Bipolar Ablation Device for Stent Restenosis

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Solution Overview

Problem

Existing medical devices and methods for treating restenosis in implanted metallic stents, such as bare metal stents, are limited in effectively addressing tissue ingrowth and occlusion without causing damage to the surrounding tissue.

Innovation Solution

A bipolar ablation device comprising an elongate shaft with an electrode and an electrode lead that can be slidably disposed within an endoscope, allowing for electrical engagement with the implanted metallic stent to form a bipolar ablation device. This device enables directional or omnidirectional ablation within the stent lumen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing medical devices and methods are used to treat restenosis in implanted metallic stents, then tissue ingrowth and occlusion can be addressed, but surrounding tissue damage occurs

Engineering Contradiction:

Improveeffectiveness of treating restenosisVSAvoidsurrounding tissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The bipolar ablation device applies energy locally between two electrodes positioned within the stent lumen, creating a focused ablation zone that treats tissue ingrowth without affecting surrounding healthy tissue. The electrical current is confined to the region between the electrodes, enabling precise local treatment of restenosis while preserving adjacent structures.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The bipolar ablation device uses electrical current as an intermediary to transfer energy from the electrodes to the occluding tissue. This intermediate energy transfer mechanism allows controlled ablation of tissue ingrowth within the stent while the insulated design prevents direct contact with and damage to surrounding tissues.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If ablation energy is applied within the stent lumen, then stenosis can be treated effectively, but control over ablation direction becomes challenging

Engineering Contradiction:

Improveeffectiveness of stenosis treatmentVSAvoidcontrol of ablation direction

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The bipolar ablation device divides the ablation function into two separate electrodes (positive and negative poles) that can be independently positioned and oriented within the stent lumen. This segmentation allows the operator to control the direction of ablation energy by adjusting the relative positions and orientations of the two electrodes, enabling precise targeting of stenotic regions.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device incorporates movable and adjustable electrode components that can be dynamically repositioned within the stent lumen. The electrodes can be rotated, extended, or repositioned to orient the ablation field in the desired direction, providing operational flexibility and precise control over where the ablation energy is directed.

Inventive Principle:

Principle #15Dynamics

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 bipolar ablation device effectively treats stenosis within implanted metallic stents by directing ablation energy precisely within the stent lumen, minimizing tissue damage outside the stent and maintaining patency of the body lumen.

Implementation Method 1

Methodology Applied

Scientific EffectBipolar ablation: Ablation

Data Source

PatentUS20250025236A1Devices and methods for inducing ablation in or around occluded implants

Publication Date: 2025.01.23 BOSTON SCIENTIFIC SCIMED INC

AI summary

A bipolar ablation device for treatment of a stenosis within an implanted metallic stent may include an elongate shaft slidably disposable within an endoscope, the elongate shaft including at least one electrode configured to form a first pole of the bipolar ablation device, and an electrode lead slidably disposable within the endoscope. The electrode lead may be configured to electrically engage the implanted metallic stent to form a second pole of the bipolar ablation device. The elongate shaft may be positionable within a lumen of the implanted metallic stent.