Standardized measurement of physiological pressures using an air-charged catheter apparatus
Inventors
Damaser, Margot • Awada, Hassan K. • Fletter, Paul C. • Cooper, Mitchell • Zaszczurynski, Paul
Assignees
Us Gov't As Represented By Department Of Veterans Affairs • Cleveland Clinic Foundation • US Department of Veterans Affairs
Publication Number
US-10537274-B2
Publication Date
2020-01-21
Expiration Date
2032-09-21
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Abstract
Systems and methods are provided for providing a standardized pressure value representing a transient pressure event within a region of interest within a living body. An air-charged catheter is configured to record pressure data representing the region of interest. A measurement assembly includes a parameter calculation component configured to calculate at least a peak pressure representing the transient pressure event and a time to peak pressure, representing the time necessary to reach the peak pressure, from the recorded pressure data. A standardization component is configured to calculate the standardized pressure value as a function of the peak pressure and the time to peak pressure. A user interface is configured to display at least the standardized pressure value at an associated display.
Core Innovation
The invention provides systems and methods for generating a standardized pressure value representing a transient pressure event within a region of interest in a living body using an air-charged catheter. The system records pressure data from the region of interest and calculates parameters including peak pressure and time to peak pressure from the recorded data. A standardization component computes a standardized pressure value as a function of the peak pressure and time to peak pressure, and this value is displayed via a user interface.
The transient pressure event can be any occurrence temporarily altering the pressure within the region of interest, such as coughing or sneezing in a urological application involving the bladder or urethra. Due to the overdamped nature of air-charged catheters compared to water-filled and microtip catheters, the measured peak pressure underestimates the true value. Many standard diagnostic values are based on water-filled catheters, creating inconsistency and difficulty in interpretation when using air-charged catheters.
This invention solves the problem by calculating a standardized pressure value that corresponds to the pressure value expected from a water-filled catheter by adjusting the air-charged catheter's measured peak pressure using the time to peak pressure. The standardization function corrects for the delay and damping characteristics of the air-charged catheter, providing clinically comparable pressure measurements while maintaining the advantages of air-charged catheter technology.
Claims Coverage
The patent includes four independent claims covering systems and methods for providing standardized pressure values using air-charged catheters, focusing on calculating peak pressure, time to peak pressure, and standardized pressure values, and displaying them.
System with air-charged catheter and measurement assembly for standardized pressure
A system comprising an air-charged catheter to record pressure data within a living body region and a measurement assembly that calculates at least a peak pressure and a time to peak pressure from the recorded data, then calculates a standardized pressure value as a function of these parameters, representing a peak pressure expected from a water-filled catheter, and a user interface that displays the standardized pressure value.
Calculation of standardized pressure as product of peak pressure and function of time to peak pressure
The measurement assembly calculates the standardized pressure value as the product of the calculated peak pressure and a function of the time to peak pressure.
Standardization function involving exponential function of time to peak pressure
The standardized pressure is calculated as the product of the calculated peak pressure and a ratio of an exponential function of time to peak pressure to the difference between that exponential function and a predetermined constant (thirty milliseconds).
Determination of peak pressure and time to peak pressure from recorded data
The measurement assembly determines peak pressure as the difference between maximum recorded pressure and baseline pressure, and time to peak pressure as the time it takes the pressure to increase from five percent of the maximum pressure to the maximum.
Data conditioning element for processing recorded pressure data
The system includes a data conditioning element that receives the recorded pressure data and processes it for analysis, including filtering to remove noise and artifact.
The claims cover a system with an air-charged catheter and associated measurement assembly that processes pressure data to compute and display a standardized pressure value corrected for the overdamped response of air-charged catheters, using peak pressure and time to peak pressure parameters. The system includes data conditioning and uses a specific function to produce the standardized pressure that aligns measurements with those expected from water-filled catheters.
Stated Advantages
Air-charged catheters are relatively inexpensive, easy to use, disposable, and significantly less subject to artifact compared to traditional water-filled or microtip pressure transducers.
The standardized pressure value allows for comparison and consistency with standard diagnostic values based on water-filled catheter measurements, thereby improving clinical interpretation when using air-charged catheters.
The system reduces inconsistency of pressure measurements between different types of catheters and diagnostic devices.
Documented Applications
Use of the system in urological applications including measurement of pressure within the bladder, urethra, or rectum of a patient.
Measurement and interpretation of transient pressure events such as coughing, sneezing, or performing a Valsalva maneuver by a patient.
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