Evertable Sheath for Atraumatic Cardiac Lead Extraction
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Solution Overview
Problem
Current methods for removing chronically implanted medical devices, such as cardiac leads, often result in trauma to surrounding tissues due to fibrous tissue growth and require complex surgical procedures or risky techniques like traction and counterpressure, which are not always safe or effective.
Innovation Solution
A medical device with an evertable tubular cover attached to the lead that tears and everts upon application of a longitudinal force, reducing the force required for extraction and minimizing tissue damage, allowing for safer and less traumatic removal of implanted devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traction force is applied to extract the lead, then the lead can be removed, but significant trauma and tissue damage occur
Solution Approach 1:
A tubular cover is introduced as an intermediary element between the lead and the surrounding tissue. The cover is attached to the lead and extends beyond its distal end, allowing the lead to be extracted through the cover while the cover absorbs and distributes the mechanical stress, preventing direct trauma to the tissue. The cover can be made of flexible materials that accommodate tissue ingrowth while facilitating atraumatic removal.
Solution Approach 2:
The tubular cover is constructed from flexible materials such as biocompatible polymers or metals that can deform and adapt to the surrounding tissue. This flexibility allows the cover to accommodate tissue ingrowth during the implantation period while enabling atraumatic extraction by distributing extraction forces along its length rather than concentrating them at the lead-tissue interface.
2Productivity
If counterpressure is applied to peel calcified tissues, then extraction is facilitated, but tissue damage occurs
Solution Approach 1:
The tubular cover serves as a mediator between the extraction force and the tissue. When counterpressure is applied to peel calcified tissues from the lead, the cover distributes this pressure over a larger area and controls its application, reducing concentrated stress points that would cause tissue damage while still facilitating the separation of calcified masses from the lead body.
3Productivity
If surgical approaches are used to remove leads, then successful removal is achieved, but morbidity and high cost result
Solution Approach 1:
The tubular cover is attached to the lead before implantation and remains in place during the implantation period. This preliminary preparation allows for atraumatic extraction without requiring surgical approaches, as the cover is already positioned to facilitate removal. The cover can be designed with features that promote tissue ingrowth during implantation while enabling easy extraction afterward, eliminating the need for morbidity-associated surgical procedures.
4Force
If the tubular cover is made to tear and evert, then extraction force is reduced, but control over the process must be maintained
Solution Approach 1:
The tubular cover can be designed with segmented or layered structures that allow controlled tearing or peeling during extraction. The cover may include weak points or separation layers that enable it to tear in a controlled manner, reducing extraction force while maintaining operator control. The segmentation allows the cover to progressively separate from the tissue rather than requiring sudden, uncontrolled force.
Data Source
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AI summary
The present invention is an implantable device for the atraumatic removal of chronically implanted medical devices.