Fluid diversion mechanism for bodily-fluid sampling
Inventors
Bullington, Gregory J. • Patton, Richard G. • Miazga, Jay M. • Gaw, Shan E.
Assignees
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Publication Number
US-12186080-B2
Publication Date
2025-01-07
Expiration Date
Abstract
An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.
Core Innovation
The invention relates to bodily-fluid transfer devices for parenteral transfer that reduce microbial contamination in blood samples by diverting an initial first volume of blood into an in-device fluid reservoir. A housing having an inlet port and an outlet port defines an inner volume that receives and contains the first bodily-fluid volume. In a first configuration, a first flow path places the inlet port in fluid communication with the inner volume, while a portion of a second flow path is obstructed to prevent later flow from being conducted through the contaminant-carrying volume.
The device is transitioned from the first configuration to a second configuration when the first volume of blood is in the inner volume of the housing, such that the second flow path places the inlet port in fluid communication with the outlet port. Subsequent flow of blood is received from the inlet port, through the second flow path, and to the outlet port while bypassing contaminants contained in the first volume of blood. This bypass behavior sequesters the first volume and its contaminants within the housing and thereby limits contamination of a subsequent second volume.
In various embodiments, an actuator establishes negative pressure in the fluid reservoir to withdraw and receive the first volume of blood, with the negative pressure optionally modulated by user force/throttling or based on pressure equilibrium with the patient. A seal member may facilitate a negative pressure differential to drive blood entering into the fluid reservoir. The specification ties the resulting sample to being substantially free from microbes, including dermally-residing microbes, and discusses downstream impacts on culture-based microbial testing to address false positives.
Claims Coverage
Independent claim coverage is provided by four independent methods (clm-00001, clm-00007, clm-00013, and clm-00018), each centered on transitioning a blood transfer device between configurations to bypass contaminants from an initial blood volume. Across these independent claims, the inventive features include an inlet/outlet housing, obstructed versus unobstructed flow paths, a configuration transition triggered by the first volume in the inner volume, and bypassing contaminants contained in the first volume for subsequent flow.
First configuration obstructs a second flow path while receiving a first volume
Establishing fluid communication between the inlet port and a patient while the blood transfer device is in a first configuration in which a first flow path is in fluid communication with the inlet port and a portion of a second flow path is obstructed, receiving a flow of blood from the inlet port through the first flow path into an inner volume defined by the housing.
Transition to second configuration after first volume is in the inner volume
Transitioning the blood transfer device from the first configuration to a second configuration when the first volume of blood is contained in or is in the inner volume defined by the housing, such that the second flow path places the inlet port in fluid communication with the outlet port.
Bypass contaminants from the first volume for subsequent flow to the outlet
Receiving a subsequent flow of blood from the inlet port through the second flow path and to the outlet port while bypassing contaminants contained in the first volume of blood.
Inner volume forms a fluid reservoir for the first volume
Receiving the first volume of blood into an inner volume defined at least in part by the housing while the blood transfer device is in a first configuration, where the inner volume forms a fluid reservoir disposed in and defined by the housing.
Seal member and negative pressure differential to receive the first volume into the fluid reservoir
Providing a seal member in the housing to form part of a fluid reservoir and establish a negative pressure differential so that receiving the first volume of blood from the inlet port into the housing includes receiving it into the fluid reservoir based on the negative pressure differential.
Across the independent claims, the core claim structure is establishing fluid communication via a housing with an inlet port and an outlet port, receiving an initial first volume while obstructing a second flow path, transitioning device configurations when the first volume is contained in the housing inner volume, and receiving subsequent blood while bypassing contaminants contained in the first volume. Some independent-claim sets further characterize the inner volume as a fluid reservoir and add a seal member facilitating a negative pressure differential for receiving the first volume.
Stated Advantages
Reduces contamination in blood samples by bypassing contaminants contained in an initial first volume of blood.
Limits contamination of a subsequent second volume of blood by sequestering the first volume and its contaminants within the housing.
Reduces false results in culture testing of a subsequent sample by preventing microbes from being introduced in the subsequent volume.
Documented Applications
Obtaining a sample substantially free from microbes (including dermally-residing microbes) for culture-based microbial testing, including culture bottles (BacT/ALERT culture bottles), to address false positives.
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