Flanged Occlusion Device Resisting Dislodgement

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Solution Overview

Problem

Existing occlusion devices are not well-suited for occluding the left atrial appendage to prevent embolisms during atrial fibrillation, as they may be dislodged by forces generated during the condition, and surgical occlusion is not always feasible or advisable.

Innovation Solution

The development of implantable occlusion devices with flanges that include concave surfaces to resist dislocation, manufactured from porous materials like braided strands that can collect thrombi and expand for secure placement within the left atrial appendage, using shape memory materials for deployment via catheters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional occlusion devices are used to occlude the left atrial appendage, then occlusion of the vessel is achieved, but the device may be dislodged by forces generated during atrial fibrillation

Engineering Contradiction:

Improvedevice retentionVSAvoiddislodgement force

Core Design Contradiction:

ReliabilityVSForce

Solution Approach 1:

The flange incorporates a concave surface that conforms to the curved geometry of the left atrial appendage ostium, creating a geometric interlock that resists dislodgement forces. The concave curvature allows the flange to nestle into the anatomical structure, transforming the device from a flat disc into a three-dimensional form that mechanically engages with the tissue geometry.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

The flange design features asymmetric geometry with a concave surface on one side and a convex outer surface on the other, creating a non-uniform structure that optimizes retention in specific anatomical orientations. This asymmetric configuration allows the device to engage differently with tissue on opposing sides, enhancing resistance to bidirectional dislodgement forces during atrial fibrillation.

Inventive Principle:

Principle #4Asymmetry

2Reliability

If surgical techniques are used for occlusion of the left atrial appendage, then secure occlusion is achieved, but the procedure is not always feasible or advisable

Engineering Contradiction:

Improveocclusion securityVSAvoidprocedure applicability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The device replaces complex surgical mechanical procedures with a minimally invasive percutaneous delivery system. The occlusion device is delivered through a catheter that is inserted through a vein and navigated to the left atrial appendage, eliminating the need for open chest surgery while achieving secure occlusion through the flanged design.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The occlusion device is designed to be nested within a delivery catheter in a compressed state, allowing it to pass through small vascular access points. Upon deployment, the device expands from its compact nested configuration to its full functional size with the flange extended, enabling secure occlusion without requiring large surgical incisions.

Inventive Principle:

Principle #7Nested doll (Nesting)

3Reliability

If flanges with concave surfaces are added to resist dislocation, then device retention is improved, but device complexity increases

Engineering Contradiction:

Improvedevice retentionVSAvoidflange structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The flange is integrated as a single unified structure with the disc body, formed from the same porous material without requiring separate components or additional attachment mechanisms. This merging of the flange and disc into one monolithic structure achieves the retention function while minimizing the increase in device complexity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The flange and disc are manufactured as a single piece from porous material, which provides both structural integrity and thrombi collection capability. The porous structure serves dual functions: maintaining mechanical strength for retention and enabling thrombus accumulation for occlusion, thereby achieving enhanced retention without proportionally increasing complexity.

Inventive Principle:

Principle #31Porous materials

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 devices effectively resist dislocation during atrial fibrillation and securely occlude the left atrial appendage, reducing the risk of embolisms by maintaining placement and promoting thrombi formation for occlusion.

Implementation Method 1

using shape memory materials for deployment via catheters

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentUS9743932B2Flanged occlusion devices and methods

Publication Date: 2017.08.29 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

Implantable occlusion devices that include one or more flanges extending from a tubular body are disclosed. The flange or flanges may assist in retention of the device within a vessel, cavity, appendage, etc. At least one flange on the occlusion device may include a concave surface proximate one end of a body. Because of the shape of the flange, e.g., its concavity, the occlusion device may resist dislocation due to e.g., the forces generated within the left atrial appendage during atrial fibrillation.