Expandable Electrode Framework for Cutting Heart Valve Leaflets
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Solution Overview
Problem
Diseased and fused valve leaflets pose challenges for transcatheter valve replacement procedures, as they may prevent the replacement heart valve implant from fully expanding and functioning properly, and balloon valvuloplasty can introduce complications.
Innovation Solution
A medical device with an expandable balloon and framework equipped with electrodes is used to cut valve leaflets, allowing for precise and controlled resection or excision of leaflets to facilitate proper implantation of replacement valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If balloon valvuloplasty is performed to pre-dilate the heart valve, then the valve is prepared for replacement implant, but complications and risks are introduced that may prevent successful implantation
Solution Approach 1:
The electrode cutting device is deployed before the replacement valve implantation to cut the diseased leaflets, preparing the valve annulus for the upcoming implantation procedure. This preliminary action eliminates the need for balloon valvuloplasty and ensures the leaflets are properly prepared without introducing additional complications.
Solution Approach 2:
The diseased valve leaflets are selectively cut and removed from the valve annulus using the electrode device. By extracting only the problematic leaflet tissue rather than using balloon dilation, the procedure avoids the complications associated with valvuloplasty while achieving the necessary preparation for replacement implantation.
2Force
If force is applied to push diseased valve leaflets aside, then space is created for replacement valve, but the force required exceeds the capabilities of the replacement heart valve implant
Solution Approach 1:
Instead of applying excessive force to move the diseased leaflets aside, the electrode device cuts and removes the leaflets from the valve annulus. This extraction eliminates the resistance that would otherwise require forces beyond the capabilities of the replacement valve implant, allowing for smooth and successful implantation.
3Ease of operation
If previous valve leaflets are pinned in the open position, then access is maintained, but the coronary artery is blocked
Solution Approach 1:
The electrode device cuts and removes the problematic portions of the valve leaflets that would otherwise need to be pinned in the open position. By extracting these leaflet portions before the procedure, the coronary artery remains unobstructed while the valve annulus is still accessible for the replacement implantation.
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 device effectively cuts valve leaflets, enabling successful expansion and seating of replacement valves, reducing complications associated with balloon valvuloplasty and improving the efficiency of transcatheter aortic valve replacement procedures.
Implementation Method 1
at least one electrode disposed on the expandable framework, wherein when the expandable framework is in the expanded configuration, the at least one electrode is configured to cut the at least one valve leaflet
Data Source
AI summary
A system for cutting at least one valve leaflet of a heart valve having multiple valve leaflets includes an elongate shaft, an expandable balloon coupled to the elongate shaft, an expandable framework disposed radially outward of the expandable balloon, and at least one electrode disposed on the expandable framework. The expandable balloon is configured to shift between a deflated configuration and an inflated configuration, and the expandable framework is configured to shift between a collapsed configuration and an expanded configuration. When the expandable framework is in the expanded configuration, the at least one electrode is configured to cut the at least one valve leaflet.


