Lead Extractor Cutter for Minimizing Tissue Damage
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Solution Overview
Problem
Current lead extraction methods for cardiac pacing leads are complex and traumatic, often causing tissue damage due to the need for mechanical force and difficulty in handling scar tissue and ingrowth, which complicates the removal process.
Innovation Solution
A lead extractor with a proximal and distal portion, a lumen for the lead, and a cutter at the distal portion to cut tissue adjacent the lead, featuring clamping members that move incrementally to secure and release the lead, allowing for relative movement within the extractor to facilitate removal with minimal tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If mechanical force is applied to free the lead from surrounding tissue, then the lead can be removed, but tissue damage occurs
Solution Approach 1:
The cutter is extracted from the standard extractor design to perform tissue cutting before lead removal. This separates the tissue disruption function from the lead extraction function, allowing the lead to be removed with minimal mechanical force and thus minimal tissue damage.
Solution Approach 2:
The cutter performs preliminary action by cutting the scar tissue and ingrowth before the lead extraction process begins. This preliminary tissue division reduces the mechanical resistance during subsequent lead removal, enabling easier extraction with less force applied to the tissue.
2Ease of operation
If a sheath is placed over the lead to reach the distal portion, then the lead can be accessed, but placement becomes difficult due to hardened tissue
Solution Approach 1:
The cutter acts as an intermediary tool that simplifies access to the distal lead portion by cutting through hardened tissue barriers. Instead of forcing the sheath through difficult tissue, the cutter prepares the path, making sheath placement and lead access easier.
3Reliability
If the lead is attached to the vein at the curve, then the lead is secured in position, but release becomes difficult
Solution Approach 1:
The cutter extracts the lead from its anchored position by cutting the tissue attachments at the vein curve. This removes the secure attachment that made release difficult, allowing the lead to be freed from its fixed position without excessive force.
4Reliability
If tissue ingrowth occurs along the lead, then the lead is firmly anchored, but removal becomes complicated
Solution Approach 1:
The mechanical extraction process is supplemented with a cutting mechanism that divides the ingrown tissue. Instead of relying solely on mechanical force to pull the lead through ingrown tissue, the cutter separates the tissue attachments, simplifying the extraction procedure.
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
The extractor enables secure and minimally traumatic removal of cardiac leads by cutting surrounding tissue as it moves relative to the lead, reducing the risk of tissue damage and simplifying the extraction process.
Implementation Method 1
a cutter at the distal portion for cutting tissue adjacent the implanted lead
Implementation Method 2
The extractor and lead are incrementally relatively movable to remove the lead
Data Source
AI summary
An extractor for removing an implanted lead from a patient. The extractor includes a lumen dimensioned to receive the lead therein, a cutter at the distal portion for cutting tissue adjacent the lead, a distal clamping structure and a proximal clamping structure The proximal clamping structure and lead are relatively movable to extract the lead.