U.S. patent application number 17/546202 was filed with the patent office on 2022-03-31 for ultrasound tracking apparatus for disposable biopsy needles.
The applicant listed for this patent is KONINKLIJKE PHILIPS N.V.. Invention is credited to Shyam BHARAT, Ramon Quido ERKAMP, Ameet Kumar JAIN, Francois Guy Gerard Marie VIGNON.
Application Number | 20220096171 17/546202 |
Document ID | / |
Family ID | |
Filed Date | 2022-03-31 |
United States Patent
Application |
20220096171 |
Kind Code |
A1 |
BHARAT; Shyam ; et
al. |
March 31, 2022 |
ULTRASOUND TRACKING APPARATUS FOR DISPOSABLE BIOPSY NEEDLES
Abstract
A system for tracking a medical device includes an introducer
(20). Two or more sensors (22) are disposed along a length of the
introducer and are spaced apart along the length. An interface (32)
is configured to connect to the introducer such that the introducer
and the interface operatively couple to and support the medical
device wherein the two or more sensors are configured to provide
feedback for positioning and orienting the medical device using
medical imaging.
Inventors: |
BHARAT; Shyam; (ARLINGTON,
MA) ; ERKAMP; Ramon Quido; (SWAMPSCOTT, MA) ;
JAIN; Ameet Kumar; (BOSTON, MA) ; VIGNON; Francois
Guy Gerard Marie; (ANDOVER, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KONINKLIJKE PHILIPS N.V. |
EINDHOVEN |
|
NL |
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|
Appl. No.: |
17/546202 |
Filed: |
December 9, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15324137 |
Jan 5, 2017 |
11197721 |
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PCT/IB2015/055352 |
Jul 15, 2015 |
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17546202 |
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62025480 |
Jul 16, 2014 |
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International
Class: |
A61B 34/20 20060101
A61B034/20; A61B 90/00 20060101 A61B090/00; A61B 10/02 20060101
A61B010/02 |
Claims
1. A system for tracking a needle of a biopsy gun having a handle,
the system comprising: an introducer having a hollow tube
configured to receive the needle of the biopsy gun within the
hollow tube; a plurality of sensors disposed along a length of the
introducer and spaced apart along the length, wherein the plurality
of sensors are configured to provide feedback on position and
orientation of the introducer; and an interface clip configured to:
(i) attach to the handle of the biopsy gun and (ii) connect to the
introducer such that the interface clip with the connected
introducer operatively couples to and supports the biopsy gun.
2. The system as recited in claim 1, wherein the sensors are
disposed within the hollow tube.
3. The system as recited in claim 1, wherein the introducer
connects to the interface clip and at least one of the introducer
and the interface clip is disposable.
4. The system as recited in claim 1, wherein the introducer is
integrated with the interface clip to form a disposable
assembly.
5. The system as recited in claim 1, wherein: each of the plurality
of sensors includes an electrical connector; and the interface clip
is configured to electrically couple each electrical connector to
adaptor electronics configured to adapt a signal from the
corresponding sensor.
6. The system as recited in claim 5, wherein the adaptor
electronics are configured to provide amplification, noise
cancellation, and/or other adaptive signal processing of the
signal.
7. The system as recited in claim 6, wherein the adaptor
electronics are integrated as a physical part of the interface
clip.
8. The system as recited in claim 6, wherein further adaptor
electronics are included in a module external to the interface
clip.
9. The system as recited in claim 1, wherein the interface clip
defines and surrounds an opening, wherein the opening is configured
to receive and fit the introducer.
10. The system as recited in claim 1, further comprising an
interpretation processor configured to receive the feedback and,
based on the feedback, generate image information indicating
position and orientation of the biopsy gun in an image.
11. The system as recited in claim 10, wherein the interpretation
processor is further configured to estimate position of a biopsy
sample based on the position and orientation of the biopsy gun.
12. The system as recited in claim 11, wherein the image processor
is configured to generate an image of the estimated position of the
biopsy sample based on the image information.
13. The system as recited in claim 1, wherein the needle of the
biopsy gun comprises an inner stylet and an outer cannula.
14. A method for tracking a needle of a biopsy gun having a handle,
the method comprising: providing an introducer with a plurality of
sensors disposed along a length of the introducer and spaced apart
along the length, the introducer being configured as a hollow tube
to receive the needle of the biopsy gun within the hollow tube;
connecting the introducer to an interface clip; attaching the
interface clip to the handle of the biopsy gun such that the
interface clip with the connected introducer operatively couples to
and supports the biopsy gun; and receiving signals, from the
plurality of sensors, configured to provide feedback on the
position and orientation of the introducer.
15. The method as recited in claim 14, wherein: each of the
plurality of sensors includes an electrical connector; and the
interface clip is configured to electrically couple each electrical
connector to adaptor electronics configured to adapt a signal from
the corresponding sensor.
16. The method as recited in claim 15, further comprising
providing, by the adaptor electronics, amplification, noise
cancellation, and/or other adaptive signal processing of the
signal.
17. The method as recited in claim 16, wherein the adaptor
electronics are integrated as a physical part of the interface
clip.
18. The method as recited in claim 16, wherein further adaptor
electronics are included in a module external to the interface
clip.
19. The system as recited in claim 1, further comprising: receiving
the feedback and, based on the feedback, generating image
information indicating a position and orientation of the biopsy gun
in an image; estimating position of a biopsy sample based upon the
position and orientation of the biopsy gun; and generating an image
of the estimated position of the biopsy sample based on the image
information.
Description
RELATED APPLICATION INFORMATION
[0001] This application is a Continuation of application Ser. No.
15/324,137, filed Jan. 5, 2017 which is the U.S. National Phase
application under 35 U.S.C. .sctn. 371 of International Application
No. PCT/IB2015/055352, which claims priority to provisional
application Ser. No. 62/025,480, filed on Jul. 16, 2014. These
applications are hereby incorporated by reference herein.
BACKGROUND
Technical Field
[0002] This disclosure relates to medical instruments and more
particularly to a system and method to track a needle under
ultrasound guidance having dedicated hardware to enable
cost-effective tracking.
Description of the Related Art
[0003] A biopsy can be described as a minimally invasive procedure
where a sample of tissue is obtained for ex vivo pathologic
analysis. Typically, a biopsy device (or biopsy gun) can comprise
an inner stylet and outer hollow cannula, both of which can be
attached to the biopsy gun handle. In many instances, the biopsy
gun can be a disposable device. A typical biopsy device can be
positioned in tissue under some form of image guidance (typically
ultrasound (US)) and then `fired`. The act of firing generally
first deploys the inner stylet and then the outer cannula in quick
succession, thus capturing a tissue sample in the slot of the inner
stylet. The actual location of the biopsy sample can be offset from
the resting position of the biopsy device prior to firing.
[0004] In many biopsy procedures, disposable biopsy guns are
employed. Since these are typically designed for one-time use only,
incorporating ultrasound sensing technology along with its
amplifying and noise-cancelling electronics on these guns can be
complex and relatively expensive.
SUMMARY
[0005] In accordance with the present principles, a system for
tracking a medical device includes an introducer. Two or more
sensors are disposed along a length of the introducer and are
spaced apart along the length. An interface is configured to
connect to the introducer such that the introducer and the
interface operatively couple to and support the medical device
wherein the two or more sensors are configured to provide feedback
for positioning and orienting the medical device using medical
imaging.
[0006] Another system for tracking a medical device includes an
introducer, and two or more sensors disposed along a length of the
introducer and being spaced apart along the length. An interface is
configured to connect to the introducer such that the introducer
and the interface operatively couple to and support the medical
device wherein the two or more sensors are configured to provide
feedback for positioning and orienting the medical device. An
interpretation module is configured to receive the feedback and
generate image information for indicating a position and
orientation of the introducer in an image.
[0007] A method for tracking a medical device includes providing an
introducer with two or more sensors disposed along a length of the
introducer and being spaced apart along the length, the introducer
being coupled to an interface; operatively supporting the medical
device by the introducer and the interface; and receiving signals
from a subject by the two or more sensors which are configured to
provide feedback for positioning and orienting the medical device
in a medical image.
[0008] These and other objects, features and advantages of the
present disclosure will become apparent from the following detailed
description of illustrative embodiments thereof, which is to be
read in connection with the accompanying drawings.
BRIEF DESCRIPTION OF DRAWINGS
[0009] This disclosure will present in detail the following
description of preferred embodiments with reference to the
following figures wherein:
[0010] FIG. 1 is a schematic block/flow diagram showing a system
for tracking a medical device which includes sensors in an
introducer in accordance with one embodiment;
[0011] FIG. 2 is a timeline and diagram showing a system for
tracking a medical device with sensors in an introducer at three
instances: before firing, after firing an inner stylet and after
firing an outer cannula in accordance with one embodiment;
[0012] FIG. 3 is a schematic block/flow diagram showing a system
for tracking a medical device where an interface does not include
adaptor electronics and is disposable in accordance with one
embodiment; and
[0013] FIG. 4 is a flow diagram showing a method for tracking a
medical device in accordance with an illustrative embodiment.
DETAILED DESCRIPTION OF EMBODIMENTS
[0014] In accordance with the present principles, a biopsy
introducer is provided that includes one or more ultrasound
sensors. The introducer may include disposable and/or
non-disposable configurations. In one embodiment, an interface clip
is provided that attaches the introducer to a biopsy gun handle.
The exemplary interface clip can be configured to retrofit multiple
biopsy gun handles in an ergonomic manner. For example, in
accordance with exemplary embodiments, an interface clip can be
non-disposable (e.g., reusable) and/or disposable. In an exemplary
non-disposable version, the interface clip can include adaptor
electronics (e.g., amplifying and noise-cancelling electronics).
The exemplary introducer in this case can be either non-disposable
or disposable.
[0015] In accordance with another exemplary embodiment, the
interface clip can be disposable. In such a case, the exemplary
introducer and interface clip can be combined into a single
hardware design (device), since they can both be disposable. The
interface clip does not need to include the adaptor electronics, as
the adaptor electronics can be housed separately. Benefits of
exemplary embodiments can include, but are not limited to, no
requirement to sterilize the adaptor, since, e.g., the adaptor may
not come in contact with the patient. In one embodiment, the
interface clip can be attached to the biopsy gun handle. Other
embodiments can be commercialized independently and made compatible
with multiple disposable biopsy needles on the market.
[0016] In accordance with exemplary embodiments, dedicated hardware
can be employed to enable cost-effective tracking of a needle or
other device. InSitu technology can be utilized for biopsy
procedures, without modifying the biopsy gun design. InSitu
technology can be employed with commercially available biopsy guns,
for example. A modular design can interface with the biopsy gun
using a combination of non-disposable and/or disposable hardware to
employ.
[0017] It should be understood that the present invention will be
described in terms of medical instruments; however, the teachings
of the present invention are much broader and are applicable to any
trackable instruments. In some embodiments, the present principles
are employed in tracking or analyzing complex biological or
mechanical systems. In particular, the present principles are
applicable to internal tracking procedures of biological systems
and procedures in all areas of the body such as the lungs,
gastro-intestinal tract, excretory organs, blood vessels, etc. The
elements depicted in the FIGS. may be implemented in various
combinations of hardware and software and provide functions which
may be combined in a single element or multiple elements.
[0018] The functions of the various elements shown in the FIGS. can
be provided through the use of dedicated hardware as well as
hardware capable of executing software in association with
appropriate software. When provided by a processor, the functions
can be provided by a single dedicated processor, by a single shared
processor, or by a plurality of individual processors, some of
which can be shared. Moreover, explicit use of the term "processor"
or "controller" should not be construed to refer exclusively to
hardware capable of executing software, and can implicitly include,
without limitation, digital signal processor ("DSP") hardware,
read-only memory ("ROM") for storing software, random access memory
("RAM"), non-volatile storage, etc.
[0019] Moreover, all statements herein reciting principles,
aspects, and embodiments of the invention, as well as specific
examples thereof, are intended to encompass both structural and
functional equivalents thereof. Additionally, it is intended that
such equivalents include both currently known equivalents as well
as equivalents developed in the future (i.e., any elements
developed that perform the same function, regardless of structure).
Thus, for example, it will be appreciated by those skilled in the
art that the block diagrams presented herein represent conceptual
views of illustrative system components and/or circuitry embodying
the principles of the invention. Similarly, it will be appreciated
that any flow charts, flow diagrams and the like represent various
processes which may be substantially represented in computer
readable storage media and so executed by a computer or processor,
whether or not such computer or processor is explicitly shown.
[0020] Furthermore, embodiments of the present invention can take
the form of a computer program product accessible from a
computer-usable or computer-readable storage medium providing
program code for use by or in connection with a computer or any
instruction execution system. For the purposes of this description,
a computer-usable or computer readable storage medium can be any
apparatus that may include, store, communicate, propagate, or
transport the program for use by or in connection with the
instruction execution system, apparatus, or device. The medium can
be an electronic, magnetic, optical, electromagnetic, infrared, or
semiconductor system (or apparatus or device) or a propagation
medium. Examples of a computer-readable medium include a
semiconductor or solid state memory, magnetic tape, a removable
computer diskette, a random access memory (RAM), a read-only memory
(ROM), a rigid magnetic disk and an optical disk. Current examples
of optical disks include compact disk-read only memory (CD-ROM),
compact disk-read/write (CD-R/W), Blu-Ray.TM. and DVD.
[0021] Further, it should be understood that any new
computer-readable medium which may hereafter be developed should
also be considered as computer-readable medium as may be used or
referred to in accordance with exemplary embodiments of the present
invention and disclosure.
[0022] Reference in the specification to "one embodiment" or "an
embodiment" of the present principles, as well as other variations
thereof, means that a particular feature, structure,
characteristic, and so forth described in connection with the
embodiment is included in at least one embodiment of the present
principles. Thus, the appearances of the phrase "in one embodiment"
or "in an embodiment", as well any other variations, appearing in
various places throughout the specification are not necessarily all
referring to the same embodiment.
[0023] It is to be appreciated that the use of any of the following
"/", "and/or", and "at least one of", for example, in the cases of
"A/B", "A and/or B" and "at least one of A and B", is intended to
encompass the selection of the first listed option (A) only, or the
selection of the second listed option (B) only, or the selection of
both options (A and B). As a further example, in the cases of "A,
B, and/or C" and "at least one of A, B, and C", such phrasing is
intended to encompass the selection of the first listed option (A)
only, or the selection of the second listed option (B) only, or the
selection of the third listed option (C) only, or the selection of
the first and the second listed options (A and B) only, or the
selection of the first and third listed options (A and C) only, or
the selection of the second and third listed options (B and C)
only, or the selection of all three options (A and B and C). This
may be extended, as readily apparent by one of ordinary skill in
this and related arts, for as many items listed.
[0024] It will also be understood that when an element such as,
e.g., a layer, region or material is referred to as being "on" or
"over" another element, it can be directly on the other element or
intervening elements may also be present. In contrast, when an
element is referred to as being "directly on" or "directly over"
another element, there are no intervening elements present. It will
also be understood that when an element is referred to as being
"connected" or "coupled" to another element, it can be directly
connected or coupled to the other element or intervening elements
may be present. In contrast, when an element is referred to as
being "directly connected" or "directly coupled" to another
element, there are no intervening elements present.
[0025] Referring now to the drawings in which like numerals
represent the same or similar elements and initially to FIG. 1, an
illustrative biopsy system 10 is shown in accordance with one
embodiment. The system 10 includes a biopsy gun 12 configured for
needle tracking. The biopsy gun 12 includes a biopsy needle 14
having an inner stylet 16 disposed within an outer cannula 18. The
needle 14 is in turn disposed within an introducer 20. The
introducer 20 encapsulates the needle 14. The introducer 20
includes one or more tracking sensors 22.
[0026] The tracking sensors 22 may include ultrasonic sensors
although other types of sensors may be employed for tracking the
needle 14.
[0027] In one embodiment, the introducer 20 is connected with an
interface 32. The interface 32 connects the introducer 20 to a
biopsy gun handle 24. The interface 32 may include adaptor
electronics 26 therein. The adaptor electronics 26 may include
noise cancellation modules 28 (software and/or hardware),
amplifiers 30 and any another signal processing modules 34 needed
to process received signals from sensors 22.
[0028] The sensors 22 function as ultrasound trackers. The
introducer 20 and the sensors 22 may be disposable or
non-disposable. In one embodiment, the ultrasound trackers for
sensors 22 may include PZT, PVDF, or other piezoelectric element
disposed between conductive plates or layers. The interface or
interface clip 32 may be employed to attach the introducer 20 to
the biopsy gun handle 24. The interface 32 may include the adaptor
electronics 26 and be reusable (non-disposable). In another
embodiment, the interface 32 may be made disposable. In another
embodiment, the introducer 20 and interface 32 can be combined into
a single disposable device. A sensor cable 36 can be provided
(although wireless connections are also contemplated) as an output
from the interface 32 and can be connected to an adaptor or other
connector. The interface 32 may be reusable (non-disposable).
[0029] In one embodiment, the introducer 20 includes a hollow tube
including one or more ultrasound trackers or sensors 22 that can be
tracked using InSitu technology. The introducer 20 may have an
inner diameter that is marginally thicker than the cannula 18,
thereby permitting the cannula 18 and the stylet 16 to fit inside
the introducer 20. The length of the introducer 20 can be
approximately equal to the length of the needle 16 in its resting
position prior to firing. If at least two sensors 22 are employed,
the orientation of the introducer 20 (and also the cannula 18 and
stylet 16) can be estimated. Therefore, the biopsy location
coordinates can be computed prior to firing.
[0030] The biopsy system 10 may work in conjunction with or be
integrated in a workstation or console 42 from which a procedure is
supervised and/or managed. Workstation 42 preferably includes one
or more processors 44 and memory 46 for storing programs and
applications. Memory 46 may store an interpretation module 45
configured to interpret feedback signals from sensors 22.
Interpretation module 45 is configured to employ the signal
feedback (and any other feedback, e.g., electromagnetic (EM)
tracking) to reconstruct position and orientation of the introducer
20 or other medical device or instrument. The other medical devices
may include a catheter, a guidewire, a probe, an endoscope, a
robot, an electrode, a filter device, a balloon device, or other
medical component, etc.
[0031] In one embodiment, workstation 42 includes an image
processing module 48 configured to receive feedback from the
sensors 22 and further process the information to determine
position and orientation of the introducer 20 within a volume
(subject) 54. An image 50 for the space or volume 54 can be
generated and displayed on a display device 52 that indicates the
position and orientation of the introducer 20 (and other
components) in a live image.
[0032] Interpretation module 45 can also be configured to determine
an estimated position of where a biopsy sample will be taken in the
subject 54. The interpretation module 45 may convey this
information to the image processing module 48 to generate an image
showing a location of the estimated position to assist a user. The
image may include a line or other shape to provide a visual
indicator (see FIG. 2, estimated position 104).
[0033] Workstation 42 includes the display 52 for viewing internal
images of a subject (patient) or volume 54 and may include the
image as an overlay or other rendering of the sensors 22,
introducer 20, needle 14, etc. Display 52 may also permit a user to
interact with the workstation 42 and its components and functions,
or any other element within the system.
[0034] This is further facilitated by an interface 60 which may
include a keyboard, mouse, a joystick, a haptic device, or any
other peripheral or control to permit user feedback from and
interaction with the workstation 42.
[0035] An imaging system 70 is provided for imaging the introducer
20 for guidance and positioning. In one embodiment, the imaging
system 70 includes an ultrasound imaging system, which employs an
imaging probe 72. The imaging probe 72 provides ultrasonic energy,
which is received by the sensors 20. The sensors 20 are
electrically connected (by wires, not shown, or wirelessly) to the
adaptor electronics 26 for signal processing and amplification. The
adaptor electronics 26 may in turn be connected to the workstation
42 where the interpretation module 45 further processes the
signals, registers the introducer 20 (and other components) to the
images collected by the imaging system 70. While the imaging system
70 is described as an ultrasound imaging system 70, other imaging
technologies may be employed.
[0036] Referring to FIG. 2, an illustrative timeline 100 is shown
for a biopsy procedure that employs the introducer with sensors in
accordance with the present principles. In a first instance 102, a
biopsy needle 14 is loaded in a ready-to-fire position. Using two
or more sensors 22 on the introducer 20, the orientation of the
introducer 20 and therefore the needle 14 will be known. An
estimated biopsy location 104 may be determined based upon the
needle/introducer orientation and a known throw of the inner stylet
16 relative to the outer cannula 18. In other words, the estimated
location 104 can easily be estimated using the positions of the
sensors 22 as a baseline and adding the throw of the inner stylet
16 in the direction of the introducer 20. The estimated biopsy
location 104 may be indicated in an image to assist the user.
[0037] The sensors 22 may include ultrasound sensors. In this case,
an ultrasound probe transmits signals that are received by the
sensors 22. Using time of flight information and knowledge of the
coordinate system of the subject, positions of the sensors 22 (and
therefore introducer 20 and the needle 14) can be determined in the
ultrasound space and the estimated location 104 determined.
[0038] In a second instance 110, the inner stylet 16 is fired. The
inner stylet 16 rapidly advances to the throw extent to capture a
biopsy sample in a chamber 106 of the inner stylet 16 that
corresponds with the estimated position 104. In a third instance
120, the outer cannula 18 is advanced to shear off the biopsy
sample in the chamber 106 and enclose the chamber 106 to safely
remove the biopsy sample from the subject.
[0039] Referring to FIG. 3, another embodiment of a biopsy system
200 is illustratively shown. Biopsy system 200 includes a
disposable interface 232. The interface 232 is attached to an
introducer 220 such that the interface 232 and the introducer 220
are removable and disposable from a biopsy gun handle 212.
[0040] The biopsy gun 212 is configured for needle tracking. The
biopsy gun 212 includes a biopsy needle 214 having an inner stylet
216 disposed within an outer cannula 218 as described above. The
needle 214 is, in turn, disposed within the introducer 220, which
may include a hollow tube introducer 220 to encapsulate the needle
214. The introducer 220 includes one or more tracking sensors 222
(e.g., on the inside diameter of the tube, although the sensors 222
may be mounted on an exterior of the introducer 220). The tracking
sensors 222 may include ultrasonic sensors although other types of
sensors may be employed for tracking the needle 214.
[0041] In one embodiment, the introducer 220 may be integrally
formed with the interface 232 or the interface 232 may be a
separate part that connects to the introducer 220. The interface
232, since it is disposable, may or may not include adaptor
electronics therein. The adaptor electronics may be included in a
separate module 228 for noise cancellation, amplifiers, etc. to
process received signals from sensors 222.
[0042] The sensors 222 may include one or more ultrasound trackers.
The introducer 220 and the sensors 222 may be disposable. In one
embodiment, the ultrasound trackers for sensors 222 may include
PZT, PVDF, or other piezoelectric element disposed between
conductive plates or layers. The interface 232 may be employed to
attach the introducer 220 to the biopsy gun handle 224. The
interface 232 may include the adaptor electronics and be reusable
(non-disposable), although a disposable embodiment may include a
reusable adaptor electronics module 228. In this instance, the
interface 232 is disposable and the adaptor electronics 228 are not
disposable. A cable 234 can be provided as an output from the
sensors 222 and can be connected to the adaptor electronics module
228 or other connector or system, e.g., a system employing InSitu
technology (see e.g., FIG. 1).
[0043] The interface 232 may include an opening 240 to receive the
introducer 220. When the introducer 220 is fitted into the
interface 232, an electrical connection is completed between a wire
or wires of the sensors 220 through the introducer 220 and to the
cable 234 from the interface 232. The introducer 220 can be
disposable or non-disposable with the sensors 222 and their wiring.
The adaptor electronics can then be housed separately (module 228)
so that it does not come in contact with the subject (e.g., the
patient).
[0044] Referring again to FIG. 1 with continued reference to FIG.
3, the use of ultrasound tracking technology (InSitu) can be
utilized to more accurately estimate a true location of the biopsy
sample. For example, InSitu technology can be used to estimate the
position of a passive ultrasound sensor (e.g., PZT, PVDF, copolymer
or other piezoelectric material) in a field of view (FOV) of a
diagnostic B-mode image by analyzing a signal received by a sensor
as beams of the imaging probe sweep the FOV. Time-of-flight
measurements can be used to provide the axial/radial distance of
the sensor 22 (FIG. 1) or 222 from the imaging array of the
ultrasound system, while amplitude measurements and knowledge of
the beam firing sequence can be used to provide (or determine) the
lateral/angular position of the sensor 22, 222. When used with 3D
transducers (e.g., 2D matrix arrays) (US imaging probe), the
elevational position of the sensor 22, 222 can also be obtained in
a similar manner. Therefore, the 3D position of the sensor 22, 222
can be estimated in real-time, provided it is present within the
FOV of the imaging transducer.
[0045] The sensors 22, 222 on the introducer 20, 220 passively
listen to the ultrasound waves impinging on them as the imaging
probe's beams sweep the field of view. Analysis of these signals
yields the position of the sensor 22, 222 on the introducer 20, 220
in the frame of reference of the ultrasound image. The position can
then be overlaid on an ultrasound image for enhanced visualization,
and the positions and their histories can be logged for tracking,
segmentation, and other applications.
[0046] Embodiments in accordance with the present principles can be
made compatible with multiple biopsy needles on the market. In
addition, the introducers described herein may be employed in
procedures other than biopsy procedures. For example, the present
principles may be employed for ablation needle guidance, catheter
guidance, endoscopic procedures, etc. Moreover, it is contemplated
that corresponding and/or related systems incorporating and/or
implementing the present principles are also contemplated and
considered to be within the scope of the present invention.
Further, corresponding and/or related methods for manufacturing
and/or using a device and/or system in accordance with the present
disclosure are also contemplated and considered to be within the
scope of the present invention.
[0047] Referring to FIG. 4, a method for tracking a medical device
is illustratively shown. In block 302, an introducer is provided
with two or more sensors disposed along a length of the introducer.
The sensors are spaced apart from adjacent sensors along the
introducer to assist in providing position and orientation
information for tracking the introducer. The introducer is coupled
to an interface at one end portion. In block 306, the medical
device is operatively supported by the introducer and the
interface. This means that, e.g., if the medical device includes a
biopsy needle, the needle fits within the introducer and is
operable (e.g., can be fired) from the introducer. In addition, the
interface supports the introducer by providing a mechanical support
between the biopsy gun and the introducer. Other configurations are
also contemplated.
[0048] In block 310, signals are received from a subject by the two
or more sensors, which are configured to provide feedback for
positioning and orienting the medical device in a medical image. In
block 312, the feedback signals are processed using adaptor
electronics configured to connect to the sensors and provide noise
cancellation, amplify the signals, filter the signals, etc.
[0049] In block 314, the introducer and therefore the medical
device is positioned in a field of view of an image and aligned
with a biopsy sample or other target using the feedback
signals.
[0050] In block 316, the medical device may include a biopsy gun
including a needle with an inner stylet and an outer cannula. An
estimate position of a biopsy sample may be determined based upon a
position and orientation of the introducer. The estimate position
may be manually determined or may be computed using an
interpretation module (FIG. 1). In block 318, an image may be
generated on a display to show the estimate position based upon the
position and orientation of the introducer. The image may include
an indicator, such as an arrow, shape, line, etc. or may include an
overlay or a virtual image. In block 320, operative tasks are
performed, for example, fire the biopsy gun, take the biopsy
sample, etc. In block 322, one or more of the introducer, the
interface, the medical instrument may be disposed. In one
embodiment, the introducer is disposable and the interface is
reusable. In another embodiment, the introducer and the interface
are disposed of as a single unit or integrated assembly. The
interface may or may not include adaptor electronics.
[0051] In interpreting the appended claims, it should be understood
that: [0052] a) the word "comprising" does not exclude the presence
of other elements or acts than those listed in a given claim;
[0053] b) the word "a" or "an" preceding an element does not
exclude the presence of a plurality of such elements; [0054] c) any
reference signs in the claims do not limit their scope; [0055] d)
several "means" may be represented by the same item or hardware or
software implemented structure or function; and [0056] e) no
specific sequence of acts is intended to be required unless
specifically indicated.
[0057] Having described preferred embodiments for ultrasound
tracking apparatus for disposable biopsy needles (which are
intended to be illustrative and not limiting), it is noted that
modifications and variations can be made by persons skilled in the
art in light of the above teachings. It is therefore to be
understood that changes may be made in the particular embodiments
of the disclosure disclosed which are within the scope of the
embodiments disclosed herein as outlined by the appended claims.
Having thus described the details and particularity required by the
patent laws, what is claimed and desired protected by Letters
Patent is set forth in the appended claims.
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