Implantable Medical Lead with Interior Fixation Elements
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Solution Overview
Problem
Existing implantable medical elongated members, such as leads for electrical stimulation systems, face challenges in preventing migration and minimizing stress points with the integumentary layer of a patient, which can lead to inflammation and unintended nerve damage.
Innovation Solution
The implementation of an implantable medical elongated member with fixation elements along its interior surface, strategically positioned to avoid the epidermis and dermis, ensuring that the exterior surface is devoid of fixation elements in certain sections to minimize stress points and prevent migration while maintaining effective anchoring within the tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If fixation elements are added to the lead body to prevent migration, then the lead stability is improved, but stress points are created against the integumentary layer causing inflammation and potential nerve damage
Solution Approach 1:
The patent applies local quality by differentiating between two surfaces of the lead body: the first outer surface portion contains fixation elements for anchoring the lead, while the second outer surface portion is substantially devoid of fixation elements to minimize stress points against the integumentary layer. This localized differentiation allows the lead to simultaneously achieve stability through fixation elements while reducing harmful stress points by their strategic omission from the second surface.
2Reliability
If fixation elements are positioned to anchor the lead securely, then migration is prevented, but tissue irritation and discomfort increase
Solution Approach 1:
The patent segments the outer surface of the lead body into two distinct portions: a first outer surface portion with fixation elements for reliable anchoring, and a second outer surface portion without fixation elements to minimize tissue irritation. This segmentation allows the lead to achieve reliable migration prevention through fixation elements while reducing harmful tissue irritation by their strategic absence from the second surface that contacts the integumentary layer.
3Stability of the object's composition
If the lead is anchored deeply in tissue to ensure stability, then migration resistance is improved, but the risk of nerve damage increases
Solution Approach 1:
The patent applies local quality by concentrating fixation elements on the first outer surface portion while leaving the second outer surface portion substantially devoid of fixation elements. This allows the lead to achieve migration resistance through fixation elements anchored in deeper tissue while minimizing the risk of unintended nerve damage by reducing the number of fixation elements that could contact or penetrate sensitive structures near the integumentary layer.
Data Source
AI summary
An implantable medical elongated member includes a first outer surface portion and a second outer surface portion extending around at least ten percent of an outer perimeter of the elongated member. A fixation element extends a distance from the first outer surface portion of the implantable medical elongated member. A longitudinally-extending section of the second outer surface portion proximate to a distal end of the elongated member is substantially devoid of any fixation elements that extend the distance from second outer surface portion. In some embodiments, the longitudinally-extending section of the second outer surface portion is substantially devoid of any exposed electrodes.