Body fluid management systems for patient care
Inventors
Morse, Stephen A. • Morse, Caitlin D. C.
Assignees
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Publication Number
US-11458249-B2
Publication Date
2022-10-04
Expiration Date
Abstract
Provided are body fluid management systems for patient care that include, in operable combination, a control system assembly comprising a fluid flow detection and control subassembly, a user data interface, a patient interface assembly comprising a wearable pressure sensor subassembly having a pressure sensor in the path of said body fluid for attaching directly to a patient proximate to an anatomical marker and an orientation sensor to monitor and/or control the pressure and/or flowrate of a body fluid such as cerebrospinal fluid, blood, or urine.
Core Innovation
The invention provides a body fluid management system for real-time monitoring of a pressure of a body fluid and integrated control of drainage of the body fluid. The system includes a control system assembly configured to monitor patient movement, patient orientation, or changes in the pressure of the body fluid based on inputs from a patient interface assembly. The control system assembly measures and records a flowrate of the drainage of the body fluid and applies an algorithm to display data, make corrective adjustments to the flowrate, or assert an alarm based on user selected operating modes and user-defined settings.
The patient interface assembly includes a wearable pressure sensor subassembly configured for attaching proximate to a patient anatomical marker. The wearable pressure sensor subassembly comprises at least one pressure sensor in direct fluid communication with the body fluid in a body fluid path, and an orientation sensor configured to detect an orientation of a body cavity containing the body fluid and a movement of the body cavity. The at least one pressure sensor comprises a first pressure sensor and a second pressure sensor in the body fluid path at a fixed spacing distance between the first and second pressure sensor, and the first pressure sensor, the second pressure sensor, and the orientation sensor are configured on a rigid member.
The control system assembly calculates an anticipated differential pressure between the first pressure sensor and the second pressure sensor based on the fixed spacing distance and a flow channel orientation detected by the orientation sensor. The control system assembly calculates an actual differential pressure between the first pressure sensor and the second pressure sensor based on direct measured pressure of the body fluid. The control system assembly detects drift in the first pressure sensor or the second pressure sensor based on a disparity between the anticipated differential pressure and the actual differential pressure.
Claims Coverage
The relevant material includes three independent claims, focused on real-time monitoring and integrated drainage control with wearable pressure sensing and orientation-based differential pressure analysis, pressure-sensor drift detection, and perfusion-pressure management.
Body fluid management with wearable pressure sensors and orientation-based anticipated differential pressure
A body fluid management system comprising a control system assembly for real-time monitoring of a pressure of a body fluid and integrated control of drainage, and a patient interface assembly with a wearable pressure sensor subassembly that attaches proximate to a patient anatomical marker and includes at least one pressure sensor in direct fluid communication with the body fluid path plus an orientation sensor to detect orientation and movement, where the control system assembly monitors patient movement, patient orientation, or pressure changes from the patient interface inputs, measures and records drainage flowrate, and uses an algorithm to display data, make corrective adjustments to drainage flowrate, or assert an alarm based on operating modes and user-defined settings.
Orientation-guided differential pressure calculation and pressure-sensor drift detection in a rigid wearable
The system where the wearable pressure sensor subassembly includes a first pressure sensor and a second pressure sensor at a fixed spacing distance on a rigid member together with the orientation sensor, and the control system assembly calculates an anticipated differential pressure between the first and second pressure sensors based on the fixed spacing distance and flow channel orientation detected by the orientation sensor, calculates an actual differential pressure based on direct measured pressure, and detects drift in the first or second pressure sensor based on a disparity between anticipated and actual differential pressure.
Perfusion-pressure management using co-located wearable pressure sensing and perfusion pressure calculation
A system for managing a body fluid according to perfusion pressure including a control system assembly and a patient interface assembly, where the control system assembly displays real-time arterial blood pressure, real-time pressure of the body fluid, and real-time perfusion pressure of a body compartment containing the body fluid and controls drainage, the patient interface assembly includes a first fluid line connected to a catheter into the body compartment and to a body fluid drainage reservoir and a second fluid line connected to a catheter fluidly connected to arterial blood and to an infusion source, and the system disposes a first flow channel and a second flow channel in the first fluid line and a third flow channel in the second fluid line with pressure sensors configured to display true body fluid pressure and true arterial blood pressure and to calculate perfusion pressure as a difference between pressure readings from the third and second flow channel pressure sensors.
Wearable pressure sensor subassembly with multiple pressure sensors, orientation-detected channel orientation, and drift detection
A wearable pressure sensor subassembly comprising a flow channel in a path of a body fluid with a plurality of pressure sensors in direct fluid communication with the body fluid and an orientation sensor configured to detect flow channel orientation, configured to detect changes in pressure of the body fluid, patient movement, or patient orientation; attachable proximate to a patient anatomical marker; where the plurality of pressure sensors comprises a first and a second pressure sensor mounted at a fixed spacing distance, and the subassembly detects an anticipated differential pressure based on flow channel orientation and detects drift in the first and second pressure sensors based on a disparity between anticipated differential pressure and an actual differential pressure.
Across the independent claims, the core claim coverage centers on real-time monitoring and integrated drainage control using wearable pressure sensing combined with an orientation sensor to compute anticipated versus actual differential pressure, using that disparity to detect sensor drift, and extending the monitoring/control concept to perfusion-pressure management by displaying multiple pressures and calculating perfusion pressure as a difference between arterial and compartment pressure readings.
Stated Advantages
Improves pressure monitoring accuracy by calculating an anticipated differential pressure based on flow channel orientation detected by the orientation sensor.
Enables detection of drift in the first pressure sensor or the second pressure sensor based on disparity between anticipated differential pressure and actual differential pressure.
Supports real-time monitoring and integrated control of drainage of the body fluid.
Supports corrective adjustments to drainage flowrate and/or asserting an alarm based on user selected operating modes and user-defined settings.
Displays pressure values for real-time arterial blood pressure, real-time body fluid pressure, and real-time perfusion pressure and calculates perfusion pressure as a difference between pressure readings.
Documented Applications
CSF drainage with integrated real-time monitoring of intracranial pressure (ICP) and perfusion-pressure-related control behavior using arterial pressure and compartment pressure to derive CPP for CSF drainage.
Intra-abdominal pressure monitoring with a drainage connection to a urinary catheter as an application of the body fluid management system.
Perfusion-pressure management using pressure measurements from wearable pressure sensor subassemblies for arterial and body-compartment pressures, with calculation and display of perfusion pressure.
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