Blood sampling device

• US 5,800,781 A
• Filed: 09/25/1996
• Issued: 09/01/1998
• Est. Priority Date: 10/21/1994
• Status: Expired due to Term

• Current Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Huang, Ming, Kuklo, Anthony Jr., Marcelino, Eduardo, Simone, Albert, Mawhirt, James A., Gavin, Michael, Cimini, Catherine M.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): CARRILLO, BIBI SHARIDAN
• Application Number:
  US08/719,779
• Time in Patent Office: 706 Days
• Field of Search: 422/58, 422/73, 422/102, 422/104, 606/181-183, 128/760, 128/763, 128/770, 128/765
• US Class Current: 422/73
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A portable device for performing coagulation tests on a patient'"'"'s blood. Blood is first drawn from a patient using a lancet. The blood is then supplied to a disposable cuvette placed within the testing device. The blood is drawn into multiple conduits within the cuvette. Each of the conduits contains a dried or lyophilized activation reagent that is rehydrated by the blood. The blood in each of the conduits is then reciprocally moved across a restricted region until a predetermined degree of coagulation occurs. Since the coagulation time is being monitored in multiple conduits, a representation coagulation time for a given sample can be determined. In at least one of the conduits a normalizing control agent is present. The normalizing control agent counteracts any effects of anticoagulants present in the blood sample, thereby allowing the blood sample to have generally normal coagulation characteristics. The normalized blood is tested simultaneously with the untreated blood to provide a reference value against which the functionality of the test system and the quality of the sample can be judged.

Claims

1. A blood sampling device for providing a blood sample in combination with a cuvette for receiving and performing a blood coagulation test on said blood sample, the combination therewith comprising:

a lancet for creating an incision in a patient'"'"'s skin that causes the patient to bleed;

a receptacle assembly coupled to said lancet, said receptacle assembly having a receptacle member for receiving a predetermined volume of blood from the patient therein and a receptacle attachment member for coupling said receptacle assembly to said lancet, said receptacle member having a conical-shaped reservoir member extending up from an unitary with a surface of said receptacle attachment member, said conical-shaped reservoir including a first opening through which blood can enter said receptacle member and a second opening through which said blood sample can be drawn from said receptacle member,

a cuvette comprising a transparent member having a plurality of conduits for receiving and performing said blood coagulation test on said blood sample and,

a channel common to said plurality on conduits through which said predetermined volume of the blood sample can be drawn from said second opening of said receptacle member into each of said conduits, of said cuvette,

a first compound contained within a first of said conduits, wherein said first compound reacts with the blood sample within the first of said conduits to produce a first coagulation characteristic, and

a second compound contained within a second of said conduits,

wherein said second compound reacts with the blood sample within the second of said conduits to produce a second coagulation characteristic.

2. The device according to claim 1, wherein said receptacle assembly and said lancet are disposable.

3. The device according to claim 2, wherein said receptacle assembly is removably attached to said lancet.

4. The device according to claim 2, wherein said receptacle assembly is unitary with said lancet.

5. The device according to claim 1, wherein said receptacle attachment member is unitary with said lancet device.

6. The device according to claim 1, wherein said first opening is substantially larger than said second opening.