U.S. patent application number 13/525422 was filed with the patent office on 2012-10-04 for biopsy device with central thumbwheel.
This patent application is currently assigned to Devicor Medical Products, Inc.. Invention is credited to Wells D. Haberstich, John A. Hibner, Gregory W. Johnson, Jessica P. Leimbach, Michael R. Ludzack, Andrew P. Nock, Shailendra K. Parihar.
Application Number | 20120253226 13/525422 |
Document ID | / |
Family ID | 41571798 |
Filed Date | 2012-10-04 |
United States Patent
Application |
20120253226 |
Kind Code |
A1 |
Parihar; Shailendra K. ; et
al. |
October 4, 2012 |
BIOPSY DEVICE WITH CENTRAL THUMBWHEEL
Abstract
A biopsy device comprises a probe and a holster. The probe has a
distally extending needle including a transverse tissue receiving
aperture. A cutter is translatable relative to the needle to sever
tissue protruding through the aperture. A thumbwheel is manually
operable to rotate the needle to reorient the angular position of
the aperture about the longitudinal axis defined by the needle. The
thumbwheel is positioned obliquely with the longitudinal axis. A
cable driven mechanism in the holster drives the cutter. A
rotatable tissue sample holder is coupled with the probe, and has
chambers configured to receive tissue samples communicated
proximally through a lumen defined by the cutter. A piezoelectric
motor in the holster drives the tissue sample holder.
Inventors: |
Parihar; Shailendra K.;
(Mason, OH) ; Hibner; John A.; (Mason, OH)
; Nock; Andrew P.; (Centerville, OH) ; Haberstich;
Wells D.; (Loveland, OH) ; Johnson; Gregory W.;
(Milford, OH) ; Leimbach; Jessica P.; (Cincinnati,
OH) ; Ludzack; Michael R.; (Maineville, OH) |
Assignee: |
Devicor Medical Products,
Inc.
Cincinnati
OH
|
Family ID: |
41571798 |
Appl. No.: |
13/525422 |
Filed: |
June 18, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12337942 |
Dec 18, 2008 |
|
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13525422 |
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Current U.S.
Class: |
600/566 ;
600/567 |
Current CPC
Class: |
A61B 2010/0225 20130101;
A61B 10/0283 20130101; A61B 10/0275 20130101; A61B 2090/0813
20160201; A61B 2010/0208 20130101 |
Class at
Publication: |
600/566 ;
600/567 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A biopsy device, comprising: (a) a probe, wherein the probe
comprises: (i) a body portion, and (ii) a needle extending distally
from the body portion, wherein the needle defines a longitudinal
axis and a transverse tissue receiving feature; and (b) a holster
removably coupled with the body portion of the probe; and (c) at
least one rotatable thumbwheel, wherein the at least one thumbwheel
extends outwardly at an oblique angle relative to the longitudinal
axis, wherein the thumbwheel is coupled with the needle, wherein
the thumbwheel is manually operable to rotate the needle about the
longitudinal axis.
2. The biopsy device of claim 1, wherein the thumbwheel extends
generally proximally at an oblique angle relative to the
longitudinal axis.
3. The biopsy device of claim 2, wherein the thumbwheel extends
from the holster.
4. The biopsy device of claim 1, wherein the thumbwheel comprises
at least one gripping feature around a periphery of the
thumbwheel.
5. The biopsy device of claim 1, wherein the probe further
comprises a cutter rotatably and translatably moveable within the
needle to sever tissue drawn into the tissue receiving feature,
wherein the cutter defines a cutter lumen.
6. The biopsy device of claim 5, wherein a vacuum source is in
communication with the cutter lumen.
7. The biopsy device of claim 5, further comprising a tissue sample
holder, wherein the tissue sample holder is rotatable relative to
the body portion, wherein the tissue sample holder is configured to
receive tissue samples communicated through the cutter lumen.
8. The biopsy device of claim 7, wherein the tissue sample holder
defines a plurality of tissue sample chambers, wherein the tissue
sample holder is rotatable to successively index each of the tissue
sample chambers to the cutter lumen.
9. The biopsy device of claim 8, wherein the thumbwheel is coupled
to the tissue sample holder, wherein the thumbwheel is manually
operable to rotate the tissue sample holder.
10. The biopsy device of claim 9, wherein rotation of the
thumbwheel is configured to index the next adjacent tissue sample
chamber to the cutter lumen.
11. The biopsy device of claim 8, wherein rotation of the tissue
receiving feature of the needle is configured to directly correlate
to rotation of the tissue sample holder.
12. The biopsy device of claim 11, wherein the tissue receiving
feature of the needle is configured to rotate at substantially the
same rotational angle as the tissue sample holder.
13. The biopsy device of claim 1, further comprising an indicator
operable to indicate the rotational orientation of the needle about
the longitudinal axis.
14. The biopsy device of claim 13, wherein the thumbwheel is
manually operable to rotate the indicator.
15. The biopsy device of claim 1, wherein the holster comprises two
thumbwheels extending outwardly at an oblique angle relative to the
longitudinal axis, wherein each thumbwheel is coupled to the
needle, wherein each thumbwheel is independently manually operable
to rotate the needle about the longitudinal axis.
16. The biopsy device of claim 15, wherein one of the thumbwheels
is located on a left side of the holster and wherein the other
thumbwheel is located on a right side of the holster.
17. The biopsy device of claim 15, further comprising a tissue
sample holder, wherein the tissue sample holder is rotatable
relative to the body portion, wherein each thumbwheel is
independently manually operable to rotate the tissue sample holder
relative to the body portion.
18. The biopsy device of claim 15, further comprising a tissue
sample holder, wherein the tissue sample holder is rotatable
relative to the body portion, wherein one thumbwheel is manually
operable to rotate the needle about the longitudinal axis, and
wherein the other thumbwheel is manually operable to rotate the
tissue sample holder relative to the body portion.
19. A biopsy device, comprising: (a) a probe, wherein the probe
comprises: (i) a body portion, and (ii) a needle extending distally
from the body portion, wherein the needle defines a longitudinal
axis and a transverse tissue receiving feature; (b) a holster
removably coupled with the body portion of the probe; (c) a tissue
sample holder, wherein the tissue sample holder is rotatable
relative to the body portion of the probe; and (d) a rotatable
thumbwheel protruding outwardly at an oblique angle relative to the
longitudinal axis, wherein the thumbwheel is coupled with one or
both of the needle or the tissue sample holder, wherein the
thumbwheel is manually operable to one or both of rotate the needle
about the longitudinal axis or rotate the tissue sample holder
relative to the body portion of the probe.
20. A biopsy device, comprising: (a) a probe, wherein the probe
comprises: (i) a body portion, and (ii) a needle extending distally
from the body portion, wherein the needle defines a longitudinal
axis and a transverse tissue receiving feature; (b) a holster
removably coupled with the body portion of the probe; (c) a tissue
sample holder, wherein the tissue sample holder is rotatable
relative to the body portion of the probe; and (d) two rotatable
thumbwheels, wherein each of the two rotatable thumbwheels extends
proximally at an oblique angle relative to the longitudinal axis,
wherein each of the two thumbwheels is coupled with one or both of
the needle or the tissue sample holder, wherein each of the two
thumbwheels is manually operable to one or both of rotate the
needle about the longitudinal axis or rotate the tissue sample
holder relative to the body portion of the probe.
Description
PRIORITY
[0001] The present application is a continuation of U.S. patent
application Ser. No. 12/337,942, entitled "Biopsy Device with
Central Thumbwheel," filed Dec. 18, 2008, the disclosure of which
is hereby incorporated by reference in its entirety.
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.
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. 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. Provisional Patent
Application Ser. No. 60/869,736, entitled "Biopsy System," filed
Dec. 13, 2006; and U.S. Provisional Patent Application Ser. No.
60/874,792, entitled "Biopsy Sample Storage," filed Dec. 13, 2006.
The disclosure of each of the above-cited U.S. Patents, U.S. Patent
Application Publications, and U.S. Provisional Patent Applications
is incorporated by reference herein. 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 FIGURES
[0003] While the specification concludes with claims which
particularly point out and distinctly claim the invention, it is
believed the present biopsy device will be better understood from
the following description of certain examples taken in conjunction
with the accompanying drawings, in which like reference numerals
identify the same elements and in which:
[0004] FIG. 1 is a schematic view of an exemplary biopsy system
being operated with a single hand and with a finger rotating a
central rotation knob to rotate a needle extending from a
probe;
[0005] FIG. 2 is an isometric view of a biopsy device of the biopsy
system of FIG. 1;
[0006] FIG. 3 is a side cross-sectional view of the biopsy device
of FIG. 2, with a probe portion separated from a holster
portion;
[0007] FIG. 4 is an enlarged side cross-sectional view of the probe
of FIG. 2;
[0008] FIG. 5 is an exploded view of the needle and a cutter
assemblies of the probe of FIG. 2;
[0009] FIG. 6 is an enlarged side cross-sectional view of a portion
of the probe of FIG. 2, showing a rotational assembly extending
from the central rotation knob to the needle;
[0010] FIG. 7 is an enlarged side cross-sectional view of a portion
of the probe of FIG. 2, showing a cutter drive assembly;
[0011] FIG. 8 is a partial perspective view of a proximal portion
of the probe of FIG. 2, with the upper cover removed to show a
vacuum manifold system and a cutter drive system;
[0012] FIG. 9 is a partial perspective view of a vacuum manifold
system FIG. 8;
[0013] FIG. 10 is a partial perspective view showing a tissue
sample holder with a cover in dashed lines and engagement with the
cutter drive system of FIG. 8;
[0014] FIG. 11 is a perspective view of the holster of FIG. 2;
[0015] FIG. 12 is a side view of the holster of FIG. 2, with a
dashed outline to indicate a lower cover of the holster and showing
a cutter drive system and a tissue sample holder drive system;
[0016] FIG. 13 is a side view of the view of the cutter drive
system and tissue sample holder drive system FIG. 12, with an
internal support structure removed to show additional components of
the cutter drive system;
[0017] FIG. 14 is a perspective view of the cutter drive system of
FIG. 12;
[0018] FIG. 15 is a perspective view of an exemplary alternate
tissue sample holder drive system linking a central rotation knob a
tissue sample holder;
[0019] FIG. 16 is a perspective view of the tissue sample holder
drive system of FIG. 15, showing the tissue sample holder drive
system extending through a cutter drive system;
[0020] FIG. 17 is a perspective view of the drive systems of FIG.
16, with a top cover of the holster removed to show engagement of
the drive systems with the lower cover of a holster;
[0021] FIG. 18 is a partial side view of an exemplary alternate
tissue sample holder coupled with the tissue sample holder drive
system of FIG. 15;
[0022] FIG. 19 is a perspective view of another exemplary
holster;
[0023] FIG. 20 is a perspective view of the holster of FIG. 19,
with components removed to show an exemplary linking mechanism;
[0024] FIG. 21 is a perspective view of another exemplary probe
coupled with another exemplary holster, with inclined
thumbwheels;
[0025] FIG. 22 is a perspective view the holster of FIG. 21;
[0026] FIG. 23 is a perspective view of another exemplary holster,
with a remote thumbwheel.
DETAILED DESCRIPTION
[0027] 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.
[0028] Several merely illustrative examples of biopsy devices (100)
(e.g., a probe (105) in combination with various holsters (205,
305, 705, 805, 905), etc.) will be described in greater detail
below. It should be understood, however, that components, features,
functionalities, methods of operation, contexts of use, etc. may be
switched among the various examples of biopsy devices (100) as
desired. For instance, features or components of one particular
holster (205, 305, 705, 805, 905) example may be described in
detail herein, while not necessarily being explicitly described
herein in the context of another holster (205, 305, 705, 805, 905)
example. This should not be read as implying that such features or
components are excluded from all versions of the other holster
(205, 305, 705, 805, 905) examples or of other combinations of
probe (105) with any other holsters (205, 305, 705, 805, 905).
Instead, repetition of certain components, features,
functionalities, methods of operation, contexts of use, etc., will
be avoided for the sake of brevity, it being understood that such
components, features, functionalities, methods of operation,
contexts of use, etc. may be applied to all biopsy devices (100)
(e.g., all combinations of probe (105) with various holsters (205,
305, 705, 805, 905), etc.) unless such crossover is clearly
inconsistent with certain versions of biopsy device (100).
I. A First Exemplary Biopsy Device
[0029] As shown in FIG. 1, an exemplary biopsy system (2) includes
a biopsy device (100) for cutting and storing tissue samples
acquired from a patient and a vacuum control module (500). As shown
in FIGS. 2-4, biopsy device (100) of the present example comprises
probe (105) and holster (205). Conduits (501) operatively attach to
biopsy device (100) and extend between biopsy device (100) and
vacuum control module (500). Biopsy device (100) of the present
example is sized and balanced for single handed operation, and
comprises a needle portion (10) extending distally therefrom for
inserting into a patient and acquiring tissue samples from the
patient. Needle portion (10) is longitudinally constrained yet
rotatable relative the remainder of biopsy device (100), though in
other versions needle portion (10) may be non-rotatable and/or
operable to translate longitudinally relative the remainder of
biopsy device (100). As will become apparent in view of the
teachings herein, some versions of biopsy device (100) may offer
size reductions, improved balance, and enhanced single handed
grasping of biopsy device (100) with an operator or surgeon's hand
(1000). For instance, biopsy device (100) may be operated in a
handheld fashion under ultrasonic imaging guidance.
[0030] As will be described in greater detail below, needle portion
(10) is operably connected to an exemplary central thumbwheel (60)
that may be accessed and rotated by a finger (1001) or thumb of the
operator's grasping hand (1000). When the operator or surgeon holds
biopsy device (100) within one hand, rotation of central thumbwheel
(60) (e.g., with a single finger or thumb) rotates needle portion
(10) relative to the remainder of biopsy device (100) and within a
desired portion of tissue. The single handed operation of the
present example does not necessarily require rotation and/or
repositioning of any of the operator's hands during use. Versions
of biopsy device (100) may be compatible for use with magnetic
resonance, x-ray, ultrasonic, PET/PEM, and/or other types of
imaging systems. Indeed, while several examples herein relate to
handheld use of biopsy device (100), it should be understood that
biopsy device may be used in a variety of other ways. For instance,
it will be appreciated in view of the disclosure herein that
holster (205) may be configured to be mounted to a table, fixture,
or other device, such as for use in a stereotactic or X-ray
setting, an MRI setting, or any other setting. By way of example
only, holster (205) may be coupled with a targeting set, such as
the targeting set disclosed in U.S. Non-Provisional patent
application Ser. No. 12/337,872, entitled "MUTLI-ORIENTATION
TARGETING SET FOR MRI BIOPSY DEVICE," filed on Dec. 18, 2008, the
disclosure of which is incorporated by reference herein. Of course,
it will be appreciated in view of the disclosure herein that biopsy
device (100) may be used in a variety of other settings and
combinations.
[0031] As will be described in greater detail below, probe (105) is
separable from its corresponding holster (205). Use of the term
"holster" herein should not be read as requiring any portion of
probe (105) to be inserted into any portion of holster (205).
Indeed, in some variations of biopsy device (100), probe (105) may
simply sit on holster (205), with tissue sample holder (140)
attached thereto. In some other variations, a portion of holster
(205) may be inserted into probe (100) with tissue sample holder
(140) attached thereto. Furthermore, in some biopsy devices (100),
probe (105) and/or holster (205) and/or tissue sample holder (140)
may be of unitary or integral construction, such that the
components cannot be separated. Still other suitable structural and
functional relationships between probe (105), holster (205), and
tissue sample holder (140) will be apparent to those of ordinary
skill in the art in view of the teachings herein.
[0032] Some variations of biopsy devices (100) may include one or
more sensors (not shown), in probe (105) and/or in holster (205)
that is/are configured to detect when probe (105) is coupled with
holster (205). Such sensors or other features may further be
configured to permit only certain types of probes (105) and
holsters (205) to be coupled together. In addition or in the
alternative, such sensors may be configured to disable one or more
functions of probe (105) and/or holster (205) until a suitable
probe (105) and holster (205) are coupled together. Of course, such
sensors and features may be varied or omitted as desired.
[0033] By way of example only, probe (105) may be provided as a
disposable component, while holster (205) may be provided as a
reusable component. Vacuum control module (500) is provided on a
cart (not shown) in the present example, though like other
components described herein, a cart is merely optional. Among other
components described herein, a footswitch (not shown) and/or other
devices may be used to provide at least some degree of control of
at least a portion of biopsy system (2). Conduits (501) provide
communication of power (e.g., electrical, pneumatic, mechanical,
etc.), control signals, saline, vacuum, and/or venting from vacuum
control module (500) to biopsy device (100). One example of a
vacuum control module (500) and how it may be used is disclosed in
U.S. Pub. No. 2008/0195066, entitled "Revolving Tissue Sample
Holder For Biopsy Device," published Aug. 14, 2008, the disclosure
of which is incorporated by reference herein. In addition, an
interface may be provided between vacuum control module (500) and
biopsy device (100). Such an interface may be provided in
accordance with the teachings of U.S. Non-Provisional patent
application Ser. No. 12/337,814, entitled "CONTROL MODULE
INTERFACE," filed on Dec. 18, 2008, the disclosure of which is
incorporated by reference herein.
[0034] It should also be understood that any of the teachings
herein may be readily incorporated with any of the teachings of
U.S. Non-Provisional patent application Ser. No. 12/337,674,
entitled "BIOPSY DEVICE WITH SLIDING CUTTER COVER," filed on Dec.
18, 2008, the disclosure of which is incorporated by reference
herein. For instance, probe (105) may include any suitable features
of any probes disclosed in U.S. Non-Provisional patent application
Ser. No. 12/337,674. Suitable ways in which teachings herein and
teachings in U.S. Non-Provisional patent application Ser. No.
12/337,674 may be interchanged and incorporated with each other
will be apparent to those of ordinary skill in the art in view of
the teachings herein and in view of the teachings in U.S.
Non-Provisional patent application Ser. No. 12/337,674.
[0035] A. Exemplary Probe
[0036] As noted above, the assembly of probe (105) and holster
(205) may be sized and configured for one handed operation, and may
further be configured for one fingered rotation of central
thumbwheel (60). In FIG. 2, probe (105) and holster (205) are shown
releasably assembled together and ready for the acquisition of
tissue samples from a patient. A grip area (190) is provided on
probe (105) and holster (205) and is configured to fit within and
to be grasped by a single hand (1000) of the operator or surgeon.
Grip area (190) is indicated between dashed lines on FIG. 2, and
may be sized, shaped, configured, textured, coated with non-skid
coatings, roughened, and/or altered in a myriad of ways to enhance
gripping between the operator's single hand (1000) and biopsy
device (100). Of course, as noted above, biopsy device (100) need
not necessarily be held in the hand (1000) of an operator during
operation of biopsy device (100).
[0037] As shown in FIGS. 2-10, probe (105) of biopsy device (100)
releasably attaches to holster (205). In FIG. 3, cross sections of
unassembled probe (105) and holster (205) are shown spaced apart
with extension lines extending between drive systems that engage
together, and the reception of central thumbwheel (60) in a recess
(204) in holster (205). The operative engagement of these
components will be described in greater detail below.
[0038] Probe (105) of the present example comprises needle portion
(10) at a distal end, a body portion (112) at a proximal end, and
central thumbwheel (60). Needle portion (10) and body portion (112)
define a longitudinal axis. Body portion (112) comprises a top
cover (114), a bottom cover (116), and a proximal base (113).
Central thumbwheel (60) extends through an opening (115) in top
cover (114) and through an opening (117) in bottom cover (116). A
needle orientation indicator (65) and central thumbwheel (60) are
operably attached to needle portion (10) such that manual rotation
of central thumbwheel (60) by an operator rotates both needle
orientation indicator (65) and needle portion (10). The location of
central thumbwheel (60) in this example is at a longitudinal
position just distal to a point of balance of biopsy device (100)
so that the operator can grasp biopsy device (100) at the point of
balance, and then extend one finger distally to rotate central
thumbwheel (60), and hence, needle portion (10). Of course, central
thumbwheel (60) may be located at any other suitable position on
biopsy device (100). Furthermore, central thumbwheel (60) may be
operated by an operator's thumb instead of, e.g., the operator's
index finger.
[0039] FIG. 8 shows a perspective view of a proximal portion of
probe (105) with top cover (114) removed. In this view, bottom
cover (116) and can be seen rotatably supporting cutter (50),
cutter rotation and translation mechanism (80), vacuum manifold
(70), and central thumbwheel (60) at various points such as at a
first saddle (124) and a second saddle (125). FIG. 9 shows vacuum
manifold (70). Attachment of top cover (114) secures these
components (50, 80, 70, 60) between top cover (114), proximal base
(113), and bottom cover (116). These components (50, 80, 70, 60)
will be described in greater detail below.
[0040] In the present example, central thumbwheel (60) does not
engage with any portion of holster (205) when probe (105) is
releasably attached to holster (205). A tissue sample holder (140)
is removably attached to a proximal end of probe (105) for the
reception of severed tissue samples therein. Probe (105) is
configured for manual insertion into a patient, or can be attached
to a stereotactic table or other motorized device for penetration
into tissue. A level (199) such as a glass tube with a bubble can
be located on top of body portion (112) to indicate when the biopsy
device (100) is level. Of course, as with any other components
described herein, level (199) may be varied, substituted,
supplemented, or omitted as desired. [0041] 1. Exemplary Needle
[0042] In the present example and as shown in FIG. 6, needle
portion (10) extends distally from probe (105), and comprises a
hollow outer cannula (12) that defines a cannula lumen (20) and a
vacuum lumen (40). A blunt tip (14) is located at a distal end of
needle portion (10) and a transverse tissue receiving aperture (16)
is located proximally from tip (14). A tissue stop (26) is provided
on the proximal side of tip (14). By way of example only, cannula
(12) may be introduced into a patient's breast by inserting cannula
(12) through a separate cannula (not shown) that has a tissue
piercing tip and an aperture that is configured to align with
tissue receiving aperture (16) of outer cannula (12). In alternate
embodiments, blunt tip (14) may be replaced with a tissue piercing
tip (not shown). Such a tissue piercing tip may be configured to
penetrate tissue without requiring a high amount of force, and
without requiring an opening to be preformed in the tissue prior to
insertion of the needle portion (10). One suitable configuration
for a tissue piercing tip is disclosed in U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein. Other suitable configurations for
a tissue piercing tip are disclosed in U.S. Non-Provisional patent
application Ser. No. 12/038,359, entitled "Needle Tip for Biopsy
Device," filed Feb. 27, 2008, the disclosure of which is
incorporated by reference herein. Of course, other suitable
configurations for a blunt tip (14) or tissue piercing tip will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0043] Transverse tissue receiving aperture (16) is configured to
receive tissue drawn within, and cannula (12) has a floor or wall
(30) opposite to tissue receiving aperture (16). Wall (30)
separates cannula lumen (20) and vacuum lumen (40). A plurality of
openings (32) may be formed through wall (30) and provide fluid
communication between cannula lumen (20) and vacuum lumen (40).
Various ways in which vacuum, saline, atmospheric air, and/or
pressurized air, etc., may be communicated through openings (32)
will be described in greater detail below. In some versions, wall
(30) extends a substantial amount of the length of needle portion
(10). In some other versions, wall (30) proximally extends just
past the proximal transverse edge of aperture (16). For instance,
cannula lumen 20 may be sized and configured such that, with a
cutter (50) disposed therein, a gap exists between the exterior of
cutter (50) and at least a portion of the interior of cannula (12).
Such a gap may define vacuum lumen (40) along part of the length of
cannula (12), proximal to the proximal end of wall (30). Still
other ways in which a vacuum lumen (40) may be provided will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0044] In some versions, a plurality of external openings (not
shown) are formed in cannula (12) and are in fluid communication
with vacuum lumen (40). Examples of such external openings are
disclosed in U.S. Pub. No. 2007/0032742, entitled "Biopsy Device
with Vacuum Assisted Bleeding Control," published Feb. 8, 2007, the
disclosure of which is incorporated by reference herein. Of course,
as with other components described herein, such external openings
are merely optional.
[0045] As noted above, needle portion (10) extends from a distal
end of body portion (112) of probe (105), and rotates around the
longitudinal axis defined by needle portion (10). As also noted
above, needle orientation indicator (65) is fixedly attached to a
proximal end of cannula (12), as an integral part thereof, by
overmolding. Of course, adhesives or other techniques or structures
may be used to secure needle orientation indicator (65) to cannula
(12). The attachment of cannula (12) may provide an airtight or
vacuum tight seal between the cannula (12) and needle orientation
indicator (65). Needle orientation indicator (65) of the present
example is located at a distal end of body portion (112), away from
the grasping and balance point of biopsy device (100), and if
desired, can be rotated by an operator's free hand.
[0046] It should be understood that the components, features,
configuration, and functionality of needle portion (10) described
above are merely exemplary. Needle portion (10) may be modified,
supplemented, or substituted in any suitable way, as desired.
Suitable variations of needle portion (10) and methods of using the
same will be apparent to those of ordinary skill in the art in view
of the teachings herein. [0047] 2. Exemplary Cutter
[0048] A hollow cutter (50) is rotatably and slidably movable
within cannula lumen (20) of cannula (12), and extends proximally
therefrom through body portion (112) of probe (105) to operatively
communicate with tissue sample holder (140). Cutter has a sharp
distal cutting end (51) to sever tissue. Cutter (50) defines a
cutter lumen (52) that is configured communicate fluid and tissue
that is severed by cutting end (51) into tissue sample holder (140)
as will be described in greater detail below. As will also be
described in greater detail below, cutter (50) is configured to
both rotate and translate longitudinally within cannula lumen (20)
as cutting end (51) cuts tissue. In particular, cutter (50) is
configured to sever a biopsy sample from tissue drawn into tissue
receiving aperture (16) of outer cannula (12) and to guide or
communicate the sample through cutter lumen (52) into tissue sample
holder (140). Merely illustrative examples of such severing and
proximal communication are described in U.S. Pat. No. 5,526,822,
the disclosure of which is incorporated by reference herein, though
any other suitable structures or techniques may be used for
severing and/or communicating tissue samples within a biopsy system
(2).
[0049] Cutter (50) may be subject to various treatments or
configurations in order to facilitate distal to proximal
transmission of tissue samples through cutter lumen (52). For
instance, examples of such treatments and configurations are
disclosed in U.S. Pub. No. 2008/0195066, entitled "Revolving Tissue
Sample Holder For Biopsy Device," published Aug. 14, 2008, the
disclosure of which is incorporated by reference herein. Still
other suitable variations of cutter (50) will be apparent to those
of ordinary skill in the art in view of the teachings herein.
[0050] 3. Exemplary Thumbwheel
[0051] As noted above, needle portion (10) and needle orientation
indicator (65) may be operatively rotated using central thumbwheel
(60). This rotational movement is around the longitudinal axis
defined by needle portion (10). As shown in the exploded view of
FIGS. 3-7, needle portion (10) is fixedly attached to needle
orientation indicator (65), and thumbwheel (60) is spaced
proximally thereto by a hollow sleeve portion (63) that attaches to
needle orientation indicator (65) and central thumbwheel (60) with
a fluid tight connection. Central thumbwheel (60) has a proximal
knob (61) configured with engagement teeth (62) around a periphery
thereof to enhance engagement with the operator's finger or thumb.
In some versions, engagement teeth (62) can be gear teeth, or may
take a variety of other configurations. Hollow sleeve portion (63)
extends distally from knob (61) and defines a hollow sleeve lumen
(69). An external flange (64) extends in a raised ring around
hollow sleeve portion (63) and is disposed a slot (118) in bottom
cover (116) of probe (105) (FIG. 6), which permits rotation of
sleeve portion (63) while restricting longitudinal movement of
sleeve portion (63). A distal keyed end (66) of hollow sleeve
portion (63) is configured to attach to both needle portion (10)
and needle orientation indicator (65) to create a fluid tight
assembly (10, 60, 65) that can be rotated with thumbwheel (60).
[0052] The assembly of thumbwheel (60), needle orientation
indicator (65), and needle portion (10) brings hollow sleeve lumen
(69) into fluid communication with cannula lumen (20) and vacuum
lumen (40). In particular, with cutter (50) disposed in hollow
sleeve lumen (69) in addition to being disposed in cannula lumen
(20), the exterior of cutter (50) and the interior of sleeve lumen
(69) may define a lumen that corresponds with vacuum lumen (69) of
cannula (12). In some versions, the fluid tight assembly (10, 60,
65) can include an adhesive (not shown) or a weld (not shown) to
join needle orientation indicator (66) and needle portion (10) with
thumbwheel (60). In other versions, the fluid tight assembly can
include a mechanical fastening with a seal. Mechanical fastenings
may include but are not limited to a snap coupling, a bayonet
coupling, a screw thread, or any other mechanical fastening. Such
fastening mechanisms may also include sealing devices such as
o-rings, etc.
[0053] As shown in FIG. 6, thumbwheel (60) rotatably mounts within
body portion (112), with thumbwheel (60) extending through opening
(115) in top cover (114) and through opening (117) in bottom cover
(116). As shown in FIG. 3, knob (61) of thumbwheel (60) is
configured to be received in a recess (204) of holster (205). The
recess (204) is configured to receive knob (61) of thumbwheel (60)
without any contact therebetween to provide free and unhindered
rotation of thumbwheel (60). However, as will be described in
greater detail below with respect to other versions, thumbwheel
(60) may have a variety of other relationships with components of
holster (205).
[0054] Thumbwheel (60) of the present example also includes a
recessed bore (67) extending into a proximal face of the knob (61),
with an internal diameter larger than the diameter of hollow sleeve
lumen (69). Recessed bore (67) extends distally past knob (61) to
define a shoulder (68). Recessed bore (67) is in open communication
with hollow sleeve lumen (69) and is configured to receive and
retain a vacuum manifold (70) within, as will be described in
greater detail below.
[0055] It should be understood that the components, features,
configuration, and functionality of needle thumbwheel (60) and
associated components described above are merely exemplary.
Thumbwheel (60) and associated components may be modified,
supplemented, or substituted in any suitable way, as desired.
Suitable variations of thumbwheel (60) and associated components
and methods of using the same will be apparent to those of ordinary
skill in the art in view of the teachings herein. [0056] 4.
Exemplary Vacuum Manifold
[0057] As shown in FIGS. 3-9, an exemplary vacuum manifold (70) is
configured to be rotatably received within recessed bore (67) of
central thumbwheel (60). Vacuum manifold (70) remains stationary
within body portion (112), creates a rotating airtight seal with
recessed bore (67) of thumbwheel (60), and creates a dynamic fluid
seal with rotating and translating cutter (50). The dynamic fluid
seal is configured to maintain fluid integrity when cutter (50) is
stationary, when cutter (50) is translating longitudinally relative
to needle manifold (80), and/or when cuter (50) rotates about the
longitudinal axis. Vacuum manifold (70) also maintains a fluid seal
with thumbwheel (60), even as thumbwheel (60) rotates about vacuum
manifold (70).
[0058] As shown in FIGS. 5, 8, and 9, vacuum manifold (70) of the
present example comprises a wheel shaped manifold ring (71) with a
manifold sleeve (72) extending proximally and distally through
manifold ring (71). A manifold lumen (73) extends longitudinally
through a center of manifold sleeve (72) and is configured to
receive a cylindrical shaped cutter seal (75). Cutter seal (75) can
be formed from an elastomeric seal material and can have at least
one inner surface configured to form a dynamic seal with cutter
(50). An o-ring (74) can be placed within each of the one or more
grooves (76) of cutter seal (75) to form a static seal with
manifold lumen (73). O-rings (74) can also provide an inward
pinching bias to ensure that cutter seal (75) maintains a dynamic
seal with cutter (50). A large o-ring seal (77) is provided to form
a rotating seal between manifold ring (71) of vacuum manifold (70)
and recessed bore (67) of the central thumbwheel (60). An internal
snap ring (78) or other type of fastening structure can retain
non-moving vacuum manifold (70) within recessed bore (67) of
rotatable central thumbwheel (60).
[0059] A vacuum port (79) enters a proximal side of central
thumbwheel (60) and contains a vacuum passage (55) connecting to a
distal side of central thumbwheel (60) to communicate with recessed
bore (67) of the central thumbwheel (60) for the transfer of vacuum
or fluids therebetween. Vacuum cannula (79) is connected to a
distal end of tube (504) to form an unbroken line of communication
(fluids and/or vacuum, etc.) between vacuum control module (500),
tube (504), vacuum passage (55), recessed bore (67), hollow sleeve
lumen (69), and vacuum lumen (40) of needle portion (10). If
desired, a vacuum control valve may be operatively coupled to tube
(504) to control when vacuum or fluids are applied thereto. For
instance, such a vacuum control valve may be located in vacuum
control module (500) or elsewhere. Suitable components and methods
relating to communication of vacuum and fluids, as may be
implemented in biopsy system (2), are described in U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein.
[0060] It should be understood that the components, features,
configuration, and functionality of vacuum manifold (70) described
above are merely exemplary. Vacuum manifold (70) may be modified,
supplemented, or substituted in any suitable way, as desired.
Suitable variations of vacuum manifold (70) and methods of using
the same will be apparent to those of ordinary skill in the art in
view of the teachings herein. [0061] 5. Exemplary Cutter Rotation
and Translation Mechanism
[0062] In the present example, and as shown in FIGS. 4, 5, 7-8, and
10, body portion (112) of probe (105) comprises a cutter rotation
and translation mechanism (80) to rotate and translate cutter (50).
Cutter rotation and translation mechanism (80) comprises a sleeve
(82) fixed to cutter (50) with an external threaded portion (81)
and a hexagonal drive portion (83). External threaded portion (81)
is configured to be in threaded engagement with one or more
internal threads (86) within a drive nut (87), and hexagonal drive
portion (83) is configured to be in sliding and driving engagement
with a hexagonal drive opening (88) within a drive member (84).
Drive member (84) further comprises an external drive gear (85)
configured to be rotated by an intermediate driven gear (238) of
holster (205) to drive cutter rotation and translation mechanism
(80).
[0063] As shown in FIG. 7, drive nut (87) is engaged with external
threaded portion (81) of sleeve (82), and drive member (84) is
slidably received on hexagonal drive portion (83) of sleeve (82).
Drive nut (87) is securably received within base (113). Drive
member (84) is rotatably received in a transverse slot (119)
between top cover (114) and base (113), with a portion of external
drive gear (85) being exposed through transverse slot (119).
External drive gear (85) is configured to drivably engage with an
intermediate driven gear (238) of holster (205) when probe (105) is
coupled with holster (205). As intermediate driven gear (238)
rotates in holster (205), the driving engagement rotates external
drive gear (85), which rotates hexagonal drive portion (83) of
sleeve (82), thereby rotating cutter (50). As cutter (50) and
sleeve (82) are rotated by drive member (84), the threaded
engagement between fixed drive nut (87) and external threaded
portion (81) of the sleeve (82) translates cutter (50) and sleeve
(82) longitudinally. Depending on the direction of rotation of
drive member (84), cutter (50) and sleeve (82) translate either
proximally or distally along the longitudinal axis. Thus, cutter
rotation and translation mechanism (80) simultaneously rotates and
translates cutter (50) in response to rotation of drive member
(84).
[0064] It will be appreciated in view of the teachings herein that
cutter rotation and translation mechanism (80) described above is
merely exemplary, and that translation and/or rotation of cutter
(50) may alternatively be provided in various other ways. For
instance, probe (105) may include a motor or other device, such
that probe (105) lacks exposed external drive gear (85). It should
also be understood that cutter rotation and translation mechanism
(80) may be constructed and used in accordance with any of the
teachings of U.S. Pub. No. 2008/0195066, entitled "Revolving Tissue
Sample Holder For Biopsy Device," published Aug. 14, 2008, the
disclosure of which is incorporated by reference herein.
Alternatively, any suitable structure other than exposed external
drive gear (85) e.g., a rack, etc. may be used to receive
communication of motion or energy from some other component, in
order to rotate and/or translate cutter (50). Furthermore, cutter
rotation and translation mechanism (120) may be configured such
that more than one external drive gear (85) is present (e.g., one
external drive gear (85) for providing translation motion, and
another external drive gear (85) for providing rotation motion,
etc.). In other merely illustrative alternatives, translation
and/or rotation of cutter (50) may be performed at least in part by
pneumatic actuators not shown, pneumatic motors not shown, or a
variety of other components. Furthermore, it will be appreciated
that pneumatic components may be combined with other mechanical
components and/or electro-mechanical components in order to
translate and/or rotate cutter (50). Still other suitable
variations of cutter rotation and translation mechanism (80) and
methods of using the same will be apparent to those of ordinary
skill in the art in view of the teachings herein. [0065] 6.
Exemplary Tissue Sample Holder and Manifold
[0066] As shown in FIGS. 3-4 and 10, proximal base (113) further
comprises a light pipe (188) mounted thereto. Light pipe (188) is
constructed from a transparent or translucent material and is
configured to be illuminated from within by a light source (not
shown). Light pipe (188) is located adjacent to a tissue sample
holder (140) and can conduct light thereto. An axial vacuum tube
(502) is coupled with light pipe (188) and is thereby placed in
fluid communication with tissue sample holder (140) by a passage
(189) formed through light pipe (188). Of course, light pipe (188)
need not be transparent or translucent. By way of example only,
light pipe (188) may instead be formed of an opaque plastic or any
other material(s) having any suitable properties.
[0067] Proximal base (113) further defines tissue sample passage
(54), through which the proximal end of cutter (50) is disposed
(FIG. 4). A seal (56) is provided at the distal interface of cutter
(50) and tissue sample passage (54), to prevent escape of vacuum or
fluid between the outer surface of cutter (50) and the tissue
sample passage (54) while permitting cutter (50) to rotate and
translate relative to seal (56). Tissue sample passage (54) is
sized such that, as cutter (50) translates during use of biopsy
device (100), the proximal end of cutter (50) remains within tissue
sample passage (54) and seal (56) maintains a dynamic seal
therewith. Tissue sample passage (54) is thus in sealed fluid
communication with cutter lumen (52). Of course, any other suitable
structures or configurations may be used. In the present example,
tissue sample passage (54) extends proximally from seal (56) to a
proximal end of proximal base (113), and is also configured to
receive and pass tissue samples emerging from the proximal end of
cutter (50). Tissue samples emerge from tissue sample passage (54)
and exit into tissue sample holder (140).
[0068] As shown in FIGS. 2-4, 8, and 10, tissue sample holder (140)
of the present example is located at a proximal end of probe (105)
and is configured to receive a plurality of severed tissue samples
within as they exit from tissue sample passage (54). Tissue sample
holder (140) is further configured to store each sample
individually, and the stored samples can be removed from the
exemplary tissue sample holder (140) for study. Tissue sample
holder (140) of the present example comprises a rotatable manifold
(144). Manifold (144) is configured to removably attach to and
rotate around a longitudinal shaft (147) (FIGS. 3 and 4) to
successively align tissue sample chambers (146) with tissue sample
passage (54) for the reception of tissue samples therefrom, as will
be described in greater detail below. Manifold (144) has a
paddlewheel like configuration, and has a plurality of outwardly
extending paddles (not shown). The paddles are radially spaced
about manifold (144), and extend longitudinally.
[0069] Manifold (144) further comprises a plurality of inner
openings (not shown) and a corresponding set of rear openings
(145). The inner openings are radially spaced about the distal face
of manifold (144), facing light pipe (188), and extend
longitudinally through a portion of manifold (144). Each inner
opening is discrete from the other inner openings, and communicates
with a respective internal passage (144) that also communicates
with an associated rear opening (145). The inner openings of
manifold (144) are positioned to successively align with passage
(189) formed through light pipe (188). Given this, and the
communication of each inner passage of manifold (144) with a
corresponding rear opening (145), those of ordinary skill in the
art will recognize in view of the teachings herein that rear
openings (145) may be successively placed in fluid communication
with tube (502) as manifold (144) is rotated by shaft (147).
Furthermore, as each inner opening of manifold (144) is indexed to
passage (189), a corresponding tissue sample chamber (166) (that
corresponds with the associated rear opening (145)) is also
concomitantly indexed to tissue sample passage (54).
[0070] As shown in FIG. 10, one or more tissue sample trays (160)
are configured to removably mount over the plurality of outwardly
extending paddles of manifold (144). Tissue sample trays (160)
define a plurality of tissue sample chambers (166) that correspond
with gaps defined between the paddles of manifold (144). The
outwardly extending paddles of manifold (144) are thus covered by
tissue sample trays (160). Tissue sample trays (160) are configured
to receive a severed tissue sample within each tissue sample
chamber (166), and are further configured for removal from manifold
(144) so that one or more trays (160) of tissue samples may be sent
to pathology. Replacement tissue sample trays (160) may be provided
to replace trays (160) removed during a procedure. Tissue sample
trays (160) may include markings or other indicia.
[0071] Tissue sample trays (160) are configured and positioned to
provide fluid communication from rear openings (145) to tissue
sample passage (54). In particular, such fluid communication may be
provided through whichever tissue sample chamber (166) is indexed
to tissue sample passage (54). It will therefore be appreciated in
view of the teachings herein that tissue sample passage (54) (and
hence, cutter lumen (52)) may be placed in fluid communication with
tube (502) via whichever tissue sample chamber (166) and associated
rear opening (145) is indexed to tissue sample passage (54). By way
of example only, a vacuum may be communicated through tube (502) to
draw a severed tissue sample through cutter lumen (52) and into
whichever tissue sample chamber (166) is indexed to tissue sample
passage (54).
[0072] Manifold (144) of the present example is thus configured to
rotate relative to proximal base (113), to align one tissue sample
chamber (166) with tissue sample passage (54). Vacuum may be
communicated to tissue sample holder (140) from tube (502). When a
tissue sample has been severed by cutting end (51) of cutter (50)
and a vacuum is applied to tissue sample holder (140) by tube
(502), the severed tissue sample is drawn down cutter lumen (52),
into the tissue sample passage (54), and is deposited into the
aligned tissue sample chamber (166).
[0073] Tissue sample holder (140) further comprises a removable cup
(141) that surrounds a rotatable manifold (144). Removable cup
(141) is releasably attached to base (113) via a coupling such as a
bayonet coupling (134). An O-ring or cup seal (136) can be placed
between base (113) and the removable cup (141) to create a vacuum
or fluid seal therewith. Rotation of removable cup (141) disengages
bayonet coupling (134), allowing cup (141) to be removed (not
shown). Removal of cup (141) exposes manifold (144) and tissue
sample trays (160) (FIG. 10). Cup (141) is also formed of a
transparent material in the present example, enabling the user to
visually inspect tissue samples in tissue sample holder (140) while
tissue sample holder (140) is still coupled with proximal base
(113). Light pipe (188) can provide illumination for the tissue
sample holder (140). Of course, cup (141) may alternatively have
any other suitable properties.
[0074] As noted above, manifold (144) is configured to removably
attach to and be rotated by shaft (147). As shown in FIGS. 3-4,
shaft (147) is rotatably received within base (113) and rotates
about an axis parallel to the longitudinal axis defined by cutter
lumen (52). The distal end of shaft (147) has a unitary gear (170),
which is configured to drive or rotate manifold (144). Shaft (147)
may rotate manifold (144) by a keyed engagement such as a blade or
woodruff key extending from a round portion of the shaft (147). As
will be described in greater detail below, gear (170) is configured
to mesh with a drive gear (251) of holster (205), such that gear
(251) may be used to impart rotation to gear (170). Such rotation
may be used to selectively (e.g., consecutively) align tissue
sample chambers (166) with tissue sample passage (54), to
successively collect a discrete tissue sample in each chamber (166)
during use of biopsy device (100).
[0075] As shown in FIG. 10, tissue sample holder (140) of the
present example has a longitudinal passage (158) formed through
manifold (144). Passage (158) of this example is a hollow
rectangular tube structure extending longitudinally, completely
through manifold (144), and is offset from but parallel with the
central axis defined by manifold (144). Like chambers (166),
passage (158) is configured to be selectively aligned with tissue
sample passage (54) and to form a continuous passageway through
tissue sample passage (54), and through cutter lumen (52). Passage
(158) of the present example is configured to permit instruments
and/or liquids, other materials, etc., to be passed through
manifold (144) and through tissue sample passage (54). For
instance, passage (158) may be used to insert an instrument for
deploying one or more markers at a biopsy site, via tissue sample
passage (54) and via cutter lumen (52), out through aperture (16).
A merely exemplary marker applier that may be inserted through
passage (158) may include the MAMMOMARK biopsy site marker applier,
by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Other suitable
marker applier devices that may be inserted through passage (158)
may include any of those described in U.S. Pat. No. 7,047,063; U.S.
Pat. No. 6,996,433; U.S. Pat. No. 6,993,375; or U.S. Pub. No.
2005/0228311, the disclosure of each of which is incorporated by
reference herein. Any of such appliers, including variations of the
same, may be introduced through passage (158) to deploy one or more
markers at a biopsy site, via aperture (16), while needle portion
(10) remains inserted in a patient e.g., shortly after biopsy
samples are extracted from the patient, etc. Such marker deployment
may be accomplished even while tissue samples reside within tissue
sample holder (140), secured to biopsy probe (105). Alternatively,
such marker appliers may be inserted directly into tissue sample
passage (54) with tissue sample holder (140) being removed from
biopsy probe (105).
[0076] It should be understood that tissue sample holder (140) and
its associated components may be constructed and used in accordance
with any of the teachings of U.S. Pub. No. 2008/0195066, entitled
"Revolving Tissue Sample Holder For Biopsy Device," published Aug.
14, 2008, the disclosure of which is incorporated by reference
herein. By way of example only, probe (105) may include a parking
pawl (not shown) to selectively engage gear (170) to prevent
rotation of manifold (144) when probe (105) is decoupled from
holster (205). As another variation, tissue sample holder (140) may
be constructed and used in accordance with any of the teachings of
U.S. Non-Provisional patent application Ser. No. 12/337,911,
entitled "BIOPSY DEVICE WITH DISCRETE TISSUE CHAMBERS," filed on
Dec. 18, 2008, the disclosure of which is incorporated by reference
herein. Still other suitable variations of tissue sample holder
(140), its associated components, and methods of using the same
will be apparent to those of ordinary skill in the art in view of
the teachings herein.
[0077] B. Exemplary Holster
[0078] As shown in FIGS. 3 and 11, holster (205) of the present
example comprises a body (212) having a top housing member (207),
through which a portion of an intermediate driven gear (238) is
exposed, and a bottom housing member (206). Recess (204) is
provided in top housing member (207) to receive thumbwheel (60)
within without interference or contact therewith when probe (105)
is coupled with holster (205). A plurality of hook members (214)
extend from top housing member (207) for selectively securing probe
(105) to holster (205), though other structures or techniques may
be used. Holster (205) of this embodiment further comprises a
cutter drive mechanism (210) and a tissue holder rotation mechanism
(240). Each of these merely exemplary components will be described
in greater detail below. Holster (205) of the present example is
configured to be coupled with a biopsy probe (105), such as biopsy
probe (105) described above, to provide a biopsy device (100). In
addition, holster (205) is configured to be handheld, such that
biopsy device (105) may be manipulated and operated by a single
hand of a user (e.g., using ultrasound guidance, etc.). However, it
will be appreciated in view of the disclosure herein that holster
(205) may be used in a variety of other settings and combinations.
[0079] 1. Exemplary Cutter Drive Mechanism
[0080] As shown in FIGS. 3 and 11-14, cutter drive mechanism (210)
of the present example comprises a drive cable (215) having an
inner wire cable (217) rotatably encased in a sheath (219). Drive
cable (215) extends between holster (205) and the vacuum control
module (500). A motor (530) is located within vacuum control module
(500) and is operably coupled to a proximal end of the drive cable
(215) (FIG. 1) to rotate inner wire cable (217) within the
non-rotating sheath (219). By way of example only, motor (530) may
be provided in accordance with, and incorporated with vacuum
control module (500) in accordance with, the teachings of U.S.
Non-Provisional patent application Ser. No. 12/337,814, entitled
"CONTROL MODULE INTERFACE," filed on Dec. 18, 2008, the disclosure
of which is incorporated by reference herein.
[0081] Drive cable (215) enters into bottom housing member (206)
through a strain relief (209). A distal end connector (208) is
crimped or attached to a distal end of non-rotating sheath (219)
for attachment to the holster (205). End connector (208) is
captured between bottom housing member (206) and a bottom portion
of a middle plate (221) of holster (205) to secure drive cable
(215) to holster (205). Middle plate (221) is an intermediate
bearing plate that mounts into bottom housing member (206) to
securely capture the distal end of non-rotating sheath (219) and
will be described in more detail below. A distal end of inner wire
cable (217) is attached to a cable drive gear (225) by a shock
assembly (228). Shock assembly (228) is an energy absorber
configured to reduce rotational drive shocks between inner wire
cable (217) and cable drive gear (225). Shock assembly (228)
comprises a flex end coupling (222) fixedly attached to the inner
wire cable (217), and a holster end coupling (224) fixedly attached
to the cable drive gear (225). Gaps between flex end coupling (222)
and holster end coupling (224) are filled with an elastomeric shock
absorber (223) that is captured between flex end coupling (222) and
holster end coupling (224). Shock absorber (223) is configured to
transmit rotation from inner wire cable (217) to cable drive gear
(225) and is also configured to accommodate misalignment between
inner wire cable (217) and cable drive gear (225). Shock absorber
(223) may also smooth velocity or rotational differences between
inner wire cable (217) and cable drive gear (225). Of course, as
with other components described herein, shock assembly (228) is
merely optional. By way of example only, inner wire cable (217) may
be directly connected to cable drive gear (225) if desired.
[0082] Cable drive gear (225) is rotatably secured between drive
gear saddles (226) extending downward from a distal end of middle
plate (221); while opposing drive gear saddles (not shown) extend
upward from an inside of bottom housing member (206) such that
cable drive gear (225) is supported therebetween. Rotation of inner
wire cable (217) rotates cable drive gear (225) in saddles
(226).
[0083] On a top of middle plate (221), a pair of driven gear
saddles (227) extend upwardly from the distal end of middle plate
(221) in direct opposition to saddles (226) extending downwardly
from middle plate (221). Driven gear saddles (227) rotatably
support an idler driven gear (230) therebetween, and are positioned
to align idler driven gear (230) directly above cable drive gear
(225) and in toothed driving engagement therewith. The driving
engagement of idler driven gear (230) with cable drive gear (225)
enables idler driven gear (230) to rotate in response to rotation
of inner wire cable (217) of drive cable (215).
[0084] An idler shaft (232) extends proximally from a center of
idler driven gear (230), and has an idler drive gear (234) attached
to idler shaft (232) at a location proximally spaced from the
driven gear (230). Both idler gear (234) and idler shaft (232) are
rotatably received in an idler saddle block (236) extending
upwardly from a proximal end of middle plate (221). Idler saddle
block (236) is configured to rotatably support inline idler shaft
(232) and idler gear (234), as well as an intermediate driven gear
(238) located above idler gear (234). As shown, idler gear (234) is
in driving engagement with intermediate driven gear (238) and is
supported above in a position where a portion of the intermediate
driven gear (238) is exposed through an opening (211) (FIG. 11)
within top housing member (207).
[0085] When top housing member (207) is attached to bottom housing
member (206), idler shaft (232), idler gear (234), and intermediate
driven gear (238) are rotatably captured between saddle block
features extending downward from top housing member (207) to engage
with driven gear saddles (227) and idler saddle block (236). With
appropriate material selection, the rotating elements of cutter
drive mechanism (210) such as idler shaft (232) may be run within
saddles (226, 227, 236, etc.). By way of example only, bearings may
be provided to support the rotating elements and to reduce
friction. These bearings may be of any conventional bearing
construction such as ball bearings, roller bearings, or sleeve
bearings, and can be provided with or without lubricants. If
needed, seals such as oil or grease seals may be provided for use
with the bearings to prevent migration of lubricants to unwanted
areas. For instance, sleeve bearings may be molded from slick or
lubricious materials such as nylons, acetals (delrin), Teflon
impregnated polymers, or any other moldable sleeve bearing
materials.
[0086] As shown in FIGS. 13-14, cable drive gear (225) may be
supported on either side by a first bearing (270) and a second
bearing (271). Third bearing (272) and fourth bearing (273) are
placed to support idler driven gear (230) on either side; and fifth
bearing (274) is placed to support a center of the idler shaft
(232). Idler drive gear (234) is supported by sixth bearing (275)
and seventh bearing (276); and intermediate driven gear (238) can
be supported by eighth bearing (277) and ninth bearing (278).
[0087] When biopsy probe (105) attaches to holster (205), external
drive gear (85) extending from biopsy probe (105) is brought into
driving engagement with intermediate driven gear (238), and cutter
drive mechanism (210) is thus operably engaged with cutter rotation
and translation mechanism (80) of the biopsy probe (105). It will
therefore be appreciated by those of ordinary skill in the art that
rotation of inner wire cable (217) of drive cable (215) causes
simultaneous rotation and translation of cutter (50) in this
example.
[0088] Of course, cutter drive mechanism (210) may take a variety
of other forms, and may have any number of alternative features,
components, configurations, and principles of operation. It should
therefore be understood that the above described cutter drive
mechanism (210) is merely one example. By way of example only, a
motor may be provided in holster (205) for driving gears (238, 85),
eliminating drive cable (215). As another merely illustrative
example, cutter drive mechanism (210) may be configured in
accordance with the teachings of U.S. Pub. No. 2008/0195066,
entitled "Revolving Tissue Sample Holder For Biopsy Device,"
published Aug. 14, 2008, the disclosure of which is incorporated by
reference herein. Other suitable features, components,
configurations, and principles of operation of a cutter drive
mechanism (210) will be apparent to those of ordinary skill in the
art in view of the teachings herein. [0089] 2. Exemplary Idler
Shaft Encoder
[0090] In the present example, an encoder assembly (240) mounts to
a proximal end of idler shaft (232) and is operably connected to
motor (530) via wiring (280) extending between holster (205) and
vacuum control module (500). Encoder assembly (240) is secured in
holster (205) between top housing member (207) and bottom housing
member (206). Wiring (280) extends to a connector (514), to which
another wire (254) is connected as described below. An encoder
cable (515) extends from connector (514) to vacuum control module
(500). Encoder assembly (240) of this example measures rotational
movement of idler shaft (232) and may be used to "count"
revolutions of idler gear shaft (232), which may be used (e.g.,
with the thread ratio of threads (81, 86)) to indirectly measure
rotation and translation (linear travel) of cutter (50) within
probe (105). Gears (225, 230, 234, 238) of the present example are
configured to provide a 1.5:1 rotational ratio between wire cable
(217, 317) of drive cable (215, 315) and idler shaft (232); and a
1:1 rotational ratio between wire cable (217, 317) of drive cable
(215, 315) and the intermediate driven gear (238). Encoder assembly
(240) "counts" 1.5 revolutions at idler shaft (232) for every
rotation of wire cable (217, 317) of drive cable (215, 315). The
rotational and positional information from encoder assembly (240)
may be used to determine if idler shaft (332) is rotating, may
measure idler shaft (332) speed, may measure rotational position of
shaft (332), and/or may be used for homing routines to determine
the location of cutter (50) (e.g., longitudinal position) within
biopsy device (101). Alternatively, any other suitable use may be
made of encoder assembly (240), to the extent that an encoder
assembly (240) is included at all.
[0091] Homing routines may engage motor (530) to move cutter (50)
to a proximal most or a distal most position. Cutter (50) may
contact a stop at the proximal most or the distal most position
that prevents further movement of cutter (50). With cutter (50)
stopped, encoder assembly 240 stops rotating, which informs motor
control system (540) that a homing position has been reached, and a
counter within motor control system (540) is set to zero. With the
counter at set at zero at the "home" position, each revolution of
idler shaft (332) may be used to calculate linear and rotational
positioning of cutter (50) within biopsy probe (105). By way of
example only, each revolution of inner wire cable (217, 317) of
drive cable (215, 315) may results in approximately 0.00012 inches
of linear translation of cutter (50), and each revolution of inner
wire cable (217, 317) rotates idler shaft (232) an amount of 1.5
revolutions. Of course, any other suitable ratios may be used.
[0092] 3. Exemplary Tissue Holder Rotation Mechanism
[0093] As described above, and as shown in FIGS. 3-4 and 10, tissue
sample holder (140) on probe (105) contains manifold (144) which is
aligned and rotated during the acquisition of consecutive tissue
samples. In particular, manifold (144) is rotated to successively
index tissue collection chambers (166) to tissue sample passage
(54), which is aligned with cutter lumen (52). The rotation and
alignment of the manifold (144) may ensure that each severed tissue
sample is stored separately in an empty tissue sample chamber
(166). In the present example, a tissue holder rotation mechanism
(242) is provided within holster (205) to engage with holder gear
(170), and to rotate manifold (144) when biopsy probe (105) is
attached to holster (205).
[0094] Tissue holder rotation mechanism (242) of the present
example comprises a piezoelectric motor (250) mounted in holster
(205). Piezoelectric motor (250) is a piezo effect stepper motor
that is slidably received in bottom housing member (206) of holster
(205) and is constrained therein by top housing member (207).
Piezoelectric motor (250) may be magnetic resonance compatable and
may be configured to operate in the magnetic resonance environment.
One suitable motor for piezoelectric motor (250) is a Shinsei
piezoelectric motor USR30-B4 or a non-magnetic Shinsei
piezoelectric motor such as the USR30-54N, both available from
Shinsei Corporation, 2-1-8 Kasuya Setagaya-ku Tokyo 157-0063 Japan.
Piezoelectric motor (250) comprises rotatable shaft (252) extending
proximally from motor (250). A holder drive gear (251) is attached
to a proximally extending portion of shaft (252) to extend
proximally through an opening (279) (FIG. 3) in a proximal end of
top housing member (207). A portion of holder drive gear (251) is
exposed by opening (279) and is configured to engage with the
exposed holder gear (170) on the underside of probe (105) when
probe (105) is coupled with holster (205). When probe (105) is
coupled with holster (205) to engage holder drive gear (251) with
the holder gear (170) and piezoelectric motor (250) is actuated,
manifold (144) is rotated within tissue sample holder (140).
[0095] An encoder (253) mounts to a distally extending portion of
shaft (252) and is used to sense rotational motion or rotational
positioning of piezoelectric motor (250), and to indirectly measure
movement of manifold (144) within the tissue sample holder (140). A
cable or wire (254) extends from encoder (253) to connector (514),
to encoder cable (515), and to vacuum control module (500). As
noted above, encoder assembly (240) and the idler shaft (232) are
also electrically coupled to vacuum control module (500) via wire
(280) connecting to connector (514) and encoder cable (515).
Encoder cable (515) may extend along sheath (219) and may be
secured thereto or therein. Alternatively, encoder cable (515) may
be provided as separate from sheath (219). Further still, encoder
cable (515) and wires (280, 254) may be eliminated, and electronic
communication may be provided wirelessly. As yet another merely
illustrative variation, cable (515) and wires (280, 254) may be
attached or integrated circumferentially with mechanical cable
(215). Of course, encoders (240, 253) may also be omitted
altogether if desired.
[0096] It should be understood that tissue holder rotation
mechanism (242) may be varied in a number of ways. By way of
example only, tissue holder rotation mechanism (242) may be
modified in accordance with the teachings of U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein. As another merely illustrative
variation, tissue holder rotation mechanism (242) may be driven by
cable (217) or another drive cable that is driven by a remote
motor. As yet another merely illustrative variation, tissue holder
rotation mechanism (242) may be omitted altogether. For instance,
tissue sample holder (140) may be manually rotatable or
non-rotatable, if desired. As yet another merely illustrative
variation, biopsy probe (100) may be configured in accordance with
U.S. Non-Provisional patent application Ser. No. 12/337,874,
entitled "MECHANICAL TISSUE SAMPLE HOLDER INDEXING DEVICE," filed
on Dec. 18, 2008, the disclosure of which is incorporated by
reference herein, and which includes several examples of how manual
rotation of tissue sample holder (140) may be provided. Still other
suitable features, components, configurations, and principles of
operation of a tissue holder rotation mechanism (242) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0097] C. Exemplary Use
[0098] In one example of operation, as biopsy probe (105) is
attached onto holster (205), such that holder gear (170) on biopsy
probe (105) is brought into engagement with holder drive gear
(251). A parking pawl (not shown) has held manifold (144) in a
first position with a first predetermined chamber (166) aligned
with tissue sample passage (54) for the reception of the first
biopsy tissue sample within. Once gears (170, 251) are engaged and
parking pawl (182) is disengaged, the rotational positioning of
manifold (144) is controlled by piezo motor (250). Software or
control logic is used to automatically reposition manifold (144)
after each tissue sample is received within an empty chamber (166)
to move a fresh empty chamber (166) into alignment with the tissue
sample passage (54) for the receipt of the next tissue sample
therein. Piezo motor (250) may also be commanded to "present" a
captured tissue sample to the operator before indexing the next
empty chamber to tissue sample passage (54). Examples of such
tissue sample presentation are disclosed in U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein.
[0099] For acquisition of a tissue sample, biopsy device (100) is
grasped in a single hand (1000) of the operator or surgeon by
grasping biopsy device (100) from the top or in any other suitable
fashion. For instance, the fingers of the surgeon's hand (1000) may
be curled under the holster (205) with the surgeon's thumb on the
top of probe (105). With biopsy device held in the surgeon's hand
(1000) in this manner, the thumb of the grasping hand may be lifted
from biopsy probe (105) and moved to reach out and access
thumbwheel (60) protruding from the top of probe (105). Lateral
movement of the surgeon's thumb (of the grasping hand) may rotate
thumbwheel (60) and needle portion (10) to orient aperture (16) at
a desired angular orientation about the axis defined by cannula
(12). Alternately, biopsy device (100) may be mounted to a
targeting set, such as any of the devices disclosed in U.S.
Non-Provisional patent application Ser. No. 12/337,872, entitled
"MUTLI-ORIENTATION TARGETING SET FOR MRI BIOPSY DEVICE," filed on
Dec. 18, 2008, the disclosure of which is incorporated by reference
herein.
II. Second Exemplary Holster
[0100] As shown in FIGS. 15-17, another exemplary biopsy device
(101) comprises the above described probe (105) in combination with
a different holster (305). The assembly thereof is sized and
configured for one handed operation, and is configured for one
fingered rotation of the central thumbwheel (60). In FIGS. 15-16,
probe (105) and holster (305) are shown releasably assembled
together and ready for the acquisition of tissue samples from a
patient. Unlike the previously described biopsy device (100), when
probe (105) is assembled with holster (305), central thumbwheel
(60) of biopsy probe (105) is rotatably coupled to a rotatable
manifold such as rotatable manifold (144) (within tissue sample
holder (140)) by holster (305). The assembly of probe (105) and
holster (305) is thus such that rotation of central thumbwheel (60)
rotates the rotatable manifold (144). Disassembly of probe (105)
from holster (305) disengages central thumbwheel (60) from
rotatable manifold (144).
[0101] The rotational linking of central thumbwheel (60) and
rotatable manifold (144) ensures that tissue samples are stored
within rotating manifold (144) at the same rotational angle as
tissue receiving aperture (16) of the needle portion (10).
Alternatively, the rotational linking may provide some other direct
correlation between the rotational angle of aperture (16) and
manifold (144). As noted above, and as will be described in greater
detail below, central thumbwheel (60) and rotatable manifold (144)
are not linked together within probe (105) in this example, for the
linking between thumbwheel (60) and manifold (144) occurs within
holster (305) when probe (105) is coupled with holster (305).
[0102] As shown in FIGS. 15-17, holster (305) of this example
further comprises an exemplary tissue holder rotational mechanism
(340) and an exemplary cable driven cutter drive mechanism (310).
Holster 305 comprises a top housing member (307) and a bottom
housing member (306). The external dimensions of holster (305) may
be identical to external dimensions and configurations as described
for the above holster (205), and holsters (205, 305) may have the
same grip area 190 as illustrated in FIG. 2. Top housing member
(307) has an opening (311) therein exposing a portion of an
intermediate driven gear (338) of cable driven cutter drive
mechanism (310). A recess (304) is provided in top housing member
(307) to receive central thumbwheel (60) of probe (105), and a
thumbwheel drive slot (303) extends through recess (304) to expose
a thumbwheel gear (350) of tissue holder rotational mechanism
(340). As will be described in greater detail below, thumbwheel
gear (350) is configured to rotatably engage with teeth (61) of
central thumbwheel (60); and intermediate driven gear (338) is
configured to rotatably engage with gear (85) extending from probe
(105) when probe (105) is coupled with holster (305).
[0103] A. Exemplary Alternate Tissue Holder Rotation Mechanism
[0104] FIG. 15 shows probe (105) attached to holster (305) to show
the exemplary tissue holder rotational mechanism (340). In this
view, top housing member (307) of holster (305) is shown attached
to probe (105), and bottom housing member (306) is shown as an
outline to show elements within. For clarity in showing elements of
the exemplary tissue holder rotational mechanism (340), elements of
the exemplary cable driven cutter drive mechanism (310) are removed
from this view with the exception of a drive cable (315) and
certain rotatable elements associated therewith.
[0105] Central thumbwheel (60) of probe (105) is shown rotatably
linked to manifold (144) located within tissue sample holder (140)
via gear (170). This rotational linking is accomplished by engaging
central thumbwheel (60) and manifold (144) with the exemplary
tissue holder rotational mechanism (340) located within holster
305.
[0106] As shown in FIG. 15, thumbwheel gear (350) of tissue holder
rotational mechanism (340) has plurality of teeth around a
periphery thereof, and thumbwheel gear (350) extends through
thumbwheel drive slot (303) in recess (304) of top housing member
(307). When probe (105) is attached to holster (305) as shown, the
plurality of teeth around a periphery of thumbwheel gear (350) are
rotatably engaged with teeth (61) of thumbwheel (60). Rotation of
thumbwheel (60) thus causes rotation of thumbwheel gear (350).
[0107] Tissue holder rotational mechanism (340) of the present
example further comprises a rotary shaft (353) that extends
proximally through a center of thumbwheel gear (350) and rotates
with thumbwheel gear (350). A takeoff gear (355) is attached to the
proximal end of shaft (353) and rotates with shaft (353). Shaft
(353) and gears (350, 355) are supported by a distal bearing (382)
mounted in a first rotary saddle (380); and by a proximal bearing
(383) mounted in a secondary rotary saddle (381). Rotary saddles
(380, 381) are configured to extend downward from the housing
member (307). An intermediate gear (356) is engaged with the
takeoff gear (355) and rotates therewith. Intermediate gear (356)
is also rotatably engaged with a distal drive gear (357), such that
rotation of the takeoff gear (355) rotates intermediate gear (356)
and distal drive gear (357). A short drive shaft (359) extends
longitudinally and proximally from distal drive gear (357) and is
attached to a proximal takeoff gear (358). Proximal takeoff gear
(358) is located below a proximal opening (279) at a proximal end
of top housing member (307) and is accessible through opening
(279). Thus, working through the gear train of the exemplary tissue
holder rotational mechanism (340), rotation of thumbwheel gear
(350) through slot (303) ultimately rotates proximal takeoff gear
(358), which is exposed in proximal opening (279) at the proximal
end of holster (350).
[0108] When probe (105) is attached to holster (305), thumbwheel
(60) of probe (105) engages with thumbwheel gear (350) of holster
(305), and the proximal takeoff gear (358) of holster (305) engages
with holder gear (170) of probe (105). As shown in FIGS. 3-4 and
10, and as described above, holder gear 170 is directly coupled
with manifold (144) within tissue sample holder (140). Thus, the
attachment of probe (105) to holster (305) rotatingly couples
thumbwheel (60) to manifold (144) via tissue holder rotational
mechanism (340), and rotation of thumbwheel (60) thereby rotates
manifold (144).
[0109] A gear drive ratio exists between the rotational input from
thumbwheel (60) and the rotational output at manifold (144). Gear
ratios within the holder rotational mechanism (340) directly affect
the gear drive ratio. The gear drive ratio (input to output) can be
configured by altering gear ratios of the holder rotational
mechanism (340) such that a given degree of rotation of thumbwheel
(60) produces a certain degree of rotation at manifold (144). Such
a ratio may be 1:1, by way of example only. In alternate
embodiments, the gear ratios can be altered so that a degree of
rotation at thumbwheel (60) produces more than a degree of rotation
at manifold (144), or a degree of rotation at thumbwheel (60)
produces less than a degree of rotation at the manifold (144).
Suitable ratios will be apparent to those of ordinary skill in the
art in view of the teachings herein.
[0110] It should also be understood that rotation of manifold (144)
may be provided in predefined increments, such as to provide some
degree of self-alignment of each tissue sample chamber (166) with
tissue sample passage (54). For instance, accurate indexing
positions can be achieved using a spring loaded detent (not shown),
using a self-aligning mechanism between a housing component of
tissue sample holder (140) and light pipe (188) or some other
component of probe (105); or using any other suitable components,
features, configurations, or techniques. Tissue holder rotation
mechanism (340) may also provide audible, visual, and/or tactile
feedback to indicate successful alignment of a tissue sample
chamber (166) with tissue sample passage (54). Still other suitable
features, components, configurations, functionalities, and
operational methods of holder rotation mechanism (340) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0111] B. Exemplary Cable Driven Cutter Drive Mechanism
[0112] In FIG. 16, all of the drive elements of a cable driven
cutter drive mechanism (310) are shown in combination with tissue
holder rotational mechanism (340). As will be described in detail
below, portions of tissue holder rotational mechanism (340), such
as a rotary shaft (353), are coaxially nested within a hollow idler
shaft (332) of cable driven cutter drive mechanism (310). Shafts
(353, 332) rotate independently from each other, and can rotate in
the same time and/or opposite rotational directions.
[0113] Cutter drive mechanism (310) of the present example is
substantially similar to cutter drive mechanism (210) of holster
(205). For instance, cutter drive mechanism (310) comprises a drive
cable (310) having an inner wire cable (317) and a sheath (319) and
which enters through a bottom strain relief. These components
respectively correlate with drive cable (215), wire cable (217),
sheath (219), and strain relief (209) of holster (205). Cutter
drive mechanism (310) further comprises a distal end connector
(308); and a shock assembly (328) comprising a flex end coupling
(322), a holster end coupling (324) fixedly attached to a cable
drive gear (325), and an elastomeric shock absorber (323) that is
captured between flex end coupling (322) and holster end coupling
(324). These components respectively correlate with distal end
connector (208, 308), shock assembly (228, 328), couplings (222,
224), cable drive gear (225), and shock absorber (223) of holster
(205) as described above. Cutter drive mechanism (310) further
comprises bearings (326, 327, 372, 373, 374 375 376, 377, 378), an
idler driven gear (330), a hollow idler shaft (332), an idler drive
gear (334), and an intermediate driven gear (338). These components
respectively correlate with bearings (226, 227, 272, 273, 274 275
276, 277, 278), idler driven gear (230), hollow idler shaft (232),
idler drive gear (234), and intermediate driven gear (238) of
holster (205).
[0114] As shown, a portion of intermediate driven gear (338)
extends through a slot (311) in top housing member (307) and is
rotatably engaged with gear 85 of probe (105). Gear (85) is engaged
with cutter rotation and translation mechanism (80) of probe (105)
to simultaneously rotate and translate cutter (50) as described
above. It will therefore be appreciated that rotation of cable
(317) in the present example will cause simultaneous rotation and
translation of cutter (50). Cutter drive mechanism (310) of probe
(305) thus operates like cutter drive mechanism (210) of probe
(205).
[0115] A hollow bore (not shown) extends longitudinally within the
hollow idler shaft (332) to concentrically surround (without
interferingly touching) rotary shaft (353) of tissue holder
rotational mechanism (340). With this coaxially nested arrangement,
either one of tissue holder rotational mechanism (340) or cutter
drive mechanism (310) may rotate or otherwise be actuated
independently without affecting the other.
[0116] Turning now to FIG. 17, drive elements of cutter drive
mechanism (310) and tissue holder rotational mechanism (340) can be
seen placed within bottom housing member (306). End connector (308)
of cable sheath (319) is held within bottom housing member (306).
Cable drive gear (325) and shock assembly (328) at a distal end of
cable (317) are supported by bearings (326, 327) in bottom housing
member (306). The assembly of thumbwheel gear (350), rotary shaft
(353), and takeoff gear (355) are rotatably supported in bearings
(382) in bottom housing member (306). A dual plate support
structure comprising a bottom plate (390) and a top plate (391)
mounts within bottom housing member (306), with proximal bearing
(383) received within to support rotary shaft (353) and takeoff
gear (355). Takeoff gear (355) is shown nested within a clearance
slot (392) within top plate (391) just proximal to proximal bearing
(383). Intermediate gear (356) that rotatably engages with takeoff
gear (355) is supported below takeoff gear (355). Drive gear (357),
short drive shaft (359), and proximal takeoff gear (358) thus
rotatably mount between bottom plate (390) and top plate (391).
Gears (357, 358) can be seen protruding from top plate (391).
Middle plate (321) and an encoder assembly (340) are not shown in
FIG. 17.
[0117] As will be appreciated, tissue holder rotational mechanism
(340) may have a variety of alternative features, components,
configurations, functionalities, and methods of operations.
Furthermore, tissue holder rotational mechanism (340) may have any
other suitable relationships with cutter drive mechanism (210).
Suitable alternatives will be apparent to those of ordinary skill
in the art in view of the teachings herein.
[0118] C. Exemplary Idler Shaft Encoder for Cutting Mechanism
[0119] As shown in FIG. 16, an encoder assembly (340) mounts to a
proximal end of the idler shaft (332) and is operably connected to
motor (530) via wiring (not shown) extending between holster (305)
and vacuum control module (500). Encoder assembly (340) may be
configured and used in the same way as encoder assembly (240) of
holster (205) described above. Alternatively, encoder assembly
(340) may be configured and/or used in any other suitable fashion,
if not omitted altogether.
[0120] D. Exemplary Alternative Tissue Sample Holder
[0121] A probe (105) that is coupled with holster (305) may have
tissue sample holder (140) described above. Alternatively, as shown
in FIG. 18, cup (141) of tissue sample holder (140) may be
substituted with a split removable cup assembly (641), which may be
coupled with probe (105) and holster (305), to provide an
alternative tissue sample holder (640). Split removable cup
assembly (641) of this example comprises a rotating cup (655) that
attaches to probe (105) over manifold (144). Cup (655) is manually
operable to rotate manifold (144) in this example. A locking ring
(650) releasably attaches to probe (105), and rotatingly secures
cup (655) to probe (105). In particular, locking ring (650) secures
cup (655) to probe (105) while permitting cup (655) to rotate
relative to locking ring (650) and probe (105). For instance, cup
(655) and locking ring (650) may include complementary annular
flanges (not shown) or other features to restrict longitudinal
motion of cup (655) relative to locking ring (650). Locking ring
(105) does not move relative to probe (105) while cup (655) rotates
in this example.
[0122] Rotating cup (655) has a proximal end wall (656) and a
sidewall (657). Sidewall (657) and/or proximal end wall (656) may
provide a grasping portion for the operator to grasp. Such a
grasping portion may include texture, bumps, ridges, or any other
features to enhance grasping of the grasping portion and rotation
of rotating cup (655). Alternatively, a feature such as an integral
knob or other protrusion may extend proximally from proximal end
wall (656). A vacuum or fluid seal (660) is placed between locking
ring (650) and rotating cup (655), and maintains fluid or vacuum
integrity therebetween, both when cup (655) is rotated relative to
ring (650) and when cup (655) is stationary relative to ring (650).
Locking ring (650) may be configured with the previously described
bayonet coupling (134) as shown in FIG. 3 for use as a releasable
attachment mechanism to probe (105). Alternatively, any other
suitable structures or configurations may be used.
[0123] Split removable cup assembly (641) is further configured
with one or more inward extending drive members (658) to drivably
engage with rotatable manifold (144), and when engaged, to rotate
therewith. Drive member (658) may comprise a keyed pin, a "D"
shaft, a hex shaft, or any other suitable structure, and may extend
inward from an inside surface of proximal end wall (656) to
drivingly engage with a drive hole (670) within rotatable manifold
(144). When split removable cup assembly (641) is attached to bring
drive member (658) into engagement with drive hole (670), and when
manifold (144) rotates, rotating cup (655) rotates therewith.
Conversely, as described in detail below, rotation of rotating cup
(655) may rotate manifold (144).
[0124] As described above, gear (170) is secured to manifold (144),
such that gear (170) and manifold (144) rotate unitarily. As also
described above, and with reference to FIG. 15, gear (170) is
coupled with thumbwheel (60) via gears (358, 357, 356, 355, 350)
and shafts (359, 353), such that gear (170) and thumbwheel rotate
concomitantly. As also described above, and with reference to FIGS.
5-6, thumbwheel (60) is secured to cannula (12), such that rotation
of thumbwheel (60) rotates cannula (12) (e.g., to angularly
reorient aperture (16)). Accordingly, those of ordinary skill in
the art will appreciate that an operator may manually rotate cup
(655) to rotate cannula (12) (e.g., to angularly reorient aperture
(16)).
[0125] To assemble split removable cup assembly (641), cup (655)
may be placed over rotatable manifold (144) to engage drive member
(658) of cup (655) with drive hole (670) in rotatable manifold
(144). Once drive member (658) is engaged with drive hole (670),
locking ring (650) may be secured to probe (105) by rotating
locking ring (650) to engage bayonet coupling (134). In this
configuration, rotation of thumbwheel (60) on probe (105) will
rotate needle portion (10), manifold (144), and rotating cup (655).
If desired, the operator may rotate needle portion (10) by manually
rotating the rotating cup (655).
[0126] Of course, a variety of other components, features,
structures, and configurations may be used in addition to or in
lieu of split removable cup assembly (641). By way of example only,
manifold (144) may be fitted with an integral and proximally
extending knob (not shown) or other feature that protrudes through
cup (141). Cup (141) may accommodate such a knob or other feature
with a seal, such that the knob or other feature may rotate
relative to cup (141) without causing loss of vacuum or fluids. In
such versions, it will be understood that the operator may rotate
needle portion (10) by manually rotating the knob or other feature
that extends proximally from manifold (144) through cup (141). In
some other variations, tissue sample holder (140) is configured in
accordance with any of the teachings of U.S. Non-Provisional patent
application Ser. No. 12/337,911, entitled "BIOPSY DEVICE WITH
DISCRETE TISSUE CHAMBERS," filed on Dec. 18, 2008, the disclosure
of which is incorporated by reference herein. Still other suitable
components, features, structures, and configurations that may be
used to permit rotation of needle portion from a tissue sample
holder (140) will be apparent to those of ordinary skill in the art
in view of the teachings herein.
[0127] E. Exemplary Method of Use of the Second Exemplary Biopsy
Device
[0128] In a merely exemplary use of biopsy device (101), biopsy
device (101) is assembled by operably coupling probe (105) with
holster (305) and then operably coupling the assembled biopsy
device (101) with vacuum control module (500). With probe (105)
attached to holster (305), thumbwheel (60) is rotatingly engaged
with the tissue holder rotational mechanism (340) in holster (305),
and is therefore rotatingly engaged with rotatable manifold (144)
within tissue sample holder (140). Furthermore, with probe (105)
attached to holster (305), gears (338, 84) are coupled such that
cutter drive mechanism (310) within holster (350) is operably
engaged with cutter (50) within the probe (105). With the cable
driven cutter drive mechanism (310) operably engaged with cutter
(50), homing routines may be performed, if required or desired, to
identify a "home" position of cutter (50) within probe (105).
[0129] An operator then places biopsy device (101) into a grasping
hand (1000) and/or couples biopsy device (101) with a fixture or
targeting set. Needle portion (10) is then inserted into a
patient's breast or elsewhere. The operator then rotates thumbwheel
(60) with a thumb or other finger to achieve a desired angular
orientation of aperture (16). Such rotation will also cause
rotation of manifold (144). The operator then actuates cutter (50)
to acquire a tissue sample, which is communicated to a tissue
sample chamber (166) in tissue sample holder (140) via cutter lumen
(52) and tissue sample passage (54). With needle portion (10) still
inserted in the patient, the operator rotates thumbwheel (60) to
simultaneously reorient aperture (16) and index another tissue
sample chamber (166) to tissue sample passage (54). The operator
then actuates cutter (50) to acquire another tissue sample. This
process may be repeated until a desired number of tissue samples
are obtained at a desired number of angular orientations about the
axis defined by needle portion (10). Of course, biopsy device (101)
may alternatively be used in any other desired fashion.
III. Third Exemplary Holster
[0130] FIGS. 19-20 show another exemplary holster (705). Holster
(705) of this example is configured for use in a stereotactic
setting. By way of example only, holster (705) may be coupled with
probe (105), with a probe as described in U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein, or with any other suitable probe.
Holster (705) comprises a top housing member (707), a bottom
housing member (708), and a needle firing fork (790). Needle firing
form (790) is positioned on the distal end of a needle firing shaft
(710), which extends distally from holster (705). Holster (705)
further comprises hook members (714), which extend from top housing
member (707), and which may removably secure probe (105) to holster
(705).
[0131] Top housing member (707) further comprises a recess (704)
exposing a thumbwheel gear (750). Thumbwheel gear (750) is
configured to mesh with thumbwheel (60) when probe (105) is coupled
with holster (705). In particular, thumbwheel gear (750) is
operable to rotate in response to manual rotation of thumbwheel
(60) when probe (105) is coupled with holster (705). A tissue
holder drive gear (751) extends from a proximal end of holster
(705). Gear (751) is configured to mesh with gear (170) of tissue
sample holder (140). In particular, gear (751) is operable to
rotate manifold (144) of tissue sample holder (140) when probe
(105) is coupled with holster (705), in the manner described
above.
[0132] A linking mechanism (740) links thumbwheel gear (750) with
gear (751). In particular, linking mechanism (740) is configured to
cause gear (751) to rotate in response to rotation of thumbwheel
gear (750). Linking mechanism (740) of this example comprises a
shaft (720) extending proximally from thumbwheel gear (750).
Another gear (722) is fixed to shaft (720). Gear (722) thus rotates
with shaft (720) and with gear (750). Gear (722) also meshes with
gear (724), which also meshes with gear (726). Gear (726) thus
rotates with gears (722, 724). A shaft (728) extends proximally
from gear (726). Another gear (730) is fixed to shaft (728). Gear
(730) thus rotates with shaft (728) and with gear (726). Gear (730)
also meshes with gear (732). A shaft (734) extends proximally from
gear (732). Another gear (736) is fixed to shaft (734). Gear (736)
thus rotates with shaft (734) and with gears (730, 732). Gear (736)
also meshes with gear (738), which also meshes with gear (740).
Gear (740) thus rotates with gears (736, 738). A shaft (742)
connects gear (740) with gear (751). Accordingly, thumbwheel gear
(750) is coupled with gear (751) via gears (722, 724, 726, 730,
732, 736, 738, 740) and shafts (720, 728, 734, 742). Linking
mechanism (740) is thus similar to tissue holder rotational
mechanism (340) of holster (305). Of course, other suitable
components, features, configurations, and methods of operation for
a linking mechanism (740) such as the one in holster (705) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0133] It should also be understood that a probe (105) with tissue
sample holder (640) may be coupled with holster (705). In such a
version, rotation of cup (655) may cause rotation of needle portion
(10) as described above, via linking mechanism (740) or
otherwise.
[0134] A cutter drive mechanism (not shown) is also provided within
holster (705). In particular, the cutter drive mechanism is
operable to rotate gear (238), which is exposed through top housing
member (707). Gear (238) is configured to mesh with gear (85) when
probe (105) is coupled with holster (705). Accordingly, rotation of
gear (238) causes concomitant rotation and translation of cutter
(50) when probe (105) is coupled with holster (705). Exemplary
components, features, configurations, and methods of operation for
a cutter drive mechanism such as the one in holster (705) are
described in U.S. Pub. No. 2008/0195066, entitled "Revolving Tissue
Sample Holder For Biopsy Device," published Aug. 14, 2008, the
disclosure of which is incorporated by reference herein. Other
suitable components, features, configurations, and methods of
operation for a cutter drive mechanism such as the one in holster
(705) will be apparent to those of ordinary skill in the art in
view of the teachings herein.
[0135] A needle firing mechanism (not shown) is also provided
within holster (705). In particular, the needle firing mechanism is
operable to cause shaft (710) and fork (790) to translate
longitudinally relative to holster (705). Fork (790) is configured
to engage needle portion (10), such that needle portion (10) will
translate longitudinally with shaft (710) and fork (790) when probe
(105) is coupled with holster (705). Suitable modifications to
probe (105) to permit needle portion (10) to translate
longitudinally relative to other components of probe (105) will be
apparent to those of ordinary skill in the art in view of the
teachings herein. Alternatively, any probe disclosed in U.S. Pub.
No. 2008/0195066, entitled "Revolving Tissue Sample Holder For
Biopsy Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein, may have its needle portion
coupled with and translated by fork (790). In either case, such
firing of needle portion (10) may be desired to forcibly urge
needle portion (10) into breast tissue or other tissue. Exemplary
components, features, configurations, and methods of operation for
a needle firing mechanism such as the one in holster (705) are
described in U.S. Pub. No. 2008/0195066, entitled "Revolving Tissue
Sample Holder For Biopsy Device," published Aug. 14, 2008, the
disclosure of which is incorporated by reference herein. Other
suitable components, features, configurations, and methods of
operation for a needle firing mechanism such as the one in holster
(705) will be apparent to those of ordinary skill in the art in
view of the teachings herein.
IV. Fourth Exemplary Holster
[0136] FIGS. 21-22 show another exemplary holster (805), coupled
with a probe (806). Probe (806) of this example is constructed in
accordance with the teachings of U.S. Pub. No. 2008/0195066,
entitled "Revolving Tissue Sample Holder For Biopsy Device,"
published Aug. 14, 2008, the disclosure of which is incorporated by
reference herein. Alternatively, holster (805) may be configured to
couple with probe (105) or with any other suitable probe. Probe
(806) of the present example comprises a needle portion (10) that
has a tissue receiving aperture (16), like probe (105) described
above. Probe (806) of the present example also has a rotatable
tissue sample holder (140), like probe (105) described above.
[0137] Holster (805) of the present example comprises hook members
(814) that are configured to removably secure probe (806) to
holster (805). Holster (805) further comprises gears (850, 838) and
inclined thumbwheels (810). Gear (850) is configured to mesh with a
needle gear (not shown) of probe (806). Such a needle gear is
secured to needle portion (10) of probe (806) such that needle
portion (10) rotates with the needle gear. Examples of such a
needle gear are disclosed in U.S. Pub. No. 2008/0195066, entitled
"Revolving Tissue Sample Holder For Biopsy Device," published Aug.
14, 2008, the disclosure of which is incorporated by reference
herein, though any other types of needle gears may be used.
[0138] Gear (838) is configured to mesh with a cutter gear (not
shown) of probe (806). In particular, probe (806) comprises a
cutter rotation and translation mechanism (80) like probe (105),
which presents the cutter gear through the bottom of probe. The
cutter rotation and translation mechanism is operable to rotate and
translate a cutter (50) within needle portion (10). Gear (838) is
thus operable to actuate a cutter (50) within needle portion (10)
of probe (806). A motor (not shown) or other mechanism may be
provided within holster (805) to drive gear (838). Alternatively,
gear (838) may be driven by a cable (217), such as in a manner
similar to cable (217) driven techniques described herein.
[0139] The proximal end of holster (805) may also present a tissue
sample holder rotation gear (not shown), which may be configured to
mesh with a gear (170) of tissue sample holder (140) when probe
(806) is coupled with holster (805).
[0140] Thumbwheels (810) are coupled with gear (850) in this
example, such that thumbwheels (810) may be used to rotate needle
portion (10). In particular, holster (805) includes a linking
mechanism (not shown) that links thumbwheels (810) with gear (850),
such that rotation of either thumbwheel (810) causes concomitant
rotation of needle portion (10). Suitable components, features, and
configurations of such a linking mechanism will be apparent to
those of ordinary skill in the art in view of the teachings herein.
By way of example only, such a linking mechanism may include a
plurality of gears (e.g., one or more bevel gears), shafts, and/or
universal joints. Such a linking mechanism may also be constructed
similar to other such linking mechanisms described herein.
[0141] It should also be understood that thumbwheels (810) may be
coupled with a tissue sample holder rotation gear of holster (805).
In particular, thumbwheels (810) may be linked with a tissue sample
holder rotation gear such that rotation of either thumbwheel (810)
causes concomitant rotation of manifold (144) within tissue sample
holder (140). Such coupling may be provided by the same linking
mechanism noted above, which couples thumbwheels (810) with gear
(850), or by some other linking mechanism. Again, suitable
components, features, and configurations for coupling thumbwheels
(810) with a tissue sample holder rotation gear will be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0142] In some versions of holster (805), one thumbwheel (810) is
linked with gear (850), while the other thumbwheel (810) is linked
with a tissue sample holder rotation gear. Holster (805) may thus
have two or more linking mechanisms, which may be either
mechanically independent of each other or somehow
interdependent.
V. Fifth Exemplary Holster
[0143] FIG. 23 shows yet another exemplary holster (905). Holster
(905) of this example may be coupled with probe (806), probe (105),
or any other suitable probe. Holster (905) comprises hook members
(914) that are configured to removably secure probe (806, 105) with
holster (905). Holster (905) further comprises gears (950, 938,
951), portions of which are exposed by holster (905). Gear (950) is
configured to mesh with a needle gear (not shown) of probe (806).
Such a needle gear is secured to needle portion (10) of probe (806)
such that needle portion (10) rotates with the needle gear.
Examples of such a needle gear are disclosed in U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein, though any other types of needle
gears may be used.
[0144] Gear (938) is configured to mesh with a cutter gear (not
shown) of probe (806). In particular, probe (806) comprises a
cutter rotation and translation mechanism (80) like probe (105),
which presents the cutter gear through the bottom of probe. The
cutter rotation and translation mechanism is operable to rotate and
translate a cutter (50) within needle portion (10). Gear (938) is
thus operable to actuate a cutter (50) within needle portion (10)
of probe (806). A motor (not shown) or other mechanism may be
provided within holster (905) to drive gear (938). Alternatively,
gear (938) may be driven by a cable (217), such as in a manner
similar to cable (217) driven techniques described herein.
[0145] The proximal end of holster (905) also presents tissue
sample holder rotation gear (951), which is configured to mesh with
a gear (170) of tissue sample holder (140) when probe (806) is
coupled with holster (905).
[0146] A remote control (975) is coupled with holster (905) in this
example via a flexible drive cable assembly (980). Drive cable
assembly (980) comprises a drive cable (not shown), much like drive
cable (217) described above, with a surrounding sheath. In
particular, the drive cable of drive cable assembly (980) is
operable to communicate rotary motion from remote control (975) to
holster (905). Drive cable assembly (980) is also flexible, such
that the drive cable of drive cable assembly (980) may still
communicate rotary motion to holster (905) even while being flexed,
without binding. Remote control (975) comprises a manually
rotatable thumbwheel (976) that is coupled with the drive cable of
drive cable assembly (980). In particular, manual rotation of
thumbwheel (976) rotates the drive cable of drive cable assembly
(980).
[0147] Thumbwheel (976) and the drive cable of drive cable assembly
(980) are coupled with gear (950) in this example, such that
thumbwheel (976) may be used to rotate needle portion (10) of a
probe (806, 105) that is coupled with holster (905). In particular,
holster (905) includes a linking mechanism (not shown) that links
thumbwheel (976) and the drive cable of drive cable assembly (980)
with gear (950), such that rotation of thumbwheel (976) causes
concomitant rotation of needle portion (10). Suitable components,
features, and configurations of such a linking mechanism will be
apparent to those of ordinary skill in the art in view of the
teachings herein. By way of example only, such a linking mechanism
may include a plurality of gears (e.g., one or more bevel gears),
shafts, and/or universal joints. Such a linking mechanism may also
be constructed similar to other such linking mechanisms described
herein.
[0148] It should also be understood that thumbwheel (976) and the
drive cable of drive cable assembly (980) may be coupled with
tissue sample holder rotation gear (951). In particular, thumbwheel
(976) and the drive cable of drive cable assembly (980) may be
linked with tissue sample holder rotation gear (951) such that
rotation of thumbwheel (976) causes concomitant rotation of
manifold (144) within tissue sample holder (140) of a probe (806,
105) that is mounted to holster (905). Such coupling may be
provided by the same linking mechanism noted above, which couples
thumbwheel (976) with gear (950), or by some other linking
mechanism. Again, suitable components, features, and configurations
for coupling thumbwheel (976) with a tissue sample holder rotation
gear will be apparent to those of ordinary skill in the art in view
of the teachings herein
[0149] It should also be understood that drive cable assembly (980)
may be of any suitable length. For instance, drive cable assembly
(980) may be less than one foot long, four feet long, ten feet
long, or any other suitable length.
VI. Exemplary Vacuum Control Module and Canister
[0150] As shown in FIG. 1, an exemplary vacuum canister (600) is
configured to be coupled vacuum control module (500). Vacuum
control module (500) is operable to induce a vacuum through vacuum
canister (600), and such a vacuum may be communicated to probe
(105) via tubes (502, 504). For instance, vacuum control module
(500) may communicate a vacuum through tube (502), which may then
communicate the vacuum through tissue sample holder (140) to cutter
lumen (52) as described above. Vacuum control module (500) may also
communicate a vacuum through tube (504) to manifold (70), which may
then communicate the vacuum to vacuum lumen (40) as described
above.
[0151] Furthermore, vacuum canister (600) is operable to collect
fluids that are communicated from biopsy probe (105) during use of
biopsy probe (105). Vacuum canister (600) may thus be regarded as
providing a fluid interface between biopsy probe (105) and vacuum
control module (500). Any suitable vacuum control module and vacuum
canister may be used such as those described in U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein. Further, any other suitable
component, system, technique, or device may be used with the
suitable control module or vacuum canister.
[0152] As noted above, vacuum control module (500) of the present
example also includes a motor (503) that is operable to rotate
cable (217), such as to actuate cutter (50) as described above. By
way of example only, motor (503) may be associated with vacuum
control module (400) as taught in U.S. Non-Provisional patent
application Ser. No. 12/337,814, entitled "CONTROL MODULE
INTERFACE," filed on Dec. 18, 2008, the disclosure of which is
incorporated by reference herein. Of course, the features and
functionality of vacuum control module (500) and vacuum canister
(600) as described herein are mere examples.
VII. Exemplary Modes of Operation
[0153] It will be appreciated in view of the disclosure herein that
there are a variety of methods by which biopsy system (2) may be
operated. For instance, regardless of the structures or techniques
that are used to selectively control communication of fluid (e.g.,
saline, vacuum, venting, etc.), through conduits (501) or otherwise
within biopsy system (2), there are a variety of timing algorithms
that may be used. Such timing algorithms may vary based on an
operational mode selected by a user. Furthermore, there may be
overlap among operational modes (e.g., biopsy system (2) may be in
more than one operational mode at a given moment, etc.). In
addition to fluid communication timing algorithms being varied
based on a selected mode of operation, other operational aspects of
biopsy system (2) may vary based on a selected operational mode.
Several merely exemplary operational modes exist, while others will
be apparent to those of ordinary skill in the art in view of the
teachings herein. Any suitable operational mode may be used include
for example any suitable mode disclosed in U.S. Pub. No.
2008/0195066, entitled "Revolving Tissue Sample Holder For Biopsy
Device," published Aug. 14, 2008, the disclosure of which is
incorporated by reference herein.
[0154] One exemplary operation of biopsy system (2) will now be
explained where needle portion (10) has been inserted into the
breast of a patient. With needle portion (10) inserted, lateral and
axial vacuum are applied. In particular, a vacuum is communicated
through tubes (502, 504). Given the fluid connection of tube (504)
with vacuum lumen (40) of outer cannula (12), communication of a
vacuum through tube (504) will draw a lateral vacuum relative to
cannula lumen (20). Communication of a vacuum through tube (502)
will draw an axial vacuum through cutter lumen (52), given the
fluid connection of tube (502) to cutter lumen (52) via tissue
sample holder (140) and passage (54) in this example.
[0155] With the axial and lateral vacuum applied as described
above, cutter (50) is retracted axially. The axial retraction of
cutter (50) will serve to "open" aperture (16), which results in
tissue prolapsing into aperture (16) under the influence of the
above-described vacuums. Cutter (50) may dwell in a retracted
position for a certain period of time to ensure sufficient prolapse
of tissue.
[0156] Next, cutter (50) is advanced distally to sever tissue that
is prolapsed through aperture (16). As the distal end of cutter
(50) passes the distal edge of aperture (16), such that cutter (50)
"closes" aperture (16), the prolapsed tissue should be severed and
at least initially contained within cutter lumen (52). Transverse
openings (32) should be configured such that at least one or more
of openings (32) are not covered by cutter (50) when cutter (50)
has reached a position to "close" aperture (16). With aperture (16)
closed and a vent being provided by transverse openings (32)
through tube (504), an axial vacuum being communicated through
cutter lumen (52) by tube (502) should draw the severed tissue
sample proximally through cutter lumen (52) and into a tissue
sample chamber (166) of tissue sample holder (140). Cutter (50) may
be reciprocated one or more times through a slight range of motion
at a distal position to sever any remaining portions that may have
not been completely severed in the first pass of cutter (50).
[0157] Before tissue sample is communicated proximally through
cutter lumen (52), with aperture (16) being closed by cutter (50),
vacuum lumen (40) being vented by tube (504), and an axial vacuum
being provided by tube (502) via cutter lumen (52), cutter (50) is
retracted slightly to expose a portion of aperture (16) for a short
period of time. During this time, saline may be provided at
atmospheric pressure to vacuum lumen (40) by tube (504). Further
retraction of cutter (50) exposes more transverse openings (32),
thereby increasing fluid communication between vacuum lumen (40)
and cannula lumen (20). Retraction of cutter (50) also exposes the
pressure of the tissue cavity (from which tissue sample was
obtained) to the distal surface of tissue sample. As a result of
the slight retraction of cutter (50) in this particular example,
the likelihood of atmospheric pressure being applied to the distal
face of tissue sample may be increased to help ensure that severed
tissue sample does not remain in needle portion (10) (a.k.a. a "dry
tap"). Cutter (50) is then fully advanced distally, closing both
aperture (16) and all transverse openings of outer cannula (12).
Such "closure" of transverse openings may ensure that if medication
is applied at this time (between samples) to reduce pain, it will
reach the breast cavity through external openings in outer cannula
(12) instead of being aspirated through transverse openings and
through cutter lumen (52) and tissue sample holder (140).
[0158] With the cutter (50) being completely advanced (e.g., such
that all transverse openings and aperture (16) are closed), and
severed tissue sample being communicated proximally through cutter
lumen (52) and into a tissue sample chamber (166) by an axial
vacuum drawn by tube (502), biopsy device (100) will be in a ready
state. In this ready state, vacuum lumen (40) is vented to
atmosphere, and axial vacuum tube (502) is sealed (a.k.a.
"dead-headed").
[0159] Other suitable components of, features of, configurations
of, and methods of operating biopsy system (2) are disclosed in
U.S. Pub. No. 2008/0195066, entitled "Revolving Tissue Sample
Holder For Biopsy Device," published Aug. 14, 2008, the disclosure
of which is incorporated by reference herein. Still other suitable
components of, features of, configurations of, and methods of
operating biopsy system (2) will be apparent to those of ordinary
skill in the art in view of the teachings herein.
[0160] 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.
[0161] Embodiments of the present invention have application in
conventional endoscopic and open surgical instrumentation as well
as application in robotic-assisted surgery.
[0162] 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.
[0163] 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.
[0164] Having shown and described various embodiments of the
present invention, further adaptations of the methods and systems
described herein may be accomplished by appropriate modifications
by one of ordinary skill in the art without departing from the
scope of the present invention. Several of such potential
modifications have been mentioned, and others will be apparent to
those skilled in the art. For instance, the examples, embodiments,
geometrics, materials, dimensions, ratios, steps, and the like
discussed above are illustrative and are not required. Accordingly,
the scope of the present invention should be considered in terms of
the following claims and is understood not to be limited to the
details of structure and operation shown and described in the
specification and drawings.
* * * * *