Balloon Catheter for Basivertebral Nerve Denervation

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Solution Overview

Problem

Conventional devices and methods fail to accurately and precisely deliver chemical denervation agents to the basivertebral nerve without causing trauma, making it difficult to effectively treat back and neck pain caused by vertebral degeneration.

Innovation Solution

A balloon catheter system is used to deliver a chemical denervation agent close to the basivertebral nerve, with the balloon expanding within the vertebra to increase surface area and release the agent, allowing for precise ablation or denervation of the nerve, minimizing trauma and providing prolonged pain relief.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional devices are used to deliver chemical denervation agents, then the nerve can be treated, but the delivery is not accurate or precise enough and causes undue trauma to the patient

Engineering Contradiction:

Improvedelivery accuracyVSAvoidpatient trauma

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The delivery system is segmented into multiple functional components: a catheter for navigation, an expandable balloon for positioning and surface area expansion, and a chemical delivery mechanism. This segmentation allows each component to perform its specific function optimally, achieving precise delivery while minimizing trauma through controlled expansion only at the target site

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The balloon catheter transitions from a collapsed one-dimensional state during insertion to an expanded three-dimensional state at the target site. This dimensional change enables the device to navigate through small incisions with minimal trauma while expanding to provide large surface area for chemical delivery directly at the nerve location

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

2Area of moving object

If the balloon is expanded within the vertebra, then the surface area increases for better agent delivery, but the device complexity increases

Engineering Contradiction:

Improveballoon surface areaVSAvoiddevice structure

Core Design Contradiction:

Area of moving objectVSDevice complexity

Solution Approach 1:

The balloon is designed to be dynamically expandable from a collapsed state during insertion to an expanded state at the target site. This dynamic transformation allows the device to maintain low profile during navigation while providing large surface area for chemical delivery, avoiding the need for a permanently complex structure

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The collapsible balloon can be nested within the catheter during insertion, similar to a nested doll structure. This nesting capability allows the large surface area balloon to be contained within a small delivery catheter, simplifying the overall device structure while maintaining the ability to expand to large surface area when needed

Inventive Principle:

Principle #7Nested doll (Nesting)

3Manufacturing precision

If chemical denervation agent is delivered within 1 mm of the basivertebral nerve, then precise ablation is achieved, but the difficulty of navigation increases

Engineering Contradiction:

Improveagent placement precisionVSAvoidnavigation difficulty

Core Design Contradiction:

Manufacturing precisionVSEase of operation

Solution Approach 1:

The expandable balloon serves as an intermediary between the delivery catheter and the basivertebral nerve. It provides a stable platform that can be positioned close to the nerve while allowing controlled chemical delivery, mediating between the navigation challenge and the precision requirement by creating a localized delivery zone

Inventive Principle:

Principle #24Intermediary (Mediator)

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 system enables accurate and minimally invasive delivery of chemical denervation agents, reducing back and neck pain while minimizing physical and psychological trauma to the patient, with the agent being released over several days or weeks for sustained pain relief.

Implementation Method 1

the balloon moves from an unexpanded or uninflated configuration to an expanded or inflated configuration within the vertebra

Methodology Applied

Scientific EffectPressure increase: Pressure Increase

Implementation Method 2

the chemical denervation agent diffuses through the balloon to deliver the chemical denervation agent at, near, or in the damaged area of the vertebra

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 3

the chemical denervation agent moves through pores the balloon to deliver the chemical denervation agent at, near, or in the damaged area of the vertebra

Methodology Applied

Scientific EffectPermeation: Permeation

Implementation Method 4

as a material that the balloon is made from degrades to prolong the release of the chemical denervation agent

Methodology Applied

Scientific EffectDegradation: Decomposition (biological)

Data Source

PatentUS11235128B2Devices for delivering a chemical denervation agent and methods of use

Publication Date: 2022.02.01 MEDTRONIC EUROPE SÀRL

AI summary

A method for treating back pain in a patient in need of such treatment is provided. The method includes positioning a balloon catheter in or adjacent to a treatment zone containing a basivertebral nerve. A chemical denervation agent is administered with the balloon catheter such that the chemical denervation agent chemically ablates at least a portion of the basivertebral nerve. Kits, systems and methods are disclosed.