Segmented Extraction Tip with Inward Radiused Edges
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Solution Overview
Problem
Existing medical devices for removing implanted cardiac leads from encapsulating tissue are often ineffective due to insufficient strength to cut through tough tissue growth and calcification, and may cause lead wrap or require expensive and equipment-intensive laser or radio frequency techniques, which are not versatile enough for all situations.
Innovation Solution
A tip structure with a proximal and distal portion, featuring a substantially flat leading face and inwardly directed radiused sides, designed to be engaged with an elongated sheath for easy rotation and disruption of encapsulating tissue, minimizing lead wrap and tissue damage, and suitable for use with both manual and powered extraction devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional extraction devices are used to remove cardiac leads, then the procedure can be performed with simple equipment, but the devices lack sufficient strength to cut through tough fibrotic tissue and calcification
Solution Approach 1:
The tip is segmented into multiple sides (6-12 sides) with each side having an inwardly directed radiused edge. This segmentation creates multiple discrete cutting points around the circumference, allowing the tip to effectively cut through tough fibrotic tissue and calcification while maintaining a manageable device structure.
Solution Approach 2:
The tip incorporates localized high-strength features at the distal end with inwardly directed radiused edges on each side. These localized features concentrate the cutting action at specific points, providing the necessary strength to cut through encapsulating tissue while the rest of the device maintains simpler construction.
2Strength
If conventional tips are used with radial protrusions, then tissue disruption capability is improved, but lead wrap is promoted
Solution Approach 1:
Instead of having radial protrusions extending outward from the tip surface, the invention inverts the geometry by creating inwardly directed radiused edges that curve into the tip. This inversion eliminates the protruding surfaces that cause lead wrap while maintaining the cutting effectiveness through the sharp inwardly directed edges.
Solution Approach 2:
The tip sides feature asymmetric geometry with inwardly directed radiused edges rather than symmetric radial protrusions. This asymmetric design creates sharp cutting points that effectively disrupt tissue while the inward curvature prevents the symmetric wrapping action that occurs with traditional radial protrusions.
3Reliability
If laser or radio frequency techniques are used for lead extraction, then effective tissue separation is achieved, but expensive equipment is required
Solution Approach 1:
The invention replaces complex laser or radio frequency systems with a purely mechanical solution. The tip's inwardly directed radiused edges provide effective tissue separation through mechanical cutting action during rotation, eliminating the need for expensive laser or RF equipment while achieving reliable lead extraction.
Solution Approach 2:
The tip is designed as a simple, potentially disposable mechanical component that can be manufactured at low cost. This disposable tip replaces expensive reusable laser or RF systems, providing effective tissue separation without the need for costly equipment investment and maintenance.
4Strength
If the tip has a longer distal portion for better tissue engagement, then tissue disruption improves, but the risk of lead wrap increases
Solution Approach 1:
The inwardly directed radiused edges invert the traditional geometry, creating tissue engagement surfaces that curve into the tip rather than protruding outward. This inversion maintains effective tissue engagement through the sharp inward edges while the concave geometry prevents lead wrap by eliminating outward-facing surfaces.
Solution Approach 2:
Tissue engagement is concentrated at the localized inwardly directed radiused edges on each side of the tip, rather than along the entire length of the distal portion. This localized quality provides effective tissue disruption at the cutting points while minimizing the surface area that could potentially cause lead wrap.
Data Source
AI summary
A tip engageable with an elongated sheath member for extracting a cardiac lead from an obstruction in a body vessel of a patient. The tip includes a tip body having a proximal end, a distal end, and a passageway extending therethrough. The tip body proximal end is engageable with the distal end of the sheath member distal end. The passageway of the tip is aligned with the passageway of the sheath such that the cardiac lead is receivable therein. The tip body distal portion has a plurality of sides extending circumferentially therearound, wherein the sides have respective ends and an inwardly directed radiused portion between the ends.