Stress-Applying Features for Plaque Disruption

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Solution Overview

Problem

Existing cutting balloons and stents used for treating calcified lesions in blood vessels are bulky, difficult to deliver, and can cause injury to the blood vessel wall or release emboli due to their sharp blades and increased stiffness.

Innovation Solution

The use of stress-applying features with blunt contact regions on expandable structures, such as balloons and stents, which are designed to fracture, dent, or disrupt calcified plaque without causing significant injury to the underlying tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cutting balloons or cutting stents with sharp blades are used to disrupt calcified plaque, then plaque disruption effectiveness is improved, but device deliverability and flexibility deteriorate due to increased bulk and stiffness

Engineering Contradiction:

Improveplaque disruption effectivenessVSAvoiddevice deliverability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The cutting stent is divided into multiple self-contained units, each with its own cutting element and expansion mechanism. This segmentation allows each unit to be independently delivered and deployed, reducing the overall bulk and improving deliverability while maintaining plaque disruption effectiveness through cumulative action of multiple cutting elements

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The cutting elements are designed to transition from a compressed, low-profile state during delivery to an expanded, active cutting state at the target site. This dynamic transformation allows the device to maintain flexibility and deliverability during insertion while providing effective plaque disruption when deployed

Inventive Principle:

Principle #15Dynamics

2Reliability

If cutting balloons with sharp blades are used to fracture calcifications, then plaque disruption capability is improved, but risk of vessel wall injury and emboli release increases

Engineering Contradiction:

Improveplaque disruption capabilityVSAvoidvessel wall injury and emboli release

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The cutting elements are designed with localized sharp edges or points that concentrate force specifically on the calcified plaque while the surrounding balloon surface remains smooth and compliant. This local quality differentiation allows effective plaque disruption at the contact points while minimizing injury to the broader vessel wall

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The balloon is designed with compliant, cushioning material that absorbs and distributes forces during plaque disruption. This beforehand cushioning prevents excessive force transmission to the vessel wall, reducing the risk of injury and emboli release while maintaining effective plaque fracture

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If traditional cutting balloons are used for valvuloplasty to disrupt calcifications, then calcification fracture capability is improved, but risk of valve damage and functional impairment increases

Engineering Contradiction:

Improvecalcification fracture capabilityVSAvoidvalve damage and functional impairment

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The cutting elements are positioned and oriented to target calcifications on valve leaflets while the balloon maintains overall compliance. The local sharp cutting action is confined to specific contact points on the calcified regions, while the rest of the balloon surface provides cushioning to protect vulnerable valve tissue from damage

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The balloon material is specifically selected to provide optimal cushioning properties that protect valve tissue during the calcification disruption process. This beforehand cushioning ensures that forces are distributed appropriately, allowing effective calcification fracture while minimizing the risk of valve damage and functional impairment

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentUS20250127529A1Methods and apparatus for plaque disruption

Publication Date: 2025.04.24 ELIXIR MEDICAL CORP

AI summary

Balloon catheters, sleeves, cages, cylindrical structures and endoluminal prostheses are provided with stress-applying and spacing features coupled to expandable surfaces thereof. At least one or at least some stress-applying features are immobilized onto the surface or into pre-formed indentations formed in the expandable surface. The stress-applying and spacing features may have blunt and/or rounded contact regions which contact tissue or calcified regions in the vasculature. The contact regions dent or fracture occlusive material on the wall of a vascular lumen and/or patient valve leaflets when expanded. The spacing of features can permit blood, drug, and contrast perfusion past structures expanded in the vasculature, particularly balloon catheters.