Surgery – Diagnostic testing – Sampling nonliquid body material
Reexamination Certificate
1999-12-28
2002-07-02
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Sampling nonliquid body material
C600S573000, C604S028000, C435S007230
Reexamination Certificate
active
06413228
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The field of this invention is devices, methods and systems for collecting breast duct fluid from humans.
2. Description of the Background Art
For several decades 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 identifying patients at risk for breast cancer. Indeed Papanicolaou himself contributed to the genesis of such a possibility of a “Pap” smear for breast cancer by analyzing the cells contained in nipple discharge. 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. See also Petrakis, “Physiological, biochemical, and cytological aspects of nipple aspirate fluid”,
Breast Cancer Research and Treatment
1986; 8:7-19; 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. More recently, markers have also been detected in nipple fluid. 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). The detection of CEA in fluids obtained by a nipple blot is described in Imayama et al. (1996)
Cancer
78: 1229-1234.
Breast cancer is believed to originate in the lining of a single breast milk duct 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). Sartorious describes use of hair-like single lumen catheters that are inserted into breast ducts using an operating microscope and the ducts were flushed with saline solution as described in Cassels, D Mar. 20
th
, 1973,
The Medical Post,
article entitled “New tests may speed breast cancer detection”. Sartorius et al, Contrast ductography for recognition and localization of benign and malignant breast lesions: an improved technique. pp. 281-300. In: Logan W W, ed. Breast Carcinoma New York, Wiley, 1977. After the fluid was infused, the catheter was removed because it was too small to collect the fluid, the breast was squeezed and fluid that oozed onto the nipple surface was removed from the surface by a capillary tube. 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 on the nipple surface. The use of a rigid 1.2 mm ductscope to identify intraductal papillomas in women with nipple discharge is described in Makita et al (1991)
Breast Cancer Res Treat
18: 179-188. It would be advantageous to develop methods and devices to collect the ductal fluid from within the duct.
Galactography, or contrast ductography has for years located breast ducts based on spontaneous nipple discharge, infused the ducts (using cannulas for this purpose) with contrast dye solutions, and taken x-ray pictures to determine the source of the discharge within the duct. See generally, The Breast: Comprehensive Management of Benign and Malignant Breast Diseases, Bland and Copeland eds. W. B. Saunders Co. Philadelphia Pa. 1991 pages 61-67.
Method and kits for obtaining fluid and cellular material from breast ducts 09/067,661 filed Apr. 28, 1998, and its CIP 09/301,058 filed Apr. 28, 1999 describe and claim infusing a small amount of fluid into the duct and collecting the fluid using a catheter. It would be beneficial to optimize the cells and fluid collected from this procedure.
U.S. Ser. No. 60/143,359 filed Jul. 12, 1999 describes and claims a multilumen catheter for collection of infused fluid. U.S. Ser. No. 60/143,476 filed Jul. 12, 1999 describes and claims devices and methods for accessing the lactiferous sinus of a breast duct. U.S. Ser. No. 60/122,076 filed Mar. 1, 1999 describes devices, methods and kits for accessing more than one breast duct at a time for delivering and/or retrieving agents or materials to and from more than one breast duct at the same time. Related applications are U.S. Ser. Nos. 60/143,476 and 60/143,359 both filed Jul. 12, 1999 and U.S. Ser. No. 60/134,613 filed May 18, 1999, and U.S. Ser. No. 60/114,048 filed Dec. 28, 1998, all of which are herein incorporated by reference in their entirety.
Osmotic agents including sugars that are poorly absorbed, for example lactulose or sorbitol, have been used as laxatives. See THE MERCK MANUAL OF MEDICAL INFORMATION, Berkow, Beers and Fletcher Eds, 1997 Merck Res. Lab., Whitehouse Station, N.J. pp. 522-523. The osmotic agent mannitol is available as an injectable, 25% (Physicians Desk Reference 1996) for a variety of indications (e.g. renal insufficiency, congestive heart failure). A mixture of sorbitol and mannitol is compared to distilled water as an irrigant during transurethral prostatectomy in Sargin et al, (1997)
Int Urol Nephrol
29:575-80. Intracranial pressure therapy has been provided by solutions of mannitol, sorbitol or glycerol as described in Treib et al, (1998)
Eur Neurol
40: 212-219. Osmotherapy for increased intracranial pressure comparing the use of mannitol and glycerol is discussed in Biestro et al, (1997)
Acta Neurochir
(
Wien
) 138: 725-32; discussion 732-3. Mannitol therapy for renal conditions is described generally in Better et al, (1997)
Kidney Int
52:886-894, and use of the osmotic diuretic mannitol for renal protection is analyzed in Visweswaran et al, (1997)
J Am Soc Nephrol
8: 1028-33. Use of mannitol during cardiac catheterization is described in Willerson et al, (1975)
Circulation
51:1095-1100 and Kurnick et al, (1991)
Am J Kidney Dis
17:62-8. The osmotic effects of polyethylene glycol are discussed in Schiller et al, (1988)
Gastroenterology
94: 933-41. Raffinose is used for peritoneal dialysis as described in Kohan et al (1998)
J Lab Clin Med
131: 71-6.
Relevant Literature
Hou et al, “A simple method of Duct Cannulation and Localization for Galactography before Excision in Patients with Nipple Discharge.”
Radiology
1995; 195; 568-569 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.”
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 in which before the fiberoptic ductoscopy “a lacrimal cannula was inserted [into the duct] for ductal washing by infusing 0.2 to 0.5 ml physiological saline twice or three times, citing also Okazaki et al
Nyugan No Ringsho
4:587-594 (1989) (in Japanese).
A company called Diagnostics, Inc. formed in 1968, produced devices 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.
A lacrimal irrigating cannula is described in U.S. Pat. No. 5,593,393 to inventors Trudell and Prouty. The cannula is graduated and used for insertion, dilation, probing and irrigating of the lacrimal drainage system of the eye. Lacrimal probes have been used to access breast ducts as depicted in The Breast: Comprehensive Management of Benign
He Xuanmin
Hung David
Ken Christopher G. M.
Nikolchev Julian
O'Leary Shawn
Banner & Witcoff , Ltd.
Marmor II Charles
Pro Duct Health, Inc.
Winakur Eric F.
LandOfFree
Devices, methods and systems for collecting material from a... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Devices, methods and systems for collecting material from a..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Devices, methods and systems for collecting material from a... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2830754