IP Library Granted Patent US 10,233,480
Granted Patent B2
US 10,233,480 · App. 15/140,993 · Granted Mar 19, 2019

Systems and methods for sample preparation using sonication

Inventors: Alexander Loo (Palo Alto, CA); Elizabeth A. Holmes (Palo Alto, CA)
Assignee: Theranos IP Company, LLC
C12Q1/04B01F11/0266B01F11/0283G01N1/286G01N1/38G01N35/00722B01F2215/0037B01L2300/0609B01L2400/0439C12N1/066G01N2001/386G01N2035/00554G01N2035/00891G01N2333/24G01N2333/31
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Quick Facts
Patent No.
US 10,233,480
App. No.
15/140,993
Granted
Mar 19, 2019
Kind
B2
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 (32)

1. A system for use with a sample comprising:

i) a device comprising a housing, and within said housing, a sonicator having a sonicator tip; a vessel holder configured to hold a vessel having a vessel wall; a sample handling system configured to move said vessel within the housing, wherein the vessel is configured to hold said sample for sonication; a solenoid disposed to urge said sonicator tip towards the vessel wall when said solenoid is activated, wherein the sonicator tip is configured to contact the vessel wall effective to transfer ultrasonic energy from said sonicator to the vessel wall upon operation of the sonicator; a spring disposed to as to urge the sonicator tip away from the vessel wall; and a detector; and

ii) a communication assembly configured to communicate with one or more of a user, another device, a laboratory, a network, or the cloud.

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

3. The system of claim 1 , wherein said detector comprises an optical detector.

4. The system of claim 1 , wherein the communication assembly comprises a display effective to provide a user with information regarding the operation of the device, information regarding the progress of an assay performed by the device, or information regarding the results of an assay performed by the device.

5. The system of claim 1 , wherein the device applies force to said vessel while applying said sonicator tip to said wall of the vessel.

6. The system of claim 1 , further comprising a cartridge for use with the sample handling system and containing at least one reagent for at least one of the following: detection of pathogen-identifying material in the sample, identification of pathogen-identifying material in the sample, and measurement of an amount of pathogen-identifying material in the sample.

7. The system of claim 1 , wherein said biological sample comprises a sample selected from the group consisting of 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.

8. The system of claim 1 , wherein said sample handling system is configured to apply force to the vessel while the sonicator tip is applied to the vessel wall of the vessel.

9. A method of detecting the presence of pathogen-identifying material in a biological sample, comprising:

placing a vessel comprising said biological sample in the vessel holder of the system of claim 1 ;

using the sample handling system to add at least one reagent that reacts with the pathogen-identifying material to generate a signal to the sample; and

detecting the presence of the pathogen-identifying material in said sample with said reagent based on the signal.

10. The method of claim 9 , wherein said detecting comprises optical detection using said detector.

11. The method of claim 9 , 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.

12. A method of measuring an amount of a pathogen-identifying material in a biological sample, comprising:

placing a vessel comprising said biological sample in the vessel holder of the system of claim 1 ;

using the sample handling system to add at least one reagent that reacts with the pathogen-identifying material to generate a signal to the sample; and

measuring an amount of a pathogen-identifying material in said sample with said reagent based on the signal.

13. The method of claim 12 , wherein said measuring comprises optical detection using said detector.

14. A system for use with a sample comprising a device comprising a housing and a sonicator within said housing, said sonicator having a sonicator tip; a sample handling means configured to move a vessel within the housing; a vessel holding means configured to hold said vessel, the vessel having a vessel wall and being configured to hold said sample for sonication; a solenoid disposed to urge said sonicator tip towards said vessel wall when said solenoid is activated, wherein the sonicator tip is configured to contact the vessel wall effective to transfer ultrasonic energy from said sonicator to the vessel wall upon operation of the sonicator; a spring disposed so as to urge the sonicator away from the vessel wall; and a detector means; and

a communication means, wherein said communication means comprises a device that is configured to communicate with one or more of a user, another device, a laboratory, a network, or the cloud.

15. The system of claim 14 , wherein said sonicator tip is configured to contact said vessel wall effective to transfer ultrasonic energy from the sonicator to the vessel wall upon operation of the sonicator.

16. The system of claim 14 , wherein said detector means comprises optical detection means.

17. The system of claim 14 , further comprising a cartridge for use with the sample handling system and containing at least one reagent for at least one of the following: detection of the pathogen-identifying material in the sample, identification of the pathogen-identifying material in the sample, and measurement of an amount of the pathogen-identifying material in the sample.

18. A method of identifying a pathogen-identifying material in a biological sample, comprising:

placing a vessel comprising said biological sample in the vessel holder of the system of claim 14 ;

using the sample handling system to add at least one reagent that reacts with the pathogen-identifying material to generate a signal to the sample; and

identifying the pathogen-identifying material in said sample with said reagent based on the signal.

19. The method of claim 18 , wherein said identifying comprises optical detection using said detector means.

20. The method of claim 18 , 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.

Assignments (5)
CHANGE OF NAME Recorded Apr 3, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052313/0011 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045101/0315 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 28, 2016
From: LOO, ALEXANDER; HOLMES, ELIZABETH A.
To: THERANOS, INC.
Reel/Frame 038556/0390 →
Continuity (3)
Continuation 14203436 · Mar 10, 2014
Provisional Application 61799533 · Mar 15, 2013
Related Publication 20170022533A1 · Jan 26, 2017