Braided Lead Embedded Fixation Structures
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Solution Overview
Problem
Implantable medical leads used for nerve stimulation often become dislodged due to ambulatory stresses, leading to inconsistent nerve stimulation and potential nerve damage, and their removal can result in fibrous tissue formation, causing breakage and fragment migration, necessitating additional surgery.
Innovation Solution
A braided medical lead with embedded reinforcing structures that increase tensile strength by at least 15% and include fixation structures that can fold against the lead body during removal, reducing the risk of dislodgement and facilitating safe extraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suture fixation devices are used for nerve stimulation leads, then the lead can be initially positioned, but the lead becomes dislodged due to ambulatory stresses
Solution Approach 1:
The lead incorporates a braid made of multiple fibers with different properties (e.g., flexible polymer fibers and stronger reinforcement fibers) woven together to create a composite structure that simultaneously provides flexibility for implantation and high tensile strength for resisting dislodgement forces
2Ease of operation
If the lead is made more flexible for implantation, then the lead can be easily positioned, but the lead becomes more susceptible to dislodgement from ambulatory stresses
Solution Approach 1:
The lead structure is divided into segments with different mechanical properties - a flexible distal section for easy implantation and positioning near the nerve, and a more rigid proximal section with higher tensile strength to resist dislodgement forces from patient movement
3Reliability
If the lead remains fixed in tissue after implantation, then stable stimulation is achieved, but fibrous tissue formation causes lead breakage and fragment migration during removal
Solution Approach 1:
The lead incorporates a retrieval cord or extraction mechanism that allows the lead to be deliberately withdrawn from the tissue before fibrous encapsulation occurs, enabling removal without fragmentation while maintaining stable stimulation during the intended implantation period
4Reliability
If the electrode is placed closer to the target nerve, then stimulation efficacy is improved, but inflammation or injury to the nerve can result
Solution Approach 1:
The lead incorporates localized features such as insulation discontinuities, coating variations, or geometric modifications at specific electrode zones to control the distribution and intensity of electrical fields, enabling effective stimulation while limiting current density to prevent nerve damage
Data Source
AI summary
In some examples, a method of making a therapy delivery element configured for at least partial insertion in a living body includes braiding a plurality of fibers to form an elongated braided structure with a lumen. At least one reinforcing structure is weaved into the fibers of the braided structure. A portion of the reinforcing structure is extended from the braided structure to form at least one fixation structure. At least one of the braided structure or the reinforcing structure can be attached to at least one of an electrode assembly or a connector assembly.