Torqueable Polymer Sheath for Pacing Lead Extraction
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Solution Overview
Problem
Current pacing lead extraction techniques face challenges such as ineffective mechanical sheaths that struggle with tortuous paths and hard tissues, leading to high forces that can result in lead breakage, and expensive laser systems that are unaffordable for many treatment centers.
Innovation Solution
A torqueable and flexible polymer sheath with a durable, radiopaque tip section and a braided composite construction, combined with a handle for improved rotation capabilities, allows for effective extraction of pacing leads by stripping or cutting adherent scar tissue with reduced force, minimizing lead breakage and ensuring patient safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If metal sheaths are used to strip scar tissue from implanted leads, then scar tissue removal capability is improved, but the ability to traverse tortuous lead paths deteriorates and application is limited to proximal locations
Solution Approach 1:
The sheath is constructed as a composite structure combining a flexible polymer shaft with a rigid tip section. The polymer shaft provides flexibility to navigate tortuous vascular paths, while the rigid tip section (made of metal or hard plastic) provides the necessary strength to penetrate and strip chronic scar tissue from the lead. This composite construction resolves the contradiction by integrating both flexible and rigid materials in a single device.
Solution Approach 2:
The sheath is divided into distinct functional segments: a flexible polymer shaft portion for navigation and a separate rigid tip section for tissue penetration. This segmentation allows each portion to be optimized independently - the shaft for flexibility and the tip for strength - thereby resolving the contradiction between traversing tortuous paths and penetrating hard tissue.
2Adaptability or versatility
If plastic sheaths are used to access distal lead locations, then ability to traverse tortuous paths is improved, but torque properties and penetration capability into hard tissue deteriorate
Solution Approach 1:
The sheath combines flexible polymer material for the shaft with rigid material (metal or hard plastic) for the tip section. This composite construction provides both the flexibility needed to reach distal locations through tortuous paths and the rigidity required to penetrate chronic scar tissue, resolving the contradiction between accessibility and penetration capability.
3Strength
If longitudinal forces are applied to dilate tissue away from the lead, then tissue separation is improved, but force loss occurs due to tortuousity and friction
Solution Approach 1:
The invention replaces the longitudinal dilation mechanism with a rotational cutting mechanism. Instead of pushing the sheath forward to dilate tissue (which loses force to friction and tortuousity), the operator rotates the sheath so that the distal tip's cutting edge mechanically severs the scar tissue attachment. This substitution of mechanical action from longitudinal to rotational resolves the energy loss problem.
4Strength
If heavy counter traction is applied to the lead during extraction, then tissue separation is improved, but pacing lead breakage risk increases
Solution Approach 1:
The invention replaces heavy longitudinal counter-traction with a rotational cutting mechanism. The distal tip of the sheath is designed with a cutting edge that severs the scar tissue attachment through rotation, requiring minimal axial force on the lead. This mechanical substitution eliminates the need for heavy counter-traction, thereby preventing lead breakage while still achieving effective tissue separation.
5Productivity
If laser devices are used to cut scar tissue away from the lead, then chronic lead removal effectiveness is improved, but cost and accessibility to treatment centers deteriorates
Solution Approach 1:
The invention employs a disposable mechanical sheath with a rigid cutting tip that can be inserted through the skin and advanced over the lead to the extraction site. This single-use device performs the tissue cutting function mechanically, replacing expensive reusable laser systems with an affordable disposable alternative that achieves the same clinical outcome without requiring expensive equipment infrastructure.
Data Source
AI summary
Systems and methods for separating an object such as a pacing lead from a patient tissue involve a flexible and torqueable shaft having an internal lumen sized to receive the object, and a hard separating mechanism for separating the object from the tissue. Typically the shaft and separating mechanism are advanced along or toward the object, and the separating mechanism is contacted with the tissue. The shaft is rotated to effect separation between the object and the tissue. The systems and methods are well suited for use in cardiac pacing or defibrillator lead explant procedures.