IP Library Granted Patent US 11,046,992
Granted Patent B2
US 11,046,992 · App. 16/265,482 · Granted Jun 29, 2021

Systems and methods for sample preparation using sonication

Inventors: Alexander Loo (Redwood City, CA); Elizabeth A. Holmes (San Francisco, CA)
Assignee: Labrador Diagnostics 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 11,046,992
App. No.
16/265,482
Granted
Jun 29, 2021
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 (33)

1. A system for use with a sample, the system comprising:

i) a cartridge containing at least the following: a sonicator vessel and a pipette tip;

ii) a device for receiving the cartridge, the device comprising a housing, and within said housing, a sonicator having a sonicator tip; a vessel holder configured to hold said sonicator 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; and a detector; and

iii) a communication assembly configured to communicate with a network.

2. The system of claim 1 wherein the network connects to a laboratory.

3. 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.

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

5. 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.

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

7. The system of claim 1 , wherein the cartridge further comprises 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.

8. 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.

9. 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.

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

contacting said biological sample with the system of claim 1 ;

using the sample handling system to add at least one reagent to the sample; and

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

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

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

contacting said biological sample with the system of claim 1 ;

using the sample handling system to add at least one reagent to the sample; and

measuring an amount of a pathogen-identifying material in said sample with said reagent.

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

14. The method of claim 10 , 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.

15. A system for use with a sample, the system comprising:

i) a cartridge containing at least the following: a sonicator vessel and a pipette tip;

ii) a device for receiving the cartridge, the device comprising a housing, and within said housing, a sonicator having a sonicator tip; a vessel holder configured to hold said sonicator 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; and a detector; and

iii) a communication assembly configured to communicate with a network,

wherein said ultrasonic energy is between about 20 kiloHertz (kHz) and about 60 kHz.

16. A system for use with a sample, the system comprising:

i) a cartridge containing at least the following: a sonicator vessel and a pipette tip;

ii) a device for receiving the cartridge, the device comprising a housing, and within said housing, a sonicator having a sonicator tip; a vessel holder configured to hold said sonicator 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; and a detector;

iii) a communication assembly configured to communicate with a network;

iv) a cap occluding an opening of the sonicator vessel.

Assignments (3)
CHANGE OF NAME Recorded Apr 15, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052410/0432 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2020
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 052385/0844 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 9, 2020
From: LOO, ALEXANDER; HOLMES, ELIZABETH A.
To: THERANOS, INC.
Reel/Frame 052354/0334 →
Continuity (4)
Continuation 15140902 · Apr 28, 2016
Division 14203436 · Mar 10, 2014
Provisional Application 61799533 · Mar 15, 2013
Related Publication 20190233872A1 · Aug 1, 2019