Neuroelectrostimulation System for Cavernous Nerve Rehabilitation
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Solution Overview
Problem
Current treatments for erectile dysfunction, particularly post-prostatectomy ED, face challenges in accurately identifying and stimulating the cavernous nerves due to complex anatomy and variability, leading to ineffective rehabilitation and increased risk of penile fibrosis.
Innovation Solution
A neuroelectrostimulation system with programmable controllers and flexible paddles equipped with electrodes, capable of optimizing electrode excitation configurations and stimulation parameters post-implantation, using directional current flows to select optimal electrode subsets and stimulation regimes for rapid erectile responses, nerve rehabilitation, and penile rehabilitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional empirical testing methods are used to determine optimal electrode configurations and stimulation parameters, then comprehensive coverage of possible configurations can be achieved, but extensive time and resources are required
Solution Approach 1:
The system performs self-testing and self-configuration by automatically scanning electrode configurations and determining optimal settings without requiring extensive external empirical testing. The programmable controller autonomously evaluates different electrode subsets and stimulation parameters to identify the most effective configuration for the patient's specific anatomy.
Solution Approach 2:
The system systematically varies stimulation parameters (current amplitude, pulse width, frequency) and electrode configuration parameters to determine optimal settings. By programmatically changing these parameters and measuring physiological responses, the system efficiently identifies the best configuration without exhaustive empirical testing.
2Adaptability or versatility
If fixed electrode configurations are used for stimulation, then device simplicity is maintained, but adaptability to individual patient anatomy and nerve locations is reduced
Solution Approach 1:
The system transitions from fixed, static electrode configurations to dynamic, programmable configurations. The programmable controller can selectively activate different subsets of electrodes based on individual patient anatomy and response to stimulation, allowing the system to adapt to each patient's unique nerve locations and tissue characteristics.
Solution Approach 2:
The electrode array is divided into multiple independently controllable electrode elements that can be selectively activated in different subsets. This segmentation allows the system to target specific nerve locations and tissue regions by activating only the relevant electrode subsets, improving adaptability without requiring a completely new device design.
3Reliability
If non-optimal stimulation parameters are used, then treatment simplicity is maintained, but treatment effectiveness and risk of penile fibrosis increase
Solution Approach 1:
The system incorporates feedback mechanisms where physiological responses to stimulation are monitored and used to adjust and optimize stimulation parameters. This feedback loop ensures that the most effective parameters are identified and maintained, improving treatment reliability while the programmable controller manages the complexity of parameter optimization.
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
This system enables reliable determination of optimal electrode configurations and stimulation parameters, improving erectile function, reducing penile fibrosis, and facilitating nerve regeneration without extensive empirical testing, thus providing a more effective and safer treatment option.
Implementation Method 1
deliver electrical stimulation to the pelvic plexus and/or at least one cavernous nerve
Data Source
AI summary
An implantable stimulation system having an implantable stimulation unit coupled to a programmable controller, a stimulation circuit and an array of electrodes disposed on a pair of flexible paddles is provided for selectively stimulating at least one cavernous nerve. The programmable controller is pre-programmed to run an excitation electrode routine that selectively scans the electrode arrays on the paddles with a series of directional current flows, in at least two directions and within at least two regions, to optimize electrode selection for use in stimulating the cavernous nerve. The implantable stimulation system may be programmed to run a first stimulation pulse sequence corresponding to a first mode for invoking a rapid erectile response, and optionally, a second nerve rehabilitation stimulation mode selected to rehabilitate neural transmission in a cavernous nerve, and/or a third penile rehabilitation mode selected to reduce penile fibrosis. Methods of operating the system also are provided.