U.S. patent application number 17/036732 was filed with the patent office on 2021-01-14 for biopsy devices and methods of use thereof.
The applicant listed for this patent is Covidien LP. Invention is credited to Graham J. CARSON, Kasey GRIM, Suchit A. MADAN, James S. F. MCGRATH, Joan ORTEGA ALCAIDE, Joe SARTOR.
Application Number | 20210007708 17/036732 |
Document ID | / |
Family ID | 1000005117692 |
Filed Date | 2021-01-14 |
View All Diagrams
United States Patent
Application |
20210007708 |
Kind Code |
A1 |
GRIM; Kasey ; et
al. |
January 14, 2021 |
BIOPSY DEVICES AND METHODS OF USE THEREOF
Abstract
A biopsy device includes an ultrasonic probe, a display, an
actuator, and a needle assembly. The display is associated with the
ultrasonic probe, and the ultrasonic probe is configured to send a
signal to the display to generate an image on the display. The
needle assembly is coupled to the actuator and is at least
partially disposed within a channel defined in the ultrasonic
probe. The actuator is configured to move the needle assembly in a
distal direction relative to the ultrasonic probe and through the
channel of the ultrasonic probe from a retracted position to a
deployed position.
Inventors: |
GRIM; Kasey; (Boulder,
CO) ; MCGRATH; James S. F.; (Broomfield, CO) ;
MADAN; Suchit A.; (Boulder, CO) ; ORTEGA ALCAIDE;
Joan; (Barcelona, ES) ; SARTOR; Joe;
(Longmont, CO) ; CARSON; Graham J.; (Louisville,
CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Covidien LP |
Mansfield |
MA |
US |
|
|
Family ID: |
1000005117692 |
Appl. No.: |
17/036732 |
Filed: |
September 29, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15490963 |
Apr 19, 2017 |
10786224 |
|
|
17036732 |
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|
62325788 |
Apr 21, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 10/0283 20130101;
A61B 2017/3413 20130101; A61B 8/462 20130101; A61B 8/4444 20130101;
A61B 17/3403 20130101; A61B 8/0841 20130101; A61B 2010/0208
20130101; A61B 10/0266 20130101; A61B 8/445 20130101 |
International
Class: |
A61B 8/08 20060101
A61B008/08; A61B 10/02 20060101 A61B010/02; A61B 8/00 20060101
A61B008/00; A61B 17/34 20060101 A61B017/34 |
Claims
1. A method of performing a biopsy, comprising: positioning a
biopsy device in proximity to target tissue; generating an image of
the target tissue on a display of the biopsy device using an
ultrasonic probe of the biopsy device; aligning a needle of a
needle assembly that is disposed within the ultrasonic probe with
the target tissue using the image of the target tissue generated on
the display; and deploying the needle of the needle assembly from
the ultrasound probe into the target tissue, thereby capturing a
tissue sample from the target tissue in the needle.
2. The method of claim 1, wherein aligning the needle with the
target tissue includes moving the biopsy device relative to the
target tissue into a position in which a projected needle pathway
animated on the display is in line with the image of the target
tissue on the display.
3. The method of claim 2, wherein deploying the needle into the
target tissue includes guiding the needle into the target tissue
along the projected needle pathway.
4. The method of claim 1, further comprising automatically
capturing an image of the needle of the needle assembly with the
tissue sample disposed therein.
5. The method of claim 1, further comprising abutting a force
sensor of the biopsy device with a tissue surface to determine a
resistance of the target tissue prior to deploying the needle into
the target tissue.
6. The method of claim 1, further comprising applying a negative
pressure to the needle assembly to draw the tissue sample into a
containment chamber defined in the needle assembly.
7. The method of claim 6, wherein the negative pressure is applied
using at least one of hydraulics or a vacuum.
8. The method of claim 1, further comprising automatically
retracting the needle into the ultrasound probe after deploying the
needle of the needle assembly from the ultrasound probe into the
target tissue.
9. The method of claim 8, wherein during deployment of the needle,
a leg of the needle assembly advances to disengage an inner sheath
of the biopsy device from a housing of the biopsy device and
axially fixes the inner sheath with the needle assembly such that
the inner sheath and the needle assembly automatically retract
together as one unit.
10. The method of claim 9, wherein the leg of the needle assembly
disengaging the inner sheath from the housing includes releasing a
tab of the inner sheath from a stop of the housing.
11. The method of claim 10, wherein axially fixing the inner sheath
with the needle assembly includes matingly engaging the leg of the
needle assembly with the tab of the inner sheath.
12. The method of claim 9, wherein the needle is automatically
retracted by a biasing member that exerts a proximally-oriented
force on the inner sheath.
13. The method of claim 1, further comprising rotating a collar of
the biopsy device from a first orientation to a second orientation
prior to deploying the needle, the collar and the needle assembly
are axially movable with one another when the collar is in the
first orientation, and the needle assembly is axially movable
relative to the collar when the collar is in the second
orientation.
14. The method according to claim 1, further comprising advancing
the needle assembly from a retracted position to an intermediate,
pre-fired position, wherein the needle is deployed from the
intermediate, pre-fired position.
15. A method of performing a biopsy, comprising: positioning a
biopsy device in proximity to target tissue; generating an image of
the target tissue on a display using an ultrasonic probe of the
biopsy device; aligning a needle of a needle assembly of the biopsy
device with the target tissue using the image of the target tissue
generated on the display; advancing the needle of the needle
assembly through the ultrasound probe into the target tissue,
thereby capturing a tissue sample from the target tissue in the
needle; and automatically retracting the needle into the biopsy
device upon capturing the tissue sample from the target tissue.
16. The method of claim 15, wherein during the advancing of the
needle, an inner sheath of the biopsy device is transitioned from a
first state, in which the inner sheath is axially fixed within the
biopsy device and the needle is axially movable relative to the
inner sheath, to a second state, in which the inner sheath is
axially movable within the biopsy device and axially fixed with the
needle.
17. The method of claim 16, wherein the needle is automatically
retracted by a biasing member that exerts a proximally-oriented
force on the inner sheath, the needle automatically retracting
after the inner sheath transitions to the second state.
18. The method of claim 17, wherein during advancement of the
needle, a leg of the needle assembly advances to simultaneously
release a tab of the inner sheath from a stop of the biopsy device
and matingly engage the tab of the inner sheath such that the inner
sheath and the needle assembly automatically retract together as
one unit.
19. The method of claim 15, further comprising rotating a collar of
the biopsy device from a first orientation to a second orientation
prior to advancing the needle, the collar and the needle assembly
are axially movable with one another when the collar is in the
first orientation, and the needle assembly is axially movable
relative to the collar when the collar is in the second
orientation.
20. The method according to claim 19, further comprising advancing
the needle assembly from a retracted position to an intermediate,
pre-fired position while the collar is in the first orientation,
wherein the needle is deployed from the intermediate, pre-fired
position after the collar is rotated to the second orientation.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 15/490,963, filed on Apr. 19, 2017, which
claims the benefit of and priority to U.S. Provisional Patent
Application No. 62/325,788, filed on Apr. 21, 2016, the entire
contents of each of which are incorporated by reference herein,
BACKGROUND
TECHNICAL FIELD
[0002] The present disclosure relates to biopsy sampling and, more
particularly, to biopsy devices, biopsy systems, and methods for
navigating a biopsy device to a target location and obtaining a
tissue sample using the biopsy device.
DESCRIPTION OF RELATED ART
[0003] To successfully treat cancer, it is critical to diagnose
cancer at an early stage. Various methods are used to identify the
existence of abnormalities in tissue prior to a patient being
symptomatic. For example, women regularly go for prophylactic
mammograms to determine whether there are any early stage tumors
developing in their breast tissue. Although mammography is
effective at identifying whether a tumor is present, mammography is
not capable of differentiating between benign and malignant tumors.
Accordingly, upon identifying an abnormality in the tissue, the
status of the abnormality needs to be determined using additional
diagnostic technique.
[0004] One method to verify whether a tissue is cancerous is to
obtain a tissue sample for histological examination through a
biopsy of the tissue (e.g., breast tissue) near the lesion. There
are a number of devices and methods for performing a biopsy. In
some instances, a tumor may be identified using manual palpation of
the breast tissue and then a biopsy needle may be positioned over
the identified tumor to take a sample of tissue. Another method
involves holding an ultrasound probe in one hand while holding the
biopsy needle h a second hand and guiding the biopsy needle along
the image plane of the ultrasound probe.
[0005] Proper placement of the biopsy needle in the target tissue
is important for accurate breast cancer diagnosis. As already
noted, traditional breast biopsy techniques involve blind, manual
palpation of the lesion or the use of a separate imaging guidance
system. Small lumps of cancerous tissue may be mobile, and
therefore may be pushed away by the biopsy device during insertion
of the biopsy device into the target tissue. Some tissue may be
hard, and therefore may deflect the biopsy device during insertion
into the target tissue, resulting in the clinician removing tissue
samples from only a small portion of the side of the target
tissue.
SUMMARY
[0006] Provided in accordance with the present disclosure is a
biopsy device including an ultrasonic probe, a display, an
actuator, and a needle assembly. The display is associated with the
ultrasonic probe, and the ultrasonic probe is configured to send a
signal to the display to generate an image on the display. The
needle assembly is coupled to the actuator and is at least
partially disposed within a channel defined in the ultrasonic
probe. The actuator is configured to move the needle assembly in a
distal direction relative to the ultrasonic probe and through the
channel of the ultrasonic probe from a retracted position to a
deployed position.
[0007] In some embodiments, the ultrasonic probe may be configured
to capture images of the target lesion and the needle position at
the extent of travel or at the instance the sample is captured
within the needle. The biopsy device may include a processor for
storing the image and transferring a memory and the needle
assembly, or otherwise transmitting the image with reference, to
the needle assembly specific ID.
[0008] The biopsy device is contemplated to have a sterile cover to
prevent the ultrasonic probe from contacting the skin of the
patient. The sterile cover may have a window for the ultrasonic
sensor. The window may be composed of a silicone, plastic and/or
gel material and may be ultrasonically conductive. The silicone or
ultrasonically conductive material may have sufficient thickness to
include a majority of a depth of a shadow formed by the gap or hole
in the sensor through which the needle passes.
[0009] In embodiments, the needle assembly may be a selectively
attachable cartridge that may be composed of a coring needle or a
needle assembly with a notched core and a sliding sleeve. The
needle may be safely positioned inside the cartridge preventing
unintended contact that could result in a puncture to the user or
loss of sterilization of the needle surface. The cartridge may have
a unique ID that is traceable to the pathologic outcomes by
transmitting the ID by electronic means to the handle processor or
a connected patient record system.
[0010] In some methods, a verification image of the biopsy may be
captured as proof that the needle successfully captured the tissue.
The cartridge is extracted with the captured portion of tissue to a
location for pathologic analysis along with the captured ultrasonic
imaging confirming the biopsy location.
[0011] In most aspects of the present disclosure, the disclosed
biopsy devices are designed to enable the user to target and
execute a biopsy with a single hand. The second hand is free for
manipulating the breast tissue to control the target location, and
bunch or flatten the tissue as needed to achieve appropriate needle
depth rather than adjusting the needle depth within the device.
[0012] In some embodiments, the ultrasonic probe may define a
longitudinal axis therealong. The ultrasonic probe emits ultrasonic
waves such that the movement of the needle assembly from the
retracted position toward the deployed position aligns with the
ultrasonic waves. The ultrasonic probe may be configured to send
signals to the display corresponding to a position of a needle of
the needle assembly to generate an image on the display of the
position of the needle of the needle assembly.
[0013] It is contemplated that the needle assembly may include a
hub and a needle extending distally from the hub. The actuator may
be configured to rotate the needle about a longitudinal axis
thereof after the needle assembly is moved from the retracted
position to the deployed position.
[0014] It is envisioned that the needle assembly may include a body
that defines a chamber therein, and a needle extending distally
from the body. The biopsy device may further include a tube
extending alongside the needle.
[0015] In some embodiments, the biopsy device may further include
an adjustment mechanism movably coupled to the ultrasonic probe and
configured to adjust and set a needle depth of the needle assembly
such that an actuation of the actuator moves the needle assembly
from the retracted position to the deployed position a longitudinal
distance corresponding to the needle depth set by the adjustment
mechanism.
[0016] It is contemplated that the ultrasonic probe may include a
distal cap defining a central opening having a needle of the needle
assembly extending therethrough. The distal cap may have a window
for conducting ultrasound waves therethrough.
[0017] It is envisioned that the biopsy device may include a force
sensor coupled to a distal end portion of the ultrasonic probe and
extending distally beyond a distal end portion of the needle
assembly when disposed in the retracted position. The ultrasonic
probe may include an annular member extending distally from the
distal end portion thereof. The force sensor may include a
plurality of force sensors disposed in an annular array on the
annular member.
[0018] In another aspect of the present disclosure, a method of
performing a biopsy is provided. The method includes positioning a
biopsy device in proximity to target tissue; generating an image of
the target tissue on a display of the biopsy device using an
ultrasonic probe of the biopsy device; aligning a needle of a
needle assembly that is disposed within the ultrasonic probe with
the target tissue using the image of the target tissue generated on
the display; and deploying the needle of the needle assembly from
the ultrasound probe into the target tissue, thereby capturing a
tissue sample from the target tissue in the needle.
[0019] In some methods, aligning the needle with the target tissue
may include moving the biopsy device relative to the target tissue
into a position in which a projected needle pathway animated on the
display is in line with the image of the target tissue on the
display. Deploying the needle into the target tissue may include
guiding the needle into the target tissue along the projected
needle pathway.
[0020] The method may further include automatically capturing an
image of the needle of the needle assembly with the tissue sample
disposed therein.
[0021] The method may further include abutting a force sensor of
the biopsy device with a tissue surface to determine a resistance
of the target tissue prior to deploying the needle into the target
tissue.
[0022] In some methods, a negative pressure may be applied to the
needle assembly to draw the tissue sample into a containment
chamber of the needle assembly. The negative pressure may be
applied using hydraulics or a vacuum.
[0023] As used herein, the term "distal" refers to the portion that
is being described which is further from a user, while the term
"proximal" refers to the portion that is being described which is
closer to a user. Further, to the extent consistent, any of the
aspects and features detailed herein may be used in conjunction
with any or all of the other aspects and features detailed
herein.
[0024] As used herein, the terms parallel and perpendicular are
understood to include relative configurations that are
substantially parallel and substantially perpendicular up to about
+ or -10 degrees from true parallel and true perpendicular.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Various aspects and features of the present disclosure are
described hereinbelow with references to the drawings, wherein:
[0026] FIG. 1 is a perspective view of an ultrasonic biopsy device
provided in accordance with the present disclosure configured for
navigation to a target location and for obtaining a tissue
sample;
[0027] FIG. 2A is a perspective view of the ultrasonic biopsy
device of FIG. 1 and a cover;
[0028] FIG. 2B is a perspective view of the ultrasonic biopsy
device of FIG. 1 illustrating the cover of FIG. 2 attached
thereto;
[0029] FIG. 3 is a partial perspective view of a needle depth stop
attached to a needle assembly of the biopsy device of FIG. 1;
[0030] FIG. 4 is a front view of the ultrasonic biopsy device of
FIG. 1 during insertion and navigation to a target tissue;
[0031] FIG. 5A is a side view of a needle of the biopsy device of
FIG. 1;
[0032] FIG. 5B is a side view of the needle of FIG. 5A having a
sample of tissue disposed therein;
[0033] FIGS. 6A-6E illustrate various methods of using the needle
of FIG. 5A to extract a tissue sample;
[0034] FIGS. 7A-7D illustrate a method of extracting two tissue
samples using the ultrasonic biopsy device of FIG. 1;
[0035] FIG. 8A is a partial perspective view of another embodiment
of a needle assembly, for use with the ultrasonic biopsy device of
FIG. 1;
[0036] FIG. 8B is a partial perspective view of the needle assembly
of FIG. 8A after rotation thereof;
[0037] FIG. 9 is a partial perspective view of another embodiment
of a needle for use with the ultrasonic biopsy device of FIG.
1;
[0038] FIG. 10A perspective view, with parts separated, of another
embodiment of a needle assembly for use with the ultrasonic biopsy
device of FIG. 1;
[0039] FIG. 10B is a perspective view of the needle assembly of
FIG. 10A in an assembled state;
[0040] FIG. 11 is a partial perspective view of another embodiment
of a needle for use with the ultrasonic biopsy device of FIG.
1;
[0041] FIGS. 12A-12E illustrate a method of extracting a tissue
sample using yet another embodiment of a needle assembly;
[0042] FIG. 13A is a perspective view of another embodiment of a
biopsy device in accordance with the present disclosure;
[0043] FIG. 13B is a bottom view of the biopsy device of FIG.
13A;
[0044] FIG. 14 is a front view of yet another embodiment of a
biopsy device in accordance with the present disclosure;
[0045] FIG. 15A is a perspective view of still yet another
embodiment of a biopsy device in accordance with the present
disclosure including a plurality of force sensors;
[0046] FIG. 15B is an enlarged perspective view of one of the force
sensors of the biopsy device of FIG. 15A;
[0047] FIG. 16 is a schematic view of the ultrasonic biopsy device
illustrating a pathway for a needle;
[0048] FIG. 17 is a schematic view of the ultrasonic biopsy device
illustrating 8 and 9 channel ultrasound modules;
[0049] FIG. 18 is a schematic view of the ultrasonic biopsy device
illustrating one ultrasound module;
[0050] FIG. 19 illustrates a scan sequence;
[0051] FIGS. 20A-20C illustrate a method of using another
embodiment of a biopsy device;
[0052] FIG. 21 is a front, cross-sectional view of a fluid station
for use with any of the biopsy devices of the present
disclosure;
[0053] FIG. 22 is a perspective view of yet another embodiment of
an ultrasonic biopsy device in accordance with the principles of
the present disclosure;
[0054] FIG. 23 is a cross-sectional view, taken alone line 23-23,
of the ultrasonic biopsy device of FIG. 22;
[0055] FIG. 24 illustrates the ultrasonic biopsy device of FIG. 23
in a disassembled state;
[0056] FIG. 25 illustrates the ultrasonic biopsy device of FIG. 23
in a partially disassembled state;
[0057] FIG. 26 is a front view, with parts removed, of the
ultrasonic biopsy device of FIG. 22;
[0058] FIG. 27 is a perspective view, with some parts removed, of
the ultrasonic biopsy device of FIG. 22;
[0059] FIG. 28 illustrates the ultrasonic biopsy device of FIG. 23
in a first pre-firing state;
[0060] FIG. 29 illustrates the ultrasonic biopsy device of FIG. 23
in a second pre-firing state;
[0061] FIG. 30 illustrates the ultrasonic biopsy device of FIG. 23
in a fired state; and
[0062] FIG. 31 illustrates the ultrasonic biopsy device of FIG. 23
in a post-fired state.
DETAILED DESCRIPTION
[0063] Biopsy devices, biopsy systems, and methods for navigating
the biopsy devices to a target location and obtaining a tissue
sample using the biopsy device are provided in accordance with the
present disclosure and described in detailed below. In one
embodiment, the biopsy device includes a handle assembly in the
form of an ultrasonic probe, and a needle coupled to the handle
assembly and configured for penetrating and extracting tissue from
a lesion. The handle assembly has a display or screen for
illustrating both a needle tip of the needle and the target tissue
such that the needle can be accurately navigated into the targeted
portion of the lesion.
[0064] Detailed embodiments of such biopsy devices, systems
incorporating such biopsy, devices, and methods using the same are
described below. However, these detailed embodiments are merely
examples of the disclosure, which may be embodied in various forms.
Therefore, specific structural and functional details disclosed
herein are not to be interpreted as limiting, but merely as a basis
for the claims and as a representative basis for allowing one
skilled in the art to variously employ the present disclosure in
virtually any appropriately detailed structure.
[0065] With reference to FIGS. 1, 2A, and 2B, a biopsy device 100
is provided in accordance with the present disclosure for obtaining
a tissue sample from a target tissue, for example, a lesion. The
biopsy device 100 generally includes a handle assembly 102 and a
needle 120 disposed within the handle assembly 102. The handle
assembly 102 includes a handle body 104 in the form of a hand-held
ultrasonic probe 104, and a display 106. The hand-held ultrasonic
probe 104 is configured to perform ultrasonic imaging at a distal
portion 104b thereof. Ultrasonic probe 104 has a proximal portion
104a on which the display or screen 106 is disposed. The ultrasonic
probe 104 communicates with the display via a central processing
unit (not shown) disposed within the probe 104 to display an image
corresponding to the signals received from the probe 104.
[0066] The handle assembly 102 may house a memory (e.g., an
EEPROM--not shown) for storing a variety of information regarding
the biopsy device 100. In addition, the memory may store operating
parameters of the biopsy device 100, e.g., power, time, RPM limits,
and information regarding the usage of the biopsy device 100. Usage
monitoring may enable limiting the re-use of the biopsy device 100
beyond a certain number of activations, amount of activation time,
or may limit the biopsy device 100 to a single use. Such usage
limitations may optionally be reset via reprocessing as is commonly
understood in the art.
[0067] With continued reference to FIG. 1, the handle assembly 102
may include an adjustment mechanism 108 movably coupled to the
probe 104b. In embodiments, the adjustment mechanism 108 may be
configured as a slider. The adjustment mechanism 108 is in
communication with the central processing unit or microprocessor
(not shown) of the biopsy device 100 and is configured to adjust
and set a needle depth of the needle 120, as will be described in
detail below. The handle assembly 102 may include an actuator or
needle firing button 110 coupled to the probe 104 and configured to
fire the needle 120 into target tissue.
[0068] The needle 120 of biopsy device 100 has a proximal end
portion 120a and a distal end portion 120b configured to penetrate
tissue. The proximal end portion 120a of the needle 120 is operably
coupled to the actuator 110 of the handle assembly 102 such that
actuation of the actuator 110 distally moves the needle 120
relative to the distal end portion 104b of the probe 104 along a
longitudinal axis defined by the needle 120. The needle 120 may be
moved distally relative to the handle assembly 102 via a spring
(not shown) that is preloaded and released upon actuation of the
actuator 110. In some embodiments, any suitable mechanism for
firing the needle 120 may be implemented, for example, an
electromechanical drive, pressurized pneumatics, a manual drive
screw, or the like. Alternately, the biopsy device 100 may be
configured to connect to a remote drive and/or power source (not
shown) to drive actuation of the needle 120.
[0069] The distal end portion 120b of the needle 120 is hollow such
that insertion of the needle 120 into tissue captures tissue in a
hollow interior defined in the needle 120. In some embodiments, the
needle 120 may be configured as a cannula having a sharpened distal
end. The distal end portion 120b of the needle 120 is disposed
within the handle assembly 102 when the needle 120 is in the
un-actuated condition, and extends distally from the handle
assembly 102 when in the deployed or actuated condition. As the
needle 120 moves from the un-actuated condition to the deployed
condition, the needle 120 passes through an ultrasound sensor or
transducer (not explicitly shown) of the probe 104 in alignment
with the direction of the ultrasonic waves.
[0070] The probe 104 is configured to send ultrasonic waves toward
the distal end portion 120b of the needle 120, whereby the distal
end portion 120b reflects sound waves back to the probe 104, Which,
in turn, sends the reflected sound waves to the central processing
unit of the biopsy device 100. The central processing unit
generates an image of the distal end portion 120b of the needle 120
on the display 106.
[0071] With reference to FIGS. 2A and 2B, sterility of the
ultrasonic probe 104 may be maintained by use of a custom cap or
sterile cover 130 that is removably coupled to the distal end
portion 104b of the probe 104. The sterile cover 130 serves as a
barrier between the ultrasonic probe 104 and a patient's skin.
Ultrasound gel may be dispensed inside the cover 130 or may be
pre-packaged with a layer of gel and a rip tab. The cover 130
defines a central opening 132 that has the needle 120 extending
therethrough when the cover 130 is attached to the distal end
portion 104b of the probe 104. The cover 130 permits ultrasound
propagation therethrough while preventing the probe 104 from
directly contacting a patient. The cover 130 may include a window
134 formed of ultrasound-opaque material.
[0072] The adjustment mechanism 108 and the actuator 110 are in
communication with the central processing unit (not shown) of the
handle assembly 102. As mentioned above, the adjustment mechanism
108 sets the depth that needle 120 can penetrate target tissue.
Specifically, the adjustment mechanism 108 sets the amount that the
needle 120 moves distally relative to the handle assembly 102 upon
actuating the needle firing button 110. As such, upon actuation of
the needle firing button 110, the needle 120 moves distally
relative to the handle assembly 102 a selected longitudinal
distance corresponding to the needle depth set by the adjustment
mechanism 108.
[0073] In one embodiment, as shown in FIG. 3, the biopsy device 100
may include a needle depth stop 140 extending distally from the
ultrasonic probe 104. The depth stop 140 may be configured as a
tube that surrounds the needle 120 of the biopsy device 100 and
extends distally beyond the needle tip 120b of the needle 120 when
the needle 120 is in the retracted position. The distance the depth
stop 140 extends distally relative to the needle tip 120b may be
manually adjusted. In this way, to set the penetration depth of the
needle 120, the depth stop 140 is moved axially relative to the
distal end portion 104b of the ultrasonic probe 104.
[0074] One use of the biopsy device 100 for extracting tissue
samples from a lesion, e.g., a tumor, is described in detail with
reference to FIGS. 1 and 4. The biopsy device 100 is positioned
such that the distal end portion 104b of the probe 104 is placed in
abutting engagement with an outer surface "S" of tissue (e.g.,
breast tissue), with the distal end portion 120b of the needle 120
in proximity to target tissue, e.g., a lesion "L." The probe 104 is
activated to emit an ultrasonic field "UF" toward the lesion "L."
and the distal end portion 120b of the needle 120. The probe 104
then receives the reflected sound waves and the central processing
unit (not shown) of the probe 104 generates an image of the distal
end portion 120b' of the needle 120 relative to the lesion "L'" on
the display 106. In addition, the central processing unit of the
biopsy device 100 may animate a projected needle pathway "P'" on
the display 106 such that a clinician can accurately predict the
pathway "P" the needle 120 will travel at any given moment if
actuated. The biopsy device 100 is moved to a position in which the
projected needle pathway "P'" animated on the display 106 is
aligned with the image of the lesion "L.'" At this time, or at any
suitable time, the adjustment mechanism 108 (FIG. 1) may be moved
to set the needle depth of the needle 120. Alternatively, if the
depth stop 140 (FIG. 3) is provided, the depth stop 140 may be
moved to set the needle depth of the needle 120. The cross-hairs
106a and 106b on the display 106 provide guidance relating to the
depth of the needle 120 when deployed.
[0075] Upon aligning, on the display 106, the projected needle
pathway "P'" with the displayed image of the lesion "L,'" on the
display 106, the needle actuator 110 may be actuated to move the
needle 120 along the projected needle pathway "P" in situ a
longitudinal distance corresponding to the needle depth set by the
adjustment mechanism 108. In some embodiments, the biopsy device
100 may be moved manually in the distal direction to penetrate the
lesion "L" with the needle 120. As the needle 120 penetrates the
lesion "L," a first tissue sample of the lesion "L" enters the
distal end portion 120b of the needle 120. In some embodiments, the
needle 120 is a center coring needle. In other embodiments, as
shown in FIG. 11, the needle 120 may be a side-biting needle.
[0076] With reference to FIGS. 5A and 5B, in some embodiments,
prior to driving the distal end portion 120b of the needle 120 into
the lesion "L," a stylet 122 may be driven through the needle 120
and into the lesion "L" to act as an introducer and to control the
starting point of the tissue sample. After inserting the stylet
122, the stylet 122 may be retracted back into the needle 120, and
the needle 120 may then be driven distally into the lesion "L."
Alternately, instead of manually retracting the stylet 122 back
into the needle 120, distal penetration of the needle 120 into the
lesion "L" may drive the stylet 122 back into the needle 120
allowing the first tissue sample "TS1" to enter the distal end
portion 120b of the needle 120.
[0077] With reference to FIGS. 6A-6D, various methods may be
employed to more effectively extract the first tissue sample "TS1"
from the lesion "L" and into the needle 120. For example, with
reference to FIG. 6A, the needle 120 may be vibrated inside of the
lesion "L." The needle 120 may be vibrated using the ultrasound
probe 104, a vibration motor, transducer, or any suitable mechanism
capable of causing the needle 120 to vibrate. With reference to
FIG. 6B, the needle 120 may be swung or pivoted about an axis that
extends perpendicularly through the needle 120. With reference to
FIG. 6C, the needle 120 may be configured as an electrosurgical
needle capable of emitting high frequency radiation to assist in
extraction of the first tissue sample "TS1." With reference to FIG.
6D, the distal end portion 120b of the needle 120 may be first
inserted into the lesion "L," extracted from the lesion "L,"
pivoted relative to the lesion "L" to a different angle, and then
re-inserted into the lesion "L" at the different angle. With
reference to FIG. 6E, the needle 120 may be rotated about its
longitudinal axis to assist in tissue extraction.
[0078] In some embodiments, after capturing the tissue sample "TS1"
in the needle 120, a vacuum may be established proximally of the
needle 120 by a one-way valve (not shown) or by drawing a negative
vacuum with a syringe or pump. The tissue sample "TS1" may be
collected within the needle 120 or in a tissue chamber (not shown)
of the needle 120. Suction may be applied in a controlled manner so
as to maintain the tissue sample "TS1" intact. In some embodiments,
a vacuum or suction source may be used to trap the tissue sample
"TS1." within the needle 120. In some embodiments, the biopsy
system 100 may include a tissue containment chamber that collects
tissue samples for testing. In one embodiment, a pressurized fluid
may be used to drive the tissue sample "TS1" from the needle into
the tissue chamber.
[0079] With reference to FIGS. 7A-7D, after inserting the distal
end portion 120b of the needle 120 into the lesion "L," the distal
end portion 120b of the needle 120 may be withdrawn from the lesion
"L" carrying the first tissue sample "TS1" therein. Proximal
withdrawal of the distal portion 120b of the needle 120 from the
lesion "L" is continued until a distal-most point 123 of the needle
120 reaches an entry hole 124 defined in the outer surface of the
lesion "L." While maintaining the distal-most point 123 of the
needle 120 at the entry hole 124, the needle 120 is then angled
relative to the lesion "L" such that the needle 120 assumes a
second projected needle pathway "P2," angled relative to the first
needle pathway "P1." The needle 120 is then re-inserted into the
access hole 124 along the second pathway "P2," thereby capturing a
second tissue sample "TS2" of the lesion "L" in the needle 120. In
some embodiments, rather than re-inserting needle 120 into access
hole 124 a second time, the needle 120 may be inserted through a
different hole (not shown) of lesion "L" to capture the second
tissue sample "TS2." The needle 120 is then retracted into the
probe 104 and out of the tissue.
[0080] The tissue samples "TS1," "TS2" may be discharged out of the
distal-most end 124 of the needle 120, or be removed from a
syringe-portion of the needle 120. In some embodiments, the tissue
samples "TS1," "TS2" may be expelled from the needle 120 using a
tissue sample removal system (not shown) coupled to the biopsy
device 100 which discharges a fluid (e.g., air or liquid) distally
through needle 120. In some embodiments, the tissue sample removal
system may be integrally formed with the biopsy device 100.
[0081] In embodiments, the biopsy device 100 may include a
mechanism configured to deploy a marker or tracking device into the
lesion "L." For example, the needle 120 may include a spring
configured to deploy the marker from the distal-most end 124 of the
needle 120 or a side opening in the needle 120. After deployment of
the marker, the needle 120 may be automatically retracted into the
biopsy device 100. In embodiments, upon the needle 120 terminating
its deployment, the biopsy device may automatically capture an
image of the tissue sample disposed in the needle 120 or at the
instant the needle 120 penetrates the tissue sample.
[0082] In one embodiment, as shown in FIGS. 8A and 8B, the needle
120 of the biopsy device 100 may be replaced with a side-biting
needle 150, which includes an outer cannula 150a and a notched
inner cannula or rod 150b disposed within the outer cannula 150a.
The side-biting needle 150 may include a wire 152 having a first
end 152a attached to a distal end portion of the outer cannula 150a
and a second end 152b attached to a distal end portion of the inner
cannula 150b. When the side-biting needle 150 is actuated, the
notched inner cannula 150b is deployed into the lesion "L" followed
by a rotating of the cannulas 150a, 150b relative to one another to
sever the tissue with the wire 152. Only one of the cannulas 150a,
150b may be configured to rotate with respect to the other of the
cannulas 150a, 150b. After deployment, the inner and outer cannulas
150a, 150b are retracted into the handle assembly 102.
[0083] In another embodiment, as shown in FIG. 9, the needle 120 of
the biopsy device 100 may be replaced with another embodiment of a
needle 160 that includes a metal wire 162 that extends across a tip
164 of the needle 160. In embodiments, the wire 162 may be any
suitable material capable of severing tissue. In use, after the
needle 160 captures a tissue specimen therein, the needle 160 is
rotated about its longitudinal axis. During rotation of the needle
160, the wire 162 severs the tissue specimen at its base allowing
for its removal from the tissue site.
[0084] In yet another embodiment, as shown in FIGS. 10A and 10B,
the needle 120 of the biopsy device 100 may be replaced with a
needle assembly 170, which includes a hub or body 172 and a needle
174 extending distally therefrom. The needle assembly 170 may
further include a hub cover 176 configured to fit over the hub 172
of the needle assembly 170, and a wire 178 having opposing ends
178a, 178b attached to opposing sides of the hub cover 176. Upon
positioning the hub cover 176 over the hub 172, the wire 178
extends taught across a needle tip 175 of the needle 174. In use,
after the needle 174 captures a tissue specimen therein, the needle
assembly 170 is rotated about its longitudinal axis. During
rotation of the needle assembly 170, the wire 178 severs the tissue
specimen at its base allowing for its removal from the tissue
site.
[0085] In some embodiments, the needle of the biopsy device 120 may
include a barb or hook that extends into the internal passageway of
the needle. The barb may be configured to allow for the passage of
tissue into the internal passageway, but inhibit the tissue from
moving distally out of the needle.
[0086] With reference to FIG. 11, another embodiment of a needle
180 to be used with the biopsy device 100 is illustrated. The
needle 180 includes a pair of flaps 182a, 182b formed with a distal
end portion of the needle 180. The flaps 182a, 182b are configured
to move from a first state in which the flaps 182a, 182b extend in
line with an outer surface of the needle 180, and a second state
(as shown in FIG. 11) in which the flaps 182a, 182b extend into an
internal passageway 184 of the needle 180. The tabs 182a, 182b may
be fabricated from a shape memory alloy, e.g., nitinol, configured
to move from the first state to the second state upon receiving an
electrical impulse or upon changing to a particular temperature
body temperature). In use, the needle 180 is deployed into tissue
with the tabs 182a, 182b in their first state. After the needle 180
captures a tissue specimen therein, the tabs 182a, 182b are shifted
toward their second state (e.g., via receiving an electrical
impulse), and ends of the tabs 182a, 182b cut into the tissue
specimen at its base allowing for its removal from the tissue
site.
[0087] With reference to FIGS. 12A-12E, another embodiment of a
needle assembly 190 for use with the biopsy device 100 is
illustrated. The needle assembly 190 includes a hollow hub or body
192 and a needle 194 extending distally therefrom and in fluid
communication therewith. The needle assembly 190 further includes a
tube 196 attached to or formed with an outer surface of the needle
194. The tube 196 extends parallel with and alongside the length of
the needle 194. The tube 196 defines a channel 198 therethrough
which acts as a ventilation channel to mitigate a tissue suction
effect that may occur during removal of a tissue specimen from
tissue "T."
[0088] In use, upon inserting the needle 194 of the needle assembly
190 into tissue "T," the tube 196 has a rod (not shown) disposed in
the channel 198 of the tube 196 to prevent tissue from entering the
channel 198 of the tube 196. The needle assembly 190 is rotated
about its longitudinal axis to sever a tissue specimen captured in
the needle 194. As the needle assembly 190 is rotated, the tube 196
radially expands the hole "H" formed by the needle 194 upon
entering the tissue "T" to form a space "S" between the needle 194
and the tissue "T." As the needle assembly 194 is extracted from
the tissue "T," the rod is removed from the channel 198 of the tube
196 to allow air to travel through the channel 198 and into the
hole "H" formed in the tissue "T." This has the effect of
preventing a vacuum from being formed in the hole "H" of the tissue
"T" during removal of the needle 194, which would otherwise cause
the tissue specimen to be drawn distally out of the needle 194
during extraction.
[0089] With reference to FIGS. 13A and 13B, another embodiment of a
biopsy device 200 is provided. The biopsy device 200 is
substantially similar to the biopsy device 100 described above.
Accordingly, the biopsy device 200 will only be described in
sufficient detail to elucidate selected differences from biopsy
device 100. The biopsy device 200 includes a handle assembly 202,
and a needle assembly or cartridge 220 configured to be removably
coupled to the handle assembly 202, The handle assembly 202 may be
an ultrasonic probe having a display 206 for displaying an
ultrasonic image. The handle assembly 202 includes a sheath or
protective sleeve 212 configured to cover a distal portion of the
handle assembly 202. The sleeve 212 permits ultrasound propagation
therethrough while preventing the handle assembly 202 from directly
contacting a patient. The sleeve 212 may include a window formed of
ultrasound-opaque material. In some embodiments, the sleeve 212 may
have pre-applied ultrasound gel disposed on a portion or portions
thereof.
[0090] The handle assembly 202 has a longitudinally-extending
channel 214 defined in the distal portion thereof. Needle assembly
220 includes a medical syringe 220a fitted with a needle 220b. The
channel 214 is configured to receive the needle assembly 220
therein. In some embodiments, the protective sleeve 212 and/or the
channel 214 may be incorporated into the biopsy device 100 of FIG.
1. The needle assembly 220 may be actuated or deployed in a similar
manner as described herein (e.g., via biasing members) or in any
other suitable way known in the art. During actuation, the needle
assembly 220 is moved relative to the handle assembly 202 distally
along a longitudinal axis defined by the biopsy device 200.
[0091] With reference to FIG. 14, another embodiment of a biopsy
device 300 is illustrated. The biopsy device 300 is substantially
similar to the biopsy device 100 described above. Accordingly, the
biopsy device 300 will only be described in sufficient detail to
elucidate selected differences from biopsy device 100. The biopsy
device 300 includes an actuation spring 302 and a motor 304 for
driving actuation of a needle 320 of the biopsy device 300. The
motor 304 raises a platform 306 on which the needle assembly 320 is
supported to compress or load the actuation spring 302. Upon
setting the motor 304 in neutral, the load of the actuation spring
302 drives the needle assembly 320 in a distal direction.
[0092] With reference to FIGS. 15A and 15B, another embodiment of a
biopsy device 400 is illustrated. The biopsy device 400 is
substantially similar to the biopsy device 100 described above.
Accordingly, the biopsy device 400 will only be described in
sufficient detail to elucidate selected differences from biopsy
device 100. The biopsy device 400 includes a handle body 402, a
needle assembly 420 connected to the handle assembly 402, and a
collar or annular member 430 extending distally from the handle
body 402. The collar 430 encapsulates the needle assembly 420 and
extends distally beyond a distal-most end of the needle assembly
420 when the needle assembly 420 is in an unactuated position.
[0093] The biopsy device 400 includes a plurality of force sensors
440 disposed in an annular array on a distally-oriented surface 432
of the collar 430. In some embodiments, the force sensors 440
and/or the collar 430 may be incorporated into the biopsy device
100. Each sensor 440 has a sensor plate 442 fixedly coupled to the
distally-oriented surface 432 of the collar 430, a proximal body
444 fixed to the sensor plate 442, and a distal body 446 that is
slidably coupled to the proximal body 444. Each sensor 440 has a
biasing member, such as, for example, a coil spring 448, disposed
between the proximal and distal bodies 444, 446 of each of the
sensors 440, to resiliently bias the distal body 446 away from the
proximal body 444.
[0094] The force sensors 440 are in communication with a central
processing unit or processor (not shown) of the handle assembly
402. The force sensors 440 relay the forces sensed by each force
sensor 440 to the processor, which sends the signals to a user
interface, for example, a display (not shown). In this way, the
force sensors 440 may allow for the determination of an amount of
resistance of the tissue against the needle assembly 420, which can
be used to confirm that a targeted lesion has been correctly
targeted, and that the needle assembly 420 has passed through the
lesion and has not struck critical structures such as a chest
wall.
[0095] With reference to FIGS. 16-19, two 64-element transducer
arrays are oriented to allow a needle pathway between them. The
signal may be processed in one of at least two ways. With reference
to FIG. 16, one way to process the signal is two 8-channel handheld
ultrasound modules that generate ultrasound pulses and sample
reflected signals. Each module performs synthetic aperture
beamforming independently and the beamformed data is then merged in
a processor into B-mode images. The scan sequence of this mode is
illustrated in FIG. 16. The processor then sends the merged data on
a USB connection to a computer with software that reads the
beamformed data from the USB and displays a B-mode image on the
screen.
[0096] With reference to FIG. 17, another way of processing the
signal is a single 16-channel handheld ultrasound module used with
synthetic aperture beamforming. The transmitter fires spherical
waves individually or with every two elements, instead of firing
focused beams with a wider transducer aperture. One advantage of
employing the synthetic aperture method is it offers flexibility in
configuring the transducers. In this case, by using a single
beamformer, it enables placing two or more separate transducer
arrays at different positions and possibly different orientations
without creating a mismatch at the border of two half images. The
scan sequence is shown in FIG. 18. The ultrasound image is
constructed either after each cycle of the aperture coverage, or
after each firing.
[0097] With reference to FIGS. 20A-20C, another embodiment of a
biopsy device 500 is illustrated. The biopsy device 500 includes a
handle assembly 510 and a needle assembly or cartridge 520
extending distally from the handle assembly 510. The handle
assembly 510 incorporates an ultrasonic transducer (not explicitly
shown) such that the handle assembly 510 acts as an ultrasonic
probe. In embodiments, the handle assembly 510 of the biopsy device
500 may be devoid of an ultrasonic transducer.
[0098] The needle assembly 520 includes a body or hub 522 and a
needle 524 extending distally from the body 522. The body 522 of
the needle assembly 520 has a proximal end 522a disposed within an
internal chamber 512 defined in the handle assembly 510, and a
distal end 522b disposed distally of the handle assembly 510. The
proximal end 522a of the body 522 defines an opening 526 in fluid
communication with the internal chamber 512 of the handle assembly
510. The body 522 of the needle assembly 520 includes a flange 528
extending radially outward of the proximal end 522a thereof. A
biasing member 530 (e.g., a swing) is disposed between the flange
528 of the body 522 and an internal structure of the handle
assembly 510 to resiliently bias the needle assembly 520 in a
distal direction. As such, upon an actuation of an actuator 514 of
the handle assembly 510, the needle assembly 520 is released,
thereby allowing the biasing member 530 to move the needle assembly
520 in a distal direction from a retracted position to a deployed
position.
[0099] The biopsy device 500 also includes a syringe 540 axially
aligned with the needle assembly 520 and disposed within the handle
assembly 510. A tube 542 of the syringe 540 has a distal end 544
defining an opening 546 dimensioned for receipt of the proximal end
522a of the body 522 of the needle assembly 520. The syringe tube
542 of the biopsy device 500 contains a fluid (e.g., water)
therein. In embodiments, the syringe tube 542 may include a gas. A
plunger 548 of the syringe 540 is movably disposed within the
syringe tube 542. Upon coupling the distal end 544 of the syringe
tube 542 with the proximal end 522a of the body 522 of the needle
assembly 520, the syringe tube 542 and the body 522 of the needle
assembly 520 form a fluid-tight seal with one another. The distal
end 544 of the syringe tube 542 may include a valve configured to
remain closed until the body 522 of the needle assembly 520 is
received therein.
[0100] In use, the needle assembly 520 is deployed to capture a
tissue specimen in the needle 524 of the needle assembly 520. With
the tissue specimen captured in the needle 524, the plunger 548 is
moved distally to advance the syringe tube 542 into engagement with
the body 522 of the needle assembly 520. As mentioned above,
coupling the syringe tube 542 with the body 522 of the needle
assembly 520 forms a fluid-tight seal between the opening 526 in
the proximal end 522a of the body 522 of the needle assembly 520
and the opening 546 defined in the distal end 544 of the syringe
tube 542. As the biopsy device 500 is withdrawn from the tissue
site, the liquid disposed in the syringe tube 542 applies a
negative pressure on the tissue specimen to prevent the tissue
specimen from exiting the needle 524 during extraction. After
extraction, the tissue specimen may be discharged from the needle
524 by distally advancing the plunger 548 of the syringe 540.
[0101] With reference to FIG. 21, an external fluid station 600 may
be provided which is configured to assist in extracting the tissue
specimen from any of the biopsy devices described herein. The fluid
station 600 includes a base 602 and a plunger 604. The base 602
defines an elongated channel 606 that contains a fluid therein. The
plunger 604 defines a longitudinally-extending passageway 608
dimensioned for receipt of a needle of one of the disclosed biopsy
devices. Upon positioning a needle in the passageway 608, a needle
tip of the needle extends distally out of the plunger 604 and into
the fluid contained in the base 602. To extract the tissue specimen
from the needle, the plunger 604 is advanced distally relative to
the base 602 to force the liquid through the needle tip. As the
liquid is force up through the needle tip, the tissue specimen
travels proximally through the needle and out of the biopsy
device.
[0102] With reference to FIGS. 22-31, another embodiment of a
biopsy device 700 is illustrated. The biopsy device 700 generally
includes a display 702, an ultrasonic probe 710, and a needle
assembly 760. The display 702 is disposed on a head 704 of the
biopsy device 700 and is in electrical communication with the
ultrasonic probe 710 such that any information sensed by the
ultrasonic probe (e.g., tissue structure) is displayed on the
display 702. The head 704 may include a processor in communication
with the display 702 and the ultrasonic probe 710 for processing
the information sensed by the ultrasonic probe 710.
[0103] With specific reference to FIGS. 22-26, the biopsy device
700 further includes a tubular shaft 706 extending distally from
the head 704. In embodiments, the tubular shaft 706 may be
monolithically formed with or integrally connected to the head 704,
The tubular shaft 706 has a needle housing 708 fixed to a distal
end portion thereof. The needle housing 708 includes a pair of tabs
or stops 709a, 709b extending laterally outward from opposite sides
thereof.
[0104] The ultrasonic probe 710 includes a housing 712 pivotably
coupled to the distal end portion of the tubular shaft 706 and an
end cap 714 secured to the housing 712. The end cap 714 has a block
716 that supports a pair of ultrasonic sensors 718a, 718b (FIG.
26). The block 716 may be fabricated from silicone or any other
suitable ultrasound-opaque material. The block 716 defines a
central opening 720 therethrough dimensioned for slidable receipt
of a needle 762 of the needle assembly 760. The ultrasonic sensors
718a, 718b are in communication with the processor and/or the
display 702 and are laterally spaced from one another to
accommodate the needle 762 of the needle assembly 762 therebetween.
In this way, the needle 762 may be moved through the ultrasonic
probe 710 without inhibiting its function.
[0105] Disposed within the tubular shaft 706 is an axially movable
inner sheath 750. The inner sheath 750 is resiliently biased in a
proximal direction by a biasing member 752 (e.g., an extension
spring) that interconnects the inner sheath 750 and the head 704.
The inner sheath 750 includes a pair of tabs or stops 754a, 754b
located at a distal end portion thereof that matingly engage with
the stops 709a, 709b of the needle housing 708 upon the inner
sheath 750 moving from a proximal position (shown in FIG. 25) to a
distal position (shown in FIG. 29). As such, when the inner sheath
750 is in the distal position, the inner sheath 750 is prevented
from being retracted by the biasing member 752 toward the proximal
position.
[0106] The inner sheath 750 defines a pair of
longitudinally-extending channels 756a, 756b in an outer surface
thereof. The channels 756a, 756b of the inner sheath 750 permit
longitudinal movement of respective arms 780a, 780b of the needle
assembly 760 therethrough. The inner sheath 750 includes a flexible
locking member 758 located at a proximal end of one of the channels
756a, 756b. The locking member 758 of the inner sheath 750 is
configured to releasably capture one of the arms 780a, 780b of the
needle assembly 760 upon the needle assembly 760 entering a
retracted position. The locking member 758 is adjacent an end of an
actuator or trigger 740 (FIG. 27) of the biopsy device 700. The
actuator 740 is pivotably coupled to the tubular shaft 706 and is
configured to flex or bend the locking member 758 of the inner
sheath 750 inwardly to selectively disengage the locking member 758
of the inner sheath 750 from the arm 780a of the needle assembly
760. As will be described in detail below, the inner sheath 750
functions to automatically retract the needle assembly 760 back to
the retracted state after the needle assembly 760 is deployed.
[0107] The needle assembly 760 of the biopsy device 700 generally
includes a needle subassembly 764 and the needle 762 extending
distally from the needle subassembly 764. The needle subassembly
764 includes a pair of distally-extending legs 766a, 766b each
having a ramped distal end 768a, 768b. The ramped distal ends 768a,
768b of the legs 766a, 766b are configured to engage with the stops
754a, 754b of the inner sheath 750 upon the needle assembly 760
moving distally into the deployed position. As will be described in
greater detail below, as the ramped distal ends 768a, 768b of the
legs 766a, 766b engage the respective stops 754a, 754b of the inner
sheath 750, the stops 754a, 754b of the inner sheath 750 are forced
radially outward and therefore out of engagement with the stops
709a, 709b of the needle housing 708.
[0108] The needle subassembly 764 further includes a pair of arms
780a 780b extending radially outward of the inner sheath 750. The
arms 780a, 780b are coupled to a collar or slider 782 that is
slidably attached to the tubular shaft 706 such that axial movement
of the collar 782 along the elongated shaft 706 causes axial
movement of the needle assembly 760. The collar 782 defines a pair
of longitudinal tracks 784a, 784b therealong and a pair of
circumferential notches 786a, 786b (FIG. 28) therein. The
longitudinal tracks 784a, 784b and the circumferential notches
786a, 786b are each configured for selective receipt of the arms
780a, 780h of the needle subassembly 764. In one instance, when the
arms 780a, 780h of the needle subassembly 764 are received in the
respective tracks 784a, 784b of the collar 782, the needle
subassembly 764 is axially movable through the tracks 784a, 784b
and relative to the collar 782. In another instance, when the arms
780a, 780b of the needle subassembly 764 are received within the
respective notches 786a, 786b (FIG. 28) defined in the collar 782
(due to a rotation of the collar 782), axial movement of the collar
782 causes the needle subassembly 764 to move with the collar
782.
[0109] The biopsy device 700 includes a pair of needle actuators
788, 790 (e.g., springs) that extend between a proximal cap 759 of
the inner sheath 750 and a proximal end of the needle subassembly
764. In some embodiments, the biopsy device 700 may include more or
less than two needle actuators. The needle actuators 788, 790
resiliently bias the needle assembly 760 distally away from the
proximal cap 759 of the inner sheath 750 toward a deployed
position.
[0110] An exemplary use of the biopsy device 700 will now be
described with reference to FIGS. 23 and 28-31. The biopsy device
700 may be used to extract tissue samples from a lesion, for
example, a tumor to be tested. With the needle 762 disposed within
needle housing 708 in a position proximal to opening 720 in the
ultrasonic probe 710, as shown in FIG. 23, the biopsy device 700 is
positioned such that the block 716 of the ultrasonic probe 710 is
in abutting engagement with an outer surface of tissue breast
tissue). The ultrasonic sensors 718a, 718b (FIG. 26) of the
ultrasonic probe 710 are activated to emit an ultrasonic field in a
distal direction through the block 716 and toward the lesion. The
ultrasonic sensors 718a, 718b then receive the reflected sound
waves and the processor of the biopsy device 700 generates an image
of the needle tip of the needle 762 and the lesion on the display
702. The biopsy device 700 is moved relative to the target tissue
until the needle tip is shown on the display 702 as being aligned
with the target tissue.
[0111] With reference to FIGS. 23 and 28, with the needle 762 in
the proper position, the biopsy device 700 may be cocked in
preparation for firing the needle assembly 760. To cock or set the
needle assembly 760, the collar 782 is rotated relative to the arms
780a, 780b of the needle subassembly 764 to position the arms 780a,
780h of the needle assembly 764 in the notches 786a, 786b of the
collar 782. With the arms 780a, 780b of the needle subassembly 764
captured in the notches 786a, 786b of the collar 782, proximal
movement of the collar 782 along the tubular shaft 706 results in a
retraction of the needle assembly 760 toward the proximal cap 759
of the inner sheath 750. Upon the needle subassembly 764 engaging
the proximal cap 759 of the inner sheath 750, one of the arms 780a,
780b of the needle subassembly 764 is received in the flexible
locking member 758 of the inner sheath 750 to lock together the
needle assembly 760 and the inner sheath 750, as shown in FIG. 28.
In addition to locking the needle assembly 760 with the inner
sheath 750, proximal retraction of the needle assembly 760 within
the tubular shaft 706 acts to compress the needle actuators 788,
790 between the needle subassembly 764 and the proximal cap 759 of
the inner sheath 750.
[0112] To further prepare the biopsy device 700 for firing, the
collar 782 is advanced distally along the elongated shaft 706,
which, in turn, drives distal advancement of the needle assembly
760 due to the arms 780a, 780b of the needle assembly 764 being
captured in the notches 786a, 786b of the collar 782. As a result
of arms 780a of the needle assembly 764 being in locking engagement
with the locking member 758 of the inner sheath 750, as the needle
assembly 760 moves distally the inner sheath 750 follows. As the
inner sheath 750 moves toward a distal position within the tubular
shaft 706, the stops 754a, 754b of the inner sheath 750 pass over
and interlock with the stops 709a, 709b of the needle housing 708,
as shown in FIG. 29. Since the needle housing 708 is fixed relative
to the tubular shaft 706, the proximally-oriented force applied to
the inner sheath 750 by the biasing member 752 (FIG. 27) will not
result in proximal movement of the inner sheath 750 back toward the
retracted position. As such, the collar 782, the needle assembly
760, and the inner sheath 750 are each prevented from moving
proximally out of the position shown in FIG. 29. In this pre-fired
position, the needle 762 is held within the opening 720 defined in
the block 716 of the ultrasonic transducer 710 without protruding
distally from the ultrasonic probe 710.
[0113] With reference to FIGS. 29 and 30, prior to firing the
actuator 740 (FIG. 27), the collar 782 is rotated to displace the
arms 780a, 780b of the needle subassembly 764 out of the notches
786a, 786b of the collar 782 and into the longitudinal tracks 784a,
784b of the collar 782. As can be appreciated by viewing, for
example, FIG. 30, the collar 782 is prevented from moving distally
relative to and along the elongated shaft 706 by virtue of an
abutting engagement with the housing 712 of the ultrasonic probe
710. As such, the collar 782 acts as a safety by preventing distal
movement of the needle assembly 760 relative thereto due to the
arms 780a, 780b of the needle subassembly 764 being captured within
the notches 786a, 786b of the collar 782. Prior to rotating the
collar 782, incidental firing of the actuator 740 (FIG. 27) will
not result in the firing of the needle assembly 760.
[0114] With the arms 780a, 780b of the needle subassembly 764
disposed within the tracks 784a, 784b of the collar 782, the needle
assembly 760 is free to move distally along and relative to the
collar 782 but for the locking engagement of the locking member 758
of the inner sheath 750 with the arm 780a of the needle subassembly
764. To deploy the needle assembly 760, the actuator 740 (FIG. 27)
is pivoted into engagement with the locking member 758 of the inner
sheath 750, which, in turn, moves the locking member 758 of the
inner sheath 750 out of locking engagement with the arm 780a of the
needle subassembly 764. With the arm 780a of the needle subassembly
764 released from the locking member 758 of the inner sheath 750,
the needle actuator 788 is free to push the needle assembly 760
distally relative to the inner sheath 750 to deploy the needle 762
through and distally beyond the ultrasonic transducer 710 and into
tissue. The second needle actuator 790 either occludes the proximal
end of the needle assembly to create a passive vacuum or pushes the
outer sheath of the side-biting needle over the inner core.
[0115] As the needle assembly 760 completes its deployment, the
ramped distal ends 768a, 768b of the legs 766a, 766b of the needle
subassembly 764 concurrently depress the stops 709a, 709b of the
needle housing 708 thereby releasing the stops 754a, 754b of the
inner sheath 750 from the stops 709a, 709b of the needle housing
708. Upon release of the inner sheath 750 from the needle housing
708, the biasing member 752 (FIG. 27) in the head 704 drives the
inner sheath 750 proximally toward the retracted position (as shown
in FIG. 31). Proximal movement of the inner sheath 750 causes the
needle assembly 760 to be retracted due to the engagement of the
stops 754a, 754b of the inner sheath 750 and the ramped distal ends
768a, 768b of the needle subassembly 764. In this way, the needle
762 is immediately and automatically retracted back into the
housing 712 of the ultrasonic probe 710 upon finishing its
deployment. With tissue captured in the needle 762, a proximal end
of the needle subassembly 764 is occluded by the movement driven by
actuator 790, thereby creating a passive vacuum in the needle
subassembly 764 to hold the tissue sample in the lumen of the
needle 762. In embodiments, the tissue may be captured by forming
an active vacuum from a plunger (not shown) activated as the needle
762 is retracted back into the housing 712. Needle actuator 752
retracts the inner sheath 750 and all components within it until
the needle is completely enclosed behind the distal end of the
ultrasound probe.
[0116] To remove the needle 762 from the needle subassembly 764,
the ultrasonic probe 710 may be pivoted relative to the tubular
shaft 706 to allow a clinician to gain access to the needle housing
708. The needle housing 708 may then be detached from the tubular
shaft 706 by, e.g., unscrewing it from the distal end portion of
the tubular shaft 706. With the needle housing 708 detached from
the tubular shaft 706, the needle 762 is accessible by a clinician
and may be removed from the biopsy device 700. With the needle 762
removed, the tissue sample may be extracted from the needle 762 and
a new, sterile needle may be loaded into the biopsy, device 700 in
preparation of reuse of the biopsy device 700.
[0117] While several embodiments of the disclosure have been shown
in the drawings, it is not intended that the disclosure be limited
thereto, as it is intended that the disclosure be as broad in scope
as the art will allow and that the specification be read likewise.
Therefore, the above description should not be construed as
limiting, but merely as exemplifications of particular embodiments.
Those skilled in the art will envision other modifications within
the scope and spirit of the claims appended hereto.
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