herein.
Valve mechanism (150) of this example comprises shuttle valve
slider (152), o-rings (210), and sleeve (204) of needle hub (200).
Shuttle valve slider (152) is positioned coaxially about cutter
(50), and is configured to translate relative to sleeve (204) and
relative to cutter (50). Shuttle valve slider (152) defines an
inner diameter that is greater than the outer diameter defined by
cutter (50), such that a gap is provided between the outer diameter
of cutter (50) and the inner diameter of shuttle valve slider
(152). Such a gap is sufficient to provide longitudinal fluid
communication (e.g., atmospheric air, etc.) between the outer
diameter of cutter (50) and the inner diameter of shuttle valve
slider (152). In addition, the proximal end of shuttle valve slider
(152) has notches (153) formed in it, providing an appearance
similar to that of a castellated nut or castle nut.
[0033] As shown, stop member (55) and shuttle valve slider (152)
are configured such that stop member (55) may push shuttle valve
slider (152) proximally when stop member (55) is engaged with
shuttle valve slider (152); while sleeve (250) and shuttle valve
slider (152) are configured such that sleeve (250) may push shuttle
valve slider (152) distally when sleeve (250) is engaged with
shuttle valve slider (152). However, the distance between the
distal end of sleeve (250) and the proximal end of stop member (55)
is greater than the length of shuttle valve slider (152), such that
there is a degree of "lost motion" between shuttle valve slider
(152) and cutter (50) as cutter (50) translates in the present
example. Accordingly, shuttle valve slider (152) and the other
components of valve mechanism (150) may be configured to allow
shuttle valve slider (152) to selectively substantially seal second
lumen (28) relative to openings (208) when cutter (50) is in a
proximal position and to selectively vent second lumen (28) to
atmosphere when cutter (50) is at other positions.
[0034] It should be understood that, as with other components
described herein, valve mechanism (150) may be varied, modified,
substituted, or supplemented in a variety of ways; and that valve
mechanism (150) may have a variety of alternative features,
components, configurations, and functionalities. Suitable
alternative versions, features, components, configurations, and
functionalities of valve mechanism (150) will be apparent to those
of ordinary skill in the art in view of the teachings herein. By
way of example only, valve mechanism (150) and/or any of its
components may be configured in accordance with any of the
teachings in U.S. Non-Provisional patent application Ser. No.
12/483,305, entitled "Tetherless Biopsy Device with Reusable
Portion," filed Jun. 12, 2009, the disclosure of which is
incorporated by reference herein.
[0035] Exemplary Tissue Sample Holder
[0036] As shown in FIGS. 1-6, tissue sample holder (40) of the
present example comprises a cap (42), an outer cup (44), and a
collection tray (46). Tissue sample holder (40) provides a fluid
management system that is configured to facilitate separation of
tissue samples from associated fluids as will be described in
greater detail below. Cup (44) is secured to probe (12) in the
present example. Such engagement may be provided in any suitable
fashion (e.g., snap fitting, complementary rigid locking features,
etc.). Outer cup (44) of the present example is substantially
transparent, allowing the user to view tissue samples on collection
tray (46), though outer cup (44) may have any other suitable
properties if desired.
[0037] Outer cup (44) is in fluid communication with cutter lumen
(52) and with vacuum pump (38) in the present example. In
particular, outer cup (44) is in fluid communication with cutter
lumen (52) via a first port (45); and is in fluid communication
with vacuum pump (38) via a second port (47). A conduit (39)
couples port (41) of vacuum pump (38) with second port (47) of
outer cup (44). A spring-loaded seal (not shown) or other feature
may optionally be provided on conduit (39) and/or second port (47)
and/or port (41) of vacuum pump (38), to substantially seal tissue
sample holder (40) and/or vacuum pump (38) when conduit (39) is
disconnected from tissue sample holder (40) or vacuum pump (38)
and/or when probe (12) is decoupled from holster (14). In the
present example, second port (47) is further coupled with a
hydrophobic filter (48), which is in fluid communication with the
interior space defined by outer cup (44). Hydrophobic filter (48)
is configured to permit vacuum pump (38) to induce a vacuum in
tissue sample holder (40) while preventing liquids from being
communicated from tissue sample holder (40) to vacuum pump (38). In
addition to or in lieu of having hydrophobic filter (48) a highly
absorbent material (e.g., hydrophilic member) may be provided in
tissue sample holder (40) to soak up liquids. Alternatively,
liquids may be dealt with in any other suitable fashion. As
described in greater detail below, the vacuum created in tissue
sample holder (40) by vacuum pump (38) is communicated to cutter
(50) in the present example. In particular, vacuum pump (38) may be
used to induce a vacuum in cutter lumen (52); with such a vacuum
being communicated through conduit (39), ports (41, 45, 47), and
the interior of outer cup (44).
[0038] As shown in FIG. 1, outer cup (44) is also in fluid
communication with fluid canister (300), which is further in fluid
communication with auxiliary vacuum source (400). In particular,
and as shown in FIGS. 3-5, outer cup (44) includes a third port
(49). A conduit (320) is coupled with third port (49) and with
fluid canister (300), such that conduit (320) provides fluid
communication from outer cup (44) to fluid canister (300). Conduit
(320) may comprise a flexible tube or other type of structure. As
will be described in greater detail below, fluid canister (300) is
coupled with auxiliary vacuum source (400) via a conduit (340),
such that conduit (340) provides fluid communication from auxiliary
vacuum source (400). Thus, a vacuum generated by auxiliary vacuum
source (400) may be communicated to outer cup (44) via conduits
(320, 340) and via vacuum canister (300). It should be understood
that the vacuum created in tissue sample holder (40) by auxiliary
vacuum source (400) is further communicated to cutter (50) in the
present example. In particular, auxiliary vacuum source (400) may
be used to induce a vacuum in cutter lumen (52); with such a vacuum
being communicated through conduits (320, 340), vacuum canister
(300), ports (45, 49), and the interior of outer cup (44).
Auxiliary vacuum source (400) may therefore provide a vacuum
supplementing or substituting the vacuum provided by vacuum pump
(38).
[0039] Fluids communicated to outer cup (44) (e.g., bodily fluids
and/or saline communicated proximally through cutter lumen (52),
etc.) may drain into fluid canister (300), which may collect such
fluids during the course of one or more tissue sampling procedures.
A spring-loaded seal (not shown), removable cap (not shown), and/or
other feature may optionally be provided on third port (49), to
substantially seal third port (49) when conduit (320) is
disconnected from tissue sample holder (40). For instance, fluid
canister (300) or auxiliary vacuum source (400) may be unnecessary
or undesired in some settings. Allowing third part (49) to be
selectively substantially sealed may thus allow the user to operate
biopsy device (10) in a manner where biopsy device (10) is
completely "untethered" to external components such as fluid
canister (300) or auxiliary vacuum source (400). It should
therefore be understood that fluid canister (300) and auxiliary
vacuum source (400) are each merely optional components. Biopsy
device (10) may be used with both fluid canister (300) and
auxiliary vacuum source (400); with just one of fluid canister
(300) or auxiliary vacuum source (400); or with neither of fluid
canister (300) or auxiliary vacuum source (400). Fluid canister
(300) and auxiliary vacuum source (400) will be described in
greater detail below.
[0040] Cap (42) is removably coupled with outer cup (44) in the
present example. A pair of latches (56) provide selective
engagement between cap (42) and outer cup (44). In particular,
latches (56) engage a lip (57) of outer cup (44). Lip (57) has gaps
(59) permitting passage of latches (56), such that a user may
secure cap (42) to outer cup (44) by aligning latches (56) with
gaps (59), pushing cap (42) onto outer cup (44), then rotating cap
(42) past gaps (59) to engage latches (56) with lip (57).
Alternatively, cap (42) may be secured to outer cup (44) in any
other suitable fashion. An o-ring (53) provides a seal when cap
(42) is engaged with outer cup (44). A vacuum may thus be
maintained within outer cup (44) when cap (42) is secured to outer
cup (44). In operation, a user may remove cap (42) to access tissue
samples that have gathered on collection tray (46) during a biopsy
process. In the present example, cap (42) is removed by rotating
cap (42) to align latches (56) with gaps (59), then pulling cap
(42) off. Of course, cap (42) may be removed from outer cup (44) in
any other suitable fashion.
[0041] Tissue sample holder (40) of the present example is
configured to hold at least ten tissue samples. Alternatively,
tissue sample holder (40) may be configured to hold any other
suitable number of tissue samples. It should be understood that, as
with other components described herein, tissue sample holder (40)
may be varied, modified, substituted, or supplemented in a variety
of ways; and that tissue sample holder (40) may have a variety of
alternative features, components, configurations, and
functionalities. For instance, tissue sample holder (40) may be
alternatively configured such that it has a plurality of discrete
tissue sample compartments that may be selectively indexed to
cutter lumen (52). Such indexing may be provided automatically or
manually. By way of example only, tissue sample holder (40) may be
configured and operable in accordance with the teachings of U.S.
Pub. No. 2008/0195066, entitled "Revolving Tissue Sample Holder for
Biopsy Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein; U.S. Non-Provisional patent
application Ser. No. 12/337,997, entitled "Tissue Biopsy Device
with Rotatably Linked Thumbwheel and Tissue Sample Holder," filed
Dec. 18, 2008; U.S. Non-Provisional patent application Ser. No.
12/337,911, entitled "Biopsy Device with Discrete Tissue Chambers,"
filed Dec. 18, 2008, the disclosure of which is incorporated by
reference herein; or U.S. Non-Provisional patent application Ser.
No. 12/337,874, entitled "Mechanical Tissue Sample Holder Indexing
Device," filed Dec. 18, 2008, the disclosure of which is
incorporated by reference herein. Other suitable alternative
versions, features, components, configurations, and functionalities
of tissue sample holder (40) will be apparent to those of ordinary
skill in the art in view of the teachings herein. Alternatively,
tissue sample holder (40) may simply be omitted, if desired.
[0042] Exemplary Cutter
[0043] As shown in FIGS. 1-6, cutter (50) of the present example is
substantially hollow, such that cutter (50) defines a cutter lumen
(52). Cutter (50) also has a substantially sharp distal edge (51),
such that cutter (50) is operable to sever a biopsy sample from
tissue protruding through lateral aperture (24) of needle (20).
Alternatively, the distal end of cutter (50) may have any other
suitable configuration. As shown in FIGS. 3-5, a proximal portion
of cutter (50) extends into tissue sample holder (40). A vacuum
created in tissue sample holder (40) by vacuum pump (38) and/or by
auxiliary vacuum source (400) is thus communicated to cutter lumen
(52). A seal (54) is provided at the interface of cutter (50) and
outer cup (44). Seal (54) is configured to substantially seal the
interface of cutter (50) and outer cup (44), even as cutter (50)
rotates and translates relative to outer cup (44). Furthermore,
cutter (50) is configured such that it remains in sealed fluid
communication with the interior of tissue sample holder (40) even
when cutter (50) is in a distal most position. For instance, the
length of cutter (50) may be such that at least a portion of cutter
(50) is always disposed in outer cup (44) of tissue sample holder
(40) during operation of biopsy device (10). Of course, cutter (50)
may have any other suitable alternative features or configurations.
Similarly, cutter (50) may have any other suitable alternative
relationships with tissue sample holder (40).
[0044] It should be understood that, as with other components
described herein, cutter (50) may be varied, modified, substituted,
or supplemented in a variety of ways; and that cutter (50) may have
a variety of alternative features, components, configurations, and
functionalities. Suitable alternative versions, features,
components, configurations, and functionalities of cutter (50) will
be apparent to those of ordinary skill in the art in view of the
teachings herein. By way of example only, cutter (50) and/or one of
its components may be configured in accordance with any of the
teachings in U.S. Non-Provisional patent application Ser. No.
12/483,305, entitled "Tetherless Biopsy Device with Reusable
Portion," filed Jun. 12, 2009, the disclosure of which is
incorporated by reference herein.
[0045] Exemplary Cutter Actuation Mechanism
[0046] In the present example, cutter actuation mechanism (60) and
its components are configured in accordance with the teachings of
the cutter actuation mechanism and components disclosed in U.S.
Non-Provisional patent application Ser. No. 12/483,305, entitled
"Tetherless Biopsy Device with Reusable Portion," filed Jun. 12,
2009, the disclosure of which is incorporated by reference herein.
In particular, and as shown in FIGS. 3-5, cutter actuation
mechanism (60) of the present example comprises motor (36), shafts
(62, 64, 68, 69), gears (72, 74, 76, 78, 80, 82, 84), and bearings
(70), each of which are contained within holster (14) in the
present example. In the present example, activation of motor (36)
will rotate gears (82, 84). As shown in FIG. 2, gears (82, 84) are
partially exposed by an opening formed in a cover plate (18) of
holster (14) in the present example.
[0047] Cutter actuation mechanism (60) of the present example
further comprises a hex nut (100) and a worm nut (120). Worm nut
(120) is supported by a bushing (138). Hex nut (100) includes a
gear (86), which is configured to rotate unitarily with hex nut
(100). Worm nut (120) also includes a gear (88), which is
configured to rotate unitarily with worm nut (120). Gear (86) is
configured to mesh with gear (82) when probe (12) and holster (14)
are coupled together; while gear (88) is configured to mesh with
gear (84) when probe (12) and holster (14) are coupled together. In
particular, and as shown in FIG. 2, gears (86, 88) are partially
exposed by an opening formed in a cover plate (16) of probe (12) in
the present example. Motor (36) is thus operable to rotatingly
drive gears (86, 88) in the present example when probe (12) and
holster (14) are coupled together. Such rotation of gears (86, 88)
will cause cutter (50) to rotate and translate simultaneously in
the present example.
[0048] Gear (86) of hex nut (100) is configured to mesh with gear
(82), such that rotation of gear (82) causes rotation of hex nut
(100). Such rotation of hex nut (100) will cause corresponding
rotation of cutter (50). It will therefore be understood that
cutter actuation mechanism (60) may cause rotation of cutter (50)
in response to activation of motor (36), with rotation of motor
(36) being communicated to cutter (50) through shafts (62, 64, 68,
69), gears (72, 74, 76, 78, 80, 82, 84, 86), hex nut (100), and
sleeve (250). Of course, any other suitable structures, components,
configurations, or techniques may be used to provide rotation of
cutter (50).
[0049] Gears (82, 84) of holster (14) rotate simultaneously when
motor (36) is activated. As noted above, gears (82, 84) mesh with
gears (86, 88) of probe (12) when probe (12) is coupled with
holster (14), such that activated motor (36) rotates gears (86, 88)
simultaneously. Activated motor (36) will thus rotate hex nut (100)
and worm nut (120) simultaneously. It should therefore be
understood that sleeve (250), cutter (50), lead screw (122), and
worm nut (120) will all rotate simultaneously when motor (36) is
activated. It will therefore be understood that the simultaneous
rotation of sleeve (250), cutter (50), lead screw (122), and worm
nut (120) will provide translation of cutter (50) in response to
activation of motor (36). Of course, any other suitable structures,
components, configurations, or techniques may be used to provide
translation of cutter (50).
[0050] In the present example, cutter (50) is retracted proximally
when motor (36) is activated to rotate cutter (50) counterclockwise
(viewed from tissue sample holder (40) toward needle (20)); while
cutter (50) is advanced distally when motor (36) is activated to
rotate cutter (50) clockwise (viewed from tissue sample holder (40)
toward needle (20)). The direction of motor (36) rotation may thus
be reversed to transition between distal and proximal translation
of cutter (50). Alternatively, cutter actuation mechanism (60) may
be configured to be self-reversing, such that cutter (50) may be
translated distally and proximally without reversing the direction
of motor (36) rotation.
[0051] In one merely illustrative example of operation of cutter
actuation mechanism (100), cutter (50) may be initially located in
a distal-most position, such that lateral aperture (24) is
"closed"; with lead screw (122) being positioned at the distal
smooth section (136) of worm nut (120). Spring (130) biases lead
screw (122) proximally to engage threads (132) with threads (134).
At this stage, clockwise rotation of cutter (50) relative to worm
nut (120) will not result in any translation of cutter (50) (e.g.,
lead screw (122) will essentially "freewheel"); while
counterclockwise rotation of cutter (50) relative to worm nut (120)
will result in proximal translation of cutter (50). As cutter (50)
is rotated by motor (36) and cutter actuation mechanism (60) in the
counterclockwise direction (viewed from tissue sample holder (40)
toward needle (20)), cutter actuation mechanism (100) causes cutter
(50) to retract proximally. As noted above, such proximal or
rearward translation may be effected through engagement of threads
(132, 134), and due to lead screw (122) rotating at a faster speed
than worm nut (120). Lead screw (122) continues to traverse threads
(134) of worm nut (120) as cutter (50) continues to retract
proximally.
[0052] Cutter (50) then reaches a proximal-most position, such that
lateral aperture (24) is "opened". At this stage, lead screw (122)
is positioned at the proximal smooth section (136) of worm nut
(120). Spring (128) biases lead screw (122) distally to engage
threads (132) with threads (134). At this stage, continued
counterclockwise rotation of cutter (50) relative to worm nut (120)
will not result in any translation of cutter (50) (e.g., lead screw
(122) will essentially "freewheel"); while clockwise rotation of
cutter (50) relative to worm nut (120) will result in distal
translation of cutter (50). To that end, motor (36) may again be
activated, with its rotation direction being reversed to reverse
the rotation direction of cutter (50) and associated components. In
particular, reversing the rotational direction of motor (36) causes
cutter (50) to rotate clockwise (viewed from tissue sample holder
(40) toward needle (20)). Such clockwise rotation of cutter (50)
causes cutter to advance distally to reach the distal-most position
again.
[0053] While cutter (50) is shown and described above as rotating
counterclockwise (viewed from tissue sample holder (40) toward
needle (20)) during retraction of cutter (50) and clockwise (viewed
from tissue sample holder (40) toward needle (20)) during
advancement of cutter (50), it should be immediately apparent to
those of ordinary skill in the art that cutter (50) may instead be
rotated clockwise during retraction of cutter (50) and
counterclockwise during advancement of cutter. For instance, such
reversal may be provided by reversing the orientation of threads
(132, 134). Alternatively, such reversal may be provided by
changing the differential such that worm nut (120) rotates faster
than cutter (50). Of course, any other suitable structures,
components, configurations, or techniques may be used to provide
translation and/or rotation of cutter (50). It should therefore be
understood that, as with other components described herein, cutter
actuation mechanism (60) may be varied, modified, substituted, or
supplemented in a variety of ways; and that cutter actuation
mechanism (60) may have a variety of alternative features,
components, configurations, and functionalities. By way of example
only, biopsy device (10) may be configured such that cutter (50)
does not translate (e.g., such that cutter (50) merely rotates,
etc.); or such that cutter (50) does not rotate (e.g., such that
cutter (50) merely translates, etc.). Other suitable alternative
versions, features, components, configurations, and functionalities
of cutter actuation mechanism (60) will be apparent to those of
ordinary skill in the art in view of the teachings herein.
[0054] Exemplary Fluid Canister
[0055] As noted above, in some versions of biopsy system (1000),
tissue sample holder (40) of biopsy device (10) is coupled with
fluid canister (300) via conduit (320). Fluid canister (300) may
comprise a conventional fluid canister (300). As shown in FIG. 7,
fluid canister (300) of the present example comprises a cup (302)
and a lid (304). Cup (302) defines a hollow interior (303) that is
configured to receive liquid (320), such that cup (302) is
configured to collect and contain liquid (320). Cup (302) may be
substantially transparent or translucent, allowing a user to see an
amount of liquid (320) in cup (302) with relative ease. Cup (302)
may also include visual indicia to indicate the volume of fluid
contained within cup (302). In addition or in the alternative, cup
(302) may include a marking indicating a fluid level at which cup
(302) needs to be emptied, etc. Lid (304) is configured to engage
cup (302), such that lid (304) may form a fluid tight seal with cup
(302).
[0056] Lid (304) of the present example comprises a first port
(308) and a second port (306). First port (308) is coupled with
conduit (320); while second port (306) is coupled with conduit
(340). In the present example, first port (308) extends upwardly
from lid (304) and is configured to insertingly receive conduit
(320), such that conduit (320) is inserted into first port (308).
Alternatively, first port (308) and conduit (320) may be configured
such that first port (308) is inserted into conduit (320). Other
suitable ways in which fluid canister (300) may be coupled with
conduit (320) will be apparent to those of ordinary skill in the
art in view of the teachings herein. It should also be understood
that first port (308) may include a check valve (not shown),
duckbill seal, spring-loaded seal (not shown), removable cap (not
shown), and/or other feature that is configured to substantially
seal first port (308) when conduit (320) is disconnected from lid
(304). Such a feature may substantially prevent accidental spillage
of fluid (310) from fluid canister (300) when conduit (320) is
disconnected from lid (304) (e.g., during transport of fluid
canister (300) after a biopsy procedure, etc.).
[0057] Conduit (340) of the present example comprises a flexible
tube, though any other suitable type of structure may be used.
Second port (306) extends upwardly from lid (304) in the present
example; and is configured to be insertingly received by conduit
(340) such that second port (306) is inserted into conduit (340).
Alternatively, second port (306) and conduit (340) may be
configured such that conduit (340) is inserted into second port
(306). Other suitable ways in which fluid canister (300) may be
coupled with conduit (340) will be apparent to those of ordinary
skill in the art in view of the teachings herein. It should also be
understood that second port (306) may include a check valve (not
shown), duckbill seal, spring-loaded seal (not shown), removable
cap (not shown), and/or other feature that is configured to
substantially seal second port (306) when conduit (340) is
disconnected from lid (304). Such a feature may further
substantially prevent accidental spillage of fluid (310) from fluid
canister (300) when conduit (340) is disconnected from lid (304)
(e.g., during transport of fluid canister (300) after a biopsy
procedure, etc.).
[0058] As is also shown in FIG. 7, a hydrophobic filter (342) is
coupled with conduit (340) in the present example. While not shown
in FIG. 7, it should be understood that another conduit (340) may
be coupled with hydrophobic filter (342) to provide fluid
communication from auxiliary vacuum source (400) to fluid canister
(300). Of course, to the extent that a hydrophobic filter (342) is
even used (hydrophobic filter (342) is not necessary in all
versions per se), hydrophobic filter (342) may alternatively be
incorporated into second port (306), into a part of auxiliary
vacuum source (400), or at any other suitable location within
biopsy system (1000). Hydrophobic filter (342) is configured to
permit auxiliary vacuum source (400) to induce a vacuum in fluid
canister (300) while preventing liquid (310) from being
communicated from fluid canister (300) to auxiliary vacuum source
(400). In addition to or in lieu of having hydrophobic filter (342)
a highly absorbent material may be provided in cup (302) to soak up
liquid (310). Alternatively, liquids may be dealt with in any other
suitable fashion.
[0059] As described elsewhere herein, fluid canister (300) may
essentially act as a relay between auxiliary vacuum source (400)
and tissue sample holder (40) of biopsy device (10), such that a
vacuum induced by auxiliary vacuum source (400) may induce a vacuum
in tissue sample holder (40) (and, hence, in cutter lumen (52),
etc.) via fluid canister (300). Furthermore, fluid canister (300)
may act as a reservoir for liquids (310) that are communicated
proximally through cutter lumen (52), such that fluid canister
(300) provides drainage of outer cup (44) via port (49) and conduit
(320). Thus, the excess fluid capacity provided by fluid canister
(300), beyond the fluid capacity that would otherwise be provided
by only outer cup (44), may allow biopsy system (1000) to be used
in settings where significant amounts of liquid (310) may need to
be handled. The use of fluid canister (300) may also permit the
fluid capacity of outer cup (44) to be less than it might otherwise
be, which may in turn allow the size of tissue sample holder (40)
to be reduced.
[0060] As another merely illustrative variation, a hydrophilic
member (not shown) or other type of absorbent member may be
positioned within hollow interior (303) of cup (302) to soak up
liquids communicated through conduit (320). Such a hydrophilic
member may swell and reduce the effective internal volume of cup
(302) as the hydrophilic member absorbs liquids, which may in turn
allow auxiliary vacuum source (400) to generate and maintain a
vacuum within outer cup (44) more easily.
[0061] While biopsy system (1000) of the present example includes
both fluid canister (300) and auxiliary vacuum source (400), it
should be understood that the components of biopsy system (1000)
may be arranged and used in various other permutations. For
instance, and as noted above, biopsy device (10) may simply be used
by itself, without conduit (320) or conduit (340) being coupled
with biopsy device (10). Fluid canister (300) and auxiliary vacuum
source (400) may both thus be omitted in some versions. Port (49)
may include a sealing feature or cap to accommodate such
arrangements; or port (49) may be simply omitted. As another merely
illustrative example, some versions of biopsy system (1000) may
include just fluid canister (300) without also including auxiliary
vacuum source (400). For instance, vacuum pump (38) and/or some
other source of vacuum may be used to generate a vacuum within
tissue sample holder (40); and liquids may drain from tissue sample
holder into fluid canister (300) under the influence of gravity or
in any other suitable fashion. Other suitable arrangements of
components for biopsy system (1000) will be apparent to those of
ordinary skill in the art in view of the teachings herein.
[0062] Exemplary Auxiliary Vacuum Source
[0063] As noted above, in some versions of biopsy system (1000)
fluid canister (300) is coupled with auxiliary vacuum source (400)
via conduit (340), with an optional hydrophobic filter (342) being
provided along the fluid path of conduit (340). Auxiliary vacuum
source (400) may comprise a conventional vacuum pump (not shown)
and any other suitable components as will be apparent to those of
ordinary skill in the art in view of the teachings herein. As also
noted above, a vacuum generated by auxiliary vacuum source (400)
may be communicated to cutter lumen (52) via conduits (320, 340),
fluid canister (300), tissue sample holder (40), and ports (45, 49,
306, 308). In some versions, auxiliary vacuum source (400) is used
to supplement a vacuum that is already being provided by vacuum
pump (38). Auxiliary vacuum source (400) and vacuum pump (38) may
thus be operated simultaneously. Furthermore, auxiliary vacuum
source (400) may be configured such that it is activated
automatically upon activation of vacuum pump (38). Various suitable
ways in which such automatic/simultaneous activation may be
provided will be apparent to those of ordinary skill in the art in
view of the teachings herein.
[0064] In some versions, auxiliary vacuum source (400) is activated
independently of vacuum pump (38). For instance, a foot pedal
switch (not shown) or some other type of activation feature may be
coupled with auxiliary vacuum source (400) to provide selective
activation of auxiliary vacuum source (400). Thus, in some such
versions, vacuum pump (38) may provide the sole source of vacuum
until the user determines that additional vacuum is warranted, in
which case the user may selectively activate auxiliary vacuum
source (400) to provide such additional vacuum. Auxiliary vacuum
source (400) may thus be selectively activated in the middle of a
biopsy procedure (or at the beginning of a biopsy procedure or at
any other suitable time). It should also be understood that vacuum
pump (38) may even be omitted in some versions, such that auxiliary
vacuum source (400) is the sole source of vacuum.
[0065] While auxiliary vacuum source (400) communicates a vacuum to
biopsy device (10) via fluid canister (300) in the present example,
it should be understood that auxiliary vacuum source (400) may
alternatively bypass fluid canister (300) if desired. For instance,
outer cup (44) of tissue sample holder (40) may include a fourth
port (not shown) that is configured to couple with a conduit (not
shown) that is also coupled with auxiliary vacuum source (400).
Such a fourth port may include a hydrophobic filter to prevent
liquids from being communicated from tissue sample holder (40) to
auxiliary vacuum source (400). In some such versions, fluid
canister (300) may simply receive liquid (310) under the influence
of gravity, without the assistance of a vacuum to draw liquid (310)
into fluid canister (300). Of course, some permutations of biopsy
system (1000) components may include the omission of fluid canister
(300) altogether. For instance, third port (49) may be coupled
directly with auxiliary vacuum source (400) via a conduit.
[0066] As another merely illustrative variation of biopsy system
(1000) (e.g., those where auxiliary vacuum source (400) is coupled
with a fourth port of tissue sample holder (40) and/or where the
vacuum source is internally within body (30), etc.), conduit (320)
may comprise a flexible tube (e.g., with a length between
approximately three inches and approximately twelve inches, etc.),
with one end coupled with third port (49) and the other end being
capped/sealed. Fluid canister (300) is omitted in some such
versions. It should be understood that such a capped/sealed
flexible tube may itself provide a volumetric extension of outer
cup (44), such that excess fluids may be drained from outer cup
(44) into the capped/sealed flexible tube. It should also be
understood that the weight of fluid within such a capped/sealed
flexible tube, along with the flexibility of such a tube, may
substantially keep fluids within the tube at a height level that is
below the height level of outer cup (44) as biopsy device (10) is
rotated about the longitudinal axis defined by needle (20). For
instance, such a capped/sealed flexible tube may maintain a
substantially vertical alignment as biopsy device (10) is rotated
+/-90.degree. about the longitudinal axis defined by needle (20)
during a process of obtaining a plurality of tissue samples (e.g.,
during a single insertion of needle (20) within a patient, etc.).
Having excess fluids substantially remain within the capped/sealed
flexible tube as biopsy device (10) is rotated in such a fashion
may substantially reduce the likelihood of such fluids contacting
hydrophobic filter (48).
[0067] As yet another merely illustrative variation, auxiliary
vacuum source (400) may be omitted, and a hydrophilic member (not
shown) may be positioned within outer cup (44) to soak up liquids
communicated proximally through cutter lumen (52). Such a
hydrophilic member may swell and reduce the effective internal
volume of outer cup (44) as the hydrophilic member absorbs liquids,
which may in turn allow vacuum pump (38) to generate and maintain a
vacuum within outer cup (44) more easily. Other suitable
arrangements of components for biopsy system (1000) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0068] It should also be understood that fluid canister (300) and
auxiliary vacuum source (400) may be integrated together in a
single device (e.g., such that conduit (340) is omitted, etc.). An
example of a vacuum source with integrated fluid canister is
described in U.S. 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. Other
suitable ways in which fluid canister (300) and auxiliary vacuum
source (400) may be integrated together will be apparent to those
of ordinary skill in the art.
[0069] It should be understood from the foregoing that fluid
canister (300) and/or auxiliary vacuum source (400) may be coupled
with biopsy device (10) and/or otherwise be used before a biopsy
procedure is initiated, during a biopsy procedure (e.g., on an "as
needed" basis), or at any other suitable time.
[0070] Exemplary Pneumatic Operation
[0071] As noted above, vacuum pump (38) and/or auxiliary vacuum
source (400) is/are operable to induce a vacuum in tissue sample
holder (40), and such vacuum may be further communicated to cutter
lumen (52). In particular, vacuum pump (38) and/or auxiliary vacuum
source (400) may start building a vacuum in cutter lumen (52) as
soon as motor (36) is activated; and such a vacuum may continue to
build or be maintained as cutter (50) starts moving proximally
toward the retracted position. At this stage, second lumen (28) is
vented to atmosphere. In particular, shuttle valve slider (152) is
in a distal position, allowing atmospheric air to reach second
lumen (28)--via openings (208), notches (153), the gap between the
inner diameter of shuttle valve slider (152) and the outer diameter
of cutter (50), and the portion of sleeve interior (206) that is
distal to shuttle valve slider (152). Alternatively, second lumen
(28) may be fluidly coupled with vacuum pump (38) and/or auxiliary
vacuum source (400), such that a vacuum is created in second lumen
(28) at this stage.
[0072] As cutter (50) moves toward retracted position, such that
lateral aperture (24) of needle (20) is "partially open," a vacuum
in cutter lumen (52) may be further communicated through first
lumen (26), which may draw tissue into lateral aperture (24). At
this stage, second lumen (28) is still vented to atmosphere. In
particular, due to the "lost motion" between cutter (50) and
shuttle valve slider (152), shuttle valve slider (152) remains in
the distal position despite proximal retraction of cutter (50).
Alternatively, second lumen (28) may be fluidly coupled with vacuum
pump (38) and/or auxiliary vacuum source (400), such that a vacuum
is created in second lumen (28) at this stage.
[0073] When cutter (50) reaches the fully retracted position, such
that lateral aperture (24) of needle (20) is "open", a vacuum in
cutter lumen (52) may continue to be further communicated through
first lumen (26), which may continue to draw tissue into lateral
aperture (24). Of course, some amount of tissue may naturally
prolapse into lateral aperture (24) without the assistance of
vacuum, such that vacuum may not even be needed to draw tissue into
lateral aperture (24). At this stage, second lumen (28) is
substantially sealed relative to atmosphere. In particular, stop
member (55) has pushed shuttle valve slider (152) to a proximal
position, such that o-rings (210) "straddle" openings (208) and
seal against the interior sidewall of sleeve portion (204) to
prevent atmospheric air from being communicated from openings (208)
to second lumen (28) via hollow interior (206) of sleeve portion
(204).
[0074] As motor (36) is reversed and cutter (50) is advanced to
sever tissue protruding through lateral aperture (24), vacuum pump
(38) and/or auxiliary vacuum source (400) may continue to induce a
vacuum in cutter lumen (52), and second lumen (28) may eventually
be vented to atmosphere. However, in the initial stages of
advancement of cutter (50) from the proximal-most position to the
distal-most position, the "lost motion" between cutter (50) and
shuttle valve slider (152) leaves shuttle valve slider (152) in the
proximal position until cutter (50) advances far enough for the
distal end of sleeve (250) to engage the proximal end of shuttle
valve slider (152). Until such engagement between the distal end of
sleeve (250) and the proximal end of shuttle valve slider (152),
o-rings (210) of shuttle valve slider (152) continue to
substantially seal second lumen (28) from openings (208). After the
distal end of sleeve (250) engages the proximal end of shuttle
valve slider (152), and after cutter (50) has continued to move
distally to a sufficient degree, the distal end of sleeve (250)
eventually pushes shuttle valve slider (152) distally, such that
the proximal-most o-ring (210) is eventually moved distal to
openings (208). With shuttle valve slider (152) reaching such a
position (and positions that are further distal to such a
position), second lumen (28) is again vented to atmosphere as
described above. As cutter (50) again finally reaches the
distal-most position, cutter (50) may completely sever the tissue
protruding through lateral aperture (24), with second lumen (28)
being vented.
[0075] With the severed tissue sample residing in cutter lumen
(52), with vacuum pump (38) and/or auxiliary vacuum source (400)
drawing a vacuum at the proximal face of the severed tissue sample,
and with the venting being provided at the distal face of the
severed tissue sample (via openings (208), second lumen (28), and
openings (27)), the pressure differential applied to the severed
tissue sample may cause the severed tissue sample to be drawn
proximally through cutter lumen (52) and into upper chamber (43a)
of tissue sample holder (40). The severed tissue sample may thus be
deposited on collection tray (46) of tissue sample holder (40); or
on a screen positioned above collection tray (46) in tissue sample
holder (40). Any fluids drawn through cutter lumen (52) into outer
cup (44) of tissue sample holder (40) may flow through port (49),
through conduit (320), and into cup (302) of fluid canister (300).
Alternatively (e.g., in versions where fluid canister (300) is
omitted), fluids drawn through cutter lumen (52) into outer cup
(44) of tissue sample holder (40) may simply remain in outer cup
(44) until outer cup (44) is emptied.
[0076] Of course, any other suitable structures, components,
configurations, or techniques may be used to provide selective
sealing and/or venting of second lumen (28). By way of example
only, while shuttle valve slider (152) is actuated mechanically
based on the axial position of cutter (50) in the present example,
it should be understood that shuttle valve slider (152) or any
other type of valve may instead be actuated electrically (e.g., via
a separate motor or solenoid), pneumatically, or otherwise.
Furthermore, in some variations of biopsy device (10), a vacuum,
saline, pressurized air, atmospheric air, and/or any other medium
may be communicated to second lumen (28) at any suitable stage of
operation of biopsy device (10) (e.g., applying vacuum or venting
to second lumen (28) during and/or upon retraction of cutter (50)
and/or during advancement of cutter (50), sealing second lumen
during advancement of cutter (50), etc.). Suitable alternative
structures, components, configurations, or techniques for
communicating severed tissue samples proximally through cutter
lumen (52) to reach tissue sample holder (40) will be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0077] Exemplary Method of Operation
[0078] In a merely exemplary use of biopsy device (10), a user
first inserts tissue piercing tip (22) into the breast of a
patient. During such insertion, cutter (50) may be advanced to the
distal-most position, such that lateral aperture (24) of needle
(20) is closed. As also noted herein, such insertion may be
performed under visual guidance, stereotactic guidance, ultrasound
guidance, MRI guidance, PEM guidance, BSGI guidance, palpatory
guidance, some other type of guidance, or otherwise. With needle
(20) sufficiently inserted into the patient's breast, the user may
then activate motor (36), which may in turn activate vacuum pump
(38) and cutter actuation mechanism (100). The user may also
activate auxiliary vacuum source (400) at this stage and/or at a
later stage in the procedure. Such activation of vacuum pump (38)
and/or auxiliary vacuum source (400) may induce a vacuum in tissue
sample holder (40) and cutter lumen (52) as described above. Such
activation of cutter actuation mechanism (60) may cause cutter (50)
to rotate counterclockwise and translate proximally. As cutter (50)
starts retracting and when cutter (50) reaches the retracted
position, vacuum from vacuum pump (38) and/or auxiliary vacuum
source (400) (as communicated through tissue sample holder (40) and
cutter lumen (52)) may draw tissue into lateral aperture (24) of
needle (20). During this time, second lumen (28) may be vented by
valve mechanism (150).
[0079] Once cutter (50) reaches a proximal-most position, vacuum
may still be communicated through vacuum lumen (52) and first lumen
(26), drawing tissue into lateral aperture (24) of needle (20).
Second lumen (28) may be substantially sealed by valve assembly
(150) at this time. In addition, lead screw (122) freewheels yet is
biased distally by spring (128) as cutter (50) continues to rotate
counterclockwise. Lateral aperture (24) is fully open at this
stage, with tissue prolapsed therein.
[0080] The rotation direction of motor (36) is then reversed and
cutter (50) begins to advance distally until again reaching the
distal-most position. As cutter (50) advances distally, vacuum is
still being communicated through vacuum lumen (52), helping to hold
tissue in place as sharp distal edge (51) of cutter (50) begins to
sever the tissue. Second lumen (28) is initially substantially
sealed by valve assembly (150) at this time, but is eventually
vented. Cutter (50) then reaches the distal-most position, thereby
"closing" lateral aperture (24), and such that sharp distal edge
(51) of cutter (50) completely severs the tissue. Vacuum is still
being communicated through cutter lumen (52) at this time, and
valve assembly (150) vents second lumen (28). As described above,
this combination of vacuum and venting provides communication of
the severed tissue sample proximally through cutter lumen (52) and
onto collection tray (46) of tissue sample holder (40). Motor (36)
may continue to operate at the end of the cutting stroke, thereby
continuing to drive vacuum pump (38) to maintain a vacuum in tissue
sample holder (40). Vacuum may also be maintained in tissue sample
holder (40) at this stage by auxiliary vacuum source (400). In
addition, spring (130) biases lead screw (122) proximally to engage
threads (132), while allowing cutter (50) to continue rotating at
the distal-most position. A cutting stroke will thus be complete,
and may be initiated as many times as desired to acquire additional
tissue samples.
[0081] As noted above, several cutting strokes may be performed to
acquire several tissue samples without the user having to withdraw
needle (20) from the patient's breast. The user may adjust the
orientation of lateral aperture (24) about the axis defined by
needle (20) by rotating the entire biopsy device (10) between
cutting strokes for multiple sample acquisition. Alternatively,
biopsy device (10) may be configured such that needle (20) is
rotatable relative to body (30), such that needle (20) may be
rotated via a thumbwheel or other feature. Once the desired number
of tissue samples have been obtained, the user may withdraw needle
(20) from the patient's breast. The user may then remove cap (42)
from cup (44) and retrieve the tissue samples from collection tray
(46).
[0082] At the end of a procedure, the user may separate probe (12)
from holster (14). Holster (14) may then be cleaned and/or
sterilized for subsequent use. Probe (12) may be disposed of.
Alternatively, as noted above, biopsy device (10) may alternatively
be formed as a unitary construction, such that there is no probe
(12) separable from a holster (14).
[0083] Of course, the above examples of use of biopsy device (10)
are merely illustrative. Other suitable ways in which biopsy device
(10) may be used will be apparent to those of ordinary skill in the
art in view of the teachings herein.
[0084] 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.
[0085] Embodiments of the present invention have application in
conventional endoscopic and open surgical instrumentation as well
as application in robotic-assisted surgery.
[0086] Embodiments of the devices disclosed herein can be designed
to be disposed of after a single use, or they can be designed to be
used multiple times. Embodiments may, in either or both cases, 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 device may
be disassembled, and any number of the particular pieces or parts
of the device may be selectively replaced or removed in any
combination. Upon cleaning and/or replacement of particular parts,
embodiments of the device 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.
[0087] 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.
[0088] 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,
geometries, 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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