Capstan-Based SNS Lead Fixation Device for Stable Skin Anchoring
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Solution Overview
Problem
Current methods for temporarily anchoring sensory nerve stimulator (SNS) leads to the skin of a patient during trialing are not satisfactory, as they allow unintended movement of the leads and can cause additional trauma to the patient.
Innovation Solution
A novel trial lead skin fixation device is provided, which includes a base with an adhesive inner face and upstanding pillars. The device secures the SNS lead to the skin by positioning it alongside the pillars and under tension, creating a capstan effect for enhanced immobilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tape and/or sutures are used to hold the SNS leads to the skin during trialing, then the leads can be temporarily secured, but unintended movement of the leads occurs and additional trauma is caused to the patient
Solution Approach 1:
The fixation device is divided into distinct functional segments: a base portion that contacts the skin, upstanding pillars that engage the lead, and a cover that protects the assembly. This segmentation allows each component to perform its specific function optimally - the base provides secure skin attachment, the pillars provide lead immobilization through mechanical engagement, and the cover provides protection, collectively achieving reliable lead stabilization without patient trauma.
Solution Approach 2:
The fixation device acts as an intermediary element between the SNS lead and the patient's skin. Rather than directly suturing or taping the lead to the skin (which causes trauma), the device provides a mechanical interface that secures the lead through its pillars engaging the lead body while the base adheres to the skin, thereby eliminating direct traumatic contact between the lead and skin.
2Reliability
If tape and/or sutures are used to hold the SNS leads to the skin during trialing, then the leads can be temporarily secured, but the leads may displace from their position adjacent to the appropriate nerves
Solution Approach 1:
The fixation device is applied to the skin at the precise location where the lead exits, before any potential displacement can occur. The pillars are positioned to engage the lead at its exit point, creating immediate mechanical constraint that prevents subsequent movement. This preliminary fixation at the critical exit point ensures the lead maintains its accurate positioning adjacent to the target nerves throughout the trialing period.
Solution Approach 2:
The fixation device concentrates its immobilizing effect locally at the lead exit point on the skin surface, where the pillars engage the lead in a focused area. This localized mechanical engagement provides precise control over lead positioning at the critical interface between external and internal segments, preventing displacement without requiring extensive fixation along the lead's entire path.
3Reliability
If a fixation device with upstanding pillars is used to secure the SNS lead, then the lead is immobilized through the capstan effect, but the device complexity increases compared to simple tape or suture methods
Solution Approach 1:
The base of the fixation device utilizes a thin film structure with integrated adhesive properties, providing a simple yet effective foundation that adheres to the skin. This thin film base supports the upstanding pillars while maintaining overall device simplicity. The flexible nature of the thin film allows it to conform to the skin surface, ensuring reliable attachment without adding unnecessary structural complexity.
Solution Approach 2:
The upstanding pillars are strategically positioned and dimensioned to create an asymmetric mechanical engagement with the lead. The pillars have specific heights and spacing that optimize the capstan effect for lead immobilization. This asymmetric design provides efficient mechanical constraint with minimal material, achieving reliable lead fixation without requiring a symmetric or overly complex structure.
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 trial lead skin fixation device effectively secures SNS leads to the skin during trialing, preventing unintended movement and reducing trauma to the patient, while allowing for easy removal and subsequent implantation of permanent leads.
Implementation Method 1
an adhesive applied to the inner face of the base
Implementation Method 2
positioning it alongside the pillars and under tension, creating a capstan effect for enhanced immobilization
Data Source
AI summary
A novel method and apparatus for securing an object to a patient. In one form of the invention, the object comprises a sensory nerve stimulator (SNS) lead. And in one form of the invention, the object is secured to a patient using a capstan effect.