Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
2001-05-10
2003-10-07
Marmor, II, Charles A. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
C604S074000
Reexamination Certificate
active
06629936
ABSTRACT:
BACKGROUND OF THE INVENTION
It is believed that breast cancer begins in the breast milk ducts and it is known that the human breast has from about 6 to 9 ducts. Emerging technology is providing systems, kits, methods and devices for collecting fluid from these ducts individually so as to keep separate the material collected from each duct and to analyze it separately. Copending and co-owned applications to methods and kits for obtaining fluid and cellular material from breast ducts, U.S. Ser. No. 09/067,661 filed Apr. 28, 1998 now U.S. Pat. No. 6,221,622, and its CIP U.S. Ser. No. 09/301,058 filed Apr. 28, 1999, now U.S. patent application Publication No. 2002/0019017 describe and claim infusing fluid into the duct and collecting the fluid using a catheter.
Previously it has been found that breasts that yielded fluid upon nipple aspiration identified the patient as being at risk for developing breast cancer. See Petrakis, “Studies on the epidemiology and natural history of benign breast disease and breast cancer using nipple aspirate fluid”
Cancer Epidemiology, Biomarkers and Prevention
(January/February 1993) 2:3-10; Petrakis, “Nipple Aspirate Fluid in epidemiological studies of breast disease”,
Epidemiologic Reviews
(1993) 15:188-195. In addition, pooled nipple aspirate fluid has been analyzed for cancer markers. See Sauter et al, “Nipple aspirate fluid: a promising non-invasive method to identify cellular markers of breast cancer risk”,
British Journal of Cancer
76(4):494-501 (1997).
Upon identification of a duct that may have abnormal cells by analysis of the ductal fluid, that duct can be targeted for breast sparing treatment including administering an agent intraductally to the duct, rather than systemically, or removing just the affected duct. In order to review the entire breast by this method, however, all 6 to 9 ducts on the breast must be identified and accessed, which is a difficult and time consuming task, and for these reasons accessing all the ducts on a breast in order to perform a diagnosis remains a suboptimal strategy.
There is thus a need in the art to develop techniques to identifying ducts that are at higher risk for cancer than other ducts on the same breast so that fewer than all the ducts on the breast can be targeted for access and analysis. The present invention provides such a solution to this problem.
SUMMARY OF THE INVENTION
It is an object of the invention to provide methods for differentiating a cancer risk status of milk ducts in a breast.
It is another object of the invention to provide kits for differentiating a cancer risk status of milk ducts in a breast.
These and other objects of the invention are provided by one or more of the embodiments described below. In one embodiment a method of differentiating a cancer risk status of milk ducts in a breast comprises aspirating the nipple, and locating at least one ductal orifice that yields fluid upon aspiration; wherein a duct that yields fluid upon aspiration is at higher risk for cancer. More than one duct can yield fluid at the orifice upon aspiration of the nipple. The method can further comprise accessing a ductal orifice that yields fluid; retrieving ductal contents from the accessed duct; recording the location of the ductal orifice once identified by yield of fluid at the orifice; and/or making an identifiable mark at the ductal orifice upon yield of fluid at the orifice. Recording can comprise one or more of transcribing the relative location of the orifice onto a paper grid, taking a photograph, recording in real time on a digital screen the fluid yielding event and/or location of the ductal orifice that yielded fluid, and making a negative imprint on the nipple surface to identify the regions of the nipple that did not yield fluid. Marking can comprise making an identifiable mark with a pen or other labeling device to identify the spot comprising the ductal orifice at a later time; and/or placing an element into the duct such as a plug, tube, wire, thread or suture. The mark can reside on the nipple surface in a range of time from a few hours to a few years. The method can further comprise contacting a ductal orifice that yields fluid with a dilator in order to accomplish one or more of discerning the precise location of the orifice, discerning the orientation of the orifice, or enlarging the proximal area of the duct so as to facilitate subsequent cannulation of the duct.
Another embodiment of the invention provides a method of differentiating a cancer risk status of milk ducts in a breast comprising aspirating the nipple, and locating at least one ductal orifice that yields fluid upon aspiration; wherein a duct that yields fluid upon aspiration is at higher risk for cancer; and collecting a bead of fluid at the nipple surface generated from aspiration and emerging from the fluid yielding duct and not mixed with fluid generated from any other fluid yielding ducts on the nipple surface. The method can further comprise analyzing the collected fluid of the duct yielding fluid separately from the fluid of any other duct yielding fluid; marking the duct that yields fluid; and/or recording the location of the ductal orifice once identified by yield of fluid at the orifice. Recording can comprise one or more of transcribing the relative location of the orifice on a paper grid, taking a photograph, recording in real time on a digital screen the fluid yielding event and/or location of the ductal orifice that yielded fluid, and making a negative imprint on the nipple surface to identify the regions of the nipple that did not yield fluid. Marking can comprise making an identifiable mark with a pen or other labeling device to identify the spot comprising the ductal orifice at a later time; and/or placing an element into the duct such as a plug, tube, wire, thread or suture. The mark can reside on the nipple surface in a range of time from a few hours to a few years. The method can further comprise contacting a ductal orifice that yields fluid with a dilator in order to accomplish one or more of discerning the precise location of the orifice, discerning the orientation of the orifice, or enlarging the proximal area of the duct so as to facilitate subsequent cannulation of the duct
Embodiments including kits for differentiating a cancer risk status of milk ducts in a breast can comprise a nipple aspiration device, a system to mark and/or record the location of an orifice that yields fluid upon aspiration, and instructions for use of the kit to differentiate a cancer risk status of milk ducts in a breast by aspirating the nipple and locating at least one ductal orifice that yields fluid upon aspiration. Such a kit can further comprise a ductal access tool and further instructions to access the duct that yields fluid upon nipple aspiration. The system to mark and/or record the location of the ductal orifice that yields fluid can comprise one or more of a pencil and paper grid, a camera, a marking tool, a digital recording and imaging device, a system to make a negative imprint on the nipple surface, and an element to place in the orifice to mark it. The kit may also comprise a dilator. Another kit for differentiating a cancer risk status of milk ducts in a breast can comprise a nipple aspiration device, ductal access tool to access a duct through an orifice that yields fluid upon aspiration, and instructions for use of the kit to differentiate a cancer risk status of milk ducts in a breast by aspirating the nipple, including instructions to locate at least one ductal orifice that yields fluid upon aspiration, and access that duct through its orifice. Optionally the kit can also comprise a dilator.
Another kit for differentiating a cancer risk status of milk ducts in a breast can comprise a nipple aspiration device, a tool to collect an emerging bead of fluid at a ductal orifice, without mixing the collected fluid with any other fluid yielded from any other duct, and instructions for use of the kit to differentiate a cancer risk status of milk ducts in a breast by locating at least one ductal o
Hung David
Love Susan
Banner & Witcoff , Ltd.
Cytyc Health Corporation
Marmor, II Charles A.
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