Tissue Slitting Tip for Lead Extraction
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Solution Overview
Problem
Current lead extraction techniques face challenges in removing implanted leads due to tissue growth forming a tubular structure around the lead, which resists removal by constricting and capturing the lead, especially in tortuous vascular paths, and existing methods often require excessive force that may lead to lead breakage or tissue damage.
Innovation Solution
A tissue slitting apparatus and method that selectively slits the tissue growth along a partial perimeter to weaken the constrictive forces, allowing for the removal of the lead without mechanically or laser ablating the entire tissue circumference, using a flexible shaft with a tissue slitting tip to separate the tissue growth and facilitate lead extraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical traction or laser devices are used to remove leads, then lead extraction can be achieved, but excessive force is required that may lead to lead breakage or tissue damage
Solution Approach 1:
The tissue slitting device performs preliminary action by cutting the tissue growth that constricts the lead before extraction. The device includes a cutting element that severs the tissue encasing the lead, eliminating the constrictive forces that would otherwise require excessive extraction force and potentially cause lead breakage or tissue damage
Solution Approach 2:
The tissue growth surrounding the lead is segmented by cutting it into separate portions. The cutting element divides the continuous tissue constriction into disconnected segments, allowing the lead to be extracted without pulling against the full circumferential tissue force
2Reliability
If dilation techniques are used to strip away scar tissue, then tissue removal is achieved, but heavy counter forces are required that may result in lead breakage
Solution Approach 1:
The patent replaces the mechanical dilation system with a cutting-based system. Instead of using a dilating sheath that pushes tissue away longitudinally requiring heavy counter forces, the tissue slitting device uses a cutting element to sever the tissue growth, eliminating the need for forceful mechanical dilation that could cause lead breakage
3Ease of operation
If complete circumferential ablation of tissue growth is performed, then lead removal is facilitated, but excessive tissue damage and procedural complexity occur
Solution Approach 1:
The tissue slitting device applies partial action by cutting only a portion of the tissue growth circumference rather than ablating the entire circumference. The cutting element severs the tissue at specific locations sufficient to release the constrictive forces on the lead, avoiding unnecessary damage to surrounding healthy tissue and reducing procedural complexity compared to complete circumferential ablation
Data Source
AI summary
Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting device is configured to engage patient formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting device is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting device 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 methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.