Balloon Catheter With Regulating Balloon for Reperfusion Control

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Solution Overview

Problem

Current catheters used in angioplasty procedures for reopening constricted blood vessels are inadequate in controlling reperfusion flow and preventing reperfusion injury, which can occur during the restoration of blood flow to ischemic tissue, leading to additional damage and complications.

Innovation Solution

A catheter design featuring an elongate tubular body with a dilatation balloon and a regulating balloon made of different materials, where the regulating balloon is more elastic than the dilatation balloon, allowing for precise control of blood flow through separate lumens and sensors for pressure and flow monitoring, enabling controlled inflation and deflation to minimize reperfusion injury.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single balloon is used for vessel dilation, then the device structure is simple, but the ability to control reperfusion flow and prevent reperfusion injury is insufficient

Engineering Contradiction:
Improveability to prevent reperfusion injuryVSAvoidcatheter structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter is divided into multiple functional segments: a dilatation balloon for vessel opening and one or more regulating balloons for flow control. Each balloon is connected to separate lumens allowing independent inflation and deflation, enabling distinct control of dilation and reperfusion flow to prevent injury while maintaining reasonable structural complexity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The regulating balloon(s) are positioned within or adjacent to the dilatation balloon structure, with both balloons mounted on the same catheter body. The balloons are nested or tandemly arranged to maximize space utilization and integrate multiple functions within a single catheter device

Inventive Principle:
Principle #7Nested doll (Nesting)

2Adaptability or versatility

If the same material is used for both balloons, then manufacturing is simpler, but the ability to independently control dilation and flow regulation is limited

Engineering Contradiction:
Improveindependent balloon controlVSAvoidballoon material selection
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

Different balloon materials are selected for specific functional requirements: the dilatation balloon uses a material optimized for controlled expansion and vessel dilation, while the regulating balloon(s) use material with different elastic properties for precise flow regulation. This local differentiation of material properties enables independent control of each balloon's function

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The catheter system employs composite material construction with at least two different balloon materials to achieve complementary functions. The combination of materials with different elastic moduli and compliance characteristics allows the dilatation and regulating balloons to operate independently with optimized performance for their respective purposes

Inventive Principle:
Principle #40Composite materials

3Productivity

If reperfusion flow is restored immediately after dilation, then blood flow restoration is maximized, but reperfusion injury occurs due to uncontrolled flow

Engineering Contradiction:
Improveblood flow restoration speedVSAvoidreperfusion injury
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The regulating balloon is inflated in advance or concurrently with the dilatation balloon to establish flow control before full reperfusion occurs. This preliminary positioning of the regulating balloon allows gradual restoration of blood flow and prevents sudden uncontrolled reperfusion that would cause injury

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system enables continuous monitoring and adjustment of reperfusion flow through the regulating balloon, allowing real-time feedback control of flow rate. This prevents excessive or uncontrolled flow that would cause reperfusion injury while maintaining adequate blood flow restoration

Inventive Principle:
Principle #23Feedback

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 catheter effectively reduces or prevents reperfusion injury by allowing for precise regulation of blood flow and pressure during angioplasty and post-conditioning treatment, minimizing tissue damage and complications.

Implementation Method 1

the regulating balloon is made of a different material than the dilatation balloon and the material of the regulating balloon is more elastic than the material of the dilatation balloon

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP2353633B1Balloon catheter for post conditioning
Publication Date: 2016.04.06 SANOFI AVENTIS DEUT GMBH
  • EP2353633B1 patent drawingFigure 1

AI summary

The present application provides a catheter adapted for use in post conditioning treatment, said catheter comprising: an elongate tubular body (4) with a proximal and a distal end, at least one dilatation balloon (2) disposed on the exterior of the tubular body (4), means for inflating and/or deflating said dilatation balloon (2) comprising a first lumen (5) in the tubular body and at least one regulating balloon (3) disposed proximal and/or distal to the dilatation balloon (2) and means for inflating and/or deflating the second balloon comprising a second lumen (6) in the tubular body (4) wherein the regulating balloon (3) is made of a different material than the dilatation balloon (2) and the material of the regulating balloon (3) is more elastic than the material of the dilatation balloon (2).