Transcatheter Valve Leaflet Severing Before Stent-Frame Expansion

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Solution Overview

Problem

Existing transcatheter devices lack the capability to manage the leaflets of a defective heart valve during catheter-based implantations of prosthetic heart valves, leading to potential obstructions.

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 to sever heart valve leaflets, allowing for the replacement of damaged or diseased heart valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a transcatheter device is used to replace a defective heart valve, then the procedure can be performed minimally invasively, but the leaflets of the defective valve may obstruct the catheter-based implantation

Engineering Contradiction:

Improveminimally invasive procedureVSAvoidleaflet obstruction

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The severing device is deployed before the prosthetic valve implantation to sever and remove the obstructing leaflets of the defective valve. This preliminary action eliminates the obstruction before the main implantation procedure, enabling minimally invasive catheter-based replacement.

Inventive Principle:

Principle #10Preliminary action

2Productivity

If the leaflets of the defective heart valve are not managed, then the catheter-based implantation can proceed without additional steps, but the leaflets will cause obstructions and complications

Engineering Contradiction:

Improveimplantation efficiencyVSAvoidimplantation success

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The severing device is activated to sever the leaflets before implantation, removing obstructions in advance. This ensures reliable implantation success while maintaining procedural efficiency.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The severing device extracts and removes the obstructing leaflets from the heart valve structure, eliminating the harmful elements that would otherwise complicate the implantation procedure.

Inventive Principle:

Principle #2Taking out (Extraction)

3Reliability

If a severing device is added to the transcatheter device, then the leaflets can be managed and obstructions prevented, but the device complexity increases

Engineering Contradiction:

Improveleaflet management capabilityVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The severing device is designed as a separate, modular component that can be integrated with the transcatheter device. This segmentation allows the severing function to be added without redesigning the entire device, thereby managing complexity while providing reliable leaflet management capability.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS20250325368A1Transcatheter devices and methods

Publication Date: 2025.10.23 MEDTRONIC INC

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.