Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2002-02-27
2003-05-20
Pelham, Joseph (Department: 3742)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S420000, C600S424000, C604S015000, C604S059000
Reexamination Certificate
active
06567689
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains generally to the field of medicine and surgery, and more particularly to methods and compositions of matter which may be used to mark the location from which a tissue sample has been removed so that subsequent treatments (e.g., surgical excision, radio-therapy, drug therapy, etc.) may be precisely performed at such location.
BACKGROUND OF THE INVENTION
A. The Use of Tissue Biopsies in Modern Medicine & Surgery
In modern medical practice small tissue samples, known as biopsy specimens, are often removed from tumors, lesions, organs, muscles and other tissues of the body. Such removal of tissue samples may be accomplished by open surgical technique (i.e., removal of a small sample of tissue through a small surgical incision using a local anesthetic), or through the use of a specialized biopsy instrument such as a biopsy needle. After the tissue samples have been removed, they are typically subjected to diagnostic tests or examinations such as a) gross and microscopic examination to determine cytology and/or histology, b) biochemical analyses to determine the presence or absence of chemical substances which indicate certain disease states, c) microbiological culturing to determine the presence of bacteria or other microbes, and/or d) other diagnostic procedures. The information obtained from these diagnostic tests and/or examinations can then be used to make or confirm diagnoses and/or to formulate treatment plans for the patient.
B. Special Considerations Relating to Biopsy of Breast Cancers
Approximately one in nine American women will develop breast cancer sometime in her life. Breast cancer is presently the most common cancer in women and is the second leading cause of cancer deaths in women. Periodic physical examination of the breasts is important for early detection of potentially cancerous lesions. Additionally, specialized X-ray studies known as mammography is a proven tool for diagnosing breast cancer in women over 40 years of age. Mammography is also believed by many medical practitioners to be diagnostically beneficial in younger women as well. In mammography, the breast is compressed between two plates while specialized x-ray images are taken.
If an abnormal mass in the breast is found by physical examination or mammography, ultrasound may be used to determine whether the mass is a solid tumor or a fluid filled cyst. Cystic lesions are generally benign and the diagnosis of a cystic lesion is often confirmed by needle aspiration of fluid from the interior of the cyst. (It should be noted, however, that the needle aspiration of cystic lesions is different from “needle biopsy” of solid masses as discussed herebelow). However, solid masses are usually subjected to some type of tissue biopsy to determine if the mass is cancerous.
If a solid mass or lesion is large enough to be palpable (i.e., felt by probing with the fingertips) a tissue specimen can be removed from the mass by a variety of techniques, including but not limited to open surgical biopsy or a technique known as Fine Needle Aspiration Biopsy (FNAB). In open surgical biopsy, an incision is made and a quantity of tissue is removed from the mass for subsequent histopathological examination. In the FNAB procedure, a small sample of cells is aspirated from the mass through a needle and the aspirated cells are then subjected to cytological examination.
If a solid mass of the breast is small and non-palpable (e.g., the type typically discovered through mammography), a relatively new biopsy procedure known as “stereotactic needle biopsy” may be used. In performing a stereotactic needle biopsy of a breast, the patient lies on a special biopsy table with her breast compressed between the plates of a mammography apparatus and two separate digital x-rays are taken from two slightly different points of view. A computer calculates the exact position of the lesion with X an Y coordinates as well as depth of the lesion within the breast. Thereafter, a mechanical stereotactic apparatus is programed with the coordinates and depth information calculated by the computer, and such apparatus is used to precisely advance the biopsy needle into the small lesion. Depending on the type of biopsy needle (s) used, this stereotactic technique may be used to obtain cytologic specimens (obtained through FNAB) and/or histologic specimens (obtained through coring needle biopsy). Usually at least five separate biopsy specimens are obtained from locations around the small lesion as well as one from the center of the lesion.
i. Potential Time Delay Between Biopsy and Commencement of Surgery or Other Treatment
For some types of biopsies (other than those of breast lesions), “frozen sections” of the biopsy specimen may be prepared by a pathologist and such frozen sections may be used to arrive at a reasonably accurate diagnosis within minutes after removal of the biopsy specimen. Such frozen sections are prepared by rapid freezing of the tissue, slicing of the tissue into sections that are approximately greater than 10 microns thick and mounting of the section(s) on glass slides for immediate microscopic examination by a pathologist. Frozen sections of this type are not typically used for biopsies of breast lesions because the usual frozen section is too thick for definitive visualization and diagnosis of the cell types found in breast tumors. Instead, breast biopsy specimens are usually prepared for histopathological examination by a more traditional non-frozen technique wherein the tissue specimen is immersed in a chemical fixative solution (e.g., formalin, glutaraldehyde, etc.) For a period of time sufficient to cause crosslinking of the connective tissue proteins present in the tissue, the fixed tissue is sliced into thin sections approximately 8 microns thick, the tissue sections are mounted on and cell selective histological stains are applied to stain the tissue prior to microscopic examination. This non-frozen tissue preparation technique typically requires at least 24-48 hours to complete and, as a result, the pathologist's diagnosis of the breast lesion may not be available until 24 to 72 hours after the biopsy specimen was removed from the breast. Thus, for these reasons, histopathological examination and diagnosis of breast lesions may be much more time consuming than the histopathological examination and diagnosis of other types of lesions. Thereafter, if a breast lesion has been diagnosed as cancerous, the patient may require sometime (e.g., several days to more than a week) to consider each of the surgical options available to her, seek second opinion(s) and reach a treatment decision. The available surgical options for cancerous lesions of the breast include various degrees of mastectomy or lumpectomy. Moreover, in some cases, depending on the histology (type of cancer), grade (how aggressive it looks under the microscope), stage (how large the cancer is and how far it has spread), and additional prognostic or predictive information, the treating physicians may recommend that some radiation therapy or chemotherapy be performed before proceeding with surgical lumpectomy.
ii. Marking of Biopsy Sites to Facilitate Subsequent Location and Treatment Of the Lesion
In order for the surgeon or radiation oncologist to direct surgical or radiation treatment to the precise location of the breast lesion several days or weeks after the biopsy procedure was performed, it is desirable that a biopsy site marker be placed in or on the patient's body to serve as a landmark for subsequent location of the lesion. Various types of biopsy site markers have been known in the prior art. For example, the prior art has included visually discernible markers that are applied externally to the patient's skin as described in U.S. Pat. Nos. 2,192,270 (Carswell, Jr.) and 5,147,307 (Gluck). Additionally, the prior art has included radiographically visible markers that may be introduced into the biopsy site such as marker wires that are inserted through the biopsy needle after a tissue sample is
Burbank Fred H.
Forcier Nancy
Jones Michael L.
Lubock Paul
coudert brothers LLP
Pelham Joseph
SenoRx, Inc.
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