Portable coagulation monitoring devices, systems, and methods

Inventors

Pearce, Matthew • Hall, Richard • DaCorta, Joseph Anthony

Assignees

Entegrion Inc

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Publication Number

US-10739358-B2

Patent

Publication Date

2020-08-11

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 relates to a portable coagulation monitoring system that measures coagulation response in a blood sample using a disposable test cartridge. The cartridge includes a first member and a second member with facing surfaces that are entirely flat and positioned substantially parallel to each other, with a gap sufficient to receive a blood sample droplet. The first and second members comprise a glass-filled thermoplastic polymer, and the gap receives the droplet to contact both facing surfaces and initiate coagulation.

The first member and second member are linearly movable relative to each other, and the system includes actuators mechanically connected to the respective members to linearly move the members in parallel while blood is in contact with the facing surfaces. Mechanical relative motion shears and activates coagulation, and the interaction between the facing surfaces is measured as an indication of coagulation response.

An optical detection sensor system detects coagulation-related changes by measurement of mechanical displacement resulting from the interaction between the facing surfaces. The measurement is associated with changes in viscosity of the blood sample and binding to the facing surfaces, and thus indicates coagulation response of the blood sample. The system includes control electronics and displacement sensing, with additional optional control mechanisms for humidity and temperature.

Claims Coverage

The independent claims cover a device that uses two flat, parallel, glass-filled thermoplastic members with a gap for a blood droplet, linear relative motion driven by actuators, and an optical detection sensor system that infers coagulation response from measurement of mechanical displacement tied to viscosity changes and binding. In total, one independent claim is explicitly provided in the partial content.

Two flat, facing, linearly movable glass-filled thermoplastic members defining a blood droplet gap

A set of test components comprising a first member with an entirely flat facing surface and a second member with an entirely flat opposing facing surface, positioned substantially parallel with a gap sufficient to receive a sample droplet of blood to contact both facing surfaces and initiate coagulation, wherein the first and second members comprise a glass-filled thermoplastic polymer and are linearly movable relative to each other.

Parallel linear actuation of the facing members while blood contacts the facing surfaces

A first actuator mechanically connected to the first member and a second actuator mechanically connected to the second member for linearly moving the first member and the second member relative to each other in parallel when a blood sample is in contact with the first member facing surface and the second member facing surface.

Optical detection sensor system using mechanical displacement from viscosity and binding

An optical detection sensor system for detecting, via measurement of mechanical displacement, the interaction between the first and second members facing surfaces resulting from changes in the viscosity of the blood sample and binding to the first and second member facing surfaces, as an indication of coagulation response of the blood sample.

The provided independent claim defines a coagulation measurement device that combines two entirely flat, facing, linearly movable glass-filled thermoplastic members separated by a blood droplet gap, parallel linear actuation to drive relative motion during sample contact, and an optical detection sensor system that measures mechanical displacement arising from viscosity changes and binding to indicate coagulation response.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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