Implantable Electrode Array for Pelvic Plexus Stimulation
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Solution Overview
Problem
Current treatments for erectile dysfunction (ED) following prostatectomy or associated with neuronal response failure, such as spinal cord injury, are invasive, risky, and often ineffective, with existing implantable neuroelectrostimulation systems facing challenges in accurately locating and stimulating the cavernous nerves due to complex anatomy and significant anatomic variability.
Innovation Solution
An implantable electrical stimulation system comprising an array of electrodes on flexible substrates sized to abut the pelvic plexus, a programmable controller for adjusting stimulation parameters, and wireless communication between implantable and external controllers to determine and store optimal electrode subsets for effective nerve stimulation, allowing for post-implantation adjustment and promoting nerve regeneration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intrapenial injections of vasodilators are used to treat ED, then erection can be produced independently of the neural pathway, but side effects such as penile pain, bleeding, hematoma, priapism, and penile fibrosis occur
Solution Approach 1:
The patent replaces the mechanical injection system (needles, syringes, direct drug delivery) with an electrical stimulation system. The implantable neuroelectrostimulation device uses electrical signals to stimulate the cavernous nerves, triggering the body's natural nitric oxide release and vasodilation processes, thereby eliminating the need for repeated needle injections and their associated traumatic side effects.
Solution Approach 2:
The patent introduces electrical stimulation as an intermediary between the external controller and the neural pathway. The implantable device with electrodes positioned on the cavernous nerves acts as a mediator that converts external electrical signals into physiological responses (neurotransmitter release, smooth muscle relaxation, increased blood flow), thereby achieving erection without direct drug injection into the penis.
2Reliability
If penile implants are used to treat ED, then erection can be achieved, but irreversible and destructive surgery with risk of intra and post-operative complications is required
Solution Approach 1:
The patent replaces the mechanical implant system (rigid or inflatable rods surgically implanted in the penis) with a neuroelectrostimulation system. The implantable device with external controller uses electrical signals to activate the existing neural and vascular pathways, thereby achieving erection without inserting foreign mechanical bodies into the penile tissue and avoiding the associated surgical risks and complications.
Solution Approach 2:
The patent enables the body's own neural and vascular systems to perform the erection function by stimulating the cavernous nerves to release nitric oxide and trigger the natural hemodynamic response. This self-service approach utilizes the patient's intact physiological mechanisms rather than relying on mechanical prostheses, thereby preserving tissue integrity and reducing surgical complications.
3Reliability
If conventional electrostimulation systems are used to treat ED, then nerve stimulation can be provided, but accurate localization and identification of the cavernosal nerve is difficult due to complex anatomy and significant anatomic variability
Solution Approach 1:
The patent divides the stimulation system into multiple independently controllable electrodes arranged in arrays on flexible substrates that can be positioned at different locations along the cavernous nerve. This segmentation allows the system to target specific segments of the nerve, accommodating anatomical variability and enabling precise localization through systematic testing of different electrode configurations without requiring perfect initial placement.
Solution Approach 2:
The patent employs a dynamic, programmable stimulation system with multiple electrodes that can be selectively activated in different patterns and sequences. The external controller enables real-time adjustment of stimulation parameters and electrode selection based on patient response, allowing the system to adapt to individual anatomical variations and locate the optimal stimulation site through iterative testing rather than relying on fixed anatomical landmarks.
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 system provides a painless, safer, and more effective alternative for treating ED by enabling precise electrical stimulation of the cavernous nerves, potentially improving erectile function and promoting nerve regeneration with reduced surgical risks and complications.
Implementation Method 1
an implantable stimulation unit including an array of electrodes disposed on at least one flexible substrate sized and shaped to abut at least a portion of a pelvic plexus of a patient... supply electrical stimulation via the stimulation circuit and the pelvic plexus to at least one cavernous nerve sufficient to cause an erection
Data Source
Figure 1
Figure 2A~2B
Figure 2C~2E
AI summary
Systems and methods are provided for treating a sexual disorder such as erectile dysfunction (ED) or female sexual arousal disorder (FSAD). An electrical stimulation system may include an implantable stimulation unit, an external patient controller, and an external physician controller. The implantable stimulation unit has an array of electrodes disposed on one or more flexible substrates configured to conform to a patient's anatomy at the pelvic plexus. Post-implantation, the physician controller may direct the stimulation unit to stimulate with select electrode(s) of the array to determine which electrode configuration provides optimal sexual arousal. The patient controller may be used to cause the stimulation unit to stimulate using the optimal electrode configuration at desired times.