Tapered Flow Modifying Implant for Refractory Angina

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Solution Overview

Problem

Chronic angina pectoris that is refractory to medical and interventional therapies poses a significant public health issue, affecting millions worldwide, particularly in patients who are not candidates for revascularization or those with obstructive coronary artery disease, microvascular disease, or hypertrophic cardiomyopathy, leading to increased cardiovascular hospitalizations and healthcare costs.

Innovation Solution

The development of flow modifying implants configured for deployment within blood vessels, comprising a hollow tubular body with a lumen and a ring that self-expands or balloon-expands to anchor within the vessel, modifying blood flow by tapering from a larger inflow end to a smaller outflow end, thereby increasing velocity and decreasing pressure, redirecting blood flow to ischemic areas and preventing reperfusion injury.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional revascularization therapies are used, then blood flow to ischemic areas is improved, but the procedure is not suitable for patients with obstructive CAD, microvascular disease, or hypertrophic cardiomyopathy

Engineering Contradiction:
Improveeffectiveness of blood flow restorationVSAvoidapplicability to different patient conditions
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The implant modifies blood flow parameters (velocity and pressure) by utilizing the Bernoulli effect through its tapered geometry. The gradual narrowing from proximal to distal end creates a pressure gradient that redirects flow into side branches, providing a non-revascularization solution for patients who cannot undergo conventional procedures

Inventive Principle:
Principle #35Parameter changes

2Reliability

If a flow modifying implant with tapered geometry is deployed, then blood flow velocity increases and pressure decreases to redirect flow, but the implant requires anchoring within the vessel which adds structural complexity

Engineering Contradiction:
Improveflow modification effectivenessVSAvoidstructural complexity for anchoring
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The implant employs asymmetric design with a tapered geometry that is narrower at the distal end and wider at the proximal end. This asymmetric shape creates the necessary pressure gradient for flow redirection while the slight flaring at the distal end provides anchoring engagement with the vessel wall without requiring additional complex anchoring structures

Inventive Principle:
Principle #4Asymmetry

3Reliability

If the implant tapering from larger inflow end to smaller outflow end is used, then blood flow is redirected to ischemic areas, but the velocity increase may cause shear stress on vessel walls

Engineering Contradiction:
Improveblood flow redirection to ischemic areasVSAvoidshear stress on vessel walls
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implant utilizes controlled parameter changes in the blood flow by creating a gradual pressure gradient through its tapered geometry. The slow, progressive narrowing allows for controlled acceleration of flow and pressure reduction, minimizing sudden changes that would cause harmful shear stress while still achieving effective flow redirection into side branches

Inventive Principle:
Principle #35Parameter changes

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 flow modifying implants effectively improve tissue oxygenation and reduce reperfusion injury by redirecting blood flow, providing a clinical solution for refractory angina patients by anchoring within the vessel and modifying blood dynamics to enhance oxygen delivery and reduce pressure-related tissue damage.

Implementation Method 1

modifying blood flow by tapering from a larger inflow end to a smaller outflow end, thereby increasing velocity and decreasing pressure

Methodology Applied
Scientific EffectBernoulli effect: Bernoulli Effect

Data Source

PatentUS20240285390A1Flow modifying implants
Publication Date: 2024.08.29 SHOCKWAVE MEDICAL INC
  • US20240285390A1 patent drawing
  • US20240285390A1 patent drawing
  • US20240285390A1 patent drawing

AI summary

Described herein are devices, systems, and methods for modifying blood flow and improving tissue oxygenation in an individual. More specifically, described herein are flow modifying implants, delivery systems, and methods of treatment using flow modifying implants. Also described herein are methods for preventing reperfusion injury in an individual using a flow modifying implant to prevent the reperfusion injury.