IP Library › Granted Patent US 11,175,303
Granted Patent B2
US 11,175,303 · App. 16/664,746 · Granted Nov 16, 2021

Automated medical sample collection and testing for providing blood coagulation indication

Inventor: Mehdi Hatamian (Mission Viejo, CA)
Assignee: 2Pi-Sigma Corp.
G01N35/1095G01N33/4905G01N35/00584
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Quick Facts
Patent No.
US 11,175,303
App. No.
16/664,746
Granted
Nov 16, 2021
Kind
B2
Abstract

A sample collection and testing device for analyzing blood is provided that includes a controller, a fluid flow pathway, a pump configured to move fluid through the fluid pathway, and an optical fluid measurement element configured to measure a light intensity of the fluid in the fluid flow pathway. The controller is configured to: start the pump to move a blood sample in the fluid flow pathway, receive a signal from the optical fluid measurement element indicating a detection of a leading edge of the blood in the fluid flow pathway, stop the pump to stop the moving of the blood in the pathway, receive a plurality of light intensity measurements from the optical measurement element, each light intensity measurement measured at a corresponding point of time, and provide a mapping of the light intensity measurements into an indication of a coagulation of the blood sample over a time period.

Claims (89)

1. A sample collection and testing device for analyzing blood, the sample collection and testing device comprising:

a controller;

a fluid flow pathway;

a pump configured to move a blood sample through the fluid flow pathway; and

first and second optical fluid measurement elements located across the fluid flow pathway such that the blood sample reaches the first optical fluid measurement element before reaching the second optical fluid measurement element, each optical fluid measurement element configured to measure a light intensity of the fluid blood sample in the fluid flow pathway;

wherein the controller is configured to:

start the pump to move the blood sample in the fluid flow pathway;

receive a signal from the first optical fluid measurement element indicating a detection of a leading edge of the blood sample in the fluid flow pathway;

stop the pump in response to receiving the signal from the first optical fluid measurement element to stop the moving of the blood sample in the fluid flow pathway;

receive a plurality of light intensity measurements from the first optical fluid measurement element, each light intensity measurement measured at a corresponding point of time;

start the pump to move the blood sample in the fluid flow pathway;

receive a signal from the second optical fluid measurement element indicating a detection of a leading edge of the blood sample in the fluid flow pathway;

stop the pump in response to receiving the signal from the second optical fluid measurement element to stop the moving of the blood sample in the fluid flow pathway;

receive a plurality of light intensity measurements from the second optical fluid measurement element, each light intensity measurement measured at a corresponding point of time;

determine a travel time of the blood sample between the first and second optical fluid measurement elements; and

provide a mapping of a combination of the travel time of the blood sample between the first and second optical fluid measurement elements and the light intensity measurements of the first and second optical fluid measurement elements into an indication of a coagulation of the blood sample over a time period.

2. The sample collection and testing device of claim 1 , further comprising:

a sample collection element configured to receive the blood sample;

wherein the controller is configured to:

receive a signal from the sample collection element indicating a detection of the blood sample at the sample collection element; and

start the pump after receiving the signal from the sample collection element.

3. The sample collection and testing device of claim 2 ,

wherein the sample collection element and the fluid flow pathway are disposable,

wherein the pump is usable over a plurality of blood samples,

wherein the pump is configured to operate by receiving pulses, and

wherein controller is configured to operate the pump for a plurality of pulses after the detection of the leading edge of the blood sample at a last optical fluid measurement element across the fluid flow pathway such that a quantity of blood reaches the last optical fluid measurement element without the leading edge of the blood reaching the pump.

4. The sample collection and testing device of claim 1 , wherein the sample collection and testing device is a first sample collection and testing device, wherein the controller is configured to:

map the light intensity measurements into the indication of the blood coagulation based on a look up of a table generated by comparing results of blood tests of similar blood samples by a prothrombin time test (PT test) device and a second sample collection and testing device with a same configuration as the first sample collection and testing device.

5. The sample collection and testing device of claim 1 , wherein the controller is configured to:

determine a viscosity of the blood sample from the plurality of light intensity measurements received from the first and second optical fluid measurement elements over the time period; and

provide the mapping of the light intensity measurements into an indication of a coagulation of the blood sample based on a change in the viscosity of the blood over the time period.

6. The sample collection and testing device of claim 1 , wherein the controller is configured to:

determine a viscosity of the blood sample from the plurality of light intensity measurements received from the first and second optical fluid measurement elements over the time period; and

provide the mapping of the light intensity measurements into an indication of a thickness or a thinness of the blood sample based on a change in the viscosity of the blood over the time period.

7. The sample collection and testing device of claim 1 , wherein each optical fluid measurement element comprises:

an emitter configured to generate an optical output; and

an absorber configured to:

receive an optical input; and

measure a light intensity of the optical input;

wherein the optical output of the emitter passes through a portion of the fluid flow pathway and is received as the optical input to the absorber after passing through the portion of the fluid flow pathway.

8. The sample collection and testing device of claim 1 , wherein the mapping of the combination of the travel time of the blood sample between the first and second optical fluid measurement elements and the light intensity measurements of the first and second optical fluid measurement elements into the indication of the coagulation of the blood sample comprises providing a mapping to a result of a prothrombin time test (PT test) indicating the coagulation of the blood sample.

9. The sample collection and testing device of claim 1 , wherein the controller is configured to:

start a digital counter when the pump is started to move the blood sample from the first optical fluid measurement element towards the second optical fluid measurement element;

stop the digital counter when the pump is stopped in response to receiving the signal from the second optical fluid measurement element; and

determine the travel time of the blood sample between the first and second optical fluid measurement elements based on a value of the digital counter.

10. An automated method of measuring blood attributes, the method comprising:

by a controller of a sample collection and testing device:

starting a pump of the sample collection and testing device to move a blood sample in a fluid flow pathway of the sample collection and testing device;

receiving a signal from a first optical fluid measurement element of the sample collection and testing device indicating a detection of a leading edge of the blood sample in the fluid flow pathway;

stopping the pump in response to receiving the signal from the first optical fluid measurement element to stop the moving of the blood in the fluid flow pathway;

receiving a plurality of light intensity measurements from the first optical fluid measurement element, each light intensity measurement measured at a corresponding point of time;

starting the pump to move the blood sample in the fluid flow pathway;

receiving a signal from a second optical fluid measurement element of the sample collection and testing device indicating a detection of a leading edge of the blood sample in the fluid flow pathway;

stopping the pump in response to receiving the signal from the second optical fluid measurement element to stop the moving of the blood in the fluid flow pathway;

receiving a plurality of light intensity measurements from the second optical fluid measurement element, each light intensity measurement measured at a corresponding point of time;

determining a travel time of the blood sample between the first and second optical fluid measurement elements; and

providing a mapping of a combination of the travel time of the blood sample between the first and second optical fluid measurement elements and the light intensity measurements of the first and second optical fluid measurement elements into an indication of a coagulation of the blood sample over a time period.

11. The automated method of claim 10 further comprising:

by the controller of the sample collection and testing device:

receiving a signal from a sample collection element of the sample collection and testing device indicating a detection of the blood sample at the sample collection element; and

starting the pump after receiving the signal from the sample collection element.

12. The automated method of claim 11 , wherein the sample collection element and the fluid flow pathway are disposable, wherein the pump is usable over a plurality of blood samples, wherein the pump is configured to operate by receiving pulses, the method further comprising:

by the controller of the sample collection and testing device, operating the pump for a plurality of pulses after the detection of the leading edge of the blood sample at a last optical fluid measurement element in the fluid flow pathway such that a quantity of blood reaches the last optical fluid measurement element without the leading edge of the blood reaching the pump.

13. The automated method of claim 10 , wherein the sample collection and testing device is a first sample collection and testing device, the method further comprising:

by the controller of the sample collection and testing device:

mapping the light intensity measurements into the indication of the blood coagulation based on a look up of a table generated by comparing results of blood tests of similar blood samples by a prothrombin time test (PT test) device and a second sample collection and testing device with a same configuration as the first sample collection and testing device.

14. The automated method of claim 10 further comprising:

by the controller of the sample collection and testing device:

determining a viscosity of the blood sample from the plurality of light intensity measurements received from the first and second optical fluid measurement elements over the time period; and

providing the mapping of the light intensity measurements into an indication of a coagulation of the blood sample based on a change in the viscosity of the blood over the time period.

15. The automated method of claim 10 further comprising:

by the controller of the sample collection and testing device:

determining a viscosity of the blood sample from the plurality of light intensity measurements received from the first and second optical fluid measurement elements over the time period; and

providing the mapping of the light intensity measurements into an indication of a thickness or a thinness of the blood sample based on a change in the viscosity of the blood over the time period.

16. The automated method of claim 10 , wherein the mapping of the combination of the travel time of the blood sample between the first and second optical fluid measurement elements and the light intensity measurements of the first and second optical fluid measurement elements into the indication of the coagulation of the blood sample comprises providing a mapping to a result of a prothrombin time test (PT test) indicating the coagulation of the blood sample.

17. The automated method of claim 10 , wherein determining the travel time of the blood sample between the first and second optical fluid measurement elements comprises:

by the controller of the sample collection and testing device:

starting a digital counter when the pump is started to move the blood sample from the first optical fluid measurement element towards the second optical fluid measurement element;

stopping the digital counter when the pump is stopped in response to receiving the signal from the second optical fluid measurement element; and

determining the travel time of the blood sample between the first and second optical fluid measurement elements based on a value of the digital counter.

18. The automated method of claim 10 , wherein determining the travel time of the blood sample between the first and second optical fluid measurement elements comprises:

by the controller of the sample collection and testing device:

starting an analog timer when the pump is started to move the blood sample from the first optical fluid measurement element towards the second optical fluid measurement element;

stopping the analog timer when the pump is stopped in response to receiving the signal from the second optical fluid measurement element; and

determining the travel time of the blood sample between the first and second optical fluid measurement elements based on a value of the analog timer.

19. The automated method of claim 10 , wherein the controller is configured to:

start an analog timer when the pump is started to move the blood sample from the first optical fluid measurement element towards the second optical fluid measurement element;

stop the analog timer when the pump is stopped in response to receiving the signal from the second optical fluid measurement element; and

determine the travel time of the blood sample between the first and second optical fluid measurement elements based on a value of the analog timer.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 18, 2020
From: HATAMIAN, MEHDI
To: 2PI-SIGMA CORP.
Reel/Frame 054692/0943 →
Continuity (4)
Continuation In Part 15954442 · Apr 16, 2018
Continuation In Part 15785755 · Oct 17, 2017
Provisional Application 62488174 · Apr 21, 2017
Related Publication 20200057086A1 · Feb 20, 2020
Cited By (2)
US 12,449,440 US 12,569,174