Expandable Valve Leaflet Separation for Proper Transcatheter Valve Seating
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Diseased and fused valve leaflets pose challenges for transcatheter valve replacement procedures, as the force required to push them aside may exceed the capabilities of replacement heart valve implants, and balloon valvuloplasty may not fully address stenosis or leaflet fusion, leading to improper seating and functioning of replacement valves.
Innovation Solution
A system comprising an elongate shaft with an expandable balloon and an expandable structure that shifts between configurations to separate valve leaflets into discrete pieces, using pressurized fluid or vacuum through apertures or slots to facilitate leaflet modification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If balloon valvuloplasty is performed prior to implanting the replacement heart valve implant, then the heart valve is pre-dilated, but stenosis or leaflet fusion may survive the procedure and prevent proper valve expansion and seating
Solution Approach 1:
The expandable structure is divided into multiple elongate fingers that can be independently positioned and configured. Each finger can engage with valve leaflets separately, allowing precise segmentation of the leaflet separation process to address surviving stenosis or fusion without requiring complex multi-step procedures
Solution Approach 2:
The expandable structure is deployed and configured to separate valve leaflets into discrete pieces before the replacement heart valve implant is fully expanded and seated. This preliminary action ensures that diseased or fused leaflets do not interfere with proper valve deployment, eliminating the need for repeated or complex pre-treatment procedures
2Ease of operation
If force is applied to push diseased valve leaflets aside, then the replacement valve can be implanted, but the force required may exceed the capabilities of the replacement heart valve implant
Solution Approach 1:
The expandable structure with elongate fingers acts as an intermediary device between the delivery system and the valve leaflets. These fingers gently engage with and separate the leaflets into discrete pieces, distributing the mechanical interaction across multiple contact points rather than requiring concentrated force, thereby facilitating easy implantation without exceeding device capabilities
Solution Approach 2:
The patent replaces the traditional mechanical pushing force with a controlled expansion mechanism. The expandable structure uses controlled radial expansion to separate leaflets, substituting the need for high axial pushing force with a distributed radial expansion force that is within the capabilities of the replacement valve implant
3Manufacturing precision
If valve leaflets are not properly separated, then the procedure is simpler, but the replacement valve cannot fully expand or seat properly within the valve annulus
Solution Approach 1:
The expandable structure with multiple elongate fingers is nested within the delivery catheter in a collapsed configuration during delivery. Upon deployment, the fingers expand outward in a controlled manner to engage and separate leaflets, then can be retracted or maintained in position to ensure proper valve seating, providing precise control without excessive external complexity
Solution Approach 2:
The expandable structure transitions dynamically between collapsed and expanded configurations. The elongate fingers can be independently positioned and adjusted during the procedure, allowing real-time adaptation to the specific anatomy and pathology of the valve, ensuring precise leaflet separation and optimal valve seating without requiring overly complex static 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
Effectively separates valve leaflets into discrete pieces, enabling proper seating and functioning of replacement heart valves, thereby improving the efficiency and success of transcatheter valve replacement procedures.
Implementation Method 1
the expandable structure may be configured to shift between a collapsed configuration and an expanded configuration. In the expanded configuration, the expandable structure may be configured to separate the at least one valve leaflet into a plurality of discrete pieces
Implementation Method 2
the lumen is in fluid communication with a source of pressurized fluid. pressurized fluid ejected from the plurality of apertures is configured to separate the at least one valve leaflet into the plurality of discrete pieces
Implementation Method 3
the lumen is in fluid communication with a vacuum source. a vacuum applied to the plurality of apertures is configured to draw a portion of the at least one valve leaflet into their respective finger to separate the at least one valve leaflet into the plurality of discrete pieces
Data Source
AI summary
A system for modifying at least one valve leaflet of a heart valve may include an elongate shaft, an expandable balloon, and an expandable structure disposed radially outward of the balloon. In an expanded configuration, the expandable structure is configured to separate the at least one valve leaflet into discrete pieces. A system may include an expandable structure comprising an elongate finger and a clamping jaw disposed proximate a distal end of the finger. In an expanded configuration, the elongate finger is offset radially outward from the elongate shaft and is configured to separate the at least one valve leaflet into discrete pieces. A system may include an electrode disposed within the balloon and configured to energize the inflation fluid. In an inflated configuration, energized inflation fluid ejected through a plurality of small apertures in the balloon is configured to separate the at least one valve leaflet into discrete pieces.