Intraductal breast fluid aspiration device

Details Intraductal breast fluid aspiration device Intraductal breast fluid aspiration device

2000-01-21

2003-02-11

Nguyen, Anhtuan T. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

Reexamination Certificate

active

06517513

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to the reduction of breast cancer risk, and, in particular, to methods and devices for influencing the transport of carotenoids and possibly other substances from the blood into the breast microenvironment.
Breast cancer is one of the leading causes of disease and death in women, with greater than 90% of breast cancer originating in the epithelial cells of ducts (American Cancer Society, 1996a). Early detection and treatment of breast cancer has focused on improving prognosis and increasing the survival rates, still such rates have only plateaued (American Cancer Society, 1996d). As a result, women's health experts have instigated a renewed focus and call for innovation in breast cancer prevention efforts (Love, 1995).
The protective effect of lactation and dietary carotenoids in breast cancer development has been supported (American Cancer Society, 1996a; Holmes, Hunter, & Willett, 1995; Stoll, 996; Weisburger, 1991). Little is known, however, about the influence the naturally-occurring physiologic process of lactation has on the microenvironment of the breast in relation to breast cancer prevention. Less is known about the presence of carotenoids in the microenvironment of the breast. No information is available on how lactation might influence transport of carotenoids into the microenvironment of the breast. Yet, lactation and diet as protective or chemopreventive processes represent health choices for women to prevent breast cancer.
The presence of fluid in the breast has been confirmed by history in the breast has been confirmed by histological study of the breast ductal system (Petrakis et al., 1975), and breast fluid has been obtained through manual aspiration from parous and nulliparous women (Petrakis et al., 1975; Sartorius, 1973, Sartorius, Smith, Morris, Benedict, & Friesen, 1977). Sartorious (1973) first reported the use of a suction device to aspirate breast fluid in a report on devising methods to detect breast cancer by studying cells from the breast fluid.
Petrakis et al. (1975, 1986, 1988a, 1988b, 1989, 1990), Sartorius et al. (1977), Visozo et al. (1992), and Wrensch et al. (1990) have conducted several studies ranging from clinical availability of breast secretions, descriptions of breast fluid regarding content, to epidemiologic investigations into cytologic changes and breast disease. These studies have supported that the epithelial lining of the breast ducts exist in a fluid environment that reflects the internal and external environment of the human. Murrell (1991) has hypothesized that under normal physiologic conditions, damage to breast epithelium by carcinogens as products of oxygen free radicals, in the absence of stimulus to clear fluid containing carcinogens, may expose the breast to increased risk of cancer development.
During the physiologic process of lactation, the fluid microenvironment of the breast is in a repetitious process of fluid synthesis and drainage. Changes in the breast epithelium lining the ducts during differentiation and growth in preparation for milk production is thought to alter the susceptibility of the cell to neoplastic changes (McTiernan & Thomas, 1986; Taylor-Papadimitriou, Lane, & Change, 1983). Furthermore, lactation acting as a mechanical cleansing process, flushes potential carcinogens in the ducts, which may represent another way in which lactation decreases risk of breast cancer (McTiernan & Thomas, 1986; Murrell, 1991; Yoo, et al., 1992). Malhotra (1977) points out that an alkaline milieu at the breast epithelial cell level results in increased mitotic activity and cell proliferation, which is carcinogenic. Stasis in the fluid environment of the breast, which can specifically occur during lactation failure, maintains the alkalinity of the cell environment. Nipple stimulation, which would likely increase oxytocin levels and lead to drainage of the breast, may be instrumental in preventing breast disease (Murrell, 1991).
While past studies on the protective effect of lactation on breast cancer risk report mixed results from nonconsequential (Haagensen et al., 1981; Kvale and Heuch, 1987; MacMahon et al., 1970) to moderate (Adami et al., 1990; Ing, Ho, and Petrakis, 1977; Levin, Sheehe, Graham, and Glidwell, 1964; Malhotra, 1977; McTierman and Thomas, 1986; Siskind et al., 1988), results from several contemporary studies support an association between lactation and decreased breast cancer risk, suggesting an independent, protective effect (Byers et al., 1985; Layde et al., 1988; Lubin et al., 1992; Newcomb et al., 1994; Yoo et al., 1992; Yuan et al., 1988). Most studies did not operationalize lactation other than in a dichotomous fashion (yes
o). Cumulative length of lactation can vary greatly among women.
Carotenoids are a group of related chemicals and natural lipid-soluble pigments found mainly in plants, certain vegetables, and in animal tissue (Britton, Liaaen-Jansen, & Pfander, 1995; DeLuca, 1978; Michnovicz & Klein, 1994) and serve as precursors of vitamin A. Of the carotenoids with provitamin A activity, beta-carotene “is the most common and most effective” (Pitt, 1985, p. 8), thus beta-carotene has become the focus of interest as a significant biologically-active nutritional and anticarcinogenic substances (Burton, 1989; Byers & Perry, 1992; Dimascio, Murphy, & Sies, 1991). The main function of antioxidant nutrition, which includes lipid-soluble molecules such as carotenoids and enzymes derived from minerals, is to prevent oxidative damage to cells and their physiological function. Beta-carotene is the major carotenoid precursor of vitamin A and is the most effective, naturally occurring single oxygen quencher (Bendich, Phillips, and Tengerdy, 1990; Burton, 1989; Burton & Ingold, 1984; Krinsky & Deneke, 1982).
Of 15 studies investigating the relationship between nutrient intake and risk of cancer, including breast cancer, six studies (Brisson et al. 1989; Katsouyanni et al. 1988; Knecht et al., 1990; Negri et al., 1995; Rohan, McMichael, & Bahurste, 1988; & Wald et al, 1984), reported a decreased risk of breast cancer with dietary intake of beta-carotene. In seven studies, (Basu et al., 1989; Ewertz & Gill, 1990; Hislop, 1990; Marubini et al., 1988; Paganini-Hill et al., 1978; Potishman et al., 1990; Van'tNeer et al., 1990), results did not support the protective effect of beta-carotene. However, methods used to index or provide beta carotene intake are fraught with error, such as controlling for cooking methods or lipid intake, which is necessary for utilization of beta carotene.
Patton, et al. (1990) identified and measured concentrations of carotenoids in human colostrum in women immediately postpartum, specifically alpha- and beta-carotene, lycopene, and beta-cryptoxanthin. The concentrations of these carotenoids were widely varied and decreased over the first week postpartum, suggesting a flushing and diluting effect of progressive lactation on substances that are normally stored in the resting breast. Covington, et al. (1998) reported the presence of carotenoids in post-weaned breast fluids. Additionally, length of time post-wean negatively influenced the carotenoid level in nipple aspirates, while cumulative duration of lactation was not significantly related to carotenoid levels.
Notwithstanding the extensive research which has been conducted in this field, there remains a need for an understanding of the role of intraductal fluid and in connection with the risk of breast cancer, as well as methods and devices for using that understanding to create an efficacious risk reduction regimen.
SUMMARY OF THE INVENTION
There is provided in accordance with one aspect of the present invention, a method of elevating intraductal carotenoid levels in a non-lactating breast in a patient. The method comprises the steps of removing intraductal breast fluid from the non-lactating breast over a predetermined regimen. Although any removal of intraductal breast fluid in accordance with the present invention may have some preventative effects, remova

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