IP Library Granted Patent US 11,061,014
Granted Patent B2
US 11,061,014 · App. 16/912,487 · Granted Jul 13, 2021

Malaria species detection

Inventors: Peter Galen (Portland, OR); James Daren Bledsoe (Portland, OR); D'Arbra Blankenship (Cleveland, OH); Robert J. Deissler (Cleveland, OH); Steven M. Goss (Salem, OR); Brian T. Grimberg (Shaker Heights, OH)
Assignee: HEMEX HEALTH, INC.
G01N33/4875B01L3/50273G01N33/48792G01N33/49G01N35/00871B01L2200/143B01L2300/021B01L2300/025B01L2300/0672B01L2300/087B01L2300/0816G01N2035/00881G01N2035/00891G01N2333/445
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Quick Facts
Patent No.
US 11,061,014
App. No.
16/912,487
Granted
Jul 13, 2021
Kind
B2
Abstract

A 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 sample can be processed for data collection and analysis to provide interpretative results indicative of a disorder, condition, disease or infection of the patient. For example, the data collection and analysis can determine one or more hemozoin characteristics.

Claims (42)

1. A diagnostic system, comprising:

a processor configured to:

determine a feature of a first slope of a data signal, the first slope representative of a response to a change in a magnetic field applied to a patient sample, the data signal representative of measurements of a feature of a hemozoin produced by the malaria species over a time measurement, the time measurement taken from a time the magnetic field applied to the patient sample is removed or lowered to a time a relaxation light transmittance value reaches a relaxation threshold or an alignment threshold,

determine a relaxation time or an alignment time of the hemozoin based on the time measurement, and

determine a malaria species based on the first slope; and an output configured to output the malaria species.

2. The system of claim 1 , wherein the feature of the hemozoin produced by the malaria species over the time measurement is associated with an amount of the hemozoin produced by the malaria species, a size of the hemozoin produced by the malaria species, a shape of the hemozoin produced by the malaria species, or combinations or multiples thereof.

3. The system of claim 1 , wherein the processor is further configured to reduce signal noise of the data signal.

4. The system of claim 3 , wherein the signal noise is reduced by baseline wander removal by applying a signal filter.

5. The system of claim 1 , wherein the processor is further configured to generate an instruction to end a test, continue the test, or extend the test beyond an initial test duration based on the data signal, the test generating the data signal representative of the measurements of the feature of the hemozoin produced by the malaria species over the time measurement.

6. The system of claim 1 , wherein the processor is further configured to:

identify an undesired fluctuation or shape in the data signal, and

generate a notification to re-test the patient sample based on the undesired fluctuation or shape in the data signal.

7. The system of claim 6 , wherein the undesired fluctuation or shape in the data signal is caused by voltage saturation, voltage drift, a bad cartridge, a new sample is required, or combinations or multiples thereof.

8. The system of claim 1 , wherein the relaxation threshold represents a starting light transmittance value or range of values that is measured before the magnetic field is applied to the patient sample.

9. The system of claim 1 , wherein the relaxation threshold represents a Brownian relaxation threshold or range of values that indicates that the hemozoin within the patient sample has a random or aligned orientation in response to the magnetic field.

10. The system of claim 1 , wherein the processor is further configured to determine the relaxation time or the alignment time of the hemozoin, the relaxation time based on a comparison of the determined relaxation time or alignment time to a known value or range of values of a known infection characteristic-specific relaxation or alignment time.

11. The system of claim 1 , wherein the output is further configured to output the malaria species correlated with the relaxation time or the alignment time.

12. The system of claim 1 , wherein the processor is further configured to generate a diagnostic recommendation based on the malaria species.

13. The system of claim 12 , wherein the output is further configured to output the diagnostic recommendation.

14. The system of claim 1 , wherein the processor is further configured to generate an instruction to cause a viscosity agent to be dispensed into the patient sample, the dispensed viscosity agent causing a viscosity of the patient sample to increase when mixed with the viscosity agent.

15. The system of claim 1 , wherein the output includes an external device having a display.

16. The system of claim 1 , wherein the processor is further configured to:

determine the feature of the first slope for a plurality of data signals, the plurality of data signals generated in response to respective cycles between a first amplitude and a second amplitude of the magnetic field, each of the cycles having a respective time measurement over which the respective relaxation light transmittance values reach the relaxation threshold or the alignment threshold,

determine the relaxation time or the alignment time for the hemozoin for each of the respective time measurements, and

determine the malaria species based on the first slope for multiple of the plurality of data signals.

17. The system of claim 16 , wherein the processor is further configured to generate an ensemble signal that includes the plurality of data signals.

18. The system of claim 17 , wherein the processor is further configured to reduce ensemble noise of the ensemble signal.

19. The system of claim 16 , wherein the first amplitude of the magnetic field is greater than the second amplitude of the magnetic field, and wherein the first slope is a positive or rising slope.

20. The system of claim 16 , wherein the first amplitude of the magnetic field is less than the second amplitude of the magnetic field, and wherein the first slope is a negative or falling slope.

21. The system of claim 1 , wherein the processor is further configured to:

determine a feature of a second slope of the data signal, the second slope representative of a response to another change in the magnetic field applied to the patient sample, and

determine the malaria species based on the first slope and the second slope.

22. The system of claim 1 , wherein the processor is further configured to:

determine a characteristic of the data signal that indicates presence of a hemozoin correlating to the malaria species in the patient sample, and

determine the malaria species based on the first slope of the data signal and the characteristic of the data signal that indicates the presence of the hemozoin associated with the malaria species in the patient sample.

23. A method for analyzing a patient sample, the method comprising:

determining a feature of a first slope of a data signal, the first slope representative of a response to a change in light transmitted through a patient sample, the change due to a change in a magnetic field applied to the patient sample, the data signal representative of measurements of a feature of a hemozoin produced by the malaria species over a time measurement, the time measurement taken from a time the magnetic field applied to the patient sample is removed or lowered to a time a relaxation light transmittance value reaches a relaxation threshold or an alignment threshold;

determining a relaxation time or an alignment time of the hemozoin based on the time measurement;

determining a malaria species based on the first slope; and

outputting the malaria species.

24. The method of claim 23 , further comprising outputting a diagnosis, a treatment, or both based on the hemozoin of the malaria species, the malaria species, or both.

25. The method of claim 23 , further comprising determining the data signal includes a characteristic that indicates presence of the hemozoin of the malaria species in the patient sample.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2021
From: GALEN, PETER; BLEDSOE, JAMES DAREN; BLANKENSHIP, D'ARBRA; DEISSLER, ROBERT J.; GOSS, STEVEN M.; GRIMBERG, BRIAN T.
To: HEMEX HEALTH, INC.
Reel/Frame 056446/0199 →
Continuity (2)
Provisional Application 62866534 · Jun 25, 2019
Related Publication 20200408735A1 · Dec 31, 2020