Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
2002-03-29
2004-02-10
Marmor, Charles (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S573000, C604S028000, C435S007230
Reexamination Certificate
active
06689070
ABSTRACT:
The present invention relates to medical devices, methods and systems for introducing fluids into and collecting a composition from a duct within a mammalian breast. More particularly, the present invention relates to medical devices, methods and systems for accessing the duct within the breast, introducing fluid within the duct, retrieving a composition from within the duct and passing the composition out of the breast so that it can be collected and analyzed without injuring the ducts within the breast or any other part of the breast.
BACKGROUND OF THE INVENTION
Breast cancer is the most common cancer in women, with well over 100,000 new cases being diagnosed each year in the United States alone. Breast cancer usually begins in the cells lining a breast duct (epithelial lining), with the first stage of the cancer thought to include the excessive proliferation of individual cell(s) that lead to “ductal hyperplasia.” Some of the hyperplastic cells may then become atypical, with a significant risk of the atypical hyperplastic cells becoming neoplastic or cancerous. Initially, the cancerous cells remain in the breast ducts, and the condition is commonly referred to as ductal carcinoma in situ (DCIS). After a time, however, the cancerous cells begin to invade outside of the ductal environment, presenting the risk of metastases, which, as is well known, can be fatal to the patient.
While breast cancer through the DCIS phase is in theory quite treatable, early diagnosis is critical to the effectiveness of the chosen treatment. At present, mammography is the most well known diagnostic tool for detecting breast cancer. However, mammography is often only able to detect tumors that have reached a size in the range from 0.1 cm to 1 cm. Such a tumor mass may not be reached until 8 to 10 years following initiation of the disease process. Detection of breast cancer at such a late stage is often too late to permit effective treatment. As a result, alternative diagnostic modalities that promise much earlier detection of breast cancer are needed.
Breast cancer is believed to originate in the lining of fluid producing breast milk ducts in the breast; and additionally human breasts are believed to contain from 6 to 8 of these ducts. See Sartorius,
JAMA
224 (6): 823-827 (1973). Therefore, in a search for an answer for early detection, significant members of the medical community dedicated to studying breast cancer have believed and shown that the cytological analysis of cells retrieved from nipple discharge from the breast milk ducts can provide valuable information leading to an early identification of patients who are at risk for breast cancer. Indeed Papanicolaou contributed to the genesis of such a possibility of a “Pap” smear for breast cancer by analyzing the cells contained in nipple discharge that collected on the outer surface of the nipple. See Papanicolaou et al, “Exfoliative Cytology of the Human Mammary Gland and Its Value in the Diagnosis of Cancer and Other Diseases of the Breast” Cancer (1958) March/April 377-409.
Other attempts to find an early detector include Sartorious's use of hair-like, single lumen fluid introduction catheters that were inserted into breast ducts using an operating microscope so that the ducts could be flushed with saline solution. After the fluid was introduced, the single lumen catheter was removed and the breast was squeezed so that fluid would be expelled out of the breast through the nipple. The expelled fluid typically collected on the outer surface of the nipple and was removed by a capillary tube positioned against the nipple. Similarly, Love and Barsky, “Breast-duct endoscopy to study stages of cancerous breast disease”,
Lancet
348 (9033):997-999, 1996 describes cannulating breast ducts with a single lumen catheter and infusing a small amount of saline, removing the catheter and squeezing to collect the fluid that returns onto the outer surface of the nipple. Additionally, in “A simple method of Duct Cannulation and Localization for Galactography before Excision in Patients with Nipple Discharge.”
Radiology
1995; 195; 568-569 Hou et al. describes injecting a “small volume of sterile, water soluble contrast material . . . (0.5 ml-2.0 ml) . . . the catheter was taped on the breast or nipple . . . the contrast material was aspirated with the same syringe and gentle manual pressure was exerted on the breast to expel the opaque medium.”
Diagnostics, Inc developed another example of a similar process for obtaining ductal fluid for cytology. This company produced devices that could be used to obtain breast ductal fluid for cytological evaluation. The devices included a hair-like single lumen breast duct catheter to infuse fluid into a breast duct and the procedure dictated that after removal of the catheter oozing fluid was collected from the nipple surface with a capillary tube. The devices were sold prior to May 28, 1976 for the purpose of collecting breast ductal fluid for cytological evaluation.
While the above-mentioned disclosures contemplate introducing fluid into a breast duct, they rely on externally applied pressure to expel fluid from within the duct. However, when the expelled fluids accumulate on the exterior of the nipple, it is very difficult, if not impossible, to determine the individual duct that expelled the fluid having the atypical or cancerous cells. Therefore, if the cytological examination comes back positive, it is very unlikely that the duct that produced the fluid can be identified and treated. Alternatively, in other instances, the ductal sphincter may prevent a necessary amount of ductal fluid that is needed for a useful sample from being expelled and collected. Additionally, the sphincter may block some of the cells from being passing out through the nipple.
SUMMARY OF THE INVENTION
The present invention includes devices and methods for obtaining ductal fluids and cellular material from a ductal network in a human breast in order to determine if the patient has or is likely to develop breast cancer. The devices and methods of the present invention permit the fluids and cellular material to be collected without collapsing the duct.
In a first embodiment of the present invention, the device for accessing a mammalian duct and collecting cellular material from within the duct comprises a catheter that can be positioned within the duct and a manifold lumen. The catheter includes a proximal end and a distal end. The distal end has an opening for delivering lavage fluid within the duct and receiving cellular material from within the duct. The manifold hub is in fluid communication with the catheter. The manifold hub comprises a distal end having a first port that is axially aligned with an internal lumen of the catheter, a second port positioned within the hub for infusing fluids into hub and a third port positioned within the hub for collecting fluid from within the hub.
In another aspect of the invention, the ductal access device comprises an elongated member that can be positioned within the breast duct. The elongated member comprises an internal lumen that is in fluid communication with a manifold hub.
The present invention also includes a ductal access device for accessing a breast duct and collecting cellular material from within the duct. The device comprises an elongated member including a proximal end, a distal end and a lumen extending between the proximal and distal ends. The device also includes a hub comprising an infusion port for delivering fluid to the lumen of the elongated member. The infusion port is in fluid communication with an infusion device. The device further includes a collection port for receiving fluid and cellular material from within the hub.
Another aspect includes a ductal access device for accessing a breast duct and collecting cellular material from within the duct. The device comprises a first elongated member having a first outer diameter for positioning within the breast duct and a second elongated member having a second outer diameter that is greater than the first outer diameter.
Hung David
Kurz Daniel R.
Olsen Philip M.
Banner & Witcoff
Cytyc Health Corporation
Marmor Charles
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