Multiple coagulation test cartridge and method of using same
Inventors
Assignees
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Publication Number
US-8372343-B2
Publication Date
2013-02-12
Expiration Date
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.
Core Innovation
The invention provides a system for determining an appropriate coagulation therapy for a patient. The system includes a multiple coagulation test system having 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. It is configured to evaluate clotting of the patient’s blood to determine whether a potential coagulation therapy is appropriate for the patient.
The system uses a disposable, single-use multiple coagulation test cartridge. Prior to use in evaluating the patient’s blood, the cartridge comprises multiple containers, where each container includes a deformable seal at at least one end and contains one or more coagulants or anticoagulants in an amount suitable for use with evaluating blood clotting in a single patient. Each potential coagulation therapy includes a different coagulant, anticoagulant, or combination thereof compared to another of the potential coagulation therapies.
When the cartridge is coupled to the multiple coagulation test system, the cartridge transitions between a first configuration and a second configuration. In the first configuration, the deformable seals keep the containers sealed. In the second configuration, the containers are unsealed and placed in fluid communication with the ports of the multiple coagulation test system so the potential coagulation therapies may be released into the test wells to allow evaluation by the multiple coagulation test system.
At least one container includes multiple volumes separated from each other by one or more membranes, and the potential coagulation therapy contained in each volume includes a different coagulant or anticoagulant. The disclosed cartridge options include container content such as freeze-dried platelets, and cartridge identification and evaluation-instruction information for controlling aliquoting and matching evaluation to the potential coagulation therapies in the cartridge.
Claims Coverage
The document includes one independent claim and dependent claims that refine the cartridge and system features. The inventive claim coverage focuses on a disposable single-use cartridge with multiple sealed containers of different coagulants or anticoagulants, transitioning to an unsealed configuration to release into multiple test wells for evaluation, with optional membrane-separated multiple volumes and additional refinements for unsealing mechanics, identification, and specific container contents and layouts.
Disposable cartridge with sealed containers of different coagulation therapies
A system for determining an appropriate coagulation therapy comprises a multiple coagulation test system and a disposable, single-use cartridge having multiple containers, each container including a potential coagulation therapy with one or more coagulants or anticoagulants in an amount suitable for use with evaluating blood clotting in a single patient, and a deformable seal at at least one end; the cartridge is configured to transition from a first configuration with sealed deformable seals to a second configuration in which containers are unsealed and in fluid communication with ports so potential coagulation therapies are released into test wells for evaluation.
Membrane-separated multiple volumes within a container for distinct coagulants or anticoagulants
At least one container includes multiple volumes separated from each other by one or more membranes, where the potential coagulation therapy in each volume includes a different coagulant or anticoagulant of the potential therapy compared to the other volumes, and each multiple volume is in fluid communication with at least one port of the multiple coagulation test system when the cartridge is in the second configuration.
Overall, the independent claim coverage centers on coupling a disposable single-use cartridge containing multiple sealed containers, including optional membrane-separated multiple volumes with distinct coagulants or anticoagulants, to a multiple coagulation test system so that unsealing releases the different potential coagulation therapies into multiple test wells for evaluation of patient blood clotting to determine an appropriate coagulation therapy.
Stated Advantages
Eliminating manual reservoir filling.
Reducing operator error.
Documented Applications
Used to evaluate patient blood clotting with multiple potential coagulation therapies to determine whether a potential coagulation therapy is appropriate for the patient.
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