Methods and devices for obtaining and assaying mammary fluid samples for evaluating breast diseases, including cancer

• US 6,287,521 B1
• Filed: 02/20/1998
• Issued: 09/11/2001
• Est. Priority Date: 08/27/1996
• Status: Expired due to Term

• Current Assignee: Atossa Therapeutics, Inc.
• Original Assignee: Atossa Healthcare, Inc. (Adhera Therapeutics, Inc.)
• Inventors: Quay, Debra L., Quay, Steven C.
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): Cook, Lisa V.
• Application Number:
  US09/027,362
• Time in Patent Office: 1,299 Days
• Field of Search: 435/6, 435/7, 435/7.1, 435/7.2, 435/7.21, 435/723, 435/29, 435/30, 435/296, 435/810, 435/975, 422/101, 422/104, 422/100, 436/501, 436/523-531, 436/64, 436/161, 436/162, 436/177, 436/178, 436/807, 436/808, 436/810, 436/813, 436/574, 436/576, 604/74-76, 604/315
• US Class Current: 604/346
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: G01N 30/90 Plate chromatography, e.g. thin layer or paper chromatography
• CPC Class Codes: G01N 33/57415 of breast
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/813 Cancer
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

Non-invasive methods are provided for obtaining biological samples of mammary fluid or mammary fluid components by administering oxytocin to a patient to stimulate expression of mammary fluid. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired Constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components obtained according to the above sample collection methods. Also provided within the invention are novel breast pump and breast pump adapter devices which incorporate a solid phase sample collection medium integrated within the breast pump or adapter or otherwise fluidly connected therewith. These devices collect a sample of expressed breast fluid by contacting the fluid with a solid phase sample collection medium while the pump or adapter is applied to the breast.

Claims

1. A sample collection device for collecting a biological sample from a mammary organ of a patient, comprising:

a breast engaging member constructed of a non-porous material sized and dimensioned to receive at least a nipple portion of a breast of said patient and form a suction seal therewith;

a solid phase sample collection medium in fluid connection with said breast engaging member for receiving a sample of expressed breast fluid; and

vacuum pump means in gaseous connection with said breast engaging member for generating negative pressure through the breast engaging member to facilitate breast fluid expression, wherein said solid phase sample collection medium is selected from the group consisting of microscopic glass slides, capillary tubes, collection tubes, columns, micro-columns, wells, plates, membranes, filters, resins, inorganic matrices, beads, particulate chromatographic media, plastic microparticles, latex particles, coated tubes, coated templates, coated beads, coated matrices, or a combination thereof.

2. The sample collection device of claim 1, including removable coupling means for removably coupling said sample collection housing with said breast engaging member.

3. The sample collection device of claim 1, wherein said solid phase sample collection medium is supported by a support member integrally or removably mounted within said sample collection housing in fluid connection with said breast engaging member.

4. The sample collection device of claim 3, wherein said support member is disc-shaped and is interposed between said breast engaging member and said sample collection housing.

5. The sample collection device of claim 3, wherein said support member has upper and lower retaining rings and supports a sheet of absorbent or adsorbent material.

6. The sample collection device of claim 3, wherein said support member supports a solid phase sample collection template selected from capillary tubes, coated tubes, columns, micro-columns, plates, wells and microscopic slides, or a combination thereof.

7. The sample collection device of claim 3, wherein said support member defines a fluid-retaining well.

8. The sample collection device of claim 3, wherein said support member includes at least one air channel to allow negative pressure to pass through the air channel to and from said breast engaging member.

9. The sample collection device of claim 1, wherein said solid phase sample collection medium is a particulate medium contained within a cartridge removably mounted within said sample collection housing and having a first end of said cartridge in fluid connection with said breast engaging member.

10. The sample collection device of claim 9, wherein said first end of said cartridge is covered by a porous barrier material.

11. A sample collection device for collecting a biological sample from a mammary organ of a patient, comprising:

a breast engaging member constructed of a non-porous material sized and dimensioned to receive at least a nipple portion of a breast of said patient and form a suction seal therewith;

a solid phase sample collection medium in fluid connection with said breast engaging member for receiving a sample of expressed breast fluid;

reciprocating means for reciprocally adjusting a position of said solid phase sample collection medium relative to said breast engaging member; and

vacuum pump means in gaseous connection with said breast engaging member for generating negative pressure through said breast engaging member to facilitate breast fluid expression.

12. The sample collection device of claim 11, wherein said reciprocating means incorporates a support member or carrier reciprocatingly mounted relative to said breast engaging member, said support member or carrier supporting the solid phase sample collection medium.

13. The sample collection device of claim 11, wherein said solid phase sample collection medium is supported by a support member removably mounted in fluid connection with said breast engaging member.

14. The sample collection device of claim 13, wherein said support member is removably mounted to a carrier reciprocatingly mounted within a sample collection housing fluidly connected with said breast engaging member.

15. The sample collection device of claim 11, wherein said reciprocating means include a rotating member of a sample collection housing sealably and rotatably interconnected with said breast engaging member, said rotating member having a lumenal, helically oriented groove dimensioned to receive a riding peg extending transversely from a support member or carrier supporting said solid phase sample collection medium and a longitudinally oriented, lumenal groove dimensioned to receive an angularly fixating keel extending transversely from said carrier or support member, whereby rotation of the rotating member of the housing drives rotation of the carrier or support member and translates the riding peg along the helical groove to cause the support member or carrier to reciprocate forward or backward relative to the breast engaging member.

16. The sample collection device of claim 15, wherein said rotating member of said housing is removably interconnected with said breast engaging member to facilitate insertion and removal of said solid phase sample collection medium.

17. The sample collection device of claim 11, wherein said reciprocating means include a slide mechanism.

18. The sample collection device of claim 17, wherein said slide mechanism includes a manifold defining an inner lumen closed at one end to prevent gaseous connection with an outer lumen of a sample collection housing through which vacuum pressure is transmitted from said pump means to said breast engaging portion, and a sliding support member or carrier supporting said solid phase sample collection medium slideably mounted within said inner lumen.