Portable coagulation monitoring device for assessing coagulation response

• US 9,063,161 B2
• Filed: 05/20/2013
• Issued: 06/23/2015
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: Entegrion, Inc.
• Original Assignee: Entegrion, Inc.
• Inventors: Dennis, Robert Glenn, Fischer, Thomas H., DaCorta, Joseph Anthony
• Primary Examiner(s): Shen, Bin
• Application Number:
  US13/897,712
• Publication Number:
  US 20130267017A1
• Time in Patent Office: 764 Days
• Field of Search: 435/287.1
• US Class Current: 1/1
• CPC Class Codes: G01N 2011/008 optical properties
• CPC Class Codes: G01N 21/17 Systems in which incident light is modified in accordance with the properties of the material investigated where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

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.

Claims

1. A device for measuring coagulation response in a blood sample, comprising:

a first member having a first surface, and a second member having a second surface, said first member positioned for having said first surface facing said second surface of said second member with sufficient space to allow a sample droplet of blood to contact said first surface and said second surface and initiate coagulation, and said first member and second member being linearly movable relative to each other;

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

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

wherein the device further comprises at least one microcontroller for controlling operation of said drive mechanism and optical detection sensor system.

2. The device of claim 1, wherein said first member and second member make up a blood sample collection cartridge which is removable from said device.

3. The device of claim 2, wherein said blood sample collection cartridge further comprises a memory device on said cartridge for storing data relating to a blood sample tested.

4. The device of claim 1, wherein the drive mechanism is programmed for moving the first member and second member at different speeds relative to each other for detecting different mechanisms involved in a coagulation response of a blood sample.

5. The device of claim 1, wherein said optical detector sensor system is adapted for detecting binding of the blood sample to the first surface and the second surface as an indication of platelet response during coagulation.

6. The device of claim 1 wherein the said first and second surfaces (1 and 2) have at least one been treated to induce, slow, or modify the coagulation process for selecting in favor of or against specific aspects of coagulation of the sample for diagnostic or for other purposes.

7. The device of claim 6, wherein said treatment of the surfaces enhances platelet or blood protein binding, reactivity, or activation.

8. The device of claim 6, wherein said treatment of the surfaces reduces platelet or blood protein binding, reactivity, or activation.

9. The device of claim 1, further comprising at least one displacement sensor for detecting and controlling the amount of relative movement between said first member and said second member.

10. The device of claim 1, further comprising a connection interface module for connecting and communicating between the device and an external system.

11. The device of claim 1, wherein said drive mechanism comprises a device capable of driving linear motion.

12. The device of claim 1, further comprising an analog to digital converter connected to optical detection sensor system for converting analog signals indicative of coagulation response of a blood sample into digital signals for storage thereof.