Device, system and methods for measurement of pressures in the urinary tract
Inventors
Assignees
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Publication Number
US-11490844-B2
Publication Date
2022-11-08
Expiration Date
Abstract
A catheter for measuring pressure in the urinary tract of a patient includes a catheter body having a proximal and distal end. A plurality of lumens is formed in the catheter body, and an adaptor is coupled to the proximal end of the catheter body. The adaptor includes a port for each lumen. A first pressure sensor, typically including a balloon, is fluidically coupled to a first lumen and is configured and positioned to measure pressure in a urethra of the patient. A second pressure sensor, also typically including a balloon, is fluidically coupled to a second lumen and is configured and positioned on the catheter body to measure pressure in a bladder of the patient. An expandable retention member, which may be coupled to a third lumen, is positioned on the catheter body between the first and second expandable pressure sensors so that the catheter body may be retained at a selected location in the urinary tract to properly position the fluid pressure sensors in the bladder and urethra, respectively.
Core Innovation
The invention relates to a method for measuring pressure at multiple locations in the urinary tract of a patient to facilitate a treatment for urinary incontinence. A catheter is advanced into the urinary tract with a first pressure sensor positioned in a urethra and a second pressure sensor positioned in a bladder. The catheter includes a plurality of lumens including at least a first lumen and a second lumen, where the first pressure sensor is fluidically coupled to the first lumen and the second pressure sensor is fluidically coupled to the second lumen.
The plurality of lumens are configured to minimize an effect of a pressure change in one lumen on a pressure in another lumen of the plurality of lumens, thereby reducing lumen-to-lumen pressure cross-talk. The method further expands an expandable retention member to retain the first pressure sensor at the first location and the second pressure sensor at the second location during exertion of a physiological force on the catheter. Pressures at the first location and the second location are measured in response to an external stimulus.
In certain aspects described, the method includes measuring the pressures substantially simultaneously and reducing interdependence between the pressure sensors so that the pressure at one location is not substantially affected by the position of the pressure sensor at the other location. The external stimulus may include an electrical neuromodulation signal generated by an electrode electrically coupled to a nerve innervating the bladder, and the pressure measurements may be used during overactive bladder treatment to evaluate treatment effectiveness based on measured urinary output behavior such as a micturition volume threshold (MVT).
Claims Coverage
The provided independent claim covers measuring urinary-tract pressure at two locations (urethra and bladder) using a multi-lumen catheter with separate fluidic coupling to separate pressure sensors, while minimizing lumen-to-lumen pressure cross-talk and retaining the sensor locations during physiological force, then measuring pressures in response to an external stimulus. Dependent claim features refine the cross-talk minimization and measurement/external stimulus characteristics.
Urinary-tract multi-location pressure measurement for urinary incontinence
Advancing a catheter into the urinary tract to position a first pressure sensor at a first location in a urethra and a second pressure sensor at a second location in a bladder, with pressures measured at the first and second locations in response to an external stimulus to facilitate treatment for urinary incontinence.
Multi-lumen fluidic coupling with cross-talk minimization between lumens
Configuring a plurality of lumens, including at least a first lumen and a second lumen, so that the first pressure sensor is fluidically coupled to the first lumen and the second pressure sensor is fluidically coupled to the second lumen, and wherein the lumens are configured to minimize an effect of a pressure change in one lumen on a pressure in another lumen.
Expandable retention member to retain sensor positions during physiological force
Expanding an expandable retention member to retain the first pressure sensor at the first location and the second pressure sensor at the second location during exertion of a physiological force on the catheter.
Substantially simultaneous multi-location pressure measurement
Measuring pressures at the first location and the second location substantially simultaneously.
Interdependence reduction between sensor positions
Specifying that measuring pressure at either location is not substantially affected by the position of a pressure sensor at the other location.
Lumen stiffness/hoop strength coupling constraint
Requiring that each lumen has sufficient stiffness or hoop strength such that a pressure change in one lumen causes a 2% or less pressure change in another lumen.
Radial rigidity range for lumens
Requiring that the radial rigidity of each lumen is in a range of about 20 to 100 N/mm.
Neuromodulation signal as external stimulus
Characterizing the electrical signal as a neuromodulation signal generated by an electrode electrically coupled to a nerve innervating the bladder.
Across the provided claims, the core coverage is a catheter-based method that measures urethral and bladder pressures using separate, fluidically coupled lumens and pressure sensors, while minimizing lumen-to-lumen pressure cross-talk through lumen configuration, retaining sensor locations via an expandable retention member during physiological force, and measuring both pressures in response to an external stimulus such as a neuromodulation electrical signal.
Stated Advantages
Minimizes an effect of a pressure change in one lumen on a pressure in another lumen of the plurality of lumens (reduces lumen-to-lumen pressure cross-talk).
Retains the first pressure sensor at the first location and the second pressure sensor at the second location during exertion of a physiological force on the catheter.
Facilitates a treatment for urinary incontinence by measuring pressure at multiple urinary-tract locations in response to an external stimulus.
Documented Applications
Using the pressure measurements during overactive bladder treatment to assess effectiveness, including based on a micturition volume threshold (MVT).
Evaluating treatment effectiveness of neuromodulation electrode placement/waveform and electrical stimulation delivered via pressure measurements.
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