Cartridge for a biological sample

• US 9,168,028 B2
• Filed: 10/23/2008
• Issued: 10/27/2015
• Est. Priority Date: 10/23/2007
• Status: Expired due to Fees

• Current Assignee: Lotus Bio (Nymphaea), Ltd.
• Original Assignee: Lotus Bio (Nymphaea), Ltd.
• Inventors: Shany, Vered, Tavori, Isaac
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US12/739,337
• Publication Number:
  US 20110086378A1
• Time in Patent Office: 2,560 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502753 characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046

Abstract

An assay device comprising a compartment adapted to receive a sealed removable cartridge, wherein said cartridge is adapted to contain a biologic sample and internally comprises two or more assay locations, wherein said cartridge is adapted to facilitate two or more assays of said biologic sample; and an actuator adapted to interface with said cartridge to transport said biologic sample towards at least one of said assay locations.

Claims

1. A device for assaying at least one biological sample, comprising:

a. at least one removable cartridge, adapted to facilitate one or more assays of said at least one biological sample, said cartridge comprising a body, said body comprises;

i. at least one compartment adapted to contain said at least one biological sample;

ii. one or more assay locations, in which at least one of said assays of said at least one biological sample is provided; and

b. at least one actuator adapted to interface with said cartridge to enable transportation of said at least one biological sample towards at least one of said assay locations,

wherein said compartment comprises;

i. a central chamber shaped as an open dimple in said body, said central chamber is bounded by a first rim defining a perimeter of said central chamber; and

ii. a peripheral chamber shaped as an open circumferential depression extending entirely around said central chamber, said peripheral chamber is shallower than said central chamber and is bounded by said first rim and a second outer rim which extends higher than said first rim, such that upon introduction of a separation-enabling fluid, said portion of said at least one biological sample can be separated according to its relative motility by transfer from one of said central chamber and said second peripheral chamber to the other over said first rim at any point along said perimeter of said central chamber.

2. The device according to claim 1, wherein said removable cartridge is sealed such that no contamination of the environment outside said cartridge is enabled.

3. The device according to claim 1, further comprising a reagent that, upon contact with said biological sample, reacts and/or produces a colored compound, said reagent selected from the group consisting of:

cell support medium, labeling compounds, markers, peptide, color-changeable pad and any combination thereof.

4. The device according to claim 1, wherein said biological sample is selected from the group consisting of:

a semen sample, a vaginal secretion sample, a vaginal cell sample, a blood sample, a urine sample, a saliva sample, a lymph sample and any combination thereof.

5. The device according to claim 1, wherein said assay is selected from the group consisting of:

a sperm concentration assay, a semen pH assay, a leukocyte threshold assay, a sperm motility assay, a sperm morphology assay, a semen volume assay, a viscosity assay, and a turbidity assay;

further wherein said assay is adapted to facilitate diagnosis of at least one sexually transmitted disease (STD) selected from the group consisting of;

syphilis, gonorrhea, Candida infection, human papilloma virus (HPV) infection, mycoplasma, ureaplasma, human immunodeficiency virus (HIV) infection, Chlamydia infection, herpes simplex virus infection, Hepatitis B, Trichomonas infection, and Hepatitis C.

6. The device according to claim 1, wherein said cartridge is made of substantially rigid materials or a substantially flexible materials or any combination thereof.

7. The device according to claim 1, wherein said actuator comprises a pump, a peristaltic pump, means of pressure difference creation, strike handle, a set of rollers, manual activation selected from a pipette, micropipette injector, syringe, any positive displacement or any combination thereof.

8. The device according to claim 1, further comprising a controller programmed to perform at least one action selected from a group consisting of:

(i) receive a reading from said at least one sensor, said sensor is in communication with said cartridge;

(ii) analyze said reading;

(iii) analyze readings received based upon said at least one of said assays; and

(iv) output said analysis of said biological sample.

9. The device according to claim 1, wherein said cartridge is further adapted to facilitate a cell separation assay;

said cell separation assay is adapted to assess motility of sperm cells and/or isolate or separate motile sperm within a semen sample for assisting fertility.

10. The device according to claim 9, wherein said rim is configured with specific surface roughness or serration to facilitate required surface tension capabilities for specific sample/reagent combination.

11. The device according to claim 9, wherein said cell separation system is adapted to isolate motile sperm cells of said semen sample for a use selected from the group consisting of:

intra uterine insemination (IUI), vaginal insemination, and in-vitro fertilization (IVF) and diagnosis of motile sperm cell.

12. The device according to claim 9, wherein said separation-enabling agent is selected from the group consisting of Ringer'"'"'s solution, Hartmann'"'"'s solution, Saline, cell support medium, cell washing medium, preparation medium, and any separation-enabling agent adapted to facilitate said separation of said sperm cells from said semen sample.

13. The device according to claim 1, wherein said cartridge is further adapted to manipulate said biological sample using at least one manipulation technique selected from the group consisting of:

homogenization, liquefaction, deposition on a reagent-loaded pad, mixing with a reagent, deposition on an antibody-loaded pad, incubation, separation, migration and sedimentation, and swim-up.

14. The device according to claim 1, wherein said at least one assay location comprises two or more assay locations.

15. A method for assaying at least one biological sample, comprising acts of:

a. providing a device according to claim 1; and

b. operating said device by steps of;

i. inserting at least one biological sample into said at least one compartment within said body of said removable cartridge;

ii. operating said actuator, thereby transporting said at least one biological sample to said central chamber while keeping said biological sample'"'"'s level below said first rim; and

iii. introducing a separation-enabling fluid into at least one of said central chamber and said second peripheral chamber, such that said separation-enabling fluid covering the entirety of said central chamber and at least a portion of said peripheral chamber;

thereby motile cells swim up through said separation-enabling fluid into said peripheral chamber.

16. The method according to claim 15, further comprising providing said removable cartridge sealed such that no contamination of the environment outside said cartridge is enabled.

17. The method according to claim 15, further comprising contacting a reagent with said biological sample, wherein said reagent is selected from the group consisting of cell support medium, labeling compounds, markers, peptide, color-changeable pad or any combination thereof.

18. The method according to claim 17, further comprising at least one step selected from the group consisting of (a) providing said at least one assay locations with two or more assay locations;

and (b) providing said at least one assay comprising two or more assays.

19. The method according to claim 17, further comprising selecting said separation-enabling agent from the group consisting of Ringer'"'"'s solution, Hartmann'"'"'s solution, Saline, cell support medium, cell washing medium, preparation medium and any separation-enabling agent adapted to facilitate said separation of said sperm cells from said semen sample.

20. The method according to claim 15, further additionally comprising at least one step selected from:

selecting said biological sample from the group consisting of;

a semen sample, a vaginal secretion sample, a vaginal cell sample, a blood sample, a urine sample, a saliva sample and a lymph sample or any combination thereof; and

selecting said assay from the group consisting of;

a sperm concentration assay, a semen pH assay, a leukocyte threshold assay, a sperm motility assay, a sperm morphology assay and a semen volume assay, a viscosity assay and a turbidity assay.

21. The method according to claim 20, additionally comprising assessing motility of sperm cells and/or isolating motile sperm within a semen sample for assisting fertility, by said cell separation assay.

22. The method according to claim 15, further comprising acilitating diagnosis of at least one sexually transmitted disease (STD) selected from the group consisting of:

syphilis, gonorrhea, Candida infection, human papiloma virus (HPV) infection, mycoplasma, ureaplasma, human immunodeficiency virus (HIV) infection, Chlamydia infection, herpes simplex virus infection, Hepatitis B, Trichomonas infection, and Hepatitis C by said assay.

23. The method according to claim 15, further comprising selecting said actuator from the group consisting of a pump, a peristaltic pump, means of pressure difference creation, strike handle, a set of rollers, manual activation selected from a pipette, micropipette injector, syringe, any positive displacement and any combination thereof.

24. The method according to claim 15, further comprising at least one step selected from the group consisting of:

receiving a reading from at least one sensor, said sensor is in communication with said cartridge;

analyzing said reading;

analyzing readings received based upon said at least one of said assays; and

outputting said analysis of said biological sample via control means.

25. The method according to claim 15, additionally comprising manipulating said biological sample using at least one manipulation technique selected from the group consisting of:

homogenization, liquefaction, deposition on a reagent-loaded pad, mixing with a reagent, deposition on an antibody-loaded pad, incubation, separation, migration and sedimentation and swim up by said cartridge.