Neuromodulation Electrode Assembly with Soft Deformable Interface
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Solution Overview
Problem
Traditional neuromodulation electrodes face issues with inconsistent skin contact due to manufacturing defects and physiological factors, leading to potential skin damage and high replacement costs, especially in non-invasive methods where hygiene requirements further compromise electrode effectiveness.
Innovation Solution
A neuromodulation electrode assembly featuring a removable protrusion with a variable diameter opening, combining a rigid conductive solid element with a soft deformable conductive element made of materials like gel or rubber, allowing for adjustable contact with the skin and improved signal distribution, along with a secure attachment mechanism to ensure effective neuromodulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If non-invasive metal electrodes are used for neuromodulation, then the risk of nerve damage and infection is reduced, but the electrode-to-skin contact area becomes inconsistent leading to skin damage and high replacement costs
Solution Approach 1:
The patent applies this principle by using a flexible adhesive layer as a thin film between the rigid electrode body and the skin. This adhesive layer conforms to the skin surface irregularities, ensuring consistent contact area while maintaining the non-invasive benefit of metal electrodes. The flexible film resolves the contradiction by providing reliable electrical contact without requiring direct rigid metal-to-skin contact.
Solution Approach 2:
The patent uses an adhesive layer as an intermediary substance between the electrode and skin. This mediator ensures consistent contact area by filling in skin irregularities, preventing both skin damage from poor contact and maintaining reliable electrical connection. The intermediary resolves the reliability issue while preserving the safety advantages of non-invasive electrodes.
2Manufacturing precision
If the electrode contact area with skin is reduced, then the manufacturing precision requirements are lowered, but the skin damage risk increases due to higher current density
Solution Approach 1:
The flexible adhesive layer compensates for manufacturing imperfections in the rigid electrode body by conforming to the skin surface. This allows the use of less precisely manufactured electrodes while still achieving consistent, safe contact area, thereby resolving the contradiction between manufacturing precision and skin safety.
Solution Approach 2:
The adhesive layer acts as a cushioning element that prevents direct transmission of manufacturing defects to the skin contact interface. By providing this protective layer beforehand, the system can tolerate lower manufacturing precision without increasing skin damage risk.
3Object-affected harmful factors
If electrodes are disinfected after each use to meet hygiene requirements, then infection risk is reduced, but micro-scratches on the electrode surface worsen the contact quality and increase replacement costs
Solution Approach 1:
The patent divides the electrode system into a reusable rigid electrode body and a disposable adhesive layer. The adhesive layer can be sterilized or replaced after each use, meeting hygiene requirements without subjecting the expensive metal electrode body to damaging sterilization processes. This segmentation resolves the contradiction between hygiene and contact quality.
Solution Approach 2:
The adhesive layer is designed as a disposable component that can be sterilized or replaced after each use. This allows the expensive electrode body to be reused without compromising hygiene, while the low-cost adhesive layer absorbs the sterilization wear and replacement costs.
4Productivity
If the stimulating current intensity is increased to overcome high skin resistance in obese patients, then the neuromodulation effectiveness is improved, but the safe threshold of 2 mA/cm2 is exceeded causing skin damage
Solution Approach 1:
The patent combines the rigid electrode body with a large-area flexible adhesive layer to create an electrode assembly with increased total contact area. This merging allows the same current to be distributed over a larger area, reducing current density and preventing skin damage while maintaining neuromodulation effectiveness in patients with high skin resistance.
Solution Approach 2:
The flexible adhesive layer adds dimensional flexibility to the electrode, allowing it to expand and conform to larger skin surfaces. This dimensional adaptation increases the effective contact area, thereby reducing current density without sacrificing treatment effectiveness.
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 electrode assembly provides a reliable and adaptable interface for neuromodulation, reducing the risk of skin damage and lowering costs by allowing for precise control of contact area and intensity, enhancing treatment efficacy while being cost-effective and hygienically manageable.
Implementation Method 1
an electrically conductive soft deformable element that projects outwards through the opening and which adapted to form an interface between the solid element and the patient skin
Data Source
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AI summary
An effective neuromodulation electrode assembly configured to provide a precise neuromodulation of a desired nerves whilst forming an efficient electro conductive interface between a patient skin and the neuromodulation electrode. The neuromodulation electrode comprising an enclosure having on one side a protrusion extending up to an end having an opening, an electrical interface, an electro conductive electrode piece coupled to the electrical interface on one end and having the opposite end configured to interact with a patient skin. The electrode piece further comprising, an electrically conductive solid element coupled on one side to the electrical interface and an electrically conductive soft deformable element that projects outwards through the opening and which adapted to form an interface between the solid element and the patient skin.