Percutaneous Aortic Valve Isolation and Flushing

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Solution Overview

Problem

Current treatments for aortic valve stenosis, such as valve replacement surgery, come with significant risks and disadvantages, and there is a need for a less invasive method to improve aortic valve flow without the use of prosthetic elements, especially in a 'beating-heart' setting.

Innovation Solution

The development of devices and methods that include an aortic valve isolation element, a shunt element, and an aortic valve flushing element, allowing for percutaneous isolation and flushing of the stenotic aortic valve with a dissolution fluid to increase valve flow, while minimizing contact with non-valve tissue and maintaining isometric pressure conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If aortic valve replacement surgery is performed, then aortic valve function is restored, but surgical risk and patient trauma increase

Engineering Contradiction:

Improveaortic valve function restorationVSAvoidsurgical risk and patient trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces mechanical surgical intervention with a chemical dissolution approach. Dissolution fluids (enzymatic, acidic, or alkaline) are delivered percutaneously to chemically dissolve calcific deposits on the aortic valve, substituting the mechanical act of surgical valve replacement with a chemical process that preserves the native valve structure while restoring function.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces dissolution fluids as intermediary substances between the treatment goal and the aortic valve. These fluids (containing enzymes like proteases, lipases, nucleases, or chemical agents like EDTA, hydrochloric acid, or sodium hydroxide) act as mediators that selectively dissolve calcific deposits without requiring direct surgical contact with the valve, thereby reducing surgical trauma while restoring valve function.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If percutaneous dissolution fluid delivery is used, then patient trauma is reduced, but dissolution fluid may contact non-valve tissue causing harm

Engineering Contradiction:

Improvepatient traumaVSAvoiddamage to non-valve tissue

Core Design Contradiction:

Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The delivery system is segmented into multiple functional components: an introducer needle for percutaneous access, a catheter with selective positioning capability, and controlled delivery mechanisms. This segmentation allows the dissolution fluid to be delivered precisely to the target aortic valve region while isolating non-target tissues, thereby reducing patient trauma and preventing damage to surrounding structures.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent applies dissolution fluid locally and selectively to the aortic valve region rather than systemically. The catheter system enables localized delivery with controlled flow rates and positioning, ensuring that the chemically active dissolution fluid contacts primarily the calcific deposits on the valve while minimizing exposure of surrounding healthy tissues, thus reducing harmful side effects.

Inventive Principle:

Principle #3Local quality

3Reliability

If dissolution fluid is delivered to aortic valve, then calcification is reduced and valve flow increases, but delivery system complexity increases

Engineering Contradiction:

Improvevalve flow improvementVSAvoiddelivery system complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The delivery system is designed with multi-functionality to reduce overall complexity. The catheter system can selectively deliver different types of dissolution fluids (enzymatic, acidic, or alkaline) through a single platform, and can be positioned to treat different regions of the aortic valve. This universal design consolidates multiple potential delivery systems into one, managing complexity while achieving effective calcification reduction and valve flow improvement.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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

This approach effectively increases aortic valve flow, reduces calcification, and alleviates symptoms associated with aortic stenosis, potentially delaying the need for valve replacement and reducing trauma to the patient compared to traditional surgical methods.

Implementation Method 1

the isolated valve is flushed with a dissolution fluid, e.g., an acidic dissolution fluid, for a period of time sufficient for the aortic valve flow of the treated valve to be increased

Methodology Applied

Scientific EffectChemical dissolution:

Data Source

PatentUS7803131B2Devices and methods for percutaneously treating aortic valve stenosis

Publication Date: 2010.09.28 CORDIS US CORP

AI summary

Devices and methods for their use in percutaneously increasing the aortic valve flow of a stenotic aortic valve are provided. The subject devices include an aortic valve isolation element, a shunt element and an aortic valve flushing element. Also provided are systems and kits that include the subject devices and can be employed in practicing the subject methods. The subject devices, methods, systems and kits find use in treating conditions associated with the presence of stenotic aortic valves.