Breast biopsy bed

Details Breast biopsy bed Breast biopsy bed

2001-12-17

2004-12-21

Trettel, Michael F. (Department: 3673)

Beds

Invalid bed or surgical support

Adapted for imaging

C005S08110C, C005S611000, C378S209000

Reexamination Certificate

active

06832399

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a support apparatus for performing mammograms and breast biopsies during which the patient is in the decubitus position. More specifically, the present invention provides an apparatus and method for accurately repositioning a patent, maintaining the patient in the selected position for breast biopsy and preventing discomfort to the patients bottom arm and shoulder which are supporting the patient's weight during mammography performed in the decubitus position.
BACKGROUND OF THE INVENTION
Advances in the field of mammography have enabled early detection and treatment of cancerous and precancerous tissues. When a mammogram is taken, it is analyzed by a radiologist. If suspicious images are found, a biopsy of the tissue is taken. Mammography typically has been 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. If suspicious tissue was observed in the mammogram the physician marked the precise area to be biopsied and a tissue sample was obtained. The procedure of marking the area for biopsy involved inserting a needle into the breast, and feeding of a wire through the needle which remains in place until the biopsy is performed.
In an improved method for performing breast biopsies, known as the core biopsy technique, the patient is placed in a standing or upright sitting position and the biopsy is taken by positioning the patient's breast between the opposed plates of a mammography device. Then, using a medical instrument known 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. Instead, the biopsy can be performed in the same location as the initial mammogram.
However, during the performance of the core biopsy, it is possible for the patient to move slightly, or worse to faint. Either reaction presents significant problems both for the patient and the technician or radiologist. In one instance a sample from the wrong area is taken, and in the other an incorrect sample can be taken and the patient can be injured by falling. One solution to this problem is to support the patient during core breast tissue sampling by using an examination table having a central, surrounded and not laterally accessible opening therein. With such an examination table, the patient lies in a prone position with her breasts hanging downwardly through the opening. This type of support table is known as a “prone table” or “Parker table.” The Parker table is large and not readily repositionable, making access to the breast region difficult. The Parker table also presents a problem in attempting to locate tumors when the patient is small breasted or the suspected tumor is adjacent the chest wall, i.e., the rib cage area.
Thus it would be beneficial if the patient could have mammograms, needle localizations and core biopsies performed when lying 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 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 patent 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 in which case a bulky portion of the device 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.
A bed or examination table which allows the patient to be positioned on her side is the subject of U.S. patent application Ser. No. 09/712,475. This patent application teaches the use of an examination table or bed in which the patient may be positioned in a left lateral decubitus or right lateral decubitus position to present her breast for examination and biopsy. While the bed or table of U.S. patent application Ser. No. 09/712,475 provides substantial benefits to the patient, additional improvements and embodiments of the examination table or bed have been discovered which can further increase patient comfort while in the decubitus position, and which can increase the accuracy of the biopsy procedure.
It will be appreciated by those skilled in the art that while a patient is in the decubitus position (
FIG. 1
) that the patient is able to roll forward and backward on the examination table. Such a forward or backward rolling movement could remove the area of the breast to be biopsied from the field of the biopsy needle. Further, it will be appreciated that the entry of a biopsy needle into the breast and the withdrawal of the needle is a procedure offering discomfort to the patient. This discomfort and the anticipation of it can cause a patient to shift position and even slightly pull away from the biopsy device. This can result in inaccurate biopsy procedures and the need to reperform the unpleasant procedure. Therefore a means for bracing the patient and reducing patient movement while in the decubitus position would greatly benefit the biopsy procedure.
An additional embodiment of the examination table or bed of U.S. patent application Ser. No. 09/712,475 is provided in the present application and which reduces or eliminates the discomfort caused to a patient from being positioned in the left lateral decubitus or right lateral decubitus position for a period of time. While in the left lateral decubitus or right lateral decubitus position much of the patient's weight is resting on the patient's downward arm and shoulder. If the patient is required to remain in the lateral decubitus position for a time the patient can experience pain or the local loss of feeling in the arm or shoulder which is in contact with the examination table. Therefore, a means for reducing the pressure of

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