Lead Extractor Cutter Clamping Tissue Damage
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Solution Overview
Problem
Current lead extraction methods are complex and traumatic, causing significant tissue damage during the removal of implanted cardiac pacing leads due to the need for mechanical force and difficulty in handling scar tissue that has grown around the leads.
Innovation Solution
A lead extractor with a lumen that includes a cutter for incremental tissue dissection and clamping structures to securely grip and move the lead, allowing for relative movement within the extractor to cut surrounding tissue, minimizing tissue damage and optimizing the extraction process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If mechanical force is applied through a sheath to free the lead from tissue, then the lead can be removed, but significant tissue damage occurs
Solution Approach 1:
The cutter is extracted from the main body of the extractor and positioned at the distal end, allowing it to cut tissue adjacent to the lead while the lead remains clamped and stationary relative to the extractor body. This separates the cutting function from the force application point, enabling tissue removal without requiring excessive mechanical force on the lead itself
Solution Approach 2:
The cutter acts as an intermediary tool that removes the obstructing tissue between the lead and the extraction path. By cutting away the scar tissue and ingrown tissue, the cutter creates a clear path for lead removal, reducing the mechanical force needed and minimizing tissue damage
2Productivity
If mechanical force is applied to free the lead, then extraction is achieved, but the procedure becomes traumatic
Solution Approach 1:
The extraction procedure is segmented into distinct phases: tissue cutting by the distal cutter, followed by incremental lead movement by the proximal clamping structure. This segmentation allows the traumatic force application to be minimized and distributed, rather than applied all at once
Solution Approach 2:
The cutter performs preliminary action by removing the obstructing tissue before the lead extraction proceeds. This preliminary tissue removal reduces the resistance against which the lead must be pulled, thereby reducing the trauma of the extraction
3Ease of manufacture
If the lead is clamped and moved incrementally, then tissue cutting is optimized, but device complexity increases
Solution Approach 1:
The clamping structures and cutter are merged into a single integrated extractor device. The proximal clamping structure, distal clamping structure, and cutter all work together in coordination within one device, allowing precise tissue dissection while maintaining a manageable device architecture
Solution Approach 2:
The proximal clamping structure is made movable relative to the distal clamping structure, allowing incremental lead movement. This dynamic element enables precise control over the extraction process, allowing the lead to be moved step-by-step as tissue is cut, optimizing the tissue dissection precision
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 effectively removes cardiac leads with minimal tissue damage by applying the necessary force directly to the site of tissue cutting, reducing the risk of trauma and improving the mechanical efficiency of the extraction process.
Implementation Method 1
a cutter at a distal portion for cutting tissue adjacent the lead
Implementation Method 2
The lead is clamped by the extractor and incremental relative movement of the lead and retractor moves the lead within the extractor lumen
Data Source
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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.