Epicardial LAA Occlusion via Inflatable Cuff and Steerable Catheter

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Solution Overview

Problem

Conventional devices for occluding the left atrial appendage (LAA) are difficult to precisely position at the base, resulting in incomplete occlusion and lack repositioning and adjustment capabilities, which can lead to ineffective closure and increased risks of thrombo-embolic events.

Innovation Solution

A steerable catheter-based device with a detachable implant and adjustable clamp mechanism that allows for epicardial occlusion of the LAA, enabling precise positioning and repositioning of the implant at the base of the LAA, using a combination of a grasping device and an inflatable cuff for secure closure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional LAA closure devices are used, then the procedure can be performed with simpler devices, but the positioning precision at the LAA base is insufficient resulting in incomplete occlusion

Engineering Contradiction:

Improvepositioning precisionVSAvoiddevice complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The device is divided into multiple functional segments: a delivery catheter for navigation, a clamp mechanism for grasping and positioning, an inflatable cuff for occlusion, and a detachable implant portion. This segmentation allows each component to be optimized for its specific function while maintaining overall device manageability during the procedure

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The implant portion and inflatable cuff are nested within the delivery catheter in a collapsed state, allowing them to be delivered through the catheter to the LAA base. The clamp mechanism is also integrated within the delivery system, enabling sequential deployment of components in a controlled manner to achieve precise positioning

Inventive Principle:

Principle #7Nested doll (Nesting)

2Adaptability or versatility

If conventional closure devices are used, then the device structure is simpler, but the repositioning and adjustment capabilities are lacking leading to ineffective closure

Engineering Contradiction:

Improverepositioning capabilityVSAvoiddevice complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The clamp mechanism is designed to be dynamically adjustable, allowing the operator to open and close the clamp to release or secure the implant portion. The inflatable cuff can be inflated to varying degrees and deflated for repositioning, providing dynamic adaptability during the procedure to ensure effective occlusion

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The delivery catheter serves as an intermediary that facilitates the deployment and initial positioning of the implant portion and inflatable cuff. The clamp mechanism acts as an intermediary tool that enables controlled release and repositioning of the implant, providing mechanical advantage and precision control during the procedure

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If open chest surgery is performed for LAA occlusion, then complete occlusion can be achieved, but the invasiveness and surgical complexity increase

Engineering Contradiction:

Improveocclusion effectivenessVSAvoidsurgical invasiveness

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device replaces open surgical mechanical closure methods with a percutaneous delivery system. The inflatable cuff provides reliable occlusion through pneumatic pressure rather than mechanical suturing or clipping, achieving effective LAA closure while avoiding the need for open chest surgery and reducing surgical invasiveness

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The inflatable cuff utilizes pneumatic pressure to occlude the LAA base. By inflating the cuff with fluid or gas, the device achieves reliable and complete occlusion of the LAA, providing a non-surgical alternative that maintains occlusion effectiveness while minimizing surgical invasiveness and associated risks

Inventive Principle:

Principle #29Pneumatics and hydraulics

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

Facilitates complete occlusion of the LAA, preventing blood clots from forming and embolizing, thereby reducing the risk of stroke and other vascular complications, while allowing for minimally invasive procedures without the need for open chest surgery.

Implementation Method 1

an inflatable cuff for secure closure

Methodology Applied

Scientific EffectInflation:

Data Source

PatentUS10660649B2System for occlusion of left atrial appendage

Publication Date: 2020.05.26 NIV

AI summary

A device for occluding an atrial appendage includes a catheter-deliverable epicardial implant that is detachably secured to a delivery device. The implant includes an inflatable cuff that is positionable about the atrial appendage to an extent that, when adjustably inflated, the cuff physiologically occludes the atrial appendage. Such occlusion addresses health risks associated with atrial fibrillation and cardiac rhythm disorder.