Implantable Stimulation Assembly With Lead Force Decoupling
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Solution Overview
Problem
Conventional implantable medical devices face issues with mechanical coupling between leads and stimulation assemblies, leading to torsional, linear, and angular forces that can cause damage to intra-cochlear structures and result in sub-optimal electrode positioning due to coiling and twisting during surgical implantation.
Innovation Solution
The implementation of a decoupling structure, such as an angular discontinuity with a pre-formed bend and proximal extension, mechanically decouples the lead from the stimulation assembly, minimizing the transfer of torsional, linear, and angular forces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the lead is mechanically coupled to the stimulation assembly, then electrical connection is achieved, but torsional and angular forces are transferred causing damage to intra-cochlear structures
Solution Approach 1:
The lead assembly is segmented into a proximal lead portion and a distal stimulation assembly portion, connected through a decoupling structure. This segmentation allows the proximal lead to be manipulated during surgery while the distal stimulation assembly remains isolated and protected from mechanical forces.
Solution Approach 2:
A decoupling structure acts as an intermediary element between the proximal lead and distal stimulation assembly. This intermediary maintains electrical connectivity while mechanically isolating the stimulation assembly from torsional and angular forces applied to the lead during surgical implantation.
2Ease of operation
If the lead is coiled during surgical implantation, then positioning flexibility is improved, but twisting forces cause sub-optimal electrode positioning
Solution Approach 1:
The lead system is divided into flexible proximal and distal segments connected by a decoupling structure. The proximal segment can be coiled and manipulated during surgery without transmitting twisting forces to the distal segment, maintaining electrode positioning precision while providing surgical flexibility.
Solution Approach 2:
The decoupling structure serves as a mediator that allows the proximal lead to be coiled for surgical access while preventing the transmission of twisting forces to the distal stimulation assembly, thereby preserving optimal electrode positioning within the cochlea.
3Object-affected harmful factors
If the lead is made more flexible to reduce force transfer, then mechanical decoupling is improved, but structural integrity may be compromised
Solution Approach 1:
The lead is segmented into proximal and distal portions with different mechanical properties. The proximal lead can be more flexible to allow coiling and manipulation, while the distal lead maintains structural integrity for reliable electrode positioning, with a decoupling structure connecting them.
Solution Approach 2:
Different portions of the lead have different mechanical qualities tailored to their specific functions. The proximal lead exhibits greater flexibility for surgical manipulation, while the distal lead maintains higher structural integrity for stable electrode placement, with the decoupling structure transitioning between these properties.
Data Source
AI summary
Presented herein are techniques for mechanically decoupling (isolating) a stimulation assembly from an associated lead via pre-formed (e.g., pre-molded) discontinuity that connects a lead to an elongate stimulation assembly in a manner that substantially minimizes the transfer of torsional, linear, and/or angular forces from the lead to the stimulation assembly.