Pivoting Electrode Scaffold for RF Treatment of Biliary Strictures

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Solution Overview

Problem

Existing treatments for pancreatico-biliary tree strictures, such as stenting, often fail to effectively restore patency to occluded ducts, and additional therapies like radiofrequency (RF) energy application are needed to address these challenges.

Innovation Solution

The development of an intracorporeal medical device with a scaffold comprising a central member and pivotable extension members, equipped with electrodes, that can be collapsed for delivery and expanded for RF energy application to treat strictures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a stent is used to treat pancreatico-biliary strictures, then structural support is provided to the duct, but the stent fails to effectively restore patency to occluded ducts

Engineering Contradiction:
Improveefficacy of stricture treatmentVSAvoidrestoration of duct patency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent combines stenting (structural support) with radiofrequency energy application (therapeutic action) into a single integrated device. The scaffold provides mechanical support while electrodes deliver RF energy to the stricture, merging two separate treatments into one unified system that addresses both structural and pathological aspects of the obstruction.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device performs multiple functions simultaneously: the scaffold provides structural support to maintain duct patency, while the electrodes deliver radiofrequency energy to treat the stricture tissue. This multi-functional approach allows a single device to address both the mechanical obstruction and the pathological tissue causing the stricture.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If additional therapy with radiofrequency energy is applied to treat strictures, then treatment efficacy is improved, but the complexity of the treatment protocol increases

Engineering Contradiction:
Improvetreatment efficacyVSAvoidtreatment protocol complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent integrates the RF energy delivery system directly into the stent structure, combining what would traditionally be separate procedures (stent placement and RF ablation) into a single device deployment. This reduces treatment protocol complexity by eliminating the need for separate therapeutic interventions.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If electrodes are integrated into the scaffold to deliver RF energy, then direct energy application to stricture is achieved, but the device structure becomes more complex

Engineering Contradiction:
Improveenergy delivery effectivenessVSAvoidscaffold structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The scaffold is divided into discrete segments or struts, with electrodes integrated at specific locations along these segments. This segmentation allows the RF energy to be delivered at multiple discrete points along the stricture, improving treatment effectiveness while maintaining a manageable structural design through modular electrode placement.

Inventive Principle:
Principle #1Segmentation

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 device effectively delivers RF energy to restore patency to occluded ducts by applying energy directly to the stricture, improving treatment efficacy.

Implementation Method 1

additional therapies like radiofrequency (RF) energy application are needed

Methodology Applied
Scientific EffectRadiofrequency energy: Electromagnetic Induction

Implementation Method 2

electrode located at a distal end of each of the plurality of extension members, wherein each electrode extends through at least a portion of the covering

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS12539168B2Medical device having extendable members
Publication Date: 2026.02.03 BOSTON SCIENTIFIC SCIMED INC
  • US12539168B2 patent drawing
  • US12539168B2 patent drawing
  • US12539168B2 patent drawing

AI summary

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device includes a scaffold including a central member and a plurality of extension members extending away from the central member. The central member includes a plurality of discrete attachment locations corresponding to each of the plurality of extension members and each of the plurality of extension members is pivotably coupled to the central member at a corresponding discrete attachment location. The medical device also includes a covering substantially surrounding the scaffold and an electrode located at a distal end of each of the plurality of extension members. Each electrode extends through at least a portion of the covering.