Deflectable Electrosurgical Wire for Precise Valve Leaflet Laceration

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Solution Overview

Problem

Existing procedures for lacerating heart valve leaflets, such as the BASILICA procedure, are complex, technically challenging, and require multiple operators, posing a risk of coronary obstruction during transcatheter aortic valve replacement.

Innovation Solution

An electrosurgical leaflet laceration device with a deflectable catheter shaft and an electrosurgical wire, which transitions between delivery and deflected configurations to lacerate valve leaflets using an energized cutting segment, facilitated by a handle and actuator to control tension on the wire.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the BASILICA procedure is used to lacerate valve leaflets, then coronary obstruction risk is reduced, but the procedure becomes complex and requires multiple operators

Engineering Contradiction:

Improvecoronary obstruction preventionVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the guidewire function and electrosurgical cutting function into a single integrated device. The electrosurgical wire serves both as a guidewire for navigation and as the cutting element, eliminating the need for separate guidewire manipulation steps and reducing procedural complexity while maintaining coronary obstruction prevention

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The electrosurgical wire performs multiple functions: it acts as a guidewire for catheter navigation, serves as the cutting element for leaflet laceration, and provides electrosurgical energy delivery. This multi-functionality reduces the number of operators needed and simplifies the overall procedure while ensuring reliable coronary obstruction prevention

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If the BASILICA procedure is used to lacerate valve leaflets, then coronary obstruction risk is reduced, but the procedure becomes lengthy and technically challenging

Engineering Contradiction:

Improvecoronary obstruction preventionVSAvoidprocedure duration

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The electrosurgical wire is pre-positioned and integrated into the delivery catheter system before reaching the target site. The wire is already in place and ready for activation, eliminating the need for separate guidewire manipulation and positioning steps that lengthen the BASILICA procedure

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

By merging the guidewire and cutting wire into a single electrosurgical wire, the patent eliminates multiple sequential steps (guidewire insertion, wire manipulation, externalization) required in the BASILICA procedure, significantly reducing procedure duration while maintaining the same safety outcome

Inventive Principle:

Principle #5Merging (Combining)

3Measurement precision

If a deflectable catheter shaft is used, then precise wire exposure is achieved, but device complexity increases

Engineering Contradiction:

Improvewire exposure precisionVSAvoidcatheter structure complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The catheter shaft incorporates a deflection mechanism that allows dynamic adjustment of the shaft angle. This enables precise positioning of the electrosurgical wire exposure site at the valve leaflet while maintaining a relatively simple catheter structure that can be controlled from the proximal end

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The deflection is localized to a specific section of the catheter shaft, allowing precise wire exposure at the target site without requiring the entire catheter structure to be complex. The deflection zone is concentrated at the distal end where it is most needed for accurate leaflet engagement

Inventive Principle:

Principle #3Local quality

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

Facilitates precise and efficient laceration of valve leaflets, reducing the risk of coronary obstruction and simplifying the procedure, potentially requiring fewer operators.

Implementation Method 1

The cutting segment of the electrosurgical wire is configured to be energized to heat the cutting segment to a temperature sufficient to cut tissue abutting or in contact with the cutting segment

Methodology Applied

Scientific EffectJoule heating: Joule Heating

Implementation Method 2

the catheter shaft is configured to bend or deflect at the deflection zone portion to transition the electrosurgical leaflet laceration device from the delivery configuration to the deflected configuration

Methodology Applied

Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS20250331917A1Electrosurgical leaflet laceration device

Publication Date: 2025.10.30 MEDTRONIC INC

AI summary

An electrosurgical leaflet laceration device is configured to transition from a delivery configuration to a deflected configuration. The electrosurgical leaflet laceration device includes a handle, a catheter shaft extending distally from the handle and including an electrosurgical wire lumen and a side opening, and an electrosurgical wire disposed within the electrosurgical wire lumen of the catheter shaft. The side opening of the catheter shaft is configured to expose a cutting segment of the electrosurgical wire with the electrosurgical leaflet laceration device in the deflected configuration. The cutting segment of the electrosurgical wire is configured to be energized cut tissue abutting or in contact with the cutting segment.