Cochlear Implant Engagement Wings for Bone Undercut Retention
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Solution Overview
Problem
Cochlear implants face challenges in stabilization within biological tissues due to dynamic forces, leading to potential migration and tissue trauma, especially with the 'pocket' approach that avoids drilling and bone bed formation, where the implant is most likely to migrate anteriorly/inferiorly.
Innovation Solution
The use of engagement wings that extend laterally from the electrode lead, which are designed to fit into undercut features in the lead channel, providing mechanical retention without the need for bone drilling or sutures, thereby preventing migration and stabilizing the implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the 'pocket' approach is used to avoid drilling and bone bed formation, then surgical invasiveness is reduced, but implant stability deteriorates leading to migration
Solution Approach 1:
The lead channel is divided into two functional zones: an upper non-undercut portion for lead passage and a lower undercut portion for mechanical retention. This segmentation allows the channel to provide both access and stabilization functions, enabling the pocket approach to maintain stability without drilling or bone bed formation.
Solution Approach 2:
The undercut feature introduces a geometric dimension change in the lead channel, creating an expansion or widening at the distal end. This dimensional change provides mechanical interlocking capability that prevents anterior/inferior migration while maintaining the minimally invasive pocket approach.
2Stability of the object's composition
If traditional bone bed formation and drilling are used, then implant stability is improved, but surgical complexity and invasiveness increase
Solution Approach 1:
The lead channel serves multiple functions: it provides a pathway for the electrode lead, acts as a structural guide, and creates mechanical retention through the undercut feature. This multi-functionality eliminates the need for separate bone bed formation and drilling procedures, reducing surgical complexity while maintaining stability.
Solution Approach 2:
The lead channel itself provides the stabilization mechanism through its undercut geometry, eliminating the need for external fixation devices, bone beds, or additional anchoring structures. The channel's design inherently provides both access and retention functions.
3Stability of the object's composition
If the implant is stabilized using traditional methods, then migration is prevented, but tissue trauma and biological responses increase
Solution Approach 1:
The lead channel is segmented into an upper portion for lead passage and a lower undercut portion for retention. This segmentation allows the implant to be stabilized without requiring extensive bone removal or aggressive fixation methods, thereby reducing tissue trauma while preventing migration.
Solution Approach 2:
The undercut feature changes the geometric parameters of the lead channel at its distal end, creating an expansion or widening that provides mechanical retention. This parameter change enables stable implant fixation through geometric interlocking rather than invasive anchoring, reducing tissue trauma.
4Stability of the object's composition
If engagement wings are added to the lead channel, then mechanical retention is improved, but device complexity increases
Solution Approach 1:
The engagement wings are merged with the lead channel structure, forming an integrated retention system. The wings extend laterally from the channel walls and work together with the undercut geometry to provide mechanical retention, eliminating the need for separate fixation components and reducing overall device complexity.
Solution Approach 2:
The engagement wings serve multiple functions: they provide mechanical retention through lateral extension, guide the implant during insertion, and work in conjunction with the undercut feature to prevent migration. This multi-functionality reduces the need for additional separate components.
Data Source
AI summary
An implant system includes an implantable body (102), a lead (190) connected to the implantable body comprising at least one electrode, and engagement wings (400) mechanically joined to the implantable body to engage an undercut bone structure (405) to prevent motion of the implantable body toward the electrode after implantation.