Patent Application
20060094957
The invention relates to an assembly for use as a biopsy site marker as well as a cut down guide for surgical procedures.
Breast cancer is one of the health threats most feared by women, and is the most common form of cancer in women. A key to treatment is early detection. For example, a mammogram is a procedure that has been used in hopes of early detection of breast cancer. One problem with mammography is that such an imaging technique can only find breast cancer once it has taken form. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited. Such methods and devices could significantly improve breast cancer survival. While breast cancer is most common among women, in rare instances the human male may also have occurrences of breast cancer.
Early detection is a key to cancer treatment. As such, more sensitive and reliable methods and devices are needed to detect cancerous, pre-cancerous, and other cancer markers of the breast at an early stage. For example, there are methods of detecting breast cancer which are based on the fact that a vast majority of instances of breast cancer begins in the lining of mammary ducts. Studies have shown that fluid within the mammary duct can contain high levels of breast cancer markers, and that an estimated 80%-90% of all breast cancers occur within the intraductal epithelium of the mammary glands.
Fluid within the breast ducts contains an assemblage and concentration of hormones, growth factors and other potential markers comparable to those secreted by, or acting upon, the surrounding cells of the alveolar-ductal system. Likewise, mammary fluid typically contains cells and cellular debris, or products that can also be used in cytological or immunological assays. One method for obtaining samples of cells from a mammary duct is ductal lavage. This method comprises the rinsing of a mammary duct with a saline solution or the like and collection of the solution along with any cells and cellular debris from the mammary duct.
Other methods of obtaining cellular or tissue samples from mammary ducts include brushing biopsies or targeted cutting operations. In brushing biopsy procedures, an introducer is guided through the nipple orifice and down a mammary duct. Typically the progress of the introducer is guided by an endoscope therein. When the distal end portion of the introducer is at the desired location, a brush is extended to scrape the intraductal epithelium. The loosened or dislodged tissue may then be collected for pathology, such as by suction. In targeted cutting operations a biopsy device, such as a cutter is guided through the introducer. For example, a biopsy device, such as shown in pending application U.S. Ser. No. 10/422,381, is utilized to excise a tissue sample by urging the desired mass through a window in a sheath and then actuating a cutter also disclosed within the sheath to excise the mass. The excised tissue is harvested and analyzed.
In the event that pathology reveals that a cellular or tissue sample so obtained warrants further examination, additional surgery or other procedures at the biopsy site may be conducted. Therefore, it is desired that the original biopsy site be marked so that such further examination of the site is facilitated. In order to mark the biopsy site, prior procedures have utilized the deposit of a radio-opaque marker at the biopsy site. Later investigations utilize an x-ray or ultrasound to view the marker to enable the practitioner to return to the site. A problem with such a marker, however, is that in mammary ducts there are numerous branches that make returning to the biopsy site through the duct system difficult.
Assuming that the biopsy site is marked or otherwise found, a further problem exists regarding how the physician reach the site for further procedures. As discussed, a radio-opaque marker is visible through use of an x-ray or ultrasound, however, such equipment is not amenable to use during surgery. Feeling for the desired tissue mass is also not possible since, as described, the biopsy site involves masses that are very small or are visually and tactilely indistinguishable from surrounding tissue.
In order to avoid this problem a technique for using a cut down guide has been developed. Cut down guides are often used in wire localization biopsies. In such a procedure, a thin wire is inserted with a needle and the end of the wire positioned at the biopsy site. Typically, this is done in the x-ray department of a hospital or clinic. A small needle is inserted under x-ray guidance pointing toward the biopsy site. A wire and a hook on the end is passed through the needle and the hook is positioned at the biopsy site. The needle is removed and the wire left in place. The patient is then taken to an operating room where the surgeon uses the wire as a guide to reach the biopsy site.
A shortcoming to this needle insertion process in association with intraductal procedures is the additional invasion of a needle probe, as well as the need for additional x-rays, both of which create discomfort for the patient. It also often involves two different departments of a hospital further complicating matters. The present invention overcomes the shortcomings.
An assembly suitable for use in mammary intraductal procedures as a biopsy site marker and cut down guide is provided. The assembly comprises an elongated filament that defines a hollow interior and has at least a pliable distal end portion together with a removable elongated core stiffener receivable within and guidable through the hollow interior. Alternatively, the entire filament may be pliable and formed of polypropylene, polyurethane, nylon or other extrudable pliant plastic material. The pliable distal end portion of the filament also includes at least one indicator suitable for marking a biopsy site. Preferably, the indicator is a radio-opaque marking on the filament. The core stiffener is formed of a rigid material, and is preferably formed of metal, such as a nickel-titanium allow, stainless or surgical steel, or the like. The core stiffener is guided through the hollow interior and provides a wire guide or cut down guide with which a physician or other practitioner is guided to the biopsy site.
The filament may be hollow along its entire length such that it takes the form of a tube. Alternatively, the filament may be hollow only along a portion of its length. For example, the distal end portion filament may include a solid portion. The distal end portion of the filament may also include an atraumatic distal end, such as a distal end portion that includes a taper, a rounded tip, or both. In such an embodiment, the filament may also be used as a dilator or obturator. Preferably, the filament also includes spaced penetration depth markers.
Unlike the prior methods described, the present assembly enables a practitioner to mark the biopsy site in an intraductal procedure with the filament, and leave the filament in place during the pathology of the obtained cellular or tissue sample, which can take several days. If it determined from the pathology that further tissue removal is required, such as if the sample proves malignant, the practitioner uses the filament as a guide for the core stiffener. The core stiffener is introduced and guided through the hollow interior of the filament. When the core stiffener is in place in the filament, the assembly acts as a cut down guide, such as the wire guide discussed above.
In the drawings,
The invention disclosed herein is, of course, susceptible of being embodied in many different devices. Shown in the drawings and described herein below in detail are preferred embodiments of the invention. It is to be understood, however, that the present disclosure is an exemplification of the principles of the invention and does not limit the invention to the illustrated embodiments.
An embodiment of the present assembly 10 is shown in
Referring to
To the extent it is determined from the pathology that a further biopsy is required, the core stiffener 14 may be inserted into hollow interior 20. Although the path of mammary ducts are not necessarily straight, typically the density of the breast tissue is such that it may be easily manipulated so that the core stiffener 16 can be guided through the hollow interior 20 as shown in
The assembly 10 thereby provides a cut down guide for a physician. As shown in
The core stiffener 14 may also incorporate small amounts of radioactive material in the distal portion inserted into the filament 12, such as a radioactive coating or incorporation of radioactive particles into the core stiffener 14 itself. The radioactive material is selected to provide a low dose of radiation such that when the distal portion is left at the biopsy site 30 for a period of time, radiation therapy is provided to the desired region.
Another embodiment of the present invention is shown in
Another embodiment of the present assembly 210 is shown in
As discussed above, the stiffener 214 can incorporate small amounts of radioactive material in the distal portion to provide a low dose of radiation such that when the distal portion is left at the biopsy site for a period of time, radiation therapy is provided to the desired region.
The foregoing description is to be taken as illustrative, but not limiting. Still other variants within the spirit and scope of the present invention will readily present themselves to those skilled in the art.
