# US 9,518,914 B2 · Portal and method for management of dialysis therapy

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- Number: US 9,518,914 B2
- Document ID: US9518914B2
- Status: Granted
- Kind: B2
- Application number: 14/430,360
- Filed: 2013-03-24
- Published: 2015-08-06
- Granted: 2016-12-13
- Earliest claimed: 2012-09-24
- Assignees: The Brigham and Women's Hospital, Inc.
- Applicants: Umut A. Gurkan; Utkan Demirci; Derya A. Yellin
- Inventors: Umut A. Gurkan; Utkan Demirci; Derya A. Yellin
- Web page: https://patentgrep.com/patent/US9518914B2

## CPC

- G01N 15/1023: {Microstructural devices for non-optical measurement}
- B01L 3/502761: {specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads or physically stretching molecules}
- G01N 15/1436: {the optical arrangement forming an integrated apparatus with the sample container, e.g. a flow cell}
- G01N 15/1484: {microstructural devices}
- G01N 33/54366: {Apparatus specially adapted for solid-phase testing}
- G06V 20/69: Microscopic objects, e.g. biological cells or cellular parts
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- B01L 2300/023: Sending and receiving of information, e.g. using Bluetooth®
- B01L 2300/027: Digital display, e.g. LCD, LED
- B01L 2300/0654: Lenses; Optical fibres
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- G01N 2015/016: {White blood cells}
- G01N 2015/1006: {for cytology}
- G01N 2015/1024: {Counting particles by non-optical means}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- G06V: IMAGE OR VIDEO RECOGNITION OR UNDERSTANDING
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

System and method for point-of-care monitoring of neutrophils in a peritoneal dialysis sample with the use of a microfluidic system. The immunoassay based chip is configured to bound neutrophils to a microfluidic channel surface while leaving auxiliary cells and particles unattached and suspended in the sample and flushable with a wash buffer. Data representing images of neutrophils, formed by an (optionally lensless) imaging system, are processed to determine a count of neutrophils based on statistical parameters including characteristics of the microfluidic channel.

## Claims

### Claim 1

A system for at least one of identifying and counting target cells in a bodily fluid sample, the system comprising:
an element with a network of microfluidic channels,
an optical detector positioned adjacently to the element to acquire a shadow cast by the element onto the optical detector in light that has passed through the element wherein said system is devoid of an optical component between the element and the optical detector, and
a non-transitory computer-readable medium having computer readable program code disposed therein, for at least one of identifying and counting the target cells in the bodily fluid sample, and comprising a series of computer-readable program steps to effect:
acquiring data representing an initial image, of at least one channel from the network of microfluidic channels, formed on a surface of the optical detector by said shadow in said light that has traversed the at least one channel;
converting the acquired data to data representing a gray-scale image of said at least one channel;
data-processing of so-converted data by filtering these data in at least one of a frequency domain and a spatial domain; and
when said at least one channel of said network of microfluidic channels contains the bodily fluid sample with identified biological cells, identifying and optionally counting target cells in relation to parameters of said at least one channel and a predefined threshold value.

### Claim 2 (depends on 1)

The system according to claim 1, further comprising a display in operable communication with said computer readable medium, wherein computer readable program code further comprises a series of computer readable program steps to effect presenting said initial image at the display, said initial image containing visually perceivable marks representing said counted identified cells.

### Claim 3 (depends on 1)

The system according to claim 1, wherein computer readable program code further comprises a series of computer readable program steps to effect submitting said count value to a server in communication with said computer readable medium.

### Claim 4 (depends on 3)

The system according to claim 3, wherein computer readable program code further comprises a series of computer readable program steps to effect receiving, from a user of said server, an input representing a change to the predetermined threshold value and displaying, based on such input, at least one of a gray-scale image and a color image containing marks that identify the counted identified cells in relation to a changed threshold value.

### Claim 5 (depends on 1)

The system according to claim 1, wherein said converting includes processing the acquired data to change a corresponding spectrum of spatial frequencies such as to increase amplitudes of high frequency components of the spectrum while maintaining amplitude of low frequency components of the spectrum.

### Claim 6

An article of manufacture comprising
data-processing circuitry and
a computer readable medium comprising computer readable program code disposed therein for counting target cells in a bodily fluid sample contained in a channel of a microfluidic system, which system includes
a microfluidic chip having one or more microfluidic channels;
an optical detector adjacent to said microfluidic chip; and
a light source configured to transmit light through said microfluidic chip onto the optical detector,
wherein the system is configured to cast a shadow at the optical detector in said light in absence of an optical component defined to form an optical conjugate of said sample at the optical detector, said shadow having an irradiance distribution representing the bodily fluid sample at the optical detector;
said computer readable program code comprising a series of computer readable program steps to enable at least one of identifying and counting of the target cells based at least in part on conversion of data representing the formed irradiance distribution to a gray scale.

### Claim 7 (depends on 6)

The article of manufacture according to claim 6, wherein the computer readable program code further comprises steps to enable said counting based on a probability of the target cells to be located near a surface of a channel and a likelihood of bond formation between so located target cells and receptors.

### Claim 8

A method for identifying cells contained in a bodily fluid sample, the method comprising:
receiving data representing an image of target cells in the bodily fluid sample formed in light that has traversed a microfluidic channel containing said bodily fluid sample and cast a shadow of said microfluidic channel on an optical detector, wherein the receiving data includes receiving data representing said image of said target cells produced without the use of an optical component configured to form an optical conjugate of said target cells at the optical detector; and
processing the received data to determine a count of the neutrophils target cells in the bodily fluid sample based on probability of the neutrophils said target cells to be located near a surface of the microfluidic channel and a likelihood of a bond formation between so located neutrophils target cells and receptors.

### Claim 9 (depends on 8)

The method according to claim 8, further comprising determining probability of a steady-state adhesion of the target cells to the surface of the microfluidic channel.

### Claim 10 (depends on 8)

The method according to claim 8, further comprising generating visually-perceivable triggering indicator when the count exceeds a threshold value that is adjustable based on a user input.

### Claim 11 (depends on 8)

The method according to claim 8, wherein said target cells include one or more of neutrophils, lymphocytes, and monocytes.