Left Atrial Appendage Closure With Sensor-Guided Thrombus Blocking

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Solution Overview

Problem

Existing medical devices for closing the left atrial appendage in patients with atrial fibrillation are inadequate in preventing thrombi formation and migration, leading to stroke or heart attack risks.

Innovation Solution

A medical system comprising a left atrial appendage closure device with an expandable framework, a proximal hub, and a sensor, which shifts between configurations, and a core wire for deployment, featuring a threaded connection mechanism to securely engage and disengage the device, along with an occlusive element to prevent thrombi passage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing medical devices are deployed to close off the left atrial appendage, then thrombi formation and migration risks are reduced, but the devices fail to effectively prevent thrombi formation and migration, leading to stroke or heart attack risks

Engineering Contradiction:

Improveeffectiveness in preventing thrombi formation and migrationVSAvoidthrombi formation and migration

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The closure device is divided into multiple functional components: an expandable framework for structural support and anchoring, an occlusive element for blocking thrombi passage, and a sensor system for monitoring. This segmentation allows each component to optimize its specific function while working together to reliably prevent thrombi formation and migration.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The sensor acts as an intermediary between the closure device and the clinical system, providing real-time monitoring data that enables detection and measurement of thrombi formation and migration risks, allowing for timely intervention and improved reliability of the overall system.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If the expandable framework is deployed to occlude the left atrial appendage, then thrombi passage is prevented, but tissue damage may occur

Engineering Contradiction:

Improveocclusion effectivenessVSAvoidtissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The occlusive element is designed as a flexible component that can conform to the contours of the left atrial appendage opening, providing effective occlusion while minimizing mechanical stress and tissue damage. The flexibility allows the element to adapt to anatomical variations without causing excessive trauma to surrounding tissues.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The expandable framework utilizes controlled expansion parameters to transition from a compressed delivery state to an expanded occlusion state. By carefully controlling expansion parameters such as radial force and contact pressure, the device achieves reliable occlusion while minimizing tissue damage through gradual and controlled deployment.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If the threaded connection mechanism is used to securely engage the device, then deployment reliability is improved, but device complexity increases

Engineering Contradiction:

Improvedeployment reliabilityVSAvoidconnection mechanism complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The threaded connection mechanism is designed to be self-aligning and self-locking, where the geometry of the threads automatically ensures proper engagement and maintains secure attachment. This self-service capability improves deployment reliability by eliminating the need for complex alignment procedures or additional locking mechanisms, thereby reducing overall device complexity.

Inventive Principle:

Principle #25Self-service

4Difficulty of detecting and measuring

If the sensor is integrated within the expandable framework, then monitoring capability is enhanced, but manufacturing complexity increases

Engineering Contradiction:

Improvethrombi detection capabilityVSAvoidsensor integration manufacturing

Core Design Contradiction:

Difficulty of detecting and measuringVSEase of manufacture

Solution Approach 1:

The sensor is nested within the expandable framework structure, utilizing the existing framework geometry to house and position the sensor. This nesting approach enhances monitoring capability by providing close proximity to the occlusion site for accurate thrombi detection, while simplifying manufacturing by leveraging the framework's existing structural elements rather than requiring separate complex sensor mounting procedures.

Inventive Principle:

Principle #7Nested doll (Nesting)

Data Source

PatentUS20260033839A1Medical system for treating a left atrial appendage

Publication Date: 2026.02.05 BOSTON SCIENTIFIC SCIMED INC

AI summary

A medical system may include a left atrial appendage closure device including an expandable framework and a proximal hub disposed along a central longitudinal axis of the expandable framework, the expandable framework being configured to shift between a collapsed delivery configuration and an expanded deployed configuration; wherein the left atrial appendage closure device includes a sensor at least partially disposed within an interior of the expandable framework and axially movable relative to the proximal hub; wherein the proximal hub includes a first threaded connection structure; and a delivery catheter including a core wire extending axially within a lumen of the delivery catheter, the core wire having a second threaded connection structure at a distal end thereof configured to releasably engage the first threaded connection structure in an unreleased configuration and the second threaded connection structure is disengaged from the first threaded connection structure in a released configuration.