Cardiac Lead Extraction Device with Bendable Sheath
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Solution Overview
Problem
The removal of pacemaker and defibrillator leads is complicated by the development of encapsulating fibrous tissue, requiring aggressive methods that can cause serious damage to veins and heart tissue, and existing solutions often necessitate high forces that are difficult to control.
Innovation Solution
A cardiac lead extraction device with a controllable bendable flexible portion and motor-activated lead extraction assistive tools, such as tissue cutters and separators, that can bend to various angles and apply controlled forces to facilitate the removal of leads with reduced tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If aggressive methods (manual dilation, mechanical rotation, laser/RF ablation) are used to remove leads from fibrous tissue, then lead removal capability is improved, but tissue damage to veins and heart increases
Solution Approach 1:
The patent introduces a telescoping sheath as an intermediary device between the extraction force and the fibrous tissue. The sheath selectively engages with the fibrous tissue through its cutting edges while protecting the vein and heart tissue from direct contact with extraction forces. This mediator approach allows aggressive tissue separation while preventing harmful effects on surrounding structures.
Solution Approach 2:
The extraction device is divided into multiple functional segments: a telescoping sheath with cutting edges for tissue separation, a stylet for lead engagement, and a receiver for lead capture. This segmentation allows each component to perform its specific function independently, with the sheath handling tissue disruption while the stylet and receiver manage lead extraction, thereby reducing overall tissue damage.
2Productivity
If high forces are applied to separate lead from fibrous tissue, then extraction effectiveness is improved, but control difficulty increases
Solution Approach 1:
The device employs dynamic force control through the telescoping mechanism, where the sheath can extend and retract in response to tissue resistance. The motor-driven system adjusts force application in real-time, increasing force when needed to cut fibrous tissue and reducing force when encountering vascular structures, thereby maintaining effectiveness while improving control.
Solution Approach 2:
The motor-driven telescoping sheath system incorporates feedback mechanisms that monitor tissue interaction forces. When the sheath encounters resistance indicative of vascular tissue, the system automatically adjusts force application, preventing excessive forces from damaging veins and heart while maintaining sufficient force to cut fibrous encapsulation.
3Device complexity
If manual dilation methods are used, then device complexity is reduced, but extraction time and operator dependency increase
Solution Approach 1:
The motor-driven telescoping sheath system performs self-adjustment based on tissue feedback, automatically extending the sheath to engage fibrous tissue and retracting when vascular structures are encountered. This self-service capability eliminates the need for continuous manual manipulation, reducing extraction time while the automated control manages the complexity of force application.
Data Source
AI summary
The invention relates to a cardiac lead extraction system, comprising: a handle; an elongated body in communication with said handle; a bendable flexible portion in communication with said elongated body, said bendable flexible portion comprising a first lumen sized and shaped to fit over a cardiac lead; said bendable flexible portion being more flexible than said elongated body; an operational distal end in communication with said bendable flexible portion; where said bendable portion is configured to bend to a bending radius of less than 4 cm while keeping said first lumen open; and where said operational distal end comprises at least one lead extraction assistive tool, said operational distal end comprising a second lumen sized and shaped to fit over a cardiac lead, said second lumen being in communication with said first lumen, and said first lumen comprises an inner diameter of from about 1 mm to about 5 mm.