Calibrated Surgical Cutting Device for Lead Extraction
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Solution Overview
Problem
Current lead extraction devices face challenges in removing implanted cardiac pacing system leads due to scar tissue formation and attachment to vascular walls, making precise control and efficient separation difficult, especially in tortuous vascular environments.
Innovation Solution
A surgical device with an intermediate sheath assembly, inner sheath assembly, and outer shield mechanism that allows for controlled rotation and translation of a cutting tip to separate tissue from the lead, enabling safe removal of implanted objects by adjusting between shielded and extended configurations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a cutting tip is used to separate tissue from implanted leads, then tissue separation efficiency is improved, but the risk of uncontrolled cutting and damage to surrounding structures increases
Solution Approach 1:
An outer shield assembly acts as an intermediary between the cutting tip and surrounding structures. The shield can be selectively positioned to expose or protect specific areas, allowing the cutting tip to efficiently separate tissue while the shield prevents uncontrolled cutting and damage to blood vessels and other sensitive structures.
Solution Approach 2:
The shield drive mechanism enables dynamic control of the shield position relative to the cutting tip. The shield can be moved between protected and exposed positions during the cutting process, allowing the operator to adapt the level of protection based on the specific tissue being cut and surrounding anatomical structures.
2Manufacturing precision
If the cutting tip is extended for better tissue access, then cutting precision is improved, but the risk of damaging surrounding structures increases
Solution Approach 1:
The outer shield assembly serves as a protective intermediary that can be positioned to expose only the specific area where precise cutting is needed while protecting adjacent structures. This allows the cutting tip to be extended for precision work while the shield prevents damage to surrounding tissues.
3Measurement precision
If the device structure is made more complex with multiple sheath assemblies and shield mechanisms, then control precision is improved, but device complexity increases
Solution Approach 1:
The device employs a nested structure with an inner sheath assembly containing the cutting tip and an outer sheath assembly containing the shield. These nested components can be independently controlled, allowing precise control of the cutting tip while the outer shield provides additional control over tissue exposure. The nesting allows complex functionality to be achieved through organized hierarchical structure.
Solution Approach 2:
The shield drive mechanism and outer sheath assembly serve multiple functions: they protect surrounding structures, control tissue exposure, and can be positioned to accommodate different cutting depths and angles. This multi-functionality reduces the need for separate components, managing complexity through versatile design.
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.