PTA Balloon Catheter Segmentation and Pressure Control

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Solution Overview

Problem

Current percutaneous transluminal angioplasty (PTA) methods face challenges such as persistent blood-vessel-wall distention, restenosis, dissection, hematoma, and pseudoaneurysm due to over-inflation and undesirable localized forces during balloon inflation, which can lead to complications like new atherosclerotic lesion formation and blood flow disruptions.

Innovation Solution

The improved PTA methodologies involve selecting appropriate balloon lengths and inflation pressures to minimize risks of over-inflation and localized forces, using differently sized balloons and adjustable catheters to tailor treatments for primary and secondary lesions, thereby reducing the likelihood of complications like persistent distention and dissection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high inflation pressure is applied to disrupt atherosclerotic lesions, then the effectiveness of vessel widening is improved, but the risk of vessel wall dissection, hematoma, and pseudoaneurysm increases

Engineering Contradiction:
Improveeffectiveness of vessel wideningVSAvoidvessel wall dissection and trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent segments the atherosclerotic lesion into multiple sections along the vessel length. The balloon catheter is inflated in a stepwise manner, treating one segment at a time rather than applying uniform high pressure across the entire lesion simultaneously. This segmentation allows controlled disruption of plaque while limiting the spread of localized forces that cause dissection.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies different inflation pressures to different segments of the lesion based on local characteristics. Softer, more compliant balloon sections are used in regions prone to dissection, while firmer sections target calcified plaque. The inflation pressure is modulated locally along the balloon length to match the specific mechanical properties of each lesion segment.

Inventive Principle:
Principle #3Local quality

2Reliability

If prolonged balloon inflation is used to ensure complete lesion disruption, then the thoroughness of treatment is improved, but the risk of persistent vessel distention and restenosis increases

Engineering Contradiction:
Improvecompleteness of lesion disruptionVSAvoidpersistent distention and restenosis
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs periodic, pulsatile inflation rather than continuous static inflation. The balloon inflates and deflates in controlled cycles, creating dynamic mechanical stress that effectively disrupts atherosclerotic plaque through fatigue mechanisms. This periodic action achieves complete lesion disruption while limiting the duration of vessel wall distention, preventing persistent elastin fiber disruption that leads to restenosis.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The patent uses rapid, high-velocity inflation pulses that quickly exceed the strength of the plaque capsule, shattering calcified elements before sustained pressure can cause excessive vessel wall distention. The inflation duration is kept brief but intense, rushing through the critical disruption phase before harmful persistent distention can occur.

Inventive Principle:
Principle #21Skipping (Rushing through)

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

These methods significantly decrease the risks of persistent vessel-wall distention, restenosis, dissection, hematoma, and pseudoaneurysm, ensuring more effective and safer treatment of obstructed blood vessels by optimizing balloon length and pressure application.

Implementation Method 1

A pressurized inflation fluid introduced into an inflation port at the proximal end of the PTA catheter then inflates the balloon, which, in turn, expands the blood vessel and disrupts the atherosclerotic lesion.

Methodology Applied
Scientific EffectPressure: Pressure Increase

Data Source

PatentUS11865279B2Precutaneous-transluminal methods that minimize vessel stress and trauma
Publication Date: 2024.01.09 CTI VASCULAR AG
  • US11865279B2 patent drawing
  • US11865279B2 patent drawing
  • US11865279B2 patent drawing

AI summary

The current document is directed to improved PTA methodologies that significantly decrease the risks of persistent blood-vessel-wall distention and subsequent restenosis and the risks of PTA-induced dissection, hematoma, and pseudoaneurysm when used to treat blood vessels. Similar improved percutaneous-transluminal-interventional methods are used to treat non-vascular vessels. The improved methods include initial selection of balloon length and inflation pressure for initial treatment of primary lesions to minimize the risks of over-inflation and generation of undesirable localized forces during balloon inflation. The improved methods further include higher-pressure treatment of remaining secondary lesions that also minimizes the risks of over-inflation and generation of undesirable localized forces. The improved methods can be practiced using differently sized balloons and conventional instrumentation, but may be facilitated by use of balloon-length-adjustable catheters.