Method and apparatus for determining anticoagulant therapy factors

An apparatus for determining a new anticoagulant therapy factor (nATF) comprising:

• a. means including a light source, a test tube, a photocell, a battery, and a variable resistor all for developing an analog electric voltage signal having an amplitude proportional to an optical density of a liquid sample containing fibrinogen;
• b. means including an A/D converter and a computer both cooperating for converting and recording the developed analog signal into a series of digital voltage signal values;
• c. means for injecting a coagulant into a liquid sample, thereby producing an abrupt change in the optical density of the liquid sample, said abrupt change producing a change in the amplitude of the electrical analog signals, which, in turn, produces an abrupt change in the value of said digital voltage signals, the value of said digital voltage signals being directly indicative of fibrinogen concentration in the liquid sample;
• d. means for recording an instant time to of said abrupt change in said value of said digital voltage signal;
• e. means, including a computer, for monitoring said voltage digital signal values for a first predetermined fibrinogen concentration quantity c1;
• f. means for recording an instant time t1 and the value of the voltage digital signal of said first predetermined fibrinogen concentration quantity c1;
• g. means, including a computer, for monitoring said voltage digital signal values for further fibrinogen concentration quantities;
• h. means for recording an instant time tMAP and the value of the voltage digital signal of said predetermined fibrinogen concentration quantity cMAP;
• i. means for recording an elapsed time between to and tMAP which defines a time to maximum acceleration from coagulant injection in step (c);
• j. means, including said computer, for monitoring for a differential change in the voltage digital signal values that include a predetermined fibrinogen concentration quantity cMAP;
• k. said fibrinogen concentration quantity cMAP and said time tMAP defining a maximum acceleration point (MAP) and a time to maximum acceleration from coagulant injection (TX) being measured as the elapsed time from the time of the coagulant injection t0 to the time to maximum acceleration tMAP, and each of the quantity cMAP and said time tMAP having a predetermined range starting prior to, at a time t<MAP, and ending after said maximum acceleration point (MAP), at a time t>MAP;
• l. means, including said computer, for monitoring voltage digital signal values at times t<MAP and t>MAP for respective predetermined fibrinogen concentration quantities c<MAP and c>MAP, and for calculating the difference between quantities c<MAP and c>MAP to provide a first differential (IUX);
• m. means, including said computer, for monitoring voltage digital signal values at time tEOT and recording an instant time tEOT the value of the voltage digital signal of said predetermined fibrinogen concentration quantity cEOT, and for calculating the difference between quantities c1 and cEOT to provide a second differential (IUT);
• n. means, including said computer, for dividing the first differential (IUX) by the second differential (IUT) to define a percentage of the total voltage digital signal value change covered by an overall range defining a new fibrinogen transformation rate (nFTR), where nFTR=IUX/IUT;
• o. means, including said computer, for dividing the time to maximum acceleration from the coagulant injection (TX) by a mean normal TX value of a sample of presumed normal patients to provide a maximum acceleration ratio (XR) which is factored to the (2−nFTR) power with the product thereof being the new anticoagulant therapy factor (nATF) is expressed by the following relationship:
• nATF=XR(2−nFTR).

A method of determining a new anticoagulant therapy factor (nATFZ) comprising the steps of developing a series of analog electrical voltage signals having voltage amplitudes proportional to an optical density of a liquid sample containing fibrinogen;

• a. converting the developed analog voltage signals into a series of digital voltage value signals;
• b. adding a coagulant into the liquid sample, thereby producing an abrupt change in the optical density of the liquid sample, said abrupt change producing an abrupt change in the amplitude of the electrical analog signals which, in turn, produces an abrupt change in the value of said digital voltage signals, the value of said digital voltage signals being directly indicative of fibrinogen concentration in the liquid sample;
• c. recording an instant time To of said abrupt change in said value of said digital voltage signal;
• d. monitoring said voltage digital signal values for coagulant activity;
• e. recording an instant time T1 corresponding to the start of clot formation;
• f. monitoring said voltage digital signal values for further fibrinogen concentration quantities;
• g. recording an instant time T2S which corresponds to a starting point of a simulated zero order kinetic and recording the value of the voltage digital signal of said fibrinogen concentration CT2S;
• h. recording an instant time T2 and the value of the voltage digital signal of said predetermined fibrinogen concentration quantity CT2;
• i. recording an elapsed time between To and T2 which defines a time to maximum acceleration (TX) from coagulant injection in step (c);
• j. monitoring for a differential change in the voltage digital signal values that include a predetermined fibrinogen concentration quantity CT2;
• k. said fibrinogen concentration quantity CT2 and said time T2 defining a maximum acceleration point (MAP) and a time to maximum acceleration from coagulant injection (TX) being measured as the elapsed time from the time of the coagulant injection T0 to the time to maximum acceleration T2;
• l. monitoring voltage digital signal values at times T2S and T2 for respective predetermined fibrinogen concentration quantities CT2S and CT2, with the difference between quantities CT2S and CT2 being a first differential IUXz;
• m. monitoring voltage digital signal values at an end of test time T3 time and recording an instant time T3 the value of the voltage digital signal of said predetermined fibrinogen concentration quantity cEOT, with the difference between quantities CT2 and cEOT being a second differential IUTZ, the first differential IUXz being divided by the second differential IUTz to define a percentage of the total voltage digital signal value change covered by an overall range defining a new fibrinogen transformation rate (nFTR), where nFTR=IUXZ/IUTZ;
• wherein a maximum acceleration ratio (XR) is determined by the time to maximum acceleration from the coagulant injection (TX) divided by a mean normal TX value (MNTX) of a sample of presumed normal patients;
• wherein the new anticoagulant therapy factor (nATFZ) is expressed by the following relationship:
• nATF=XR(2−nFTR)

An apparatus for determining a new anticoagulant therapy factor (nATF) comprising:

• a. means including a light source, a test tube, a photocell, a battery, and a variable resistor all for developing an analog electric voltage signal having an amplitude proportional to an optical density of a liquid sample containing fibrinogen;
• b. means including an A/D converter and a computer both cooperating for converting and recording the developed analog signal into a series of digital voltage signal values;
• c. means for injecting a coagulant into a liquid sample, thereby producing an abrupt change in the optical density of the liquid sample, said abrupt change producing a change in the amplitude of the electrical analog signals, which, in turn, produces an abrupt change in the value of said digital voltage signals, the value of said digital voltage signals being directly indicative of fibrinogen concentration in the liquid sample;
• d. means for recording an instant time To of said abrupt change in said value of said digital voltage signal;
• e. means, including a computer, for monitoring said voltage digital signal values for coagulant activity;
• f. means for recording an instant time T1 corresponding to the start of clot formation;
• g. means, including a computer, for monitoring said voltage digital signal values for further fibrinogen concentration quantities;
• h. means for recording an instant time tMAP and the value of the voltage digital signal of said predetermined fibrinogen concentration quantity cMAP;
• i. means for recording an instant time T2 and the value of the voltage digital signal of said predetermined fibrinogen concentration quantity cMAP;
• j. means for recording an elapsed time between To and T2 which defines a time to maximum acceleration (TX) from coagulant injection in step (c);
• k. means, including said computer, for monitoring for a differential change in the voltage digital signal values that include a predetermined fibrinogen concentration quantity CT2;
• l. said fibrinogen concentration quantity CT2 and said time T2 defining a maximum acceleration point (MAP) and a time to maximum acceleration from coagulant injection (TX) being measured as the elapsed time from the time of the coagulant injection T0 to the time to maximum acceleration T2;
• m. means, including said computer, for monitoring voltage digital signal values at times T2S and T2 for respective predetermined fibrinogen concentration quantities CT2S and CT2, and for calculating the difference between quantities CT2S and CT2 to provide a first differential (IUXZ);
• n. means, including said computer, for monitoring voltage digital signal values at an end test time T3 and recording an instant time T3 the value of the voltage digital signal of said predetermined fibrinogen concentration quantity cEOT, and for calculating the difference between quantities CT2S and cEOT to provide a second differential (IUTZ);
• o. means, including said computer, for dividing the first differential (IUXZ) by the second differential (IUTZ) to define a percentage of the total voltage digital signal value change covered by an overall range defining a new fibrinogen transformation rate (nFTR), where nFTR=IUXZ/IUTZ;
• p. means, including said computer, for dividing the time to maximum acceleration from the coagulant injection (TX) by a mean normal TX value of a sample of presumed normal patients to provide a maximum acceleration ratio (XR) which is factored to the (2−nFTR) power with the product thereof being the new anticoagulant therapy factor (nATF) is expressed by the following relationship:
• nATFZ=XR(2−nFTR).

A method of determining a new anticoagulant therapy factor (nATF) comprising the steps of:

• a. determining for a sample of a bodily fluid the start (T2S) of a zero order kinetic rate of conversion of fibrinogen to fibrin for a reaction of a reagent which reacts with fibrinogen present in the body fluid sample to convert the fibrinogen to fibrin, and a unit value corresponding to the start time (T2S);
• b. determining the time to maximum acceleration (T map) for the rate of conversion of fibrinogen to fibrin for the body fluid sample;
• c. determining a first differential (IUX) based on the unit values obtained between the start (T2S) of the zero order kinetic rate and the time to maximum acceleration (Tmap);
• d. determining a second differential (IUT) based on the unit values obtained between the theoretical end of test (TEOT) for the zero order kinetic rate, and the start (T2S);
• e. determining a first value V1 based on a ratio of IUT and IUX;
• f. determining a value V2 based on a fractional portion of the start time (T2S);
• and
• g. determining an anticoagulant therapy factor value by taking the product of V1 and V2.

An apparatus for determining a new anticoagulant therapy factor (nATF) comprising:

• a. means including a light source, a test tube, a photocell, a battery, and a variable resistor all for developing an analog electric voltage signal having an amplitude proportional to an optical density of a liquid sample containing fibrinogen;
• b. means including an A/D converter and a computer both cooperating for converting and recording the developed analog signal into a series of digital voltage signal values;
• c. means for injecting a coagulant into a liquid sample, thereby producing an abrupt change in the optical density of the liquid sample, said abrupt change producing a change in the amplitude of the electrical analog signals, which, in turn, produces an abrupt change in the value of said digital voltage signals, the value of said digital voltage signals being directly indicative of fibrinogen concentration in the liquid sample;
• d. means, including a computer, for monitoring said voltage digital signal values for coagulant activity;
• e. means for recording an instant time (T2S) the start of a zero order kinetic rate of conversion of fibrinogen to fibrin for a reaction of a reagent which reacts with fibrinogen present in the body fluid sample to convert the fibrinogen to fibrin, and a unit value corresponding to the start time (T2S);
• f. means for recording a time to maximum acceleration (T map) for the rate of conversion of fibrinogen to fibrin for the body fluid sample;
• g. means, including said computer, for monitoring voltage digital signal values at times T2S and the time to maximum acceleration (Tmap) for respective predetermined fibrinogen concentration quantities CT2S and CTmap, and for calculating the difference between quantities CT2S and CT2 to provide a first differential (IUXt);
• h. means, including said computer, for monitoring voltage digital signal values at times T2S and the time to maximum acceleration (Tmap) for respective predetermined fibrinogen concentration quantities CT2S and CTmap, and for calculating the difference between quantities CT2S and CT2 to provide a first differential (IUXt);
• i. means, including said computer, for monitoring voltage digital signal values at times T2S and the theoretical end of test TEOT for respective predetermined fibrinogen concentration quantities CT2S and CTEOT, and for calculating the difference between quantities CT2S and CTEOT to provide a second differential (IUTt);
• j. means, including said computer, for determining a first value V1 based on a ratio of IUT and IUX;
• k. means, including said computer, for determining a value V2 based on a fractional portion of the start time (T2S);
• and
• l. means, including said computer, for taking the product of V1 and V2, with the product thereof being the new anticoagulant therapy factor (nATF) expressed by the following relationship:
• nATFt=V1*V2.