X-ray or gamma ray systems or devices – Specific application – Mammography
Reexamination Certificate
2001-08-03
2004-07-20
Arana, Louis (Department: 2859)
X-ray or gamma ray systems or devices
Specific application
Mammography
C378S208000
Reexamination Certificate
active
06765984
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to devices and methods for cushioning surfaces, and more particularly to devices and methods for cushioning or padding surfaces of compression plates applied to body parts during x-ray procedures, for example, during mammography, biopsies, and the like.
BACKGROUND
During mammography, a patient's breast is placed under compression by opposing plates attached to a mammography unit. Once under compression, an x-ray may be taken to determine the presence or absence of suspect lesions in the breast tissue, e.g., calcifications or tumors. An important reason for compressing the breast during mammography is to provide a thinner cross-section of tissue for the x-rays to pass through. When the breast is compressed, it may provide optimal imaging of tissue abnormalities and/or may allow lower doses of x-ray radiation to be used, thereby reducing x-ray radiation exposure to the patient.
FIGS. 1
,
2
A, and
2
B show a mammography unit
10
, including a base
12
and a rotating assembly
14
that includes an x-ray source
16
, a compression paddle
18
, and an x-ray plate
20
. The x-ray plate
20
, often referred to as a “bucky,” is stationary relative to the rotating assembly
14
, while the compression paddle
18
may be attached to an interchange assembly
22
that is movable relative to the x-ray plate
20
.
As best seen in
FIG. 2A
, the x-ray plate
20
generally includes two patient contact surfaces, a primary tissue contact surface
24
and a front surface
26
, as well as side surfaces
28
. At least one of the side surfaces
28
may include an opening
30
into which an x-ray cassette
32
may be inserted.
FIGS. 4A and 4B
show attachments that may be placed on the x-ray plate
20
to enhance imaging, e.g., an attachment
40
for spot compression and an attachment
42
for magnification.
As best seen in
FIG. 2B
, the compression paddle
18
also generally includes two patient contact surfaces, a primary tissue contact surface
34
and a front surface
36
, as well as two side surfaces
38
.
FIGS. 3A-3C
show other configurations of compression paddles
44
-
48
that may have various shapes and sizes depending upon a patient's anatomy and/or the type of x-ray view that is desired.
With the patient (not shown) leaning against the front surfaces
26
,
36
, the patient's breast (also not shown) is placed on the primary contact surface
24
of the x-ray plate
20
and the compression paddle
18
is moved towards the x-ray plate
20
to compress the breast between the primary contact surfaces
24
,
34
. A series of x-rays may be taken of the breast tissue, e.g., involving moving the rotating assembly
14
and/or repositioning the patient's breast after each film exposure.
One of the problems with mammography is that the patient may experience significant discomfort during compression of the breast. Because of this, some women may avoid having a mammogram taken, rather than experience the pain that may be caused during the procedure. Although patients may tolerate the pain caused by compression up to about ten to eleven (10-11) compression units, clinical mammography may involve up to sixteen to eighteen (16-18) compression units. If greater compression is used, the quality of the mammogram may be enhanced, thereby increasing the physician's ability to detect cancers or suspect lesions. However, with greater compression comes increased discomfort.
U.S. Pat. No. 5,541,972, issued to Anthony, discloses a padding device that may be added to cover the front surface of an x-ray plate. Because the padding device is made from materials that may be radiopaque, the padding device is generally positioned to avoid disposing it within the field of the x-ray plate.
U.S. Pat. No. 5,185,776 discloses a radiolucent pad that is glued to a sleeve. An x-ray cassette may be inserted into the sleeve, a patient may be disposed against the pad, and an x-ray image obtained. The sleeve and pad are disposed of after the x-ray procedure. Disposing of the entire x-ray sleeve after a single use, however, may increase the cost of x-ray procedures.
Accordingly, improved devices and methods for increasing patient comfort during mammography and/or for allowing increased compression without substantially increased discomfort would be useful.
SUMMARY OF THE INVENTION
The present invention is directed to devices and methods for cushioning surfaces, for example, for cushioning or padding surfaces of compression devices applied to body parts during x-ray procedures, such as during mammography, biopsies, and the like.
In accordance with one aspect of the present invention, a compressible and/or resilient pad is provided for cushioning a compression surface of a mammography unit. The pad is formed at least partially from radiolucent material, and includes first and second surfaces. A radiolucent tape includes a first surface that is attached to the first surface of the pad, and a second exposed surface that includes a radiolucent pressure sensitive adhesive for removably attaching the exposed surface to an object.
Preferably, the tape is a double coated tape, e.g., including a polyester or polyethylene base film, and an acrylic adhesive on the first and second surfaces. The adhesive on the first surface may substantially permanently attach the tape to the first surface of the pad, while the adhesive on the exposed surface may allow attachment to an object, such as an x-ray plate, a compression paddle, or other compression device. A cover sheet may cover the exposed surface of the tape, the cover sheet being removable before attaching the exposed surface to an object.
In one embodiment, the entire pad may be formed from radiolucent material, while alternatively, the pad may include a radiolucent region, e.g., a central region, and a radiopaque region, e.g., a border around the central region. The pad may include one or more side regions adjacent the central region, at least one of which may include a slot therethrough. In a further alternative, the pad may include a window for providing access through the pad.
In accordance with another aspect of the present invention, an apparatus is provided for compressing a tissue structure using a compression device that includes a primary contact surface formed from radiolucent material, and one or more side surfaces extending laterally from the primary contact surface. The compression device may be an x-ray plate, a compression paddle, or an attachment to such devices. A pad, such as that described above, may be secured to the compression device. The pad includes a tissue contact surface formed from radiolucent material that may be removably secured against the primary contact surface, and one or more side regions removably secured along respective side surfaces of the compression device. In one embodiment, the pad may include a pair of side regions extending from opposing edges of the tissue contact surface. The side regions may extend around the compression device and connect to one another such that the tissue contact surface is secured adjacent the primary contact surface of the compression device with or without using an adhesive. In addition, or alternatively, the pad may include a front region removably secured to a front surface of the compression device. The front region may simply cover the front surface or it may be sufficiently long such that the front region and at least one of the side regions overlap to substantially secure the pad to the compression device.
In another embodiment, the pad may be a sleeve that may be received around at least a portion of the compression device. Preferably, the pad is sized to slidably engage the compression device sufficiently to secure the tissue contact surface adjacent the primary contact surface. The sleeve may include a top panel, side panels, a bottom panel, and/or a back panel. One or more side regions may include a slot therein corresponding to an opening in a side surface of the compression device, thereby providing access to the openin
Hermann George D.
Higgins Sheryl W.
Howell Thomas A.
Lebovic Gail
Willis David
Arana Louis
BioLucent, Inc.
Cohen & Sakaguchi LLP
English William A.
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