Segmented Expansion Device for Vascular Perfusion

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Solution Overview

Problem

Existing heart valve treatment methods, such as balloon valvuloplasty and transcatheter heart valve delivery, face challenges with blood flow occlusion during the expansion of prosthetic devices, which can lead to complications and require rapid pacing of the heart, limiting deployment time and increasing risks.

Innovation Solution

The development of expansion devices with a system that includes an elongate shaft and an expandable member, featuring an inner and outer expandable structure, allowing for independent expansion and perfusion lumens to maintain blood flow, reducing occlusion and enabling longer deployment times without the need for rapid heart pacing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a balloon member is expanded within a native valve or other vascular passageway to treat heart valve disease, then the opening size and blood flow through the valve are improved, but blood flow is temporarily blocked or restricted through the passageway

Engineering Contradiction:

Improveblood flow through valveVSAvoidblood flow occlusion

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The expansion device is divided into multiple segments including an inner expandable member and multiple outer expandable members that can be expanded independently or sequentially. This segmentation allows different portions of the device to perform different functions: the inner member expands the valve opening while the outer members are positioned to allow blood flow through gaps between them, thus resolving the contradiction between improving valve flow and preventing passageway occlusion

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The outer expandable members act as intermediaries between the inner expandable member and the surrounding tissue. These outer members are configured with gaps or openings that allow blood to flow through them, serving as a mediator that enables the expansion function while maintaining blood flow pathways, thus resolving the occlusion problem

Inventive Principle:

Principle #24Intermediary (Mediator)

2Manufacturing precision

If the balloon member is inflated for an extended period to allow proper positioning and deployment, then deployment accuracy is improved, but serious injury or death can occur due to prolonged blood flow blockage

Engineering Contradiction:

Improvedeployment positioning accuracyVSAvoidpatient safety

Core Design Contradiction:

Manufacturing precisionVSReliability

Solution Approach 1:

The device is segmented into independently controllable expandable members that can be expanded in a controlled sequence. The inner member can be expanded first for positioning, followed by the outer members, allowing extended deployment time without complete occlusion since the outer members have flow-permissive gaps

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The outer expandable members are designed with gaps that maintain continuous blood flow through the passageway even when the device is fully expanded. This continuity of useful action (blood flow) persists throughout the entire deployment process, eliminating the harmful interruption that would otherwise limit deployment time

Inventive Principle:

Principle #20Continuity of useful action

3Device complexity

If a single expandable member is used to simplify the device structure, then device complexity is reduced, but the ability to control expansion independently and maintain blood flow is compromised

Engineering Contradiction:

Improveexpansion device structureVSAvoidindependent expansion control

Core Design Contradiction:

Device complexityVSAdaptability or versatility

Solution Approach 1:

The expansion device is divided into an inner expandable member and multiple outer expandable members, each capable of independent expansion. This segmentation provides adaptability and versatility in controlling the expansion process, allowing the operator to expand different portions at different times to optimize positioning and maintain blood flow

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The outer expandable members are nested around the inner expandable member, creating a compact structure when collapsed that simplifies delivery. When deployed, the nested configuration allows independent expansion control while maintaining a relatively simple overall device architecture, thus resolving the contradiction between complexity and adaptability

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS9707078B2Expansion device and method for treating vascular passageways

Publication Date: 2017.07.18 EDWARDS LIFESCIENCES CORP

AI summary

Method for delivering an expandable member to a treatment location includes an elongate shaft and an expandable member coupled to a distal end of the elongate shaft. Embodiments of the expandable member are moveable between a collapsed configuration and an expanded configuration, and have an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member, and are suitable for delivering prosthetic heart valves and performing vavuloplasties.