Stiffener Wire Occluding PFO Device

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Solution Overview

Problem

Current medical devices for occluding PFOs face challenges in deploying through a lower profile catheter, achieving accurate placement with minimal distortion of the PFO flap, providing improved clamping force for a secure seal, and minimizing tissue abrasion while allowing selective clamping force adjustment.

Innovation Solution

A medical device featuring a tubular structure with braided material and a stiffener wire, configured to expand from a reduced delivery configuration to a preset configuration at the target site, with non-coaxial end sections and a shape memory material to ensure secure fixation and minimal distortion, along with a softer tubular structure to reduce tissue abrasion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If an elastic elongated central member is used to connect and urge disk members toward each other, then the device allows for variation in tunnel length and eccentricity of openings, but the clamping force is applied in line with the tunnel causing distortion of the PFO flap

Engineering Contradiction:

Improvevariation in tunnel length and eccentricityVSAvoiddistortion of PFO flap

Core Design Contradiction:

Adaptability or versatilityVSShape

Solution Approach 1:

The device divides the clamping function into two independent components: the elastic central member provides adaptability to tunnel variations, while the stiffener wire provides perpendicular clamping force to prevent flap distortion. This segmentation allows each component to optimize its specific function without compromising the other.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The stiffener wire acts as an intermediary element that transfers clamping force perpendicular to the disk members, rather than applying force along the tunnel axis. This intermediary mechanism redirects the clamping force to achieve the desired sealing effect without distorting the PFO flap.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Force

If a stiffer material is used to provide adequate clamping force, then the sealing effectiveness is improved, but the tissue abrasion increases

Engineering Contradiction:

Improveclamping forceVSAvoidtissue abrasion

Core Design Contradiction:

ForceVSObject-affected harmful factors

Solution Approach 1:

The device applies different material properties to different components: the stiffener wire uses stiffer material to provide adequate clamping force, while the disk members use softer material to minimize tissue abrasion. This local differentiation of material quality allows each component to optimize its specific function.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The device combines materials with different mechanical properties in a single system - stiffer material in the stiffener wire for structural support and clamping force, and softer material in the disk members for tissue contact. This composite material approach resolves the contradiction between clamping force and tissue protection.

Inventive Principle:

Principle #40Composite materials

3Ease of operation

If the device is designed with a lower profile for catheter delivery, then the ease of delivery is improved, but the ability to provide adequate clamping force is reduced

Engineering Contradiction:

Improveease of delivery through catheterVSAvoidclamping force

Core Design Contradiction:

Ease of operationVSForce

Solution Approach 1:

The stiffener wire is nested within or integrated with the elastic central member, allowing both components to be delivered through the catheter in a compact configuration. Upon deployment, the stiffener wire extends or activates to provide the necessary clamping force, thus achieving both easy delivery and adequate sealing 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 rapid and effective occlusion of PFOs with improved clamping force, reduced distortion, and minimized tissue abrasion, facilitating easier deployment and placement through smaller catheters, while maintaining adequate sealing and fixation.

Implementation Method 1

The tubular structure and stiffener wire include respective preset, expanded configurations and are configured to be constrained to respective reduced configurations for delivery to the target site and to at least partially return to their respective preset, expanded configurations at the target site when unconstrained

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Implementation Method 2

at least one layer of braided material configured to facilitate thrombosis

Methodology Applied

Scientific EffectThrombosis: Coagulation

Data Source

PatentUS10702275B2Medical device with stiffener wire for occluding vascular defects

Publication Date: 2020.07.07 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

One exemplary device includes a tubular structure having proximal and distal ends and at least one layer of braided material configured to facilitate thrombosis. The tubular structure includes an end section at the proximal or distal end having a cross-sectional dimension that is larger than that of an opening of the target site. The device also includes a stiffener wire coupled to the tubular structure, and the wire is configured to extend at least partially through the opening and facilitate securing the end section over the opening. The tubular structure and stiffener wire include respective preset, expanded configurations and are configured to be constrained to respective reduced configurations for delivery to the target site and to at least partially return to their respective preset, expanded configurations at the target site when unconstrained.