Urethral catheters and methods for facilitated introduction into the urinary tract
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Assignees
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Publication Number
US-10589093-B2
Publication Date
2020-03-17
Expiration Date
Abstract
Embodiments of the invention provide apparatus, systems and methods for facilitating introduction of a urinary drainage catheter (UDC) into the urinary tract (UT). One embodiment provides a UDC including electrodes for delivering high frequency current to a patient's pudendal nerves to relax the urinary sphincter (US) before passing the UDC therethrough so as reduce the resistance force on the UDC and discomfort to the patient. The electrodes can comprise at least one pair of bipolar electrodes and may be flexible so as to bend and flex within the urethra. The UDC includes one or more lumens including a drainage lumen and an inflation lumen for inflating an anchoring device on the UDC. The UDC can include a pressure sensor to assess relaxation of the US. The UDC may include a second set of electrodes and irrigation lumen for relaxing the US and flushing the urethra with the UDC in place.
Core Innovation
The disclosed invention relates to urethral drainage catheter systems and methods that introduce a urinary drainage catheter through a patient's urethra into the patient's bladder. The method advances a distal tip of the drainage catheter through the urethra until the tip reaches the urinary sphincter, delivers high frequency current to the patient's pudendal nerve to relax the urinary sphincter, and advances the catheter tip through the sphincter while the sphincter remains relaxed.
The disclosed catheter system includes catheter electrodes for delivering high frequency current and includes a controller and a power supply for operation. Flexible bipolar electrode configurations are described, including electrode sets that may be patch/ring, with distal and optional proximal electrode sets and flexible electrode spacing considerations. In at least some implementations, the system includes sensors for feedback/control, including pressure/force sensing and thermal sensing to support control based on temperature thresholds.
In additional implementations, the catheter system can include multiple lumens, including a drainage lumen and an inflation lumen for bladder anchoring. Optional irrigation/flush functionality is described via an irrigation lumen with the catheter in place, and irrigation fluid can be delivered through an opening in the urinary drainage catheter to flush the urethra. Dependent refinements also describe quantitative constraints associated with sphincter relaxation effectiveness and temperature threshold control using values including <45°C, <42.5°C, and <40°C.
Claims Coverage
The provided independent claim is directed to one inventive feature: introducing a urinary drainage catheter through a patient's urethra into the patient's bladder by relaxing the urinary sphincter with high frequency current delivered to the pudendal nerve. Dependent features add quantitative relaxation constraints, feedback control, and optional urethral flushing/irrigation and anchoring-related structures.
Advancing the catheter through relaxed urinary sphincter
Advance the distal tip of the drainage catheter through the urethra until the tip reaches the urinary sphincter, relax the urinary sphincter by delivering high frequency current to the pudendal nerve, advance the distal tip through the urinary sphincter while the sphincter remains relaxed, and position the distal tip in the patient's bladder.
The core coverage is the controlled relaxation of the urinary sphincter via high frequency current delivered to the pudendal nerve to enable advancement of a urinary drainage catheter through the sphincter and into the bladder, with dependent refinements to include force/temperature constraints, feedback using measured urinary sphincter pressure, and optional irrigation/flush functionality via catheter openings and lumens.
Stated Advantages
Reduced force and discomfort by relaxing the urinary sphincter to facilitate catheter advancement.
Reduced trauma and infection risk by relaxing the sphincter and optionally flushing the urethra.
Documented Applications
Method for introducing a urinary drainage catheter through a patient's urethra into the patient's bladder by relaxing the urinary sphincter using high frequency current delivered to the pudendal nerve.
Urethral flushing/irrigation during catheter placement using irrigation fluid delivered through an opening in the urinary drainage catheter.
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