Interatrial Pressure Vent with Flow Control Element

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Solution Overview

Problem

Current treatments for heart failure, particularly diastolic heart failure, are inadequate in reducing elevated left atrial pressure and preventing thrombi formation, leading to symptoms like breathlessness and increased risk of systemic emboli.

Innovation Solution

A controlled interatrial pressure venting device is introduced, featuring a tubular opening between the left and right atria that allows blood to vent from the left to the right atrium while minimizing flow in the opposite direction, equipped with a flow control element to prevent thrombi entry and reduce pressure-related tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stress or pressure

If an opening is created in the interatrial septum to relieve elevated left atrial pressure, then left atrial pressure is reduced and symptoms are alleviated, but there is a risk of thrombi or embolic material entering the arterial circulation

Engineering Contradiction:
Improveleft atrial pressureVSAvoidthrombi formation and embolic material entry
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The device employs a porous or mesh-like structure that permits blood flow from the left atrium to the right atrium while filtering out thrombi and embolic material. The pore size is designed to allow passage of blood cells while blocking larger pathological structures.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The device acts as an intermediary structure positioned in the interatrial septum that mediates between the high-pressure left atrium and the lower-pressure right atrium, enabling controlled flow while preventing harmful material transfer.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If a flow control element is added to minimize reverse flow from right to left atrium, then thrombi formation is reduced, but device complexity increases

Engineering Contradiction:
Improvereverse flow and thrombi formationVSAvoiddevice structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The flow control element utilizes dynamic pressure differential to automatically regulate flow direction. When left atrial pressure exceeds right atrial pressure, flow is permitted from left to right. When pressures equalize or reverse, the element passively closes to prevent reverse flow, eliminating the need for active control mechanisms.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The flow control element is designed to self-regulate based on pressure differential without external control. The structural design allows it to automatically open for forward flow and close for reverse flow, making the device self-regulating and reducing overall system complexity.

Inventive Principle:
Principle #25Self-service

3Stress or pressure

If the vent allows sufficient flow to relieve elevated left atrial pressure, then symptoms are alleviated, but excessive pressure against the wall can cause tissue injury

Engineering Contradiction:
Improveleft atrial pressure reliefVSAvoidtissue damage to interatrial septum
Core Design Contradiction:
Stress or pressureVSObject-affected harmful factors

Solution Approach 1:

The device incorporates a flexible body element that can conform to the interatrial septum geometry and distribute contact pressure. The flexibility allows the device to adapt to pressure changes while maintaining gentle contact with the tissue, preventing focal pressure points that could cause injury.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The device distributes the pressure load from the high-pressure left atrium across a larger surface area by extending into the radial dimension. The flange segments and mesh structure create a distributed contact interface rather than a concentrated point contact, reducing pressure density on the tissue.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

4Duration of action of stationary object

If a mesh body assembly is used to reduce calcium and protein deposition, then long-term functionality is improved, but manufacturing precision requirements increase

Engineering Contradiction:
Improvedevice longevity and functionalityVSAvoidmesh structure fabrication
Core Design Contradiction:
Duration of action of stationary objectVSManufacturing precision

Solution Approach 1:

The mesh body assembly utilizes a porous structure with controlled pore size and distribution that prevents calcium and protein deposition. The porous architecture allows fluid flow while the surface properties and geometric configuration inhibit crystallization and fouling processes.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The mesh structure creates periodic flow patterns that prevent stagnant zones where deposition could occur. The geometric arrangement induces continuous fluid movement and shear stress that disrupts the formation of calcium and protein deposits over time.

Inventive Principle:
Principle #19Periodic action

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 device effectively reduces left atrial pressure, alleviates symptoms of heart failure, minimizes thrombi formation, and prevents embolic risks, while also addressing tissue damage and arrhythmias associated with elevated atrial pressure.

Implementation Method 1

the flow control element provides greater resistance to flow in one direction than it does in another direction

Methodology Applied
Scientific EffectPressure differential: Pressure Gradient

Data Source

PatentEP3146937A1Devices to treat heart failure
Publication Date: 2017.03.29 CORVIA MEDICAL INC
  • EP3146937A1 patent drawingFigure 1
  • EP3146937A1 patent drawingFigure 2
  • EP3146937A1 patent drawingFigure 2A~2B

AI summary

Several unique intracardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intracardiac pressure vents presented allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms but also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombus or other embolic material from entering the arterial circulation. Deployment of the interatrial pressure vent preferably occurs in a series of steps comprising first advancing the placement catheter through the septal opening, second deploying a first flange, third retracting the placement catheter to position the first flange against the septal wall, and fourth deploying a second flange on the other side of the septal wall from the first flange.