Diagnostics systems and methods

• US 10,349,589 B2
• Filed: 09/08/2017
• Issued: 07/16/2019
• Est. Priority Date: 09/08/2016
• Status: Active Grant

• Current Assignee: Hemex Health, Inc.
• Original Assignee: Hemex Health, Inc.
• Inventors: Galen, Peter, Gurkan, Umut Atakan, Fraiwan, Arwa, Hasan, Muhammad Noman, Grupp, Daniel E., Hoyt, Joshua King, Thorne, James, Grimberg, Brian T.
• Primary Examiner(s): Siefke, Samuel P
• Application Number:
  US15/699,962
• Publication Number:
  US 20180064384A1
• Time in Patent Office: 676 Days
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15192 comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/025 Displaying results or values with integrated means
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/18 Means for temperature control
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0421 : electrophoretic flow
• CPC Class Codes: B01L 2400/0481 : squeezing of channels or chambers
• CPC Class Codes: B01L 3/502 : with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 1/312 : for samples mounted on planar substrates
• CPC Class Codes: G01N 2333/805 : Haemoglobins; Myoglobins
• CPC Class Codes: G01N 27/44704 : Details; Accessories
• CPC Class Codes: G01N 27/44717 : Arrangements for investigating the separated zones, e.g. localising zones
• CPC Class Codes: G01N 27/44743 : Introducing samples
• CPC Class Codes: G01N 27/44756 : Apparatus specially adapted therefor
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

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 an electrophoresis detection system that uses electrophoresis testing to identify and quantify various components of the blood sample. The reader can process data from the various patient sample analysis to provide interpretative results indicative of a disorder, condition, disease and/or infection of the patient.

Claims

1. A point-of-care diagnostic system, comprising:

a cartridge having;

a blood sample chamber that is structured to receive a patient blood sample, the patient blood sample containing one or more hemoglobin types, and to store the patient blood sample within the blood sample chamber;

an electrophoresis strip structured to receive at least a portion of the patient blood sample from the blood sample chamber and to receive a selectively applied electric current;

a reader having;

a cartridge receptacle shaped to receive the cartridge and initiate an electrophoresis diagnostic process in response to receiving the cartridge;

an electrophoresis module structured to cause the selectively applied electric current to be applied to the electrophoresis strip of the cartridge, the electrophoresis strip having thereon received at least a portion of the patient blood sample;

an electrophoresis band detection module structured to detect one or more bands of at least a portion of the patient blood sample on the electrophoresis strip caused by the selectively applied electric current and to generate band detection data based on the one or more bands of the at least a portion of the patient blood sample;

a processor programmed to;

receive the band detection data;

analyze the band detection data to determine one or more band characteristics for each of the one or more bands, each of the one or more bands corresponding to one of the one or more hemoglobin types of the patient blood sample;

identify the one more hemoglobin types of the patient blood sample based on the one or more band detection characteristics of each of the one or more bands;

generate diagnostic results based at least in part on the one or more hemoglobin types of the patient blood sample; and

transmit the diagnostic results to an output.

2. 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 extend to produce the patient blood sample,

a retractable lancet that, upon actuation, is structured to extend to produce the patient blood sample and to retract into the cartridge after the blood sample is collected,

a stationary lancet that is structured to remain static to produce the blood sample and retracts into the cartridge after collecting the blood sample,

or a fixed lancet structured for a user to manually produce the patient blood sample.

3. The point-of-care diagnostics system of claim 1, wherein the cartridge further includes at least one of a pre-loaded marker or buffer stored in one or both of the blood sample chamber and a treatment chamber in fluid communication with the blood sample chamber, the treatment chamber either located within one or the other of the cartridge and the reader or integrated within the blood sample chamber.

4. The point-of-care diagnostics system of claim 3, further comprising one or both of a passive and an active mechanism that, when actuated, automatically causes one or more of the pre-loaded marker to mix with the patient blood sample or the buffer to be applied to the electrophoresis strip.

5. The point-of-care diagnostics system of claim 4, wherein one or the other of the reader and the cartridge further include a mixing chamber in which the pre-loaded marker is mixed with the patient blood sample.

6. The point-of-care diagnostics system of claim 1, wherein one or the other of the reader and the cartridge further include a sample depositor configured to selectively deposit a portion of the patient blood sample to the electrophoresis strip in a controlled manner.

7. The point-of-care diagnostics system of claim 6, wherein the controlled manner includes a pre-determined volume of the patient sample and pre-determined deposit area having a defined shape.

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

9. The point-of-care diagnostics system of claim 1, wherein the electrophoresis strip includes electrodes that are releasably connected to the electrophoresis module when the cartridge is inserted in the reader.

10. The point-of-care diagnostics system of claim 1, wherein the electrophoresis module includes electrodes that contact the electrophoresis strip of the cartridge after the cartridge is inserted in the reader.

11. The point-of-care diagnostics system of claim 1, further comprising one or both of:

an actuator that is positioned to be 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.

12. The point-of-care diagnostics system of claim 1, wherein the electrophoresis module is further structured to stain the electrophoresis strip.

13. The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to automatically generate the diagnostic results.

14. The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to transmit the diagnostic results to a display.

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

16. The point-of-care diagnostics system of claim 14, wherein the display is integrated into the reader.

17. The point-of-care diagnostics system of claim 14, wherein the display is integrated into a remote computing device.

18. 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.

19. 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 electrophoresis module, the electrophoresis band detection module and the processor.

20. The point-of-care diagnostics system of claim 1, further comprising an output configured to receive the diagnostic results 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.

21. The point-of-care diagnostics system of claim 20, wherein the remote computing element is wirelessly connected to the reader or is connected to the reader via a wired electrical connection.

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

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

24. The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to determine the relative proportions of the one or more hemoglobin types in the patient blood sample and to generate the diagnostic results based at least in part on the relative proportions of the one or more hemoglobin types in the patient blood sample.

25. The point-of-care diagnostics system of claim 1, further comprising an actuator electrically coupled to the processor, the actuator being structured to indicate that the cartridge is received within the cartridge receptacle, and the processor being further programmed to transmit instructions to the electrophoresis module to begin applying a voltage to the electrophoresis strip in response to the actuator indicating that the cartridge is received within the cartridge receptacle.

26. The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to measure the spacing from the application point and between each of the bands, and to automatically generate the diagnostic results to include the measurement of the spacing between each of the bands.

27. The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to:

analyze the received band detection data to identify the one more hemoglobin types of the patient blood sample and determine the relative proportions of the one or more hemoglobin types in the patient blood sample,

automatically generate the diagnostic results that indicates the one or more hemoglobin types of the patient blood sample and relative proportions of the one or more hemoglobin types of the patient blood sample based on the received band detection data, and

automatically output the diagnostic results.

28. The point-of-care diagnostics system of claim 27, wherein the processor is further programmed to transmit the diagnostic results to one or both of a display integrated in the reader and a remote computing system.

29. The point-of-care diagnostics system of claim 1, wherein the processor is further programmed to automatically analyze the received band detection data to measure the spacing to and between each of the bands and to automatically generate the diagnostic results to include the measured spacing of each of the bands.

30. The point-of-care diagnostics system of claim 1, wherein the one or more band detection characteristics include an intensity and location for each of the one or more bands and the processing circuitry is further configured to correlate the band detection data of the blood sample with a level of each of the hemoglobin types of the blood sample.