Stabilization Device for Safe Lead Tip Extraction

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Solution Overview

Problem

Current lead tip removal methods often result in excessive damage to the heart wall due to inadequate stabilization, leading to risks such as tearing or perforation of blood vessels and major bleeding during the extraction process.

Innovation Solution

The use of a stabilization device, such as a sheath with a stabilization device at its tip or a balloon, to stabilize the area around the lead tip, allowing for less forceful removal and distributing the traction force over a larger surface area, thereby reducing the risk of tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current lead tip removal methods are used without additional stabilization, then the removal process can be performed, but excessive damage occurs to the heart wall due to inadequate stabilization

Engineering Contradiction:

Improvesafety of lead tip removalVSAvoiddamage to heart wall

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A stabilization device is introduced as an intermediary element between the lead tip and the heart wall. This device provides additional stabilization and support during the removal process, distributing forces and preventing direct trauma to the heart wall tissue, thereby reducing damage while enabling safe extraction

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If force is applied to remove the lead tip from the heart wall, then the lead can be extracted, but tissue damage and bleeding occur due to excessive force requirements

Engineering Contradiction:

Improveefficiency of lead tip removalVSAvoidtissue damage and bleeding

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The stabilization device is positioned and activated before the lead tip removal force is applied. It creates a cushioning effect by providing structural support and force distribution to the heart wall area, allowing the extraction to proceed with reduced force requirements and minimized tissue trauma

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If the stabilization device is added to the removal system, then the risk of heart wall injury is reduced, but the device complexity increases

Engineering Contradiction:

Improvesafety of lead tip removalVSAvoidcomplexity of removal system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The stabilization device is designed to be nested within or integrated with the existing lead extraction system. It can be contained within a delivery catheter or sheath that is advanced over the lead, allowing the stabilization function to be added without requiring a completely separate complex system

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS10039569B2Stabilization device assisted lead tip removal

Publication Date: 2018.08.07 SPECTRANETICS CORP

AI summary

Lead tip removal is accomplished by first stabilizing an area around the lead tip attachment site in the heart wall. A balloon located at the tip of the lead when inflated expands substantially perpendicular to the lead, stabilizing the area around the lead tip. Upon further inflation, the balloon expands substantially parallel with the lead, causing the lead tip to pull away from the heart wall. In another embodiment, a sheath is inserted over the lead and advanced to the heart wall. A passive or active stabilization device is attached to the sheath tip to stabilize the area around the lead tip. In another embodiment, a balloon is located at the tip of the sheath that, when inflated, expands substantially perpendicular to the lead, stabilizing the area around the lead tip. The lead tip is removed with less force due to the stabilization provided to the lead tip area.