Portable coagulation monitoring device for assessing coagulation response

Inventors

Dennis, Robert Glenn • Fischer, Thomas H. • DaCorta, Joseph Anthony

Assignees

Entegrion Inc

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Publication Number

US-9063161-B2

Patent

Publication Date

2015-06-23

Expiration Date


Abstract

A device, system and method is disclosed in which small volume blood samples are subjected to shear forces and shear stresses between two parallel planar surfaces to which linear motion trajectories are imparted. The formation of clots or coagulation of the sample is measured from dynamic mechanical coupling which occurs between the two parallel planar surfaces. Detection of the coagulation response can be achieved through optical probing or by measurement of physical effects of the blood sample binding to the planar surfaces, and restricting movement thereof.

Core Innovation

The invention describes a device for measuring coagulation response in a blood sample. The device includes a first member having a first surface and a second member having a second surface, positioned so the first surface faces the second surface with sufficient space for a sample droplet to contact both surfaces and initiate coagulation. The first member and second member are linearly movable relative to each other.

A drive mechanism connected to at least one of the first member and the second member linearly moves the members relative to each other in parallel while the blood sample is in contact with the first surface and the second surface. The drive mechanism comprises at least one motor. The device further includes an optical detection sensor system for detecting interaction of light with the blood sample located between the first and second members, as an indication of coagulation response.

At least one microcontroller controls operation of the drive mechanism and the optical detection sensor system. The invention is directed to measuring coagulation response using parallel linear relative motion between facing planar surfaces and light interaction sensing of the blood sample positioned between the surfaces under microcontroller control. The approach supports diagnostic use by providing an indication of coagulation response based on optical detection.

The disclosed system is further characterized by optional implementations that include different relative speeds for detecting different mechanisms involved in a coagulation response, optical detection configured to detect blood sample binding as an indication of platelet response, and optional signal processing such as an analog-to-digital conversion path for sensor signals. Additional optional features include displacement sensing to detect and control the amount of relative movement, and treated surfaces on the first and second surfaces to induce, slow, or modify coagulation.

Claims Coverage

The independent claim defines a portable device architecture with three core inventive areas: linearly movable facing members for initiating a coagulation response, an optical detection sensor system for light interaction as an indication of coagulation response, and microcontroller control of the drive mechanism and optical sensing. Dependent claims further refine the device with constraints on motion and detection targets, added signal conversion/storage, displacement sensing, and surface treatments to induce or modify coagulation.

Linearly movable facing surfaces for initiating coagulation

A first member and a second member having respective first and second surfaces positioned facing each other with sufficient space for a blood sample droplet to contact both surfaces and initiate coagulation, wherein the first member and second member are linearly movable relative to each other.

Parallel linear drive mechanism controlled relative motion

A drive mechanism connected to at least one of the first member and the second member for linearly moving the first member and second member relative to each other in parallel when a blood sample is in contact with the first surface and the second surface, wherein the drive mechanism comprises at least one motor.

Optical detection of light interaction as coagulation indication

An optical detection sensor system for detecting interaction of light with a blood sample located between the first member and second member, as an indication of coagulation response of the blood sample.

Microcontroller control of drive and optical detection

At least one microcontroller for controlling operation of the drive mechanism and the optical detection sensor system.

Surface treatment to induce, slow, or modify coagulation

First and second surfaces configured to induce, slow, or modify the coagulation process in a sample, including selecting for or against specific aspects of coagulation for diagnostic or other purposes.

Optical detection of blood sample binding for platelet response

The optical detector sensor system configured to detect blood sample binding to the first surface and the second surface as an indication of platelet response during coagulation.

Different relative speeds for detecting different coagulation mechanisms

The drive mechanism configured to move the first member and second member at different relative speeds for detecting different mechanisms involved in a coagulation response of a blood sample.

Analog-to-digital conversion of optical signals

An analog-to-digital converter connected to the optical detection sensor system that converts analog signals indicative of coagulation response of a blood sample into digital signals for storage.

Displacement sensing of relative movement

At least one displacement sensor to detect and control the amount of relative movement between a first member and a second member.

Overall, the claims cover a device that initiates coagulation between facing surfaces that are linearly movable in parallel under motor drive, uses an optical detection sensor system to detect light interaction as an indication of coagulation response, and employs microcontroller control for the drive and optical detection. Dependent features refine motion and detection behavior, add signal conversion/storage and displacement sensing, and introduce treated surfaces to induce, slow, or modify coagulation.

Stated Advantages

Provides an indication of coagulation response of a blood sample based on optical detection of interaction of light.

Supports diagnostic selection by configuring treated first and second surfaces to induce, slow, or modify the coagulation process.

Allows detection of different mechanisms involved in a coagulation response by moving the members at different relative speeds.

Detects platelet response via optical detection of blood sample binding to the first and second surfaces.

Converts analog signals from the optical detection sensor system into digital signals for storage.

Enables detection and control of the amount of relative movement using a displacement sensor.

Documented Applications

Diagnostic or other purposes involving coagulation, including use of treated surfaces to induce, slow, or modify aspects of coagulation.

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