Systems, apparatus, and methods for reducing fluid pressure in a fluid line
Inventors
Lane, Andrew • Steele, Savannah K. • Robertson, Galen C. • Piehl, Mark D. • Latham, Stephen • Rodenkirch, Douglas • Darley, Jesse • IRWIN, Curtis • CHOURASIA, Amrish
Assignees
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Publication Number
US-12085963-B2
Publication Date
2024-09-10
Expiration Date
Abstract
In some embodiments, a tube portion can be configured to be fluidically coupled to a patient access component. A source of pressurized fluid can be coupled to the tube portion and can be configured to deliver fluid to the tube portion at a source pressure. A fluid pressure regulating device can include an expandable reservoir and can be coupled to the tube portion such that the expandable reservoir is in fluidic communication with the tube portion. The fluid pressure regulating device can be configured such that, when fluid is delivered from the source of pressurized fluid to the lumen of the tube portion at the source pressure, the expandable reservoir of the fluid pressure regulating device can receive fluid such that the expandable reservoir of the fluid pressure regulating device expands and fluid is delivered from the lumen of the tube portion to the patient via the patient access component.
Core Innovation
The disclosed invention concerns medical fluid-delivery tubing systems that reduce pressure and smooth pulsatile infusion from a source of pressurized fluid delivered through a tube lumen to a patient. A source of pressurized fluid delivers fluid at a source pressure into a tube system including a fluid pressure regulating device. The fluid pressure regulating device includes a tube defining a reservoir that expands from a first configuration to a second configuration with a second volume greater than the first configuration when the pressure within the reservoir increases.
The reservoir is resiliently biased toward the first configuration and is configured to transition the tube so that delivered fluid is expelled when reservoir pressure drops and the reservoir size decreases. In the first configuration, fluid flows from the source through an inlet and into contact with an inner wall of the tube along the inner wall from the first end to the second end, and then exits through an outlet. When fluid is delivered from the source at source pressure into the reservoir, the tube expands and fluid is delivered from the reservoir through the tube outlet as a pulsatile flow rate.
The disclosed system further describes implementation variations for an expandable reservoir and for regulating delivery, including configurations such as an expandable inner tube within an outer tube, reservoirs using a spring and translate seal, gas-compressed reservoirs, and manufacturing approaches such as multi-lumen extrusion. Design and state behavior are addressed, including reducing peak pressures and instantaneous flow rates to lower shear forces and hemolysis during blood transfusion, smoothing average infusion rate, and controlling tactile feel and external indicators of reservoir pressure/state. The method correspondingly expels fluid from the source to deliver at a first instantaneous flow rate, then discontinues expelling and allows delivery from the reservoir at a second instantaneous flow rate lower than the first.
Claims Coverage
The partial claim set includes two independent claims: one directed to a system with an expandable, resiliently biased tube reservoir coupled to a one-way pressurized-fluid source, and one directed to a method that delivers at a first instantaneous flow rate and then continues delivery at a second instantaneous flow rate lower than the first. Across the dependent claims provided, inventive features refine delivery path components, source state behavior, structural implementations of the expandable reservoir tube, configuration/geometry constraints related to priming and orientation, and conditional reservoir-volume driven delivery behavior, as well as concurrent drawing behavior and manual actuation with tactile feedback.
One-way pressurized fluid source with expandable tube reservoir delivering pulsatile flow
A source of pressurized fluid configured to deliver fluid at a source pressure with a fluid receptacle and a one-way valve that allows flow in a first direction and prevents opposite flow into the receptacle; and a fluid pressure regulating device including a resiliently biased tube defining a reservoir that expands from a first configuration to a second configuration when reservoir pressure increases, delivering pulsatile flow from the reservoir through an outlet when the source delivers fluid into the reservoir at source pressure.
Reservoir tube inner-wall flow path across first and second configurations
In the first configuration, the tube allows fluid to flow from the source through the inlet, into contact with an inner wall of the tube, flowing along and in contact with the inner wall from the first end to the second end, and flowing from the second end through the outlet.
Expulsion then lower instantaneous flow delivery
Expelling fluid from the source of pressurized fluid to a tube portion via a fluid pressure regulating device at a source pressure such that fluid is delivered into the reservoir and delivered to a patient at a first instantaneous flow rate; discontinuing expelling; and allowing the fluid pressure regulating device to deliver fluid from the reservoir to the patient via the tube portion at a second instantaneous flow rate lower than the first instantaneous flow rate.
Expelling transitions tube from first volume to second volume reservoir configuration
The method delivers fluid into the reservoir such that the tube transitions from a first configuration having a first volume to a second configuration having a second volume greater than the first volume, with the tube configured so that in the first configuration fluid flows through an inlet into contact with an inner wall, along the inner wall from the first end to the second end, and through an outlet.
The system claim coverage is centered on coupling a one-way pressurized-fluid source to a resiliently biased, expandable tube reservoir that expands from a first to a second volume configuration under source-pressure input to deliver pulsatile flow through an outlet, with fluid flowing along the inner wall in the first configuration. The method claim coverage centers on expelling to deliver at a first instantaneous flow rate, discontinuing expelling, and continuing delivery at a second instantaneous flow rate lower than the first via the reservoir, with the tube transitioning between first and second reservoir-volume configurations.
Stated Advantages
Reduces peak pressures and instantaneous flow rates to lower shear forces and hemolysis during blood transfusion.
Smooths pulsatile infusion and can reduce required syringe pressure/force while maintaining or improving average infusion rate smoothing.
Provides control of tactile feel and external indicators/visual markings related to reservoir pressure/state.
Documented Applications
Medical fluid delivery to a patient using tube portions and a patient access component (including peripheral/central/intraosseous catheter as described).
Blood transfusion delivery with reduced peak pressures/instantaneous flow rates to address hemolysis and shear forces.
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