Blood sample optimization system and blood contaminant sequestration device and method
Inventors
Rogers, Bobby E. • Kang, Gino • Detloff, John
Assignees
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Publication Number
US-11963769-B2
Publication Date
2024-04-23
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 disclosed invention provides a blood sample control device for receiving blood from a patient and delivering blood to an outlet. The device includes an inlet, an outlet, and a chamber connected with the inlet, where the chamber has a vent that includes an air permeable blood barrier. A sampling channel is connected to the outlet, and a junction connects the inlet, the chamber, and the sampling channel.
At the junction, the blood conveyed from the patient is divided into a first portion and a second portion. The first portion flows into the chamber to displace air in the chamber through the air permeable blood barrier. The second portion bypasses the chamber and the first portion of blood at least temporarily contained therein, and is directed into the sampling channel toward the outlet.
In bodily fluid control device variations connected along a fluid sampling pathway that includes a patient needle or catheter and a sample collection device, the same diversion and sampling concept is used. A diversion chamber having a vent with an air permeable blood barrier is connected to an inlet, and a sampling channel delivers a second portion to an outlet connected to the sample collection device. The air permeable barrier is configured such that, when exposed to a first portion of bodily fluid, it at least partially seals to enable at least temporary containment in the diversion chamber.
The invention further defines structural and functional implementation through a vented chamber and a bypass sampling channel connected via a junction. The device can include a housing that houses and defines the inlet, the outlet, and the chamber, and can include a housing that defines parts of the inlet, outlet, chamber, and sampling channel. In some embodiments, the diversion chamber includes a curved channel defined in the housing, and the chamber and junction are configured to direct the first portion toward the air permeable bodily fluid barrier while enabling a second portion of bodily fluid to bypass the chamber via the junction toward the outlet.
Claims Coverage
The independent claims are directed to bodily fluid control devices with inlet/outlet fluid pathways, a vented chamber using an air permeable blood/bodily fluid barrier, and a junction that divides flow into a first portion that displaces air and a second portion that bypasses the chamber into a sampling channel toward the outlet. Across the independent claims, the coverage centers on the diversion-chamber venting and bypassing architecture plus barrier sealing behavior and the defined sampling pathway connections.
Vented chamber with air permeable blood barrier and divided flow at junction
An inlet configured to receive blood from a patient, an outlet, a chamber connected with the inlet and having a vent including an air permeable blood barrier, a sampling channel having a distal end connected with the outlet, and a junction connected between the inlet, the chamber and the sampling channel sized and configured such that a first portion of blood flows into the chamber to displace air therein through the air permeable blood barrier and such that a second portion of blood bypasses the chamber to be directed into the sampling channel toward the outlet.
Bodily fluid control device along sampling pathway with diversion chamber vented by air permeable blood barrier
A bodily fluid control device connected along a fluid sampling pathway that includes a patient needle or catheter and a sample collection device, including an inlet connected with the patient needle or catheter, an outlet connected with the sample collection device, a diversion chamber having a vent that includes an air permeable blood barrier, a sampling channel with a distal end connected with the outlet, and a junction connected such that a first portion of the bodily fluid flows into the diversion chamber to displace air therein through the air permeable blood barrier and a second portion bypasses the diversion chamber and the first portion of the bodily fluid therein to be directed into the sampling channel toward the outlet and the sample collection device.
Chamber vented with air permeable bodily fluid barrier that at least partially seals to enable temporary containment
A bodily fluid control device comprising an inlet, a junction connected with the inlet, an outlet, a chamber connected with the inlet via the junction with a vent that includes an air permeable bodily fluid barrier that at least partially seals upon contact with a first portion of bodily fluid, a housing that houses and defines the inlet, the outlet, and the chamber, wherein the chamber and the junction direct the first portion of bodily fluid into the chamber toward the air permeable bodily fluid barrier to displace air in the chamber, whereupon at least partially sealing enables at least temporary containment of the first portion in the chamber, and enables a second portion of bodily fluid to bypass the chamber via the junction and be directed toward the outlet.
The independent claim set broadly covers a junction-based diversion architecture in which a vented chamber with an air permeable blood/bodily fluid barrier receives a first portion to displace air and achieve at least temporary containment, while a second portion bypasses the chamber via the junction into a sampling channel toward an outlet, including implementations connected to a patient needle/catheter and a sample collection device.
Stated Advantages
Allows a first portion of blood/bodily fluid to displace air through an air permeable blood/bodily fluid barrier in a vented chamber while enabling at least temporary containment of the first portion in the chamber.
Enables a second portion of blood/bodily fluid to bypass the chamber and be directed into a sampling channel toward the outlet and, in pathway-connected embodiments, toward a sample collection device.
Reduces contamination and false positive readings.
Documented Applications
Blood sampling optimization in which a blood contaminant sequestration device is placed along a sampling pathway between a patient needle and a sample needle/blood collection container to reduce contamination and false positive readings.
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