Combined Stent Reperfusion System with Occlusion Balloon

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Solution Overview

Problem

Current methods for treating microvascular obstruction and reperfusion injury in coronary circulation are inadequate, as reperfusion itself often triggers microvascular obstruction, leading to adverse outcomes in heart attack patients, and existing technologies do not effectively prevent reperfusion injury during stent placement.

Innovation Solution

A combined stent delivery and occlusion device using a catheter with a pressure/temperature-sensing guidewire, which includes a stent delivery balloon and an occlusion balloon, allowing for real-time pressure and temperature measurement, and infusion of cardio-protective agents to minimize reperfusion injury, with the stent remaining in place to ensure continued perfusion after balloon deflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If reperfusion is performed to restore blood flow after myocardial infarction, then epicardial blood flow is restored, but microvascular obstruction and reperfusion injury are triggered

Engineering Contradiction:
Improveepicardial blood flow restorationVSAvoidmicrovascular obstruction and reperfusion injury
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The occlusion balloon is inflated before stent deployment to prevent reperfusion injury. Cardio-protective agents are infused through the infusion lumen during the occlusion period, preparing the microvasculature before blood flow restoration. This preliminary action protects against the harmful effects of reperfusion while maintaining epicardial flow restoration.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The occlusion balloon acts as an intermediary device that controls blood flow timing. It temporarily blocks the vessel to allow cardio-protective agent infusion, then controlled deflation allows gradual reperfusion. The infusion lumen serves as an intermediary pathway for delivering protective agents directly to the target site.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If stent delivery balloon is inflated to deploy stent, then stent is deployed to maintain perfusion, but reperfusion injury occurs upon balloon deflation

Engineering Contradiction:
Improvecontinued epicardial perfusionVSAvoidreperfusion injury upon deflation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The occlusion balloon is inflated before stent deployment to pre-condition the microvasculature with cardio-protective agents. This preliminary protection is in place before the reperfusion event occurs upon stent balloon deflation, reducing the harmful effects while maintaining the beneficial perfusion restoration.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Cardio-protective agents are infused through the infusion lumen during the occlusion period, providing a protective cushion against the upcoming reperfusion injury. This prior cushioning prepares the tissue to withstand the mechanical and biochemical stress of reperfusion when the stent balloon is deflated.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Object-generated harmful factors

If occlusion balloon is used to prevent reperfusion, then reperfusion injury is avoided, but real-time monitoring of microvascular status is needed

Engineering Contradiction:
Improvereperfusion injury preventionVSAvoidmicrovascular obstruction detection
Core Design Contradiction:
Object-generated harmful factorsVSDifficulty of detecting and measuring

Solution Approach 1:

Pressure/temperature-sensing guidewires provide real-time feedback on microvascular status during occlusion and reperfusion. Temperature changes detected by the guidewire indicate microvascular obstructions, allowing the operator to adjust the occlusion duration and reperfusion timing to optimize protection while detecting complications.

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 solution effectively reduces reperfusion injury and maintains epicardial perfusion by using a stent delivery and occlusion balloon system that infuses cardio-protective agents, allowing for precise measurement and treatment of microvascular damage, thereby improving patient outcomes.

Implementation Method 1

a pressure/temperature-sensing guidewire to allow for real-time measurement of distal vessel pressure and temperatures

Methodology Applied
Scientific EffectPressure sensing:

Implementation Method 2

a pressure/temperature-sensing guidewire to allow for real-time measurement of distal vessel pressure and temperatures

Methodology Applied
Scientific EffectTemperature sensing:

Implementation Method 3

an occlusion balloon with an infusion lumen... the stent balloon, while inflated, acts as an occlusion balloon

Methodology Applied
Scientific EffectMechanical occlusion: Mechanical Force

Implementation Method 4

The catheter has an infusion lumen, which can infuse cardioprotective or therapeutic agents into the coronary circulation

Methodology Applied
Scientific EffectFluid infusion:

Implementation Method 5

the stent delivery balloon is deflated. After deflation, the stent remains in place to promote continued epicardial perfusion of the coronary tree

Methodology Applied
Scientific EffectBalloon expansion: Pressure Increase

Data Source

PatentEP3592304B1Combined stent reperfusion system
Publication Date: 2023.09.13 CORFLOW THERAPEUTICS AG
  • EP3592304B1 patent drawingFigure 1~3
  • EP3592304B1 patent drawingFigure 4~6

AI summary

Devices and methods for preventing reperfusion injuries when an occlusion balloon is deflated. A catheter having an infusion lumen exiting the catheter distal of a stent balloon and/or occlusion balloon allows a therapeutic agent to be introduced to a target location to establish desired temperatures and pressures prior to deflation of the balloon such that negative effects of reperfusion are minimized.