Catheter assemblies, oxygen-sensing assemblies, and related methods
Inventors
Silverton, Natalie A. • Kuck, Kai • Stringer, Bradley J. • Shumway, Spencer B. • Lofgren, Lars
Assignees
Swsa Medical Ventures LLC • University of Utah • University of Utah Research Foundation Inc
Publication Number
US-11660032-B2
Publication Date
2023-05-30
Expiration Date
2038-09-04
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Abstract
An oxygen-sensing assembly for attachment to a urinary catheter may include a housing having a flow pathway extending between an inlet end and an outlet end thereof, an oxygen sensor in operable communication with the flow pathway of the housing, the oxygen sensor configured to detect oxygen levels of a fluid flowing through the flow pathway and a flowrate sensor configured to detect a flowrate of the fluid flowing through the flow pathway. A risk of acute kidney injury may be determined based on the mass flowrate of oxygen through the flow pathway, determined based on the detected oxygen levels and the flowrate of the fluid through the flow pathway. Related catheter assemblies and methods are also disclosed.
Core Innovation
The invention provides a catheter assembly capable of real-time monitoring of oxygen tension and flow in urine by integrating an oxygen-sensing assembly with a urinary catheter. The assembly incorporates an oxygen sensor in direct communication with the fluid flow pathway, a flowrate sensor to detect the rate of fluid movement, and a control system programmed to process these signals. The control system receives detected oxygen tension and flowrate, and determines a mass flowrate of oxygen through the pathway.
Conventional methods for diagnosing acute kidney injury (AKI), such as serum creatinine and urine output measurements, have significant delays and are insensitive to acute renal function changes. The lack of tools for real-time monitoring of renal perfusion limits prevention of AKI during and after procedures like cardiac surgery. There is therefore a need for a system that can provide immediate and continuous indications of kidney oxygenation status through non-invasive means.
The disclosed catheter assembly addresses this problem by providing a urinary catheter with a detachable or integrated oxygen-sensing assembly. The system detects real-time oxygen tension and flowrate directly from urine and employs a processor to calculate the mass flowrate of oxygen, enabling detection of risk for AKI or assessment of medullary oxygenation. Various sensor types (fiber-optic, electrochemical, etc.) and configurations (with or without temperature sensing or barriers for sensor protection) are contemplated, ensuring accurate, time-correlated data for clinical decision making.
Claims Coverage
There are three independent claims covering three main inventive features.
Catheter assembly with integrated oxygen-sensing and flowrate sensors, and control system for real-time oxygen assessment
A catheter assembly comprising: - A urinary catheter with at least one lumen between an inlet and outlet. - An oxygen-sensing assembly in fluid communication with the catheter, including: - A housing with a flow pathway attachable to the catheter. - An oxygen sensor configured to detect oxygen tension in fluid through the pathway. - A flowrate sensor disposed between the oxygen sensor and inlet, configured to detect flowrate. - A control system operably coupled to both sensors, including: - At least one processor. - At least one non-transitory computer-readable storage medium with instructions to receive detected oxygen tension and flowrate of the fluid and to determine mass flowrate of oxygen through the flow pathway based at least in part on these measurements.
Oxygen-sensing assembly for catheter with oxygen sensor, flowrate sensor, and control for risk assessment
An oxygen-sensing assembly for attachment to a urinary catheter comprising: - A housing with a flow pathway between an inlet and an outlet. - An oxygen sensor operable to detect oxygen tension of fluid through the pathway. - A flowrate sensor disposed in the flow pathway to detect flowrate. - A control system operably coupled to both sensors, including a processor and at least one non-transitory computer-readable storage medium with instructions to determine the risk of acute kidney injury based, at least in part, on a mass flowrate of oxygen determined by the oxygen tension and the flowrate.
Method for detecting mass flowrate of oxygen and risk of acute kidney injury using catheter with oxygen and flowrate sensors
A method comprising: 1. Attaching an oxygen-sensing assembly to a urinary catheter and disposing the catheter within a subject's bladder. 2. Detecting oxygen tension of fluid through the catheter and pathway with an oxygen sensor, and detecting flowrate with a flowrate sensor. 3. Determining the mass flowrate of oxygen in the fluid based at least in part on detected oxygen tension and flowrate. 4. Determining a risk of acute kidney injury, medulla oxygenation, or both, based at least partially on the mass flowrate of oxygen.
These inventive features define a system and method for real-time monitoring of oxygen tension and mass flowrate in urine by integrating oxygen and flowrate sensors into a catheter assembly, and a control system configured for risk assessment of acute kidney injury or medulla oxygenation.
Stated Advantages
Provides continuous and real-time monitoring of kidney hypoxia and risk for acute kidney injury in patients.
Removes the inherent lag time present in conventional AKI diagnosis methods, allowing earlier detection of patients at risk for acute kidney injury.
Offers a relatively non-invasive solution, as it can be attached to urinary catheters already in place without increasing procedural invasiveness.
Reduces the risk of infection and disease by not increasing invasive procedures.
Allows use with a wide variety of different urinary catheters, improving versatility for healthcare providers.
Facilitates more flexible clinical decision-making, as the oxygen-sensing assembly can be added to existing catheters at any point during patient care.
May result in reduced hospital stays, lower medical costs, improved recovery times, and may ultimately save lives by enabling earlier and more effective intervention.
Simplifies installation and reduces the risk of infection, fiber breakage, and dye leaching compared to conventional fiber-up-catheter systems.
Provides real-time urinary flowrate data, allowing assessment of clinical interventions such as medications and fluid administration.
Documented Applications
Determining the risk of acute kidney injury and/or medulla oxygenation in septic patients.
Assessing trauma and burn patients for risk of acute kidney injury and medullary oxygenation.
Post cardiac arrest patient monitoring for kidney hypoxia and AKI risk.
Monitoring hospitalized patients with heart failure exacerbations for acute kidney injury risk.
Assessing patients undergoing surgery or post-operative patients for risk of AKI and medulla oxygenation.
Utilization in patients with kidney transplant for risk assessment and monitoring of kidney oxygenation.
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