Temperature-Responsive Implantable Lead Fixation Mechanism
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Solution Overview
Problem
Existing implantable neurostimulation leads face challenges in maintaining electrode contact with sacral nerves due to movement and migration, requiring fixation mechanisms that are difficult to reposition once deployed.
Innovation Solution
An implantable medical electrical lead with a modifiable portion that changes configuration from a first to a second temperature, providing greater resistance to movement within the body tissue, coupled with electrodes for electrical stimulation, allowing for easier positioning and fixation without surgical sutures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If fixation mechanisms such as sutures or tines are used to prevent lead migration, then lead stability is improved, but the ability to reposition the lead is lost
Solution Approach 1:
The lead fixation mechanism transitions from a static state during implantation to a dynamic locked state after deployment. The retention member is initially in a first configuration that allows the lead to be moved, and after deployment it transforms to a second configuration that prevents movement, thus resolving the contradiction between initial repositioning ease and final stabilization.
Solution Approach 2:
The retention member is pre-configured in a movable state during the implantation process, allowing the lead to be positioned and repositioned as needed. Once the lead is properly positioned, the retention member is deployed to lock the lead in place, ensuring long-term stability without compromising the initial ability to reposition.
2Ease of operation
If the lead is allowed to move freely for positioning, then ease of implantation is improved, but electrode contact stability deteriorates
Solution Approach 1:
The system dynamically transitions from a mobile state during implantation to a fixed state after deployment. The retention member enables the lead to move freely during positioning, then locks into place to ensure stable electrode contact with the sacral nerve, resolving the contradiction between positioning ease and contact stability.
3Stability of the object's composition
If permanent fixation is applied immediately, then lead migration is prevented, but adjustment capability is lost
Solution Approach 1:
The retention member is prepared in advance in a non-restrictive configuration that allows full adjustment capability during implantation. After the lead is properly positioned and adjusted, the retention member is deployed to provide permanent fixation, thus preventing migration while maintaining the ability to adjust during the critical positioning phase.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The lead's temperature-responsive configuration enhances stability and resistance to movement, improving the efficacy of neurostimulation by maintaining optimal electrode contact with sacral nerves, thus addressing the challenges of lead migration and repositioning.
Implementation Method 1
at least one modifiable portion that exhibits a first configuration when exposed to a first temperature and a second configuration when exposed to a second temperature, wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration, and the second temperature is higher than the first temperature
Data Source
AI summary
The invention includes an implantable medical electrical lead for electrical stimulation of body tissue that includes at least one modifiable portion that exhibits a first configuration when exposed to a first temperature and a second configuration when exposed to a second temperature, wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration, and the second temperature is higher than the first temperature; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems including leads of the invention and methods of implanting leads of the invention are also included.