Cardiac Lead Extraction With Motorized Fibrous-Tissue Disruption
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Solution Overview
Problem
The removal of cardiac leads is complicated by the development of encapsulating fibrous tissue, often requiring aggressive dilation or ablation, which can cause serious damage to veins and heart tissue due to high forces exerted during the procedure.
Innovation Solution
A cardiac lead extraction device with a controllable bendable flexible portion and motor-activated lead extraction assistive tools, such as a tissue cutter or separator, allows for controlled manipulation and reduced force application during lead separation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If aggressive dilation or ablation is used to remove encapsulating fibrous tissue, then lead extraction capability is improved, but tissue damage to veins and heart increases
Solution Approach 1:
The device performs preliminary action by mechanically fracturing and disrupting the fibrous tissue encapsulation before lead extraction. The distal tip with its specialized structure breaks down the tissue barriers in advance, allowing subsequent lead removal with reduced force and minimized tissue damage.
Solution Approach 2:
The device segments the fibrous tissue encapsulation into smaller fragments through mechanical disruption at the distal tip. This fragmentation approach allows the tissue to be broken down progressively rather than requiring aggressive single-force extraction, thereby reducing overall tissue trauma.
2Reliability
If high forces are exerted during lead removal, then lead extraction success is improved, but damage to vein walls and heart tissue increases
Solution Approach 1:
The device applies preliminary mechanical disruption to the fibrous encapsulation at the distal tip, weakening the tissue-adhesion bonds before the lead is pulled. This preliminary action reduces the peak forces required during extraction, ensuring reliable lead removal while protecting vein and heart tissue from high-force damage.
3Object-affected harmful factors
If manual dilation is used to remove fibrous tissue, then tissue damage is reduced, but extraction efficiency decreases
Solution Approach 1:
The device combines preliminary mechanical disruption at the distal tip with a dilation mechanism. This approach pre-weakens the fibrous tissue encapsulation, enabling more efficient extraction with reduced force requirements, thereby improving extraction efficiency without compromising tissue safety.
Solution Approach 2:
The device segments the fibrous tissue through mechanical disruption, breaking it into manageable fragments that can be more easily separated from the lead. This segmentation improves extraction efficiency by reducing the cohesive strength of the encapsulation without requiring aggressive high-force maneuvers that would damage tissue.
4Ease of operation
If inexperienced users perform lead removal, then procedure accessibility is improved, but risk of complications increases
Solution Approach 1:
The device performs self-service by automatically disrupting the fibrous tissue encapsulation through its distal tip mechanism. This reduces the skill level required from the operator, as the device handles the complex tissue separation function autonomously, improving accessibility while maintaining safety and reducing complication risks even for inexperienced users.
Data Source
AI summary
The invention relates to a cardiac lead extraction device, comprising: a handle; an elongated body having a first proximal end, a first distal end, and a first lumen extending from said first proximal end toward said first distal end, said lumen sized and shaped to fit over a cardiac lead; a controllable bendable flexible portion more flexible that said elongated body and having a second proximal end, a second distal end and a second lumen extending from said second proximal end toward said second distal end, said lumen sized and shaped to fit over a cardiac lead; said second proximal end interconnected to said first distal end; said second distal end interconnected to an operational distal end; wherein said operational distal end comprises at least one lead extraction assistive tool, said lead extraction helping tool is activated by a motor located at said handle or proximally to said handle.