Surgery – Instruments – Electrical application
Reexamination Certificate
1999-09-16
2002-05-21
Kearney, R. (Department: 3739)
Surgery
Instruments
Electrical application
C606S002000, C606S013000, C606S014000, C606S020000, C606S027000, C606S032000
Reexamination Certificate
active
06391026
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical methods and apparatus for treating breast tissues. More particularly, the present invention relates to methods and apparatus for ablating or inhibiting the proliferation of epithelial and other cells lining a breast duct.
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, with the first stage thought to be excessive proliferation of individual cell(s) leading 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 referred to as ductal carcinoma in sitU (DCIS). After a time, however, the cancerous cells are able to invade outside of the ductal environment, presenting the risk of metastases, which can be fatal to the patient.
While breast cancer through the DCIS phase is in theory quite treatable, effective treatment requires both early diagnosis and an effective treatment modality. At present, mammography is the state-of-the-art diagnostic tool for detecting breast cancer. Often, however, mammography is only able to detect tumors, which have reached a size in the range from 0.1 cm to 1 cm. Such a tumor mass may be reached as long as from 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.
Alternative diagnostic modalities, which promise much earlier detection of breast cancer and DCIS, are described in co-pending application Ser. Nos. 08/931,786; 09/067,661; and 09/301/058, the full disclosures of which are incorporated herein by reference. Together, these applications describe techniques for identifying one or more (usually all) individual ductal orifices on a nipple in a breast and for collecting cellular and other materials from individual ductal networks to determine if hyperplasia, DCIS, or other abnormal conditions are present in that network. While these techniques will be very useful in providing early and accurate diagnosis of breast cancer and other diseased conditions, they do not directly provide for treatment of the condition once it is diagnosed.
Conventional treatments for breast cancer have been focused on the treatment of a latter stage disease and include removal of the breast, localized removal of the tumor (“lumpectomy”), radiation, and chemotherapy. While these techniques are often very effective, they suffer from certain deficiencies. Removal of the breast provides the best assurance against recurrence of the cancer, but is disfiguring and requires the patient to make a very difficult choice. Lumpectomy is less disfiguring, but is associated with greater risk of recurrence of the cancer. Radiation and chemotherapy are arduous and are not completely effective against recurrence. Such conventional treatments will not always be able to take full advantage of emerging diagnostic techniques, which promise to allow detection of pre-cancerous and cancerous conditions in the breast at a very early stage.
For these reasons, it would be desirable to provide improved and alternative techniques for treating breast cancer and pre-cancerous conditions such as ductal carcinoma in situ (DCIS) and atypical ductal hyperplasia (ADH). In particular, it would be desirable to provide treatment modalities, which can be used in conjunction with the newly developed techniques for diagnosing DCIS and other abnormal conditions within individual breast ducts. Such techniques should be less invasive and traumatic to the patient than the present techniques, should result in minimum or no disfigurement of the breast, and should be effective locally within target sites within the breast duct and/or throughout an entire ductal network. Preferably, the techniques should be capable of being performed in a single or very few treatment session(s). At least some of these objectives will be met by the invention described hereinafter.
2. Description of the Background Art
Co-pending application Ser. Nos. 08/931,786; 09/067,661; and 09/301,058 have been described above. Publications by the inventor herein relating to breast duct access include Love and Barsky (1996)
Lancet
348: 997-999; Love (1992) “Breast duct endoscopy: a pilot study of a potential technique for evaluating intraductal disease,” presented at 15th Annual San Antonio Breast Cancer Symposium, San Antonio, Tex., Abstract 197; Barsky and Love (1996) “Pathological analysis of breast duct endoscoped mastectomies,” Laboratory Investigation, Modern Pathology, Abstract 67. A description of the inventor's earlier breast duct access work was presented in Lewis (1997) Biophotonics International, pages 27-28, May/June 1997.
Nipple aspiration and/or the introduction of contrast medium into breast ducts prior to imaging are described in Sartorius (1995)
Breast Cancer Res. Treat.
35: 255-266; Satorius et al. (1977) “Contrast ductography for the recognition and localization of benign and malignant breast lesions: An improved technique,” in: Logan (ed.), Breast Carcinoma, New York, Wiley, pp. 281-300; Petrakis (1993)
Cancer Epidem. Biomarker Prev.
2: 3-10; Petrakis (1993)
Epidem. Rev.
15: 188-195; Petrakis (1986)
Breast Cancer Res. Treat.
8: 7-19; Wrensch et al. (1992)
Am. J. Epidem.
135: 130-141; Wrensch et al. (1990)
Breast Cancer Res. Treat.
15: 39-51; and Wrensch et al. (1989)
Cancer Res.
49: 2168-2174. The presence of abnormal biomarkers in fine needle breast aspirates is described in Fabian et al. (1993)
Proc. Ann. Meet. Am. Assoc. Cancer Res.
34: A1556. The use of a rigid 1.2 mm ductoscope to identify intraductal papillomas in women with nipple discharge is described in Makita et al. (1991)
Breast Cancer Res. Treat.
18: 179-188. The use of a 0.4 mm flexible scope to investigate nipple discharge is described in Okazaki et al. (1991)
Jpn. J Clin. Oncol.
21: 188-193. The detection of CEA in fluids obtained by a nipple blot is described in Imayama et al. (1996)
Cancer
78: 1229-1234. Delivery of epithelium-destroying agents to breasts by ductal cannulation is described in WO 97/05898 and U.S. Pat. No. 5,763,415.
A company called Diagnostics Inc., formed in 1968, produced devices to obtain breast ductal fluid for cytological evaluation. The devices included a breast nipple aspiration device to collect NAF (nipple aspirate fluid) from subjects, and catheters to retrieve ductal fluid from breast ducts. The devices were sold prior to May 28, 1976 for the purpose of collecting breast ductal fluid for cytological evaluation.
Energy-mediated ablation of the uterus, gall bladder, blood vessels, and other hollow body organs are described in the following U.S. Pat. Nos.: 4,776,349; 4,869,248; 4,872,458; 4,979,948; 5,045,056; 5,100,388; 5,159,925; 5,222,938; 5,277,201; 5,242,390; 5,403,311; 5,433,708; 5,507,744; and 5,709,224.
SUMMARY OF THE INVENTION
The present invention provides improved methods for treating individual milk ducts in human and animal breasts. Such treatments will usually be performed in patients diagnosed with cancer or precancerous conditions but may also find use prophylactically in patients at risk of cancer or other ductal diseases. Treatment is directed at individual ducts in ductal networks within the breast and typically comprises transferring energy to or from a lumen of the duct in an amount sufficient to destroy (ablate) or inhibit proliferation of cells lining the duct, such as epithelial cells which are atypical, excessively proliferating (neoplastic), and/or at risk of excessive proliferation. In an exemplary embodiment, high frequency electrical current is directed to the lumen in order to ablate or necrose at least a portion of the cellular lining of the duct. The present invention also encompasses directing other forms of energy to the lumen of
Hung David
Ken Chris
Love Susan
Nikolchev Julian
O'Leary Shawn
Banner & Witcoff , Ltd.
Pro Duct Health, Inc.
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