Stiff Tissue Dilator Assembly for Controlled Valve Leaflet Perforation

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Solution Overview

Problem

Existing methods for transcatheter aortic valve replacement, such as lacerating leaflets to mitigate coronary ostial obstruction, require high spatial precision and surgical skill, and can lead to aortic insufficiency and vascular occlusion risks, especially when dealing with calcified leaflets.

Innovation Solution

A tissue perforation assembly comprising a dilator and perforating guidewire is used to create a pilot puncture in the target tissue, followed by dilator expansion to form an opening, allowing for the implantation of a prosthetic valve without damaging leaflets.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If lacerating or severing a portion of the leaflets is performed to mitigate coronary ostial obstruction, then the risk of blocking the coronary ostia is reduced, but the existing heart valve may function poorly and increase the risk of aortic insufficiency

Engineering Contradiction:

Improvecoronary ostial obstruction riskVSAvoidaortic valve function

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The invention extracts the problematic leaflet tissue that causes coronary ostial obstruction by creating a controlled opening in the leaflet, removing the harmful portion while preserving the functional portions of the valve structure

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention performs preliminary action by creating the leaflet opening before implanting the prosthetic valve, thereby preventing coronary ostial obstruction from occurring in the first place rather than addressing it after it happens

Inventive Principle:

Principle #10Preliminary action

2Object-affected harmful factors

If lacerating or severing a portion of the leaflets is performed, then the leaflets are displaced toward the inner wall of the aortic root, but high spatial precision and surgical skill are required

Engineering Contradiction:

Improvecoronary ostial obstructionVSAvoidsurgical precision requirement

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The invention introduces an intermediary device (the delivery assembly with perforation mechanism) that mediates between the surgeon's intent and the actual leaflet modification, providing a controlled and reproducible method that reduces dependence on manual dexterity and spatial precision

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention replaces the manual mechanical laceration technique with a controlled perforation system that uses a delivery assembly with a perforation mechanism, substituting hand-based precision with instrument-based controlled precision

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If lacerating calcified leaflets is performed, then coronary ostial obstruction is mitigated, but there is a risk that particulate or other debris is released into the blood stream

Engineering Contradiction:

Improvecoronary ostial obstructionVSAvoiddebris release

Core Design Contradiction:

Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The invention converts the potentially harmful effect of disrupting calcified tissue into a beneficial outcome by using a controlled perforation approach that creates a clean opening without generating debris, turning what would be a harmful mechanical disruption into a safe surgical intervention

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The invention replaces the mechanical laceration method that generates debris with a controlled perforation system that creates a clean opening, substituting a debris-generating mechanism with a debris-free alternative

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS20250375293A1Tissue perforation assemblies with stiff dialators

Publication Date: 2025.12.11 EDWARDS LIFESCIENCES CORP

AI summary

The present disclosure relates to tissue perforation assemblies that can be used for perforation and hole dilation through a tissue, such as forming an opening in a host leaflet of a host valvular structure, in which a prosthetic valve can be implanted. In an example, the tissue perforation assembly comprises a delivery nosecone and a dilator distal to the delivery nosecone. Each of the delivery nosecone and the dilator can have a tapering distal portion. A perforating guidewire extends distally from the dilator, and a delivery guidewire extends proximally from the dilator, through a channel of the delivery nosecone. The tissue perforation assembly can be advanced towards the host valvular structure and optionally form a pilot puncture through the host leaflet by the perforating guidewire, after which the dilator can be passed through the puncture to further expand the opening.