Balloon and Mesh Aortic Protection for TAVI Alignment

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Solution Overview

Problem

Conventional transcatheter delivery devices for collapsible prosthetic heart valves face challenges in aligning the distal sheath with the native annulus and often cause damage to the aortic arch, with the risk of calcified particles detaching and forming emboli during valve deployment.

Innovation Solution

An assembly comprising an elongated shaft with a balloon and a mesh material that can be inflated and deployed to guide the sheath and prevent emboli, allowing precise alignment and reducing contact with the aortic arch, featuring a balloon with lobes and a mesh with stiffening wires to maintain position and prevent particle entry into great vessels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a conventional delivery device is used to deliver a collapsible prosthetic valve, then the valve can be delivered less invasively via catheter, but the distal sheath may contact and stretch the inner wall of the aortic arch causing damage

Engineering Contradiction:

Improveless invasive deliveryVSAvoiddamage to aortic arch inner wall

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

A balloon is introduced as an intermediary element between the delivery device and the aortic arch. The balloon is inflated within the aortic valve annulus to act as a protective barrier, preventing the distal sheath from directly contacting and damaging the aortic arch inner wall while still allowing the valve to be delivered through the catheter system

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The balloon is inflated in advance before the valve deployment to create a cushioning effect. This pre-inflation protects the aortic arch structures from potential damage during the subsequent valve delivery and deployment process, allowing the distal sheath to be positioned without direct contact with vulnerable tissues

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Measurement precision

If the distal sheath is steered through the aortic arch to reach the native annulus, then alignment may be improved, but the sheath may still contact and stretch the inner wall during navigation

Engineering Contradiction:

Improvealignment with native annulusVSAvoidcontact and stretch of inner wall

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The inflated balloon serves as a mediator that allows the steerable distal sheath to navigate and align with the native annulus while preventing direct contact with the aortic arch inner wall. The balloon's presence enables precise positioning without the harmful side effect of wall contact

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If conventional delivery methods are used, then valve deployment is straightforward, but calcified particles may detach from the native valve or aortic wall forming emboli that may cause stroke or vascular occlusion

Engineering Contradiction:

Improvevalve deployment simplicityVSAvoidemboli formation from calcified particles

Core Design Contradiction:

Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The balloon acts as an intermediary barrier between the delivery device and the aortic valve annulus. During valve deployment, the balloon prevents calcified particles from detaching and forming emboli, while still allowing the straightforward deployment process to occur

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The balloon is inflated beforehand to provide protective cushioning during the valve deployment process. This pre-positioned protection prevents calcified particles from detaching and forming emboli that could cause stroke or vascular occlusion, while maintaining ease of valve deployment

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 enables precise alignment of the sheath with the aortic annulus, reduces contact with the aortic arch, and prevents emboli formation by deploying a mesh to capture calcified particles, enhancing the safety and efficacy of valve deployment.

Implementation Method 1

a balloon affixed to the shaft and movable between a collapsed condition and an expanded condition, the balloon projecting away from the shaft in the expanded condition

Methodology Applied

Scientific EffectFluid pressure expansion: Pressure Increase

Implementation Method 2

a mesh material affixed to the shaft and movable between a collapsed condition and an expanded condition, the mesh material projecting away from the shaft in the expanded condition... to capture calcified particles

Methodology Applied

Scientific EffectPhysical containment: Physical Containment

Data Source

PatentUS10441418B2Apparatus and method for aortic protection and tavi planar alignment

Publication Date: 2019.10.15 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

An assembly for guiding a medical apparatus within a patient includes an elongated shaft and a balloon affixed to the shaft and movable between a collapsed condition and an expanded condition. A mesh material may be affixed to the shaft and movable between a collapsed condition and an expanded condition. The balloon may project away from the shaft when the balloon is in the expanded condition. The mesh material may project away from the shaft when the mesh material is in the expanded condition.