U.S. patent application number 14/288500 was filed with the patent office on 2014-09-18 for handheld biopsy device with needle firing.
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 John A. Hibner, Richard P. Nuchols, Edward A. Rhad.
Application Number | 20140276209 14/288500 |
Document ID | / |
Family ID | 45997450 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140276209 |
Kind Code |
A1 |
Hibner; John A. ; et
al. |
September 18, 2014 |
HANDHELD BIOPSY DEVICE WITH NEEDLE FIRING
Abstract
A biopsy device includes a body, a needle, and a cutter. A motor
is operable to both move the cutter relative to the needle and
actuate a needle firing assembly to retract and fire the needle
relative to the body. The biopsy device also includes a needle
rotation assembly that is configured to substantially prevent
rotation of the needle about the longitudinal axis when the needle
is in a proximal position yet permit rotation of the needle about
the longitudinal axis when the needle is in a distal position. A
valve assembly of the biopsy device includes a slider that
selectively couples a secondary lumen in the needle with either
atmospheric air or saline based on the longitudinal position of the
slider. The cutter passes through the slider.
Inventors: |
Hibner; John A.; (Mason,
OH) ; Nuchols; Richard P.; (Williamsburg, OH)
; Rhad; Edward A.; (Fairfield, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Devicor Medical Products, Inc. |
Cincinnati |
OH |
US |
|
|
Assignee: |
Devicor Medical Products,
Inc.
Cincinnati
OH
|
Family ID: |
45997450 |
Appl. No.: |
14/288500 |
Filed: |
May 28, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12953715 |
Nov 24, 2010 |
8764680 |
|
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14288500 |
|
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61408795 |
Nov 1, 2010 |
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Current U.S.
Class: |
600/567 |
Current CPC
Class: |
A61B 10/0283 20130101;
A61B 2010/0208 20130101; A61B 10/0266 20130101; A61B 10/0096
20130101; A61B 10/0275 20130101 |
Class at
Publication: |
600/567 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1.-20. (canceled)
21. A biopsy device, comprising: (a) a body; (b) a needle
associated with the body, wherein the needle defines a first lumen
and a second lumen, wherein the first lumen extends along a first
longitudinal axis, wherein the second lumen extends along a second
longitudinal axis, wherein the needle includes an opening fluidly
coupling the first lumen with the second lumen; (c) a cutter,
wherein the cutter is configured to translate relative to the
needle to sever tissue; and (d) a valve assembly, comprising: (i) a
valve body having an interior, one or more vent openings in
communication with the interior, and one or more saline openings in
communication with the interior, wherein the interior is in
communication with the second lumen, wherein the one or more vent
openings are further in communication with atmospheric air, wherein
the one or more saline openings are further in communication with a
source of saline, and (ii) a translating member slidably disposed
in the valve body, wherein the translating member is configured to
selectively couple the second lumen with either the one or more
vent openings or the one or more saline openings based on the
longitudinal position of the translating member within the valve
body, wherein the cutter extends through the valve body and through
the translating member.
22. The biopsy device of claim 21, wherein the translating member
is responsive to the longitudinal position of the cutter.
23. The biopsy device of claim 21, further comprising a first
member secured to the cutter, wherein the first member is
configured to move the translating member distally within the valve
body when the cutter is moved distally.
24. The biopsy device of claim 23, further comprising a second
member secured to the cutter, wherein the second member is
configured to move the translating member proximally within the
valve body when the cutter is moved proximally.
25. The biopsy device of claim 24, wherein the first member and the
second member are disposed on the cutter a first distance from each
other, wherein the first distance is longer than a longitudinal
length of the translating member, wherein the difference between
the first distance and the longitudinal length of the translating
member is configured to create lost motion before either the first
member or the second member moves the translating member.
26. The biopsy device of claim 21, wherein the cutter defines an
outer diameter, wherein the translating member has a bore defining
an inner diameter, wherein the inner diameter is greater than the
outer diameter such that a gap is provided between the inner
diameter of the translating member and the outer diameter of the
cutter, the translating member further including a transverse
opening in fluid communication with the gap, wherein the transverse
opening is configured to provide fluid communication from either
the one or more vent openings to the gap or from the one or more
saline openings to the gap based on the longitudinal position of
the translating member within the valve body.
27. The biopsy device of claim 21, wherein the translating member
is configured to, based at least in part on the longitudinal
position of the cutter, selectively move between a first
longitudinal position, a second longitudinal position, and a third
longitudinal position.
28. The biopsy device of claim 27, wherein the second lumen is
coupled with the one or more vent openings when the translating
member is in the first longitudinal position.
29. The biopsy device of claim 27, wherein the second lumen is
coupled with the one or more saline openings when the translating
member is in the second longitudinal position.
30. The biopsy device of claim 27, wherein the second lumen is
substantially sealed relative to the one or more vent openings and
relative to the one or more saline openings when the translating
member is in the third longitudinal position.
31. The biopsy device of claim 21, wherein a distal end of the
translating member includes a plurality of notches extending
distally from the translating member.
32. The biopsy device of claim 21, wherein the translating member
comprises a plurality of recesses extending circumferentially
around the translating member, wherein the recesses are configured
to seal against the interior of the valve body.
33. A biopsy device, comprising: (a) a body; (b) a needle extending
distally from the body, the needle including a tip and a transverse
aperture proximal to the tip, wherein the needle defines a first
lumen and a second lumen, wherein the transverse aperture is in
communication with the first lumen and the second lumen; (c) a
cutter disposed within the first lumen, wherein the cutter is
configured to translate relative to the needle to sever tissue; and
(c) a valve assembly, comprising; (i) a sheath extending proximally
from the needle, wherein the sheath defines an interior, wherein
the sheath is in communication with the second lumen, wherein the
sheath comprises one or more proximal openings and one or more
distal openings, wherein the openings are in communication with the
interior of the sheath, (ii) a saline manifold, wherein the saline
manifold is disposed over the exterior of at least a portion of the
sheath, wherein the saline manifold is configured to communicate
saline through the one or more proximal openings of the sheath, and
(iii) a shuttle valve slider translatable within the sheath,
wherein the shuttle valve slider comprises a plurality of recesses
configured to seal against an interior diameter of the sheath,
wherein the shuttle valve sheath is configured to selectively
couple the second lumen with either the one or more proximal
openings or the one or more distal openings by translating the
recesses relative to the sheath.
34. The biopsy device of claim 33, wherein the saline manifold
includes a port, wherein the port is in communication with an
interior region of the saline manifold, wherein the port is
configured to communicate saline into the interior region of the
saline manifold.
35. The biopsy device of claim 34, wherein the interior region of
the saline manifold is defined by the saline manifold, a pair of
exterior regions on opposite sides of the interior region and the
sheath.
36. The biopsy device of claim 33, wherein the sheath and the
shuttle valve slider are coaxially disposed about the cutter.
37. The biopsy device of claim 33, wherein the saline manifold is
fixed relative to the sheath.
38. The biopsy device of claim 33, further comprising a first
member and a second member secured to the cutter, wherein the first
member is configured to move the shuttle valve slider distally
within the sheath when the cutter is moved distally, wherein the
second member is configured to move the shuttle valve slider
proximally within the sheath when the cutter is moved
proximally.
39. The biopsy device of claim 38, wherein the first member and
second member define a first distance, wherein the first distance
is the distance between the first member and second member, wherein
the first distance is longer than a longitudinal length of the
shuttle valve slider.
40. A biopsy device, comprising: (a) a body; (b) a needle
associated with the body, wherein the needle defines a first lumen
and a second lumen, wherein the needle includes an opening fluidly
coupling the first lumen with the second lumen; (c) a cutter,
wherein the cutter is configured to translate relative to the
needle to sever tissue; and (d) a valve assembly, comprising: (i) a
valve body having an interior, one or more vent openings in
communication with the interior, and one or more saline openings in
communication with the interior, wherein the interior is in
communication with the second lumen, wherein the one or more vent
openings are further in communication with atmospheric air, wherein
the one or more saline openings are further in communication with a
source of saline, and (ii) a translating member slidably disposed
in the valve body, wherein the translating member comprises a
plurality of annular recesses, wherein the translating member is
configured to selectively couple the second lumen with either the
one or more vent openings or the one or more saline openings based
on the longitudinal position of the annular recesses within the
valve body, wherein the cutter extends through the valve body and
through the translating member.
Description
PRIORITY
[0001] This application claims priority to U.S. Provisional
Application Ser. No. 61/408,795, entitled "Handheld Biopsy Device
with Needle Firing," filed Nov. 1, 2010, 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.
Pub. No. 2010/0152610, entitled "Hand Actuated Tetherless Biopsy
Device with Pistol Grip," published Jun. 17, 2010; U.S. Pub. No.
2010/0160819, entitled "Biopsy Device with Central Thumbwheel,"
published Jun. 24, 2010; U.S. Non-Provisional patent application
Ser. No. 12/483,305, entitled "Tetherless Biopsy Device with
Reusable Portion," filed Jun. 12, 2009; and U.S. Non-Provisional
patent application Ser. No. 12/709,624, entitled "Spring Loaded
Biopsy Device," filed Feb. 22, 2010. 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. In the drawings some components or
portions of components are shown in phantom as depicted by broken
lines.
[0006] FIG. 1 depicts a perspective view of an exemplary biopsy
device;
[0007] FIG. 2 depicts a perspective view of a probe portion of the
biopsy device of FIG. 1 separated from a holster portion of the
biopsy device of FIG. 1;
[0008] FIG. 3 depicts a top plan view of the probe portion of the
biopsy device, with a top chassis removed;
[0009] FIG. 4 depicts an exploded perspective view of cutter
actuation components of the probe of FIG. 3;
[0010] FIG. 5A depicts a partial cross-sectional side view of the
cutter actuation components of FIG. 4, as well as a distal portion
of the needle and cutter, with the cutter in a distal position;
[0011] FIG. 5B depicts a partial cross-sectional side view of the
cutter actuation components of FIG. 4, as well as a distal portion
of the needle and cutter, with the cutter in an intermediate
position;
[0012] FIG. 5C depicts a partial cross-sectional side view of the
cutter actuation components of FIG. 4, as well as a distal portion
of the needle and cutter, with the cutter in a proximal
position;
[0013] FIG. 6 depicts an exploded perspective view of tissue sample
holder components of the probe of FIG. 3;
[0014] FIG. 7A depicts a partial cross-sectional side view of the
tissue sample holder of FIG. 6;
[0015] FIG. 7B depicts a cross-sectional end view of the cup of the
tissue sample holder of FIG. 6;
[0016] FIG. 8 depicts an exploded perspective view of needle firing
and valving components of the probe of FIG. 3;
[0017] FIG. 9A depicts a partial cross-sectional side view of the
needle valving components of FIG. 8, with the cutter in a distal
position;
[0018] FIG. 9B depicts a partial cross-sectional side view of the
needle valving components of FIG. 8, with the cutter in an
intermediate position;
[0019] FIG. 9C depicts a partial cross-sectional side view of the
needle valving components of FIG. 8, as well as a distal portion of
the needle and cutter, with the cutter in a proximal position;
[0020] FIG. 10A depicts a partial top plan view of the needle
firing components of FIG. 8, with the needle firing mechanism in a
ready to arm configuration;
[0021] FIG. 10B depicts a partial top plan view of the needle
firing components of FIG. 8, with the needle firing mechanism in an
armed and ready to retract configuration;
[0022] FIG. 10C depicts a partial top plan view of the needle
firing components of FIG. 8, with the needle firing mechanism
transitioning to a ready to fire configuration;
[0023] FIG. 10D depicts a partial top plan view of the needle
firing components of FIG. 8, with the needle firing mechanism in a
retracted and ready to fire configuration;
[0024] FIG. 10E depicts a partial top plan view of the needle
firing components of FIG. 8, with the needle firing mechanism in a
fired configuration;
[0025] FIG. 11 depicts a schematic diagram showing components of
the holster portion of the biopsy device of FIG. 1;
[0026] FIG. 12 depicts a side elevational view of the holster of
FIG. 11, with housing components and other components removed,
showing a motor and drive components;
[0027] FIG. 13 depicts various views of exemplary alternative
versions of the biopsy device of FIG. 1;
[0028] FIG. 14 depicts a perspective view of an exemplary
alternative biopsy probe;
[0029] FIG. 15 depicts a top plan view of the probe of FIG. 14,
with a top chassis removed;
[0030] FIG. 16 depicts an exploded perspective view of valving
components of the probe of FIG. 15;
[0031] FIG. 17 depicts a side cross-sectional view of a saline
manifold of the valving components of FIG. 16;
[0032] FIG. 18A depicts a side cross-sectional view of valving
components of the probe in FIG. 15, with a shuttle valve slider in
a proximal position;
[0033] FIG. 18B depicts a side cross-sectional view of valving
components of the probe in FIG. 15, with a shuttle valve slider in
a distal position;
[0034] FIG. 19A depicts a schematic view of exemplary communicative
states for a second lumen of the needle of the probe of FIG. 15, in
relation to the longitudinal position of the cutter within the
needle, during advancement of the cutter from a proximal position
to a distal position; and
[0035] FIG. 19B depicts a schematic view of exemplary communicative
states for a second lumen of the needle of the probe of FIG. 15, in
relation to the longitudinal position of the cutter within the
needle, during retraction of the cutter from a distal position to a
proximal position.
[0036] 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
[0037] 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.
[0038] I. Overview of Exemplary Biopsy Device
[0039] FIGS. 1-2 show an exemplary biopsy device (10). Biopsy
device (10) of this example comprises a probe (100) and a holster
(500). A needle (110) extends distally from probe (100), 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 in a tissue sample holder (300) at the proximal end of
probe (100), as will also be described in greater detail below. It
should also be understood that the use of the term "holster" herein
should not be read as requiring any portion of probe (100) to be
inserted into any portion of holster (500). Indeed, in the present
example, and as best seen in FIG. 2, a finger (502) extends
distally from holster (500), and is received in a corresponding
slot (102) of probe (100) to help secure probe (100) and holster
(500) together. Other components of probe (100) and holster (500)
mate when probe (100) and holster (500) are coupled together, as
will be described in greater detail below. It should be understood
that a variety of types of structures, components, features, etc.
(e.g., bayonet mounts, latches, clamps, clips, snap fittings, etc.)
may be used to provide removable coupling of probe (100) and
holster (500). Furthermore, in some biopsy devices (10), probe
(100) and holster (500) may be of unitary or integral construction,
such that the two components cannot be separated. By way of example
only, in versions where probe (100) and holster (500) are provided
as separable components, probe (100) may be provided as a
disposable component, while holster (500) may be provided as a
reusable component. Still other suitable structural and functional
relationships between probe (100) and holster (500) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0040] Some variations of biopsy device (10) may include one or
more sensors (not shown), in probe (100) and/or in holster (500),
that is/are configured to detect when probe (100) is coupled with
holster (500). Such sensors or other features may further be
configured to permit only certain types of probes (100) and
holsters (500) to be coupled together. In addition or in the
alternative, such sensors may be configured to disable one or more
functions of probes (100) and/or holsters (500) until a suitable
probe (100) and holster (500) are coupled together. Of course, such
sensors and features may be varied or omitted as desired.
[0041] Biopsy device (10) of the present example is sized and
configured such that biopsy device (10) may be operated by a single
hand of a user. In particular, a user may grasp biopsy device (10),
insert needle (100) 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 (10) with more than one hand and/or with any desired
assistance. It should also be understood that biopsy device (10)
may be grasped and fully operated by a single hand using a variety
of different kinds of grips, including but not limited to a pencil
grip. 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 (300), and later retrieved from
tissue sample holder (300) 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 (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
(e.g., prostate, thyroid, etc.). Various exemplary components,
features, configurations, and operabilities of biopsy device (10)
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.
[0042] II. Exemplary Probe
[0043] FIGS. 3-10 show probe (100) of the present example in
greater detail. As noted above, probe (100) includes a distally
extending needle (110). Probe (100) also includes a chassis (120)
and a base housing (130), which are fixedly secured together.
Tissue sample holder (300) is removably coupled with base housing
(130) in this example, though it should be understood that tissue
sample holder (300) may alternatively be non-removably secured to
base housing (130). A pair of gears (202, 204) are exposed through
an opening (122) in chassis (120), and are operable to drive a
cutter actuation mechanism (200) in probe (100) as will be
described in greater detail below. An arming finger grip (402)
extends downwardly from the bottom of base housing (130), and is
operable to arm a needle firing mechanism (400) in probe (100) as
will also be described in greater detail below.
A. Exemplary Needle
[0044] Needle (110) of the present example includes a piercing tip
(112), a lateral aperture (114) located proximal to tip (112), and
a rotation knob (116). Tissue piercing tip (112) 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 (112). Alternatively, tip (112)
may be blunt (e.g., rounded, flat, etc.) if desired. Tip (112) may
also be configured to provide greater echogenicity than other
portions of needle (110), providing enhanced visibility of tip
(112) under ultrasound imaging. By way of example only, tip (112)
may be configured in accordance with any of the teachings in U.S.
Non-Provisional patent application Ser. No. 12/875,200, entitled
"Echogenic Needle for Biopsy Device," filed Sep. 3, 2010, the
disclosure of which is incorporated by reference herein. Other
suitable configurations that may be used for tip (112) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0045] Lateral aperture (114) is sized to receive prolapsed tissue
during operation of device (10). A tubular cutter (150) having a
sharp distal edge (152) is located within needle (110). As
described in greater detail below, cutter (150) is operable to
rotate and translate relative to needle (110) and past lateral
aperture (114) to sever a tissue sample from tissue protruding
through lateral aperture (114). While lateral aperture (114) is
shown oriented in a downward position in FIG. 1, it should be
understood that needle (110) may be rotated to orient lateral
aperture (114) at any desired angular position about the
longitudinal axis of needle (110). Such rotation of needle (110) is
facilitated in the present example by rotation knob (116), which is
secured to needle (110). In particular, and now referring to FIG.
8, a needle overmold (410) is fixedly secured to needle (110), and
is configured to transfer rotation from rotation knob (116) to
needle (110). By way of example only, needle (110) may be formed of
metal, and needle overmold (410) may be formed of a plastic
material that is overmolded about needle (110) to unitarily secure
and form needle overmold (410) to needle (110). Needle overmold
(410) and needle (110) may alternatively be formed of any other
suitable material(s), and may be secured together in any other
suitable fashion. Needle overmold (410) includes a distal portion
(412) having a pair of flats (414). Distal portion (412) of needle
overmold (410) is slidably disposed in a bore (not shown) of a
rotation hub (140). This bore of rotation hub (140) includes flats
that complement flats (414) of needle overmold (410), such that
rotation of rotation hub (140) will rotate needle overmold (140),
thereby rotating needle (110). The relationship between rotation
hub (140) and needle overmold (410) in the present example will
nevertheless permit needle (110) and needle overmold (410) to
unitarily translate relative to rotation hub (140), as will be
described in greater detail below.
[0046] Rotation hub (140) also includes a pair of flats (142) and
an annular recess (144). As shown in FIG. 9, rotation knob (116) of
the present example is formed of a first half (116a), and a second
half (116b), which are configured to snap fit together about
rotation hub (140). Halves (116a, 116b) have bosses (117) that
engage flats (142) of rotation hub (140), such that rotation of
rotation knob (116) will rotate rotation hub (140). Halves (116a,
116b) also include proximal rims (119) that engage annular recess
(144) of rotation hub (140), such that rotation knob (116) will
translate longitudinally with rotation hub (140). Rotation knob
(116) of the present example also includes a pair of distal
latching members (115), which may removably engage other components
of a biopsy system such as a targeting set for use in an MRI biopsy
setting, etc.
[0047] As best seen in FIGS. 10A-10E, rotation hub (140) also
includes a proximal flange (148) having a plurality of notches
(149) formed therein. A coil spring (146) is coaxially disposed
about rotation hub (140), and is positioned between a proximally
facing distal inner surface (131) of base housing (130) and the
distal face of proximal flange (148) of rotation hub (140). Spring
(146) is resiliently biased to urge proximal flange (148)
proximally toward posts (133) of base housing (130). A boss (not
shown) extends upwardly from the lower surface of base housing
(130) and is configured to engage a downwardly presented notch
(149) of proximal flange (148). Such engagement substantially
secures the rotational position of rotation hub (140) about the
longitudinal axis defined by needle (110). The bias of spring (146)
further promotes engagement between this boss and whichever notch
(149) is downwardly presented by urging proximal flange (148)
proximally. Thus, in order to change the rotational orientation of
needle (110), a user may grasp rotation knob (116) and push or pull
rotation knob (116) distally against the resilient bias of spring
(146) to disengage the boss from the most downwardly presented
notch (149), rotate rotation knob (116) while holding rotation knob
(116) in a distal position to rotate needle (110) (thereby
re-orienting lateral aperture (114) about the longitudinal axis of
needle (110)), then release rotation knob (116) to allow spring
(146) to move rotation hub (140) proximally (thereby engaging the
boss with the notch (149) now downwardly presented). With needle
(110) at the adjusted angular orientation, the engagement between
the boss and the now downwardly presented notch (149), promoted by
the resilient bias of spring (146), will maintain needle (110) at
the adjusted angular orientation. In some versions, the underside
of chassis (120) includes a downwardly extending boss that engages
an upwardly presented notch (149), in addition to or in lieu of an
upwardly extending boss of base housing (130) engaging a downwardly
presented notch (149).
[0048] Various other suitable ways in which manual rotation of
needle (110) may be provided will be apparent to those of ordinary
skill in the art in view of the teachings herein. It should also be
understood that rotation of needle (110) may be automated in
various ways, including but not limited to the various forms of
automatic needle rotation described in various references that are
cited herein.
[0049] As best seen in FIGS. 8 and 5A-5C, needle (110) also
includes a longitudinal wall (160) extending proximally from the
proximal portion of tip (112). While wall (160) does not extend
along the full length of needle (110) in this example, it should be
understood that wall (160) may extend the full length of needle
(110) if desired. Wall (160) of the present example proximally
terminates at a longitudinal position that is just proximal to the
longitudinal position of distal cutting edge (152) of cutter (150)
when cutter (150) is in a proximal position (see FIG. 5C). Thus,
wall (160) and cutter (150) together define a second lumen (162)
that is lateral to and parallel to cutter (150). Of course, wall
(160) may alternatively proximally terminate at a longitudinal
position that is just distal to the longitudinal position of distal
cutting edge (152) of cutter (150) when cutter (150) is in a
proximal position; or wall (160) may terminate at any other
suitable longitudinal position. Wall (160) includes a plurality of
openings (164) that provide fluid communication between second
lumen (162) and the upper portion of needle (110), as well as fluid
communication between second lumen (162) and the lumen (154) of
cutter (150). For instance, as will be described in greater detail
below, second lumen (162) may selectively provide atmospheric air
to vent cutter lumen (154) during operation of biopsy device (10)
as will be described in greater detail below. Openings (164) are
arranged such that at least one opening (164) is located at a
longitudinal position that is distal to the distal edge of lateral
aperture (114). Thus, cutter lumen (154) and second lumen (162) may
remain in fluid communication even when cutter (150) is advanced to
a position where cutting edge (152) is located at a longitudinal
position that is distal to the longitudinal position of the distal
edge of lateral aperture (114) (se FIG. 5A). Of course, as with any
other component described herein, any other suitable configurations
may be used.
[0050] It should be understood that, as with other components
described herein, needle (110) may be varied, modified,
substituted, or supplemented in a variety of ways; and that needle
(110) may have a variety of alternative features, components,
configurations, and functionalities. A plurality of external
openings (not shown) may also be formed in needle (110), and may be
in fluid communication with second lumen (162). For instance, such
external openings may be configured in accordance with the
teachings of 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. Cutter
(150) may also include one or more side openings (not shown). Of
course, as with other components described herein, such external
openings in needle (110) and cutter (150) are merely optional. As
another merely illustrative example, needle (110) may simply lack
second lumen (162) altogether in some versions. Other suitable
alternative versions, features, components, configurations, and
functionalities of needle (110) will be apparent to those of
ordinary skill in the art in view of the teachings herein.
B. Exemplary Cutter Actuation Mechanism
[0051] As shown in FIGS. 3-5C, cutter actuation mechanism (200) of
the present example comprises a variety of components that interact
to provide simultaneous rotation and distal translation of cutter
(150) relative to base housing (130) and needle (110) in a firing
stroke. Cutter actuation mechanism (200) is also operable to
retract cutter (150) proximally to ready cutter (150) for firing.
Cutter actuation mechanism (200) of the present example includes a
pair of gears (202, 204), a lead screw (206), a cutter sleeve or
overmold (210), and a plurality of sleeves (230). All of these
components (202, 204, 206, 210, 230) are coaxially aligned with
cutter (150). Cutter overmold (210) is fixedly secured to cutter
(150), such that cutter overmold (210) and cutter (150) will rotate
and translate unitarily together in the present example. By way of
example only, cutter (150) may be formed of metal, and cutter
overmold (210) may be formed of a plastic material that is
overmolded about cutter (150) to unitarily secure and form cutter
overmold (210) to cutter (150). Cutter overmold (210) and cutter
(150) may alternatively be formed of any other suitable
material(s), and may be secured together in any other suitable
fashion. Cutter overmold (210) includes a proximal portion (212)
having external flats (214), a distal flange (216), and a proximal
flange (218).
[0052] An annular recess (220) divides proximal portion (212) of
cutter overmold (210) into a distal region (222) and a proximal
region (224). Lead screw (206) is slidably positioned along distal
region (222) of proximal portion (212). A clip (226) is secured to
annular recess (220), such that lead screw (206) is retained
between clip (226) and proximal flange (218). Lead screw (206)
includes internal flats (207) that complement external flats (214)
of cutter overmold (210). In particular, engagement between flats
(207, 214) provides simultaneous rotation of lead screw (206) and
cutter overmold (210) while also permitting lead screw (206) to
translate relative to cutter overmold (210). Such translation will
be restricted by clip (226) and proximal flange (218). Furthermore,
a pair of coil springs (227, 229) are configured to resiliently
bear against opposite ends of lead screw (206). A washer (208) is
located between proximal spring (229) and clip (226) in this
example, though it should be understood that washer (208) may be
omitted if desired. The spacing between flange (218) and washer
(208) permits some freedom of movement for lead screw (206) along
part of distal region (222) between flange (218) and washer (208);
while springs (227, 229) bias lead screw (206) to be substantially
centered between flange (218) and washer (208). It should be
understood that any other suitable type of resilient member may be
used in addition to or in lieu of coil springs (227, 229). It
should also be understood that the location of lead screw (206)
between flange (218) and washer (208) may be substantially fixed,
if desired.
[0053] Gear (202) also includes internal flats (203) that
complement external flats (214) of cutter overmold (210). In
particular, engagement between flats (203, 214) provides
simultaneous rotation of gear (202) and cutter overmold (210) while
also permitting lead cutter overmold (210) translate relative to
gear (202). While all flats (203, 207, 214) are octagonal in the
present example, it should be understood that other suitable
structures may be used, including but not limited to hexagonal
flats, complementary keys and keyways, etc. The longitudinal
position of gear (202) remains substantially constant relative to
base housing (130) during operation of biopsy device (10) of the
present example. As shown in FIGS. 3 and 5A-5C, gear (202) is
supported by a bushing (232), which is disposed within an integral
support structure (132) of base housing (130). Gear (202) is
positioned and configured to mesh with a complementary gear (550)
of holster (500) when probe (100) and holster (500) are coupled
together. As will be described in greater detail below, components
in holster (500) are operable to rotatingly drive gear (550), which
in turn rotates gear (202). As noted above and as will also be
described in greater detail below, rotation of gear (202) provides
rotation of cutter overmold (210), cutter (150), and lead screw
(206), which further provides translation of cutter (150).
[0054] A threaded sleeve (240) extends distally from gear (204).
Threaded sleeve (240) and gear (204) rotate unitarily in the
present example. For instance, threaded sleeve (240) and gear (204)
may be molded as a single unitary piece, as two separate pieces
that are later joined together, etc. As shown in FIG. 5B, cutter
actuation mechanism (200) is configured such that external
threading (242) of lead screw (206) meshes with internal threading
(244) of threaded sleeve (240). This meshing of threading (242,
244) provides translation of lead screw (206), and hence, cutter
overmold (210) and cutter (150), when lead screw (206) and threaded
sleeve (240) are rotated relative to each other. The longitudinal
position of gear (204) and threaded sleeve (240) remains
substantially constant relative to base housing (130) during
operation of biopsy device (10) of the present example. As shown in
FIGS. 3 and 5A-5C, threaded sleeve (240) is supported by sleeves
(230), which are disposed within integral support structures (134)
of base housing (130) and chassis (120). Gear (204) is positioned
and configured to mesh with a complementary gear (554) of holster
(500) when probe (100) and holster (500) are coupled together. As
will be described in greater detail below, components in holster
(500) are operable to rotatingly drive gear (554), which in turn
rotates gear (204). While sleeves (230) are shown as separate
components, it should be understood that a single sleeve (230) may
be used.
[0055] As described in greater detail below, holster (500) may be
activated to rotate gears (550, 554) simultaneously. As noted
above, gears (202, 204) mesh with gears (550, 554) when probe (100)
and holster (500) are coupled together, such that simultaneous
rotation of gears (550, 554) provides corresponding simultaneous
rotation of gears (202, 204). This further provides corresponding
simultaneous rotation of cutter overmold (210), cutter (150), lead
screw (206), and sleeve (240). It should also be understood that
gears (550, 554) have different pitch diameters in the present
example (i.e., the pitch diameter of gear (550) is different from
the pitch diameter of gear (554)). Gears (202, 204) also have
different pitch diameters (i.e., the pitch diameter of gear (202)
is different from the pitch diameter of gear (204)). Accordingly,
when a motor (528) in holster (500) that drives gears (550, 554)
rotates at one rotational speed, gear (202) and threaded sleeve
(240) simultaneously rotate in the same direction as each other yet
at different rotational speeds relative to each other. Since
rotation of lead screw (206) is driven by rotation of gear (202),
lead screw (206) and threaded sleeve (240) also simultaneously
rotate in the same direction as each other yet at different
rotational speeds relative to each other.
[0056] Even though lead screw (206) and threaded sleeve (240)
rotate simultaneously in the same direction, the difference between
rotational speeds of lead screw (206) and threaded sleeve (240)
provide a net result of lead screw (206) rotating relative to
threaded sleeve (240), and such relative rotation provides
translation of cutter (150) as cutter (150) rotates. By way of
example only, with motor (528) in holster (500) providing an output
speed of approximately 8,000 rpm, the above-described configuration
may provide rotation of cutter (150) at a speed of approximately
1,000 rpm and rotation of threaded sleeve (240) at a speed of
approximately 850 rpm, resulting in a net rotation of cutter (150)
relative to threaded sleeve (240) at approximately 150 rpm. Of
course, any other suitable differential may be provided. In the
present example, the direction of rotation provided by motor (528)
is simply reversed to reverse the direction of translation of
cutter (150). Alternatively, cutter actuation mechanism (200) may
be configured to be self-reversing, such that cutter (150) may be
translated distally and proximally without reversing the direction
of motor (528) rotation. By way of example only, cutter actuation
mechanism (200) may be configured to self-reverse in accordance
with the teachings of U.S. Pub. No. 2010/0292607, entitled
"Tetherless Biopsy Device with Self-Reversing Cutter Drive
Mechanism," published Nov. 18, 2010, the disclosure of which is
incorporated by reference herein.
[0057] In one merely illustrative example of operation of cutter
actuation mechanism (200), cutter (150) may be initially located in
a distal-most position, such that lateral aperture (14) is "closed"
as shown in FIG. 5A; with lead screw (206) being positioned distal
to threaded sleeve (240), as also shown in FIG. 5A. Spring (227)
biases lead screw (206) proximally to engage threading (242) with
threading (244). At this stage, rotation of cutter (150) relative
to threaded sleeve (240) in a first rotational direction will not
result in any distal translation of cutter (150) (e.g., lead screw
(206) will essentially "freewheel"); while rotation of cutter (150)
relative to threaded sleeve (240) in a second rotational direction
will result in proximal translation of cutter (150). As cutter
(150) is rotated by motor (528) and cutter actuation mechanism
(200) in the second rotational direction, cutter actuation
mechanism (200) causes cutter (150) to retract proximally, as shown
in FIG. 5B. As noted above, such proximal or rearward translation
may be effected through engagement of threading (242, 244), and due
to lead screw (206) rotating at a faster speed than threaded sleeve
(240). Lead screw (206) continues to traverse threading (244) of
threaded sleeve (240) as cutter (150) continues to retract
proximally.
[0058] Cutter (150) then reaches a proximal-most position, such
that lateral aperture (114) is "opened" as shown in FIG. 5C. At
this stage, lead screw (206) is positioned at a proximal smooth
interior section (245) of threaded sleeve (240) that lacks
threading (244), as also shown in FIG. 5C. Spring (229) biases lead
screw (206) distally to engage threading (242) with threads (244).
At this stage, continued rotation of cutter (150) relative to
threaded sleeve (240) in the second rotational direction will not
result in any further proximal translation of cutter (150) (e.g.,
lead screw (206) will essentially "freewheel"); while rotation of
cutter (150) relative to threaded sleeve (240) in the second
rotational direction will result in distal translation of cutter
(150). To that end, motor (528) may again be activated, with its
rotation direction being reversed to reverse the rotation direction
of cutter (150) and associated components. Such reversed rotation
of cutter (150) causes cutter (150) to advance distally to reach
the distal-most position again, as shown in FIG. 5A.
[0059] When cutter (150) is retracted to a proximal position,
thereby effectively opening lateral aperture (114), tissue may
prolapse through lateral aperture (114) under the force of gravity,
due to internal pressure of the tissue (e.g., caused by
displacement of the tissue upon insertion of needle (110), etc.),
caused by manual external palpation of the patient's breast by the
physician, and/or under the influence of vacuum provided through
cutter lumen (154) as described elsewhere herein. When cutter (150)
is then advanced distally, distal edge (152) severs tissue
protruding through lateral aperture (114). This severed tissue is
captured within cutter lumen (154). A vacuum applied through cutter
lumen (154) (as described herein or otherwise) will be encountered
by the proximal face of a severed tissue sample within cutter lumen
(154). A vent may be applied through second lumen (162) of needle
(110), which may be communicated to the distal face of the severed
tissue sample via openings (164), providing a pressure differential
for the severed tissue sample. This pressure differential may
facilitate proximal transport of the severed tissue sample through
cutter lumen (154), whereby the severed tissue sample eventually
reaches tissue sample holder (300) as described elsewhere herein.
Alternatively, tissue samples severed by cutter (150) may be
communicated proximally to tissue sample holder (300) or be
otherwise dealt with in any other suitable fashion.
[0060] Of course, any other suitable structures, components,
configurations, or techniques may be used to provide translation
and/or rotation of cutter (150). It should therefore be understood
that, as with other components described herein, cutter actuation
mechanism (200) may be varied, modified, substituted, or
supplemented in a variety of ways; and that cutter actuation
mechanism (200) 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 (150)
does not translate (e.g., such that cutter (150) merely rotates,
etc.); or such that cutter (150) does not rotate (e.g., such that
cutter (150) merely translates, etc.). As another merely
illustrative example, cutter (150) may be actuated pneumatically in
addition to or in lieu of being actuated by mechanical components.
Other suitable alternative versions, features, components,
configurations, and functionalities of cutter actuation mechanism
(200) will be apparent to those of ordinary skill in the art in
view of the teachings herein.
C. Exemplary Tissue Sample Holder
[0061] As shown in FIGS. 6-7, tissue sample holder (300) of the
present example comprises an outer cup (302) and a cap (304), with
a frame (306) interposed between cap (304) and cup (302). A seal
(308) is interposed between frame (306) and cup (302). Tissue
sample holder (300) also includes a collection tray (310).
Collection tray (310) is configured to receive and hold tissue
samples that are captured by cutter (150) and that are communicated
proximally through cutter (150) as will be described in greater
detail below. A distal port (312) of collection tray (310) aligns
with the longitudinal axis of cutter (150) such that severed tissue
samples communicated proximally through cutter lumen (154) will be
received on collection tray (310) via distal port (312). Collection
tray (310) includes a plurality of openings (314) that are sized
and configured to allow fluids to drain through collection tray
(310) while also retaining tissue samples on collection tray (310).
In some versions, outer cup (302) is transparent and/or
translucent, allowing a user of biopsy device (10) to see tissue
samples residing on collection tray (310). Of course, outer cup
(302) may alternatively be opaque or any desired combination of
transparent, translucent, and/or opaque.
[0062] A protrusion (316) protrudes proximally from collection tray
(310), and is removably received in an opening (318) formed in cap
(304). Cap (304) is formed of an elastomeric material, such that
friction substantially secures collection tray (310) to cap (304).
However, collection tray (310) may be decoupled from cap (304) by
first withdrawing cap (304) and collection tray (310) together from
cup (302), then squeezing side portions (320) of cap (304) inwardly
toward each other. For instance, portions of cap (304) may bear
against ramped surfaces (322) of collection tray (310) when side
portions (320) of cap (304) are squeezed inwardly toward each
other, urging collection tray (310) distally away from cap (304).
Thus, in some versions, cap (304) and collection tray (310) may be
together removed from cup (302), with tissue samples residing on
collection tray (310), then collection tray (310) may be ejected
from cap (304) by squeezing side portions (320) inwardly toward
each other and then releasing to deposit collection tray and the
tissue samples directly into a cup of formalin (not shown), etc.
These features of tissue sample holder (300) (among other features
of tissue sample holder (300)) may thus be configured an operable
in accordance with the teachings of U.S. Provisional Patent App.
No. 61/381,466, entitled "Biopsy Device Tissue Sample Holder with
Removable Basket," filed Sep. 10, 2010, the disclosure of which is
incorporated by reference herein. It should also be understood that
the elastomeric properties of cap (304) may provide a substantially
fluid tight seal with frame (306). In addition, the elastomeric
properties of cap (304) provide a substantially fluid tight seal
against protrusion (316) when protrusion (316) is inserted in
opening (318). Of course, collection tray (310) and cap (304) may
have any other suitable components, features, configurations, and
relationships.
[0063] The hollow interior of outer cup (302) is in fluid
communication with cutter lumen (154) and with at least one vacuum
source in the present example. In particular, a probe port (330)
extends distally from outer cup (302) and into base housing (130),
and receives cutter (150) as shown in FIG. 7A. A dynamic seal (332)
is provided at the interface of probe port (330) and cutter (150),
providing a substantially fluid tight seal even as cutter (150)
rotates and translates relative to outer cup (302). A vacuum may be
provided to the interior of outer cup (302) via a primary vacuum
port (340), which extends upwardly from outer cup (302). Primary
vacuum port (340) is positioned and configured to couple with a
complementary vacuum port (566) in holster (500) when probe (100)
and holster (500) are coupled together. Complementary vacuum port
(566) is in fluid communication with a vacuum pump (566) in holster
(500), which is operable to generate a vacuum as will be described
in greater detail below. A filter (342) is positioned between
primary vacuum port (340) and outer cup (302), in the fluid path of
a vacuum between primary vacuum port (340) and the interior of
outer cup (302). In some versions, filter (342) comprises a
hydrophobic filter. In some other versions, filter (342) comprises
a hydrophilic filter. As yet another variation, a combination of a
hydrophobic filter and a hydrophilic filter may be used.
Alternatively, any other suitable type of filter or combination of
filters may be used, including no filter (342) at all if desired. A
pair of o-rings (344) also provide a seal between primary vacuum
port (340) and the housing of outer cup (302), to substantially
prevent leaking at the interface between primary vacuum port (340)
and the housing of outer cup (302).
[0064] Tissue sample holder (300) of the present example also
includes a secondary vacuum port (350), which extends proximally
from frame (306). Secondary vacuum port (350) is configured to be
coupled with an external vacuum source (e.g., a conventional vacuum
pump, etc.) to supplement or substitute the vacuum provided by
vacuum pump (560). Various examples of how such a secondary vacuum
source may be provided and used with biopsy device (10) are
described in U.S. Non-Provisional patent application Ser. No.
12/709,695, entitled "Biopsy Device with Auxiliary Vacuum Source,"
filed Feb. 22, 2010, the disclosure of which is incorporated by
reference herein. As best seen in FIGS. 6-7, a tube (352) extends
distally from frame (306) and is in fluid communication with
secondary vacuum port (350). It should be understood that a cap or
plug (not shown) may be selectively secured to secondary vacuum
port (350) to substantially seal secondary vacuum port (350), such
as when biopsy device (10) is used without a secondary vacuum
source and vacuum pump (560) is the sole source of vacuum.
[0065] As best seen in FIGS. 7A-7B, a set of baffles (354) are
provided without outer cup (302), between tube (352) and collection
tray (310). In some versions, baffles (354) are configured to allow
a vacuum to be communicated through tube (352) to the entire hollow
interior of outer cup (302), yet baffles (354) are also configured
to "stir" the fluid flow within outer cup (302) to provide a
cyclonic suction action. In addition or in the alternative, baffles
(354) may provide a tortuous path to reduce the likelihood of fluid
within tissue sample holder (300) reaching filter (342) when biopsy
device (10) is rotated about the longitudinal axis of biopsy device
(10) during use. For instance, if a first set of biopsy samples are
collected with port (340) oriented upwardly, fluid may drain below
baffles (354), and may substantially remain below at least one of
baffles (354) in the event that biopsy device is rotated in either
direction such that port (340) is oriented sideways or upwardly
during the collection of additional biopsy samples during the same
use. Of course, as with other components described herein, baffles
(354) may be configured in any other suitable fashion, and may even
be omitted if desired. It should also be understood that one or
more filters may be provided in or near tube (352), including but
not limited to particulate filters, hydrophobic filters,
hydrophilic filters, etc. In some other versions, secondary vacuum
port (350) is simply omitted altogether. In addition or in the
alternative, primary vacuum port (340) and vacuum pump (560) may be
omitted if desired.
[0066] Tissue sample holder (300) of the present example also
includes a guidance funnel (360). Guidance funnel (360) includes a
central opening (362) that is configured to align with the axis of
cutter lumen (154) and distal port (312) of collection tray (310).
Guidance funnel (360) is fixedly secured to a proximal portion of
probe port (330), as best seen in FIG. 7. When collection tray
(310) is positioned within outer cup (302) and cap (304) is secured
to frame (306), the proximal portion of guidance funnel (360) abuts
the distal face (364) of collection tray (310). When collection
tray (310) and cap (304) are removed from tissue sample holder
(300), guidance funnel (360) remains within outer cup (302),
secured to the proximal portion of probe port (330). A plurality of
openings (366) are formed in the body of guidance funnel (360).
Such openings (366) are configured to prevent guidance funnel (360)
from being secured to distal face (364) of collection tray (310)
like a suction cup, which might otherwise make it more difficult to
remove collection tray (310) from outer cup (302). In addition or
in the alternative, such openings (366) may be configured to allow
fluid (e.g., blood, saline, air, etc.) to fill the space between
guidance funnel (360) and collection tray (310), to make greater
use of the internal volume of outer cup (302). When collection tray
(310) and cap (304) are removed from tissue sample holder (300),
guidance funnel (360) may facilitate insertion of a biopsy site
marker applier shaft (not shown) into cutter lumen (154) by helping
to guide the marker applier shaft to be coaxial with cutter lumen
(154). It should therefore be understood that, after one or more
biopsy samples are captured by biopsy device (10), and with needle
(110) still inserted in tissue, a user may remove collection tray
(310) and cap (304) from tissue sample holder (300) then insert a
marker applier shaft into cutter lumen (154) via guidance funnel
(360) to deploy one or more biopsy site markers to the biopsy site
via lateral aperture (114). In addition or in the alternative,
guidance funnel (360) may facilitate administration of a pain
medication to a biopsy site from a syringe having a catheter-like
tube coupled with the distal end of the syringe barrel, by
facilitating insertion of the catheter-like tube from the proximal
end of biopsy device (10).
[0067] Tissue sample holder (300) of the present example is also
selectively removable from probe (100). In particular, outer cup
(300) includes a pair of latches (370) that selectively engage base
housing (130). Latches (370) are resiliently biased to secure
tissue sample holder (300) to base housing (130), yet may be
deflected to disengage tissue sample holder (300) from base housing
(130). Each latch (370) includes a respective button portion (372)
to provide such disengagement. In particular, latches (370) may be
disengaged from base housing (130) by pressing button portions
(372) inwardly toward each other. With button portions (372)
depressed inwardly, latches (370) deflect to disengage housing
(130), such that tissue sample holder (300) may be pulled
proximally to separate tissue sample holder (300) from probe (100).
In some versions, vacuum port (340) slides free from outer cup
(302), such that vacuum port (340) remains coupled with probe (100)
and/or holster (500) when tissue sample holder (300) is pulled
free. Alternatively, vacuum port (340), probe (100), and/or holster
(500) may be configured to allow vacuum port (340) to be disengaged
from probe (100) and/or holster (500) with outer cup (302) when
tissue sample holder (300) is pulled free. In some other versions
(e.g., those that only rely on an external source coupled with
secondary vacuum port (350) for vacuum), vacuum port (340) is
omitted entirely. It should also be understood that biopsy device
(10) may include one or more features configured to substantially
seal the proximal end of cutter (150) when tissue sample holder
(300) is removed from biopsy device (10). For instance, such a seal
may substantially prevent blood and/or other bodily fluids from
exiting the proximal end of cutter lumen (154) when sample holder
(300) is removed from biopsy device (10) while needle (110) is
still inserted in tissue. Such a seal may also effectively open
when tissue sample holder (300) is re-coupled with biopsy device
(10). Various suitable ways in which such a seal may be provided
will be apparent to those of ordinary skill in the art in view of
the teachings herein. Similarly, various other suitable ways in
which tissue sample holder (300) may be selectively engaged with
base housing (130) will be apparent to those of ordinary skill in
the art in view of the teachings herein.
[0068] As best seen in FIGS. 2, 6, and 7, tissue sample holder
(300) of the present example includes a contact (380) that is
configured to engage a corresponding contact sensor (520) (which is
only shown in FIG. 11) of holster (500) when probe (100) and
holster (500) are coupled together. Thus, as will be described in
greater detail below, a control module (510) in holster (500) may
sense when tissue sample holder (300) is coupled with or decoupled
from probe (100), and may control or restrict operation of biopsy
device (10) accordingly. Of course, biopsy device (10) may
alternatively include a variety of other types of features
configured to sense when tissue sample holder (300) is coupled with
or decoupled from probe (100). Furthermore, some variations of
biopsy device (10) may include a tissue sample holder (300) that is
not removable from probe (100).
[0069] Tissue sample holder (300) of the present example is
configured to hold up to at least ten tissue samples before
collection tray (310) must be removed, though it should be
understood that tissue sample holder (300) may be configured to
hold any other suitable number of tissue samples. In some
alternative versions, in lieu of having a stationary collection
tray (310), tissue sample holder (300) may have a plurality of
trays that are removably coupled with a rotatable manifold, such
that the manifold is operable to successively index each tray
relative to cutter lumen (154) to separately receive tissue samples
obtained in successive cutting strokes of cutter (150). For
instance, tissue sample holder (300) may be constructed and
operable in accordance with the teachings of 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. As another merely illustrative
example, tissue sample holder (300) may be constructed and operable
in accordance with the teachings of U.S. Pub. No. 2010/0160824,
entitled "Biopsy Device with Discrete Tissue Chambers," published
Jun. 24, 2010, the disclosure of which is incorporated by reference
herein. Still other suitable ways in which tissue sample holder
(300) may be constructed and operable will be apparent to those of
ordinary skill in the art in view of the teachings herein.
D. Exemplary Needle Valving Mechanism
[0070] As shown in FIGS. 8-9C, probe (100) further includes
components that are operable to selectively vent or seal second
lumen (162) of needle (110) relative to atmosphere. These
components include a vent sleeve (420) and a shuttle valve slider
(430). Vent sleeve (420) is secured relative to chassis (120) and
base housing (130), such that vent sleeve (420) does not move
during operation of biopsy device (10); while shuttle valve slider
(430) translates based on operational movement of cutter (150). A
distal portion of vent sleeve (420) is slidably disposed within
proximal portion (416) of needle overmold (410). The outer diameter
of vent sleeve (420) and the inner diameter of proximal portion
(416) of needle overmold (410) are secured together unitarily in
the present example, such that vent sleeve (420) and needle
overmold (410) translate unitarily. It should also be understood
that, even with cutter disposed through vent sleeve (420), the
interior of vent sleeve (420) is in fluid communication with second
lumen (162) of needle (110) via needle overmold (410). Vent sleeve
(420) includes a plurality of transverse openings (422) that are
longitudinally co-located with each other and that are
equidistantly spaced from each other about the outer perimeter of
vent sleeve (420) at their common longitudinal position. Transverse
openings (422) provide communication of atmospheric air to the
interior of vent sleeve (420) as will be described in greater
detail below. As best seen in FIGS. 9A-9C, the proximal end of vent
sleeve (420) is sealed by an o-ring (424), which is disposed in an
annular recess (426) formed in distal portion (211) of cutter
overmold (210). Biopsy device (10) of this example is configured
such that o-ring (424) remains positioned within vent sleeve (420)
at all times during operation of biopsy device (10), even when
cutter (150) is at a proximal position as shown in FIG. 10.
[0071] Shuttle valve slider (430) is disposed coaxially about
cutter (150), and has an inner diameter permitting shuttle valve
slider (430) to longitudinally slide freely relative to cutter
(150). Shuttle valve slider (430) also translates relative to vent
sleeve (420). A pair of o-rings (432) are positioned at the ends of
shuttle valve slider (430), and are configured to seal against the
inner surface of vent sleeve (420) yet still permit shuttle valve
slider (430) to translate relative to vent sleeve (420). Shuttle
valve slider (430) is longitudinally positioned between the distal
end (428) of cutter overmold (210) and an annular stop member
(434), which is unitarily secured to cutter (150) by a friction
fit. Shuttle valve slider (430) defines an inner diameter that is
greater than the outer diameter defined by cutter (150), such that
a gap is provided between the outer diameter of cutter (150) and
the inner diameter of shuttle valve slider (430) along the length
of the interior of shuttle valve slider (430). Such a gap is
sufficient to provide longitudinal fluid communication (e.g.,
atmospheric air, etc.) between the outer diameter of cutter (150)
and the inner diameter of shuttle valve slider (430). In addition,
the distal and proximal ends of shuttle valve slider (430) include
notches (436) formed therein, providing an appearance similar to
that of a castellated nut or castle nut.
[0072] The proximal end of shuttle valve slider (430) is also
configured to be engaged by distal end (428) of cutter overmold
(210), such that cutter overmold (210) may push shuttle valve
slider (430) distally as described below. Notches (436) at the
proximal end of shuttle valve slider (430) are configured to
provide fluid communication to the interior of shuttle valve slider
(430), even as distal end (428) of cutter overmold (210) engages
the proximal end of shuttle valve slider (430). Similarly, the
distal end of shuttle valve slider (430) is configured to be
engaged by stop member (434), such that stop member (434) may push
shuttle valve slider (430) proximally as described below. Notches
(436) at the distal end of shuttle valve slider (430) are
configured to provide fluid communication to the interior of
shuttle valve slider (430), even as stop member (434) engages the
distal end of shuttle valve slider (430).
[0073] As described elsewhere herein, cutter (150) is configured to
rotate and translate relative to base housing (130), while vent
sleeve (420) remains substantially stationary relative to base
housing (130). As noted above, cutter overmold (210) and stop
member (434) translate unitarily with cutter (150). In addition,
stop member (434) and shuttle valve slider (430) are configured
such that stop member (434) may push shuttle valve slider (430)
proximally when stop member (434) is engaged with shuttle valve
slider (430) (see, e.g., FIG. 9C); while cutter overmold (210) and
shuttle valve slider (430) are configured such that cutter overmold
(210) may push shuttle valve slider (430) distally when cutter
overmold (210) is engaged with shuttle valve slider (430) (see,
e.g., FIG. 9A). Shuttle valve slider (430) may thus translate
within vent sleeve (420) in accordance with translation of cutter
(150) relative to base housing (130). However, the distance between
distal end (428) of cutter overmold (210) and the proximal end of
stop member (434) is greater than the length of shuttle valve
slider (430), such that there is a degree of "lost motion" between
shuttle valve slider (430) and cutter (150) as cutter (150)
translates in the present example. In other words, shuttle valve
slider (430) remains substantially stationary during certain stages
of a cutter (150) actuation stroke (see, e.g., FIGS. 9A-9B), such
that shuttle valve slider (430) only translates when cutter (150)
starts closely approaching the distal-most position travelling from
the proximal-most position; and when cutter (150) starts closely
approaching the proximal-most position (see, e.g., FIG. 9C).
[0074] As noted above, openings (422) of vent sleeve (420)
communicate with ambient air; and shuttle valve slider (430) is
operable to selectively vent second lumen (162) to atmosphere. In
particular, shuttle valve slider (430) remains distal to openings
(422) when cutter (150) is at a distal-most position (see, e.g.,
FIG. 9A); when cutter (150) is transitioning between the
distal-most position and the proximal-most position (see, e.g.,
FIG. 9B); and at latter stages of cutter (150) transitioning from
the proximal-most position to the distal-most position. During
these stages of operation, second lumen (162) is exposed to ambient
air via openings (422) in vent sleeve (422), notches (436) in
shuttle valve slider (430), the gap between the inner diameter of
shuttle valve slider (430) and the outer diameter of cutter (150),
and the portion of the interior of vent sleeve (420) that is distal
to shuttle valve slider (430). However, shuttle valve slider (430)
and o-rings (432) substantially seal second lumen (162) relative to
openings (422) when cutter (150) is in a proximal position, such as
is shown in FIG. 9C. In particular, when cutter (150) moves to the
proximal position, stop member (434) pushes shuttle valve slider
(430) proximally such that openings (422) are longitudinally
positioned between o-rings (432). O-rings (432) thus substantially
seal off second lumen (162) relative to openings (422) when
openings (422) are between o-rings (210). When cutter (150) begins
moving again distally toward the distal-most position, shuttle
valve slider (430) remains at this proximal position momentarily,
continuing to substantially seal second lumen (162) relative to
openings (422), until distal end (428) of cutter overmold (210)
engages the proximal end of shuttle valve slider (430) and begins
pushing shuttle valve slider (430) distally to the point where the
proximal-most o-ring (432) is moved distal to openings (422). Once
the proximal-most o-ring (432) moves distal to openings (422),
second lumen (162) is again vented to atmosphere as noted above.
Thus, the valve mechanism of the present example substantially
seals off second lumen (162) relative to atmosphere when cutter
(150) is at a proximal position and when cutter (150) is at initial
stages of distal advancement; while venting second lumen (162) to
atmosphere when cutter (150) is at other positions.
[0075] It should be understood that, as with other components
described herein, the valving components described above may be
varied, modified, substituted, or supplemented in a variety of
ways; and that a valve mechanism may have a variety of alternative
features, components, configurations, and functionalities. Suitable
alternative versions, features, components, configurations, and
functionalities of a valve mechanism will be apparent to those of
ordinary skill in the art in view of the teachings herein. It
should also be understood that, in some versions of biopsy device
(10) that lack a vacuum pump (566) (e.g., vacuum only provided by
external vacuum pump through secondary vacuum port (350), etc.),
valving functions may be performed by valve components located
between biopsy device (10) and an external vacuum source, such that
biopsy device (10) may lack a valve mechanism altogether.
E. Exemplary Needle Firing Mechanism
[0076] Biopsy device (10) of the present example is operable to
selectively fire needle (110) distally relative to chassis (120)
and relative to base housing (130) through a needle firing
mechanism (400). A user may wish to employ needle firing mechanism
(400) in instances where needle (110) is encountering dense tissue
or under other circumstances. Of course, biopsy device (10) may
also be operated without ever using needle firing mechanism (400).
As shown in FIGS. 8 and 10A-10E, needle firing mechanism (400) of
the present example includes a coil spring (440), a catch (450),
and an arming slider (460). Coil spring (440) is positioned
coaxially about cutter (150) and vent sleeve (420). The distal end
of coil spring (440) bears against the proximal end (442) of needle
overmold (410); while the proximal end of coil spring (440) bears
against an integral boss (444) of base housing (130). Coil spring
(440) is resiliently biased to urge needle overmold (410) (and,
hence, needle (110)) distally. Distal movement of needle (110) is
restricted by a bumper washer (446), which abuts a pair of bosses
(448) formed in base member (130). Bumper washer (446) of the
present example is formed of an elastomeric material that is
configured to absorb at least some of the shock created by sudden
distal movement of needle overmold (410) when needle (110) is fired
distally. Of course, bumper washer (446) may be substituted or
supplemented with a variety of other components (e.g., spring,
etc.); or may be omitted altogether.
[0077] Catch (450) of needle firing mechanism (400) comprises an
elongate beam (452), an annular member (454) at the distal end of
elongate beam (452), and a transverse projection (456) at the
proximal end of elongate beam (452). Elongate beam (452) is formed
of a resilient material such as plastic, and is biased to assume a
bowed configuration as shown in FIGS. 10A and 10E in some versions.
In some other versions, elongate beam (452) is resiliently biased
to assume a substantially straight configuration, but is capable to
being bent to the bowed configuration shown in FIGS. 10A and 10E.
Annular member (454) is coaxially disposed about distal portion
(412) of needle overmold (410), proximal to bumper washer (446).
The inner diameter of annular member (454) is less than the outer
diameter of proximal portion (416) of needle overmold (410).
Accordingly, when catch (450) is pulled proximally as described in
greater detail below, annular member (454) pulls needle (110) from
a distal position to a proximal position, against the distal bias
provided by spring (440). Similarly, as needle (110) is fired
distally from a proximal position to a distal position, proximal
portion (416) of needle overmold (410) pushes annular member (454)
(and, hence, catch (450)) distally. Transverse projection (456)
projects inwardly toward other components of needle firing
mechanism (400), and is configured to selectively engage distal
flange (216) of cutter overmold (210) as will be described in
greater detail below.
[0078] A pin (458) is inserted through the proximal end of elongate
beam (452), near the position from which transverse projection
(456) projects. Pin (458) extends upwardly and downwardly from
elongate beam (452). A lower portion of pin (458) is disposed in a
track (470) that is formed in base housing (130). An upper portion
of pin is disposed in a corresponding track (not shown) that is
formed in the underside of chassis (120) and that has a shape
complementing the shape of track (470). The portion of chassis
(120) presenting this corresponding track may include reinforcement
to provide additional strength to bear stresses imposed by pin
(458) during operation of needle firing mechanism (400). Track
(470) in base housing (130) includes an inner portion (472) and an
outer portion (474). Viewed from the top down and from the bottom
up, inner portion (472) runs along a path that is substantially
parallel to the longitudinal axis of cutter (150) and various other
components; while outer portion (474) runs along a path that
includes a curved portion to allow transverse projection (456) to
clear distal flange (216) of cutter overmold (210) as will be
described in greater detail below. In other words, inner portion
(472) does not stray transversely away from or toward the
longitudinal axis of cutter (150) along a horizontal plane passing
through inner portion (472); while outer portion (474) does stray
transversely away from the longitudinal axis of cutter (150) along
a horizontal plane passing through outer portion (474).
[0079] Inner portion (472) and outer portion (474) are generally
located at different heights in this example. In particular, in
some versions, a proximal part of outer portion (474) runs at a
generally lower (474) height (e.g., in relation to chassis (120))
than the proximal part of inner portion (472). In the distal part
of track (470), the height transition between portions (472, 474)
is substantially smooth. In particular, as pin (458) travels from
outer portion (474) to and along inner portion (472), pin (458)
ascends a generally gradual incline. However, in the proximal
portion of track (470), a step (476) separates inner portion (472)
from outer portion (474). Thus, as pin (458) transitions back from
inner portion (472) to outer portion (474), pin (458) jumps down
step (476) to reach outer portion (474) of track (470). In the
present example, step (476) is formed at an angle that is oblique
to the longitudinal axis defined by cutter (150), along a
horizontal plane that runs through track (470), to further promote
pin (458) jumping down step to reach outer portion (474) as pin
(458) reaches a proximal-most position. In some versions, outer
portion (474) of track (470) defines an incline ascending upwardly
toward chassis (120) as outer portion (474) progresses from the
proximal end of track (470) to the distal end of track (470). It
should therefore be understood that pin (458) may ascend upwardly
toward chassis (120) as it travels proximally from the distal end
of inner portion (472) to the proximal end of inner portion (472),
then jump down step (476) when it transitions to outer portion
(474), then ascend upwardly again toward chassis (120) as it
travels distally from the proximal end of outer portion (474) to
the distal end of outer portion (474). Pin (458) may encounter
another step (not shown) at the distal end of outer portion (474),
to jump down to reach the distal end of inner portion (474). Of
course, track (470) may alternatively have any other suitable
features or configurations.
[0080] As noted above, beam (452) is resiliently biased to assume a
bent configuration, which in turn provides a resilient bias for pin
(458) to be disposed in outer portion (474) of track (470).
Nevertheless, while pin (458) travels proximally from the distal
end of inner portion (472) toward the proximal end of inner portion
(472), track (470) is configured to keep pin (458) in inner portion
(472) until pin (458) reaches the proximal end of inner portion
(472). Once pin (458) reaches the proximal end of inner portion
(472), the resilient urging of beam (452), as well as the angled
orientation of step (476), causes pin (458) to jump down into outer
portion (474) of track (470). It should also be understood that the
upward travel of pin (458) along inner portion (472) of track (470)
may further cause vertical deflection in beam (452), which may
provide a downward bias of beam (452) to further urge pin (458)
downward into inner portion (472) of track (470) when pin (458)
reaches the proximal end of inner portion (472).
[0081] Arming slider (460) of the present example is operable to
deflect beam (452) inward, to selectively transition pin (458) from
outer portion (474) to inner portion (472) at the distal end of
track (470). Arming slider (460) is slidable relative to base
housing (130) and comprises a finger grip (402) protruding
downwardly from base housing (130). An inner sidewall (462) is
configured and positioned to push inwardly against beam (452) to
deflect beam (452) inwardly as slider (460) is slid proximally.
Slider (460) is also configured to move upwardly toward chassis
(120) in the present example. Slider (460) includes a set of
resilient angled tabs (464) that are configured to bear against the
underside of chassis (120), biasing slider (460) downwardly away
from chassis (120). In addition, a coil spring (470) is positioned
about a post (466) of slider (460), and bears against a boss (473)
in base housing (130). Coil spring (470) is resiliently biased to
urge slider (460) to a distal position. Being movable upwardly
toward chassis (120), slider (460) is further operable to push
upwardly on beam (452), thereby facilitating transition of pin
(458) from outer portion (474) of track (470) to inner portion
(472) of track (470). Such capability may be useful in versions
where beam (452) is resiliently biased to assume a downwardly bent
configuration in addition to being resiliently biased to assume an
outwardly bent configuration; and/or in versions where the
transition from outer portion (474) of track (470) to inner portion
(472) of track (470) includes a step or is otherwise not very
gradual at the distal end of track (472). In some versions, base
housing (130) includes a stepped track that substantially prevents
arming slider (460) from being slid proximally without slider (460)
also being simultaneously pushed upwardly toward chassis (120).
Such a stepped track (or other component/feature/etc.) may serve as
a lockout preventing inadvertent proximal movement of slider (460)
relative to base housing (130).
[0082] FIGS. 10A-10E show needle firing mechanism (400) at various
stages of operation, which will be described below. In particular,
FIG. 10A shows needle firing mechanism (400) in a ready to arm
configuration. In this configuration, cutter (150) is in a distal
position, such that distal flange (216) of cutter overmold (210) is
located at a longitudinal position that is distal to (yet lateral
to) the longitudinal position of transverse projection (456) of
catch (450). The resilient bias of beam (452) provides beam (452)
with an outwardly bent configuration, with pin (458) disposed in
outer portion (474) of track (474) such that transverse projection
(456) is positioned away from distal flange (216). In some
versions, needle (110) is inserted in tissue (e.g., a human breast,
etc.) when biopsy device (10) is in this configuration. It should
be understood that, at the stage of operation shown in FIG. 10A,
other components of biopsy device (10) of the present example are
in the positions and configurations shown in FIGS. 5A and 9A.
[0083] FIG. 10B shows needle firing mechanism (400) in an armed and
ready to retract configuration. In particular, a user has slid
arming slider (460) to a proximal position, such as by pulling
proximally on finger grip (402) or otherwise. In some versions, the
user has also pushed upwardly to move slider (460) toward chassis
(120) in addition to pulling proximally on finger grip (402) to
slide arming slider (460) to a proximal position. Cutter (150) has
not moved between the stages shown in FIGS. 10A-10B, such that the
longitudinal position of distal flange (216) has remained
consistent at this stage. As seen in FIG. 10B, inner sidewall (462)
has pushed inwardly against beam (452) to deflect beam (452)
inwardly as slider (460) was slid proximally. This inward
deflection of beam (452) (and upward deflection of beam (452), in
some versions) has moved transverse projection (456) inwardly to an
armed position. With transverse projection (456) in this armed
position, pin (458) has moved to the inner portion (472) of track
(470) and transverse projection (456) is now located adjacent to
and just proximal to distal flange (216) of cutter overmold (210).
In some versions, there is no change in height between outer
portion (474) of track (470) and inner portion (472) of track (470)
at this distal end of track (470). In some other versions, while
moving from outer portion (474) of track (470) to inner portion
(472) of track (470), pin (458) traverses a slight incline (or a
step, in some versions) to move slightly upwardly toward chassis
(130).
[0084] FIG. 10C shows needle firing mechanism (400) transitioning
to a retracted and loaded or ready to fire configuration. In
particular, cutter actuation mechanism (200) has been activated to
retract cutter (150) proximally, which in turn has retracted distal
flange (216) proximally. In some versions, cutter (150) is not yet
in a fully proximal position at this stage. In some other versions,
cutter (150) is in a fully proximal position at this stage. As can
be seen in FIG. 10C, the proximal retraction of cutter (150) and
distal flange (216) has moved catch (450) proximally due to
engagement between distal flange (216) and transverse projection
(456). This proximal movement of catch (450) has also moved needle
overmold (410) proximally due to engagement between annular member
(454) of catch (450) and proximal portion (416) of needle overmold
(410). With needle overmold (410) moved proximally and being
unitarily secured to needle (110), needle (110) has also been moved
to a proximal position relative to base housing (130) at this
stage. Spring (440) is now in a more compressed state, resiliently
urging needle overmold (410) (and, hence, needle (110)) distally.
It should be understood that, at the stage of operation shown in
FIG. 10C, other components of biopsy device (10) of the present
example are in the positions and configurations shown in FIGS. 5B
and 9B. It should also be understood that needle (110) and cutter
(150) have translated proximally together during the transition
between the stage depicted in FIG. 10B and the stage depicted in
FIG. 10C.
[0085] FIG. 10D shows needle firing mechanism (400) at a stage
where needle firing mechanism (400) is in a retracted and ready to
fire configuration. In particular, cutter actuation mechanism (200)
has continued to retract cutter (150) proximally, which in turn has
retracted distal flange (216) further proximally. At this stage,
catch (450) has been retracted to a point where pin (458) has
jumped down step (476) to transition from inner portion (472) of
track (470) to outer portion (474) of track (470). Also at this
stage, proximal retraction of cutter (150) is ceased at least
temporarily. Since some versions of biopsy device (10) permit
biopsy device (10) to be used regardless of whether needle firing
mechanism (400) is also used, it may be beneficial for biopsy
device (10) to have intelligence permitting control components of
biopsy device (10) to discern whether needle firing mechanism (400)
is being used or not and to operate cutter actuation mechanism
(200) accordingly. That is, such intelligence may determine whether
retraction of cutter (150) should cease when cutter (150) reaches
the position shown in FIG. 10D (i.e., in cases where needle firing
mechanism (400) is being used by the user) or if cutter (150)
should continue retracting without cessation when cutter (150)
reaches the position shown in FIG. 10D (i.e., in cases where needle
firing mechanism (400) is not being used by the user). For
instance, as described in greater detail below, holster (500)
includes a control module (510) that is in communication with motor
(528) and with an encoder sensor (526), which is configured to
monitor movement produced by motor (528). Control module (510) may
include a logic configured to monitor the current profile (and/or
other performance related characteristic) of motor (528) with
respect to the longitudinal position of cutter (150) as discerned
by data from encoder sensor (526), in relation to a baseline
current profile. When needle firing mechanism (400) is being used
by the user, the work required to compress spring (440) may impose
an additional load on motor (528) that can be detected based on the
amount of current drawn by motor (528) with respect to the
longitudinal position of cutter (150), as compared to a baseline
current that might be expected when needle firing mechanism (400)
is not being used by the user. Control module (510) may thus cease
retraction of cutter (150) when cutter reaches the position shown
in FIG. 10D when that additional load is detected.
[0086] As another merely illustrative example, one or more sensors
(e.g., hall effect sensor, proximity sensor, etc.) within probe
(100) may be used to detect whether needle firing mechanism (400)
is being used by the user, and such one or more sensors may provide
such data to control module (510) to alert control module (510) to
cease retraction of cutter (150) when cutter reaches the position
shown in FIG. 10D. Various forms that such sensors may take as well
as various ways in which such sensors may communicate with control
module (510) will be apparent to those of ordinary skill in the art
in view of the teachings herein. Regardless of the structures and
methods used to determine whether needle firing mechanism (400) is
being used by the user, it may also be desirable in versions where
cutter (150) retraction is ceased at the stage shown in FIG. 10D to
notify the user of biopsy device (10) that needle firing mechanism
(400) is cocked and ready to fire. Such notification may be
provided through various components of holster (500) (e.g., speaker
(522), LEDs (524), etc.), through one or more mechanical components
that provide a loud audible click or other form of audible
feedback, etc. Needle firing mechanism (400) may then be fired when
the user activates a button (516) on holster (500). Such activation
may also automatically continue a sampling cycle by completing
retraction of cutter (150) and then advancing cutter (150) distally
to sever a tissue sample. Alternatively, control module (510) may
be configured to require a first activation of button (516) to fire
needle firing mechanism (400) after needle firing mechanism (400)
has reached the stage shown in FIG. 10D; and a second activation of
button (516) to continue/complete a sampling cycle. This may allow
needle (110) to be fired repeatedly during a single insertion of
needle (110) in tissue before a tissue sample is captured by cutter
(150).
[0087] When the user activates button (516) to fire needle firing
mechanism (400), control module (510) activates cutter actuation
mechanism (200) to reverse motion of cutter (150) to advance cutter
(150) slightly distally in order to facilitate disengagement of
transverse projection (456) from distal flange (216) once needle
firing mechanism (400) has reached the configuration shown in FIG.
10D. It should be understood that, in some such versions, step
(476) keeps pin (458) in outer portion (474) of track (470) even if
cutter (150) is advanced slightly at this stage. It should also be
understood that, with pin (458) being positioned in outer portion
(474), and with transverse projection (456) disengaged from distal
flange (216), beam (452) may return to a bent configuration (e.g.,
in versions where beam (452) is resiliently biased to assume a bent
configuration, etc.) or otherwise be bent to assume a bent
configuration (e.g., in versions where beam (452) is resiliently
biased to assume a straight configuration, etc.). It should also be
understood that the oblique orientation of step (476) may encourage
beam (452) to transition to a bent configuration by providing a
transversely located cam surface against pin (458). In addition to
or in lieu of advancing cutter slightly distally in order to
facilitate disengagement of transverse projection (456) from distal
flange (216) once needle firing mechanism (400) has reached the
configuration shown in FIG. 10D, a resilient outward bias of beam
(452) alone may suffice to disengage transverse projection (456)
from distal flange (216) once needle firing mechanism (400) has
reached the configuration shown in FIG. 10D.
[0088] As can also be seen in FIG. 10D, the user of biopsy device
(10) has released finger grip (402) of arming slider (460),
allowing arming slider (460) to return to a distal position under
the resilient distal urging of spring (470). In some versions, and
as discussed above, biopsy device (10) may provide an audio,
visual, and/or tactile indication to the user indicating that
needle firing mechanism (400) is ready to fire. This may alert the
user to release arming slider (460) to the extent that the user has
not already released arming slider (460) at this stage. In some
versions, arming slider (460) includes a chamfer or similar feature
at the proximal end of inner sidewall (462), which substantially
prevents re-arming of firing mechanism (400) if arming slider (460)
is not released between tissue sampling cycles (i.e., cutting
strokes/cycles of cutter (150)).
[0089] In the present example, with transverse projection (456)
disengaged from distal flange (216) (shortly after the moment
depicted in FIG. 10D), the resilient bias of spring (440) suddenly
urges needle overmold (410) distally relative to base housing
(130), thereby firing needle (110) distally. It should be
understood that cutter (150) is still not yet fully retracted at
this stage. It should also be understood that needle (110)
translates distally relative to cutter (150), in addition to
translating distally relative to base housing (130), when needle
(110) is fired distally by needle firing mechanism (400). FIG. 10E
shows needle firing mechanism (400) upon firing of needle (110). In
particular, and as noted above, disengagement between transverse
projection (456) and distal flange (216) has allowed spring (440)
to fire needle (110) to a distal position. During the transition
from FIG. 10D to FIG. 10E (e.g., during actual firing of needle
(110)), pin (458) has traversed the full path of outer portion
(472) of track (470), returning to the distal region of track
(470). It should be understood that, after needle (110) is fired by
firing mechanism (400), cutter actuation mechanism (200) may
suspend movement of cutter (150) in the present example, in
addition to or in lieu of suspending movement of cutter (150) when
needle firing mechanism (400) is cocked and ready to fire as
described above with reference to FIG. 10D. In some versions,
cutter actuation mechanism (200) may continue retracting cutter
(150) proximally after suspending movement of cutter (150) for a
suitable duration (e.g., after predetermined duration, until the
user again actuates a button (516) of holster (500), etc.).
Alternatively, cutter actuation mechanism (200) may continue to
retract cutter (150) proximally after needle (110) is fired by
firing mechanism (400), without providing at least temporary
suspension of movement of cutter (150). It should be understood
that, at the stage of operation shown in FIG. 10E, other components
of biopsy device (10) of the present example are in the positions
and configurations shown in FIGS. 5C and 9C.
[0090] In the present example, vent sleeve (420) translates when
needle firing mechanism (400) is cocked and fired. In particular,
needle overmold (410) pushes vent sleeve (420) proximally as needle
firing mechanism (400) pulls needle (110) proximally (see FIG. 9B).
Needle overmold (410) pulls vent sleeve (420) distally as needle
firing mechanism (400) pushes needle (110) distally (see FIG. 9C).
When biopsy device (10) is used without firing needle (110) (e.g.,
when needle firing mechanism (400) is present but not used by the
user of biopsy device (10)), vent sleeve (420) simply remains in
the distal position (see FIG. 9A). It should be understood that the
valving components described above will operate in the same manner
as described above regardless of whether a user decides to operate
needle firing mechanism (400). In other words, second lumen (162)
will be vented or sealed relative to atmosphere at the same stages
of cutter (150) actuation regardless of whether needle firing
mechanism (400) is used.
[0091] It should be understood that the above described components,
features, configurations, and operabilities of needle firing
mechanism (400) are merely illustrative. Any of these components,
features, configurations, and operabilities may be varied,
modified, substituted, supplemented, or even omitted as desired.
Various other suitable components, features, configurations, and
operabilities that may be incorporated into needle firing mechanism
(400) will be apparent to those of ordinary skill in the art in
view of the teachings herein. It should also be understood that
various other types of devices, including but not limited to any of
the biopsy devices described in the references that are cited
herein, may be modified to include a needle firing mechanism
(400).
[0092] II. Exemplary Holster
A. Exemplary Electrical Components of Holster
[0093] FIG. 11 shows various electrical and electromechanical
components that are incorporated into holster (500) of biopsy
device (10) of the present example. It should be understood that
each of these components is merely illustrative, and that any of
these components may be modified, varied, substituted,
supplemented, or even omitted, as desired. As shown in FIG. 11,
holster (500) of the present example includes a control module
(510), a battery (512), an accelerometer (514), buttons (516),
charging circuitry (518), a tissue sample holder sensor (520), a
speaker (522), LEDs (524), an encoder sensor (526), and a motor
(528). Control module (510) essentially serves as a hub for the
other components (512, 514, 516, 518, 520, 522, 524, 526, 528), as
all of the other components (512, 514, 516, 518, 520, 522, 524,
526, 528) are in communication with control module (510). As shown
in FIGS. 1-2 and 12, holster (500) further comprises a chassis
(504), an upper housing (506), and a vacuum pump (560). Each of
these components will be described in greater detail below, while
other suitable components for holster (500) will be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0094] While control module (510) is referred to in the singular,
it should be understood that control module (510) may comprise a
plurality of components and even a plurality of separate control
modules. For instance, control module (510) may comprise a
plurality of circuit boards, one or more storage devices configured
to store data, and/or a variety of microprocessors, etc. In
addition, control module (510) may include one or more wireless
communication technologies (e.g., Bluetooth technology, etc.) that
are operable to communicate with smart phones, foot pedal actuation
means, keypads, etc. Various suitable components, features, and
configurations that may be employed to form control module (510)
will be apparent to those of ordinary skill in the art in view of
the teachings herein.
[0095] Battery (512) of the present example comprises a
rechargeable battery (e.g., nickel cadmium, lithium ion, lithium
polymer, etc.). Just like control module (510) and various other
components described herein, while battery (512) is referred to in
the singular, it should be understood that more than one battery
(512) may be incorporated into holster (500). Battery (512) is
configured to provide power to motor (528) to operate cutter
actuation mechanism (200). For instance, battery (512) may provide
any suitable voltage, and may be configured to provide power for at
least five biopsy procedures or any other suitable number of
procedures before requiring a recharge or replacement. Charging
circuitry (518) in holster (500) is configured to recharge battery
(512). For instance, holster (500) may be selectively coupled with
a docking station to enable charging circuitry (518) to recharge
battery (512). Such charging may be provided through contact
between complementary exposed metal contacts (not shown) of the
docking station and holster (500), through inductive charging
components, and/or in any other suitable fashion. It should also be
understood that charging circuitry (518) may be configured to
monitor the charge level of battery (512). In some such versions,
charging circuitry (518) may be configured to drive a battery
charge indicator to constantly show the charge level of battery
(512), to simply provide an indication (e.g., through speaker (522)
and/or LEDs (524), etc.) when the charge level of battery (512)
falls below a threshold, and/or provide any other suitable type of
notification. Of course, battery (512) may be non-rechargeable, if
desired. Furthermore, holster (500) may use an external source
(e.g., conventional AC power source or piece of capital equipment,
etc.) to power motor (528), in addition to or in lieu of using
battery (512). It should also be understood that biopsy device (10)
may use an external source to drive cutter actuation mechanism
(200) (e.g., may omit motor (528) and use speedometer cables from a
remote drive source, use pneumatic components driven by pressurized
air, etc.).
[0096] In some versions (e.g., where battery (512) is charged
through electrical contacts that contact complementary contacts in
a charging station, etc.), charging circuitry (518) is omitted and
a balun type of transformer is used in its place. Of course, a
balun transformer may also be used in versions where battery (512)
is charged inductively instead of being charged through electrical
contacts, in versions where battery (512) is omitted and biopsy
device (10) receives power in some other fashion, etc. In some
versions where a balun transformer is used, the balun may convert
electrical signals from balanced to unbalanced and/or vice versa.
Such a balun may be coupled with motor (528), either directly
and/or through control module (510). In addition or in the
alternative, such a balun may be coupled with encoder sensor (526)
and/or other components of holster (500). Of course, as with other
components described herein, a balun may be substituted,
supplemented, or even omitted, as desired.
[0097] Accelerometer (514) is yet another component that is
referred to in the singular but may in fact comprise several
separate accelerometers. For instance, some versions of holster
comprise three accelerometers (514), each being configured and
positioned to sense movement in a respective direction. Movement
data from accelerometer (514) may be used to provide both automated
power down of holster (500) when holster (500) is not moved for a
certain time period and/or to automatically power on holster (500)
when holster (500) is moved. For instance, control module (510) may
include a logic configured to power down holster (500) and at least
substantially cease consumption of power from battery (512) if
accelerometer (514) fails to indicate movement of holster (500)
over a period of approximately 10 minutes. Any other suitable
inactivity duration threshold may be used. This logic may also
receive input from charging circuitry (518) to ensure that holster
(500) is not fully powered down when battery (512) is being charged
(e.g., by a docking station, etc.), even if holster (500) is not
moved beyond the inactivity duration threshold while holster (500)
is charging. Accelerometer (514) may also be used to detect the
orientation of biopsy device (10), and control module (510) may
include a logic configured to modify operation of biopsy device
(10) based at least in part on orientation data from accelerometer
(514). For instance, control module (510) may be configured to stop
operation of motor (528) (and, hence, vacuum pump (560) when biopsy
device (10) is held in an upside-down orientation (e.g., with
holster (500) positioned vertically below probe (100)) beyond a
certain threshold duration. Such cessation of vacuum pump (560)
operation may reduce the likelihood that filter (342) becomes
saturated with bodily fluids. Other suitable ways in which
accelerometer (514) may be used will be apparent to those of
ordinary skill in the art in view of the teachings herein. It
should also be understood that, as with various other components
described herein, accelerometer (514) may simply be omitted if
desired.
[0098] Buttons (516) are operable to selectively activate motor
(528) to drive cutter actuation mechanism (200). Buttons (516) may
comprise thin film switches, capacitive switches, spring-loaded
mechanical buttons, and/or any other suitable type of user input
feature. As shown in FIG. 1, a plurality of buttons (516) are
provided at different positions on holster (500). Having buttons
(516) at various positions may facilitate use of biopsy device (10)
using different grip styles, which may vary depending on the user's
preference and/or based on the angle at which needle (110) is
inserted into tissue, etc. In some versions, any one of buttons
(516) may be used at any given time, and pressing any button (516)
will provide the same result as pressing any other button (516). In
some other versions, once one button (516) is pressed (e.g.,
pressed once, pressed and held down for a certain duration, or
pressed twice in rapid succession, etc.), a logic in control module
(510) identifies that button (516) as the active button (516) and
all other buttons (516) are de-activated. Of course, each button
(516) may be assigned to provide a different function. For
instance, one button (516) may be assigned to initiate a tissue
sampling cycle when activated, while another button (516) may be
assigned to perform a clear probe cycle. Examples of such cycles
are 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. In
addition or in the alternative, one button (516) may be operable to
selectively restrict the degree to which cutter (150) may be
retracted, thereby allowing the user to selectively define the
effective length of lateral aperture (114). Examples of such
operations are described in U.S. Pat. No. 7,517,322, entitled
"Biopsy Device with Variable Side Aperture," issued Apr. 14, 2009,
the disclosure of which is incorporated by reference herein. In
some such versions, needle firing mechanism (400) may be rendered
inoperable if cutter (150) is not allowed to retract far enough,
while in some other versions needle firing mechanism (400) will
remain fully operable even if cutter (150) is only allowed to
retract slightly. In some versions where needle firing mechanism
(400) remains fully operable despite receipt of user input to
significantly restrict the retraction of cutter (150) (e.g., the
user wishes to use a very short effective aperture (114), etc.),
control module (510) may allow cutter (150) to retract as far as
needed to provide operation of needle firing mechanism (400), then
provide the user-specified limit on the retraction of cutter (150)
during a cutting stroke/cycle after needle (110) has been
fired.
[0099] By way of example only, buttons (516) may be configured and
operable in accordance with any of the teachings of U.S.
Non-Provisional patent application Ser. No. 12/542,775, entitled
"Multi-Button Biopsy Device," filed Aug. 18, 2009, the disclosure
of which is incorporated by reference herein. In versions where one
button (516) is selectively assigned as the active button (516),
one or more of LEDs (524) may be activated to provide a visual
indication to the user showing which button (516) is active. As
another merely illustrative variation, a button (516) that is
selectively assigned as the active button (516) may be illuminated
while the other buttons (516) remain non-illuminated. Other
suitable ways in which buttons (516) may be provided an operable
will be apparent to those of ordinary skill in the art in view of
the teachings herein.
[0100] Tissue sample holder sensor (520) is operable to sense when
tissue sample holder (300) is coupled with probe (100). Control
module (510) may include a logic that prevents or restricts
activation of motor (528) and/or other components of biopsy device
(10) when tissue sample holder sensor (520) does not sense the
presence of tissue sample holder (300) coupled with probe (100). In
addition or in the alternative, during operation of biopsy device
(10), when tissue sample holder (300) is removed from probe (100)
in order to deposit a marker at a biopsy site using an applier fed
through cutter lumen (154), control module (510) may include a
logic that automatically retracts cutter (150) (or otherwise allows
retraction of cutter (150)) proximally to effectively open lateral
aperture (114) of needle (110) to allow the marker to be deployed
at the biopsy site through lateral aperture (114). It should also
be understood that control module (510) may be configured to rely
on the presence of contact (380) as sensed by tissue sample holder
sensor (520) to determine whether probe (100) is coupled with
holster (500). For instance, holster (500) may remain in a
powered-down state when tissue sample holder sensor (520) does not
sense the presence of tissue sample holder (300) through contact
(380). As soon as probe (100) and holster (500) are first coupled
together, tissue sample holder sensor (520) may detect such
coupling by sensing the presence of contact (380), and control
module (510) may accordingly place holster (500) in a powered-on
and/or idle state that is ready for full operation of biopsy device
(10). Control module (510) may further be configured to at least
substantially disable functioning of buttons (516) before tissue
sample holder sensor (520) detects the coupling of probe (100) with
holster (500). It should also be understood that control module
(510) may react differently in a period before probe (100) is first
coupled with holster (500) than it reacts in a period when tissue
sample holder (300) is decoupled from probe (100) after probe (100)
has been coupled with holster (500). For instance, holster (500)
may remain at least substantially powered down in the first period
while motor (528) may be activated to retract cutter (150) in the
second period.
[0101] As noted above, tissue sample holder sensor (520) may
comprise a metal contact that is configured and position to make
contact with contact (380) of tissue sample holder (300) when
holster (500) and probe (100) are coupled together. While sensor
(520) and contact (380) make direct contact in this example, it
should be understood that tissue sample holder sensor (520) may
alternatively sense the presence of tissue sample holder (300) in a
variety of other ways, including but not limited to using RFID, EE
proms, or EAS technology. Furthermore, in some versions, tissue
sample holder sensor (520) may be used to perform authenticity
verification of tissue sample holder (500), permitting full
operation of biopsy device (10) only when a properly authenticated
tissue sample holder (300) is coupled with probe (100), and
preventing at least some operation of biopsy device (10) when a
non-authenticated tissue sample holder (300) is coupled with probe
(100). Still other suitable ways in which a tissue sample holder
sensor (520) may be configured an operable will be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0102] Speaker (522) and LEDs (524) may be used to provide various
forms of feedback to a user operating biopsy device (10). As shown
in FIG. 1, top housing (506) of holster (500) includes a plurality
of speaker openings (508) to facilitate transmission of sound from
speaker (522) to the user of biopsy device (10). While not shown in
FIGS. 1-2, it should be understood that LEDs (524) may be
positioned at any suitable locations on holster (500). In some
versions, control module (510) is configured to communicate sound
through speaker (522) and/or to illuminate/un-illuminate one or
more LEDs (524) when an error condition is detected (e.g., battery
(512) power low, drive mechanism jammed, motor current profile
deviating from norm beyond acceptable range, motor rotation speed
deviating from norm beyond acceptable range, etc.). In addition or
in the alternative, control module (510) may be configured to
communicate sound through speaker (522) and/or to
illuminate/un-illuminate one or more LEDs (524) to indicate to the
user which state of operation biopsy device (10) is in (e.g.,
cutter (150) at a distal position, cutter (150) being retracted,
cutter (150) at a proximal position, cutter (150) being advanced,
needle firing mechanism (400) loaded to point where arming slider
(460) should be released, etc.). Various other suitable ways in
which speaker (522) and/or LEDs (524) may be used will be apparent
to those of ordinary skill in the art in view of the teachings
herein. It should also be understood that speaker (522) and/or LEDs
(524) may be substituted or supplemented with other user feedback
features such as an LED display, etc.; and that speaker (522)
and/or LEDs (524) may simply be omitted if desired.
[0103] As shown only in FIG. 12, holster (500) of the present
example also includes a vacuum sensor (572). Vacuum sensor (572) is
coupled with a sensor fitting (570), which is further coupled with
vacuum port (566). Vacuum sensor (572) is thus configured to sense
the level of vacuum that is provided by vacuum pump (560) and that
is being communicated to tissue sample holder (300). Vacuum sensor
(572) may comprise a diaphragm, a capacitive coupling, a strain
gauge, or any other suitable device(s), component(s), or
configurations. While not shown in FIG. 11, vacuum sensor (572) of
the present example is in communication with control module (510),
which may include a logic configured to process signals from vacuum
sensor (572) and affect operation of biopsy device (10)
accordingly. By way of example only, if vacuum sensor (572)
indicates that the vacuum level within tissue sample holder (300)
has not fallen below a predefined level (which may indicate that a
tissue sample is lodged in aperture (114) and/or cutter lumen
(154)), a "clear probe" algorithm may be initiated as described in
at least one of the references cited herein. As another merely
illustrative example, control logic (510) may be configured to
initiate a cutting stroke by cutter (150) only after a vacuum level
sensed by vacuum sensor (572) has fallen below a threshold. In
addition or in the alternative, vacuum sensor (572) may be
configured and/or used in accordance with any of the teachings in
U.S. Pub. No. 2009/0171243, entitled "Vacuum Sensor and Pressure
Pump for Tetherless Biopsy Device," published Jul. 2, 2009, the
disclosure of which is incorporated by reference herein. Still
other suitable ways in which vacuum sensor (572) may be configured
and used will be apparent to those of ordinary skill in the art in
view of the teachings herein. It should also be understood that, as
with other components described herein, vacuum sensor (572) may be
substituted, supplemented, or even omitted, as desired.
B. Exemplary Drive Components of Holster
[0104] Motor (528) of the present example comprises a conventional
DC motor, though it should be understood that any other suitable
type of motor may be used. By way of example only, motor (528) may
comprise a pneumatic motor (e.g., having an impeller, etc.) that is
powered by pressurized air, a pneumatic linear actuator, an
electromechanical linear actuator, a piezoelectric motor (e.g., for
use in MRI settings), or a variety of other types of
movement-inducing devices. As mentioned above, motor (528) receives
power from battery (512). While motor (528) is located onboard
biopsy device (10) in the present example, it should be understood
that motor (528) may instead be located some distance from biopsy
device (10) and provide energy to biopsy device (10) via a drive
shaft or cable, etc.
[0105] As also noted above, motor (528) is operable to drive cutter
actuation mechanism (200). An exemplary drive train that may be
coupled with motor (528) to drive cutter actuation mechanism (200)
is shown in FIG. 12. In this example, the first end (530) of a main
drive shaft extends distally from motor (528) while a second end
(532) of the main drive shaft extends proximally from motor (528).
An encoder wheel (534) is coupled with first end (530). Encoder
wheel (534) is a conventional encoder wheel in this example, and
includes a plurality of slots, openings, and/or tabs evenly spaced
circumferentially at or near the outer periphery of encoder wheel
(534). Encoder sensor (526) is positioned relative to encoder wheel
(534) in a manner allowing encoder sensor (526) to track rotation
of encoder wheel (534). Encoder sensor (526) is thus operable to
track operation of motor (528). It should be understood that, with
control module (510) being in communication with encoder sensor
(526), encoder wheel (534), encoder sensor (526), and control
module (510) may be used to gather data relating to the rotational
speed and rotational position of first end (530), which may be
processed to reflect the translation rate of cutter (150), the
rotation rate (150) of cutter, the longitudinal position of cutter
(150), etc. Such information may be used to control operation of
other components of biopsy device (10), as described elsewhere
herein or in other ways that will be apparent to those of ordinary
skill in the art in view of the teachings herein.
[0106] First and second ends (530, 532) of the main drive shaft
rotate simultaneously and in the same direction. A first gear (536)
is secured to second end (532) of the main drive shaft, such that
rotation of the main drive shaft when motor (528) is activated will
also rotate first gear (536). First gear (536) is engaged with a
second gear (538), which is secured to a second drive shaft (540).
Accordingly, rotation of the main drive shaft is transmitted to
second drive shaft (540) via meshing gears (536, 538). Second drive
shaft (540) is fed into vacuum pump (560). Vacuum pump (560) of the
present example comprises a conventional diaphragm pump. In
particular, second drive shaft (540) 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 (540), etc.), which is configured to cause a rod (not
shown--e.g., the rod may be coupled with or otherwise driven by the
eccentric disk, etc.) of vacuum pump (560) to reciprocate as motor
(528) rotates second drive shaft (540). This rod of vacuum pump
(560) drives a diaphragm (not shown) of vacuum pump (560) as the
rod reciprocates, causing vacuum pump (560) to induce a vacuum. It
should be understood that vacuum pump (560) of the present example
operates in the same way regardless of which direction motor (528)
rotates. Of course, any other suitable type of vacuum pump may be
used.
[0107] Vacuum pump (560) of the present example includes a port
(562) that is coupled with a conduit (564), which is further
coupled with vacuum port (566). Vacuum pump (560) is thus operable
to draw a vacuum through vacuum port (566) via port (562) and
conduit (564) when motor (528) rotates second drive shaft (540). As
noted above, primary vacuum port (340) is configured to couple with
vacuum port (566) when holster (500) and probe (100) are coupled
together. It should therefore be understood that vacuum pump (560)
is operable to induce a vacuum in tissue sample holder (300) when
motor (528) rotates second drive shaft (540) when holster (500) and
probe (100) are coupled together. The term "vacuum" as used herein
should read broadly to include suction in general (e.g., any
pressure below atmospheric pressure), and should not be read as
necessarily requiring a pressure level of exactly zero or a
negative pressure level, etc. As noted above, vacuum pump (560) may
be assisted with or replaced by an external vacuum source that is
coupled with secondary vacuum port (350) of tissue sample holder
(300). Other suitable forms that vacuum pump (560) may take, as
well as other suitable ways in which a vacuum pump (560) may be
operated, will be apparent to those of ordinary skill in the art in
view of the teachings herein. Alternatively, biopsy device (10) may
be configured to operate without a vacuum pump.
[0108] A third gear (542) is also secured to second drive shaft
(540), and rotates unitarily therewith. Third gear (542) meshes
with a fourth gear (544), which is secured to a third drive shaft
(546). Accordingly, rotation of the main drive shaft is transmitted
to third drive shaft (546) via meshing gears (536, 538, 542, 544)
and second drive shaft (540). A fifth gear (548) is also secured to
third drive shaft (546), and rotates unitarily therewith. Fifth
gear (548) meshes with a sixth gear (550), which is secured to a
fourth drive shaft (552). Sixth gear (554) is also secured to
fourth drive shaft (552) and rotates unitarily therewith.
Accordingly, rotation of the main drive shaft is transmitted to
gears (550, 554) via meshing gears (536, 538, 542, 544, 548, 554)
and drive shafts (540, 546, 552). Drive shafts (540, 546, 552) are
supported by various bearings (556) that are coaxially disposed
about drive shafts (540, 546, 552). Gears (550, 554) are exposed
through an opening formed through chassis (504) of holster (500),
and are configured to mesh with gears (202, 204) exposed through
chassis (120) of probe (100) as described above. Motor (528) is
thus able to rotatingly drive cutter actuation mechanism (200) of
probe (100) through meshing of gears (550, 554, 202, 204) when
probe (100) and holster (500) are coupled together. Of course, a
variety of other components or configurations may be used to
provide a coupling between motor (528) and cutter (150), in
addition to or in lieu of any or all of those drive components
described above.
[0109] In some versions, holster (500) includes one or more
headlights (not shown) that are operable to illuminate an insertion
area for needle (110). Examples of such use of headlights are
disclosed 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. In
addition or in the alternative, holster (500) may include a laser
light source that is operable to project a laser beam to assist in
targeting for needle (110). Various examples of such a use of a
laser are disclosed in U.S. Pub. No. 2010/0106056, entitled
"Methods for Medical Device Alignment," published Apr. 29, 2010,
the disclosure of which is incorporated by reference herein. Still
other suitable components, features, configurations, and
operabilites that may be incorporated into holster (500), for
driving cutter actuation mechanism (200) or otherwise, will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0110] V. Exemplary Alternative Versions
[0111] FIG. 13 depicts various exemplary alternative versions of
biopsy device (10). For instance, FIG. 13 depicts a version of a
biopsy device having a laser light source (600) as mentioned above.
FIG. 13 also depicts a version of a biopsy device having a fixed
graphical display (602); as well as a version of a biopsy device
having a tilting graphical display (604). In addition, FIG. 13
depicts a biopsy device disposed in a docking station (606), with
docking station (606) having a graphical display (608). It should
be understood that any of these features, among others, may be
readily incorporated into biopsy device described above, as well as
any other type of biopsy device.
[0112] FIGS. 14-15 show another exemplary biopsy probe (700), which
may be coupled with holster (500) just like probe (100) described
above. Unless otherwise indicated herein, components of probe (700)
in this example are substantially identical to components of probe
(100) described above. For instance, probe (700) of this example
includes a tissue sample holder (702) that is substantially
identical to tissue sample holder (300) described above. Similarly,
probe (700) of this example includes a cutter actuation mechanism
(704) that is substantially identical to cutter actuation mechanism
(200) described above. In probe (700), however, there is no needle
firing mechanism (400), though it should be understood that probe
(700) may alternatively have a needle firing mechanism (400) (or
variation thereof), if desired.
[0113] Probe (700) of the present example also includes a needle
(710) that is larger than needle (110) of biopsy device (10). For
instance, needle (710) may have a size of approximately 8 gauge;
with needle (110) having a size of approximately 13 gauge. Needle
(710) of this example is otherwise configured the same as needle
(110) described above. In some uses of a needle having such a
relatively large size, there may be an increased risk of excess
bleeding when a relatively large sized needle (710) is inserted
into tissue. In some instances, such excess bleeding may present
risks that the biopsy device might malfunction, such as due to
coagulation of the excess blood on moving parts of the device, etc.
Accordingly, probe (700) of the present example includes a port
(720) for communicating saline through needle (710), to facilitate
flushing of any excess blood. In some versions, port (720) is
coupled with a source of pressurized saline. In some other
versions, port (720) is coupled with a source of saline that is
positioned vertically higher than biopsy probe (700), such that
saline is fed into port (720) by gravity. In addition or in the
alternative, saline may simply be drawn through port (720) from a
saline source by a vacuum induced by vacuum pump (560) through the
inner lumen (754) of cutter (750).
[0114] As shown in FIG. 15, probe (710) also includes a conduit
(722) that couples port (720) with a port (732) in a saline
manifold (730). As shown in FIG. 17, port (732) communicates with
an interior region (734) of saline manifold (730). A pair of
exterior regions (736) are on opposite sides of interior region
(734), and are separated from interior region (734) by annular
walls (738). A respective o-ring (not shown) is positioned in each
exterior region (736), providing a substantial seal for annular
walls (738). In other words, saline communicated to interior region
(734) will not leak out into exterior regions (736) when saline
manifold (730) is disposed about a valve sleeve (740) as described
in greater detail below.
[0115] As shown in FIG. 16, various valving components are
coaxially disposed about cutter (750) of probe (700). In
particular, a needle manifold (752) is located distal to other
valving components. Needle overmold (752) is coupled with needle
(710) in a manner similar to the coupling of needle overmold (410)
with needle (110) described above. Cutter overmold (754) is coupled
with cutter (750) in a manner similar to the coupling of cutter
overmold (210) with cutter (150) as described above. Cutter
overmold (754) is also configured similar to cutter overmold (210),
except that cutter overmold (754) of this example lacks distal
flange (216). Cutter overmold (754) includes a distal end (756) and
an annular recess (758) just proximal to distal end (756). Annular
recess (758) is configured to receive an o-ring (not shown).
[0116] Saline manifold (730) is coaxially positioned about valve
sleeve (740). Valve sleeve (740) is inserted into the proximal end
of needle overmold (752) such that the interior of valve sleeve
(740) communicates with a second lumen (not shown) of needle (710),
similar to communication of the interior of vent sleeve (420) with
second lumen (168) of needle (710). Valve sleeve (740) is secured
unitarily to needle overmold (752). Unlike vent sleeve (420), valve
sleeve (740) does not translate within probe (710) in this example
(e.g., since needle (710) cannot be fired in this example). Valve
sleeve (740) includes a distal set of openings (742) and a proximal
set of openings (744). Saline manifold (730) is positioned along
the length of valve sleeve (740) at a location where interior
region (734) is in fluid communication with proximal openings
(744). This position and relationship of saline manifold (730) and
valve sleeve (740) stays constant during operation of probe
(710).
[0117] A shuttle valve slider (760) is coaxially positioned within
valve sleeve (740), and is configured to translate in response to
actuation of cutter (750). Shuttle valve slider (760) includes
first, second, third, fourth, and fifth annular recesses (762, 764,
766, 768, 770). Each annular recess (762, 764, 766, 768, 770) is
configured to receive a respective o-ring (not shown) to seal
against the inner surface of valve sleeve (740). Shuttle valve
slider (760) is similar in this respect to shuttle valve slider
(430) described above. Shuttle valve slider (760) also includes a
transverse opening (772), which is configured to selectively
communicate with distal openings (742), communicate with proximal
openings (744), or be substantially sealed relative to either set
of openings (742, 744), depending on the longitudinal position of
shuttle valve slider (760) in valve sleeve (740). Transverse
opening (772) is longitudinally positioned between third and fourth
annular recesses (766, 768).
[0118] An annular stop member (780) is unitarily secured to cutter
(150) by a friction fit, and is configured to engage the distal end
of shuttle valve slider (760) as cutter (750) is moved proximally
and thereby push shuttle valve slider (760) proximally relative to
valve sleeve (740). Shuttle valve slider (760) may be pushed
distally by distal end (756) of cutter overmold (754) when cutter
(750) is moved distally.
[0119] Like shuttle valve slider (430), shuttle valve slider (760)
of the present example defines an inner diameter that is greater
than the outer diameter defined by cutter (750), such that a
longitudinally extending gap (751) is provided between the outer
diameter of cutter (750) and the inner diameter of shuttle valve
slider (760). Such a gap (751) is sufficient to provide
longitudinal fluid communication (e.g., atmospheric air, saline,
etc.) between the outer diameter of cutter (750) and the inner
diameter of shuttle valve slider (760). In addition, the distal end
of shuttle valve slider (760) include notches (774) formed therein,
providing an appearance similar to that of a castellated nut or
castle nut.
[0120] As noted above, translation of cutter (750) provides
translation of shuttle valve slider (760) due to engagement between
either annular stop member (780) and the distal end of shuttle
valve slider (760) or distal end (756) of cutter overmold (754) and
the proximal end of shuttle valve slider (760). The distance
separating annular stop member (780) and distal end (756) of cutter
overmold (754), even when cutter (750) is at a distal-most
position, is greater than the length of shuttle valve slider (760).
Thus, like with shuttle valve slider (430) as described above,
there is some degree of "lost motion" between shuttle valve slider
(760) and cutter (750) as cutter (750) translates in either
direction. It should be understood that shuttle valve slider (760)
may be located at various positions within valve sleeve (740)
during various stages of translation of cutter (750). In
particular, shuttle valve slider (760) may be located at positions
where distal openings (742) are positioned between one pair of
annular recesses (762, 764, 766, 768, 770) and their corresponding
o-rings; with proximal openings (744) being positioned between
another pair of annular recesses (762, 764, 766, 768, 770) and
their corresponding o-rings. In some versions, shuttle valve slider
(760) may travel to a proximal-most position (FIG. 18A), whereby
distal openings (742) are positioned proximal to first annular
recess (762) and its o-ring and distal to second annular recess
(764) and its o-ring. In addition or in the alternative, shuttle
valve slider (760) may travel to a distal-most position (FIG. 18B),
whereby proximal openings (744) are positioned proximal to fourth
annular recess (768) and its o-ring and distal to fifth annular
recess (770) and its o-ring.
[0121] In configurations where shuttle valve slider (760) is
positioned such that distal openings (742) are positioned between
first and second annular recesses (762, 764) and their
corresponding o-rings (see FIG. 18A), between second and third
annular recesses (764, 766) and their corresponding o-rings, or
between fourth and fifth annular recesses (768, 770) and their
corresponding o-rings, the interior of valving sleeve (740) (and,
hence, the second lumen of needle (710)) is substantially sealed
relative to atmospheric air. However, in configurations or stages
of operation where shuttle valve slider (760) is positioned such
that distal openings (742) are positioned between third and fourth
annular recesses (766, 768) and their corresponding o-rings, as
shown in FIG. 18B, the interior of valving sleeve (740) (and,
hence, the second lumen of needle (710)) is in communication with
atmospheric air via distal openings (742) and transverse opening
(772). In some versions of probe (700), the actual range of travel
for shuttle valve slider (760) does not include all of these
longitudinal positions. FIG. 19A shows the range of cutter (750)
travel where the second lumen of needle (710) is vented by shuttle
valve slider (760) and distal openings (742) during distal
advancement of cutter (750) in the present example; while FIG. 19B
shows the range of cutter (750) travel where the second lumen of
needle (710) is vented by shuttle valve slider (760) and distal
openings (742) during proximal retraction of cutter (750) in the
present example.
[0122] Similarly, in configurations where shuttle valve slider
(760) is positioned such that proximal openings (744) are
positioned between first and second annular recesses (762, 764) and
their corresponding o-rings, between second and third annular
recesses (764, 766) and their corresponding o-rings (see FIG. 18A),
or between fourth and fifth annular recesses (768, 770) and their
corresponding o-rings (see FIG. 18B), the interior of valving
sleeve (740) (and, hence, the second lumen of needle (710)) is
substantially sealed relative to saline from saline manifold (730).
However, in configurations where shuttle valve slider (760) is
positioned such that proximal openings (744) are positioned between
third and fourth annular recesses (766, 768) and their
corresponding o-rings, the interior of valving sleeve (740) (and,
hence, the second lumen of needle (710)) is in communication with
saline from saline manifold (730) via proximal openings (744) and
transverse opening (772). Again, in some versions of probe (700),
the actual range of travel for shuttle valve slider (760) does not
include all of these longitudinal positions. FIG. 19A shows the
range of cutter (750) travel where saline is provided to the second
lumen of needle (710) by shuttle valve slider (760) and proximal
openings (744) during distal advancement of cutter (750) in the
present example; while FIG. 19B shows the range of cutter (750)
travel where saline is provided the second lumen of needle (710) by
shuttle valve slider (760) and proximal openings (744) during
proximal retraction of cutter (750) in the present example.
[0123] It should also be understood that shuttle valve slider (760)
may be located at longitudinal positions where neither saline nor
atmospheric air is communicated to the interior of valving sleeve
(740) (and, hence, the second lumen of needle (710)). For instance,
shuttle valve slider may be located at a position where distal
openings (742) are located between first and second annular
recesses (762, 764) and their corresponding o-rings; with proximal
openings (744) being located between second and third annular
recesses (764, 766) and their corresponding o-rings. In such a
configuration, as shown in FIG. 18A, the interior of valving sleeve
(740) (and, hence, the second lumen of needle (710)) is
substantially sealed relative to both atmosphere and saline
manifold (730). FIG. 19A shows the range of cutter (750) travel the
second lumen of needle (710) is substantially sealed by shuttle
valve slider (760) during distal advancement of cutter (750) in the
present example; while FIG. 19B shows the range of cutter (750)
travel the second lumen of needle (710) is substantially sealed by
shuttle valve slider (760) during proximal retraction of cutter
(750) in the present example.
[0124] Various stages of actuation of cutter (750) at which any of
the above-noted fluid communication states for the interior of
valving sleeve (740) (and, hence, the second lumen of needle (710))
may apply will be apparent to those of ordinary skill in the art in
view of the teachings herein. An exemplary algorithm is shown in
FIGS. 19A-19B, which depicts the fluid communication state of the
second lumen of needle (710) as cutter (750) moves in relation to
the lateral aperture (714) of needle (710). The solid line in the
field of the charts shown in FIGS. 19A-19B represents the position
of the distal end of cutter (750) during translation of cutter
(750) within needle (710). In addition, the arrowheads in FIGS.
19A-19B simply indicate the direction in which cutter (750) is
moving (not necessarily the direction in which fluid is
flowing).
[0125] In the present example, with cutter (750) fully retracted to
a proximal position, shuttle valve slider (760) is in a proximal
position as shown in FIG. 18A. As shown in FIG. 19A, the second
lumen of needle (710) is thus initially sealed (relative to
atmosphere and saline) as cutter (750) begins advancing from the
proximal position to a distal position. During the initial stages
of cutter (750) advancement, the second lumen of needle (710)
remains sealed by shuttle valve slider (760). As cutter (750)
begins approaching a distal position, but before cutter (750)
effectively closes lateral aperture (714), cutter overmold (754)
eventually engages shuttle valve slider (760) and begins to push
shuttle valve slider (760) distally, such that the second lumen of
needle (710) eventually receives saline through openings (744, 772)
and gap (751). With suction being applied to the inner lumen (754)
of cutter (752), such saline (along with blood, etc., from the
biopsy site) may be drawn proximally through inner lumen (754) of
cutter (752), such that the saline, etc., will ultimately be
communicated to tissue sample holder (702). As cutter (750)
continues to advance distally, cutter overmold (754) continues to
push shuttle valve slider (760) distally, such that the second
lumen of needle (710) is eventually vented by receiving atmospheric
air through openings (742, 772) and gap (751). When cutter (750)
reaches a distal-most position, as shown in FIG. 18B, the second
lumen of needle (710) continues to be vented. It should be
understood that, with a suction being applied proximally through
inner lumen (754) of cutter (750), and with a vent being applied to
the second lumen of needle (710), the resulting pressure
differential will provide communication of tissue samples
proximally through inner lumen (754) of cutter (750), ultimately
depositing the severed tissue samples into tissue sample holder
(702).
[0126] As shown in FIG. 19B, as cutter (750) is initially retracted
from a distal position (FIG. 18B) to a proximal position (FIG. 18A)
in the present example, the second lumen of needle (710) is vented
to atmosphere via openings (742, 772) and gap (751). As cutter
(750) continues to retract proximally, stop member (780) eventually
engages shuttle valve slider (760) and pushes shuttle valve slider
(760) proximally, such that the second lumen of needle (710)
eventually receives saline via openings (742, 744) and gap (751).
While cutter (750) continues to retract further proximally, shuttle
valve slider (750) eventually moves to a proximal position shown in
FIG. 18A, where shuttle valve slider (750) substantially seals the
second lumen of needle (710) (relative to atmosphere and relative
to saline). Of course, the communicative states for the second
lumen of needle (710) and their relation to the movement/position
of cutter (750) described above are mere examples. Various other
suitable communicative states for the second lumen of needle (710)
and their relation to the movement/position of cutter (750) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0127] 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.
[0128] Embodiments of the present invention have application in
conventional endoscopic and open surgical instrumentation as well
as application in robotic-assisted surgery.
[0129] 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.
[0130] 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.
[0131] 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.
* * * * *