Percutaneous Heart Valve Cutting Device with Centralizing Wires

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Solution Overview

Problem

Traditional valve replacement surgery for aortic stenosis is not suitable for patients with higher surgical risk factors, necessitating alternative treatments to improve their lifestyle without the invasiveness of open heart surgery.

Innovation Solution

A percutaneously-deployable cutting device with a delivery catheter and cutting unit, comprising cutting wires and centralizing wires, is used to repair heart valves by cutting through stenosis, separating leaflets, and reestablishing normal function without open surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional valve replacement surgery is performed, then valve function is restored, but patient surgical risk increases due to invasiveness

Engineering Contradiction:

Improvevalve function restorationVSAvoidsurgical risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical system with a percutaneous catheter-based system. The cutting device is delivered through a catheter inserted via peripheral access, eliminating the need for sternotomy and cardiopulmonary bypass, thus reducing surgical risk while restoring valve function

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The cutting device utilizes a flexible catheter shaft that can navigate through the vascular system to reach the heart valve. The flexible delivery catheter allows percutaneous access without requiring open surgical incisions, reducing trauma and surgical risk

Inventive Principle:

Principle #30Flexible shells and thin films

2Productivity

If a cutting device is deployed to repair the valve, then stenosis is removed and blood flow improves, but device complexity increases

Engineering Contradiction:

Improveblood flow restorationVSAvoidcutting device structure

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The cutting device is divided into functional segments: a delivery catheter for access, a cutting unit with multiple cutting wires for stenosis removal, and centralizing wires for positioning. This segmentation allows each component to perform its specific function efficiently while being deliverable through a relatively simple catheter

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The cutting unit with cutting wires and centralizing wires is nested within the delivery catheter in a compressed state for delivery. Upon deployment, the cutting unit expands from the catheter to perform the cutting function, then can be withdrawn while maintaining centralizing wire expansion to preserve vessel patency

Inventive Principle:

Principle #7Nested doll (Nesting)

3Productivity

If cutting wires are used to remove stenosis, then valve function is improved, but risk of vessel damage increases

Engineering Contradiction:

Improvestenosis removal efficiencyVSAvoidvessel damage risk

Core Design Contradiction:

ProductivityVSObject-generated harmful factors

Solution Approach 1:

The centralizing wires act as intermediaries between the cutting wires and the vessel wall. They maintain the cutting unit in a centered position within the vessel lumen, preventing the cutting wires from contacting and damaging the vessel wall while still allowing effective cutting of the stenosis

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The centralizing wires are deployed simultaneously with or before the cutting wires to establish a protective framework that prevents cutting wires from deviating and damaging the vessel wall during the cutting process

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentUS9364255B2Medical cutting devices and methods of use

Publication Date: 2016.06.14 BOSTON SCIENTIFIC SCIMED INC

AI summary

A cutting device for repairing a heart valve may include a delivery catheter, a cutting unit including an elongate shaft and a plurality of cutting wires, and a plurality of centralizing wires configured to center the cutting unit within a treatment site. A method of repairing a heart valve may include withdrawing a cutting unit through a treatment site while maintaining a plurality centralizing wires in an expanded centering configuration.