Portable coagulation monitoring devices, systems, and methods
Inventors
Pearce, Matthew • Hall, Richard • DaCorta, Joseph Anthony
Assignees
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Publication Number
US-11768210-B2
Publication Date
2023-09-26
Expiration Date
Abstract
Portable coagulation monitoring devices, systems, and methods are disclosed. Namely, a test cartridge is provided for use in a portable coagulation monitor (PCM) device. Further, the test cartridge comprises two glass-filled thermoplastic polymer plates and a disposable blood introduction device. The two glass-filled thermoplastic polymer plates are arranged substantially in parallel with a small gap therebetween for receiving a sample of blood to be tested. Using the PCM device, the two glass-filled thermoplastic polymer plates can be moved linearly relative to each other. Methods of measuring coagulation response in a blood sample using the test cartridge and the PCM device are provided. A method of introducing blood into the test cartridge using the disposable blood introduction device is provided.
Core Innovation
The invention provides a device for measuring coagulation response in a blood sample using a test cartridge with a first member and a second member. The first member has a first flat surface and the second member has a second flat surface positioned to face the first flat surface to define a space therebetween sized to allow a sample of blood to be introduced into the space to contact both flat surfaces. The first member is configured to linearly move and oscillate so the first flat surface oscillates relative to the second flat surface to cause the sample of blood to coagulate and bind thereto.
The second member moves from a stationary configuration responsive to movement of the first member via the coagulated sample of blood. This changes mechanical displacement between the first and second members, which is measured to determine a coagulation response of the sample. The portable system includes a portable coagulation monitor that linearly moves the plates to generate controlled shear and waveforms, where the response is tied to the viscoelastic coupling between members through the coagulated blood.
The portable cartridge and monitor are further described with an optics system to optically detect coagulation response via light interaction and mechanical-displacement-related signals. The cartridge uses glass-filled thermoplastic polymer plates separated by a test gap sized to allow blood introduction, and a disposable blood introduction device delivers blood volume into the plate gap by capillary action without pipetting. The disclosure also outlines optional humidity control mechanism and temperature control mechanism, as well as concepts for multi-speed or phase measurement such as platelet response versus fibrin polymerization.
The described embodiments include alternative plate-motion and geometry concepts, including a rotation mechanism with a glass-filled rod, and optional dual-channel operation for simultaneous tests. The disclosure also includes inference-based concepts in which strain rates from relative movement and viscoelastic coupling due to the blood sample are used to determine coagulation response based on the sample’s viscoelasticity and the detected strain rates.
Claims Coverage
The document contains one independent claim that broadly covers a coagulation-measuring cartridge and device architecture, with multiple dependent claims refining materials, geometry, sensing, and signal interpretation. The main independent claim includes at least two inventive elements.
Oscillating first flat surface to cause coagulation binding
A test cartridge with a first member having a first flat surface and a second member having a second flat surface positioned to face the first flat surface to define a space therebetween, where the first member is configured to linearly move and oscillate to cause the first flat surface to oscillate relative to the second flat surface to cause the sample of blood to coagulate and bind thereto.
Blood-mediated movement of second member to change mechanical displacement
The second member is configured to move from a stationary configuration responsive to movement of the first member via the coagulated sample of blood, thereby changing mechanical displacement between the first and second members for measuring a coagulation response of the sample of blood.
Across the independent claim scope, the measured coagulation response is produced by oscillatory linear motion between facing flat surfaces that induces blood coagulation and binding, followed by blood-mediated motion of the second member that changes mechanical displacement for measurement.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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