Laser Ablation for Heart Valve Leaflet Tissue Modification
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Solution Overview
Problem
Current heart valve prosthetics, particularly those undergoing second valve replacement procedures, often experience coronary obstruction and decreased blood flow due to pinned leaflet tissue and commissural misalignment, which existing methods like BASILICA struggle to address effectively.
Innovation Solution
The use of laser ablation to remove portions of the primary prosthetic valve leaflet tissues between the stent structure, guided by a laser fiber catheter, to improve blood flow and prevent coronary obstruction, allowing for precise tissue modification and alignment correction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a second prosthetic valve is implanted within the first (valve-in-valve procedure), then the failing valve is replaced, but coronary obstruction and sinus sequestration occur due to pinned leaflet tissue
Solution Approach 1:
The patent extracts or removes the problematic pinned leaflet tissue from between the stent structure and the second valve prosthetic using laser ablation technology. This extraction eliminates the obstruction causing coronary artery blockage while preserving the valve-in-valve configuration.
Solution Approach 2:
The patent replaces mechanical cutting methods (such as wires or knives used in BASILICA procedure) with laser ablation technology. The laser energy precisely vaporizes the pinned tissue without mechanical contact, reducing the risk of damaging surrounding structures and improving procedural safety.
2Object-affected harmful factors
If electrified wires are used to incise leaflets (BASILICA procedure), then blood flow to coronary arteries is improved, but commissural alignment is compromised and procedural complexity increases
Solution Approach 1:
The patent substitutes mechanical wire cutting with laser ablation technology. The laser fiber can be navigated through the circulatory system to precisely ablate pinned tissue without requiring complex external manipulation or compromising commissural alignment, thereby simplifying the procedural approach.
Solution Approach 2:
The patent applies laser ablation locally to specific pinned leaflet tissue regions identified during the procedure. This localized treatment approach allows precise modification of only the obstructing tissue while preserving the overall valve structure and commissural alignment, avoiding the need for extensive procedural interventions.
3Object-affected harmful factors
If laser ablation is applied to remove leaflet tissue, then blood flow is improved and coronary obstruction is prevented, but procedural precision requirements increase
Solution Approach 1:
The patent employs laser ablation technology which inherently provides high precision through optical focusing. The laser fiber can be positioned and controlled to ablate tissue with sub-millimeter accuracy, meeting the stringent precision requirements for removing pinned leaflet tissue while preserving surrounding structures.
Solution Approach 2:
The patent uses a laser fiber as an intermediary delivery mechanism that can be navigated through the circulatory system to reach the target pinned tissue. This intermediary approach allows precise energy delivery to the specific location without requiring direct surgical access or complex positioning mechanisms.
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 method enhances blood flow by creating strategic openings in the leaflet tissue, reducing the risk of coronary obstruction, and can be applied to various transcatheter heart valves, including mitral, pulmonary, and tricuspid positions, offering a safer and more precise alternative to existing procedures.
Implementation Method 1
applying laser ablation to remove portions of the primary prosthetic valve leaflet tissues between the stent structure of the primary prosthetic valve
Data Source
AI summary
A method for improving blood flow in a patient who has undergone a first heart valve replacement procedure followed by a second heart valve replacement procedure is disclosed. The method includes positioning a second prosthetic replacement valve to replace a primary prosthetic replacement valve within the patient, providing a laser fenestration system including a laser fiber, guiding the laser fiber through the patient's circulatory system to the second prosthetic replacement valve, performing a laser ablation process using the laser fiber to remove portions of a leaflet tissue between any stent structure of the primary prosthetic replacement valve, removing the laser fiber from the patient's circulatory system, and finalizing the second prosthetic valve replacement procedure. In embodiments, the method includes removing native leaflet tissue using laser ablation. In embodiments, a fenestration system for implementing the described method is disclosed.