Nitinol Umbrella Cardioplegia Catheter for Aortic Valve Incompetence
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Solution Overview
Problem
Incompetent aortic valves allow cardioplegia to leak into the left ventricle during cardiopulmonary bypass, leading to inadequate myocardial protection and increased oxygen demand due to cardioplegia entering the ventricle instead of the coronary arteries.
Innovation Solution
A cardioplegia catheter with a nitinol wire lumen that deploys a folded nitinol umbrella or ring with a non-porous membrane to block the aortic valve, preventing cardioplegia from entering the left ventricle and ensuring it flows down the coronary arteries, even in cases of aortic valve incompetence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cardioplegia is administered in the ascending aorta below the cross clamp, then the cardioplegia is trapped between the cross clamp and the aortic valve forcing it down the coronary arteries, but in patients with aortic insufficiency the cardioplegia leaks through the aortic valve into the left ventricle
Solution Approach 1:
An umbrella device is introduced as an intermediary element between the aortic valve and the cross clamp. This umbrella acts as a mediator that blocks the incompetent aortic valve, preventing cardioplegia from leaking into the left ventricle while allowing the cardioplegia to be effectively trapped and forced down the coronary arteries for myocardial protection
2Reliability
If the aortic valve is incompetent, then cardioplegia enters the left ventricle instead of the coronary arteries, but blocking the aortic valve is not addressed by prior art devices
Solution Approach 1:
The umbrella device transitions from a collapsed delivery state to an expanded deployed state. In the collapsed state, it can be delivered through the aortic root via a standard cardioplegia cannula. Upon deployment, it expands to cover the aortic valve, adapting to the anatomical need for blocking an incompetent valve while maintaining delivery feasibility through standard access routes
3Ease of operation
If a standard cardioplegia cannula is used, then the delivery route is simple, but it cannot deliver a blocking device to the aortic valve
Solution Approach 1:
The umbrella device is nested within the cardioplegia catheter in a collapsed configuration during delivery. This nesting allows the blocking function to be delivered through the simple, existing cardioplegia cannula route. Once at the target site, the umbrella is deployed from its nested state to provide the valve-blocking function, thus adding functionality without complicating the delivery system
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
Effectively delivers cardioplegia to the coronary arteries, enhancing myocardial protection by preventing cardioplegia leakage into the left ventricle and maintaining adequate coronary perfusion, thus improving surgical outcomes.
Implementation Method 1
a cardioplegia catheter with a nitinol wire lumen that deploys a folded nitinol umbrella or nitinol ring
Implementation Method 2
a non-porous membrane to block the aortic valve, preventing cardioplegia from entering the left ventricle
Data Source
AI summary
A method and device that addresses the problem of an incompetent aortic valve by using a simple cardioplegia catheter that can deliver cardioplegia solution to the coronary arteries through the usual aortic cannulation site even in the presence of aortic valve incompetence. The device includes a cardioplegia cannula (32) with an additional lumen containing a nitinol wire (34) inside it that allows advancement of a folded nitinol umbrella (36) with a non-porous membrane or a compressed nitinol ring that covers the aortic valve when opened. During installation, after puncture of the aorta by the coaxial needle and removal of the coaxial needle but before installation of the cardioplegia solution through the central lumen of the catheter, the nitinol umbrella (in folded position) or nitinol ring (in compressed position) is advanced through the second lumen into the aorta just above the aortic valve. The nitinol umbrella is unfolded using the nitinol wire to expose the inverted umbrella configuration with attached membrane and is then advanced as a unit with the cardioplegia catheter until the nitinol umbrella covers the aortic valve at its deployed position.