Multi-zone falling washer blood clot detection

Patent metadata

Field	Value
Publication number	US-9429563-B2
Application number	US-201213706453-A
Country	US
Kind code	B2
Filing date	Dec 6, 2012
Priority date	Dec 6, 2011
Publication date	Aug 30, 2016
Grant date	Aug 30, 2016

Abstract

Activated clotting time (ACT) tests detect blood clotting time based on the viscosity changes of a test sample, using a ferromagnetic washer lifted to the top of a test chamber and then dropped from the top via gravity; a drop time greater than a preset threshold value indicates clotting of the test sample. Blood samples which have high levels of heparin usually produce very weak clots that may easily be destroyed by the lifting movement of the washer. But if the clot threshold is set low to detect the weak clots, false detections occur during early testing cycles when activators are not fully suspended during the mixing cycle. Improved algorithms for lifting the washer and adjusting over time enable accurate detection of weak clots.

First claim

What is claimed is:

1. A method of detecting formation of a clot in a blood sample with a washer dropping over a distance through the sample, comprising:
a. dividing the distance into a plurality of zones;
b. during a plurality of initial cycles, dropping the washer repeatedly through the distance and determining an initial drop time for each of the zones;
c. calculating a clot-detecting threshold for each zone by multiplying its initial drop time by a scale factor, wherein the scale factor may be the same or different for one or more time periods of the test;
d. for each zone and each time period, measuring a plurality of zone drop times of the washer dropping through the zone;
e. declaring clot formation when at least one measured zone drop time is greater than the corresponding threshold.

2. The method of claim 1 , wherein the one or more time periods of the test comprise at least a first period and a second period, and wherein the scale factor of the first period is equal to a first constant and the scale factor of the second period is equal to a second constant less than the first constant.

3. The method of claim 2 , wherein the first period and the second period are separated by a transition period, and wherein the scale factor of the transition period is less than the first constant and greater than the second constant.

4. The method of claim 3 , wherein the scale factor of the transition period is reduced with time at a constant rate.

5. The method of claim 1 , wherein step e comprises declaring clot formation when the measured zone drop time of each of at least two zones is greater than the corresponding threshold.

6. The method of claim 1 , wherein the initial drop time for each of the zones is an average over the initial cycles through that zone.

Assignees

• Medtronic Inc

Inventors

• Cheek Daniel
• Erickson Lawrence
• Huang Trevor
• Kanayinkal Tessy
• Petersen Craig
• Yuan Charlene

Classifications

• G01N33/86

  involving blood coagulating time {or factors, or their receptors} · CPC title

• G01N33/4905 Primary

  Determining clotting time of blood (by chemical methods G01N33/86, C12Q1/56) · CPC title