System and method for monitoring health based on collected bodily fluid

• US 9,918,702 B2
• Filed: 07/06/2016
• Issued: 03/20/2018
• Est. Priority Date: 08/12/2014
• Status: Active Grant

• Current Assignee: NextGen Jane, Inc.
• Original Assignee: NextGen Jane, Inc.
• Inventors: Tariyal, Ridhi, Gire, Stephen
• Primary Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US15/203,464
• Publication Number:
  US 20160324506A1
• Time in Patent Office: 622 Days
• Field of Search: 600573, 600582
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0058 for taking sperm samples artificial insemination A61B17/43; for animals A61D19/021; genital receptacles for the male member A61F5/453; massage of the genitals A61H19/00
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 2010/0074 Vaginal or cervical secretions
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0216 Sampling brushes
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61F 13/2045 Cup-shaped type tampons non-absorbent catamenial cups A61F5/4553
• CPC Class Codes: A61F 13/472 specially adapted for female use A61F13/474, A61F13/475, A61F13/476 take precedence
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

A medical kit for analysis of vaginal biological samples includes a sample collector, an extractor, and an assay cartridge. The sample collector is compressible and insertable in a vaginal canal for collecting biological samples, and includes a cup-shaped head configured to cradle a cervical os. The extractor includes a sample receptacle configured to receive the sample collector via an open end. The extractor includes a compression mechanism with a compression element that is movable inwards into the open end of the sample receptacle to apply a compression force in response to activation of a release element. The extractor further includes a reservoir in fluid communication with the sample receptacle, the reservoir receiving the biological samples from the sample collector in response to the compression force being applied within the sample receptacle. The assay cartridge has a docking mechanism configured to fluidly communicate with the reservoir of the extractor.

Claims

1. A system for extracting and preserving components of a biological sample of a subject in their original state, comprising:

a sample collector that non-invasively collects said biological sample from a vaginal canal of said subject, wherein said sample collector collects and retains said biological sample from said vaginal canal;

an extractor comprising (i) a sample receptacle that receives said sample collector via an opening, (ii) a breakable buffer pouch comprising a buffer for preserving said components of said biological sample in their original state during storage or shipping of said biological sample for subsequent processing or analysis of said biological sample, wherein said breakable buffer pouch is separate from said sample receptacle and configured to release said buffer to contact said sample collector in said sample receptacle when said breakable buffer pouch is broken, and (iii) a collection reservoir that is in fluid communication with each of said sample receptacle and said breakable buffer pouch when said breakable buffer pouch is broken, wherein said collection reservoir receives a solution, said solution comprising said buffer from said breakable buffer pouch and said biological sample from said sample receptacle, when said sample collector is in said sample receptacle, wherein said collection reservoir is separate from said sample receptacle and said breakable buffer pouch; and

a cartridge comprising a chamber that comes in fluid communication with said collection reservoir upon docking with said extractor, wherein upon said chamber coming in fluid communication with said collection reservoir, said solution comprising said buffer and said biological sample is subjected to flow from said collection reservoir to said cartridge.

2. The system of claim 1, wherein said sample collector comprises an absorbent-diffuse material that collects, retains, or releases said biological sample.

3. The system of claim 2, wherein said absorbent-diffuse material comprises one or more of a plant fiber material, a disposable material, a flushable material, a biodegradable material, and an organic material.

4. The system of claim 1, wherein said sample collector is insertable in said vaginal canal.

5. The system of claim 1, wherein said sample collector comprises a cup, a rod, a pad, or a threaded matrix.

6. The system of claim 1, wherein said extractor comprises a compression mechanism with a compression unit, wherein said compression unit is movable inwards into said sample receptacle to apply a compression force.

7. The system of claim 6, wherein said compression mechanism comprises a spring, threaded screw, lever, air-tight plunger, or manual push syringe that forces said compression element inwards into said sample receptacle in response to activation of said compression mechanism.

8. The system of claim 1, wherein said extractor further comprises a filter disposed between said sample receptacle and said collection reservoir.

9. The system of claim 8, wherein said filter is selected from the group consisting of a cellulose filter, a plastic filter, a metal filter, and any combination thereof.

10. The system of claim 1, further comprising a docking unit that brings said cartridge in fluid communication with said collection reservoir.

11. The system of claim 10, wherein said docking unit comprises a one-way pressure valve or a resealable slit.

12. The system of claim 1, wherein upon said chamber coming in fluid communication with said collection reservoir, said solution comprising said buffer and said biological sample is subjected to flow from said collection reservoir to said cartridge under the influence of a pressure drop.

13. The system of claim 1, wherein said biological sample comprises one or more members selected from the group consisting of cervicovaginal fluid, blood, vaginal mucosa, semen, interstitial fluid, cervical secretions, fetal tissues, reproductive cells, cervical cells, endometrial cells, fallopian cells, ovarian cells, and trophoblast cells.

14. The system of claim 1, wherein said solution comprises a reagent necessary for analyzing said biological sample.

15. The system of claim 1, wherein said solution comprises a reagent necessary for (i) hydrolyzing, diffusing, or releasing said biological sample, (ii) analyzing, preserving or extracting deoxyribonucleic acid, ribonucleic acid or protein in said biological sample, (iii) reducing analysis background noise, (iv) precipitating or removing a contaminant in said biological sample, or (v) testing said biological sample for a presence or absence of an analyte in said biological sample.

16. The system of claim 1, further comprising a container for storing or shipping said cartridge.

17. The system of claim 1, further comprising a cartridge reader for (1) detecting an analyte in said biological sample, and (2) capturing and interpreting a result from said detecting.

18. The system of claim 17, wherein said analyte is for testing a presence or absence of a health condition of said subject selected from the group consisting of sexually transmitted infections, yeast infection, fungal infection, bacterial infection, viral infection, viroid infection, parasite infection, protozoa infection, cancer, pregnancy, fertility, semen, hormone levels, endometriosis, polycystic ovarian syndrome, reproductive disorders, immune disorders, and nutrient levels.

29. The system of claim 1, wherein said breakable buffer pouch in said extractor comprises a buffer for diffusing or releasing said biological sample from said sample collector.

19. A method for extracting and preserving components of a biological sample of a subject in their original state, comprising:

(a) using a sample collector to non-invasively collect said biological sample from a vaginal canal of said subject, wherein said sample collector collects and retains said biological sample from said vaginal canal;

(b) bringing said sample collector in proximity to an extractor comprising (i) a sample receptacle configured to receive said sample collector via an opening, (ii) a breakable buffer pouch comprising a buffer for preserving said components of said biological sample in their original state during storage or shipping of said biological sample for subsequent processing or analysis of said biological sample, wherein said breakable buffer pouch is separate from said sample receptacle and configured to release said buffer to contact said sample collector in said sample receptacle when said breakable buffer pouch is broken, and (iii) a collection reservoir that is in fluid communication with each of said sample receptacle and said breakable buffer pouch when said breakable buffer pouch is broken, wherein said collection reservoir is separate from said sample receptacle and said breakable buffer pouch;

(c) depositing said sample collector through said opening into said sample receptacle;

(d) receiving, in said collection reservoir, a solution comprising said buffer from said breakable buffer pouch and said biological sample from said sample receptacle; and

(e) docking a cartridge comprising a chamber with said extractor, thereby bringing said chamber in fluid communication with said collection reservoir, wherein upon said chamber coming in fluid communication with said collection reservoir, said solution comprising said buffer and said biological sample is subjected to flow from said collection reservoir to said cartridge.

20. The method of claim 19, wherein said sample collector comprises an absorbent-diffuse material that collects, retains, or releases said biological sample.

21. The method of claim 19, wherein said sample collector is insertable in said vaginal canal.

22. The method of claim 19, wherein said sample collector comprises a cup, a rod, a pad, or a threaded matrix.

23. The method of claim 19, wherein said biological sample comprises one or more members selected from the group consisting of cervicovaginal fluid, blood, vaginal mucosa, semen, interstitial fluid, cervical secretions, fetal tissues, reproductive cells, cervical cells, endometrial cells, fallopian cells, ovarian cells, and trophoblast cells.

24. The method of claim 19, wherein said solution comprises a reagent necessary for analyzing said biological sample.

25. The method of claim 19, further comprising (1) detecting an analyte in said biological sample, and (2) capturing and interpreting a result from said detecting.

26. The method of claim 25, wherein said analyte is for testing a presence or absence of a health condition of said subject selected from the group consisting of sexually transmitted infections, yeast infection, fungal infection, bacterial infection, viral infection, viroid infection, parasite infection, protozoa infection, cancer, pregnancy, fertility, semen, hormone levels, endometriosis, polycystic ovarian syndrome, reproductive disorders, immune disorders, and nutrient levels.

27. The method of claim 19, further comprising sequencing a nucleic acid in said biological sample.

28. The method of claim 19, further comprising storing or shipping said cartridge comprising said solution comprising said biological sample.