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System to measure blood coagulation related parameters

System to measure blood coagulation related parameters description/claims

The invention relates to portable devices and methods for measuring coagulation time, such as for example prothrombin time or activated partial thromboplastine time.

In case of atrial fibrillation, deep venous thrombosis, pulmonary embolism or after replacement of cardiac valve, taking medication is necessary to maintain normal blood fluidity. The most commonly used drugs are heparin and warfarin. Heparin is administrated subcutaneously or intravenously. Heparin activates a plasmatic protein, the antithrombin III that is a natural inhibitor of protease implicated in the coagulation cascade (factors VIIa, XIa, IXa, Xa, IIa). The rate of inactivation of these proteases by AT-III increases 1000-fold due to the binding of heparin. Warfarin decrease blood coagulation by interfering with vitamin K metabolism by inhibiting the effective synthesis of biologically active forms of the Vitamin-K-dependent clotting factors II, VII, IX and X, as well as the regulatory factors protein C, protein S and protein Z. Warfarin has the advantage that it may be taken orally. However dosing warfarin is complicated by the fact that it is known to interact with many commonly used medications and other chemicals that may be present in appreciable quantities in food. But with both medications, dangerous side effects such as bleeding exist. Therefore in order to optimize the therapeutic effect and minimize risks for the patient, close monitoring of the degree of anticoagulation is required by blood testing. Two coagulation test measures are routinely used: the prothrombin time and the activated partial thromboplastin time. Both tests measure clotting time to evaluate a patient's baseline haemostatic state or to monitor the response to anticoagulant therapy as well as the overall function and status of the coagulant system. Prothrombin time is tested when warfarin is used and activated partial thromboplastin time when heparin is used. These tests are mainly done in hospital with relatively large laboratory instrument of complex technology and therefore must be done by qualified personnel. These types of tests are expensive and can be done only once a month approximately. Another possibility is to use point-of-care device. In this case the patient can perform the test by himself. This allows a better control over time as the test can be done daily. However, even if it has been shown self-management improves the quality of oral anticoagulation [1], this method is little used. This is mainly due to the cost of the test strips and to the complexity of use of the actual devices. Therefore new easy of use and inexpensive point-of-care devices and methods for blood coagulation testing are needed.

Methods for coagulation measurement using portable device are described in the following patents U.S. Pat. No. 5,908,786: measurement of blood displacement using liquid crystal and heat U.S. Pat. No. 6,673,622 BI: measurement of change in impedance WO 2005/114140: measurement of blood displacement using magnetic beads U.S. Pat. No. 5,302,348: measurement of blood displacement speed. U.S. Pat. No. 4,964,728: measurement of blood turbidity by optical means US 2005/0233466: measurement of blood viscosity using ferromagnetic agitator

[1] C. Heneghan, Self-monitoring of oral anticoagulation: a systematic review and meta-analysis, Lancet 2006, 367:404-11

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