Deflectable Laser Catheter for Heart Valve Leaflet Splitting
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Solution Overview
Problem
Current transcatheter procedures for transcatheter aortic valve replacement (TAVR) and mitral valve implantation face complications due to displacement of native or prosthetic valve leaflets, leading to coronary obstruction or Left Ventricular Outflow Tract (LVOT) obstruction, which are technically challenging and require cumbersome techniques like BASILICA and LAMPOON, limiting widespread adoption.
Innovation Solution
A laser catheter is transvascularly inserted to deliver laser energy via optical fibers for precise severing, splitting, drilling, or ablating heart valve leaflets before new valve implantation, utilizing a deflectable tip and capturing element to ensure accurate and controlled leaflet modification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional mechanical splitting techniques (BASILICA, LAMPOON) are used to prevent coronary obstruction, then coronary obstruction risk is reduced, but the procedure becomes technically demanding and cumbersome requiring considerable expertise
Solution Approach 1:
The patent replaces traditional mechanical splitting techniques (BASILICA, LAMPOON) with a laser-based system. The laser catheter delivers optical energy to precisely split or ablate valve leaflets without requiring complex mechanical manipulation or specialized expertise, thereby maintaining coronary obstruction prevention while significantly simplifying the procedure
Solution Approach 2:
The invention changes the physical parameter of energy delivery from mechanical force to optical energy. The laser system delivers controlled optical energy to the valve leaflet tissue, enabling precise cutting and splitting with a different energy modality that is easier to control and deliver through a catheter-based approach
2Ease of operation
If laser energy is delivered via optical fibers to split or ablate leaflets, then procedure simplicity and accessibility are improved, but precise positioning and control of the catheter tip is required
Solution Approach 1:
The catheter incorporates a deflectable distal segment that can be dynamically positioned and oriented. This dynamic capability allows the operator to precisely angle the catheter tip toward the target valve leaflet while maintaining overall catheter access through standard vascular routes, balancing ease of operation with positioning precision
Solution Approach 2:
The patent employs imaging guidance (fluoroscopy, echocardiography) as an intermediary to visualize and guide catheter positioning. This intermediary system provides real-time feedback on catheter tip location, enabling precise targeting of the valve leaflet without requiring direct tactile feedback or complex mechanical 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
The laser catheter effectively prevents coronary and LVOT obstructions by safely and efficiently splitting or ablating leaflets, reducing the risk of complications and simplifying the procedure, making it more accessible and reliable.
Implementation Method 1
the one or more optical fibers deliver laser energy to the leaflet when a laser coupled to a proximal end of the catheter is activated, such that the laser energy severs, splits, drills through, cuts, and/or ablates at least part of the leaflet
Data Source
AI summary
A catheter is configured to be inserted transvascularly into a body of a subject and advanced toward a leaflet of a native heart valve of the subject or a prosthetic heart valve implanted in the body of the subject. The catheter includes a distal segment including a distal tip, the distal segment configured to deflect so as to position the distal tip with respect to the leaflet. A pre-shaped nitinol wire guide loop is configured to be deployed and brought into contact with the leaflet. One or more optical fibers deliver laser energy to the leaflet via the distal tip when (i) the distal tip is positioned with respect to the leaflet and (ii) a laser coupled to a proximal end of the catheter is activated, and (iii) the proximal end of the catheter is disposed outside the body of the subject. Other embodiments are also described.