IP Library › Granted Patent US 12,546,700
Granted Patent B2
US 12,546,700 · App. 19/025,994 · Granted Feb 10, 2026

Method for testing leukocytes for a disease state

Inventors: Dino Di Carlo (Los Angeles, CA); Daniel R. Gossett (Los Angeles, CA); Henry T. K. Tse (San Francisco, CA)
Assignee: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
G01N15/1433B01L3/502715B01L3/50273B01L3/502776C12Q1/02G01N15/1404G01N15/1459G01N15/1484G01N33/487G01N33/574G16B99/00B01L2200/0605B01L2200/0647B01L2200/0652B01L2300/0654B01L2300/0864G01N15/01G01N2015/1006G01N2015/1415G01N15/149G01N2015/1495G01N2015/1497G01N2800/7028
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Quick Facts
Patent No.
US 12,546,700
App. No.
19/025,994
Granted
Feb 10, 2026
Kind
B2
Abstract

A system is disclosed that enables the automated measurement of cellular mechanical parameters at high throughputs. The microfluidic device uses intersecting flows to create an extensional flow region where the cells undergo controlled stretching. Cells are focused into streamlines prior to entering the extensional flow region. In the extensional region, each cell's deformation is measured with an imaging device. Automated image analysis extracts a range of independent biomechanical parameters from the images. These may include cell size, deformability, and circularity. The single cell data that is obtained may then be used to in a variety of ways. Scatter density plots of deformability and circularity may be developed and displayed for the user. Mechanical parameters such as deformability and circularity may be gated or thresholded to identify certain cells of interest or sub-populations of interest. Similarly, the mechanical data obtained using the device may be used as cell signatures.

Claims (20)

1 . A method for testing one or more leukocytes within a cell sample for a disease state, the method comprising:

receiving the cell sample from an individual;

measuring a value of a set of characteristics of the one or more leukocytes within the cell sample by performing operations comprising:

passing the one or more leukocytes from the cell sample through a region of a microfluidic channel wherein the one or more leukocytes pass through the region of the microfluidic channel at a rate of at least about 1000 leukocytes/second, and

determining the value of the set of characteristics of a leukocyte of the one or more leukocytes as the leukocyte passes through the region of the microfluidic channel,

wherein the set of characteristics comprises a morphological parameter of the leukocyte; and

wherein a representation of a suspicion of the disease state based on the of characteristics is displayed, the representation comprising an illustration of the disease state separately from a non-disease state.

2 . The method of claim 1 , wherein the one or more leukocytes pass through the microfluidic channel at a velocity of at least about 1 m/s.

3 . The method of claim 1 , wherein the one or more leukocytes each passes through the region in less than about 500 μs.

4 . The method of claim 1 , wherein the morphological parameter comprises a leukocyte shape, cell circularity, or cell size.

5 . The method of claim 4 , wherein the morphological parameter comprises the leukocyte size.

6 . The method of claim 1 , wherein the measuring the value of the set of the characteristics further comprises applying a threshold to the value of the morphological parameter of the leukocyte.

7 . The method of claim 6 , wherein the threshold is applied to determine if the leukocyte indicates a positive or negative disease state.

8 . The method of claim 7 , wherein the suspicion of the disease state is based on a percentage of leukocytes of the one or more leukocytes that are identified as indicating the positive disease state.

9 . The method of claim 8 , wherein the positive disease state is based at least in part on a size of the leukocyte.

10 . The method of claim 1 , wherein the representation of a suspicion of the disease state comprises a plot of the set of characteristics of the one or more leukocytes within the cell sample.

11 . The method of claim 10 , wherein the plot is a scatter plot.

12 . The method of claim 11 , wherein an axis of the scatter plot comprises the morphological parameter.

13 . The method of claim 1 , further comprising diagnosing the individual based at least on a distribution of the set of characteristics of the one or more leukocytes within the cell sample.

14 . The method of claim 1 , wherein the suspicion of the disease state is based at least in part on an activation of the one or more leukocytes.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2025
From: DI CARLO, DINO; GOSSETT, DANIEL R.; TSE, HENRY T.K.
To: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
Reel/Frame 069906/0779 →
Continuity (6)
Continuation 17496758 · Oct 7, 2021
Continuation 15868025 · Jan 11, 2018
Continuation 14552256 · Nov 24, 2014
Continuation 13823109
Provisional Application 61385268 · Sep 22, 2010
Related Publication 20250155355A1 · May 15, 2025
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