IP Library Granted Patent US 12663428
Granted Patent B2
US 12663428 · App. 17/788,869 · Granted Jun 23, 2026

Blood coagulation time measurement method

Inventor: Toshiki Kawabe (Chuo-ku, JP)
Assignee: SEKISUI MEDICAL CO., LTD.
G01N33/86G01N21/77
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Quick Facts
Patent No.
US 12663428
App. No.
17/788,869
Granted
Jun 23, 2026
Kind
B2
Abstract

Provided is a blood coagulation time measurement method. In the method, reaction X(i) is acquired through smoothing and zero-point adjustment of a measured value P(i) for coagulation reaction of a blood specimen, and then an integration ratio Z(i) of the reaction X(i) is acquired. These values are used to calculate an index for coagulation time Tc calculation, and it is determined whether or not the index satisfies the criteria. The procedure is sequentially repeated until an index that satisfies the criteria is obtained.

Claims (192)

1 . A blood coagulation time measurement method, comprising:

[1] acquiring reaction X(i) through smoothing and zero-point adjustment of a measured value P(i) for coagulation reaction of a blood specimen;

[2] acquiring an integration ratio Z(i) of the reaction X(i), wherein the Z(i) is a ratio of an integrated value of X in a first measurement section to an integrated value of X in a second measurement section adjacent to the first measurement section;

[3] calculating parameters te[k], X(te[k]), tc[k], te[k−1], X(te[k−1]), and tc[k−1], wherein,

k is an integer of 2 or more,

te[k] and te[k−1] are a measurement time at i satisfying Z(i)<Zs[k] and a measurement time at i satisfying Z(i)<Zs[k−1], respectively,

X(te[k]) and X(te[k−1]) are reactions X at te[k] and te[k−1], respectively,

tc[k] and tc[k−1] are a measurement time at i satisfying X(i)={X(te[k])×Q %} and a measurement time at i satisfying {X(te[k−1])×Q %}, respectively, and

1<Q<100;

[4] calculating at least one of an index R[k] and an index TR[k], wherein,

R

[

k

]

=

X

(

te

[

k

]

)

/

X

(

te

[

k

-

1

]

)

(

2

)

TR

[

k

]

=

Δ

tc

[

k

]

/

Δ

te

[

k

]

(

5

)

Δ

tc

[

k

]

=

tc

[

k

]

-

tc

[

k

-

1

]

(

3

)

Δ

te

[

k

]

=

Δ

te

[

k

]

-

te

[

k

-

1

]

;

and

(

4

)

[5] determining the tc[k] or the tc[k−1] as a coagulation time Tc in a case where at least one of R[k] and TR[k] satisfy a predetermined condition,

wherein Zs[k]<Zs[k−1] is satisfied, Zs[k] is greater than 1, and Zs[1] is 1.100 or less.

2 . The method according to claim 1 , wherein the steps [3] to [5] are repeated with k=k+1 in a case where the R[k] or TR[k] does not satisfy the predetermined condition in the step [5].

3 . The method according to claim 2 , further comprising acquiring a result that Tc is not normally determined when Tc is not determined through the repetition of the steps [3] to [5].

4 . The method according to claim 1 , wherein k is 10 or less.

5 . The method according to claim 1 , wherein a difference between Zs[k−1] and Zs[k] is from 0.050 to 0.001.

6 . The method according to claim 1 , wherein Z(i) is represented by the following equation:

Z

(

i

)

=

{

X

(

i

+

1

)

+

X

(

i

+

2

)

+

+

X

(

i

+

m

)

}

/

{

X

(

i

-

m

)

+

X

(

i

-

m

+

1

)

+

+

X

(

i

-

1

)

}

(

1

)

(

m

=

10

to

30

)

.

7 . The method according to claim 1 , wherein the step [3] is performed after i reaches a predetermined calculation start point s.

8 . The method according to claim 7 , wherein the calculation start point s is a measurement point after a time when a rate of coagulation reaction becomes a maximum.

9 . The method according to claim 7 , further comprising detecting, as the calculation start point s, a measurement point that is later with V(i)=Vs when a number of measurement points between two points when V(i)=Vs is satisfied exceeds a predetermined value, wherein V(i) is a differential value of the reaction X(i).

10 . The method according to claim 7 , wherein the calculation start point s is a measurement point after Z(i) acquired in the step [2] has reached a peak of Z(i).

11 . The method according to claim 1 , wherein the steps [1] and [2] and the steps [3] to [5] are performed in parallel.