Transcatheter Severing Device for Heart Valve Leaflet Management
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Solution Overview
Problem
Existing transcatheter devices lack the capability to effectively manage and replace damaged or diseased heart valves, particularly in managing the leaflets of defective heart valves during catheter-based implantations of prosthetic heart valves.
Innovation Solution
A transcatheter device equipped with a severing device that includes a shaft, handle, distal tip, and a sheath, featuring a severing mechanism that can pivot from a loaded to a deployed state, allowing for precise laceration of heart valve leaflets, followed by radial expansion of an expandable stent frame to replace the defective valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a transcatheter device is used to replace a damaged heart valve, then the procedure becomes minimally invasive, but the device lacks the capability to effectively manage and replace damaged leaflets
Solution Approach 1:
The device is divided into functionally independent components: a severing device for managing leaflets, an expandable stent frame for structural support and valve replacement, and a delivery catheter for minimally invasive delivery. This segmentation allows each component to perform its specific function effectively while maintaining overall minimally invasive capability.
Solution Approach 2:
The transcatheter device integrates multiple functions into a single system: the severing device can sever and manage leaflets, the expandable stent frame can provide structural support and enable valve replacement, and the delivery catheter facilitates minimally invasive delivery. This multi-functionality resolves the contradiction by providing both minimally invasive delivery and effective leaflet management capabilities.
2Reliability
If the severing device is deployed to sever leaflets, then the replacement capability is improved, but the device complexity increases
Solution Approach 1:
The severing device is pre-loaded in a compressed state within the delivery catheter before insertion. The severing elements are positioned and ready to engage with the leaflets upon deployment, eliminating the need for complex in-situ assembly or adjustment mechanisms.
Solution Approach 2:
The severing device is nested within the delivery catheter and stent frame structure during delivery, with the severing elements contained within a protective sheath. Upon deployment, the sheath is retracted to expose the severing elements, allowing a compact nested configuration during delivery and an expanded functional configuration during the procedure.
Data Source
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AI summary
Transcatheter devices comprise a shaft comprising a proximal portion and a distal portion. The transcatheter devices further comprise a handle device coupled to the proximal portion of the shaft. The handle device comprises a first actuator. The transcatheter devices further comprise a distal tip coupled to the distal portion of the shaft. The transcatheter devices further comprise a severing device comprising a proximal portion pivotally mounted to the distal tip. The severing device configured to be pivoted from a loaded state to a deployed state. Methods include moving a severing device from a loaded state to a deployed state. Methods further include severing at least one leaflet with the severing device in the deployed state and radially expanding the expandable stent frame.