U.S. patent application number 12/365918 was filed with the patent office on 2009-06-04 for user interface system for mammographic imager.
Invention is credited to John Conner, Curtis Daly, Morgan W. Nields.
Application Number | 20090143674 12/365918 |
Document ID | / |
Family ID | 24933944 |
Filed Date | 2009-06-04 |
United States Patent
Application |
20090143674 |
Kind Code |
A1 |
Nields; Morgan W. ; et
al. |
June 4, 2009 |
USER INTERFACE SYSTEM FOR MAMMOGRAPHIC IMAGER
Abstract
The present invention provides for x-ray imaging and ultrasound
imaging of a body region of interest in a spatially correlatable
manner. The resultant x-ray and ultrasound images may be
combinatively employed to provide three-dimensional information
regarding a location of interest within the body, and is
particularly apt for use in the analysis/biopsy of potential
lesions and suspicious masses in a female breast. The invention
provides for direct body contact by an ultrasound imaging head, as
well as targeted ultrasound imaging of a selected portion of the
region from which x-ray images are obtained. A user interface
system facilitates various procedures including ultrasound guided
needle biopsy procedures.
Inventors: |
Nields; Morgan W.;
(Englewood, CO) ; Conner; John; (Elizabeth,
CO) ; Daly; Curtis; (Denver, CO) |
Correspondence
Address: |
CYTYC CORPORATION;Darry Pattinson, Sr. IP Paralegal
250 CAMPUS DRIVE
MARLBOROUGH
MA
01752
US
|
Family ID: |
24933944 |
Appl. No.: |
12/365918 |
Filed: |
February 5, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10260719 |
Sep 27, 2002 |
7496398 |
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12365918 |
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09449267 |
Nov 24, 1999 |
6459925 |
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10260719 |
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09111094 |
Jul 6, 1998 |
6102866 |
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09449267 |
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08730107 |
Oct 15, 1996 |
5776062 |
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09111094 |
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Current U.S.
Class: |
600/437 |
Current CPC
Class: |
A61B 8/406 20130101;
A61B 6/4417 20130101; A61B 6/0435 20130101; A61B 6/502 20130101;
A61B 6/5247 20130101; A61B 8/4218 20130101; A61B 8/5238 20130101;
A61B 10/0233 20130101; A61B 8/0825 20130101; A61B 90/17 20160201;
A61B 17/3403 20130101; Y10S 128/916 20130101; Y10S 128/915
20130101 |
Class at
Publication: |
600/437 |
International
Class: |
A61B 8/00 20060101
A61B008/00 |
Claims
1. An apparatus for use in performing medical procedures on a
patient's breast, comprising: an immobilizer for immobilizing the
patient's breast; an ultrasound device for obtaining real-time
ultrasound images of the patient's breast for use in identifying a
region of interest; a processor, operatively couplable to at least
one of the immobilizer and a medical instrument for controlling
relative positions of the immobilization assembly and medical
instrument in response to information in the real-time ultrasound
image
2-11. (canceled)
12. A method comprising the steps of: immobilizing a patient's
breast using an immobilization assembly; obtaining a real-time
ultrasound image of the patient's breast; using the real-time
ultrasound image to identify a region of interest in the patient's
breast; and controlling using an operatively connected processor,
relative positions of at least one of the immobilization assembly
and a medical instrument in response to the real-time ultrasound
image to position the medical instrument relative to the region of
interest
13. (canceled)
Description
RELATED APPLICATION INFORMATION
[0001] This application claims priority from U.S. Provisional
Patent Application Ser. No. 09/449,267, filed Nov. 24, 1999, which
is a continuation-in-part of prior U.S. patent application Ser.
Nos. 60/109,881, filed on Nov. 25, 1998 and 09/111,094, filed on
Jul. 6, 1998, both of which are incorporated herein by reference in
their entireties. The latter application is a continuation-in-part
of U.S. patent application Ser. No. 08/730,107, now issued as U.S.
Pat. No. 5,776,062.
FIELD OF THE INVENTION
[0002] The present invention relates to medical imaging/biopsy
systems, and more particularly, to an enhanced system that employs
x-ray imaging and targeted ultrasound imaging in a combinative,
spatially correlatable manner that is particularly apt for breast
imaging/biopsy procedures. The invention further relates to
targeted ultrasound features that yield plural modalities of
operation as well as improved biopsy capabilities and a user
interface system for facilitating targeting of a medical instrument
to an area of interest within a patient's breast.
BACKGROUND OF TUE INVENTION
[0003] The benefits of early detection and tissue diagnosis of
potential lesions and/or suspicious masses within the body is now
well established. Indeed, as medical practice and managed care
plans continue to evolve, the role of early detection and tissue
diagnosis is ever-increasing. With such emphasis, both efficacy and
efficiency are at a premium, Specifically, reduction of the time
requirements of highly trained medical personnel, patient office
visits and medical equipment costs (e.g., via use of
multiple-purpose equipment) are primary objectives for procedures
utilized in the early detection and tissue diagnosis of potential
lesions and otherwise suspicious masses.
[0004] Of particular ongoing interest is the area of mammography
and breast biopsy. Currently, it is common for patients to receive
regular screening mammograms, wherein two x-ray images are
generated for each breast in order to identify potential lesions or
masses suspicious for malignancy. In the event of equivocal
screening mammograms, further x-ray or ultrasound imaging/exams may
be performed to obtain additional information. The obtainment of a
diagnostic mammogram and/or an ultrasound exam requires another
patient office visit and additional medical personnel time. For
example, if the presence of a suspicious mass is confirmed, an
ultrasound procedure may be performed in order to further
characterize the mass. Specifically, a free-hand procedure can be
performed in which a hand-held ultrasound probe is manipulated on
the breast while viewing a display to obtain depth-profile
information As can be appreciated, location of a potential
lesion/suspicious mass can be difficult, and the ultrasound images
obtained are frequently difficult to mentally associate with the
x-ray images. As such, the ability to utilize ultrasound
technologists as opposed to experienced physician specialists to
perform most breast ultrasound procedures is limited.
[0005] Should a breast lesion show signs of malignancy pursuant to
diagnostic mammography or ultrasound, a breast biopsy is typically
performed. Needle localized surgical biopsy means have recently
been giving way to stereotactic x-ray biopsy with automated core
needles and tissue removal systems. A patient is typically
positioned prone (e.g., on a solid table) with the breast
immobilized within a predetermined frame of reference (e.g., the
breast passes through an opening in the table and is immobilized
between opposing compression plates). Stereotactic X-ray images are
then generated (e.g., via x-ray film or digital imaging) for review
by medical personnel to identify a specific location of interest
(e.g., corresponding with a potential lesion or suspicious mass)
within the predetermined frame of reference. A puncture instrument,
mounted in predetermined relation to the predetermined frame of
reference, is then positioned/utilized to obtain a sample of tissue
from the location of interest. Of note, current state-of-the-art
breast biopsy systems include the MAMMOTEST.RTM., MAMMOVISION.RTM.
and SENOSCAN.TM. products offered by Fischer Imaging Corporation of
Denver, Colo. Such systems are further described in U.S. Pat. Nos.
5,078,142, 5,240,011, 5,415,169, 5,526,394 and 5,735,264, hereby
incorporated by reference in their entirety.
[0006] While breast lesions may typically be biopsied utilizing
stereotactic x-ray imaging, only recently have technical
improvements in ultrasound allowed certain lesions to be biopsied
under ultrasound guidance (i.e., With hand-held ultrasound probe
and/or biopsy means). In this regard, ultrasound may be preferred
due to the lack of ionizing radiation and the established
availability of real time imaging to reduce procedure time.
[0007] Recent developments in tissue removal systems have resulted
in larger, heavier devices that are difficult for a physician to
use in conjunction with free-hand ultrasound guidance. As an
example, the MAMMOTOME.TM. from Biopsys Medical, Inc. of Irvine,
Calif. allows rapid removal of breast tissue through a small
puncture hole in the breast. Due to the weight and size of the
device, physicians are performing more stereotactic x-ray
procedures with the MAMMOTOME.TM. due to the solid support of the
device by prone stereotactic tables.
[0008] In the event that analysis of tissue by histopathologic
techniques indicates that a lesion or undesirable mass should be
removed from a breast, the surgeon will typically review the
various breast images previously obtained to develop a therapeutic
surgical strategy, with the goal of removing the entire potential
lesion and/or suspicious mass while achieving acceptable cosmetic
results.
SUMMARY OF THE INVENTION
[0009] It is an object of the present invention to provide an
enhanced imaging/biopsy system that can reduce trained medical
personnel time requirements in diagnostic and biopsy procedures for
tissue diagnosis. It is a related objective to provide such a
system in a cost-effective manner; namely through the provision of
a system having relatively expensive components that can be
utilized for multiple medical procedures combinatively employed in
a single system.
[0010] A further objective of the present invention is to provide
an enhanced imaging/biopsy system for obtaining spatially
correlated three-dimensional image information regarding a location
of interest in the body, such system being apt for the obtainment
of three-dimensional image information regarding a potential lesion
or suspicious mass in a female patient's breast. It is a further
objective to provide such information in a manner allowing for
enhanced use of tissue removal systems used for obtaining tissue
samples from the body, including specifically, tissue from a
potential lesion or suspicious mass within a female patient's
breast. Such information may also be used in conjunction with other
targeted instruments such as guide wire placement devices and
instruments for ablation, delivery, etc.
[0011] Yet another objective of the present invention is to provide
an enhanced imaging/biopsy system for obtaining depth-related image
information for diagnostic use and for otherwise yielding
biopsy-related control and access advantages.
[0012] These objectives and additional advantages are met by
various aspects of the present invention. In this regard, one
aspect of the present invention provides for the combinative use of
x-ray imaging and targeted ultrasound imaging. More particularly,
this inventive aspect provides for the transmission of x-ray
radiation through a selected body region-of-interest within a
predetermined, three-dimensional frame of reference to obtain x-ray
image data corresponding with one or more x-ray images.
Additionally, an ultrasound signal is directed into a limited,
selectively targeted portion of the x-rayed body region of interest
to provide ultrasound image data corresponding with one or more
ultrasound images of the targeted portion of the selected body
region. The x-ray and ultrasound image data are acquired in spatial
co-relation by utilizing x-ray imaging means and ultrasound imaging
means each supportably positioned in known co-relation to the
predetermined, three-dimensional frame of reference. This
arrangement allows the x-ray and ultrasound image data to
combinatively provide correlated, three-dimensional image data
corresponding with the body region of interest. In turn, the
spatially correlated information allows for an enhanced medical
diagnosis of a given location of interest within the body region
(e.g., potential lesion or suspicious mass in a breast application)
and enhanced biopsy options in relation thereto.
[0013] In an additional aspect of the present invention, an
ultrasound imaging means is provided that is advantageously
positionable in direct contact with the body region of interest for
optimal ultrasound image acquisition. More particularly, in breast
imaging applications, opposing compression plates may be employed
to immobilize a patient's breast within the predetermined,
three-dimensional frame of reference, wherein an opening is
provided in one of the compression plates for selectively
positioning an ultrasound imaging head (e.g., comprising a linear
ultrasound transducer array) therethrough in contact with the
patients breast for imaging. The ultrasound imaging means may be
positioned below and on either side of a center axis of a patient
support table, or alternatively, may be positioned below and in
substantially coaxial relation to a patient support table.
[0014] Yet another aspect of the present invention, a locating
means (e.g., an image data processor with display/user interface)
is provided for using x-ray and ultrasound image data to identify a
particular location of interest within the body region of interest;
and a biopsy means is provided for obtaining a sample from the
identified location of interest. In this regard, the biopsy means
may include positioning means for selectively and supportably
positioning an elongated puncture instrument or other tissue
removal system relative to the predetermined, three-dimensional
frame of reference, including for example positioning at a desired
entry angle.
[0015] In a further aspect of the present invention, an ultrasound
imaging means is provided that comprises a means for selectively
positioning an elongated ultrasound imaging head in a known
position relative to the predetermined, three-dimensional frame of
reference, including angulation of the ultrasound imaging head
relative to the predetermined frame of reference. In the latter
regard, the imaging head may be angled to image a layer, or
"slice," of the body region of interest from a direction orthogonal
to a direction from which an angled puncture instrument or other
tissue-removal system may be advanced within such layer (i.e., the
longitudinal axes of the imaging head and puncture instrument are
substantially parallel). Such ultrasound imaging allows for
processor simulation/display of a biopsy procedure using a
tissue-removal system from a given biopsy position, as well as
real-time imaging/control of a biopsy device as it is actually
advanced into the body region of interest.
[0016] In an additional aspect of the present invention, an
ultrasound imaging means is provided that comprises a positioning
means for supportably and selectively positioning an ultrasound
imaging probe in known spatial relation to the predetermined,
three-dimensional frame of reference, while also and alternatively
allowing the ultrasound imaging probe to be disengaged from the
positioning means and manually manipulated in hand-held procedures.
More particularly, the positioning means may comprise a holder
means for selectively receiving an ultrasound imaging probe that is
also adapted for hand-held use, wherein the probe may be
selectively employed for hand-held manipulation or alternatively
positioned within the holder means (e.g., via sliding and/or
"snap-in" engagement). In the later regard, the positioning means
may be employed to supportably position the ultrasound imaging
probe in predetermined relation relative to the predetermined
three-dimensional frame of reference to obtain depth information in
a desired layer, or "slice" of the body region of interest.
Further, the positioning means may comprise one or more drive means
for providing at least partial automated positioning of tile
ultrasound imaging probe (e.g., for automated X and/or Y dimension
positioning and/or for automated rotational positioning about a Z
axis within an MY plane).
[0017] As indicated above x-ray images may be employed to select a
limited, or targeted, portion of the x-rayed body region of
interest to be imaged utilizing the ultrasound signal. Such
targeted ultrasound imaging avoids the acquisition, storage and
processing of unneeded imaging data, and otherwise facilitates
efficient use of medical personnel time, and otherwise
advantageously accommodates direct contact with the body portion to
be imaged. Further, where necessary, the provision of a hand-held
ultrasound imaging option provides practitioners with added
flexibility as may be desirable in certain applications.
[0018] According to a further aspect of the present invention, an
ultrasound imaging apparatus is provided that has an improved
imaging focal depth. It has been noted that a linear array of
transducer elements may have a focal depth that is only a portion
of the thickness of a patient's immobilized breast. En this regard,
in order to provide for more complete imaging for a range of
patients, it is desirable to provide a greater focal depth. In
particular, it would be desirable to provide a focal depth
approaching to accommodate a range of patients and procedures. A
corresponding apparatus with improved focal depth includes a probe
structure supporting a transducer array that includes at least a
first set of transducer elements disposed a first distance from the
signal interface surface of the probe structure and a second set of
transducer elements disposed a second distance from the signal
interface surface. The first and second sets of elements thereby
provide a combined focal depth that is greater than the focal
depth-that would be provided by either of the transducer sets
considered alone. In a preferred implementation, a transducer array
includes 7 or more columns of array elements where each column is
disposed a different distance from the signal interface surface of
the probe structure. Such a structure provides for improved imaging
for a range of patients.
[0019] In accordance with a still further aspect of the present
invention, a display is provided proximate to the patient's breast
in order to facilitate real time monitoring of insertion of a
medical instrument into the patient's breast. The associated
apparatus includes: an immobilizer for immobilizing the patient's
breast; a first graphical display for displaying one or more images
of the patient's breast so as to permit identification of an area
of interest within the patient's immobilized breast; a medical
instrument operative for insertion to the identified area of
interest within the patient's breast; and a second graphical
display, separate from the first graphical display and located
proximate to the patient's immobilized breast, for providing real
time images of the patient's compressed breast so that a user can
monitor insertion of the medical instrument to the identified
location of interest using the second graphical display located
proximate to the patient's immobilized breast. Preferably, the
second graphical display can be translated and rotated to
facilitate viewing during a medical procedure. In one embodiment,
the patient is supported in a prone position on a table with the
breast under examination protruding through an opening in the table
and the second display is disposed beneath the table for convenient
viewing, Real time images such as ultrasound images can be
monitored on the second display during insertion of a medical
instrument such as a biopsy needle for improved guidance and
confidence regarding sampling of suspicious masses.
[0020] According with a still further aspect of the present
invention, an improved graphical interface is provided for guiding
a user through a medical procedure. The associated method includes
the steps of: providing a mammographic medical device for use in
performing a medical procedure on a patient's breast; providing a
display device having a graphical viewing area; providing a
processor operative to drive the display device so as to display
selected information in the viewing area; operating the display
device using the processor to provide a first display whereby the
user is presented with options corresponding to different operating
modes of the medical device; operating the processor in response to
an input regarding the operating mode to provide instructions for
operating the medical device to obtain first and second images,
where at least one of the images is an ultrasound image; operating
the processor to display the images in a first portion of the
graphical viewing area and provide graphical objects in a second
portion of the viewing area for use in entering information related
to the medical procedure; and using the first and second images to
perform a medical procedure on the patient's breast.
[0021] Preferably, one of the images is an x-ray image and the
other image is an ultrasound image. In response to prompts provided
via the display device, the user can identify a location of
interest within the patient's breast on each of the first and
second images. The user may also enter certain image enhancement
functions and enter additional information such as needle type
using the display device. In one implementation, the processor is
operative for displaying a projected penetration path of a medical
instrument in superimposition on at least one of the images. The
processor may further be operative for comparing an actual
penetration path to the projected penetration path to identify any
deviation therebetween and, if desired, to provide appropriate
warnings. The graphical user interface system thereby provides
enhanced functionality, provides simple to follow instructions for
medical personnel and allows for close monitoring of a medical
procedure for increased accuracy and confidence in the results.
[0022] Additional features and advantages of the present invention
will become apparent upon consideration of the further description
provided herein.
DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 is a top view of a stereotactic x-ray imaging system
with integrated ultrasound imaging and biopsy components
combinatively defining one embodiment of the present invention with
a central patient/table portion cutaway to show key components.
[0024] FIG. 2 is a partial end cross-sectional view of the
embodiment of FIG. 1 cut along AA.
[0025] FIG. 3 is a partial side cross-sectional view of the
embodiment of FIG. 1 cut along BB.
[0026] FIG. 4 is a perspective view of the immobilization,
ultrasound imaging and biopsy assemblies of the embodiment of FIG.
1.
[0027] FIG. 5 is a perspective view of an ultrasound imaging head
employable in the present invention.
[0028] FIG. 6 illustrates spatially correlated x-ray and ultrasound
images of a potential breast lesion/suspicious mass obtainable with
the present invention.
[0029] FIG. 7 illustrates a side-view of an alternative embodiment
of an ultrasound imaging assembly comprising the present
invention.
[0030] FIG. 8 illustrates a partially cut-away end view of the
alternate ultrasound imaging assembly embodiment of FIG. 7.
[0031] FIG. 9A is a schematic diagram of a linear ultrasound probe
head array in accordance with the present invention.
[0032] FIG. 9B is a schematic diagram illustrating an ultrasound
signal profile for the probe of FIG. 9A.
[0033] FIG. 9C is a schematic diagram of a planar ultrasound probe
head array in accordance with the present invention.
[0034] FIG. 9D is a schematic diagram showing an ultrasound signal
profile for the probe head of FIG. 9C.
[0035] FIGS. 10-20 show various screens of a user interface system
in accordance with the present invention.
DETAILED DESCRIPTION
[0036] FIGS. 1-6 illustrate one embodiment of a diagnostic
ultrasound/x-ray biopsy system comprising the present invention, as
adapted for mammography/breast biopsy use.
[0037] Generally; the system comprises a support assembly 10 having
a patient table 12 with breast-opening 14 therethrough, an
immobilization assembly 30 for immobilizing a patient's breast
within a predetermined XYZ frame of reference under the opening 14
of table 12, an x-ray imaging assembly 40 for providing
two-dimensional x-ray images (e.g., X-Y images) of the patient's
immobilized breast in correlated spatial relation to the
predetermined XYZ frame of reference, and an ultrasound imaging
assembly 100 for providing orthogonal depth-profile images (e.g.,
X-Z, Y-Z and/or X, Y-Z images) of the immobilized breast in
correlated spatial relation to the predetermined XYZ frame of
reference. A biopsy assembly 50 having puncture instrument 52 is
also provided for obtaining samples from a patient's breast while
the breast is immobilized in the predetermined XYZ frame of
reference. A display/processor assembly 60 is provided for
recording/displaying the various images obtained/generated, for
determining the coordinates of a user-identified location of
interest within the breast and for
monitoring/controlling/simulating the position of the various
positionable assembly components.
[0038] As will be appreciated, the illustrated embodiment may
utilize the x-ray, automated biopsy and other functionalities
embodied in the current MAMMOTEST.RTM. and MAMMOVISION.RTM.
products of Fischer Imaging Corp. of Denver, Colo., U.S.A. In this
regard, the present invention allows for the integration and
effective use of ultrasound imaging with such products, thereby
allowing medical equipment cost efficiencies to be realized. As
noted previously, the MAMMOTEST.RTM. and MAMMOVISION.RTM. products
include features corresponding with the disclosures in U.S. Pat.
Nos. 5,078,142, 5,240,011 and 5,415,169, and 5,735,264, which are
incorporated by reference in their entirety.
[0039] Support assembly 10 Her includes pedestal 16 and
cantilevered first and second support arms 20 and 22, respectively,
for supportably interfacing the breast immobilization assembly 30,
x-ray imaging assembly 40, ultrasound imaging assembly 100 and
biopsy assembly 50 in a predetermined spatially correlated manner.
First and second supports arms 20 and 22 can be jointly pivoted
relative to pedestal 16, thereby providing imaging/biopsy access to
the breast from different directions (e.g., 0.degree., +90.degree.
and -90.degree. relative to the table longitudinal axis).
Additionally, second support arm 22 can be selectively pivoted
relative to first support arm 20, to provide for stereotactic x-ray
imaging (e.g., +15.degree. and -15.degree. relative to the first
support arm longitudinal axis).
[0040] Breast immobilization assembly 30 is supported on first
support arm 20 and includes a stationary face plate 32 and opposing
compression paddle 34 for immobilizing a patient's breast
therebetween. Compression paddle 34 is x-ray transmittent and
further includes a window 36 for direct breast access by the
ultrasound imaging assembly 100 and/or biopsy assembly 50.
Compression paddle 34 is selectively positionable along first
support arm 20 (e.g., via motorized and position sensor systems)
for controlled, registered movement toward/away from face plate 32
to accommodate breast positioning/removal and differing breast
sizes. Compression paddle 34 can be readily removed
from/interconnected to the first support arm 20 to accommodate the
selective use of compression paddles of differing sizes, shapes,
window positions, etc. As shown in FIG. 1, compression assembly 30
may further include selectively advanceable/retractable auxiliary
side paddles 38, each having optional openings for breast access
(e.g., by a puncture instrument or an ultrasound imaging head) for
further compression/breast immobilization within the predetermined
XYZ frame of reference, and particularly during use of biopsy
assembly 50. In this regard, compression paddle 34 and faceplate 32
are intended to define abreast imaging area of substantially common
thickness and to immobilize such area during imaging/biopsy
procedures, and to otherwise provide direct access to the breast
for targeted ultrasound imaging/biopsy procedures.
[0041] X-ray imaging assembly 40 includes x-ray tube source 42
mounted on the end of second support arm 22 and x-ray
receiver/imager 44 mounted on first support arm 20. As will be
appreciated, x-ray tube source 42 provides x-ray radiation having a
center axis C substantially perpendicular to the fronts of face
plate 34 and x-ray receiver/imager 44, such x-ray radiation having
a focal point positioned along the center axis C at a determinable
location between the face plate 32 and compression paddle 34 during
use. In this regard, and by way of example only, the predetermined
XYZ frame of reference can be defined in the illustrated embodiment
in relation to an X-Y plane corresponding with the front surface of
the face plate 32 and/or parallel back surface of compression
paddle 34, together with orthogonal X-Z and Y-Z planes within which
the x-ray radiation center axis passes (i.e., all three planes
being orthogonal). X-ray opaque markings (not shown) can be
provided on compression paddle 34 and/or face plate 32 to
facilitate spatial correlation of the radiation center axes and
x-ray receiver/imager.
[0042] In the illustrated embodiment, the x-ray receiver/imager 44
is disposed in abutting relation with the face plate 32. X-ray
receiver/imager 44 may comprise an image receptor consisting of a
removable radiographic film cassette (e.g., for full-field breast
imaging) and/or digital camera (e.g., for partial field, real-time
imaging/display). In the latter regard, a partial field, digital
CCD camera 46 (e.g., having a 5 mm.times.10 mm or 5 mm.times.5 mm
imaging area) may be disposed for selective, driven XY movement
(e.g., via a servo-drive arrangement) in registered relation to the
predetermined XYZ frame of reference.
[0043] In the illustrated embodiment, ultrasound imaging assembly
100 and biopsy assembly 50 are selectively and alternatively
connectable to opposing sides of first support arm 20 via
connection/locking handles 102 and 55, respectively. Additionally,
biopsy assembly 50 may be mounted in an axially aligned manner on
first support arm 20 for breast access through window 36. A
reference, or "home," position for each assembly in a given mounted
location is known relative to the predetermine XYZ frame of
reference. Further, positioning of the various components of each
assembly during use is automatically determinable via position
sensor/control systems. As will be appreciated, such positioning
can be automated via corresponding processor-controlled, servo
motors.
[0044] Biopsy assembly 50 comprises a punction sub-assembly 54,
which includes puncture instrument 52, and positioner sub-assembly
56. Positioner sub-assembly 56 includes horizontal axis and
vertical control motors 58 and 60, respectively, for selective
sideward movement and upward angulation of the punction instrument
52. By way of example, punction sub-assembly 56 may comprise the
AUTOGUIDE.TM. assembly of Fischer Imaging Corporation. As will
become appreciated, the illustrated embodiment may be particularly
apt for use with punction subassemblies for obtaining samples
having relatively large cross-sections, including, for example, the
MAMMOTOME.TM. from Biopsys Medical, Inc. of Irvine, Calif.
[0045] Ultrasound imaging assembly 100 comprises an ultrasound
imaging head, or probe, 110 interconnected to arm assembly 130 and,
in turn, to XYZ ultrasound positioning assembly 140. As will be
further explained, XYZ ultrasound positioning assembly 140 is
employed to selectively position ultrasound imaging head 110
through the window 36 of compression paddle 34 to establish direct
breast contact for targeted ultrasound imaging in determinable
spatial relation to the predetermined XYZ frame of reference.
[0046] As shown in FIG. 5, ultrasound probe 110 may include an
elongated housing 112 with an elongated ultrasound transducer
module 114 positioned therein. Ultrasound transducer module 114
provides an ultrasound signal having a focal point on a signal
center axis at a location between compression paddle 34 and face
plate 32 Ultrasound transducer module 114 may include, for example,
a phased linear array of ultrasound transducers positioned along a
longitudinal axis of the ultrasound probe 110. The ultrasound probe
110 emits signal pulses and detects corresponding echo pulses to
generate the depth-profile images. More particularly, and as will
be appreciated by those skilled in the art, detected echo pulses
will result from ultrasound transmissivity differences (i.e.,
ultrasound impedance mismatches) at tissue-type transition areas
(e.g., transitions between healthy tissue and a potential
lesion/suspicious mass) and at structural obstructions (e.g., the
front surface of face plate 32). The housing 112 of ultrasound
probe 110 may include a recess 118 (exaggerated in FIG. 5) for
receiving a cold-pack 120 for orthogonal application to a biopsy
site after a biopsy procedure. Applying pressure and a cold medium
directly over a biopsy site in the breast has been shown to reduce
hematoma bleeding and bruising.
[0047] XYZ ultrasound positioning assembly 140 includes X, Y and Z
platforms 142, 146 and 148, respectively, mounted for selective,
registered movement on corresponding support members 152, 156 and
158 relative to the predetermined XYZ frame of reference. In this
regard, XYZ positioning assembly 140 may include internal X, Y and
Z optical position encoders. XYZ positioning assembly 140 can
further include X, Y and Z motor drives for automatic, selective
positioning of ultrasound imaging head 110 in registered XYZ
relation to the predetermined XYZ frame of reference. The XYZ
positioning assembly 140 may also include counterbalance and
electro-lock components to accommodate ready manual positioning and
to maintain a selected ultrasound imaging/biopsy position,
respectively.
[0048] Arm assembly 130 is provided to allow the ultrasound imaging
probe 110 to be rotated about one or more of selected X, Y and Z
axes to obtain a desired pitch, roll and/or yaw orientation). For
example, arm assembly 130 can be controlled to selectively rotate
the longitudinal axis, or pitch, of probe 110 so that the
ultrasound signal may be employed to obtain depth-profile image in
a plane, or "slice," within which an upwardly angled punction
instrument 52 of biopsy assembly 50 may be orthogonally advanced,
as will be further discussed.
[0049] In the illustrated embodiment, arm assembly 130 includes
pivot arm 132 pivotally interconnected to XYZ ultrasound
positioning assembly 140 via a lock/release mechanism (not shown)
for selective, centered rotation of probe 116 about axis YY.
[0050] Arm assembly 130 further includes arm 134 rotatably
interconnected to arm 132 via a lock/release mechanism (not shown)
for selective, centered rotation of probe 116 about axis XX, and
arm 136 rotatably interconnected to arm 134 via a lock/release
mechanism (not shown) for selective, centered rotation of probe 116
about axis ZZ. Internal optical encoders (not shown) may be
provided at the various arm interconnections, wherein the pitch,
roll and/or yaw of probe 110 is automatically determinable in
relation to the predetermined XYZ frame of reference. In this
regard, internal automated micro-positioners may also be utilized
under processor control.
[0051] As will be appreciated, the ultrasound signal may be scanned
to obtain depth-profile information for a predetermined layer, or
"slice," within the region of interest By way of primary example,
such scanning may be provided electrically by driving a phased
linear array of transducers comprising probe 110 in a known manner
and/or via manual or automatic-driven control of XYZ positioning
assembly 140 to mechanically move ultrasound imaging head 110.
[0052] As shown in FIG. 6, display/processor 60 includes a display
screen 62 for displaying the acquired x-ray images on a first
portion 62a and displaying corresponding depth-profile ultrasound
images on a second portion 62b, each in registered co-relation to
the predetermined XYZ frame of reference. Display/processor 60 may
further include a user interface means 64, e.g., keyboard 65 and
mouse 66 and screen point cursor 68 (e.g., on both display portions
62a, 62b), wherein a user may identify (e.g., click upon) a
specific location-of-interest within both an x-ray image and
corresponding ultrasound image (e.g., corresponding with a
potential lesion or suspicious mass), e.g., for automatic processor
determination of the three-dimensional coordinates of the location
within the predetermined XYZ frame of reference. User interface
means may further allow for user selection/display of a particular
desired ultrasound depth-profile image, e.g., via mouse 66 and
screen "slice" cursor 70 on the x-ray image display portion 62a.
More particularly, screen "slice" cursor 70 may be employed to
identify a particular slice, or layer, of an X-Y x-ray image for
which a corresponding ultrasound depth-profile image is to be
obtained (e.g., thereby resulting in processor-assisted positioning
and imaging using probe 110) and/or accessed and displayed (e.g.,
where such ultrasound depth-profile image has been previously
obtained/stored for selective subsequent review).
[0053] As indicated, display/processor 60 may be operatively
interconnected (e.g., via electrical lines 80) to the various
positionable assembly components for monitoring/controlling their
respective positions relative to the predetermined XYZ frame of
reference, including the positionable components of immobilization
assembly 30, x-ray imaging assembly 40, ultrasound imaging assembly
110 and biopsy assembly 50. By way of primary example,
display/processor 60 may determine the three-dimensional
coordinates of a specific location of interest, as described above,
and in turn assist/control the positioning of biopsy assembly 50 so
as to position the assembly for obtainment of a tissue sample from
the location of interest. In this regard, the display/processor 60
may also be employable to visually project, or simulate, the entry
of a punction instrument 52 into a given location of interest,
thereby allowing physicians the opportunity to insure an optimal
positioning for biopsy entry prior to an actual biopsy procedure.
Since three-dimensional visualization of a potential
lesion/suspicious mass can be provided by the present invention,
and since the disclosed arrangement allows for breast access by
biopsy assembly 50 from a plurality of aspects (e.g., by selective
mounting on either side of or coaxial along support aim 20), such
simulated biopsy modeling may prove to be of particular
advantage.
[0054] The present invention allows for spatial correlation of the
x-ray and ultrasound images utilizing various techniques. By way of
primary example, it can be appreciated that the X-Y x-ray images
obtained can be readily correlated to the predetermined XYZ frame
of reference since the position and attributes of x-ray source 42
and x-ray receiver/imager 44 are each known in relation to the
predetermined XYZ frame of reference. Additionally, in stereotactic
imaging procedures, the two X-Y stereotactic x-ray images can be
employed to obtain a Z location for particular location of interest
relative to the predetermined XYZ frame of reference utilizing
known triangulation techniques, as will be appreciated by those
skilled in the art, Further, the XYZ positioning of ultrasound
imaging head 110 is determinable relative to the predetermined XYZ
frame of reference, as noted above. Relatedly, in the embodiment
described above, the ultrasound imaging head 110 will emit/detect
ultrasound signals in substantially the same plane as the surface
of compression paddle 34 contacting the imaged breast. The position
of such surface relative to the predetermined XYZ frame of
reference (e.g., the Z distance to face plate 32) is also
determinable. In view of the foregoing, it can be seen that
utilizing known ultrasound pulse/echo techniques a depth profile
comprising a potential lesion/suspicious mass can be spatially
related in a reliable manner to the acquired x-ray images.
[0055] In use, a patient can be positioned on the table 12 with a
breast positioned through opening 14. Compression paddle 34 is then
advanced along first support arm 20 to compress the breast to
define a cross-sectional imaging area having a common thickness and
to otherwise immobilize the breast in a set position within the
predetermined XYZ frame of reference. X-ray imaging assembly 40 is
then selectively positioned to obtain the desired x-ray images.
Such x-ray images are then reviewed using display/processor 60, to
identify, analyze and or otherwise confirm the presence and
location of a potential lesion or suspicious mass for ultrasound
imaging. Alternatively, the general location of a potential lesion
or suspicious mass may already be known due to prior x-ray
screening,
[0056] In either case, to proceed with ultrasound imaging, the
patient should be positioned/repositioned so that the potential
lesion or suspicious mass is positioned within the accessible field
of view of ultrasound imaging head 110 when it is maneuvered
through the window 36 of compression paddle 34 in direct contact
with the imaged breast. As can be appreciated, in order for the
present invention to yield spatially correlatable image information
with respect to a potential lesion or suspicious mass, new x-ray
and corresponding ultrasound images should be generated for each
position in which a breast is immobilized within the predetermined
XYZ frame of reference. As such, the benefit of utilizing a digital
camera 46 in x-ray receiver 44 for partial field, real-time imaging
via display/processor 60 can be readily understood.
[0057] Once it is verified that the area of interest is positioned
adjacent to the window 36, ultrasound imaging probe 110 is
positioned through the window 36 and a series of ultrasound images
are obtained and displayed on display/processor 60. Cursor 66
control of the ultrasound images taken across the area of interest
provides additional, valuable information as to the type of
potential lesion/suspicious mass originally noted on an original
mammogram. For example, with proper training of ultrasound and
x-ray imaging techniques, physicians may rule out the possibility
of a solid mass in favor of a fluid-filled cyst. Or, additional
ultrasound characteristics may aid the physician in making a
definitive diagnosis.
[0058] If it is determined that a biopsy is desired, the specific
location from which tissue is to be obtained can be identified
using mouse 66 to position screen point cursor 68 on both the x-ray
image and correlated ultrasound depth-profile image on
display/processor 60. Three-dimensional coordinates can then be
determined and utilized by display/processor 60 to control
positioning of biopsy assembly 50. In this regard, it will be
appreciated that specific attributes of the particular punction
subassembly 54 utilized will have been previously entered into by
display/processor 60. Further, and as noted above, given such
previous input information, display/processor 60 may be employed to
simulate the advancement of punction instrument 52 into the breast
from a given potential position, thereby allowing the physician to
determine if breast biopsy access from a different position may be
more desirable.
[0059] After the biopsy subassembly 50 is positioned as desired,
biopsy procedures may be completed. In conjunction with such
procedures, the ultrasound imaging head 110 may be utilized to
provide continuous, successive depth profile images, thereby
allowing for real-time monitoring and user control of the
advancement of the punction instrument 52 into the breast. More
particularly, when the punction instrument is positioned at an
angle .theta. as illustrated in FIG. 2, ultrasound imaging head 110
may be similarly angled at .theta. (e.g., relative to horizontal)
so as to yield real-time ultrasound depth-profile images of the
layer. into which punction instrument 52 is advanced. After biopsy
procedures are completed, ultrasound imaging head 110 may be
repositioned so as to allow for pressure application of a cold pack
120.
[0060] Referring to FIGS. 2-4, an ultrasound display system is
generally identified by the reference numeral 300. In order to
facilitate certain procedures such as a sampling of a suspicious
lesion or tissue harvesting (or other targeted procedures such as
guide wire placement, laser ablation or treatment delivery), it is
desirable to provide an ultrasound display system in proximity to
the patient's compressed breast. In this regard, the availability
of a substantially real time ultrasound display is desirable to
monitor the actual penetration path of a biopsy needle or other
instrument into the patient's breast, for example, to verify that
the instrument traverses the desired tissue and properly targets
the area of interest. In the latter regard, it will be appreciated
that certain instruments such as biopsy needles may have a tendency
to deflect, particularly if the instrument contacts calcifications
or other dense tissue structure. Accordingly, the availability of
an ultrasound display system in proximity to the patient's breast
allows the physician to verify that the instrument is properly
targeting the area of interest and has not strayed due to
deflection or otherwise. Moreover, the physician may wish to verify
that a breast lesion has been sampled after activation of the
biopsy instrument. Again, the availability of the ultrasound
display system in proximity to the patient's breast facilitates
such monitoring of a sampling process and sample verification.
[0061] In the illustrated embodiment, such monitoring is
facilitated by providing an ultrasound display system 300 in
proximity to the patient's breast under the table 12. In this
regard, the system 300 may be mounted to the table 12, the pedestal
16 or another part of the support assembly 10, or may be otherwise
positionable in proximity to the patients breast beneath the table
12.
[0062] As noted above the illustrated embodiment allows for
sampling from various positions, including from either side of the
patient's breast. In order to allow for convenient positioning of
the ultrasound display system 300 for monitoring during a medical
procedure, the illustrated system includes a support and
positioning assembly 306. More specifically, the system includes a
monitor 302 having a screen 304 for displaying ultrasound images.
The illustrated assembly 306 allows for a three-dimensional
translation of the monitor 302 as well as angular orientation of
the screen 304 for easy viewing by a physician during such a
medical procedure. The various types of motion that are
accommodated by the assembly 306 are generally indicated by arrows
in FIG. 3.
[0063] The support and positioning assembly 306 includes an
articulated positioning system including an upper arm 308 and a
lower arm 314. The upper arm is interconnected to the table 12 by
way of a swivel mechanism 310 and an upper pin 312. The swivel
mechanism 310 allows the assembly 306 to rotate relative to the Y
axis as indicated in FIG. 3. In addition, the upper aim can pivot
about upper pin 312. The upper arm 308 and lower arm 314 are
interconnected in a manner that allows for relative swiveling and
pivoting motion therebetween. In this regard, a central pivoting
mechanism 316 allows for pivotal motion between the arms 308 and
314.
[0064] The lower arm 314 is also rotatable about pin 318 so as to
allow for relative swiveling motion between arm 314 and arm 308.
The lower arm 314 in turn is interconnected to the monitor 302 in a
manner that allows for swiveling and pivoting motion therebetween.
In this regard, lower pivoting mechanism 320 allows for pivotal
motion between 314 and monitor 302. The monitor 302 can swivel
relative to the arm 314 by rotating about lower pin 324. The lower
pivoting mechanism 320 allows for rotation about the post 322. It
will thus be appreciated that the assembly 306 allows for
three-dimensional translation of the monitor to a position as
desired by the physician/user, and also allows for positioning of
the screen 304 in a desired angular orientation relative to both
vertical and horizontal planes. It will be appreciated that other
types of positioning mechanisms including slides, telescoping arms,
and linear drive mechanisms can be used to provide some or all of
the illustrated motions, and such motions may be actuated manually
or driven by motors.
[0065] FIGS. 9A-9D show different ultrasound probe head
configurations that may used to achieve different ultrasound signal
characteristics in accordance with present invention. Referring
first to FIG. 9A, a front perspective of an ultrasound head 900 in
accordance with the present invention as shown. The illustrated
head 900 is a linear head including a linear array of conventional
ultrasound probe elements 902. Each such element includes an
ultrasound transducer operative for both transmitting ultrasound
signals to the patient and receiving echo signals returning from
the patient. For example, the ultrasound elements may include a
piezo transducer that is operative to transmit ultrasound signals
by flexing or otherwise displacing in response to input electrical
signals. Conversely, the return signals cause the transducer
element to flex or otherwise displace thus creating an electrical
output representative of the received return ultrasound signal. As
is known, the wave form of the output signal provides information
regarding the density of the tissue from which the signal was
reflected. The transit time, i.e., the elapsed time between signal
transmission and signal detection, provides information regarding
the distance or depth relative to the head of the tissue that
reflected the signal. In this manner, the ultrasound image provides
information regarding the nature and location of tissue within the
patient's breast. The illustrated head 900 may include, for
example, 128 elements arranged in a single row and may be driven
by, for example, a 10 MHz signal.
[0066] FIG. 9B shows a top schematic view of the probe 900. The
probe head transmits a focused ultrasonic signal 901 having a
profile as generally illustrated. In this regard, the signal
includes a focal area within which high quality images can be
obtained. In the illustrated embodiment, the depth of this focal
region is indicated by D.sub.1. In order to limit the ultrasound
image to the area corresponding to depth D.sub.1, the ultrasound
imaging system may process the return signal over a corresponding
time period. Specifically, ultrasound probes are generally operated
in a series of alternating transmit and receive time periods.
During a first transmit time period, an ultrasound signal is
transmitted into the patient. At the end of the transmit time
period, the transmission signal is terminated and the probe remains
available for receiving return signals. The time at which return
signals are received depends on the depth of the tissue from which
such signals are reflected. Thus, an image corresponding to the
area indicated by D.sub.1 can be provided by processing the return
signal over the corresponding time period.
[0067] FIG. 9C shows a front perspective view of a planar
ultrasound probe head arrangement, The head 904 includes ultrasound
elements arranged in rows 908 and columns 906. In use, the forward
surface of the front column 908 is disposed approximate to the
patient. Thus, the various columns 908 are disposed at varying
distances from the patient.
[0068] FIG. 9D shows a top schematic view of the head 904 of FIG.
9C. The elements in each of the columns 908 transmit focused
ultrasound signals 905. Because the columns are disposed at
different distances from the patient or at different locations
relative to the signal axis, the signals transmitted from the
elements of the various columns 908 define a focal region having a
depth D.sub.2 that is greater than the depth D.sub.1 of the head
900 of FIGS. 9A and 9B. The illustrated head 900 includes more than
one column 908 and may include, for example, seven or more columns.
Each column may include, for example, 128 elements 906.
[0069] In certain cases, the planar array configuration of head 904
provides imaging advantages. In this regard, it is desirable to
provide a focal region depth, D.sub.2, of at least about 5
centimeters as such depth allows for complete ultrasound imaging
across the entire thickness of the compressed breast for most
patients. The head 904 provides such focal depth. Accordingly, for
most patients, the head 904 can provide high quality images of an
area of interest within the patient's breast regardless of the
location of the area of interest relative to the thickness of the
patient s compressed breast.
[0070] Although the illustrated embodiment allows for utilization
of x-ray images in conjunction with ultrasound images for
three-dimensional localization of an area of interest within a
patient's breast, it will be appreciated that such
three-dimensional localization may be accomplished using only
ultrasound imaging. For example, the ultrasound imaging assembly
100 may be initially used to obtain a scout image or image set. In
this regard, arm 136 may be positioned so that the ultrasound head
116 is in a vertical orientation, i.e., substantially aligned with
axis Y of FIG. 2. The assembly 100 can then be moved along the X
axis of FIG. 2 so as to obtain ultrasound imaging exposures at
various known locations along the X axis to thereby image the area
of interest 46, e.g., in the form of multiple ultrasound image
slices. In this manner, three-dimensional imaging information is
provided. for the location of interest 46 This information can then
be used to provide targeting coordinates for the biopsy assembly
50.
[0071] During a subsequent medical procedure such as a needle
biopsy, the arm 136 cam be rotated such that it is aligned with
axis 52 of a medical instrument such as a biopsy needle or gun. In
this manner, the imaging assembly 100 can be used to provide
substantially real time imaging information for monitoring
insertion of the biopsy needle and sampling of the location of
interest 46.
[0072] FIGS. 7 and 8 pertain to an alternate embodiment of an
ultrasound imaging assembly 200. In this regard, it should be noted
that while the ultrasound imaging assembly 100 described
hereinabove is supportably positioned below and on one side of a
center axis of patient table 12, the alternate ultrasound imaging
assembly 200 is provided to be supportably positioned immediately
below and in substantial coaxial alignment with patient table 12
Such positioning of the ultrasound imaging assembly 200 allows for
the alternate positioning of a biopsy a assembly 50, as described
above, on either side below patient table 12, thereby yielding
enhanced access to the above-noted predetermined XYZ frame of
reference.
[0073] As illustrated in FIGS. 7 and 8, the ultrasound imaging
assembly 200 is supportably positioned on and in coaxial relation
to the first support arm 20. First support arm 20 also carries
breast immobilization assembly 30. As with the embodiment described
above, the breast immobilization assembly 30 includes a stationary
face plate 32 and opposing compression paddle 34 for immobilizing a
patient's breast therebetween. Compression paddle 34 again is x-ray
transmittent and includes a window 36 for direct breast access
therethrough by the ultrasound imaging assembly 200 and/or a biopsy
assembly 50. Compression paddle 34 is selectively positionable
along the first support arm 20. In this regard, a locking mechanism
portion 38 of compression paddle 34 is sized in the embodiment of
FIG. 7 for positioning under at least a portion of ultrasound
imaging assembly 200 to yield overall enhanced access and
compactness advantages.
[0074] Support arm 20 may also support an x-ray image
receiver/imager 244 positioned in opposing relation to the x-ray
tube source 42. Image receiver/imager 244 may comprise a removable
radiographic film cassette and/or digital CCD camera assembly for
partial or full-field, real time imaging. In the later regard,
receiver/imager 244 may comprise a CCD assembly for fill-field
imaging as described in U.S. Pat. No. 5,526,394, hereby
incorporated by reference.
[0075] With further respect to ultrasound imaging assembly 200, the
assembly includes an ultrasound imaging probe 210 having an imaging
head 212 (e.g., comprising an ultrasound transducer and/or linear
array of transducers) positioned at the end of an elongated handle
portion 214. The handle portion 214 is configured for selective
grasping during hand-held use and alternatively for positioning
within a holder 220 having a cradle-like configuration. In the
illustrated embodiment, the holder 220 includes two interconnected
and aligned u-shaped portions for conformally receiving a
cylindrically shaped probe handle 214 (e.g., via "snap-in" and/or
slide-in engagement). As will be appreciated, probe handle 214 and
holder 220 may include projections and receiving slots or other
means for establishing a predetermined positional relationship
therebetween when engaged. The probe 210 may include an
interconnect line 218 for transferring image data to a
display/processor 60. For positioning relative to the predetermined
XYZ frame of reference, bolder 220 is mounted to an XYZ positioning
assembly 240.
[0076] The XYZ ultrasound positioning assembly 240 includes X, Y
and Z platforms 242, 246 and 248, respectively, mounted for
selective, registered movement on corresponding support members
252, 256 and 258 relative to the predetermined XYZ frame of
reference (i.e., defined between compression paddle 34 and face
plate 32). The entire assembly 200 may be selectively removed
from/interconnected to the support arm 20 utilizing a carrier
assembly 260 having a depressible hand grasp 262 for
retracting/advancing a locking pin(s) that interfaces with one or
more openings along support arm 220.
[0077] Ultrasound imaging assembly 200 further comprises a first
motor assembly 270 for driving X platform 242 for automated
side-to-side movement of probe 210 in the X dimension. Similarly,
ultrasound imaging assembly 200 also comprises a second motor
assembly 280 for automated driving of platform 246 for up/down
positioning of probe 210 in the Y dimension. Positioning in the Z
dimension may be established by moving platform 248 relative to
support member 258. Ultrasound imaging assembly 200 also includes a
third motor assembly 290 for rotational movement of the holder 220,
and in turn probe 210 mounted therewithin, about the axis ZZ. In
this regard, holder 220 includes a microencoder for establishing
the particular desired rotational angle of the ultrasound imaging
probe head 212 (i.e., and the transducer and/or transducer array
thereof relative to the ZZ axis within the XY plane defined by the
face 214 of the probe 210.
[0078] FIGS. 10-20 illustrate screens of a user interface system
that may be employed in connection with the embodiments described
above for procedures including localization, targeting and sampling
of an area of interest in a patient's breast. Referring first to
FIG. 10, an initial screen of the user interface system is shown.
The screen may be displayed on a conventional display system such
as an LCD or CRT computer monitor. For example, the screens may be
displayed on the display/processor assembly 60 of FIGS. 1-6.
[0079] The initial screen, as shown in FIG. 10, includes an image
display area 1000 and a user input area 1002. The user input area
1002 includes a number of graphical objects or buttons
corresponding to particular functions such that the functions can
be assessed and/or implemented by activating a cursor relative to
the graphical objects, touching the graphical objects or other
inputs relative to the objects. As shown in FIG. 10, the objects
include a button 1004 labeled "Mammotest", a button 1006 labeled
HF-X, a button 1008 labeled "Ultrasound", a button 1010 labeled
"Help", a button 1012 labeled "U/S Image Procedure", a button 1014
labeled "Utilities" and a button 1016 labeled "HF-X Only
Utilities". These buttons allow the user to select as between
various operating modes of the system. In this regard, the system
may be used for conventional upright x-ray procedures corresponding
to the button HP-X, prone stereotactic imaging applications.
corresponding to the button labeled "Mammotest" or, of particular
relevance with respect to the present discussion, for
ultrasound-based procedures corresponding to the buttons 1008 and
1012.
[0080] The Help button 1010 can be used to access a variety of
instructional information and operating information for the system.
The Utilities button 1014 can be used to access various utilities
screens, for example, relating to accessing records, changing
display parameters such as brightness, etc. The HF-X Only Utilities
button 1016 provides access to utility information relating to the
HF-X mode of operation. For the purposes of the present discussion,
the user may activate ultrasound button 1008 in order to initiate
ultrasound related procedure.
[0081] FIG. 11 illustrates a subsequent screen of the user
interface system. The screen includes a display area 1102, a user
input area 1104 and an instruction area 1106. The instruction area
1106 provides instructions to the user with regard to tie current
screen. In this regard, the illustrated screen includes
instructions directing the user to enter patient data and to click
"Done" when finished. The user may then enter a patient name,
patient identification number, a physician name, a date of
procedure, a technician's initials and any other information as
desired into the display area 1102. Such information is used, for
example, for purposes of maintaining records and facilitating later
retrieval of desired images.
[0082] The user input area includes graphical objects 1108, 1110
and 1112 respectively labeled "Lateral Approach", "Target on
Scout", and print DB Entry. The Print button 1112 can be used to
provide a hard copy of the screen including, for example, the
entered patient information. The lateral approach button 1108
allows the user to indicate when a lateral approach is being
utilized for imaging the patient's breast. The Target on Scout 1110
allows the user to indicate that a scout image is to be obtained.
For example, an x-ray scout image may initially be displayed to
identify the area of interest for use in positioning the targeted
ultrasound system. It will thus be appreciated that the sequence of
screens presented to the user may vary depending on the specific
procedure to be implemented as indicated through appropriate
entries relative to the displayed graphical objects.
[0083] FIG. 12 illustrates a screen which may be presented in the
case where the user desires to obtain an initial scout image. As
shown, the display area 1202 is blank pending acquisition of the
scout image. The instructions in area 1204 indicate that the system
is ready for acquiring the scout image and provides information
regarding positioning of the x-ray tube. Specifically, the
instructions indicate that the x-ray tube should be positioned to 0
degrees corresponding to a top to bottom imaging angle relative to
the patients breast. It is also possible for the user to skip the
digital scout image by selecting the skip digital scout button 1208
in input area 1206. For acquisition of the scout image, the
ultrasound imaging system may be removed to avoid interference.
[0084] As noted above, the three-dimensional coordinates of a
location of interest within the patients breast can be identified
based on a digital x-ray image and an ultrasound image. In FIG. 13,
a digital x-ray image is displayed in the display area 1302. This
x-ray image can be used to identify the location of interest
relative to the two dimensional image so as to allow for
appropriate positioning of the ultrasound imaging system.
[0085] In order to enhance the image and facilitate identification
of the location of interest, a number of image enhancement features
can be accessed and implemented elative to the buttons provided in
user input area 1304. These buttons include. a reverse video button
for reversing the tone of the displayed x-ray image, i.e., to
provide a negative of the displayed image; a squeeze button for
minimizing the display area occupied by the image; a contrast
button for varying the contrast of the image; a ruler button for
providing a scale for dimensional reference with respect to the
image; a full resolution button for displaying the image with
maximum resolution; an edge enhancement button for identifying and
enhancing the edges of displayed structural features for enhanced
structure identification; an autocontrast button for automatically
fixing the contrast level; a zoom button for zooming in on a
particular area of the image, for example, as identified by a
cursor input; a KV button for activating a kilovolt sensor to
control the power of an exposure; and an exposure control button
for allowing the user to manually control exposure. After the image
has been displayed to the satisfaction of the user, the user may
proceed to ultrasound image acquisition. In this regard, the
instruction box 1306 provides instructions to install the
ultrasound positioner (an ultrasound imaging system).
[0086] FIGS. 14 and 15 illustrate a process for positioning an
ultrasound probe. In the illustrated implementation of the present
invention, the x-ray image is used in conjunction with an
ultrasound image to localize an area of interest in three
dimensions in the following manner. First, the x-ray image is
display in the display area as shown at 1402 in FIG. 14. A line
within the image in the display area 1402 indicates a current
position of the ultrasound probe. For convenient reference, an
arrowhead is provided at one end of the line to indicate a rearward
end of the ultrasound probe. As indicated by the instructions in
area 1404, the user can position the ultrasound probe by clicking
on the location of interest in the x-ray image. In response to this
data entry, the motors associated with the ultrasound positioner
will drive the ultrasound probe to the desired location relative to
the two dimensions of the x-ray image.
[0087] As indicated in FIG. 15, the ultrasound probe automatically
moves to the indicated point on the x-ray scout image. It will thus
be appreciated that two dimensional coordinates of the location of
interest are encoded into the position of the ultrasound
transducer. The ultrasound imaging system can then be used to
identify the third dimension, or depth, of the location of
interest. To this end, the ultrasound image system is activated to
provide a second image which is displayed in the display area 1502
as shown in FIG. 15. In order to identify the location of interest
relative to the ultrasound image, the user first selects the mark
lesion button in user input area 1504 and then positions and
activates the cursor over the location of interest on the
ultrasound image, per the instructions in area 1506. This process
is illustrated in FIG. 16.
[0088] FIGS. 15 and 16 also include a select needle button in the
user input area. It will be appreciated that different biopsy
needles have different dimensions which need to be accounted for in
targeting the location of interest for sampling. Such information
can be entered by using the select needle button. In addition, it
is possible in accordance with the present invention to show a
representation of a needle on the images, for example, to project
the penetration path so that a physician can plan a sampling
procedure. For example, a physician may wish to alter a potential
penetration path in order to traverse less breast tissue or to
avoid certain intervening structure on the way to the location of
interest.
[0089] FIG. 17 shows the results of a three dimensional
localization procedure. Specifically, the target coordinates
together with certain other patient and procedural information are
displayed in display area 1702. The information displayed in this
regard may include three-dimensional coordinate information as well
as adjusted coordinate information to account for certain offsets
relating, for example, to the geometry of the needle holder and
needle. Also shown in the ultrasound image in the display area 1702
is a projected needle path for the sampling procedure. In order to
fiber enhance the physician's ability to understand the displayed
images, an indication may be provided in the display area 1702 or
otherwise regarding the angular orientation of the displayed
images. In this regard, the illustrated display area 1702 includes
an indication that the ultrasound positioner is rotated to a
position identified as 43 degrees.
[0090] FIGS. 18-20 illustrate a subsequent needle biopsy procedure.
As has been described above, the ultrasound probe may be aligned
relative to the penetration axis of the biopsy needle such that
penetration of the biopsy needle can be viewed in real time. This
video information, which is also displayed on the under table
monitor, is shown in FIGS. 18-20. Specifically, FIG. 18 shown an
initial penetration of the biopsy needle towards the location of
interest. An indicated of the penetration path is overlaid in the
image relative to the biopsy needle. The biopsy needle may deflect
from its intended course, for example, due to contact with
calcifications or other dense structure within the patient's
breast. For this reason, the availability of real time ultrasound
imaging during this process is an important advantage of the
illustrated system. In the event that the needle appears to be
diverting from the intended course, the user can manually correct
the positioning of the biopsy needle. In this regard, the
instructions in area 1804 remind the user to consider correcting
the course by using raised needle and lower needle buttons provided
in conjunction with the ultrasound probe positioner. If desired,
the illustrated system can be programmed to identify any diversion
between the actual penetration path and the projected penetration
path so as to issue an alert or allow for automatic correction.
[0091] FIG. 19 shows a position of the biopsy needle prior to
activation of the needle to harvest tissue or cells from the area
of interest. In this regard, typical biopsy needle guns are
operated by positioning the biopsy needle a short distance from the
location of interest and pointed towards the location of interest
and then activating the gun so that the needle is thrown a distance
through the area of interest such as under spring force. In this
regard, FIG. 19 shows the pre-fire position of the biopsy needle
and FIG. 20 shows the post-fire position of the biopsy needle.
These images can be viewed in real time so that the physician may
be satisfied that the location of interest has in fact been sampled
and that the resulting biopsy will be reliable.
[0092] While the present invention has been described in relation
to one embodiment, it will be appreciated that the invention may be
utilized in numerous additional embodiments and procedures. Such
additional embodiments and procedures are within the scope of the
present invention, as defined by the claims which follow.
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