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EP-4603188-B1 - COAGULATION TEST DEVICE, SYSTEM, AND METHOD OF USE

EP4603188B1EP 4603188 B1EP4603188 B1EP 4603188B1EP-4603188-B1

Inventors

  • GOLDSTEIN, SHELDON
  • KAGAN, MICHAEL
  • LAUDER, Nicholas
  • COSMAN, MAURY D.

Dates

Publication Date
20260513
Application Date
20190315

Claims (15)

  1. A device (10) for processing a cartridge (30) containing a whole blood sample, the device comprising: a recess (18) for receiving the cartridge, a vacuum source (12) configured to be coupled to the cartridge, an actuator (32) configured to be linked to the cartridge to agitate the cartridge, a controller (20), a plurality of sensors (54) in communication with the controller, each sensor configured to be associated with a test chamber of a plurality of test chambers comprised in the cartridge, and a plurality of magnets (50, 118), wherein each magnet is configured to be positioned adjacent to a test chamber of the plurality of test chambers comprised in the cartridge; wherein, in use, the controller is configured to: activate the vacuum source to move the whole blood sample from a container into a plurality of channels in the cartridge and subsequently into a plurality of reagent chambers in the cartridge where the blood mixes with a reagent, and then through a plurality of serpentine-shaped channels to a plurality of test chambers in the cartridge, each of the plurality of test chambers comprising a spherical member, activate the actuator to agitate the cartridge, receive signals from the plurality of sensors, each sensor associated with a test chamber, wherein the signals are based on the presence of the spherical member in a respective test chamber within a magnetic field generated by a magnet of the plurality of magnets, determine whether coagulopathy is present in the whole blood for each test chamber, and output an indicator whether coagulopathy is present in the whole blood for each test chamber on a display.
  2. The device of claim 1, wherein the vacuum source is configured to selectively couple to a plurality of vacuum ports (42) in the cartridge, wherein the cartridge comprises a plurality of hydrophobic filters in line with each of the vacuum ports, the hydrophobic filters configured to stop the flow of blood when each of the plurality of reagent chambers is filled.
  3. The device of claim 1, further comprising a heating element (16, 42) configured to apply thermal energy to the cartridge and to the whole blood sample.
  4. The device of claim 3, wherein the heating element heats the whole blood sample to a temperature between 34 degrees Celsius and 37 degrees Celsius
  5. The device of claim 3, wherein the heating element heats the whole blood sample to a temperature between 30 degrees Celsius and 33 degrees Celsius.
  6. The device of claim 4, wherein, in use, the whole blood sample is mixed with a reagent in each of the plurality of reagent chambers and incubated between 1 minute and 10 minutes.
  7. The device of claim 6, wherein the reagents in each of the plurality of reagent chambers is isolated from its adjacent reagent chambers.
  8. The device of claim 1, wherein the controller is further configured to determine a length of time to clot formation in each of the plurality of test chambers.
  9. The device of claim 8, wherein the length of time is based on how long a respective sensor of the plurality of sensors that is associated with a test chamber detects movement of the spherical member.
  10. The device of claim 1, wherein for each test chamber, two sensors of the plurality of sensors (54) are configured to be associated with a test chamber, optionally wherein the two sensors are configured to be adjacent to the test chamber, optionally still wherein the two sensors spaced apart and located linearly along the travel path of the spherical member (114).
  11. The device of claim 10, wherein the controller is further configured to determine clot formation.
  12. The device of claim 11, wherein clot formation is determined when the controller detects the absence of two peaks in each agitation cycle and is indicative that the spherical member has stopped moving within the test chamber.
  13. The device of claim 11, wherein the controller is further configured to determine clot integrity, optionally: (a) wherein a clot of high integrity is determined where neither one of the two sensors generates a signal after the clot formation; or (b) wherein a clot of low integrity is determined where one of the two sensors continues to generate a signal indicating that the clot is allowing the spherical member to move over a limited distance; or (c) wherein clot integrity is based on an average signal in the test chamber generated by the two sensors from the time the clot formed to the end of the test.
  14. The device of claim 1, wherein the cartridge includes 18 test chambers, optionally wherein each test chamber is associated with a reagent chamber, and wherein each test chamber receives a whole blood-reagent complex from the associated reagent chamber.
  15. The device of claim 1: (a) wherein the spherical member in each test chamber passes over the sensors associated with each test chamber to generate a signal that is proportional to the viscosity of the whole blood sample within each test chamber; or (b) wherein the controller is further configured to determine a diagnosis based on results of the coagulopathy; or (c) wherein the controller is further configured to output the diagnosis on the display.

Description

BACKGROUND Most existing coagulation tests, both point-of-care (POC) and laboratory based, diagnose bleeding abnormalities, but provide insufficient information regarding the underlying cause of bleeding. Current management of bleeding patients often includes use of "Massive Transfusion Protocols" (MTP). This protocol-guided strategy manages all patients with a one-size fit all approach and without consideration of underlying etiologies of coagulopathy in each individual patient. Laboratory tests for factor levels or visco-elastic tests require time and skilled technical staff to execute. SUMMARY The coagulation test device described herein requires little-to-no laboratory skills to operate and presents individualized, evidence-based results, which may aide in treatment decisions within 15 minutes from inserting the sample tube to obtaining results. Furthermore, there have been reported cases of treatment selection and administration, which have led to thromboembolic events. The device allows for the in-vitro testing of potential therapeutic agents, which can aid in determining the underlying cause of coagulopathy, and guard against the administration of agents that may induce thromboembolic events US2014/315228 discloses a known system comprising a cartridge containing a fluid sample placed in a blood analyzer device, a ferromagnetic material such as a ferromagnetic washer residing within a blood clotting analysis chamber is raised through the fluid sample and allowed to drop. The analyzer device then detects and measures the time required for the ferromagnetic material to fall through the fluid sample. As the viscosity of the fluid changes (either increasing or decreasing), the fall time of the ferromagnetic material through the fluid sample will change correspondingly. The coagulation test device described herein is an in vitro diagnostic point-of-care device for measuring clotting time and clot characteristics of a whole blood sample under different hemostatic conditions. Results of the test are used as an aid in management of patients with coagulopathy of unknown etiology in order to help the physician determine appropriate clinical action to arrest bleeding. Additionally, the device addresses a key problem in perioperative medicine and solves this problem by testing the effect of specific hemostatic therapeutic agents on whole blood clotting time in a bleeding patient. In the existing state of clinical practice abnormal test results are typically addressed with an experience-based educated guess on the course of therapy to administer. The coagulation test device described herein provides personalized, clinical guidance to physicians regarding etiology of the patient's specific coagulopathy. The device simultaneously compares the effect of several hemostatic agents on whole blood clotting time and derives the underlying etiology, based on the measured responses across these hemostatic agents. In accordance with independent claim 1, a device is disclosed for processing a cartridge containing a whole blood sample. The device comprises a recess for receiving the cartridge, a vacuum source coupled to the cartridge, an actuator linked to the cartridge to agitate the cartridge; and a controller, a plurality of sensors in communication with the controller, each sensor configured to be associated with a test chamber of a plurality of test chambers comprised in the cartridge, and a plurality of magnets, wherein each magnet is configured to be positioned adjacent to a test chamber of the plurality of test chambers comprised in the cartridge. The controller is configured to activate the vacuum source to move the whole blood sample from a container into a plurality of channels in the cartridge and subsequently into a plurality of reagent chambers where the blood mixes with a reagent, and then through a plurality of serpentine-shaped channels to a plurality of test chambers, activate the actuator to agitate the cartridge, receive signals from a plurality of sensors, each sensor associated with one of the test chambers, where the signals are based on the presence of a spherical member within a magnetic field generated by a magnet positioned adjacent to each of the test chambers, determine whether coagulopathy is present in the whole blood for each test chamber, and output an indicator whether coagulopathy is present in the whole blood for each test chamber on a display. Further embodiments are defined by the dependent claims. Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a coagulation test device according to an embodiment.FIG. 2 is a block diagram of the coagulation test device shown in FIG. 1.FIG. 3 is a perspective view of the coagulation test device shown in FIG. 1 with a test cartridge and protective cover removed,FIG. 4 is a perspective top view of a test cartridge wit