Sensing foley catheter

Inventors

BURNETT, Daniel R.LEE, Greg J.O'Connor, Richard W.MENSH, Brett

Assignees

Potrero Medical Inc

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Publication Number

US-11883174-B2

Patent

Publication Date

2024-01-30

Expiration Date


Abstract

Foley type catheter embodiments for sensing physiologic data from a urinary tract of a patient are disclosed. The system includes the catheter and a data processing apparatus and methods for sensing physiologic data from the urinary tract. Embodiments may also include a pressure sensor having a pressure interface at a distal end of the catheter, a pressure transducer at a proximal end, and a fluid column disposed between the pressure interface and transducer. When the distal end is residing in the bladder, the pressure transducer can transduce pressure impinging on it into a chronological pressure profile, which can be processed by the data processing apparatus into one or more distinct physiologic pressure profiles, for example, peritoneal pressure, respiratory rate, and cardiac rate. At a sufficiently high data-sampling rate, these physiologic data may further include relative pulmonary tidal volume, cardiac output, relative cardiac output, and absolute cardiac stroke volume.

Core Innovation

The disclosure relates to a measurement system using a Foley-type catheter having a fluid lumen, a pressure interface disposed on the catheter in communication with a fluid column, and a pressure transducer coupled to the fluid column. The fluid column is coupled to a gas delivery system such that a controller receives a pressure signal from the pressure transducer and controls the gas delivery system to transmit pressure to the pressure interface via gas delivery in response to the pressure signal. This arrangement generates a high-fidelity chronological pressure profile in the bladder while maintaining a pressure differential for the delivered pressure interface measurement.

The system processes the chronological pressure profile into distinct physiologic pressure profiles including peritoneal pressure, respiratory rate, and cardiac rate. At higher sampling rates relative pulmonary tidal volume, the system produces cardiac output, relative cardiac output, and absolute cardiac stroke volume. Additional embodiments further add temperature sensing, urine analyte sensors, electrical activity sensors including EKG/EGG, and light-based sensing including pulse oximetry.

The system further combines expandable pressure-delivery balloons and light detection to determine bladder or urethral tissue perfusion pressure. It also includes automatic pressure priming and tuning to maintain a minimal pressure differential, with a gas delivery and valving scheme associated with the controller’s pressure transmission. System-level features include bedside console or networked monitoring with alerts, urine receptacle volume and analyte sensing with an RFID chip, docking and communication, and automated infusion therapy control based on sensed physiologic data, including monitoring for intra-abdominal hypertension and abdominal compartment syndrome, cardiac and respiratory status, hemorrhage or shock, and patient movement.

Claims Coverage

The independent claim covers a measurement system combining a catheter pressure-transmitting column and controllable gas-delivery pressure interface with urine-flow monitoring and controller-based predictive signal analysis. The claim set includes six listed dependent inventive refinements.

Fluid-column pressure interface with gas delivery controlled by pressure signal

A catheter having a fluid lumen; a fluid column having a pressure-transmitting column and a fluid disposed in the catheter and coupled to a gas delivery system; a pressure interface disposed on the catheter in communication with the fluid column; a pressure transducer coupled to the fluid column and configured to receive a pressure signal from the pressure interface via the fluid column; and a controller configured to receive the pressure signal and control the gas delivery system to transmit pressure to the pressure interface via gas delivery in response to receiving the pressure signal.

Predictive electrical-property urine analysis with urine-flow alerting

One or more sensors in communication with the controller, wherein the controller is configured to detect an electrical property of the urine via the one or more sensors and apply signal analysis and a predictive algorithm on the detected electrical property and is further configured to monitor a rate of the flow of urine and provide an alert when the rate is outside of a predetermined range.

Urine parameters relevant to kidney function monitoring

The controller is further configured to monitor one or more parameters of the urine relevant to kidney function.

Urine analyte level determination

The controller is further configured to determine a level of an analyte from the urine.

Infusion console controlled delivery of infusion fluid based on controller input

The system further comprises an infusion console in communication with the controller, configured to control delivery of an infusion fluid to the subject in response to input received by the controller.

Integration of external data with internal controller data

The controller is further configured to receive external data from an external source and integrate the external data with internal data within the controller.

The independent claim centers on controllably transmitting pressure to a catheter pressure interface through a fluid column coupled to a gas delivery system, with a controller reacting to received pressure signals, while detecting an electrical property of urine to perform signal analysis with a predictive algorithm and to alert based on urine flow rate outside a predetermined range. Dependent refinements add urine monitoring relevant to kidney function, determination of an analyte level from urine, optional infusion-console delivery control based on controller input, and integration of externally received data with internal data.

Stated Advantages

Provides an alert when the rate of the flow of urine is outside of a predetermined range.

Documented Applications

Detecting electrical properties of urine and providing alerts based on urine flow rate outside a predetermined range.

Monitoring urine parameters relevant to kidney function.

Determining a level of an analyte from the urine.

Controlling delivery of an infusion fluid to a subject using an infusion console based on controller input.

Integrating external data with internal data within the controller for use in the measurement system.

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