Cardiac Stimulation Lead With Fixed Helix for Septal Puncturing

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Solution Overview

Problem

Existing cardiac pacing methods, such as traditional right ventricular apical pacing, lead to deleterious effects on left ventricular function and inefficient ventricular contraction, while alternative methods like left bundle branch pacing face challenges in minimizing septum impact, downsizing, and ensuring long-term reliability.

Innovation Solution

A lead device with a fixed distal helix and specific dimensions, combined with a screwing stylet, facilitates controlled puncturing through the septum, providing improved torque transfer and reliability for precise placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a traditional right ventricular apical pacing lead is used, then lead position stability is improved, but left ventricular contraction efficiency deteriorates

Engineering Contradiction:

Improvelead position stabilityVSAvoidleft ventricular contraction efficiency

Core Design Contradiction:

Stability of the object's compositionVSProductivity

Solution Approach 1:

The lead device segments the pacing function by providing multiple electrodes at different locations (RV apex, RVOT, and septal electrodes). This allows selective pacing of different cardiac regions to achieve both stable lead positioning and improved left ventricular contraction efficiency through physiological activation patterns.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The invention extends pacing from traditional single-site RV apical pacing to multi-dimensional pacing by adding electrodes in the RVOT and septal regions. This spatial dimensionality change enables optimization of both lead stability and ventricular activation efficiency simultaneously.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

2Productivity

If left bundle branch pacing is performed through septal puncturing, then physiological ventricular activation is improved, but tissue damage risk increases

Engineering Contradiction:

Improveventricular activation efficiencyVSAvoidseptum tissue damage

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The lead device applies local quality by providing multiple electrodes at specific locations (RV apex, RVOT, and septum). This allows concentrated pacing energy at the septal target site for physiological activation while distributing mechanical stress across multiple lead segments, reducing overall tissue damage risk.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The RVOT electrode serves as an intermediary, allowing pacing to be delivered near the septum without requiring direct septal puncture in some configurations. This mediates between the need for physiological activation and the risk of tissue damage.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If the lead tip diameter is reduced for easier insertion, then puncturing ease is improved, but structural strength deteriorates

Engineering Contradiction:

Improveinsertion easeVSAvoidlead tip structural strength

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The lead tip is segmented into multiple functional components (electrodes, insulation layers, conductive elements). This segmentation allows each component to be optimized independently - thin electrodes for easy insertion while maintaining overall structural integrity through the multi-layer construction.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The lead device uses composite materials with varying properties along its length - softer, more flexible materials at the insertion tip for ease of puncturing, transitioning to stronger, more rigid materials in the shaft for structural support and electrical conductivity.

Inventive Principle:

Principle #40Composite materials

4Ease of operation

If a fixed helix is added to the lead tip for better control, then handling during puncturing is improved, but device complexity increases

Engineering Contradiction:

Improvepuncturing controlVSAvoidlead tip structure

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The fixed helix is merged with the lead tip structure, combining the mechanical anchoring function of the helix with the electrical pacing function of the electrodes. This integration achieves puncturing control without requiring separate control mechanisms, thus limiting the increase in device complexity.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS12440670B2Lead device for improved puncturing for cardiac stimulation

Publication Date: 2025.10.14 SORIN CRM

AI summary

The invention relates to a lead device with improved puncturing capability and reliability. The proposed structure, shape and dimensions of a tip of the lead device are configured to enable a controlled and smooth puncturing process through the septum or other tissue at the target area with high reliability and longevity. A fixed helix is provided to facilitate handling and an additional screwing sty let with screwdriver functionality may be provided to improve torque transfer to the tip of the lead device for better control of a puncturing process.