Braided Reinforcement for Implantable Nerve Stimulation Leads
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Solution Overview
Problem
Implantable nerve stimulation leads often dislodge due to ambulatory stresses, requiring repositioning surgeries and risking nerve damage or inflammation, and their removal can lead to fragmentation and infection due to fibrous tissue formation.
Innovation Solution
A therapy delivery element with a braided reinforcement structure providing high elasticity and tensile strength, allowing for secure implantation and minimally invasive removal, featuring a free-floating proximal end that distributes tension forces effectively between the connector assembly and electrode assembly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional leads are used without braided reinforcement, then the lead is more flexible and easier to implant, but the lead is prone to dislodgement and fracture under ambulatory stresses
Solution Approach 1:
The lead incorporates a braided reinforcement structure consisting of multiple strands woven together to form a mesh-like pattern. This braided structure is integrated with the lead body, creating a composite construction that combines the flexibility of the lead material with the tensile strength of the braided reinforcement, thereby resolving the contradiction between strength and structural complexity.
2Reliability
If the lead is secured firmly to prevent dislodgement, then stimulation efficacy is maintained, but removal becomes difficult and may cause tissue damage
Solution Approach 1:
The braided reinforcement structure is designed as a separate, removable component that can be selectively engaged or disengaged from the lead body. During implantation, the braided structure provides firm anchoring to prevent dislodgement and maintain stimulation efficacy. During removal, the braided structure can be detached, allowing the lead to be extracted with minimal tissue damage, thus resolving the contradiction between reliability and harmful factors.
3Duration of action of stationary object
If the lead remains in place for extended periods, then consistent nerve stimulation is achieved, but fibrous tissue formation increases removal difficulty and infection risk
Solution Approach 1:
The braided reinforcement structure is designed to change its mechanical properties over time. Initially, it provides strong anchoring for reliable long-term stimulation. Over extended implantation periods, the braided structure can be designed to gradually degrade or become less tenacious, allowing for easier removal after the intended therapy duration, thus resolving the contradiction between duration of action and ease of manufacture.
Data Source
AI summary
A therapy delivery element configured for at least partial insertion in a living body. A braided structure surrounds the conductor assembly. A distal end of the braided structure is attached to an electrode assembly and a free floating proximal end is located near a connector assembly. An outer tubing surrounds the braided structure. The outer tubing includes a proximal end attached to the connector assembly and a distal end attached to the braided structure near the electrode assembly. A proximal tension force applied to the connector assembly acts substantially on the outer tubing and the conductor assembly and a proximal tension force applied to the free floating proximal end acts substantially on the braided structure.