Distal End Supported Tissue Slitting Apparatus for Lead Extraction
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Solution Overview
Problem
Current lead extraction techniques face challenges, particularly when leads are embedded in tortuous paths or structurally weak vascular areas, as they require high longitudinal forces that can lead to lead breakage or complications, and existing methods assume direct tissue adherence to the lead, which is not always the case.
Innovation Solution
A tissue slitting device and method that exploit the tubular growth of tissue around leads by creating a partial slit along the tissue's circumference, allowing for lead removal without extensive mechanical or laser-based tissue removal, using a flexible shaft with a distal end tissue slitting tip that can cut, drill, or ablate tissue to weaken the tissue's hold on the lead.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical traction or dilation techniques are used to extract leads, then lead removal can be achieved, but high longitudinal forces are required that may cause lead breakage or vascular damage
Solution Approach 1:
The tissue growth surrounding the lead is segmented by creating a circumferential slit, dividing the continuous tissue constraint into separated sections that no longer exert unified restrictive force on the lead
Solution Approach 2:
The restrictive tissue growth is selectively removed or severed from the lead by the slitting action, extracting the harmful constraining element while preserving the lead integrity
2Productivity
If high longitudinal forces are applied to extract leads from tortuous paths, then lead removal may be achieved, but lead breakage risk increases significantly
Solution Approach 1:
The tissue growth is pre-cut or pre-weakened by the slitting action before lead extraction attempts, preparing the tissue in advance to reduce resistance during subsequent lead removal
Solution Approach 2:
The mechanical traction system is replaced with a tissue-cutting system that severs the tissue constraint, substituting direct force application on the lead with indirect tissue separation
3Adaptability or versatility
If existing tissue removal methods are used, then tissue adherence is addressed, but they assume direct tissue-lead contact which is not always the case with tubular tissue growth
Solution Approach 1:
The slitting action is applied locally at the tissue-lead interface or adjacent to it, targeting only the specific region where tissue growth constrains the lead while leaving other areas unaffected
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
Enables efficient lead extraction by reducing restrictive forces from tissue growth, allowing for the lead to be removed without damaging the lead or the vascular structure, by creating a slit that allows the lead to peel away from the surrounding tissue.
Implementation Method 1
a flexible shaft with a distal end tissue slitting tip that can cut, drill, or ablate tissue to weaken the tissue's hold on the lead
Data Source
AI summary
Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting apparatus is configured to engage formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting apparatus is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting apparatus causes the tissue to separate along an axial direction of the length of the formed tissue and releases at least some of the force containing the object. The slitting apparatus is supported by a distal end support device configured to lock onto the lead. While supported, a slitting element of the apparatus places fibers of the formed tissue under tension and performs a lifting cut operation. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.