Systems and methods for delivering a fluid to a patient with reduced contamination
Inventors
Bullington, Gregory J. • Patton, Richard G. • Gaw, Shan E.
Assignees
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Publication Number
US-12133968-B2
Publication Date
2024-11-05
Expiration Date
Abstract
An apparatus includes a cannula assembly, a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing includes an inlet port removably coupled to the cannula assembly and defines an inner volume. The fluid reservoir is fluidically coupled to the housing and configured to receive and isolate a volume of bodily fluid from a patient. The flow control mechanism is at least partially disposed in the inner volume. The actuator is operably coupled to the flow control mechanism and is configured to move the flow control mechanism between a first configuration, in which bodily fluid can flow, via a fluid flow path defined by the flow control mechanism, from the cannula assembly, through the inlet port and into the fluid reservoir, to a second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.
Core Innovation
The invention relates to a fluid transfer device for venipuncture and parenteral delivery that reduces contamination by handling dermally residing microbes contained in a first volume of bodily fluid. The apparatus includes a cannula assembly and a housing with one or more inlet/distal ports, and a fluid reservoir receives the first volume of bodily fluid so that the reservoir is configured to isolate the received bodily fluid carrying dermally residing microbes from a parenteral fluid delivery pathway.
The fluid transfer device includes a movable flow control mechanism driven by an actuator, including a valve and seal, that switches between a first configuration and a second configuration. In the first configuration, bodily fluid flows from a patient through a channel toward the reservoir, and in the second configuration, the reservoir is fluidically isolated from the cannula while enabling delivery of a substantially microbes-free parenteral fluid from an external source through a bypass flow path.
The switching behavior is defined such that the valve transitions to a closed state when at least the portion of the first volume is contained within the channel. In the closed state, the valve and seal enable a second volume of fluid to flow through a fluid flow path that bypasses the channel and the first volume contained therein, including pressure equilibrium and associated negative pressure/suction force concepts to drive pressure-based transitioning between open and closed states.
Claims Coverage
The partial record includes three independent claims: a device claim and two method claims. Across these independent claims, the coverage centers on a valve-and-seal channel that temporarily contains a first volume of patient fluid, followed by a bypass flow path enabling a second volume while the valve transitions to a closed state, including pressure equalization concepts in the method claims.
Two-port fluid transfer device with valve and seal containing a first volume
A fluid transfer device includes a first port configured to be fluidically coupled to a patient and a second port configured to be fluidically coupled to an external fluid reservoir, and further includes a valve and a seal. A channel between the first port and the seal is configured to contain a first volume of fluid received from the patient, with the valve open and the seal allowing at least a portion of the first volume to flow toward the valve or the seal. The valve transitions to a closed state when at least the portion of the first volume is contained in the channel, and in the closed state the valve and seal collectively allow a second volume of fluid to flow through a fluid flow path that bypasses the channel and the first volume contained therein.
Method with seal in first and second states and valve open then closed for first and second volume reception
A method establishes fluid communication between a patient and a port of a fluid transfer device having a seal, with the seal in a first state when establishing fluid communication. The method receives a first volume of fluid from the patient into a first channel via the port while the valve is in an open state, and after at least a portion of the first volume is contained in the first channel, receives a second volume of fluid into a second channel with the seal in a second state and the valve in a closed state during receiving the second volume of fluid.
Pressure equalization triggered bypass receiving second volume with valve closed and seal second state
A method establishes fluid communication between a patient and a port of a fluid transfer device including a seal in a first state when establishing fluid communication. The method receives a first volume of fluid from the patient into a first channel via the port with the valve in an open state, and receives a second volume of fluid into a second channel after pressure equalizes between at least a portion of the first channel and a portion of the patient with the seal in a second state and the valve in a closed state. The receiving of the second volume of fluid is such that the second volume bypasses the first channel and the first volume contained therein.
The independent claims collectively cover a two-port device architecture using a valve and seal to contain a first volume of patient fluid in a channel, and a sequential method where the seal and valve states change between receiving the first volume and receiving a second volume via a bypass flow path, with one method specifically requiring pressure equalization to trigger the transition to the sealed and closed state enabling bypass.
Stated Advantages
Reduces contamination by handling dermally residing microbes contained in a first volume of bodily fluid.
Isolates the received bodily fluid carrying dermally residing microbes from a parenteral fluid delivery pathway.
Enables delivery of a substantially microbes-free parenteral fluid from an external source through a bypass flow path.
Documented Applications
No documented applications found
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