Implantable Tibial Nerve Stimulator for Long-Life Bladder Therapy
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing medical devices for treating urinary and bowel incontinence, such as sacral nerve stimulators and percutaneous tibial nerve stimulation, suffer from large implant sizes, short lifespan, invasive qualification steps, and frequent patient sessions, leading to discomfort and inefficiency.
Innovation Solution
A miniature implantable neurostimulator for sciatic nerves with a low duty cycle and low current drain, designed for long-term implantation in the leg, providing a smaller, more comfortable, and safer alternative with a potential lifespan of 5 to 35 years.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a sacral nerve stimulator is implanted to treat urinary or bowel incontinence, then therapy effectiveness is achieved, but the device size becomes large (14 cc) and implantation becomes complex requiring long lead wires and invasive qualification steps
Solution Approach 1:
The patent extracts the stimulation function from the complex sacral nerve stimulator system and relocates it to a smaller implantable device positioned in the leg, separating the electrode placement from the generator location to simplify the overall system architecture
Solution Approach 2:
The patent changes the spatial dimension of implantation from the pelvic region (sacral area) to the leg region, allowing for a smaller device footprint and simpler lead wire routing while maintaining therapeutic effectiveness through alternative nerve stimulation pathways
2Reliability
If a sacral nerve stimulator is implanted with high duty-cycle stimulation, then effective therapy is delivered, but the battery lifespan becomes limited (approximately 4.4 years)
Solution Approach 1:
The patent employs periodic or intermittent stimulation patterns instead of continuous high-duty-cycle stimulation, allowing the battery to conserve energy while maintaining therapeutic effectiveness through optimized pulse delivery schedules
Solution Approach 2:
The patent changes the stimulation parameters including duty cycle, pulse width, and frequency to optimize the balance between therapeutic effectiveness and power consumption, extending battery lifespan while maintaining treatment efficacy
3Reliability
If a temporary electrode is implanted for qualification, then therapy success can be verified, but the process becomes invasive and requires multiple procedures
Solution Approach 1:
The patent performs preliminary qualification through external or percutaneous stimulation before permanent implantation, allowing therapy effectiveness to be verified in advance and reducing the need for invasive trial implantations
Solution Approach 2:
The patent uses an external or percutaneous electrode as an intermediary qualification tool that can be removed after verification, separating the qualification function from the permanent implant and reducing overall invasiveness
4Reliability
If percutaneous tibial nerve stimulation is used, then therapy can be delivered, but frequent patient sessions (once per week initially) are required which reduces convenience
Solution Approach 1:
The patent transitions from clinic-based percutaneous stimulation requiring frequent professional visits to a self-contained implantable device that patients can use independently in the comfort of their own homes, eliminating the need for frequent clinic sessions
Solution Approach 2:
The patent enables continuous or near-continuous stimulation therapy through the implantable device, replacing the intermittent weekly sessions of percutaneous stimulation and providing more consistent therapeutic benefit while improving patient convenience
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The implant offers a medically acceptable device longevity, reduced discomfort, and simplified implantation, while maintaining effective therapy for urinary and bowel incontinence, with the option for customizable stimulation schedules and wireless power options.
Implementation Method 1
The electrode assembly may direct a stimulation signal to the tissue of the subject
Data Source
AI summary
A method of implanting a nerve stimulation device in treating an overactive bladder condition includes providing an external programmer and providing an implantable tibial nerve stimulation device (ITNS device) including a pulse generator enclosing circuitry and a lead coupling an electrode assembly to the pulse generator. The external programmer wirelessly communicates with the circuitry of the pulse generator to program a stimulation therapy for the ITNS device.