# US 10,768,166 B2 · Diagnostics systems and methods

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- Number: US 10,768,166 B2
- Document ID: US10768166B2
- Status: Granted
- Kind: B2
- Application number: 15/599,368
- Filed: 2017-05-18
- Published: 2018-03-08
- Granted: 2020-09-08
- Earliest claimed: 2016-09-08
- Assignees: Hemex Health, Inc.
- Applicants: Hemex Health, Inc.
- Inventors: Peter Galen; David John Sayler; Joshua King Hoyt; Daniel E. Grupp; Brian T. Grimberg; Umut Atakan Gurkan
- Web page: https://patentgrep.com/patent/US10768166B2

## CPC

- G01N 33/49: Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)}
- A61B 5/15003: {for venous or arterial blood}
- A61B 5/150633: {Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves}
- A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing}
- A61B 5/15103: {Piercing procedure}
- G01N 21/1717: {with a modulation of one or more physical properties of the sample during the optical investigation, e.g. electro-reflectance}
- G01N 21/84: Systems specially adapted for particular applications
- G01N 27/44756: {Apparatus specially adapted therefor}
- G01N 33/48792: {Data management, e.g. communication with processing unit (for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C)}
- G01N 35/00871: {Communications between instruments or with remote terminals}
- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles
- B01L 2200/143: Quality control, feedback systems
- B01L 2300/0654: Lenses; Optical fibres
- B01L 2300/0672: Integrated piercing tool
- B01L 2400/043: magnetic forces
- B01L 2400/0481: squeezing of channels or chambers
- G01N 2021/1727: {Magnetomodulation}
- G01N 2035/00881: {network configurations}
- G01N 2035/00891: {Displaying information to the operator}
- G01N 2333/445: Plasmodium
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

A point-of-care diagnostic system that includes a cartridge and a reader. The cartridge can contain a patient sample, such as a blood sample. The cartridge is inserted into the reader and the patient sample is analyzed. The reader contains various analysis systems, such as a magneto-optical system that measures a light transmission differential through the patient sample in varying magnetic fields. The reader can process data from the various patient sample analysis to provide interpretative results indicative of a disease, infection and/or condition of the patient.

## Claims

### Claim 1

A point-of-care diagnostics system, comprising:
a cartridge having:
a blood sample chamber structured to receive and store a patient blood sample,
a dilutant chamber structured to store a pre-loaded dilutant, and
a barrier separating the blood sample and dilutant chambers, the barrier is structured to, upon actuation, automatically release the dilutant to be mixed with the patient blood sample to form a diluted sample within the cartridge;
a reader having:
a cartridge receptacle shaped to receive the cartridge;
a magnetic field source structured to apply either a high magnetic field or a low magnetic field to at least the blood sample chamber of the cartridge when the cartridge is received within the cartridge receptacle;
a light source positioned to selectively transmit light through the diluted sample when the cartridge is received in the cartridge receptacle;
a light detector positioned to sense one or more characteristics of the light transmitted through the diluted sample and to generate light detection data based, at least in part, on the sensed one or more characteristics of the light transmitted through the blood sample;
a processor electrically coupled to the light detector and programmed to:
cause the light detector to sense the one or more characteristics of the light transmitted through the diluted sample and to generate the light detection data at a first time when the high magnetic field is applied or the low magnetic field is applied to the blood sample chamber of the cartridge;
after the light detection data is generated at the first time, cause the magnetic field source to apply the high magnetic field or the low magnetic field, whichever was not applied at the first time, to the blood sample chamber;
cause the light detector to sense the one or more characteristics of the light transmitted through the diluted sample and to generate the light detection data at a second time when the high magnetic field or the low magnetic field is applied, whichever was not applied at the first time;
determine a difference in a value of the light detection data between the first time and the second time;
receive the difference in the value of the light detection data;
analyze the received difference in the value of the light detection data to identify whether at least one compound that is sensitive to the applied magnetic field is present in the diluted sample;
generate interpretative data that indicates presence of the compound in the diluted sample based, at least in part, on the difference in the value of the analyzed light detection data; and
output the interpretative data.

### Claim 2 (depends on 1)

The point-of-care diagnostics system of claim 1, further comprising an integrated blood sample collector that includes one or more of:
a moveable lancet that, upon actuation, is structured to automatically extend to collect the patient blood sample, and, after the blood sample is collected, automatically retract into the cartridge,
a retractable lancet that is structured to remain static to collect the blood sample and, after collecting the blood sample, retracts into the cartridge,
or a fixed lancet.

### Claim 3 (depends on 2)

The point-of-care diagnostics system of claim 2, wherein the barrier includes one or both of a passive and an active mechanism that, when actuated, automatically causes the release of the dilutant to mix with the patient blood sample.

### Claim 4 (depends on 3)

The point-of-care diagnostics system of claim 3, wherein the cartridge further includes a mixing chamber in which the pre-loaded dilutant is mixed with the patient blood sample.

### Claim 5 (depends on 1)

The point-of-care diagnostics system of claim 1, further comprising a physical disruption component structured to cause lysing of one or more compounds in the blood sample.

### Claim 6 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the light source is positioned to transmit light through a portion of the blood sample chamber with the diluted sample.

### Claim 7 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the blood sample chamber is further structured to store one or both of a pre-loaded anti-pathogen and a pre-loaded anti-foaming compound.

### Claim 8 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the cartridge has a vent structured to maintain an internal pressure of the blood sample chamber at or near a pressure of an ambient environment surrounding the cartridge.

### Claim 9 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the light source is positioned to transmit light through the diluted sample at a controlled angle with respect to surfaces of the cartridge through which the light enters and exits the cartridge.

### Claim 10 (depends on 1)

The point-of-care diagnostics system of claim 1, further comprising one or both of:
an actuator that is positioned to be automatically actuated when the cartridge is received in the cartridge receptacle, and
a cartridge sensor that is configured to detect the presence of the cartridge within the cartridge receptacle, the cartridge sensor electrically coupled to the processor and configured to transmit cartridge data indicating the presence of the cartridge in the cartridge receptacle to the processor.

### Claim 11 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to cause the light detector to sense the relative intensity of the transmitted light a single time or multiple times, and if the light detector is configured to sense the relative intensity multiple times, then the processor causes the light detector to sense the relative intensity of the transmitted light over a period of time during which the light detector repeatedly detects the relative intensity at set intervals or randomly throughout the period of time.

### Claim 12 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to automatically generate the interpretative data that indicates presence of the compound in the diluted sample.

### Claim 13 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to automatically transmit the output interpretive data to a display.

### Claim 14 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to receive user input requesting the interpretive data and, based on the received user input, is also further configured to automatically transmit the output interpretive data to the display.

### Claim 15 (depends on 13)

The point-of-care diagnostics system of claim 13, wherein the display is integrated into the reader.

### Claim 16 (depends on 13)

The point-of-care diagnostics system of claim 13, wherein the processor is further programmed to transmit the output interpretive data to the display and the display is integrated into a remote computing device.

### Claim 17 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein a portion or all of one or both of the cartridge and the reader are temperature-controlled.

### Claim 18 (depends on 1)

The point-of-care diagnostics system of claim 1, further comprising an integrated power source in the reader, the power source electrically coupled to the light detector and the processor.

### Claim 19 (depends on 1)

The point-of-care diagnostics system of claim 1, further comprising an output configured to receive the interpretative data and the output is integrated within the reader and includes one or more of a display, a visual indicator, an audible indicator, and a computing element remote from the reader.

### Claim 20 (depends on 19)

The point-of-care diagnostics system of claim 19, wherein the remote computing element is wirelessly connected to the reader or is connected to the reader via a wired electrical connection.

### Claim 21 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is integrated within the reader.

### Claim 22 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor includes processing circuitry that is wirelessly connected to the light detector and is integrated partially or entirely in a computing element remote from the reader.

### Claim 23 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor includes processing circuitry and at least a portion of the processing circuitry is integrated within the cartridge.

### Claim 24 (depends on 1)

The point-of-care diagnostics system of claim 1, further comprising an actuator that, when actuated, indicates that the cartridge is received within the cartridge receptacle, and that the actuator is electrically coupled to the processor, wherein the processor is further programmed to cause the light source to begin transmitting light through the patient blood sample when the processor receives a data transmission that the cartridge is received within the cartridge receptacle.

### Claim 25 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to measure a relative intensity of the light transmitted through the diluted sample, and to automatically generate the interpretive data to include the measurement of the relative intensity.

### Claim 26 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor includes reader processing circuitry and remote computing element processing circuitry, wherein
the reader processing circuitry is configured to receive the light detection data, and
the remote computing element processing circuitry configured to the analyzing, generating, and outputting steps, wherein the generating and outputting steps are performed automatically.

### Claim 27 (depends on 26)

The point-of-care diagnostics system of claim 26, wherein the remote computing element processing circuitry is further configured to transmit the output interpretive data to one or both of a display integrated in the reader and a display integrated in the remote computing system.

### Claim 28 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to automatically analyze the light detection data to measure the amount of the compound that is present in the diluted sample and to automatically generate the interpretive data to include the measured amount of the compound.

### Claim 29 (depends on 1)

The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to correlate the one or more sensed characteristics of the light transmitted through the blood sample with a level of hemozoin.

### Claim 30 (depends on 1)

The point-of-care diagnostic system of claim 1, wherein the magnetic field source is a pair of permanent magnets.

### Claim 31 (depends on 1)

The point-of-care diagnostic system of claim 1, wherein, the high magnetic field is applied at the first time and the low magnetic field is applied at the second time.

### Claim 32 (depends on 1)

The point-of-care diagnostic system of claim 1, wherein the low magnetic field is applied at the first time and the high magnetic field is applied at the second time.

### Claim 33 (depends on 1)

The point-of-care diagnostic system of claim 1, wherein the interpretative data is output automatically.

### Claim 34 (depends on 1)

The point-of-care diagnostic system of claim 1, wherein the interpretative data is based on the values of the analyzed light detection data when applying the high and low magnetic fields at the first time and the second time, respectively.

### Claim 35 (depends on 1)

The system of claim 1, further comprising a mechanical lysing element structured to mechanically lyse the patient blood sample.

### Claim 36 (depends on 35)

The system of claim 35, wherein the mechanical lysing element is structured to mechanically lyse the patient blood sample without physically contacting the patient blood sample.

### Claim 37 (depends on 35)

The system of claim 35, wherein the mechanical lysing element is structured to mechanically lyse the patient blood sample from a position external to the cartridge.

### Claim 38 (depends on 1)

The system of claim 1, wherein the cartridge is one or both of a single-use cartridge and a disposable cartridge.

### Claim 39 (depends on 1)

The system of claim 1, wherein the actuation of the barrier is manual or automatic.

### Claim 40 (depends on 1)

The system of claim 1, wherein the barrier is semi-permeable.

### Claim 41 (depends on 1)

The system of claim 1, wherein the barrier is impermeable.

### Claim 42 (depends on 1)

The system of claim 1, wherein the barrier is a physical barrier at least partially bisecting the cartridge to form the blood sample and dilutant portions.

### Claim 43 (depends on 1)

The system of claim 1, wherein the barrier is destroyable.

### Claim 44 (depends on 43)

The system of claim 43, wherein the barrier is puncturable or dissolvable.

### Claim 45 (depends on 1)

The system of claim 1, wherein the barrier is moveable.