Implantable Nerve Stimulation Lead with Spaced Electrodes and Fixation
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Solution Overview
Problem
Current nerve stimulation technologies face challenges in effectively accessing and stabilizing electrodes within the body to target specific nerves, such as the pudendal and sacral nerves, due to issues like lead migration and inadequate fixation, which can lead to suboptimal treatment outcomes.
Innovation Solution
The development of a stimulation lead with spaced electrodes and fixation structures that allow for precise anchoring and adjustable positioning, enabling simultaneous stimulation of multiple nerves, including the pudendal and sacral nerves, using a single device via various approaches like the transforaminal method, with flexible electrode configurations and deployable fixation mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single stimulation lead is used to target multiple nerves, then the number of leads implanted is reduced, but the complexity of electrode positioning and fixation increases
Solution Approach 1:
The stimulation lead is divided into multiple independent electrodes (first electrode, second electrode, third electrode) spaced at different positions along the lead body. Each electrode can be independently positioned and activated to target specific nerves (pudendal nerve, sacral nerves S2-S4), allowing a single lead to perform multiple stimulation functions that would otherwise require separate leads.
2Reliability
If fixation structures are added to prevent lead migration, then lead stability is improved, but the complexity of the lead device increases
Solution Approach 1:
The fixation structures are integrated directly onto the lead body as a unified component rather than being separate attachment devices. The fixation structures include features such as fins or barbs that are formed as part of the lead body itself, providing anchoring to surrounding tissue while maintaining a relatively simple overall device structure.
3Adaptability or versatility
If electrodes are spaced apart to stimulate multiple nerves, then the ability to target different nerves is improved, but the precision of electrode placement becomes more difficult
Solution Approach 1:
Different regions of the lead body are designed with specific electrode configurations optimized for targeting particular nerves. The first electrode is positioned for pudendal nerve stimulation, while second and third electrodes are positioned for sacral nerve stimulation. Each electrode's location, orientation, and activation parameters can be independently adjusted to achieve precise neural targeting.
4Reliability
If a modifiable portion with temperature-dependent configuration is added, then lead anchoring is improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The modifiable portion of the lead body contains shape memory material or other temperature-responsive material that changes its physical configuration in response to temperature variations. During implantation, the lead is introduced in a first configuration that is easy to deploy, and then heated to transform into a second configuration with enhanced anchoring features that engage surrounding tissue more effectively.
Data Source
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Figure 5A~5B
AI summary
In various examples, an apparatus includes a stimulation lead including an elongate body including a distal end and a proximal end. At least one first electrode is disposed proximate the distal end of the elongate body and is configured to stimulate a first target nerve. At least one second electrode is disposed between the at least one first electrode and the proximal end of the elongate body and is configured to stimulate a second target nerve. At least one first fixation structure is disposed between the at least one second electrode and the proximal end of the elongate body. The at least one first fixation structure is configured to anchor the stimulation lead proximate the sacrum, wherein the at least one first fixation structure is located on the elongate body and spaced a first distance proximally along the elongate body from the at least one first electrode.