Anchoring Units for Implantable Nerve Stimulation Leads
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Solution Overview
Problem
Implantable electrical stimulation systems face challenges in securely anchoring leads on or around bony structures, such as sacra, due to patient movement causing leads to dislodge, and existing tines may not provide adequate anchoring or prevent lead migration through foramina.
Innovation Solution
The use of anchoring units with tines, springs, expandable stents, and deformable materials on the leads, which can be deployed after implantation to securely anchor the leads to bony structures, preventing migration and ensuring optimal positioning for stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing tines are used for anchoring leads, then the lead anchoring function is provided, but the anchoring is inadequate and leads may dislodge or migrate through foramina due to patient movement
Solution Approach 1:
The anchoring unit is divided into multiple functional segments: tines for initial positioning, expandable elements for securing, and deformable materials for adaptation. This segmentation allows each component to perform its specific function optimally while collectively providing reliable anchoring without excessive overall complexity.
Solution Approach 2:
The anchoring unit incorporates dynamic elements that can change state: tines that can be deployed or retracted, expandable elements that adjust to foramen dimensions, and deformable materials that adapt to bony structures. This dynamic capability ensures reliable anchoring while allowing the structure to remain compact during implantation.
2Stability of the object's composition
If anchors are placed within foramina to prevent lead migration, then lead stability is improved, but the implantation procedure becomes more complex and time-consuming
Solution Approach 1:
The anchoring unit is pre-configured with tines and expandable elements in a compressed state that allows for quick insertion through the foramen. Once positioned, the elements are rapidly deployed to secure the lead, minimizing the time required for anchoring while ensuring stable positioning.
Solution Approach 2:
The implantation procedure utilizes a rapid deployment mechanism where the anchoring unit is inserted quickly in a compact state and then rapidly expanded or deployed once positioned. This approach rushes through the critical anchoring phase, reducing overall implantation time while maintaining stability.
3Reliability
If multiple anchoring mechanisms are combined to prevent dislodgment, then anchoring effectiveness is improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
Multiple anchoring mechanisms (tines, expandable elements, deformable materials) are merged into a single integrated anchoring unit that functions as one cohesive component. This merging provides effective multi-mechanism anchoring while simplifying manufacturing compared to assembling separate components.
Solution Approach 2:
The anchoring unit is designed as a multi-functional component that performs multiple anchoring functions simultaneously: mechanical interlocking via tines, expansion for securing, and deformation for adaptation. This universality allows one component to replace what would otherwise require multiple separate devices, easing manufacturing.
Data Source
AI summary
A nerve stimulation lead has a distal end, a proximal end, and a longitudinal length. The nerve stimulation lead includes a plurality of electrodes disposed at the distal end, a plurality of terminals disposed at the proximal end, and a plurality of conductive wires electrically coupling the plurality of electrodes electrically to the plurality of terminals. The nerve stimulation lead also includes at least one anchoring unit disposed on the nerve stimulation lead. The at least one anchoring unit is configured and arranged for anchoring the nerve stimulation lead against a bony structure.