Claims for Patent: 9,808,225

Summary for Patent: 9,808,225

Title:	Retrieval of biological materials from the human uterus, ovary and cervix by suction
Abstract:	The invention provides devices and methods for self-administered noninvasive retrieval of biological materials of the uterus and/or cervix. The cervical device comprises a receptacle with a variable volume receptacle cavity, a controller configured to change the volume of the receptacle cavity, a surface for collection of biological materials, and a flexible pouch for generation of suction to facilitate efficient retrieval of biological materials. The biological materials retrieved include various biomarkers of diseases and disorders of reproduction, are directly isolated from a site of pathology, and are not metabolized or diluted. Information generated by analyzing these biological materials permits early diagnosis and prognosis assessments of disease and disorders of the female reproductive organs, irregularities of pregnancy, anomalies of the fetus in utero, and microbial infections.
Inventor(s):	Sanyal; Mrinal K. (Guilford, CT)
Assignee:
Application Number:	14/471,433
Patent Claims:	1. A device for retrieving biological materials of the uterus and/or cervix of a subject comprising: a receptacle having an open end configured to be placed over the cervix and a wall defining a variable volume receptacle cavity; wherein the device further comprises a flexible pouch and a controller, wherein expansion or compression of the pouch generates suction inside the cavity; and wherein the controller is configured to change the volume of the receptacle cavity by expanding or compressing the pouch; the controller having a proximal end and a distal end. 2. The device according to claim 1, further comprising: a removable surface for collection of the biological materials, the surface having an anterior wall facing the open end of the receptacle and a posterior wall facing opposite to the open end of the receptacle; and wherein the pouch is hollow inside and having a second anterior wall facing the open end of the receptacle and a second posterior wall facing opposite of the open end of the receptacle wall; wherein the surface is removably fitted within the receptacle cavity. 3. The device according to claim 1, wherein the receptacle further comprises a flexible rim extending from the open end and attaching the receptacle over the cervix. 4. The device according to claim 1, wherein the receptacle is made of silicone or a synthetic polymer. 5. The device according to claim 1, wherein the surface further comprises: a pull tab for detaching the surface from the receptacle cavity; and a platform holding a matrix or mesh of permeable substrate materials. 6. The device according to claim 5, wherein the substrate materials are selected from the group consisting of: cotton mesh, nylon mesh, collagen matrix, hydrogel matrix, synthetic sponge or tissue culture scaffold. 7. The device according to claim 2, wherein the pouch is an inflated pouch. 8. The device according to claim 7, the inflated pouch comprising one or more perforations on the second posterior wall. 9. The device according to claim 8, wherein the controller is configured to expel air contained in the pouch through the perforations of the posterior wall to generate suction. 10. The device according to claim 2, wherein the pouch is a compressed pouch. 11. The device according to claim 10, the compressed pouch comprising one or more pillars separating the second anterior wall and the second posterior wall. 12. The device according to claim 1, wherein the proximal end comprises a handle and the distal end comprises a bead. 13. The device according to claim 4, wherein the silicone is medical grade. 14. The device according to claim 1, further comprising: a removable surface; and a flexible pouch; wherein the surface is removably fitted within the receptacle cavity. 15. The device according to claim 1, wherein the receptacle further comprises a flexible rim extending from the open end. 16. The device according to claim 5, wherein the matrix or mesh contains a solution for irrigation and washing of the cervix. 17. The device according to claim 16, wherein the solution is physiological saline or tissue culture media. 18. The device according to claim 16, wherein the irrigation solution comprises a proteolytic enzyme, collagenase, and or DNase. 19. The device according to claim 18, wherein the proteolytic enzyme comprises trypsin, pronase and or proteinase K. 20. A method of retrieving biological materials of the uterus and/or cervix of a subject comprising the steps of: providing a device having a receptacle with an open end and a wall defining a variable volume receptacle cavity, wherein the device further comprises a flexible pouch, wherein expansion or compression of the pouch generates suction inside the cavity; and wherein the device further comprises a controller configured to change the volume of the receptacle cavity by expanding or compressing the pouch; positioning the open end of the device facing the cervix of the subject; generating suction by changing the volume of the pouch cavity through the controller; collecting biological material from the uterus and/or cervix of the subject; and removing the device after a specified time period. 21. The method according to claim 20, further comprising the step of: analyzing the biological material to identify a subject with a particular disease or disorder. 22. The method according to claim 20, wherein the biological material collected is selected from the group consisting of: uterine cells, cervical cells, glandular secretions, migrating WBCs, migrating RBCs, placental cells, fetal cells, peritoneal fluid of the abdomen, DNA, RNA, antibodies and pathologic microbes. 23. The method according to claim 20, wherein the disease or disorder is selected from the group consisting of uterine cancer, cervical cancer, ovarian cancer, a disorder of pregnancy, a developmental defect, infertility, and microbial infection.

Details for Patent 9,808,225

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2033-08-29