Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2002-08-30
2004-01-20
Jaworski, Francis J. (Department: 3737)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S439000
Reexamination Certificate
active
06679850
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a device for stabilizing a breast during a medical procedure. More particularly, the device securely holds the breast for an ultrasound guided biopsy or cyst aspiration.
2. Description of Related Art
Biopsies or cyst aspirations on a breast are typically performed using a procedure commonly known as “freehand.” The patient is recumbent and is usually turned obliquely to one side. The breast lies free and unsupported while ultrasound locates the lesion to be biopsied or aspirated. One way to perform “freehand” is to have an ultrasound technician hold the ultrasound transducer while the physician guides the needle into the breast and to the lesion. However, “freehand” can also be carried out by the physician alone, who manipulates the ultrasound transducer with one hand and the biopsy needle or other medical instrument with the other hand.
Performing “freehand,” however, requires considerable experience and skill as well as time and effort. As most breasts are very mobile, because they contain fatty tissue giving them a soft consistency, it is often very difficult and time-consuming to manipulate the breast in order to introduce a biopsy needle or other medical instrument accurately and efficiently without a device securing the breast.
Components of a mammography machine can be used to stabilize the breast during a biopsy or cyst aspiration, making the biopsy or cyst aspiration more accurate and efficient. The breast is placed in a position as to do a cranio-caudal or top-to-bottom image of the breast and placed in the compression position. A compression plate with an aperture is then utilized to secure the breast while the biopsy or cyst aspiration is performed.
However, using a mammography machine for biopsies or cyst aspirations unnecessarily occupies the machine for a few hours. The machine instead could be producing life-saving mammograms. Further, many hospitals or clinics, because of their patient loads, cannot afford to have one of their mammography machines off-line and not producing mammograms for a few hours. Even if a mammography machine is purchased only for the purpose of performing biopsies or cyst aspirations, which can be expensive, or if the mammography machine is broken and only being used for biopsies or cyst aspirations, the extra machine takes up too much space. It is well known that most hospitals need every square inch of extra space.
Devices independent of mammography machines that secure the breast during medical procedures are known in the art. Such devices, however, have complicated parts, are hard to control, are bulky and intimidate the patient. A device used for stabilizing the breast during a biopsy or cyst aspiration is therefore needed that is independent of a mammography machine, that has simple yet reliable parts, is easy to use and control, is sturdy, is lightweight and portable. The device also needs to be comfortable, painless and not intimidating for the patient using the device. Lastly, the device needs to securely hold the breast in place during a biopsy or cyst aspiration, thereby making biopsies and cyst aspirations of the breast more accurate and efficient. These and other advantages are provided by the invention disclosed below.
SUMMARY OF THE INVENTION
A breast stabilizer is disclosed herein that is independent of a mammography machine and that renders a medical procedure, more specifically a biopsy or cyst aspiration of the breast, easier. The invention securely holds the breast between two plates thereby stabilizing the breast while a physician performs the biopsy or cyst aspiration. This allows the physician to perform the biopsy or cyst aspiration quickly and accurately without the breast moving.
The breast stabilizer of the invention comprises a base plate, pressure plate, support members, column and frictional engagement device. The base plate has an upper surface and a lower surface, the lower surface of the base plate being secured to the support members. Two of the four support members secure the column that extends vertically upward from the support members and beyond the base plate. The frictional engagement device releasably grips the column above the upper surface of the base plate. The frictional engagement device is connectable to the pressure plate, which slidably cooperates with the column and is positioned parallel to and above the upper surface of the base plate. Using the frictional engagement device, the pressure plate can be raised and lowered in a controlled manner relative to the base plate to secure the breast between the pressure plate and the upper surface of the base plate. The frictional engagement device uses micro-adjustments to move the pressure plate up and down the column and prevents movement of the pressure plate except when the physician or other operator desires to adjust the position of the plate relative to the base plate. For better access to the top of the breast, the pressure plate contains an aperture having internal beveled walls, used to guide a biopsy needle or other medical instrument. The base plate, pressure plate and support members are preferably made of a transparent polymeric material, and the base plate and pressure plate have rounded edges and corners to avoid injuries to the patient.
The patient may be seated upright or standing when the present invention is used. The breast is placed on the upper surface of the base plate below the raised pressure plate. The physician or other operator can then use the frictional engagement device to lower the pressure plate in a controlled manner. Once the pressure plate contacts the top of the breast, the pressure plate is lowered until the breast is securely held between the pressure plate and the upper surface of the base plate. The physician can then perform the biopsy or cyst aspiration without the breast shifting. When the physician has completed the biopsy or cyst aspiration, the pressure plate can then be raised using the frictional engagement device.
The present invention has simple but reliable parts, is lightweight, easily portable between rooms of a hospital or clinic and is sturdy due to the use of support members. The device is-easy to use and control, for example, because the frictional engagement device allows for the controlled movement of the pressure plate, which in turn allows the patient to be relaxed and unafraid of injury. The device is also comfortable, painless and not intimidating for the patient. The removal of tissue while using the present of invention is very successful, as the only lesions, perhaps unattainable are those located deep in the chest wall.
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Jaworski Francis J.
Locke, Liddle & Sapp LLP
Paris Kristen R.
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