Disposable BioMEMS coagulation profiling cartridge with a tracked oscillating disc

Inventors

Joseph, Luke B.Hasling, Thomas A.

Assignees

Ifirst Medical Technologies Inc

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Publication Number

US-12203834-B1

Patent

Publication Date

2025-01-21

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 relates to a handheld medical analyzer that performs coagulation profiling using disposable BioMEMS coagulation profiling cartridges. In the cartridge, a BioMEMS disc is oscillated in a liquid capable of coagulating, and the oscillation motion changes over time as the liquid coagulates. The method tracks the oscillating motion of tracking points on the disc to generate a coagulation profile that reflects the progression of coagulation.

The disc includes a first tracking point at the rotational center and a second tracking point located at a distance from the rotational center. Tracking the oscillating motion of the tracking points generates a coagulation profile, including amplitude plotted versus time and parameters related to reaction time, max clot, and slopes. In one embodiment, baseline trace differencing is used to derive the coagulation profile from the tracked motion over time.

Oscillation is induced externally to the cartridge using magnetic actuation, such that a motor or servo controls a magnet that drives the oscillation. The cartridge/reader design includes a well with a lid and a spindle and bearing arrangement, with a slidable lid and abutment configured to drop the disc into the well for magnetic coupling. Alternative embodiments are described, including a fixed-magnet operation and a torsion-spring disc/ring with oscillating magnet coupling.

Claims Coverage

The partial content identifies three independent methods that share a core inventive concept: oscillating a disc in a coagulating liquid, tracking one or two tracking points on the disc, and generating a coagulation profile that varies as coagulation proceeds. The independent claims are clm-00001, clm-00010, and clm-00018.

Oscillating disc with dual tracking points to generate a time-varying coagulation profile

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, wherein the disc comprises a first tracking point at the rotational center of the disc and a second tracking point located at a distance from the rotational center of the disc; tracking the oscillating motion of the first tracking point and the second tracking point of the disc to generate a coagulation profile, wherein the oscillating motion changes over time as the liquid coagulates

Specific rotational pattern oscillation with two tracking points

turning 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 located at a rotational center of the disc and a second tracking point located at a distance from the rotational center of the disc; tracking the oscillating motion of the first tracking point and the second tracking point of the disc while the liquid coagulates, wherein the disc oscillates in a specific rotational pattern

Measuring coagulation using oscillation tracked at an offset tracking point to evaluate abnormalities

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, wherein the disc comprises a first tracking point proximate the rotational center of the disc and a second tracking point located at a distance from the rotational center of the disc; tracking the oscillating motion of the second tracking point of the disc to generate a coagulation profile, wherein the coagulation profile is configured to facilitate evaluation of coagulation abnormalities

Across clm-00001, clm-00010, and clm-00018, the claim coverage centers on disc oscillation in a coagulating liquid and tracking one or more disc tracking points to generate a coagulation profile that changes as coagulation proceeds. Dependent claim refinements further specify how tracking is performed, constraints of the rotational pattern, and how the oscillation is induced, but the independent inventive features remain focused on oscillation-and-tracking for coagulation profiling and abnormality evaluation.

Stated Advantages

Facilitates evaluation of coagulation abnormalities.

Documented Applications

Generating a coagulation profile in an ambulance.

Disposing the disc and liquid in a well of a cartridge positioned within a handheld medical analyzer.

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