Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-11-12
2001-12-11
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S514000
Reexamination Certificate
active
06328709
ABSTRACT:
FIELD OF THE INVENTION
The field of this invention is medical apparatus and methods for nipple fluid aspiration.
Classically, breast pumps have been made and used to aspirate mother's milk from lactating women in order to provide mothers the convenience of storing milk for their babies during times when mother and child could not be together. In non-lactating women, discharges and secretions of the nipple from the milk ducts have been obtained by removing the keratin material that plugs the ducts and using a nipple aspirator device to obtain small amounts of fluid secreted from the ductal orifices on the nipple surface. See page 51, Goodson W H & King E B, Chapter 4: Discharges and Secretions of the Nipple, The Breast: Comprehensive Management of Benign and Malignant Diseases (1998) 2nd Ed. vol. 2, Bland & Kirby Eds. W. B. Saunders Co, Philadelphia, Pa. pp. 51-74. This fluid is called nipple aspirate fluid or NAF. The human breast typically has from 6 to 12 ductal systems per breast that empty into the nipple through separate orifices, and in about 50-60% of non-lactating women fluid can be collected under vacuum pressure from at least one duct.
Cytological findings in NAF classified as moderate or atypical hyperplasia have shown a close association with histological findings of a similar classification. In correlating the NAF cytology findings with benign breast biopsies, 54% of those biopsies having histological lesions of atypical hyperplasia also had cytological findings of atypical hyperplasia. See King et al, (1983) J. Natl Cancer Inst 71: 115-1121. Also, women with moderate hyperplasia or atypical hyperplasia (as identified by random biopsy and subsequent histological examination of the biopsy specimen) have been shown to have a 1.5 to 5 times greater risk of breast cancer respectively than women with no biopsy. (See Goodson & King, (ref. 32) page 60). Histological lesions of moderate or atypical hyperplasia are associated with increase risk of breast cancer. See Petrakis et al, (1987) Lancet 2:505; Rogers and Page, (1979) Breast 5:2-7; Wellings et al, (1975) J. Natl Cancer Inst 55:231-273. It is currently also suggested that biomarkers identifiable in NAF may prove useful in breast cancer screening methods, or to evaluate response to a chemopreventative agent. See Sauter et al, British J. Cancer (1997) 76(4): 494-501. Therefore it may be of benefit to the medical and patient community to collect NAF for cytological or other analysis of breast conditions including breast cancer or its precursor conditions.
The present invention provides improvements to the existing NAF collection and aspiration devices to aid a practitioner to specifically identify a duct yielding fluid, and, if necessary or desired, the device provides a means to access the duct under the vacuum, mark the duct for further access or observation, or collect the fluid from a yielding duct before it mixes with other fluid in the collection cup.
Relevant Literature
Sartorius (1971) U.S. Pat. No. 3,608,540 describes a device for irrigating the breast ducts with saline solution under vacuum to be able to examine the retrieved solution for cytological abnormalities in the duct epithelial cells retrieved. Sartorius (1971) U.S. Pat. No. 3,786,801 describes a device for suctioning off breast duct fluid in a vacuum to be able to examine the epithelial cells in the duct fluid cytologically. Methods and kits for accomplishing nipple aspiration and collecting samples are claimed and described in U.S. Pat. No. 5,798,266 to Quay (1998).
Nipple aspiration techniques and device are described in Sartorius et al, “Cytologic evaluation of breast fluid in the detection of breast disease”, Journal of the National Cancer Institute (1977) 59(4): 1073-80, Wrensch et al., “Breast cancer incidence in women with abnormal cytology in nipple aspirates of breast fluid”, American Journal of Epidemiology (1992) 135(2): 130-41, and Sauter et al, “Nipple aspirate fluid: a promising non-invasive method to identify cellular markers of breast cancer risk”, British Journal of Cancer (1997) 76(4):494-501.
A Company called Diagnostics, Inc. formed in 1968, produced devices to obtain breast ductal fluid for cytological evaluation. The devices included a nipple aspiration device to collect NAF from subjects. The devices were sold prior to May 28, 1976 for the purpose of collecting breast ductal fluid for cytological evaluation.
SUMMARY OF THE INVENTION
The invention provides devices, methods, and kits for aspirating and retrieving breast duct fluid. The device comprises an enclosure having an interior volume, an aperture adapted to circumscribe and seal against the base of a human breast nipple, and a vacuum port for connecting an external vacuum source to draw a vacuum in the interior volume. The device comprises a viewing window in the enclosure, optionally with a magnifying lens, where the window is positioned near the nipple surface so that a practitioner can look through the window and see an optionally magnified nipple surface under a vacuum. The magnification can provide the practitioner the ability to identify a ductal orifice, e.g. a ductal orifice from which fluid is secreted or from which a keratin plug is released under a vacuum. The device can further comprise one or more access ports for providing access to the nipple surface with a tool including, e.g. a ductal access tool, a ductal orifice marking tool, or a ductal fluid retrieval tool, wherein the access port also comprises a seal for maintaining vacuum before and during access with the tool. The ductal access tool can comprise a fiberoptic endoscope. The optional magnifying lens can be at an angle relative to the nipple surface, for example at an angle less than 90 degrees relative to the nipple surface.
The invention also provides a device for aspirating and retrieving breast duct fluid comprising an enclosure having an interior volume, an aperture adapted to circumscribe the base of a human breast nipple, and a vacuum port for drawing a vacuum with the interior volume, where the device comprises window, i.e. a transparent a solid surface that is clear and integral to the enclosure and that provides visual access to the nipple surface. The device further comprises at least anchor structure on the exterior of the enclosure to which a loupe, lens, microscope or other magnifying tool can be removably mounted so that a practitioner can see a magnified nipple surface under a vacuum. The device can further comprise one or more access ports for providing access to the nipple surface with a tool including, e.g. a ductal access tool, a ductal orifice marking tool, or a ductal fluid retrieval tool, wherein the access port also comprises a seal for maintaining vacuum before and during access with the tool.
The retrieval tool can comprise a lumen operably connected to a mechanism that provides suction in the lumen for drawing off fluid that collects on the nipple surface. The devices can comprise a skirt connected to the aperture made of a flexible material, wherein the flexible material is capable of maintaining a seal with the breast skin. The access port can be accessed with a fiberoptic endoscope.
The invention provides a method of identifying a breast milk duct having a ductal orifice (wherein the duct is capable of yielding fluid or releasing a keratin plug upon aspiration in a vacuum) comprising placing a device of the invention on the breast of a patient so that the nipple is covered, applying a vacuum to the device from the vacuum port, and identifying by magnification of the nipple surface at least one ductal orifice from which fluid is secreted or a keratin plug is released under a vacuum. The method can further comprise performing a task including marking a ductal orifice, accessing a ductal orifice or collecting fluid from a ductal orifice by placing a tool through the access port and accessing the nipple surface to perform the task. Marking can comprise marking the ductal orifice with a mark made by a reagent or tool including dye, ink, pen, plug, or wire. Accessing the
George William R.
Hung David
Love Susan M.
Nikolchev Julian
Banner & Witcoff , Ltd.
Nguyen Anhtuan T.
Pro Duct Health, Inc.
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