Multi-Helical Balloon for Renal Neuromodulation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current pharmacologic strategies for managing chronic sympathetic nervous system overactivity, particularly in conditions like hypertension and heart failure, have limited efficacy, compliance issues, and significant side effects, necessitating alternative treatment approaches.

Innovation Solution

Cryotherapeutic devices with integral multi-helical balloons are used for renal neuromodulation, specifically designed to inhibit or disrupt renal sympathetic nerves through cryogenic cooling, providing a minimally invasive method for reducing sympathetic tone and addressing associated disease states.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pharmacologic strategies are used to manage renal sympathetic overactivity, then sympathetic tone can be reduced, but efficacy is limited and side effects occur

Engineering Contradiction:

ImproveefficacyVSAvoidside effects

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent replaces pharmacologic (chemical) treatment with a mechanical/physical approach using cryotherapeutic balloons that deliver controlled cooling to renal sympathetic nerves. The balloons are inflated within renal arteries and cooled to temperatures between -20°C and -80°C to denature nerve proteins and disrupt sympathetic signaling, thereby substituting drug-based therapy with a physical energy-based intervention to achieve more reliable efficacy reduction without pharmacologic side effects.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If traditional thermal ablation is used to disrupt renal nerves, then sympathetic activity can be reduced, but vessel stenosis and pain occur

Engineering Contradiction:

Improveneuromodulation effectivenessVSAvoidvessel stenosis and pain

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the thermal parameter from high-temperature ablation (>50°C) to low-temperature cryotherapy (-20°C to -80°C). This parameter change fundamentally alters the tissue interaction mechanism: cryogenic temperatures cause controlled protein denaturation and nerve fiber disruption without the excessive heat damage that leads to vessel stenosis and severe pain. The lower temperature range provides a more favorable safety profile while maintaining neuromodulation effectiveness.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs periodic or intermittent cooling cycles rather than continuous thermal exposure. The cryotherapeutic balloons can be cooled in cycles with duration controlled between seconds to minutes, allowing periodic disruption of sympathetic nerves while providing intervals for tissue recovery and reducing cumulative thermal damage. This periodic action reduces the risk of excessive pain and vessel injury compared to continuous high-temperature ablation.

Inventive Principle:

Principle #19Periodic action

3Area of stationary object

If multiple separate balloons are used to treat renal arteries, then coverage can be improved, but device complexity increases

Engineering Contradiction:

Improverenal artery coverageVSAvoiddevice structure

Core Design Contradiction:

Area of stationary objectVSDevice complexity

Solution Approach 1:

The patent merges multiple separate balloon structures into a single integrated multi-chambered balloon device. The balloon comprises multiple chambers (first chamber in left renal artery, second chamber in right renal artery) that are part of one unified structure with a common body and control mechanism. This merging approach provides comprehensive bilateral renal artery coverage while simplifying the overall device structure, reducing the number of separate components, and enabling simultaneous or coordinated treatment of both kidneys through a single device insertion.

Inventive Principle:

Principle #5Merging (Combining)

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 cryotherapeutic approach effectively reduces renal sympathetic activity, offering a promising alternative to traditional pharmacologic treatments by providing long-term or short-term neuromodulation, potentially benefiting various organs and structures innervated by the sympathetic nervous system, with reduced pain and minimal risk of complications like vessel stenosis.

Implementation Method 1

Cryotherapeutic devices with integral multi-helical balloons are used for renal neuromodulation, specifically designed to inhibit or disrupt renal sympathetic nerves through cryogenic cooling

Methodology Applied

Scientific EffectCryogenic cooling: Cryogenics

Implementation Method 2

The shaft can include an inflatable body or region configured to expand and define a treatment region

Methodology Applied

Scientific EffectThermal expansion: Thermal Expansion

Data Source

PatentUS9095321B2Cryotherapeutic devices having integral multi-helical balloons and methods of making the same

Publication Date: 2015.08.04 MEDTRONIC ARDIAN LUXEMBOURG SARL

AI summary

A cryotherapeutic device having an integral multi-helical balloon section and methods of making the same. A method of forming the cryotherapeutic device can include forming an extruded integral shaft having first and second substantially parallel lumens. The method can further include twisting a distal section of the shaft such that the first and second lumens form intertwined helical portions. The first and second helical portions can be plastically enlarged to form an inflatable body configured to deliver therapeutically effective cryogenic cooling to a treatment site.