IP Library Granted Patent US 11,644,410
Granted Patent B2
US 11,644,410 · App. 17/135,437 · Granted May 9, 2023

Systems and methods for sample use maximization

Inventors: Anthony J. Nugent (Dublin, CA); Daniel L. Young (San Francisco, CA); Elizabeth A. Holmes (Palo Alto, CA); Michael Siegel (San Francisco, CA); Ryan Wistort (San Francisco, CA)
Assignee: Labrador Diagnostics LLC
G01N21/0303B01L3/0275B04B5/0421C12Q1/42C12Q1/48C12Q1/52C12Q1/6806C12Q1/689C12Q1/6809G01N1/4077G01N21/00G01N21/51G01N21/59G01N33/5308G01N33/54326G01N33/54393G01N33/56972G01N33/56983G01N33/573G01N33/74G01N33/743G01N33/80G01N33/82G01N33/92G01N35/10G06T3/4084G06T7/0002G06T7/0012H04N23/64B01L2300/168C12Q2600/158G01N2001/4083G01N2035/00495G01N2035/1018G01N2333/575G01N2333/62G01N2333/91188G01N2333/96463G06T2207/30004G06T2207/30168G16C20/20
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Quick Facts
Patent No.
US 11,644,410
App. No.
17/135,437
Granted
May 9, 2023
Kind
B2
Abstract

The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.

Claims (49)

1. A field testing device for preparing a test sample for an assay process, the field testing device comprising:

a sample receptacle configured to receive the test sample, the test sample being a portion of a bodily fluid;

a pipette tip configured to extract the test sample from the sample receptacle;

a centrifuge configured to receive the test sample and centrifuge the test sample, the centrifuge including:

a circular rotor;

a motor configured to rotate the circular rotor; and

a bucket hanging vertically from the rotor via a pivot point connection, the bucket configured to configured to retain the test sample during the centrifugation process; and

one or more processors configured to initiate a stop procedure after a predetermined amount of time has lapsed, the stop procedure including:

shifting the motor into a neutral gear;

allowing the rotor to naturally reduce its rotational speed in response to the shifting;

monitoring the rotational speed of the rotor;

detecting that a predetermined low threshold rotational speed has been met; and

activating a cam coupled to the rotor to stop the rotor.

2. The field testing device of claim 1 , wherein the bucket is configured to rotate to a substantially horizontal position during the centrifugation process.

3. The field testing device of claim 2 , wherein the bucket rotates via the pivot point connection as a result of centrifugal force caused by a rotation of the rotor.

4. The field testing device of claim 1 , wherein the bucket is configured to receive the pipette tip containing the sample.

5. The field testing device of claim 1 , wherein the rotor includes a counterbalance configured to offset a weight of the bucket and test sample.

6. The field testing device of claim 1 , wherein the rotor further includes a second bucket hanging vertically from the rotor via a second pivot point connection, the second bucket configured to configured to retain the test sample during the centrifugation process.

7. The field testing device of claim 6 , wherein the second bucket is positioned on the rotor such that it is substantially in balance with the first bucket.

8. The field testing device of claim 1 , wherein the pivot point connection is configured to limit outward rotation of the bucket to one of 15, 30, 45, 60 or 75 degrees.

9. The field testing device of claim 1 , wherein the motor is configured to spin the rotor at between 10,000 and 15,000 rotations per minute.

10. A method for preparing a test sample for an assay process within a field testing device, the method comprising:

receiving the test sample, the test sample being a portion of a bodily fluid;

extracting the test sample using a pipette tip;

centrifuging the test sample, the centrifuging including:

inserting the test sample into a bucket vertically hanging from a circular rotor;

rotating the rotor using a motor; and

transitioning the bucket from the vertical position to an angled position in response to the rotating; and

initiating a stop procedure after a predetermined amount of time has lapsed, the stop procedure including:

shifting the motor into a neutral gear;

allowing the rotor to naturally reduce its rotational speed in response to the shifting;

monitoring the rotational speed of the rotor;

detecting that a predetermined low threshold rotational speed has been met; and

activating a cam coupled to the rotor to stop the rotor.

11. The method of claim 10 , wherein the angled position is a substantially horizontal position.

12. The method of claim 11 , further comprising providing a pivot point connection for affixing the bucket to the rotor that allows the bucket to transition from the vertical position to the angled position as a result of centrifugal force caused by the rotation of the rotor.

13. The method of claim 10 , further comprising inserting the pipette tip with the test sample into the bucket.

14. The method of claim 10 , further comprising counterbalancing the combined weight of the bucket and the test sample on the rotor.

15. The method of claim 10 , further comprising providing a second test sample to a second test bucket that vertically hangs from the rotor via a second pivot point connection.

16. The method of claim 15 , further comprising positioning the second bucket so as to balance the weight of the bucket on the rotor.

17. The method of claim 10 , wherein the angled position is one of 15, 30, 45, 60, or 75 degrees from vertical.

18. The method of claim 10 , wherein the rotating of the rotor occurs at between 10,000 and 15,000 rotations per minute.

19. The method of claim 18 , further comprising initiating a stop procedure after a predetermined amount of time has lapsed.

20. The method of claim 19 , wherein the stop procedure includes:

shifting the motor into a neutral gear;

allowing the rotor to naturally reduce its rotational speed in response to the shifting;

monitoring the rotational speed of the rotor;

detecting that a predetermined low threshold rotational speed has been met; and

activating a cam coupled to the rotor to stop the rotor.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2023
From: WISTORT, RYAN
To: THERANOS, INC.
Reel/Frame 062628/0690 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2023
From: NUGENT, ANTHONY; YOUNG, DANIEL; HOLMES, ELIZABETH A.; SIEGEL, MICHAEL
To: THERANOS, INC.
Reel/Frame 062628/0727 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2023
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 062682/0569 →
SECURITY INTEREST Recorded Feb 8, 2023
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 062682/0609 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2023
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 062682/0729 →
CHANGE OF NAME Recorded Feb 8, 2023
From: THERANOS IP COMPANY LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 062683/0234 →
Continuity (6)
Continuation 15584974 · May 2, 2017
Continuation 14789967 · Jul 1, 2015
Continuation 14562066 · Dec 5, 2014
Division 13355458 · Jan 20, 2012
Provisional Application 61435250 · Jan 21, 2011
Related Publication 20210223163A1 · Jul 22, 2021