Cuvette-Based Apparatus for Blood Coagulation Measurement and Testing

Abstract

An apparatus for measuring blood clotting time includes a blood clot detection instrument and a cuvette for use with the blood clot detection instrument. The cuvette includes a blood sample receptor-inlet; a channel arrangement including at least one test channel for performing a blood clotting time measurement, a sampling channel having at least one surface portion that is hydrophilic, communicating with the blood sample receptor-inlet and the at least one test channel, and a waste channel having at least one surface portion that is hydrophilic, communicating with the sampling channel; and a vent opening communicating with the sampling channel. The sampling channel, the vent opening and the waste channel, coact to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel.

1 . A cuvette with a self-filling sample channel for use with a blood clot detection instrument, the cuvette comprising:
 a main body including:
 a blood sample receptor-inlet; 
 a channel arrangement comprising:
 at least one test channel for performing a blood clotting time measurement; 
 a sampling channel communicating with the blood sample receptor-inlet and the at least one test channel at least the sampling channel having a hydrophilic surface portion; and 
 a waste channel communicating with the sampling channel through a restriction, the restriction having a smaller cross sectional area than the sample channel and the waste channel; and 
 
 a vent opening communicating with the sampling channel, the vent opening located between the at least one test channel and the restriction, 
   wherein the sampling channel, the vent opening and the waste channel are configured to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel,   whereby the hydrophilic surface portion of the sampling channel draws blood form the sample receptor-inlet into the sampling channel, the vent opening vents air from the sampling channel as the sampling channel automatically fills with blood, and the restriction delays filling of the waste channel until the requisite volume of blood has filled the sample channel.   
     
     
         2 . (canceled) 
     
     
         3 . The cuvette of  claim 1 , wherein the channel arrangement further comprises a vent channel connecting the vent opening with the sampling channel. 
     
     
         4 . (canceled) 
     
     
         5 . The cuvette of  claim 1 , wherein the channel arrangement is formed in a surface of the main body. 
     
     
         6 . The cuvette of  claim 5 , further comprising a substrate for closing and sealing at least a portion of the channel arrangement formed in the surface of the main body. 
     
     
         7 . The cuvette of  claim 6 , wherein the substrate forms the at least one surface portion of the sampling channel that is hydrophilic. 
     
     
         8 . The cuvette of  claim 6 , wherein the substrate comprises a film with a hydrophilic surface, the hydrophilic surface of the substrate forming the at least one surface portion of the sampling channel that is hydrophilic. 
     
     
         9 . The cuvette of  claim 6 , wherein the substrate comprises a film and a layer of hydrophilic material disposed on the film, the hydrophilic material forming the at least one surface portion of the sampling channel that is hydrophilic. 
     
     
         10 . The cuvette of  claim 9 , wherein the hydrophilic material is an adhesive which attaches the substrate to the main body. 
     
     
         11 . The cuvette of  claim 1 , further comprising a blood clotting reagent disposed in the at least one test channel. 
     
     
         12 . The cuvette of  claim 1 , wherein the at least one test channel includes a section having at least one textured surface. 
     
     
         13 . The cuvette of  claim 1 , wherein the at least one test channel includes a restriction. 
     
     
         14 . The cuvette of  claim 1 , wherein the main body is made of one of a hydrophobic material, a hydrophilic material, or a combination of a hydrophobic material and a hydrophilic material. 
     
     
         15 . The cuvette  claim 1 , wherein the waste channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic. 
     
     
         16 . The cuvette of  claim 1 , wherein the at least one test channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic or hydrophobic. 
     
     
         17 . The cuvette of  claim 3 , wherein the vent channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic. 
     
     
         18 . The cuvette of  claim 1 , wherein the restriction comprises a jumper channel or a restriction. 
     
     
         19 . The cuvette of  claim 18 , wherein the jumper channel or the restriction has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic. 
     
     
         20 . (canceled) 
     
     
         21 . An apparatus for measuring blood clotting time, the apparatus comprising:
 A) a blood clot detection instrument, the blood clot detection instrument comprising:
 a pump module; and 
 at least one pressure sensor; and 
   B) a cuvette with a self-filling sample channel for use with the blood clot detection instrument, the cuvette comprising:
 a main body including:
 i) a blood sample receptor-inlet; 
 ii) a channel arrangement comprising:
 a) at least one test channel for communicating, with the pump module when the cuvette is operatively coupled to the clot detection instrument; 
 b) a sampling channel communicating with the blood sample receptor-inlet and the at least one test channel, at least the sampling channel having a hydrophilic surface portion; and 
 c) a waste channel communicating with the sampling channel through a restriction, the restriction having a smaller cross sectional area than the sample channel and the waste channel; and 
 
 iii) a vent opening communicating with the sampling channel, the vent opening located between the at least one test channel and the restriction, 
 
   wherein compressed air within the blood clot detection instrument and the at least one test channel, the sampling channel, the vent opening and waste channel, are configured to automatically draw a requisite volume of a blood sample deposited at the blood receptor-inlet, into the sampling channel, and   wherein the at least one test channel of the cuvette, and the pump module and the at least one pressure sensor of the clot detection instrument, coact to perform a blood clotting time measurement on the requisite volume of the blood sample,   whereby the hydrophilic surface portion of the sampling channel draws blood from the sample receptor-inlet into the sampling channel, the vent opening vents air from the sampling channel as the sampling channel automatically fills with blood, and the restriction delays filling of the waste channel until the requisite volume of blood has filled the sample channel.   
     
     
         22 . (canceled) 
     
     
         23 . The apparatus of  claim 21 , wherein the channel arrangement further comprises a vent channel connecting the vent opening with the sampling channel. 
     
     
         24 . (canceled) 
     
     
         25 . The apparatus of  claim 21 , wherein the channel arrangement is formed in a surface of the main body. 
     
     
         26 . The apparatus of  claim 25 , further comprising a substrate for closing and sealing at least a portion of the channel arrangement formed in the surface of the main body. 
     
     
         27 . The apparatus of  claim 26 , wherein the substrate forms the at least one surface portion of the sampling channel that is hydrophilic. 
     
     
         28 . The apparatus of  claim 26 , wherein the substrate comprises a film with a hydrophilic surface, the hydrophilic surface of the substrate forming the at least one surface portion of the sampling channel that is hydrophilic. 
     
     
         29 . The apparatus of  claim 26 , wherein the substrate comprises a film and a layer of hydrophilic material disposed on the film, the hydrophilic material forming the at least one surface portion of the sampling channel that is hydrophilic. 
     
     
         30 . The apparatus of  claim 29 , wherein the hydrophilic material is an adhesive which attaches the substrate to the main body. 
     
     
         31 . The apparatus of  claim 21 , further comprising a blood clotting reagent disposed in the at least one test channel. 
     
     
         32 . The apparatus of  claim 21 , wherein the at least one test channel includes a section having at least one textured surface. 
     
     
         33 . The apparatus of  claim 21 , wherein the at least one test channel includes a restriction. 
     
     
         34 . The apparatus of  claim 21 , wherein the main body is made of one of a hydrophobic material, a hydrophilic material, or a combination of a hydrophobic material and a hydrophilic material. 
     
     
         35 . The apparatus of  claim 21 , wherein the waste channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic. 
     
     
         36 . The apparatus of  claim 21 , wherein the at least one test channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic or hydrophobic. 
     
     
         37 . The apparatus of  claim 23 , wherein the vent channel has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic. 
     
     
         38 . The apparatus of  claim 21 , wherein the restriction comprises a jumper channel or a restriction. 
     
     
         39 . The apparatus of  claim 38 , wherein the jumper channel or restriction has at least one surface portion, a coating, an insert or liner, and any combination thereof, that is hydrophilic. 
     
     
         40 - 44 . (canceled) 
     
     
         45 . The cuvette of  claim 1 , wherein the main body comprises three test channels in parallel communication with the sampling channel, a reagent disposed in each test channel. 
     
     
         46 . The cuvette of  claim 45 , wherein the reagents are all the same, different, or combinations thereof. 
     
     
         47 . The apparatus of  claim 21 , wherein the main body comprises three test channels in parallel communication with the sampling channel, a reagent disposed in each test channel. 
     
     
         48 . The apparatus of  claim 47 , wherein the reagents are all the same, different, or combinations thereof. 
     
     
         49 . The apparatus of  claim 21 , wherein air compressed within the blood clot detection instrument, the at least one test channel of the cuvette, and the section of the sampling channel extending beyond the vent opening of the cuvette, coacts with the waste channel to cause a leading edge of the blood sample drawn into the sampling channel from the blood receptor-inlet, to pull back within the sampling channel and uncover an optical sensor of the blood clot detection instrument, the volume of the blood sample in the sampling channel at the time when the blood sample is pulled back to uncover the optical sensor, equaling the requisite volume, the uncovering of the optical sensor activating the pump module of the blood clot detection instrument, which draws the requisite volume of the blood sample into the at least one test channel. 
     
     
         50 . The cuvette of  claim 1 , further comprising: a first substrate with hydrophilic properties for closing and sealing the sampling channel and the waste channel; and a second substrate with hydrophobic properties for closing and sealing the at least one test channel. 
     
     
         51 . The cuvette of  claim 50 , wherein the sampling channel and the waste channel are formed in a first surface of the cuvette and the first substrate is affixed to the first surface, and the at least one test channel is formed in second surface of the cuvette and the second substrate is affixed to the second surface. 
     
     
         52 . The cuvette of  claim 51 , wherein the first and second surfaces are opposed to one another. 
     
     
         53 . The cuvette of  claim 50 , wherein the channel arrangement further comprises: a vent channel connecting the vent opening with sampling channel, wherein the first substrate closes and seals the vent channel and the jumper channel. 
     
     
         54 . The apparatus of  claim 21 , further comprising; a first substrate with hydrophilic properties for closing and sealing the sampling channel and the waste channel; and a second substrate with hydrophobic properties for closing and sealing the at least one test channel. 
     
     
         55 . The apparatus of  claim 54 , wherein the sampling channel and the waste channel are formed in a first surface of the cuvette and the first substrate is affixed to the first surface, and the at least one test channel is formed in second surface of the cuvette and the second substrate is affixed to the second surface. 
     
     
         56 . The apparatus of  claim 55 , wherein the first and second surfaces are opposed to one another. 
     
     
         57 . The apparatus of  claim 54 , wherein the channel arrangement further comprises: a vent channel connecting the vent opening with sampling channel, wherein the first substrate closes and seals the vent channel and the jumper channel. 
     
     
         58 . The cuvette of  claim 1 , wherein the hydrophilic surface is a coating, an insert, a liner, the material from which the main body is made, and any combination thereof. 
     
     
         59 . The cuvette of  claim 3 , wherein the sampling channel has a larger cross-section than the vent channel. 
     
     
         60 . The cuvette of  claim 20 , wherein the sampling channel has a larger cross-section than the jumper channel. 
     
     
         61 . The cuvette of  claim 61 , wherein the waste channel has a larger cross-section than the jumper channel.