Implanted Lead Repositioning Device for Safe Extraction
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Solution Overview
Problem
Existing methods for removing implanted elongated structures, such as cardiac leads, from the body are often ineffective due to encapsulation by fibrotic tissue, particularly in curved pathways, leading to complications like vein damage and the need for costly open heart surgery.
Innovation Solution
A device with a manipulator mechanism and elongated shaft, featuring controllable manipulator arms that can capture and lock the lead, allowing for repositioning along a less curved pathway to facilitate removal without causing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the lead is removed directly from the curved pathway, then the removal process is straightforward, but the fibrotic tissue encapsulation causes vein damage and dissection
Solution Approach 1:
The device performs preliminary action by repositioning the lead from a curved pathway to a straighter pathway before the actual removal process. The manipulator mechanism captures the lead and advances it along a different anatomical route, preparing the lead for safe extraction without causing vein damage during the repositioning or removal process.
Solution Approach 2:
The device acts as an intermediary tool between the implanted lead and the extraction process. The manipulator mechanism with its capture structure serves as a mediator that temporarily holds and repositions the lead, facilitating safe removal by changing the extraction pathway from curved to straighter route.
2Reliability
If open heart surgery is performed to remove the lead, then complete removal is achieved, but significant risk and cost are incurred
Solution Approach 1:
The invention replaces the need for open heart surgery with a less invasive mechanical device. The manipulator mechanism, delivered through catheter-based access, performs lead repositioning and removal functions that would otherwise require surgical intervention, thereby eliminating significant surgical risks while maintaining complete lead removal.
Solution Approach 2:
The device changes the parameters of the removal procedure by transitioning from a surgical approach to a percutaneous approach. This involves changing the access method, the pathway geometry (from curved to straighter), and the level of invasiveness, all while achieving the same goal of complete lead removal.
3Object-affected harmful factors
If the lead is left in place to avoid removal complications, then vein damage is avoided, but lead thrombosis and heart attack risks remain
Solution Approach 1:
The invention converts the potential harm of lead removal (vein damage) into a beneficial outcome by using the repositioning strategy. Instead of leaving the lead in place where it causes thrombosis risk, the device enables safe removal by changing the pathway, thereby converting the removal procedure from harmful to beneficial.
Solution Approach 2:
The device performs preliminary repositioning action to change the lead's pathway from curved to straighter route before final extraction. This preliminary maneuver eliminates the thrombosis risk associated with leaving the lead in place while avoiding vein damage that would occur with direct removal from the curved pathway.
4Adaptability or versatility
If multiple leads are present in the vein, then comprehensive cardiac monitoring is achieved, but vein obstruction and arrhythmia risk increase
Solution Approach 1:
The device enables extraction of unnecessary or problematic leads from the vein. By providing a mechanism to capture and reposition leads to a straighter pathway for removal, the device allows elimination of excess leads that cause vein obstruction, while preserving the monitoring function through selective lead removal rather than complete lead elimination.
Data Source
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AI summary
A device (10) for adjusting a position of an elongated structure implanted in biological tissue to facilitate removal. An inner sleeve (60) is received in an outer sleeve (50), and movable relative thereto. A manipulator mechanism (80) is engaged with the inner sleeve distal end, and extends in a distal direction. The manipulator mechanism is arranged to capture the elongated structure, and to lock the elongated structure to the device upon relative movement of the sleeves. A handle (12) is engaged with the inner sleeve, and a plunger (30) is engaged with the outer sleeve. The plunger is engaged with the handle and movable relative thereto, wherein the outer sleeve advances distally relative to the inner sleeve to maneuver the manipulator mechanism to capture the implanted elongated structure. The position of the elongated structure may be controllably adjusted to facilitate removal thereof from the biological tissue.