Sterile bodily-fluid collection device and methods
Inventors
Bullington, Gregory J. • Patton, Richard G. • Gaw, Shan E.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12150763-B2
Publication Date
2024-11-26
Expiration Date
Abstract
An apparatus includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The diversion mechanism has an inlet port couplable to a lumen-defining device to receive bodily-fluids from a patient, a first outlet port fluidically couplable to the pre-sample reservoir, and a second outlet port fluidically couplable to a sample reservoir. The diversion mechanism defines a first fluid flow path and a second flow path that are configured to place the first outlet port and the second outlet port, respectively, in fluid communication with the inlet port. The flow metering mechanism is configured to meter a flow of a predetermined volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir, to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir, and to display a volumetric indicator associated with the predetermined volume and the second volume.
Core Innovation
A system for obtaining a bodily-fluid sample from a patient includes a sample reservoir and a transfer device with a distribution member defining a pre-sample reservoir and a fluid flow path in fluid communication with an outlet. A flow controller in fluid communication with the distribution member transfers a pre-sample volume of bodily-fluid from the patient to the pre-sample reservoir in a first state, then transitions to a second state to transfer a volume of bodily-fluid to the fluid flow path while bypassing the pre-sample volume contained in the pre-sample reservoir.
The distribution member is configured to be coupled to the sample reservoir after the volume of bodily-fluid is transferred to the fluid flow path, such that the outlet places the fluid flow path in fluid communication with the sample reservoir to transfer a sample volume of bodily-fluid into the sample reservoir. The transfer device further includes a flow metering mechanism in fluid communication with the fluid flow path, which meters a flow of the sample volume of bodily-fluid from the fluid flow path to the sample reservoir and displays a volumetric indicator associated with the sample volume of bodily-fluid transferred to the sample reservoir.
In multi-reservoir configurations, the system includes a plurality of sample reservoirs arranged as a pre-packaged set, and a distribution member that is coupled to the plurality of sample reservoirs so that a sample volume of the bodily fluid disposed in the distribution member is allowed to flow into each sample reservoir concurrently as a result of coupling. The distribution member includes a fluid flow path and a plurality of outlets, where each outlet establishes fluid communication with a different sample reservoir to allow a sample volume to be transferred into each sample reservoir from the fluid flow path.
Claims Coverage
The partial content provides three independent claims. The inventive features center on a pre-sample reservoir, a flow controller with a state change that bypasses the pre-sample volume, and flow metering with a volumetric indicator, with claim-specific expansion to multiple reservoirs and concurrent delivery.
Pre-sample-to-bypass flow controller with fluidic routing to a sample reservoir and metered volumetric indication
A sample reservoir and a transfer device with a distribution member defining a pre-sample reservoir and a fluid flow path in fluid communication with an outlet, and a flow controller configured such that in a first state a pre-sample volume is transferred to the pre-sample reservoir, in a second state a volume is transferred to the fluid flow path while bypassing the pre-sample volume, with a transition from the first state to the second state after the pre-sample volume is transferred, the distribution member coupled to the sample reservoir so the outlet places the fluid flow path in fluid communication with the sample reservoir, and the transfer device further including a flow metering mechanism that meters the flow and displays a volumetric indicator associated with the sample volume.
Multiple outlet distribution to different sample reservoirs with metering and volumetric indicators
A system having a plurality of sample reservoirs and a transfer device including a distribution member defining a fluid flow path in fluid communication with a plurality of outlets and a flow controller configured such that in a first state a pre-sample volume is transferred to a pre-sample reservoir contained in the distribution member, in a second state a volume is transferred to the fluid flow path while bypassing the pre-sample volume with a transition after the pre-sample volume is transferred, the distribution member coupled to the plurality of sample reservoirs after the volume is transferred such that each outlet establishes fluid communication with a different sample reservoir to allow a sample volume to be transferred into each sample reservoir, and wherein the transfer device includes a plurality of flow metering mechanisms, each metering a flow to a different sample reservoir and displaying a volumetric indicator associated with the sample volume.
Pre-packaged set concurrent delivery from a pre-sample reservoir with metered volumetric indication
A system comprising a fluid transfer device with a pre-sample reservoir and a distribution member disposed in a housing, configured to transfer a pre-sample volume of bodily-fluid from an inlet to the pre-sample reservoir in a first state and transitioned to a second state after the pre-sample volume is transferred to sequester the pre-sample volume and allow a flow into the distribution member, and a plurality of sample reservoirs arranged as a pre-packaged set configured to be coupled to the distribution member so a sample volume disposed in the distribution member is allowed to flow into each sample reservoir concurrently as a result of coupling, wherein the transfer device further includes a plurality of flow metering mechanisms, each metering a flow of the sample volume from the distribution member to a different sample reservoir and displaying a volumetric indicator associated with the sample volume.
Across the independent claims, the inventive coverage is directed to bodily-fluid sampling systems that sequester and bypass a pre-sample volume using a flow controller state transition, then route a subsequent sample volume into one or more sample reservoirs via a distribution member/outlet architecture. The claims further require flow metering mechanisms that meter flow to each sample reservoir and display volumetric indicators, with expanded claim scope to multiple reservoirs and concurrent delivery using a pre-packaged set.
Stated Advantages
The transferred bodily-fluid volume is mostly substantially free of dermally-residing contaminants.
The pre-sample volume and transferred sample volume are characterized by a dermally-contaminant quality distinction, with the pre-sample volume containing dermally-residing contaminants.
Volumetric indicator display supports verification associated with the sample volume of bodily-fluid transferred to the sample reservoir(s).
Concurrently transferring sample volume into each sample reservoir from a pre-packaged set of sample reservoirs.
Documented Applications
Obtaining bodily-fluid samples from a patient for transferring a sample volume into sample reservoirs in configurations including multiple sample reservoirs and pre-packaged sets.
Interested in licensing this patent?