Rotating Cutting Tip Sheath for Lead Extraction
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Solution Overview
Problem
Current lead extraction techniques face challenges in removing implanted cardiac pacing system leads due to scar tissue formation and attachment to vascular structures, making it difficult to safely and effectively remove leads from the body.
Innovation Solution
A surgical device with a sheath assembly and cutting tip mechanism that rotates to cut and separate tissue from the lead, featuring a shielded and extended configuration to navigate and remove leads from vascular structures, allowing for precise control and efficient tissue separation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If mechanical traction or simple sheath devices are used for lead extraction, then the procedure is simpler, but the ability to cut through scar tissue and separate lead from vascular structures is insufficient
Solution Approach 1:
The device employs a nested sheath configuration with an outer sheath and an inner sheath, where the inner sheath containing the cutting tip is housed within the outer sheath. This nested structure allows the device to maintain a compact, simple form for insertion while enabling complex cutting and tissue separation functions when deployed, thus resolving the contradiction between device simplicity and tissue separation effectiveness.
Solution Approach 2:
The cutting tip is designed to rotate relative to the sheath assembly, transforming from a static insertion configuration to a dynamic cutting configuration. This rotational capability enables the cutting tip to effectively separate scar tissue and lead from vascular structures, while the device remains simple and controlled during insertion, addressing the contradiction between operational simplicity and cutting effectiveness.
2Reliability
If a cutting tip is extended outside the sheath for tissue cutting, then tissue separation effectiveness improves, but the risk of damage to vascular structures increases
Solution Approach 1:
The outer sheath is positioned and deployed first to establish a protective barrier around the vascular structures before the inner sheath with the cutting tip is extended. This preliminary protective action ensures that even when the cutting tip is extended outside the sheath for effective tissue cutting, the vascular structures remain protected by the outer sheath, thus resolving the contradiction between cutting effectiveness and vascular structure protection.
3Object-affected harmful factors
If a shielded configuration is used to protect vascular structures, then safety improves, but the ability to access and cut tissue attached to the lead is reduced
Solution Approach 1:
The sheath assembly is segmented into distinct functional components: an outer sheath for protection and an inner sheath for tissue access and cutting. This segmentation allows the outer sheath to remain in place providing continuous vascular structure protection, while the inner sheath can be independently extended to access and cut tissue attached to the lead, thus resolving the contradiction between protective shielding and tissue accessibility.
4Reliability
If multiple sheath assemblies are used for controlled lead extraction, then safety and control improve, but device complexity increases
Solution Approach 1:
The device merges multiple protective and functional features into an integrated sheath assembly where the outer sheath and inner sheath work together as a coordinated system. The outer sheath provides initial protection and guidance, while the inner sheath provides targeted tissue cutting capability. This merging of functions into a single integrated assembly achieves reliable controlled lead extraction without the excessive complexity of multiple separate devices, resolving the contradiction between extraction control and device complexity.
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 device enables safe and effective removal of implanted leads by efficiently cutting and separating tissue, reducing the risk of damage to vascular structures and facilitating successful lead extraction.
Implementation Method 1
a cutting tip, the cutting tip including a cutting surface adapted to cut tissue coupled to the implanted object as the cutting tip rotates
Data Source
AI summary
Devices for removing implanted objects from body vessels are provided. A device includes a sheath assembly having a cutting tip. The cutting tip includes a cutting surface that is adapted to cut tissue coupled to an implanted object as the cutting tip rotates. The sheath assembly further includes an outer shield carried outside of the cutting tip. The outer shield includes a distal opening, and the outer shield is translatable relative to the cutting tip from a first position to a second position and vice versa. In the first position the cutting surface of the cutting tip is disposed within the outer shield, and in the second position the cutting tip extends through the distal opening and the cutting surface is at least partially disposed outside of the outer shield.