US5504011A — Portable test apparatus and associated method of …

Claim 1

Independent Claim 233 words

A method of performing a prothrombin time test on a blood sample that contains an anticoagulant, comprising the steps of: providing a plurality of conduits that extend from a first end to a second end, wherein at least one restriction is disposed between said first end and second end in each of said conduits, said plurality of conduits including at least one test conduit and at least one control conduit; providing a normalizing agent in said at least one control conduit, wherein said normalizing agent is capable of counteracting effects of the anticoagulant in the blood sample; drawing a predetermined volume of blood into each of said plurality of conduits; simultaneously moving the blood in each of said plurality of conduits back and forth through said at least one restriction from a first position to a second position, wherein said normalizing agent in said control conduit mixes with the blood and creates a normalized blood sample; timing how long it takes the blood in each of said test conduits to move from said first position to said second position, until a predetermined degree of coagulation occurs; analyzing the coagulation times occurring in said test conduit, to obtain a representative prothrombin time for the blood sample; and using the normalized blood sample in the control conduit as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

Claim 2

Independent Claim 233 words

A method of performing a prothrombin time test on a blood sample that contains an anticoagulant, comprising the steps of: providing a plurality of conduits that extend from a first end to a second end, wherein at least one restriction is disposed between said first end and second end in each of said conduits, said plurality of conduits including at least one test conduit and at least one control conduit; providing a normalizing agent in said at least one control conduit, wherein said normalizing agent is capable of counteracting effects of the anticoagulant in the blood sample; drawing a predetermined volume of blood into each of said plurality of conduits; simultaneously moving the blood in each of said plurality of conduits back and forth through said at least one restriction from a first position to a second position, wherein said normalizing agent in said control conduit mixes with the blood and creates a normalized blood sample; timing how long it takes the blood in each of said test conduits to move from said first position to said second position, until a predetermined degree of coagulation occurs; analyzing the coagulation times occurring in said test conduit, to obtain a representative prothrombin time for the blood sample; and using the normalized blood sample in the control conduit as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

Claim 3

Dependent Claim 26 words

The method according to claim 1, further including the step of mixing the blood in each of said plurality of conduits with a prothrombin time reagent.

Claim 4

Dependent Claim 22 words

The method according to claim 2, wherein said prothrombin time reagent is selected from a group including thromboplastin extract and tissue factor.

Claim 5

Dependent Claim 61 words

The method according to claim 1, further including steps of: mixing the blood in one of said plurality of conduits with an anticoagulant, thereby creating an abnormal blood sample with abnormal coagulation characteristics; using the abnormal blood sample in the prothrombin time test as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

Claim 6

Dependent Claim 21 words

The method according to claim 1, wherein said normalizing agent includes Vitamin K dependent clotting factor concentrate and barium citrate eluate.

Claim 7

Dependent Claim 21 words

The method according to claim 5, wherein said normalizing agent also includes gluconic acid, trehalose, malto dextrin and barbital buffered saline.

Claim 8

Dependent Claim 19 words

The method according to claim 1, wherein each of said plurality of conduits are disposed within a common cuvette.

Claim 9

Dependent Claim 60 words

The method according to claim 7, further including the steps of: pricking the finger of a patient with a lancet to draw blood; discarding a first droplet of blood formed on the finger; transferring a second droplet of blood formed on the finger to the cuvette, wherein the second droplet of blood can be drawn into the plurality of conduits.

Claim 10

Dependent Claim 51 words

The method according to claim 7, further including the steps of: drawing blood from a patient with a lancet; placing a sample of the drawn blood in a reservoir device; coupling the reservoir device to the cuvette, wherein the blood can be drawn into the plurality of conduits from the reservoir.

Claim 11

Dependent Claim 35 words

The method according to claim 9, wherein said reservoir device is coupled to said lancet and said step of coupling the reservoir device to the cuvette includes bringing the lancet in contact with the cuvette.

Claim 12

Dependent Claim 27 words

The method according to claim 1, wherein said normalizing agent includes Vitamin K dependent clotting factor concentrate, barium citrate eluate, trehalose, malto dextrin and barbital buffered saline.

Claim 13

Dependent Claim 14 words

The method according to claim 11, wherein said normalizing agent further includes gluconic acid.

Claim 14

Dependent Claim 13 words

The method according to claim 11, wherein said normalizing agent further includes heparin.

Claim 15

Dependent Claim 31 words

The method according to claim 11, wherein said normalizing agent includes 1.0μ/ml-3.5μ/ml Vitamin K dependent clotting factor concentrate, 0.009μ/ml-0.05μ/ml barium citrate eluate, 0.008M-0.03M gluconic acid, 3.0%-8.0% trehalose and 2.0%-6.0% malto dextrin.

Claim 16

Independent Claim 231 words

A method of performing a prothrombin time test on a blood sample, comprising the steps of: providing a plurality of conduits that extend from a first end to a second end, wherein at least one restriction is disposed between said first end and second end in each of said conduits, said plurality of conduits including at least one test conduit and at least one control conduit; providing an anticoagulant in said at least one control conduit, wherein said anticoagulant is capable of producing an abnormal blood sample with abnormal coagulation characteristic when mixed with the blood sample; drawing a predetermined volume of blood into each of said plurality of conduits; simultaneously moving the blood in each of said plurality of conduits back and forth through said at least one restriction from a first position to a second position, wherein said anticoagulant in said control conduit mixes with the blood and creates said abnormal blood sample; timing how long it takes the blood in each of said test conduits to move from said first position to said second position, until a predetermined degree of coagulation occurs; analyzing the coagulation times occurring said test conduit, to obtain a representative prothrombin time for the blood sample; and using the abnormal blood sample in the control conduit as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

Claim 17

Independent Claim 231 words

A method of performing a prothrombin time test on a blood sample, comprising the steps of: providing a plurality of conduits that extend from a first end to a second end, wherein at least one restriction is disposed between said first end and second end in each of said conduits, said plurality of conduits including at least one test conduit and at least one control conduit; providing an anticoagulant in said at least one control conduit, wherein said anticoagulant is capable of producing an abnormal blood sample with abnormal coagulation characteristic when mixed with the blood sample; drawing a predetermined volume of blood into each of said plurality of conduits; simultaneously moving the blood in each of said plurality of conduits back and forth through said at least one restriction from a first position to a second position, wherein said anticoagulant in said control conduit mixes with the blood and creates said abnormal blood sample; timing how long it takes the blood in each of said test conduits to move from said first position to said second position, until a predetermined degree of coagulation occurs; analyzing the coagulation times occurring said test conduit, to obtain a representative prothrombin time for the blood sample; and using the abnormal blood sample in the control conduit as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

Claim 18

Dependent Claim 25 words

The method according to claim 15, further including the step of mixing the blood in each of said plurality conduits with a prothrombin time reagent.

Claim 19

Dependent Claim 23 words

The method according to claim 16, wherein said prothrombin time reagent is selected from a group including tissue thromboplastin, extract and tissue factor.

Claim 20

Dependent Claim 73 words

The method according to claim 15, further including the steps of: mixing the blood in one of said conduits with a normalizing agent that counteracts the effects of an anticoagulant in the blood sample, thereby creating a normalized blood sample with generally normal coagulation characteristics; using the normalizing blood sample in the prothrombin time test as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

Claim 21

Dependent Claim 21 words

The method according to claim 18, wherein said normalizing agent includes Vitamin K dependent clotting factor concentrate and barium citrate eluate.

Claim 22

Dependent Claim 21 words

The method according to claim 5, wherein said normalizing agent also includes gluconic acid, trehalose, malto dextrin and barbital buffered saline.

Claim 23

Dependent Claim 19 words

The method according to claim 15, wherein each of said plurality of conduits are disposed within a common cuvette.

Claim 24

Dependent Claim 60 words

The method according to claim 21, further including the steps of: pricking the finger of a patient with a lancet to draw blood; discarding a first droplet of blood formed on the finger; transferring a second droplet of blood formed on the finger to the cuvette, wherein the second droplet of blood can be drawn into the plurality of conduits.

Claim 25

Dependent Claim 66 words

The method according to claim 21, further including the steps of: drawing blood from a patient with a lancet; placing a sample of the drawn blood in a reservoir device; coupling the reservoir device to the cuvette, wherein the transferring a second droplet of blood formed on the finger to the cuvette, wherein the blood can be drawn into the plurality of conduits from the reservoir.

Claim 26

Dependent Claim 35 words

The method according to claim 23, wherein said reservoir device is coupled to said lancet and said step of coupling the reservoir device to the cuvette includes bringing the lancet in contact with the cuvette.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1999-04-02	1999-10-02	2000-04-02	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2003-04-02	2003-10-02	2004-04-02	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2007-04-02	2007-10-02	2008-04-02	$7700.00	Window Closed / Lapsed

Portable test apparatus and associated method of performing a blood coagulation test

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