초록 ▼

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 flu

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.

대표청구항 ▼

We claim: 1. A sample collection device for collecting a biological sample from a mammary organ of a subject, comprising: a breast engaging member sized and dimensioned for engaging a breast of the subject to establish fluid connection between the engaging member and a nipple or alveolar duct of th

We claim: 1. A sample collection device for collecting a biological sample from a mammary organ of a subject, comprising: a breast engaging member sized and dimensioned for engaging a breast of the subject to establish fluid connection between the engaging member and a nipple or alveolar duct of the breast; pressure changing means connected with said breast engaging member for changing pressure at a surface of the nipple or within the alveolar duct to induce or facilitate breast fluid expression from the nipple or alveolar duct; and a solid phase sample collection medium in fluid connection with said breast engaging member interposed between said breast engaging member and said pressure changing means for receiving a sample of expressed breast fluid from the nipple or alveolar duct, said solid phase sample collection medium 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, and combinations thereof. 2. The sample collection device of claim 1, wherein said pressure changing means comprises a vacuum pump in gaseous connection with said breast engaging member that exerts negative pressure on the nipple surface or within the alveolar duct. 3. The sample collection device of claim 1, wherein said pressure changing means comprises a semi-rigid portion of said breast engaging member that provides for manual compression of the nipple or of an aureolar portion of the breast to generate positive pressure within the alveolar duct that facilitates expression or causes expulsion of the sample of expressed breast fluid there from. 4. The sample collection device of claim 1, wherein said pressure changing means is provided by said solid phase sample collection medium which operates by wicking or capillary action in contact with the nipple or alveolar duct to facilitate expression or evacuation of the sample of expressed breast fluid there from. 5. The sample collection device of claim 1, wherein said pressure changing means functions to induce or facilitate expulsion of breast fluid from the nipple or alveolar duct independently of, or in conjunction with, positive pressure generated within the alveolar duct of the breast by spontaneous or oxytocin-induced contraction, or manual compression, of the alveolar duct. 6. The sample collection device of claim 1, wherein said solid phase sample collection medium is in fluid contact with said nipple or alveolar duct when the breast engaging member is applied to the breast and positive or negative pressure is generated by said pressure changing means. 7. The sample collection device of claim 1, wherein said solid phase sample collection medium is removably placed in fluid connection with a breast pump. 8. The sample collection device of claim 1, wherein said biological sample is selected from the group consisting of whole mammary fluid, whole cells, cell fragments, cell membranes, proteins, glycoproteins, peptides, nucleotide components of mammary fluid, or a combination thereof. 9. The sample collection device of claim 1, wherein said biological sample comprises one or more breast disease marker(s) selected from the group consisting of a protein, a peptide, a glycoprotein, a lipid, a glycolipid, a DNA polynucleotide, an RNA polynucleotide, or a combination thereof. 10. The sample collection device of claim 1, wherein said biological sample comprises one or more breast disease marker(s) selected from the group consisting of Ki67 Growth Factor, Cyclin B1, Cyclin D1, Proliferating Cell Nuclear Antigen, Transforming Growth Factor a, Tissue Plasminogen Activator, Insulin Growth Factor Receptors, Collagenase Type IV, Laminins, Laminin Receptor, Integrins, p53, rb, nm23, ras, c-myc, c-myb, Heat Shock Proteins, Prolactin, Neuron-Specific Enolase, IR-14, KA 1, KA 14, Alpha-Lactalbumin, Actin, CEA, HIVIFG, MCA, PSA, Vasopressin, Cathepsin D, PGE2, pS2; IL-10, S-100 protein; Vimentin; Epithelial Membrane Antigen, bcl-2, CA15-3, CA 19-9, Tn Antigen, Alpha-lactalbumin, LASA, Gal-GalNAC, GCDFP-15, Le(y)-Related Carbohydrate Antigen, CA 125, uPA, uPA related antigens and complexes, uPA Receptor, PAl-1 and PAl-2, Beta-glucuronidase, CD31, CD44 splice variants, blood group antigens including ABH, Lewis, and MN, and genetic lesions or altered expression levels of CCND1, EMS1, BRCA1 and BRCA2 genes, or a combination thereof. 11. The sample collection device of claim 1, wherein said solid phase sample collection medium is integrally or removably mounted in said device in fluid connection with said breast engaging member. 12. The sample collection device of claim 11, further comprising a support member that supports the solid phase sample collection medium. 13. The sample collection device of claim 11, wherein said support member defines a fluid-retaining well. 14. The sample collection device of claim 11, wherein said solid phase sample collection medium is a particulate medium contained within a cartridge removably mounted in fluid connection with said breast engaging member.