Beds – Invalid bed or surgical support – Adapted for imaging
Reexamination Certificate
2000-11-14
2002-04-09
Trettel, Michael F. (Department: 3628)
Beds
Invalid bed or surgical support
Adapted for imaging
C005S613000, C378S209000
Reexamination Certificate
active
06367104
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention concerns a support apparatus and method for performing mammograms and breast biopsies with the patient positioned in the decubitus position. More particularly, it is concerned with a support apparatus which provides excellent patient support and access by both a technician and a mammography machine during the performance of decubitus breast mammography and biopsy procedures.
2. Description of the Prior Art
The women's health field has increasingly benefitted from advances in the field of mammography which enables early detection and treatment of cancerous and precancerous tissues. When a mammogram is taken, it is analyzed by a radiologist and if suspicious images are found, a biopsy of the tissue is taken. Mammography has been typically performed with the patient in the standing position, and the breast positioned between two opposed plates which flatten the tissue and hold it in place. Detection of suspicious tissue has then required that the physician mark the precise area to be biopsied and send the patient to the operating room. This procedure necessitated inserting a needle into the breast, and feeding of a wire through the needle which remains in place until the biopsy is performed, typically at a remote location.
An improved method for performing breast biopsies is the core biopsy technique. Again, the patient is standing or sitting in an upright position, wherein the biopsy is taken by positioning the patient with her breast between the opposed plates of a mammography device, and then, using a medical instrument (hereinafter referred to as a “breast tissue sampler”), a core of tissue is cut at the position indicated by the mammogram. This procedure represents a significant advance, in that the patient is not required to remain with a wire projecting from her breast or move to a remote location for the surgical biopsy, but rather can have it performed in the same physical area as the initial mammogram.
One problem with such procedures is that during the performance of the core biopsy, the patient can move slightly, or worse to faint. Such vasovagal reactions present significant problems both for the patient and the technician or radiologist.
One alternative support table for supporting a patient during core breast tissue sampling is a table with a central, surrounded and not laterally accessible opening therein, wherein the patient lies in a prone position with her breasts hanging through the opening. This support table, known as a “prone table” or “Parker table”, is large and not readily repositionable, making access to the breast region difficult, and presents a problem in attempting to locate tumors where the patient is small breasted or the suspected tumor is adjacent the chest wall, i.e., the ribcage area.
Thus it would be beneficial if the patient could have mammograms, needle localizations and core biopsies performed when laying on her side. This is known as the decubitus position, wherein the patient's breast is oriented toward the mammogram—preferably with the upper breast positioned for mammography or biopsy, but sometimes with the lower breast examined. The patient may thus be positioned in a left lateral decubitus (left side of patient down) or right lateral decubitus (right side of patient down) to present her breast to for examination. This may require the patient to position her head at either end of the support, or to rotate longitudinally (with feet and head remaining at the same relative ends of the bed) to present the breast in the proper position. The patient must be adequately supported and this support must be provided without giving the patient a sense of anxiety about falling off the support. Additionally, the support must permit access by the technician and access to the mammography and core biopsy machine to enable performance of the mammogram and/or biopsy procedure.
Prior art patient supports are perhaps best shown in U.S. Pat. Nos. 5,184,363 and 5,461,739 to Falbo, Sr., and U.S. Pat. No. 5,950,262 to Smoler et al., the disclosures of which are incorporated herein by reference. Such supports are beneficially configured with drop-out sections to permit access by the technician to the patient. However, these patient supports are not configured to meet the peculiar demands of decubitus breast mammography and biopsy. For example the U.S. Pat No. 5,184,363 discloses a support bed useful for cardiac sonography having two drop-out sections, the first to permit sonographic diagnosis of a patient lying on the bed, the second to accommodate the legs or other aspect of a person performing the diagnosis. However, the openings do not admit access by a mammography and core biopsy device, nor is the table particularly configured to permit alternate positioning of the patient on either the left or right side. Moreover, a mammography device often must be tilted wherein a bulky portion must lie adjacent the patient's head and below the top surface of the table, which is not possible with the aforementioned support bed. The U.S. Pat. No. 5,461,739 support apparatus is also designed for performing cardiac sonography, but with the patient in a supine position (resting on the back) and accommodating a pedaling device. It also teaches the use of one, or alternatively two, patient drop-out sections, but is not configured to admit into the openings a mammography and core biopsy device, nor to allow the patient to rest in a variety of different positions to present the breast for examination.
There has thus developed a need for an improved patient support apparatus which is designed for the performance of mammography, needle localizations and breast biopsies with the patient in a decubitus position. There has also developed a need for an improved method of performing mammography and breast biopsy which allows the patient to have the mammography and/or breast biopsy performed with the patient in a decubitus position.
SUMMARY OF THE INVENTION
These needs have largely been met by the method and apparatus of the present invention. That is to say, the method and apparatus of the present invention permit the performance of mammography, needle localization and breast biopsy whereby the patient may be positioned for optimum imaging, provide great flexibility in space utilization, give the patient excellent support while in a decubitus position, and provide economies by permitting a single examination room to serve for mammography, needle localization and core biopsy.
The patient support apparatus of the present invention broadly includes a patient support deck including a frame and pad defining a multiplicity of openings. To provide the most flexibility and safety, the openings are preferably occupied by filler sections which are most preferably shiftably mounted to the frame to permit access by examiners and a mammography device into the openings. The filler sections may be shifted by either pivoting or translational movement, or altogether removed from the frame when an opening is desired. The deck is supported by a deck support, and head and foot supports may be mounted at opposed ends of the deck. The head support preferably has a smaller transverse dimension than the width of the bed to provide an open area adjacent the head support, thereby permitting a mammography device to be tilted into and occupy the open area during examination.
The frame and openings are arranged to provide opposite openings (and preferably corresponding filler sections) which permit ingress from the sides of the deck by examiners such as technicians, nurses and physicians, and positioning of the mammography device therein. The openings are sized and positioned to receive mammography devices therein, with the openings preferably separated by a frame member of sufficient strength to bear the weight of the patient thereon. The frame preferably includes a laterally centered, longitudinally extending spine with center and end cross-channels extending perpendicular thereto in a common horizontal plane, thereby d
Baker Gary H.
Falbo, Sr. Michael G.
Hovey & Williams, LLP
Medical Positioning, Inc.
Trettel Michael F.
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