Septal Closure Device with Radially Expandable Center

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Solution Overview

Problem

Existing septal closure devices face challenges in adapting to different defect geometries, often resulting in insecure seating, thrombus formation, and inconsistent performance due to complex manufacturing processes, which can lead to leaks and inadequate occlusion.

Innovation Solution

A tubular occluder device with radially expandable center and side portions, featuring axially extending slits that form struts and loops upon deployment, providing a self-centering mechanism to securely occlude apertures in the septum and prevent leaks, made from materials like metals, shape memory alloys, or polymers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If existing septal closure devices are used to adapt to different defect geometries, then the device can be deployed in various aperture shapes, but the device results in insecure seating and inconsistent performance

Engineering Contradiction:

Improveadaptability to different defect geometriesVSAvoidseating security and performance consistency

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The occluder device features a center portion with distinct physical properties (radially expandable, self-centering mechanism) that differ from the side portions. This local quality differentiation allows the center portion to specifically address centering requirements while the side portions provide secure anchoring, resolving the contradiction between adaptability and seating security.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The occluder is divided into distinct segments: a center portion and side portions, each with specific functions. The center portion handles centering and positioning, while the side portions handle anchoring and occlusion. This segmentation allows each part to optimize its function, improving both adaptability and reliability simultaneously.

Inventive Principle:

Principle #1Segmentation

2Manufacturing precision

If complex manufacturing processes are used to create septal closure devices, then the device can achieve precise geometries, but the process leads to inconsistent performance and leaks

Engineering Contradiction:

Improvegeometric precision of the deviceVSAvoidperformance consistency and leak prevention

Core Design Contradiction:

Manufacturing precisionVSReliability

Solution Approach 1:

The center portion of the occluder incorporates a self-centering mechanism that automatically positions the device within the aperture during deployment. This self-service feature compensates for manufacturing variations and ensures consistent performance without requiring complex manufacturing processes, thereby resolving the contradiction between manufacturing precision and reliability.

Inventive Principle:

Principle #25Self-service

3Reliability

If the device is designed with a self-centering mechanism, then the device can securely occlude apertures and prevent leaks, but the device structure becomes more complex

Engineering Contradiction:

Improveocclusion security and leak preventionVSAvoidstructural complexity of the occluder

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The self-centering capability is localized to the center portion of the occluder rather than being distributed throughout the entire device. This concentrated approach achieves the desired reliability while minimizing overall device complexity, as only a specific region requires the self-centering mechanism.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The occluder is segmented into a center portion with self-centering functionality and side portions with anchoring functionality. This segmentation allows the self-centering mechanism to be implemented in a focused manner, reducing overall device complexity while maintaining high reliability for occlusion and leak prevention.

Inventive Principle:

Principle #1Segmentation

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

The device ensures secure and consistent occlusion of septal defects by self-centering within the aperture, preventing leaks and accommodating anatomical variability, thus improving the reliability of septal closure procedures.

Implementation Method 1

a radially expandable center portion

Methodology Applied

Scientific EffectRadial expansion:

Implementation Method 2

featuring axially extending slits that form struts and loops upon deployment

Methodology Applied

Scientific EffectShape transformation:

Data Source

PatentUS20240358361A1Septal closure device with centering mechanism

Publication Date: 2024.10.31 WL GORE & ASSOC INC

AI summary

In one aspect, the present invention provides a device for occluding an aperture in a body, for example, a patent foramen ovale (PFO), including a first side adapted to be disposed on one side of the septum and a second side adapted to be disposed on the opposite side of the septum. The device has an elongated, low-profile delivery configuration and a shortened, radially expanded deployment configuration. The first and second sides are adapted to occlude the aperture upon deployment of the device at its intended delivery location. The device also includes a radially expandable center portion. In some embodiments, the center portion includes a plurality of ribs provided by slits in device. The ribs expand radially when the device is deployed. The expandable center portion facilitates the positioning of the device in the aperture. The device can be secured in the deployed configuration using a catch system.