DEVICES, SYSTEMS AND METHODS FOR SAMPLE PREPARATION

• US 20140272938A1
• Filed: 03/10/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A., Loo, Alexander
• Granted Patent: US 9,359,632 B2
• Time in Patent Office: Days
• US Class Current: 435/5
• CPC Class Codes: B01F 2101/23 Mixing of laboratory samples e.g. in preparation of analysing or testing properties of materials
• CPC Class Codes: B01F 31/86 with vibration of the receptacle or part of it
• CPC Class Codes: B01F 31/87 transmitting the vibratory energy by means of a fluid, e.g. by means of air shock waves
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2400/0439 ultrasonic vibrations, vibrating piezo elements
• CPC Class Codes: C12N 1/066 by physical methods
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: G01N 1/286 involving mechanical work, e.g. chopping, disintegrating, compacting, homogenising microtomes G01N1/06; pulverising in general B02C; mixing in general B01F
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 2001/386 Other diluting or mixing processes
• CPC Class Codes: G01N 2035/00554 using ultrasound
• CPC Class Codes: G01N 2035/00891 Displaying information to the operator
• CPC Class Codes: G01N 2333/24 from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia
• CPC Class Codes: G01N 2333/31 from Staphylococcus (G)
• CPC Class Codes: G01N 35/00722 Communications; Identification

Abstract

Devices, systems and methods including a sonicator for sample preparation are provided. A sonicator may be used to mix, resuspend, aerosolize, disperse, disintegrate, or de-gas a solution. A sonicator may be used to disrupt a cell, such as a pathogen cell in a sample. Sample preparation may include exposing pathogen-identifying material by sonication to detect, identify, or measure pathogens. A sonicator may transfer ultrasonic energy to the sample solution by contacting its tip to an exterior wall of a vessel containing the sample. Multipurpose devices including a sonicator also include further components for additional actions and assays. Devices, and systems comprising such devices, may communicate with a laboratory or other devices in a system for sample assay and analysis. Methods utilizing such devices and systems are provided. The improved sample preparation devices, systems and methods are useful for analyzing samples, e.g. for diagnosing patients suffering from infection by pathogens.

Claims

1. A device configured to assay a sample for the presence of pathogen-identifying material, said device comprising a sonicator;

a sample handling system;

a vessel holder configured to hold a vessel having a vessel wall; and

a detector.

2. The device of claim 1, wherein said sonicator comprises a sonicator tip configured to contact a vessel wall effective to transfer ultrasonic energy from said sonicator to said vessel wall upon operation of said sonicator.

3. The device of claim 1, wherein said sonicator comprises a sonicator horn comprising a tip, wherein said tip is configured to contact a vessel wall effective to transfer ultrasonic energy from said sonicator to said vessel wall upon operation of said sonicator.

4. The device of claim 1, wherein said detector comprises an optical detector.

5. The device of claim 1, further comprising a communication assembly configured to communicate with a user, a device, a laboratory, a network, or the cloud.

6. The device of claim 1, wherein the device is configured to apply force to a vessel while applying a sonicator tip to a wall of a vessel.

10. A device of claim 1, wherein said assay for the presence of pathogen-identifying material comprises an assay selected from detection of pathogen-identifying material in a sample, identification of pathogen-identifying material in a sample, and measurement of an amount of pathogen-identifying material in a sample.

12. A device of claim 1, wherein said biological sample comprises a sample selected from blood, urine, sputum, tears, material from a nasal swab, material from a throat swab, material from a cheek swab, and another bodily fluid, excretion, secretion, and tissue obtained from a subject.

13. A system comprising a device of claim 1.

14. A method of assaying a biological sample for the presence of pathogen-identifying material, comprising:

Contacting said biological sample with a device of claim 1; and

Assaying for the presence of a pathogen-identifying material in said biological sample, wherein assaying for the presence of a pathogen-identifying material is selected from detecting the presence of a pathogen-identifying material in said biological sample, identifying a pathogen-identifying material in said biological sample, measuring an amount of a pathogen-identifying material in said biological sample, and combinations thereof.

15. The method of claim 14, wherein said assaying comprises optical detection.

20. The method of claim 14, wherein said biological sample comprises a sample selected from blood, urine, sputum, tears, material from a nasal swab, material from a throat swab, material from a cheek swab, and another bodily fluid, excretion, secretion, and tissue obtained from a subject.

21. A method of assaying a biological sample for the presence of pathogen-identifying material, comprising:

Contacting said biological sample with a system of claim 13; and

Assaying for the presence of a pathogen-identifying material in said biological sample, wherein assaying for the presence of a pathogen-identifying material is selected from detecting the presence of a pathogen-identifying material in said biological sample, identifying a pathogen-identifying material in said biological sample, measuring an amount of a pathogen-identifying material in said biological sample, and combinations thereof.

22. The method of claim 21, wherein said assaying comprises optical detection.

23. The method of claim 21, wherein said biological sample comprises a sample selected from blood, urine, sputum, tears, material from a nasal swab, material from a throat swab, material from a cheek swab, and another bodily fluid, excretion, secretion, and tissue obtained from a subject.

24. The device of claim 6, comprising a spring configured to apply force to a vessel while applying a sonicator tip to a wall of a vessel.

7. A device configured to assay a sample for the presence of pathogen-identifying material, said device comprising a sonicator;

a sample handling means;

a vessel holding means configured to hold a vessel having a vessel wall; and

a detector means.

8. The device of claim 7, wherein said sonicator is configured to contact a vessel wall effective to transfer ultrasonic energy from said sonicator to said vessel wall upon operation of said sonicator.

9. The device of claim 7, wherein said detector means comprises optical detection means.

11. A device of claim 7, wherein said assay for the presence of pathogen-identifying material comprises an assay selected from detection of pathogen-identifying material in a sample, identification of pathogen-identifying material in a sample, and measurement of an amount of pathogen-identifying material in a sample.

16. (canceled)

17. (canceled)

18. (canceled)

19. (canceled)