# US 10,371,694 B2 · Clot protection and detection algorithm for activated clotting time testing

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- Number: US 10,371,694 B2
- Document ID: US10371694B2
- Status: Granted
- Kind: B2
- Application number: 15/135,327
- Filed: 2016-04-21
- Published: 2016-08-18
- Granted: 2019-08-06
- Earliest claimed: 2011-12-06
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Daniel Cheek; Lawrence Erickson; Trevor Huang; Tessy Kanayinkal; Craig Petersen; Charlene Yuan
- Web page: https://patentgrep.com/patent/US10371694B2

## CPC

- G01N 33/4905: {Determining clotting time of blood (by chemical methods G01N33/86, C12Q1/56)}
- G01N 33/86: involving blood coagulating time {or factors, or their receptors}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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.

## Claims

### Claim 1

A method of detecting formation of a clot in a sample of blood with a ferromagnetic washer moving over a distance through the sample, comprising:
a. determining calibration values for at least one of a distance span and a drop velocity of the ferromagnetic washer moving through the sample when the blood is unclotted;
b. measuring the distance span or the drop velocity of the ferromagnetic washer moving through the sample; and
c. detecting formation of the clot by comparing the value of the distance span or drop velocity measured with the corresponding calibration value.

### Claim 2 (depends on 1)

The method of claim 1, wherein:
measuring the distance span or the drop velocity of the ferromagnetic washer moving through the sample is repeated in a plurality of consecutive washer cycles; and
detecting formation of the clot is performed in each of the plurality of consecutive washer cycles.

### Claim 3 (depends on 1)

The method of claim 1, in which a calibration value for at least one of a distance span and a drop velocity of the ferromagnetic washer moving through the sample when the blood is unclotted is determined from at least a first pass of the ferromagnetic washer moving through the sample in which only a portion of distance through the sample moved by the ferromagnetic washer is considered, and a second pass in which a fixed time based on only the portion of the distance considered in the first pass is determined.