Multiple coagulation test cartridge and method of using same
Inventors
Assignees
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Publication Number
US-9857383-B2
Publication Date
2018-01-02
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 relates to determining at least one appropriate coagulation affecting therapy to modify a patient's coagulation status in a therapeutically beneficial manner using a multiple coagulation test system. A disposable, single-use cartridge includes multiple sealed containers, each pre-filled with a potential coagulation therapy comprising one or more coagulants or anticoagulants in amounts suitable for evaluating blood clotting.
At least one container comprises multiple volumes separated by one or more deformable membranes, and the potential coagulation therapy contained in the multiple volumes includes a different coagulation affecting substance in each volume. When the cartridge is coupled with the multiple coagulation test system, the sealed containers become unsealed and the deformable membranes are broken to place the containers in fluid communication with ports of the test system.
The unsealed containers provide the multiple potential coagulation therapies into multiple test wells for mixing with blood from the patient to form multiple different mixtures. Clotting is measured with one or more coagulation detectors for each mixture, and the measured clotting is compared to determine at least one appropriate coagulation therapy based on the comparison. The cartridge is removed from the test system and discarded after use.
Additional refinements include a cartridge identifier and a reader/module that processes machine-readable instructions associated with the cartridge to support adjusting blood and/or therapy amounts, and comparing measured clotting to baseline clotting information, including an untreated baseline control well.
Claims Coverage
The document includes one independent claim defining the core method for selecting at least one appropriate coagulation affecting therapy using a multiple coagulation test system and a disposable cartridge with multiple sealed pre-filled containers, including multi-volume containers with deformable membranes. The dependent claims add cartridge self-identification for processing instructions, narrower identifier types, a specific mixing configuration pooling therapies into a single test well, inclusion of lyophilized Factor VII, and comparing to baseline clotting information.
Disposable multi-container coagulation cartridge with membrane-separated multi-volume therapies
A cartridge having multiple sealed containers, each sealed container pre-filled with a potential coagulation therapy, where each potential coagulation therapy includes one or more coagulants or anticoagulants in amounts suitable for evaluating blood clotting, and where at least one container comprises multiple volumes separated by one or more deformable membranes with different coagulation affecting substances in each volume.
Unsealing and membrane-breaking on coupling to a multiple coagulation test system
Coupling the cartridge with the multiple coagulation test system causes the sealed containers to become unsealed and breaks the one or more deformable membranes, thereby placing the multiple containers in fluid communication with ports of the test system.
Multiple therapy mixtures in multiple test wells for clotting measurement
The respective potential coagulation therapies are introduced into the test wells, blood from the patient is mixed with the multiple potential coagulation therapies within the test wells to form multiple different mixtures, and clotting is measured with respect to each mixture using the one or more coagulation detectors.
Selecting therapy based on comparing measured clotting across mixtures
The measured clotting for each mixture is compared and at least one appropriate coagulation therapy is determined based on the comparison, then the cartridge having unsealed containers is removed from the multiple coagulation test system and discarded.
Cartridge identifier and processed instructions to adjust blood and/or therapy amounts
The identifier is read to obtain information indicative of instructions for performing evaluations using the cartridge, the instructions are processed with a module, and the amount of blood and the amount of the potential coagulation therapy mixed in at least one mixture are adjusted based on the processed information.
Machine-readable identifier selected from RFID, barcode, or pin code
The identifier is selected from a radio frequency identification (RFID) tag, a barcode, or a pin code.
Pooling therapies from multiple containers into a single test well mixture
Potential coagulation therapies from two or more cartridge containers are combined with blood from the patient in a single test well to form one of the multiple different mixtures.
Lyophilized Factor VII in a cartridge container
A first container includes lyophilized Factor VII as a potential coagulation therapy component.
Baseline clotting comparison for selecting therapy
The measured clotting for each mixture is compared to baseline clotting information.
Overall claim coverage centers on determining an appropriate coagulation affecting therapy by using a multiple coagulation test system with multiple test wells and coagulation detectors coupled to a disposable cartridge with multiple sealed, pre-filled therapy containers, including deformable membrane multi-volume containers that become unsealed on coupling. Dependent claims further cover machine-readable cartridge identification for processed instructions, narrowed identifier types, a specific pooling mixing configuration, lyophilized Factor VII inclusion, and comparison to baseline clotting information.
Stated Advantages
Avoids manual reservoir filling.
Reduces human error.
Improves shelf-life handling.
Documented Applications
Determining at least one appropriate coagulation affecting therapy to modify a patient's coagulation status using a multiple coagulation test system.
Using a baseline/untreated control well for clotting comparison to baseline clotting information.
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