Systems, devices and methods for draining and analyzing bodily fluids and assessing health

Inventors

Stanton, KellySUTARIA, SaheelSokolov, DimitriBURNETT, Daniel R.

Assignees

Potrero Medical Inc

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Publication Number

US-12114978-B2

Patent

Publication Date

2024-10-15

Expiration Date


Abstract

Systems, devices and methods for draining and analyzing bodily fluids and assessing health are described and generally comprise a drainage tube in fluid communication with at least one opening near or at a distal end of a catheter, a pump in fluid communication with the drainage tube and configured to apply a negative pressure to the drainage tube, and a valve configured for unidirectional flow and in fluid communication with the drainage tube. A controller is configured to actuate the pump to apply the negative pressure for clearing an airlock and to monitor a urine output from the patient over a first predetermined period of time above a urine output threshold and over a second predetermined period of time below the urine output threshold. The controller may determine a risk of acute kidney injury if the urine output below the urine output threshold exceeds the second predetermined period of time.

Core Innovation

The invention relates to a medical urine-drainage and monitoring system for assessing health of a patient using urine output measured from a drainage tube in fluid communication with at least one opening positioned near or at a distal end of a catheter. A pump applies negative pressure to the drainage tube, and a valve configured for unidirectional flow is provided in fluid communication with the drainage tube. A controller actuates the pump to apply the negative pressure for clearing an airlock from the drainage tube.

The controller monitors the urine output over a first period of time when the urine output is determined to be above a urine output threshold, and then monitors the urine output over a second period of time and determines a second urine output. An increased risk of acute kidney injury (AKI) is determined when the second urine output from the second period of time is below the urine output threshold and when the urine output from the first period of time exhibits a downward trend.

The related method receives urine output via a catheter having at least one opening near or at a distal end of the catheter, applies negative pressure to a drainage tube in fluid communication with the at least one opening until an airlock is cleared, and monitors urine output over a first period of time when the urine output is above a urine output threshold. The method then monitors over a second period of time to determine a second urine output and determines an increased risk of AKI if the second urine output is below the urine output threshold and the urine output from the first period of time exhibits a downward trend.

Claims Coverage

The document includes two independent claims: a system claim and a method claim. Across the independent claims, the inventive coverage centers on airlock clearing using negative pressure, urine-output monitoring over first and second time periods relative to a urine output threshold, and AKI risk determination based on below-threshold second urine output together with a downward trend in the first period.

Airlock-clearing negative pressure drainage

A drainage tube in fluid communication with an opening near or at a distal end of a catheter, a pump configured to apply negative pressure to the drainage tube, and a valve configured for unidirectional flow, with a controller actuating the pump to apply the negative pressure for clearing an airlock from the drainage tube.

Two-period urine-output monitoring with threshold and trend

The controller monitors urine output over a first period of time when the urine output is determined to be above a urine output threshold, monitors urine output over a second period of time after the first period of time, and determines a second urine output.

Increased AKI risk determination

An increased risk of acute kidney injury (AKI) is determined if the second urine output from the second period of time is below the urine output threshold and if the urine output from the first period of time exhibits a downward trend.

Airlock-clearing negative pressure drainage method

A method receives urine output from a patient via a catheter having at least one opening near or at a distal end of the catheter, applies negative pressure to a drainage tube in fluid communication with the opening until an airlock is cleared, and monitors urine output over a first period of time when the urine output is determined to be above a urine output threshold.

AKI-risk determination from second-period below-threshold output and first-period downward trend

The method monitors urine output over a second period of time after the first period of time to determine a second urine output, and determines an increased risk of acute kidney injury (AKI) if the second urine output is below the urine output threshold and if the urine output from the first period of time exhibits a downward trend.

Across the independent claims, the coverage centers on clearing an airlock using negative pressure with a unidirectional-flow valve, then performing two-period urine-output monitoring tied to a urine output threshold, and determining increased AKI risk based on second-period below-threshold urine output combined with a downward trend during the first period.

Stated Advantages

Provides a mechanism to determine an increased risk of acute kidney injury (AKI) based on urine output trends over time.

Documented Applications

Assessing health of a patient using urine output monitoring coupled with negative-pressure urine drainage and airlock clearing to support AKI risk determination.

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