Multiple coagulation test cartridge and method of using same

• US 8,372,343 B2
• Filed: 12/07/2007
• Issued: 02/12/2013
• Est. Priority Date: 12/07/2007
• Status: Active Grant

• Current Assignee: Coagulation Sciences LLC
• Original Assignee: Sheldon Goldstein
• Inventors: Goldstein, Sheldon
• Primary Examiner(s): FOSTER, CHRISTINE E
• Application Number:
  US11/952,914
• Publication Number:
  US 20090148882A1
• Time in Patent Office: 1,894 Days
• Field of Search: None
• US Class Current: 422/73
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: B01L 3/5635 connecting two containers face to face, e.g. comprising a filter
• CPC Class Codes: G01N 2500/00 Screening for compounds of potential therapeutic value
• 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

Abstract

Embodiments of the present invention relate to multiple coagulation test cartridges and methods of using such cartridges. In one embodiment the cartridge is a disposable single-use cartridge for use in evaluating blood clotting. The cartridge includes multiple containers, such as tubes, each of which includes one or more coagulation affecting substances. The containers can be pre-filled with substances in amounts suitable for use with a single patient'"'"'s blood sample. The cartridge may include one or more containers, each of which has multiple sections, or volumes, each section storing a different coagulation affecting substance. In another embodiment the cartridge is used in a method for determining at least one appropriate coagulation affecting substance for modifying a patient'"'"'s coagulation status using a multiple coagulation test system.

Claims

1. A system for determining an appropriate coagulation therapy for a patient, comprising:

a multiple coagulation test system comprising a holder for containing the patient'"'"'s blood, one or more coagulation detectors, multiple test wells, and multiple ports in fluid communication with the test wells;

a disposable, single-use cartridge, which prior to use in evaluating the patient'"'"'s blood, comprises;

multiple containers, wherein each container includes;

a potential coagulation therapy for administering to the patient, each potential coagulation therapy including one or more coagulants or anticoagulants in an amount suitable for use with evaluating blood clotting in a single patient to determine whether the potential coagulation therapy is appropriate for the patient; and

a deformable seal at at least one end of the container;

the cartridge configured to be coupled with the multiple coagulation test system, in which the cartridge has a first configuration prior to the cartridge being coupled with the multiple coagulation test system, in which the containers are sealed by the deformable seals, and a second configuration after the cartridge is coupled with the multiple coagulation test system, in which the containers are unsealed and in fluid communication with the ports of the multiple coagulation test system so the potential coagulation therapies in the containers may be released from the containers into the test wells of the multiple coagulation test system to allow for evaluation of clotting of the patient'"'"'s blood with the potential coagulation therapies by the multiple coagulation test system; and

wherein each of the potential coagulation therapies includes a different coagulant, anticoagulant or combination thereof as compared to another of the potential coagulation therapies; and

wherein at least one of the containers includes multiple volumes that are separated from each other by one or more membranes and the potential coagulation therapy contained in the at least one container includes a different coagulant or anticoagulant of the potential therapy in each of the multiple volumes, and wherein each of the multiple volumes is in fluid communication with at least one port of the multiple coagulation test system when the cartridge is in the second configuration.

2. The system of claim 1 wherein at least one of the deformable seals is a removable seal.

3. The system of claim 1 wherein at least one of the deformable seals is a puncturable membrane.

4. The system of claim 1 wherein the one or more membranes are deformable membranes.

5. The system of claim 4 wherein the deformable membranes are puncturable membranes.

6. The system of claim 1 wherein the containers have an arrangement selected from the group consisting of:

linear, circular;

rectangular;

polygonal;

L-Shaped;

two-dimensional; and

multiple rows of containers.

7. The system of claim 1 wherein at least one container includes freeze-dried platelets having at least partial glycoprotein IIb/IIIa expression and secretory function.

8. The system of claim 1 further comprising at least one machine-readable identifier secured to the cartridge, the machine-readable identifier including information indicative of instructions for performing evaluations using the cartridge.

9. The system of claim 8 wherein the information indicative of instructions for performing evaluations using the cartridge includes information identifying the potential coagulation therapies included in the cartridge.

10. The system of claim 8 wherein the cartridge is adapted for use with the multiple coagulation test system and wherein the information indicative of instructions for performing evaluations using the cartridge includes information identifying instructions for control of the multiple coagulation test system.

11. The system of claim 8 wherein the machine-readable identifier is selected from the group consisting of:

a radio frequency identification (RFID) tag, barcode, and pin code.

12. The system of claim 1 wherein at least one container includes freeze-dried platelets having at least partial glycoprotein IIb/IIIa expression.

13. The system of claim 1 wherein at least one container includes freeze-dried platelets having at least partial secretory function.

14. The system of claim 1 wherein the multiple coagulation test system further includes one or more puncture elements configured to pierce the deformable seals of the containers when the cartridge is in the second configuration.