Apparatus, methods and kits for simulaneous delivery of a substance to multiple breast milk ducts

• US 20040092894A1
• Filed: 06/27/2003
• Published: 05/13/2004
• Est. Priority Date: 03/01/1999
• Status: Active Grant

• Current Assignee: Atossa Therapeutics, Inc.
• Original Assignee: Cytyc Health Corp. (Hologic Incorporated)
• Inventors: He, Xuanmin, Hung, David
• Granted Patent: US 7,029,462 B2
• Time in Patent Office: Days
• US Class Current: 604/284
• CPC Class Codes: A61B 10/0041 Detection of breast cancer mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61M 2210/1007 Breast; mammary
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 3/0212 after use
• CPC Class Codes: A61M 3/0216 Pressure
• CPC Class Codes: A61M 3/022 Volume; Flow rate
• CPC Class Codes: A61M 3/0262 manually, e.g. by squeezing a bulb
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10

Abstract

Apparatus, methods and kits for simultaneous delivery of a fluid or other substance to two or more breast milk ducts are provided. The fluid can be delivered for a variety of purposes including lavage of the ducts and administering an agent for therapeutic, prophylactic, or diagnostic purposes.

Claims

1. A method for delivering a substance to two or more ductal networks in a breast, said method comprising:

establishing access to two or more ductal network in the breast through a ductal orifice of each of said ductal network; and

delivering a substance to and/or collecting a fluid simultaneously from two or more of the ductal networks.

2. A method as in claim 1, wherein establishing access comprises inserting an access probe in each ductal orifice to be accessed.

3. A method as in claim 2, wherein at least some of the access probes are fluidly connected by a manifold so that substance may be delivered simultaneously to the connected probes through the manifold.

4. A method as in claim 3, wherein all of the access probes are fluidly connected to the manifold so that fluid may be delivered simultaneously to all probes.

5. A method as in claim 1, wherein the substance is delivered simultaneously to all of the accessed ductal networks.

6. A method as in claim 1, wherein fluid is collected in separate receptacles for each ductal network.

7. A method as in claim 1, wherein access is established to all of the ductal networks in a breast.

12. A kit for delivering a substance to two or more ductal networks in a breast, said kit comprising:

a two or more of probes each having a lumen and being configured for introduction into a ductal network of the breast, and instructions for use setting forth a method according to any of claims 1-11.

8. A method for delivering a fluid to two or more ductal networks in a breast, said method comprising:

locating two or more ductal networks in a nipple of the breast;

inserting an access probe through an orifice of each of the located ductal networks; and

infusing the fluid through a manifold to each of the probes.

9. A method as in claim 8, further comprising connecting individual probes to the manifold so that the number of probes connected to the manifold is the same as the number of probes inserted into ductal orifices.

10. A method as in claim 8, further comprising providing an assembly comprising a number of access probes greater than the number of ductal orifices, wherein said access probes are pre-loaded on the manifold, and selectively blocking those access probes connected to the manifold which are not inserted to a ductal network.

11. A method as in claim 8, further comprising collecting fluid from each accessed ductal network, wherein the fluid is collected separately so that no one fluid from a ductal network is mixed with fluid from another ductal network.

13. A method for delivering a fluid to two or more ductal networks in a breast, said method comprising the steps of:

locating at least two ductal networks in a nipple of the breast;

providing an apparatus having a plurality of ductal network access probes;

inserting one of the access probes through an orifice of each of the located ductal networks;

closing any of the access probes that do not access one of the ductal networks; and

infusing the fluid through a manifold of said apparatus to each of the probes that accesses one of the ductal networks.

14. A method as in claim 13, further comprising the step of controlling a fluid flow through collection lumens, each said collection lumen being connected at a distal end to one of the probes that accesses one of the ductal networks and at a proximal end to a separate collection receptacle.

15. A method as in claim 14, further comprising the step of collecting fluid in a respective one of the separate collection receptacles for each accessed duct.

16. A method as in claim 14, wherein the step of controlling a fluid flow through collection lumens comprises:

closing fluid flow valves in the collection lumens corresponding to the access probes inserted in the ductal networks while fluid is infused into the accessed ductal networks;

closing back flow valves in the access probes corresponding to the collection lumens; and

opening the fluid flow valves for the collection lumens corresponding to the access probes inserted in the ductal networks to permit fluid from the ductal networks to flow through the collection lumens and into the collection receptacles.

17. A method as in claim 16, further comprising massaging the breast just before and/or after the step of opening the fluid flow valves in the collection lumens.