Claims
- 1. A method for obtaining material from a milk duct in a breast of a patient, said method comprising:
(a) locating a single milk duct; (b) introducing a washing fluid substantially throughout the duct without rupture; (c) collecting at least a portion of the washing fluid from the duct; and (d) identifying materials in the washing fluid collected from the duct.
- 2. A method as in claim 1, further comprising obtaining material from at least one additional single milk duct of the same breast by repeating steps (a) through (d) on another single milk duct.
- 3. A method as in claim 2, wherein the steps are repeated for all ducts in the nipple.
- 4. A method as in claim 1, wherein the materials identified in the washing fluid include ductal epithelial cells.
- 5. A method as in claim 4, further comprising examining the morphology of the epithelial cells in the washing fluid to determine if they are atypical in order to assess the likelihood of a cancer present in the cellular lining of the duct.
- 6. A method as in claim 1, wherein the materials comprise molecular species.
- 7. A method for obtaining material from a milk duct in a breast of a patient, said method comprising:
(a) locating at least one of the ductal orifices on a nipple of the breast; (b) introducing a catheter having at least one lumen through one of the ductal orifices and into the ductal passage; (c) introducing a washing fluid through a lumen into the ductal passage; (d) collecting the washing fluid from the ductal passage through a lumen of the catheter; and (e) identifying materials present in the collected washing fluid.
- 8. A method as in claim 7, further comprising dilating the ductal orifice prior to introducing the catheter.
- 9. A method as in claim 7, wherein the catheter includes at least two lumens and washing fluid introducing and collecting steps are performed through separate lumens in the catheter.
- 10. A method as in claim 9, wherein a preselected volume of the washing fluid is introduced to the duct through one lumen and excess volume flows out of the duct through another catheter lumen.
- 11. A method as in claim 10, wherein the volume of washing fluid is at least 5 ml.
- 12. A method as in claim 8, wherein the volume of washing fluid is at least 10 ml.
- 13. A method as in claim 7, further comprising obtaining and identifying material from at least one additional single milk duct of the same breast by repeating steps (a) through (e) on another single milk duct.
- 14. A method as in claim 13, wherein the steps are repeated for all ducts in the nipple.
- 15. A method as in claim 6, wherein the material in the washing fluid include epithelial cells.
- 16. A method as in claim 15, further comprising examining the morphology of the epithelial cells in the washing fluid to determine if they are atypical in order to assess the likelihood of a cancer present in the cellular lining of the duct.
- 17. A method as in claim 7, wherein the materials comprise molecular species.
- 18. A kit for obtaining material from a milk duct of a breast, said kit comprising:
a catheter; and instructions setting forth a method for use of the dual-lumen catheter according to claim 7.
- 19. A method for obtaining fluid and cellular material from a breast duct including fluid and cellular material from distal areas of the ductal architecture of a breast milk duct comprising:
(a) introducing washing fluid into a milk duct, (b) applying external pressure to the breast; and (c) collecting at least a portion of the washing fluid from the duct, wherein the portion of the washing fluid collected comprises fluid and cells from the duct.
- 20. A method as in claim 19, wherein introducing washing fluid comprises introducing a sufficient amount of washing fluid thereby substantially filling the duct.
- 21. A method as in claim 19, wherein the pressure is applied manually.
- 22. A method as in claim 19, wherein the pressure is applied mechanically.
- 23. A method as in claim 19, wherein applying external pressure mixes the fluid and cells together in a duct.
- 24. A method as in claim 19, wherein the pressure is applied beginning at the base of the breast and moving towards the areola and nipple regions of the breast.
- 25. A method as in claim 19, wherein introducing a washing fluid comprises continuous or intermittent infusion of washing fluid over a period of time.
- 26. A method as in claim 19, wherein applying external pressure to the breast comprises applying external pressure periodically, continuously, or cyclically during infusion of the wash fluid.
- 27. A method for obtaining fluid and cellular material from a breast duct including fluid and cellular material from distal areas of the ductal architecture of a breast milk duct comprising:
(a) introducing washing fluid into a milk duct, and providing continuous or intermittent infusion of the wash fluid for a period of time; (b) applying external pressure to the breast and repeating application of external pressure periodically, continuously, or cyclically during infusion of the wash fluid; and (c) collecting the washing fluid from the duct during the infusion and application of external pressure, wherein the washing fluid collected comprises fluid and cells from the duct.
- 28. The method of claim 27, wherein the pressure is applied manually or mechanically.
- 29. A method as in claim 19 or 27, wherein introducing and collecting comprise access of a breast duct by an access tool having at least one lumen
- 30. The method of claim 28, wherein collecting comprises applying suction to an outflow lumen of a dual lumen catheter to draw fluid out from the duct.
- 31. A method of obtaining material from a milk duct in a breast of a patient comprising:
(a) locating at least one ductal orifice on a nipple of the breast; (b) introducing an access tool having at least one lumen through one of the ductal orifices and into the ductal passage; (c) introducing a washing fluid through a lumen into the ductal passage; (d) applying external pressure to the breast; (e) collecting the washing fluid from the ductal passage through a lumen of the access tool during or after fluid introduction and application of external pressure to the breast; and (f) identifying materials present in the collected washing fluid.
- 32. The method according to any of claims 19, 27, or 31, wherein the washing fluid comprises a mixture of air and fluid.
- 33. A kit for obtaining material from a milk duct of a breast comprising:
an access tool having at least one lumen, instructions setting forth a procedure according to the method of any of claims 19, 20, 21, 22, 23, 24, 25, 26, 27, 28 or 31, and a container for the kit contents.
- 34. A kit as in claim 33, further comprising reagents for washing, collection, preservation or analysis of ductal fluid.
- 35. A kit for obtaining material from a milk duct of a breast comprising:
an access tool having at least one lumen; instructions setting forth a procedure according to the method of claim 29; and a container for the kit contents.
- 36. A kit for obtaining material from a milk duct of a breast comprising:
an access tool having at least one lumen; instructions setting forth a procedure according to the method of claim 30; and a container for the kit contents.
- 37. A kit for obtaining material from a milk duct of a breast comprising:
an access tool having at least one lumen; instructions setting forth a procedure according to the method of claim 32; and a container for the kit contents.
Parent Case Info
[0001] This application is a continuation-in-part of application Ser. No. 09/067,661, filed on Apr. 28, 1998, the contents of which are incorporated herein by reference.
Government Interests
[0002] This invention was made with Government support under contract DAMD 17-96-C-6117. The government has certain rights in this invention.
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
09067661 |
Apr 1998 |
US |
Child |
09301058 |
Apr 1999 |
US |