Foil-Like Implantable Stimulator for Precise Nerve Placement
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Solution Overview
Problem
Existing implantable stimulators face challenges in achieving precise and comfortable placement under nerve tissue due to issues like incorrect electrode placement, electrical resistance, and discomfort, particularly in thin skin areas, which can lead to irritation and reduced satisfaction during minimally invasive procedures.
Innovation Solution
A method for implanting an implantable stimulator with a conformable foil-like substrate, having electrodes with a thickness of 0.5 mm or less, is introduced, allowing precise placement between the skin layers and aponeurosis layer to reduce tissue damage and improve comfort, using introducer sheaths and guide wires for accurate positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a traditional stimulator with thicker substrate is used, then structural stability is improved, but placement precision and comfort under nerve tissue deteriorate
Solution Approach 1:
The stimulator substrate is divided into two distinct portions: a first portion with thickness of 0.5mm or less for precise placement under nerve tissue, and a second portion with greater thickness for structural stability and component housing. This segmentation allows each portion to be optimized for its specific function, resolving the contradiction between thinness for precision and thickness for stability.
Solution Approach 2:
Different thickness characteristics are applied to different portions of the stimulator substrate. The first portion (distal end) has local quality of thinness (≤0.5mm) for conformability and precision placement, while the second portion (proximal end) has local quality of greater thickness for structural support. This local differentiation resolves the contradiction by applying appropriate thickness properties where needed.
2Ease of operation
If the stimulator is placed subcutaneously in thin skin areas, then implantation simplicity is improved, but subject comfort and skin irritation worsen
Solution Approach 1:
The stimulator is segmented into a thin first portion for subcutaneous placement in sensitive areas and a thicker second portion for structural functions. The thin first portion (≤0.5mm) can be placed directly under thin skin without causing irritation, while maintaining overall device stability through the thicker second portion.
Solution Approach 2:
The first portion of the stimulator substrate is designed as a thin film structure (≤0.5mm thickness) that provides flexibility and conformability for comfortable placement under thin skin. This thin film design reduces the risk of skin irritation while maintaining ease of implantation.
3Manufacturing precision
If the substrate thickness is reduced to 0.5mm or less, then conformability and placement precision are improved, but structural strength deteriorates
Solution Approach 1:
The substrate is segmented into a thin first portion (≤0.5mm) for precision placement and a thicker second portion for structural strength. The thin first portion achieves conformability and placement precision, while the thicker second portion provides the necessary structural support and housing for electronic components.
Solution Approach 2:
The substrate exhibits local quality variations in thickness: the first portion has local quality of thinness (≤0.5mm) for conformability, while the second portion has local quality of greater thickness for structural integrity. This local differentiation resolves the contradiction between thinness for precision and thickness for strength.
4Productivity
If incorrect electrode placement occurs, then implantation speed is improved, but electrical resistance and treatment effectiveness worsen
Solution Approach 1:
The stimulator is pre-configured with the thin first portion (≤0.5mm) designed specifically for precise placement under nerve tissue. This preliminary design feature guides the implantation process to achieve correct electrode positioning, reducing electrical resistance and improving treatment effectiveness while maintaining implantation speed.
Data Source
AI summary
In general, implantation of neurostimulation systems or device includes subcutaneous or percutaneous placement of at least the electrodes. Preferred are minimally invasive implantation procedures, systems and devices that can reliably operate for extended periods, and systems and devices providing a high degree of comfort for the subject. The implantation specialist may need to address adequate placement of the electrodes with respect to the nerve tissue to be stimulated, and to choose between one or more convenient locations for the elements of the system or device.Methods are provided comprising forming a first 1250 and second 1260 incision on opposite sides of a target location, and introducing a first introducer sheath 3050a under the skin with a maximum internal transverse cross-section less than the further maximum transverse cross-section 710 of an implantable stimulator. Such a method is advantageous if the maximum transverse cross-section 710 of the further portion is at least 1.2 times greater than the maximum transverse cross-section 730 of the first portion—the dimensions of the implantation tools may be reduced.A further method is provided wherein the first portion 630 with at least two electrodes 200, 400 is introduced in the skin layers between the nerve tissue 2003 to be stimulated and above or in the aponeurosis layer 2009. By being implanted deeper and/or more accurately, comfort and/or reliability for the subject may be improved. In addition, the chance that the stimulator is implanted under the nerve tissue is greatly increased.