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

• US 7,029,462 B2
• Filed: 06/27/2003
• Issued: 04/18/2006
• Est. Priority Date: 03/01/1999
• Status: Expired due to Fees

• Current Assignee: Atossa Therapeutics, Inc.
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: He, Xuanmin, Hung, David
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US10/607,142
• Publication Number:
  US 20040092894A1
• Time in Patent Office: 1,026 Days
• Field of Search: 604/284, 604/29, 604/73, 604/74, 604/514, 604/94.01
• 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 kit for simultaneously accessing two or more ductal networks in a breast, said kit comprising:

an apparatus for simultaneously accessing two or more ductal networks in a breast, said apparatus comprising;

a manifold having an inlet for receiving fluid and at least two outlets;

at least two individual ductal access probes, each ductal access probe having a lumen connected to a respective one of said at least two outlets and configured for insertion through an orifice of a ductal network; and

a collection tube connected to at least one probe for receiving biological material from within the breast; and

instructions including steps for using said apparatus, said instructions comprising the steps of;

a) introducing a respective one of said ductal access probes into each of at least two of the ductal networks in the breast through a ductal orifice of each of said respective ductal networks;

b) delivering a substance to at least two of the ductal networks; and

c) collecting a ductal fluid sample from the at least two ductal networks using a plurality of said ductal access probes.

2. The kit according to claim 1 wherein said collection tube further comprises a fluid control device capable of controlling fluid flow in said collection tube.

3. The kit according to claim 1 wherein at least one of said ductal access probes further comprises a fluid control device capable of controlling fluid flow in said lumen of said at least one probe.

4. The kit according to claim 1 wherein the collection tube further comprises a fluid control device capable of controlling fluid flow in said collection tube, and wherein at least one of said probes further comprises a fluid control device capable of controlling fluid flow in the lumen of said at least one of said probes.

5. The kit according to claim 1 further comprising a plurality of collection tubes, wherein each collection tube is connected to a respective one of said ductal access probes.

6. The kit according to claim 5 wherein each said ductal access probe comprises a fluid control device capable of controlling fluid flow in the lumen of each respective ductal access probe, and each collection tube comprises a fluid control device capable of controlling fluid flow in each respective collection tube.

7. The kit according to claim 1 wherein at least one of said outlets is unconnected to a respective one of said ductal access probes and the at least one unconnected outlet is closed to fluid flow.

8. The kit according to claim 1 wherein the ductal access probes are removably connectable to the manifold.

9. The kit according to claim 1 wherein said instruction further include the step of collecting fluid from each accessed ductal network, wherein the fluid is collected separately so that fluid from one of the ductal networks is free of fluid from another of the ductal networks.

10. The kit according to claim 1 wherein said instructions further comprise the steps of:

closing fluid flow valves in each of the lumens of the ductal access probes not inserted in one of the ductal networks while fluid is infused into the accessed ductal networks through the introduced ductal access lumens.