Implantable Medical Lead Distal Helix Bias
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Solution Overview
Problem
Transvenous medical leads face challenges during implantation due to issues with lead migration and orientation, particularly in varying patient anatomies, where the size and shape of lumens can complicate stable fixation and effective electrode placement.
Innovation Solution
The development of an implantable medical lead with a distal helix portion featuring a predetermined bias, including multiple coils with varying diameters and electrode configurations, allows for customizable sizing and shape to match patient-specific anatomy, ensuring stable implantation and optimal electrode positioning within veins.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If transvenous leads are implanted using minimally invasive procedures, then post-surgical trauma is reduced, but lead migration and orientation difficulties occur
Solution Approach 1:
The distal portion of the lead body is formed into a helical configuration with coils of predetermined diameter, creating a curved rather than straight structure. This helical shape allows the lead to better conform to the natural curvature of blood vessels and lumens, improving stability and reducing migration while maintaining minimally invasive implantation benefits
Solution Approach 2:
The lead design incorporates variable parameters including different helical diameters (small: 14-18mm, medium: 19-23mm, large: 24-28mm), varying coil configurations (constant, increasing, or decreasing diameter), and different lead body diameters (1.6-2.15mm). These parameter variations allow selection of optimal lead characteristics for different patient anatomies, improving both stability and compatibility with minimally invasive approaches
2Ease of manufacture
If leads are designed with fixed dimensions, then manufacturing is simplified, but adaptability to varying patient anatomies is reduced
Solution Approach 1:
The patent provides multiple lead embodiments with varying parameters including three size categories (small, medium, large) based on helical diameter, different coil configurations (constant, increasing, decreasing diameter), and multiple electrode arrangements. These parameter variations enable adaptation to different patient anatomies while maintaining standardized manufacturing processes for each size category
Solution Approach 2:
The lead is divided into distinct segments with different functional characteristics: a proximal portion with generally straight configuration for stable implantation, and a distal portion with helical configuration for enhanced stability and orientation. This segmentation allows each portion to be optimized for its specific function while simplifying the overall manufacturing approach
Data Source
AI summary
An implantable medical electrical lead includes a lead body having a longitudinal axis, the lead body including proximal and distal portions, the proximal portion being generally straight, and the distal portion being formed with a helix having a central axis; and a plurality of electrodes arranged along the helix, each of the electrodes having a length parallel to a lead body portion on which each of the electrodes is disposed, where the longitudinal axis and the central axis are approximately coaxial. The helix is formed with a predetermined bias, and may include at least two coils with electrodes, and optionally a third coil to provide a stabilization function. A method for implanting the lead includes inserting the lead in a lumen, and positioning the lead to dispose the plurality of electrodes against an internal wall of the lumen, in order to stimulate an adjacent structure, such as the phrenic nerve.