Blood sample optimization system and blood contaminant sequestration device and method
Inventors
Rogers, Bobby E. • Kang, Gino • Stroup, David Karl • Cochran, Jonas Dean • Deptala, Arthur • Detloff, John • Pogue, Lonnie • Macowski, Brian
Assignees
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Publication Number
US-11311219-B2
Publication Date
2022-04-26
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 approach that reduces contamination-induced false positive readings associated with blood cultures. A blood sequestration device is positioned between a patient needle and a sample needle/vacutainer such that an initial portion of potentially contaminated blood is diverted into a sequestration chamber rather than being delivered directly to the sample collection device. The diverted blood is sequestered in the sequestration chamber using an air-permeable, blood-impermeable barrier that permits venting of displaced air while inhibiting air from entering the sequestration chamber.
The device includes an inlet port and an outlet port, with a sequestration chamber connected to the inlet port via a junction. A sampling channel is connected such that, in use, a first portion of blood flows into and toward the air permeable blood barrier for sequestration, while a second portion of blood bypasses the sequestration chamber and is directed into the sampling channel toward the outlet port. The vent includes an outer wall that at least partially circumscribes the air permeable blood barrier and a cap that at least partially covers the wall, where the cap includes a one-way seal abutting the air permeable blood barrier to inhibit air from entering the sequestration chamber.
The system further describes structural variations for the vent and barrier configuration, including inner and outer walls defining the vent and the placement of the one-way seal relative to the inner and outer walls. The cap may include an inner surface facing the air permeable blood barrier and a fulcrum that enables the seal to flexibly unseal to allow displaced air to escape the sequestration chamber. The air permeable blood barrier can include sealing material that seals the vent when it contacts blood, and a filter configuration including a first layer and a second layer with hydrophobic material that repels blood.
Claims Coverage
The partial content identifies three independent claims: clm-00001, clm-00008, and clm-00015. Across these independent claims, the inventive coverage centers on routing a first portion of blood into a sequestration chamber with a vented air-permeable blood barrier that inhibits air entry, while routing a second portion through a sampling channel to an outlet port or sample collection device.
Vented sequestration chamber with air-permeable blood barrier and one-way seal cap
A blood sequestration device having an inlet port, an outlet port, and a sequestration chamber connected with the inlet port via a junction, where the sequestration chamber has a vent defined by an outer wall circumscribing an air permeable blood barrier, and further including a cap covering the wall with a one-way seal abutting the air permeable blood barrier that inhibits air from entering the sequestration chamber.
Bypass-and-sequester blood flow via sampling channel
A sampling channel having a proximal end connected with the inlet port via the junction and a distal end connected with the outlet port, where the sequestration chamber, the sampling channel, and the junction are sized and configured such that a first portion of blood flows into the sequestration chamber toward the air permeable blood barrier for sequestration and a second portion of blood bypasses the sequestration chamber and the first portion sequestered therein and is directed into the sampling channel toward the outlet port.
Blood sequestration and sampling system integrated with patient needle and sample collection device
A blood sequestration and sampling system comprising a blood sampling pathway with a patient needle at a proximal end and a sample collection device at a distal end, and a blood sequestration device attached on the blood sampling pathway between the proximal end and distal end, the blood sequestration device including an inlet port coupled toward the patient needle and an outlet port coupled toward the sample collection device.
Sequestration chamber filling by first portion to displace air and second portion bypass
A blood sequestration device in which the sequestration chamber and sampling channel are sized and configured so a first portion of blood fills the sequestration chamber to displace air through the vent and a second portion bypasses the sequestration chamber and is directed into the sampling channel toward the outlet port.
Across the independent claims, the coverage focuses on a blood sequestration device and system that route a first portion of blood into a sequestration chamber where displaced air is vented through a vent defined by an air permeable blood barrier with a one-way seal cap, while a second portion bypasses the sequestration chamber through a sampling channel to an outlet port or sample collection device.
Stated Advantages
Reduces contamination-induced false positive readings associated with blood cultures.
Documented Applications
Blood culture sampling of potentially contaminated blood, to reduce false positive readings.
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