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| United States Patent | 5426685 |
| Link to this page | http://www.wikipatents.com/5426685.html |
| Inventor(s) | Pellegrino; Anthony J. (New Fairfield, CT);
Stoller; Milton (West Hartford, CT);
DeFreitas; Kenneth F. (Patterson, NY);
Camarra; David D. (Fairfield, CT);
Scandura; Anthony M. (Scotland, CT);
Schutz; Richard F. (Brewster, NY);
Storm; Jeffrey R. (Springfield, MA) |
| Abstract | An elongated prone patient-supporting examining table for X-ray mammography
is centrally supported at variable heights by a rear pedestal. The table
is provided with a central breast-receiving aperture through which the
patient's pendulant breast is exposed to a horizontal beam of X-rays from
a tubehead source mounted on an arm angularly movable through an arc of
some 210.degree. centered on the patient's breast. The patient's feet may
be positioned at either end of the elongated table on an extensible
footrest, permitting X-ray projection through more than 360.degree. around
the patient's body. Diagnosis of suspect lesions and fine needle biopsy
are both facilitated by stereotactic examination. Digital imaging using a
CCD camera and image enhancement software provides magnification, contrast
enhancement, window and level manipulation and high resolution images,
with low exposure levels, short exposure times, and greatly reduced
imaging times. |
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Title Information  |
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| Publication Date |
June 20, 1995 |
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| Filing Date |
January 24, 1994 |
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| Parent Case |
CROSS REFERENCE TO RELATED APPLICATION
This is a divisional application of co-pending application Ser. No.
07/957,275 filed on Oct. 6, 1992, now U.S. Pat. No. 5,289,520, issued on
Feb. 22, 1994, which is a continuation-in-part of Ser. No. 07/799,412,
filed Nov. 27, 1991, now abandoned. |
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Title Information  |
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References  |
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U.S. References |
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| | Reference | Relevancy | Comments | Reference | Relevancy | Comments | 3165630
|      Your vote accepted [0 after 0 votes] | | 3556081
|      Your vote accepted [0 after 0 votes] | | 5289520 Pellegrino
Feb,1994 |      Your vote accepted [0 after 0 votes] | | 5213100 Summ 600/429 May,1993 |      Your vote accepted [0 after 0 votes] | | 5209232 Levene 600/427 May,1993 |      Your vote accepted [0 after 0 votes] | | 5199054 Adams 378/21 Mar,1993 |      Your vote accepted [0 after 0 votes] | | 5142557 Toker 378/37 Aug,1992 |      Your vote accepted [0 after 0 votes] | | 5107843 Aarnio
Apr,1992 |      Your vote accepted [0 after 0 votes] | | 5078142 Siczek
Jan,1992 |      Your vote accepted [0 after 0 votes] | | 5056523 Hotchkiss, Jr. 600/427 Oct,1991 |      Your vote accepted [0 after 0 votes] | | 5050197 Virta 378/37 Sep,1991 |      Your vote accepted [0 after 0 votes] | | 5018176 Romeas 378/37 May,1991 |      Your vote accepted [0 after 0 votes] | | 4987307 Rizzo 250/368 Jan,1991 |      Your vote accepted [0 after 0 votes] | | 4930143 Lundgren 378/37 May,1990 |      Your vote accepted [0 after 0 votes] | | 4926452 Baker 378/22 May,1990 |      Your vote accepted [0 after 0 votes] | | 4905265 Cox 378/98.8 Feb,1990 |      Your vote accepted [0 after 0 votes] | | 4890311 Saffer
Dec,1989 |      Your vote accepted [0 after 0 votes] | | 4878234 Pfeiffer 378/40 Oct,1989 |      Your vote accepted [0 after 0 votes] | | 4875478 Chen 600/429 Oct,1989 |      Your vote accepted [0 after 0 votes] | | 4873708 Cusano 378/19 Oct,1989 |      Your vote accepted [0 after 0 votes] | | 4852137 Mackay 378/62 Jul,1989 |      Your vote accepted [0 after 0 votes] | | 4727565 Ericson 378/205 Feb,1988 |      Your vote accepted [0 after 0 votes] | | 4245158 Burstein 250/370.09 Jan,1981 |      Your vote accepted [0 after 0 votes] | | 4099880 Kano 356/611 Jul,1978 |      Your vote accepted [0 after 0 votes] | | 4051380 Lasky 378/37 Sep,1977 |      Your vote accepted [0 after 0 votes] | | 3973126 Redington 378/17 Aug,1976 |      Your vote accepted [0 after 0 votes] | | 3963933 Henkes, Jr. 378/20 Jun,1976 |      Your vote accepted [0 after 0 votes] | | 3609355 Schwarzer 435/114 Sep,1971 |      Your vote accepted [0 after 0 votes] | | 3578971 Lasky 218/84 May,1971 |      Your vote accepted [0 after 0 votes] | | | | | |
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Public's "Guesstimation" of Royalty Value
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Market Review  |
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Technical Review  |
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Claims  |
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What is claimed is:
1. A stereotactic mammographic biopsy apparatus for performing
stereotactically guided biopsy localization comprising:
a base;
a pedestal extending upwardly from the base;
an imaging arm pivotally mounted to the pedestal, the imaging arm having a
near end supporting an image receptor responsive to X-ray exposure and a
remote end supporting an X-ray source having an X-ray focal point, wherein
the imaging arm is pivotally mounted to the pedestal at a point between
the near end and the remote end;
a compression arm pivotally mounted to the pedestal, the compression arm
having a near end and a remote end, wherein the compression arm is
pivotally mounted to the pedestal at a point between its near end and its
remote end and wherein the pivot point of the compression arm is axially
aligned with the pivot point of the imaging arm;
a first compression plate slidably attached to the compression arm at its
near end, wherein the first compression plate is slidable along the
compression arm from the near end of the compression arm to the remote end
of the compression arm;
a carriage slidably attached to the compression arm, wherein the carriage
is slidable along the compression arm from the near end of the compression
arm to the remote end of the compression arm and wherein the carriage is
positioned between the remote end and the first compression plate;
a second compression plate supported by the carriage; and
a multi-dimensionally positionable biopsy needle guide supported by the
carriage.
2. The stereotactic mammographic biopsy apparatus of claim 1 wherein the
image receptor includes a substantially planar image receiving surface and
wherein the image receptor is supported on the imaging arm such that the
image receiving surface is substantially normal to a central ray extending
from the focal point of the X-ray source to the image receiving surface.
3. The stereotactic mammographic biopsy apparatus of claim 2 further
comprising a moving Bucky grid having divergently slanted vanes, wherein
the moving Bucky grid is attached to the imaging arm between the image
receptor and the X-ray source such that divergently slanted vanes are
substantially aligned with the focal point of the X-ray source and wherein
X-rays from the X-ray source pass through the moving Bucky grid prior to
impingement on the image receiving surface of the image receptor.
4. The stereotactic mammographic biopsy apparatus of claim 2 wherein the
moving Bucky grid is oriented such that the divergently slanted vanes are
substantially parallel to the common axis of the imaging arm and
compression arm pivot points.
5. The stereotactic mammographic biopsy apparatus of claim 1 wherein the
image receptor comprises:
a phosphor plate responsive to X-ray exposure, wherein the phosphor plate
produces visible light proportional to the intensity of X-radiation
impinging thereon;
a charge coupled device (CCD) camera; and
a visible light collecting means positioned adjacent to the phosphor plate,
whereby the visible light from the phosphor plate is directed to the CCD
camera by the visible light collecting means.
6. A stereotactic mammographic biopsy apparatus for performing
stereotactically guided biopsy localization comprising:
a base;
a pedestal extending upwardly from the base;
an imaging arm pivotally mounted to the pedestal, the imaging arm having a
near end and a remote end, wherein the imaging arm is pivotally mounted to
the pedestal at a point between the near end and the remote end;
an image forming means including a charge coupled device (CCD) array for
converting X-rays impinging on the image forming means into an array of
electronic signals representative of the intensity and location of the
impinging X-rays, wherein the image forming means is supported by the
imaging arm at its near end;
an X-ray source having a focal point, wherein the X-ray source is supported
by the imaging arm at its remote end and wherein the focal point of the
X-ray source is directed at the image forming means;
a compression arm pivotally mounted to the pedestal, the compression arm
having a near end and a remote end, wherein the compression arm is
pivotally mounted to the pedestal at a point between its near end and its
remote end and wherein the pivot point of the compression arm is axially
aligned with the pivot point of the imaging arm;
a first compression plate slidably attached to the compression arm, wherein
the first compression plate is slidable along the compression arm from the
near end of the compression arm to the remote end of the compression arm;
a carriage slidably attached to the compression arm, wherein the carriage
is slidable along the compression arm from the near end of the compression
arm to the remote end of the compression arm and wherein the carriage is
positioned between the remote end and the first compression plate;
a second compression plate supported by the carriage;
a display means for receiving the array of electrical signals from the CCD
and for displaying at least a portion of the array of electrical signals;
and
a multi-dimensionally positionable biopsy needle guide supported by the
carriage. |
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Claims  |
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Description  |
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This invention relates to a patient-supporting table and associated
equipment for X-ray mammography and stereotactic needle biopsy of breast
tissue suspected to contain lesions requiring radiographic evaluation.
RELATED ART
Since the publication of an article entitled "Stereotaxic Instrument for
Needle Biopsy of the Mamma" by Jan Bolmgren et al, published in the
American Journal of Roentgenology Vol. 129, Page 121 in July 1977, needle
biopsy of breast lesions to minimize unnecessary surgical invasion of the
patient's tissue has achieved increasing acceptance. Guidance of the
biopsy needle by stereotactic X-ray exposures traditionally required
development of the two X-ray film images and their comparison to determine
the X, Y and Z coordinates of the lesion in question. Insertion of the
biopsy needle via a carefully placed needle guide directed toward the
lesion site could be verified only by additional stereo X-ray film
exposures.
Mammograms made while the patient sits erect before the X-ray equipment may
introduce unavoidable patient movement and resulting inaccuracy, while
conventional tables supporting the patient in the prone position with the
breast depending through a suitable aperture in the table generally
require a patient's arms to be raised, tensing arm muscles, straining or
distorting the breast tissue and again introducing inaccuracies. In
addition, relatively flat and rigid tables often impose undue stress and
discomfort on the patient's joints and vertebra, inducing undesired
restless movements.
SUMMARY OF THE INVENTION
The unique prone position mammography tables of the present invention
provide comfortable support for the prone patient, with a front edge
portion being removable, permitting the patient's arm and shoulder to be
lowered to more normal positions and thus minimizing patient discomfort
and involuntary movements, leaving the patient normally relaxed during the
procedure. In addition, a central concave torso depression formed in these
tables exposes the maximum volume of breast tissue for X-ray examination.
Furthermore, the central concave torso depression encircling the
breast-receiving aperture is positioned at the center of a
longer-than-normal table having an extensible footrest at each end, which
is supported by a rear pedestal opposite the removable front edge portion.
The X-ray tube and the biopsy needle guide are thus afforded access to the
patient's pendulant breast from all possible angles, over a range of more
than 360.degree..
With this invention, accurate placement of the biopsy needle is further
achieved via electronic imaging of the tissue X-rayed utilizing charge
coupled devices or CCDs, with computer enhancement software designed to
increase the sharpness of contrast between portions of the image most
indicative of particular lesion structures of possible interest. This
CCD-based imaging system offers such advantages in visualization and
differentiation of nonpalpable lesions that contrast resolution and system
sensitivity exceed that available with conventional screen or film X-ray
mammography, often permitting definitive diagnosis of equivocal findings
without the need for biopsy. Visualization capabilities are further
increased by electronic image processing techniques to enhance contrasts.
Delays in film development and evaluation are eliminated by the systems of
the present invention, providing virtually instant confirmation of proper
biopsy needle placement, reducing patient discomfort during this critical
phase of the procedure.
This virtually real time imaging of the stereotactic X-ray images, and
their computer enhancement, are preferably facilitated by an optical
system interposed in the position normally occupied by the X-ray film
cassette. This preferred optical system employs a phosphor screen exposed
to the arriving X-rays passing through the breast tissue, and the image
created on the phosphor screen by the arriving X-rays is reflected by a
mirror surface provided by a pellicle reflector, comprising an extremely
thin sheet of select optical grade nitrocellulose, on the order of five to
nine microns in thickness, stretched like a drumhead over a black anodized
flat metal frame and bonded to the precision lapped edge of the frame. The
X-radiation passes directly through this thin film to the phosphor screen,
while the visible light image of the phosphor screen is reflected from the
film's underside directly toward the camera lens, due to a reflective
coating of metallic material such as aluminum silicate, deposited on the
underside of the thin film. Suitable coatings produce up to nearly sixty
percent reflectance, depending upon wavelength. In a preferred embodiment,
a second flat mirror surface redirects the reflected image, thereby
producing a compact folded optical system conveniently enclosed in a
light-tight housing occupying very little more space than conventional
X-ray film cassettes and associated film holder structures. The preferred
camera is Peltier cooled, and incorporates a rectangular CCD format with
one thousand or more pixels along each orthogonal edge.
The comfortable table for supporting the patient in the prone position with
minimum distortion of normal breast configuration cooperates with the
stereotactic X-ray projection system mounted directly under the table.
When desired, the folded CCD imaging system replaces the normal X-ray film
cassette, and the unique software enhances the contrast and sharpness of
the resulting virtually real time image. Preferably the image-receptor and
the X-ray tube are mounted on the same angularly movable C-arm, assuring
that the X-ray image is always perpendicular to the optic axis of the
arriving X-rays. This permits a bucky grid to have all of its grid planes
permanently aligned with the X-ray source, minimizing lateral scatter
radiation and producing X-ray images of maximum sharpness and clarity.
These aspects of the invention all combine to produce a highly useful prone
patient-supporting table for X-ray mammography and an effective
stereotactic mammography system serving to minimize patient discomfort and
trauma while permitting highly precise location and needle biopsy of
suspected breast lesions, avoiding invasive surgery in a large number of
cases.
Thus, a principal object of the present invention is to provide highly
precise mammography systems providing uniquely accurate images of the
observed breast structures of the patient.
Another object of the invention is to provide such systems incorporating
prone patient supporting tables designed to expose the breast for
mammographic examination while also assuring its undistorted orientation
and the optimum comfort and relaxation for the patient during the
procedure.
Still another object of the invention is to provide such systems with the
capability for accurate guidance of needle biopsy procedures employing
virtually real time electronic imaging and needle placement verification,
eliminating delays for film cassette loading, changing, unloading,
developing and evaluation.
A further object of the invention is to provide such systems which-are
capable of stereotactic imaging of the maximum volume of the patient's
breast tissue to provide three dimensional location of internal lesions or
other internal sites requiring surgical examination.
A still further object of the invention is to provide folded CCD optical
systems taking advantage of large CCD devices to provide extremely high
resolution images of the patient tissue sites under study.
Another object of the invention is to provide digital X-ray image
processing techniques using window and level manipulation, region of
interest analysis, filters and edge enhancement, providing definitive
X-ray diagnosis in many cases.
Other objects of the invention will in part be obvious and will in part
appear hereinafter.
The invention accordingly comprises the features of construction,
combinations of elements, and arrangements of parts which will be
exemplified in the constructions hereinafter set forth, and the scope of
the invention will be indicated in the claims.
THE DRAWINGS
For a fuller understanding of the nature and objects of the invention,
reference should be made to the following detailed description taken in
connection with the accompanying drawings in which:
FIG. 1 is a top perspective view of the prone patient supporting
mammography table of the present invention;
FIG. 2 is an end perspective view of the same table showing the base,
pedestal and angularly movable C-arm carrying the X-ray tube and the image
receptor, as well as the separate compression arm carrying compression
plates and needle guide;
FIG. 3 is a front elevation view of the same table supporting a prone
female patient at maximum elevation above the floor, delivering
X-radiation to the underside of the breast, toward the table's right end;
FIG. 4 is a schematic top plan view of the table showing the range of X-ray
tube positions made possible by the rear pedestal construction of the
unit;
FIG. 5 is a top plan view of the table of FIGS. 1-3, with the C-arm
positioned for delivering X-radiation from the side of the patient;
FIG. 6 is a schematic front elevation view of the same table, with the
C-arm positioned for delivering X-radiation toward the table's left end;
FIGS. 7A, 7B and 7C are corresponding successive fragmentary top plan
schematic views showing the compression arm carrying the breast
compression plates and needle guide in a fixed position beneath the table,
while the underlying C-arm carrying the X-ray tube and image receptor is
moved to different angular positions;
FIG. 8 is a schematic diagram of the stereotactic mammography procedure of
this invention, comparing the X-radiation paths through a suspect lesion
and a reference point on the compression plate for two angularly offset
tubehead source positions, when the image receptor pivots with the
tubehead on the C-am;
FIG. 9 is a fragmentary enlarged schematic diagram showing the lower end of
FIG. 8 in more detail;
FIG. 10 is a schematic diagram of the two images produced at the image
receptor by X-radiation from the same two source positions;
FIGS. 11 and 12 are schematic diagrams of the X-radiation paths for two
angularly offset stereo tubehead source positions utilizing a folded CCD
optical imaging system inserted in the position occupied by the X-ray film
cassette in film mammography but with the digital CCD optical imaging
system of FIGS. 13-17 pivoting with the tubehead.
FIG. 13 is a top plan schematic view of the conventional stereotactic
mammography procedure performed on prior art devices, showing the
X-radiation arriving at significant angles of inclination from the
perpendicular, introducing undesired image degradation, when the image
receptor is stationary.
FIG. 14 is a schematic diagram illustrating the stereotactic images
employed to identify the coordinates of the target lesion with the imaging
system of FIG. 13;
FIG. 15 is a perspective top view of the folded optical system employed in
the stereotactic CCD imaging system of FIGS. 11 and 12, with a portion of
the light-tight housing removed to reveal the location of the various
components of the optical system;
FIG. 16 is a top plan view of the thin film pellicle mirror employed in the
optical system of FIG. 15;
FIG. 17 is an edge elevation view of the same pellicle mirror;
FIG. 18 is a schematic diagram showing the imaging of the patient's
compressed breast on a phosphor plate in the optical system delivering a
focussed image to the CCD sensor and the proc | | |