Systems and methods for fluid handling

• US 10,518,265 B2
• Filed: 02/10/2017
• Issued: 12/31/2019
• Est. Priority Date: 09/25/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos IP Company, LLC
• Inventors: Holmes, Elizabeth A., Roy, Joy, Frankovich, John Kent
• Primary Examiner(s): Hixson, Christopher Adam
• Application Number:
  US15/430,197
• Publication Number:
  US 20170312746A1
• Time in Patent Office: 1,054 Days
• CPC Class Codes: B01L 2200/028 Modular arrangements
• CPC Class Codes: B01L 2200/0631 Purification arrangements, e.g. solid phase extraction [SPE]
• CPC Class Codes: B01L 2200/0647 Handling flowable solids, e.g. microscopic beads, cells, particles
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/082 Handling hazardous material
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0829 Multi-well plates; Microtitration plates
• CPC Class Codes: B01L 2400/0409 centrifugal forces
• CPC Class Codes: B01L 2400/043 magnetic forces
• CPC Class Codes: B01L 2400/0677 phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• CPC Class Codes: B01L 3/0217 of the plunger pump type medical syringes A61M
• CPC Class Codes: B01L 3/5021 Test tubes specially adapted for centrifugation purposes centrifuges B04B5/04
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• CPC Class Codes: B01L 3/523 with means for closing or opening
• 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
• CPC Class Codes: B01L 9/06 Test-tube stands; Test-tube holders
• CPC Class Codes: G01N 2035/00277 Special precautions to avoid contamination (e.g. enclosures, glove- boxes, sealed sample carriers, disposal of contaminated material)
• CPC Class Codes: G01N 35/00 : Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
• CPC Class Codes: G01N 35/1072 : with provision for selective pipetting of individual channels
• CPC Class Codes: Y10T 436/25 : including sample preparation

Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Claims

1. A method of nucleic acid amplification, the method comprising:

providing a nucleic acid amplification vessel comprising at least one reagent and a barrier material, wherein the barrier material extends across an opening of the vessel and can transition between (1) a molten state that is configured to prevent fluid from passing through the material in the absence of an object inserted through the material, and (2) a solid state that is configured to prevent fluid and the object from passing through the material;

heating the barrier material to be in the molten state;

using a sample delivery tip to insert a sample into the vessel and deposit the sample below the barrier material in the molten state;

bringing an open end of the sample delivery tip into contact with the barrier material;

covering the open end of the assay tip with the barrier material and sealing the contents of the sample delivery tip;

removing the sample delivery tip from the vessel, wherein the tip has a portion coated with barrier material in the molten state;

hardening the barrier material on the sample delivery tip as it is exposed to air and cools; and

performing nucleic acid amplification under the barrier material in the vessel.

2. The method of claim 1 further comprising performing post-amplification wax solidification to change the barrier material to the solid state and seal sample and reagent in the nucleic acid amplification vessel after amplification.

3. The method of claim 1 wherein heating the barrier material comprises heating the vessel to heat the barrier material.

4. The method of claim 3 using a heating block to heat the vessel.

5. The method of claim 1 wherein the barrier material comprises wax.

6. The method of claim 1 wherein the barrier material has a melting point between 50°

C. and 60°

C.

7. The method of claim 1 wherein the barrier material has a melting point less than and/or equal to about 35°

C.

8. The method of claim 1 wherein the barrier material has a melting point less than and/or equal to about 40°

C.

9. The method of claim 1 wherein the barrier material has a melting point less than and/or equal to about 45°

C.

10. The method of claim 1 using a heating block to heat the vessel.

11. The method of claim 1 wherein the reagent is a lyophilized reagent.

12. The method of claim 1 wherein the reagent is an aqueous reagent.

13. The method of claim 1 comprising taking turbidity readings during or after amplification.

14. The method of claim 1 comprising the barrier material provides a containment barrier for DNA generated by the nucleic acid amplification.

15. The method of claim 1 wherein the barrier material is sufficiently viscous to remain on the sample delivery tip.

16. The method of claim 1 further comprising using a pipette nozzle to lift the sample vessel, wherein an outer diameter of the pipette nozzle is sized to fit and engage an opening of the sample vessel for transport purposes.