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Publication Number
US-11832944-B2
Publication Date
2023-12-05
Expiration Date
Abstract
Blood sample optimization systems and methods are described that reduce or eliminate contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. A blood sample optimization system can include a blood sequestration device located between a patient needle and a sample needle. The blood sequestration device can include a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.
Core Innovation
The invention relates to a blood sample optimization system that reduces false-positive results in blood cultures by sequestering a first portion of a blood sample. The system uses a blood sequestration device including a chamber connected with an inlet port and an outlet port, where the chamber collects a first portion of the blood sample. The chamber includes a material that is air permeable and blood impermeable, functioning as a vent/barrier that permits air passage while preventing blood passage into the sampled flow path.
The system further includes a sampling channel connected with the inlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber. This bypass arrangement routes subsequent blood away from the chamber, such that the chamber receives the first potentially contaminated aliquot while the outlet/sample pathway conveys a less-contaminated subsequent portion.
Multiple implementations are described, including passive filling based on patient blood pressure, optional indicators, and structural and fluid-routing features such as one-way flap/duck bill valve concepts, protective covers, pathway splitters and T/Y connectors to divert initial blood. Additional implementations include chamber geometry with comparative cross-sectional area between the chamber and the sampling channel, housing structures with top and bottom members, and non-vented or wicking-material sequestration chamber concepts with air-permeable but blood-impermeable barrier materials, including polymer bead matrix concepts with self-sealing swelling material.
Claims Coverage
The independent claim set covers a blood-sampling device with three core inventive structures: an inlet port and outlet port connected by a chamber that collects a first portion using an air permeable but blood impermeable material, and a sampling channel that conveys a subsequent portion to the outlet while bypassing the chamber. Dependent claims further refine fluid movement behavior, routing structures, housing formation, comparative cross-sectional geometry, and valve features.
Air permeable and blood impermeable sequestration chamber for a first portion
A chamber connected with the inlet port and the outlet port, configured to collect a first portion of the blood sample, where the chamber includes a material that is air permeable and blood impermeable.
Bypassing sampling channel for a subsequent portion
A sampling channel connected with the inlet port and configured to convey a subsequent portion of the blood sample to the outlet port while bypassing the chamber.
Draw-induced filling from outlet port into inlet and chamber
A device configured so that applying a drawing force at an outlet port draws blood into an inlet port and into a chamber.
Initial aliquot contact and back-up into the chamber material
A device configured so that an initial aliquot of blood contacts a specified material and back up into a chamber.
Comparative chamber geometry larger than sampling channel
A device in which the chamber has a cross-sectional area larger than that of the sampling channel.
Housing formed by bottom member joined to top member
A device in which a housing has a bottom member joined to a top member, where both members together form the inlet port, outlet port, chamber, and sampling channel.
Clip valve on the sampling channel
A device in which the valve is a clip.
Overall, the claim set covers a blood-sampling device that sequesters a first portion in an air permeable but blood impermeable chamber and bypasses that chamber for conveying a subsequent portion through a sampling channel to the outlet. Dependent claims narrow operation by specifying draw-force filling behavior and initial-aliquot contact/back-up, and narrow structure by adding routing/junction concepts, housing construction, comparative cross-sectional geometry, specific barrier material options, and a clip valve on the bypass channel.
Stated Advantages
Reduces false-positive results in blood cultures by sequestering a first potentially contaminated aliquot of blood.
Documented Applications
Used as a blood sample optimization system to reduce false-positive results in blood cultures.
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