Stretchable Electrode Assemblies for Renal Nerve Ablation

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Solution Overview

Problem

Current medical devices for renal nerve ablation lack effective alternatives in design, materials, and manufacturing methods, which limits their ability to provide precise and controlled energy delivery for targeted tissue treatment without damaging neighboring nerves or organs.

Innovation Solution

A medical device with a catheter shaft and an expandable member or compliant balloon equipped with stretchable electrical pathways that change configuration from nonlinear to linear, allowing for controlled energy delivery through resistive flexible electrode assemblies, enabling precise ablation of renal nerves without exact contact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If rigid electrode assemblies are used, then structural stability is improved, but adaptability to expandable member configurations deteriorates

Engineering Contradiction:
Improvestructural stabilityVSAvoidadaptability to expandable member configurations
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The electrode assembly employs a flexible substrate that can conform to the expandable member's configuration. This flexible substrate allows the electrode assembly to adapt to different expanded configurations while maintaining structural integrity through its material properties and design.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The electrode assembly is designed to dynamically change its configuration as the expandable member expands or contracts. The flexible substrate and electrical pathways are engineered to accommodate dimensional changes, transitioning from a compressed state during delivery to an expanded state during operation.

Inventive Principle:
Principle #15Dynamics

2Device complexity

If electrical pathways are arranged in nonlinear configuration during delivery, then device complexity is reduced, but manufacturing precision deteriorates

Engineering Contradiction:
Improvedevice complexityVSAvoidmanufacturing precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The electrical pathways are designed with curved or serpentine configurations in the compressed state, which naturally accommodate the folding and compression of the flexible substrate. This curved design simplifies the delivery configuration while the manufacturing process ensures precise pathway geometry is maintained through standard flexible PCB or printed circuit techniques.

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Measurement precision

If expandable member is inflated, then energy delivery precision is improved, but device complexity increases

Engineering Contradiction:
Improveenergy delivery precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The expandable member is divided into multiple segments or zones with electrode assemblies distributed across different regions. This segmentation allows selective inflation of specific segments to target particular anatomical structures, improving energy delivery precision while keeping each individual segment relatively simple in design.

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 enables precise and controlled energy delivery for renal nerve ablation, reducing the risk of damage to surrounding tissues and allowing for effective treatment of conditions like hypertension by adjusting energy dosage and configuration for optimal therapeutic outcomes.

Implementation Method 1

a plurality of electrode assemblies fixedly attached to the compliant balloon, the plurality of electrode assemblies including a plurality of stretchable electrical pathways capable of stretching when the compliant balloon shifts to the inflated configuration

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

allowing for controlled energy delivery through resistive flexible electrode assemblies, enabling precise ablation of renal nerves

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS10413357B2Medical device with stretchable electrode assemblies
Publication Date: 2019.09.17 BOSTON SCIENTIFIC SCIMED INC
  • US10413357B2 patent drawing
  • US10413357B2 patent drawing
  • US10413357B2 patent drawing

AI summary

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter shaft. An expandable balloon may be coupled to the catheter shaft. The balloon may be capable of shifting between an unexpanded configuration and an expanded configuration. Electrode assemblies with electrical pathways may be coupled to the balloon. The electrical pathways may be capable of shifting between a serpentine configuration when the balloon is unexpanded to a straighter configuration when the balloon is expanded.