Method of using disposable BioMEMS coagulation profiling cartridge
Inventors
Joseph, Luke B. • Hasling, Thomas A.
Assignees
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Publication Number
US-11788941-B1
Publication Date
2023-10-17
Expiration Date
Abstract
A handheld medical analyzer works with different disposable application cartridges to perform a variety of interrogations on specimen samples. One application includes attaching a biological microelectromechanical systems (BioMEMS) cartridge that generates blood coagulation profiles indicative of particular forms of coagulation disorders. The device makes coagulopathy testing simpler for small hospitals, clinics, ambulances, remote locations and individuals and permits for a larger number of parallel or serial devices operating simultaneously. One insertion of a cartridge actuates an oscillating circular motion to generate a blood coagulation profile based on a change in rotational motion as blood coagulates in a sample. Change in rotational motion is analyzed through a video camera such as in a smartphone and is plotted to show an amplitude over time. Actuation of the BioMEMS can be achieved by magnetic actuation of a motor controlled by an iPhone or a smart phone to provide a specific rotational pattern.
Core Innovation
The invention provides a disposable BioMEMS coagulation profiling cartridge used with a handheld medical analyzer to generate a coagulation profile. A disc in the cartridge is actuated to oscillate within a liquid capable of coagulating using magnetic coupling, and the cartridge mechanics include a well and lid, a spindle or bearing region, a magnetic portion for contactless coupling, and a drop-in disc actuation within a microfluidic/sample channel.
Rotation changes of the disc are tracked over time using a video camera and a processor. The disc includes tracking points comprising a first color and a second color, where the first tracking point is proximate to or at a rotational center of the disc and the second tracking point is spaced apart from the rotational center, and the processor performs tracking and motion analysis by calculating motion changes over time and generating a coagulation profile as amplitude over time, including baseline-trace differencing.
The system emphasizes external magnetic actuation to produce a defined oscillation pattern, with tracking supported by real-time motion calculation and centroid calculation of the tracking points. Prototype validation differentiates Haemoscope Level I versus Level II controls with repeatability across multiple cartridges, and alternate embodiments are described, including a fixed magnet embodiment and torsion spring-supported disc or ring embodiments.
Claims Coverage
The independent claims collectively cover oscillating a magnetic disc in a coagulating liquid with video-based tracking of two color-coded tracking points and processor-based motion analysis to determine a coagulation profile; across the claim set, the inventive features include reversal-direction oscillation, two-color tracking point geometry, video camera tracking, and processor calculation of motion changes to determine the coagulation profile.
Opposite-direction oscillation of a magnetic coagulation disc with color-tracking points
Turning a disc in a first direction and a second direction opposite the first direction in an oscillating motion within a liquid capable of coagulating with a magnetic coupling, wherein the disc is magnetic and comprises a first tracking point with a first color and a second tracking point with a second color, the first tracking point proximate to or at the rotational center of the disc and the second tracking point spaced apart from the rotational center of the disc.
Video camera and processor tracking to generate a coagulation profile
Tracking the rotational motion of the first tracking point and the second tracking point of the disc over time with a video camera and processor to generate a coagulation profile.
Oscillating disc tracking using a video camera and relative motion calculation
Rotating a disc in a first direction and a second direction opposite the first direction in an oscillating motion in a liquid capable of coagulating, wherein the disc comprises a first tracking point comprising a first color located at a rotational center and a second tracking point comprising a second color located at a distance from the rotational center, tracking the first tracking point and the second tracking point of the disc with a video camera, and calculating changes in motion of the second tracking point with respect to the first tracking point of the disc with a processor to determine a coagulation profile.
Determining coagulation profile by motion changes of a tracked point
Rotating a disc in a first direction and a second direction opposite the first direction in an oscillating motion in a liquid capable of coagulating, with a disc having a first tracking point comprising a first color at a rotational center and a second tracking point comprising a second color spaced apart from the rotational center, tracking the motion of the second tracking point of the disc, and calculating changes in motion of the second tracking point with a processor to determine a coagulation profile.
Across the independent claims, coagulation measurement is defined by oscillating a disc, using color-defined tracking points, capturing tracking with a video camera, and using a processor to compute motion changes to determine a coagulation profile.
Stated Advantages
Prototype validation differentiates Haemoscope Level I versus Level II controls with repeatability across multiple cartridges.
HDDA polymer improving fibrin adhesion.
Documented Applications
Coagulation disorder testing using a disposable BioMEMS coagulation profiling cartridge with a handheld medical analyzer.
Other BioMEMS assays on a broader cartridge/analyzer platform, including Limulus amebocyte lysate (LAL) and viscosity/elasticity/viscoelasticity measurements.
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