Transcatheter Leaflet-Cutting Tool for BASILICA Obstruction Prevention

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Solution Overview

Problem

Current transcatheter procedures for valve-in-valve replacements lack specialized tools for performing a safe and consistent BASILICA procedure to prevent coronary artery obstruction, which is a significant challenge in existing technologies.

Innovation Solution

A medical instrument including a flexible sheath configured to pass through the femoral artery, an inner catheter at least partially disposed within the sheath and a pair of opposing jaws coupled to the inner catheter, the inner catheter having a deflectable section, a pair of opposing jaws coupled to the inner catheter, the pair of opposing jaws configured to pass through the aortic arch, a pair of opposing jaws with a cutting mechanism, and a cutting mechanism, the cutting mechanism comprising an electrosurgical wire passing through the inner catheter to a generator, and extending through a first of the pair of opposing jaws and toward a second of the pair of opposing jaws, and a conductive wire terminating in a conductive receptacle disposed in the second of the pair of opposing jaws, the conductive receptacle being coupleable with the electrosurgical wire to form an electrical circuit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional transcatheter valve replacement procedures are performed without specialized cutting tools, then the procedure is simpler, but coronary artery obstruction cannot be prevented

Engineering Contradiction:
Improveprevention of coronary artery obstructionVSAvoidcomplexity of procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The electrosurgical cutting mechanism is activated before the prosthetic valve is fully deployed to create a preliminary incision or tear in the leaflet tissue. This preliminary action prevents coronary artery obstruction by creating a gap before the valve frame compresses the tissue, thereby resolving the contradiction by performing the protective cutting action in advance rather than requiring complex post-deployment intervention

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The electrosurgical wire acts as an intermediary tool that delivers controlled thermal energy to cut the leaflet tissue. This intermediary mechanism enables precise tissue modification without requiring direct mechanical contact or complex surgical instruments, thus improving reliability while maintaining procedural simplicity

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If an electrosurgical cutting mechanism is added to the catheter system, then precise leaflet cutting is enabled, but the device complexity increases

Engineering Contradiction:
Improveprecision of leaflet cuttingVSAvoidcomplexity of catheter system
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The catheter system is designed to perform multiple functions: navigation through vasculature, positioning at the valve site, and electrosurgical cutting of the leaflet. By integrating the cutting mechanism into the existing catheter framework rather than requiring a separate dedicated cutting device, the system achieves multi-functionality that reduces overall device complexity while maintaining cutting precision

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The electrosurgical wire and cutting mechanism are nested within the catheter structure, with the wire passing through the catheter lumen and the cutting elements positioned within the catheter tip. This nested configuration allows the cutting function to be contained within the existing catheter footprint, minimizing additional device complexity while enabling precise cutting capability

Inventive Principle:
Principle #7Nested doll (Nesting)

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

Enables a safe and consistent BASILICA procedure by allowing precise cutting of prosthetic heart valve leaflets, reducing the risk of coronary artery obstruction during valve-in-valve replacements.

Implementation Method 1

a cutting mechanism comprising an electrosurgical wire passing through the inner catheter to a generator, and extending through a first of the pair of opposing jaws and toward a second of the pair of opposing jaws, and a conductive wire terminating in a conductive receptacle disposed in the second of the pair of opposing jaws, the conductive receptacle being coupleable with the electrosurgical wire to form an electrical circuit

Methodology Applied
Scientific EffectElectrical current: Conduction (electrical)

Data Source

PatentEP4389025B1Transcatheter tools for basilica or lampoon procedure
Publication Date: 2025.12.10 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP4389025B1 patent drawingFigure 1A
  • EP4389025B1 patent drawingFigure 1B~1E
  • EP4389025B1 patent drawingFigure 1F~1H

AI summary

In some embodiments, a medical instrument includes a flexible sheath configured to pass through the femoral artery, an inner catheter (720) at least partially disposed within the sheath and rotatable relative thereto, the inner catheter has a deflectable section, a pair of opposing jaws (730a,b) coupled to the inner catheter, the pair of opposing jaws having an open condition and a closed condition, and a cutting mechanism (740) disposed adjacent to at least one of the pair of opposing jaws.